實 證 期 刊 閱 讀 報 告 ebm-style journal reading

26
實 實 實 實 實 實 實 實 EBM-style Journal Reading 報報報PGY 報報 Email:[email protected] 報報報報報報 報報報報報 / 報報報報報 報報2009/10/29 報報 報報報 :一 82 報報報

Upload: emory

Post on 10-Jan-2016

97 views

Category:

Documents


3 download

DESCRIPTION

實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading. 報告人: PGY 夏紹剛 Email:[email protected] 指導臨床教師:何昌益醫師 / 謝堯棚醫師 日期: 2009/10/29 地點:一般內科 82 討論室. Clinical Scenario (臨床情境). 個案為 73 歲已婚男性,有高血壓及糖尿病病史,右腳糖尿病足於 97 年 9 月接受高壓氧治療後痊癒,本次因雙足潰瘍已兩週入院,診斷為糖尿病足,右足壞疽嚴重經外科清瘡治療後,外科醫師建議 植皮 以加速復原,病人僅希望再次進行 高壓氧治療 不願植皮。􀇻. - PowerPoint PPT Presentation

TRANSCRIPT

Page 1: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

實 證 期 刊 閱 讀 報 告EBM-style Journal Reading

報告人 PGY 夏紹剛 Email143920cchorgtw

指導臨床教師何昌益醫師 謝堯棚醫師日期 20091029

地點一般內科 82 討論室

2

Clinical Scenario (臨床情境)個案為 73 歲已婚男性有高血壓及糖尿病病史右腳糖尿病足於 97 年 9 月接受高壓氧治療後痊癒本次因雙足潰瘍已兩週入院診斷為糖尿病足右足壞疽嚴重經外科清瘡治療後外科醫師建議植皮以加速復原病人僅希望再次進行高壓氧治療不願植皮1049083

3

Clinical Uncertainty rarr PICO 問題

對於糖尿病足部潰瘍患者單純接受高壓氧治療相較於植皮是否仍有理想的復原能力

4

臨床個案的 PICO

Patient ProblemPatient who has Type 2 DM with foot ulcers

(foot ulcer or diabetic foot)

InterventionHBO OR hyperbaric oxygenation

Comparisonskin graft or skin transplantation

Outcome enhance the wound healing

Type of Question Therpy

5

Search Terms amp Strategy (搜尋關鍵字與策略)

資料庫 Pubmed搜尋日期 20091023搜尋關鍵字與隅策略

如圖表

6

Best available evidence(挑選可獲得之最佳研究證據)

Citations

A systematic review of the effectiveness of interventions to enhance the healing of chronic ulcers of the foot in diabetes(2008)

Lead authors name

RJHinchliffe GDValk JApelqvist DGArmstrong KBakker FLGame AHartemann-Heurtier MLondahl PEPrice WHvan HoutumW JJeffcoate

7

The Study (研究效度) - 1 Prospective and retrospective controlled studies

published in any language that evaluated interventions for the treatment of chronic foot ulcers in people aged 18 years or older with either type 1 or type 2 diabetes mellitus were considered

Randomized controlled trials (RCTs) case-control studies prospective and retrospective cohort studies control before-and-after (CBA) design and interrupted time series (ITS) designs were included

MEDLINE (1966 - 2006)EMBASE(1980 - 2006)

The Cochrane database of systematic reviews and the Cochrane Central Controlled Trials Register (2006)

8

The Study (研究效度) - 2 One reviewer assessed all identified references by

title and abstract on the basis of patient group intervention and outcome

Full paper copies of identified articles were then assessed for eligibility by two independent reviewers (agreement was reached)

Each included paper was further assessed by two reviewers working independently and information was extracted on study design patient group intervention outcomes duration of and loss to followup using standard data extraction sheets

9

The Study (研究效度) - 3 Each study was scored for methodological

quality using designspecific scoring based on checklists developed by the Dutch Cochrane Center(RCT score1-9)

The SIGN instrument (1) RCTs and (2) studies with case-control cohort CBA or ITS design Studies were also rated as ++ (high quality with low risk of bias) + (well conducted with low risk of bias) and ndash (low quality with higher risk of bias)

10

The Study (研究效度) - 5

HBO therapy 6 篇 RCT(114 studies identified ) Bioengineered skin and skin grafts 6 篇 RCT(72

papers identified)

Level of Evidence 1A(SR of RCTs)

11

The Study (研究效度) - 6本篇文獻的 PICO (T)

Patient Problem

chronic foot ulcers in people aged 18 years or older with either type 1 or type 2 diabetes Mellitus

Intervention

Dressings Debridement Bioengineered skin and skin grafts Electromagnetic laser and ultrasound Stem cell therapy Abnormalities of wound biology and gene therapy Reduction of tissue oedema Hyperbaric oxygen Resection of the chronic woundsurgical procedures

Comparison

OutcomeThe healing of chronic ulcer ulcer area amputation rate

Time 3 months ndash 1 years

12

The Evidence (研究重要結果) - 1

Topical HBO inclusion of the affected foot into a sealed chamber containing hyperbaric oxygen (HBO)

Systemic HBO the patient spending prolonged periods of time in a large HBO chamber

13

The Evidence (研究重要結果) - 2

HBO-1

14

The Evidence (研究重要結果) - 3

HBO-2

15

The Evidence (研究重要結果) - 4

Bioengineered skin and skin grafts-1

16

The Evidence (研究重要結果) - 5

Bioengineered skin and skin grafts-2

17

Comment amp Discussion -1 Systemic HBO may reduce the incidence

of major amputation While further evidence of effectiveness and cost-effectiveness is required from larger more robust and blinded studies

The benefit of topically administered HBO is not established

18

Comment amp Discussion -2 Bioengineered skin products and skin grafts

are widely used in some areas but their benefit has not been clearly established

Many clinicians will reserve the use of these relatively expensive treatments for ulcers that fail to respond to simpler approaches and yet bioengineered skin products have not been evaluated in such populations

19

Comment amp Discussion -3 本篇 review針對高壓氧植皮等各種糖尿病足部潰瘍

之治療方法進行探討關鍵字及搜尋範圍拉到十分大故各種療法皆有許多篇 paper被 identified(高壓氧114 篇植皮 72 篇 ) 但最後對此兩種療法僅各評值 6篇 RCT雖應可推論這幾篇為證據等級較高之 paper但評值的文章數或許過少而無法充分代表其療法之療效結論

關於自體植皮方面僅有一篇文章被選出並且是兩種植皮方法的比較故未針對植皮本身之療效進行評值而結論提出植皮的益處仍未清楚確立或許是因以其篩選之方法目前關於植皮療效之文章之嚴謹程度仍未達其篩選標準(文章中僅聲稱 Reduction of tissue oedema Hyperbaric oxygen Resection 有療效)

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 2: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

2

Clinical Scenario (臨床情境)個案為 73 歲已婚男性有高血壓及糖尿病病史右腳糖尿病足於 97 年 9 月接受高壓氧治療後痊癒本次因雙足潰瘍已兩週入院診斷為糖尿病足右足壞疽嚴重經外科清瘡治療後外科醫師建議植皮以加速復原病人僅希望再次進行高壓氧治療不願植皮1049083

3

Clinical Uncertainty rarr PICO 問題

對於糖尿病足部潰瘍患者單純接受高壓氧治療相較於植皮是否仍有理想的復原能力

4

臨床個案的 PICO

Patient ProblemPatient who has Type 2 DM with foot ulcers

(foot ulcer or diabetic foot)

InterventionHBO OR hyperbaric oxygenation

Comparisonskin graft or skin transplantation

Outcome enhance the wound healing

Type of Question Therpy

5

Search Terms amp Strategy (搜尋關鍵字與策略)

資料庫 Pubmed搜尋日期 20091023搜尋關鍵字與隅策略

如圖表

6

Best available evidence(挑選可獲得之最佳研究證據)

Citations

A systematic review of the effectiveness of interventions to enhance the healing of chronic ulcers of the foot in diabetes(2008)

Lead authors name

RJHinchliffe GDValk JApelqvist DGArmstrong KBakker FLGame AHartemann-Heurtier MLondahl PEPrice WHvan HoutumW JJeffcoate

7

The Study (研究效度) - 1 Prospective and retrospective controlled studies

published in any language that evaluated interventions for the treatment of chronic foot ulcers in people aged 18 years or older with either type 1 or type 2 diabetes mellitus were considered

Randomized controlled trials (RCTs) case-control studies prospective and retrospective cohort studies control before-and-after (CBA) design and interrupted time series (ITS) designs were included

MEDLINE (1966 - 2006)EMBASE(1980 - 2006)

The Cochrane database of systematic reviews and the Cochrane Central Controlled Trials Register (2006)

8

The Study (研究效度) - 2 One reviewer assessed all identified references by

title and abstract on the basis of patient group intervention and outcome

Full paper copies of identified articles were then assessed for eligibility by two independent reviewers (agreement was reached)

Each included paper was further assessed by two reviewers working independently and information was extracted on study design patient group intervention outcomes duration of and loss to followup using standard data extraction sheets

9

The Study (研究效度) - 3 Each study was scored for methodological

quality using designspecific scoring based on checklists developed by the Dutch Cochrane Center(RCT score1-9)

The SIGN instrument (1) RCTs and (2) studies with case-control cohort CBA or ITS design Studies were also rated as ++ (high quality with low risk of bias) + (well conducted with low risk of bias) and ndash (low quality with higher risk of bias)

10

The Study (研究效度) - 5

HBO therapy 6 篇 RCT(114 studies identified ) Bioengineered skin and skin grafts 6 篇 RCT(72

papers identified)

Level of Evidence 1A(SR of RCTs)

11

The Study (研究效度) - 6本篇文獻的 PICO (T)

Patient Problem

chronic foot ulcers in people aged 18 years or older with either type 1 or type 2 diabetes Mellitus

Intervention

Dressings Debridement Bioengineered skin and skin grafts Electromagnetic laser and ultrasound Stem cell therapy Abnormalities of wound biology and gene therapy Reduction of tissue oedema Hyperbaric oxygen Resection of the chronic woundsurgical procedures

Comparison

OutcomeThe healing of chronic ulcer ulcer area amputation rate

Time 3 months ndash 1 years

12

The Evidence (研究重要結果) - 1

Topical HBO inclusion of the affected foot into a sealed chamber containing hyperbaric oxygen (HBO)

Systemic HBO the patient spending prolonged periods of time in a large HBO chamber

13

The Evidence (研究重要結果) - 2

HBO-1

14

The Evidence (研究重要結果) - 3

HBO-2

15

The Evidence (研究重要結果) - 4

Bioengineered skin and skin grafts-1

16

The Evidence (研究重要結果) - 5

Bioengineered skin and skin grafts-2

17

Comment amp Discussion -1 Systemic HBO may reduce the incidence

of major amputation While further evidence of effectiveness and cost-effectiveness is required from larger more robust and blinded studies

The benefit of topically administered HBO is not established

18

Comment amp Discussion -2 Bioengineered skin products and skin grafts

are widely used in some areas but their benefit has not been clearly established

Many clinicians will reserve the use of these relatively expensive treatments for ulcers that fail to respond to simpler approaches and yet bioengineered skin products have not been evaluated in such populations

19

Comment amp Discussion -3 本篇 review針對高壓氧植皮等各種糖尿病足部潰瘍

之治療方法進行探討關鍵字及搜尋範圍拉到十分大故各種療法皆有許多篇 paper被 identified(高壓氧114 篇植皮 72 篇 ) 但最後對此兩種療法僅各評值 6篇 RCT雖應可推論這幾篇為證據等級較高之 paper但評值的文章數或許過少而無法充分代表其療法之療效結論

關於自體植皮方面僅有一篇文章被選出並且是兩種植皮方法的比較故未針對植皮本身之療效進行評值而結論提出植皮的益處仍未清楚確立或許是因以其篩選之方法目前關於植皮療效之文章之嚴謹程度仍未達其篩選標準(文章中僅聲稱 Reduction of tissue oedema Hyperbaric oxygen Resection 有療效)

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 3: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

3

Clinical Uncertainty rarr PICO 問題

對於糖尿病足部潰瘍患者單純接受高壓氧治療相較於植皮是否仍有理想的復原能力

4

臨床個案的 PICO

Patient ProblemPatient who has Type 2 DM with foot ulcers

(foot ulcer or diabetic foot)

InterventionHBO OR hyperbaric oxygenation

Comparisonskin graft or skin transplantation

Outcome enhance the wound healing

Type of Question Therpy

5

Search Terms amp Strategy (搜尋關鍵字與策略)

資料庫 Pubmed搜尋日期 20091023搜尋關鍵字與隅策略

如圖表

6

Best available evidence(挑選可獲得之最佳研究證據)

Citations

A systematic review of the effectiveness of interventions to enhance the healing of chronic ulcers of the foot in diabetes(2008)

Lead authors name

RJHinchliffe GDValk JApelqvist DGArmstrong KBakker FLGame AHartemann-Heurtier MLondahl PEPrice WHvan HoutumW JJeffcoate

7

The Study (研究效度) - 1 Prospective and retrospective controlled studies

published in any language that evaluated interventions for the treatment of chronic foot ulcers in people aged 18 years or older with either type 1 or type 2 diabetes mellitus were considered

Randomized controlled trials (RCTs) case-control studies prospective and retrospective cohort studies control before-and-after (CBA) design and interrupted time series (ITS) designs were included

MEDLINE (1966 - 2006)EMBASE(1980 - 2006)

The Cochrane database of systematic reviews and the Cochrane Central Controlled Trials Register (2006)

8

The Study (研究效度) - 2 One reviewer assessed all identified references by

title and abstract on the basis of patient group intervention and outcome

Full paper copies of identified articles were then assessed for eligibility by two independent reviewers (agreement was reached)

Each included paper was further assessed by two reviewers working independently and information was extracted on study design patient group intervention outcomes duration of and loss to followup using standard data extraction sheets

9

The Study (研究效度) - 3 Each study was scored for methodological

quality using designspecific scoring based on checklists developed by the Dutch Cochrane Center(RCT score1-9)

The SIGN instrument (1) RCTs and (2) studies with case-control cohort CBA or ITS design Studies were also rated as ++ (high quality with low risk of bias) + (well conducted with low risk of bias) and ndash (low quality with higher risk of bias)

10

The Study (研究效度) - 5

HBO therapy 6 篇 RCT(114 studies identified ) Bioengineered skin and skin grafts 6 篇 RCT(72

papers identified)

Level of Evidence 1A(SR of RCTs)

11

The Study (研究效度) - 6本篇文獻的 PICO (T)

Patient Problem

chronic foot ulcers in people aged 18 years or older with either type 1 or type 2 diabetes Mellitus

Intervention

Dressings Debridement Bioengineered skin and skin grafts Electromagnetic laser and ultrasound Stem cell therapy Abnormalities of wound biology and gene therapy Reduction of tissue oedema Hyperbaric oxygen Resection of the chronic woundsurgical procedures

Comparison

OutcomeThe healing of chronic ulcer ulcer area amputation rate

Time 3 months ndash 1 years

12

The Evidence (研究重要結果) - 1

Topical HBO inclusion of the affected foot into a sealed chamber containing hyperbaric oxygen (HBO)

Systemic HBO the patient spending prolonged periods of time in a large HBO chamber

13

The Evidence (研究重要結果) - 2

HBO-1

14

The Evidence (研究重要結果) - 3

HBO-2

15

The Evidence (研究重要結果) - 4

Bioengineered skin and skin grafts-1

16

The Evidence (研究重要結果) - 5

Bioengineered skin and skin grafts-2

17

Comment amp Discussion -1 Systemic HBO may reduce the incidence

of major amputation While further evidence of effectiveness and cost-effectiveness is required from larger more robust and blinded studies

The benefit of topically administered HBO is not established

18

Comment amp Discussion -2 Bioengineered skin products and skin grafts

are widely used in some areas but their benefit has not been clearly established

Many clinicians will reserve the use of these relatively expensive treatments for ulcers that fail to respond to simpler approaches and yet bioengineered skin products have not been evaluated in such populations

19

Comment amp Discussion -3 本篇 review針對高壓氧植皮等各種糖尿病足部潰瘍

之治療方法進行探討關鍵字及搜尋範圍拉到十分大故各種療法皆有許多篇 paper被 identified(高壓氧114 篇植皮 72 篇 ) 但最後對此兩種療法僅各評值 6篇 RCT雖應可推論這幾篇為證據等級較高之 paper但評值的文章數或許過少而無法充分代表其療法之療效結論

關於自體植皮方面僅有一篇文章被選出並且是兩種植皮方法的比較故未針對植皮本身之療效進行評值而結論提出植皮的益處仍未清楚確立或許是因以其篩選之方法目前關於植皮療效之文章之嚴謹程度仍未達其篩選標準(文章中僅聲稱 Reduction of tissue oedema Hyperbaric oxygen Resection 有療效)

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 4: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

4

臨床個案的 PICO

Patient ProblemPatient who has Type 2 DM with foot ulcers

(foot ulcer or diabetic foot)

InterventionHBO OR hyperbaric oxygenation

Comparisonskin graft or skin transplantation

Outcome enhance the wound healing

Type of Question Therpy

5

Search Terms amp Strategy (搜尋關鍵字與策略)

資料庫 Pubmed搜尋日期 20091023搜尋關鍵字與隅策略

如圖表

6

Best available evidence(挑選可獲得之最佳研究證據)

Citations

A systematic review of the effectiveness of interventions to enhance the healing of chronic ulcers of the foot in diabetes(2008)

Lead authors name

RJHinchliffe GDValk JApelqvist DGArmstrong KBakker FLGame AHartemann-Heurtier MLondahl PEPrice WHvan HoutumW JJeffcoate

7

The Study (研究效度) - 1 Prospective and retrospective controlled studies

published in any language that evaluated interventions for the treatment of chronic foot ulcers in people aged 18 years or older with either type 1 or type 2 diabetes mellitus were considered

Randomized controlled trials (RCTs) case-control studies prospective and retrospective cohort studies control before-and-after (CBA) design and interrupted time series (ITS) designs were included

MEDLINE (1966 - 2006)EMBASE(1980 - 2006)

The Cochrane database of systematic reviews and the Cochrane Central Controlled Trials Register (2006)

8

The Study (研究效度) - 2 One reviewer assessed all identified references by

title and abstract on the basis of patient group intervention and outcome

Full paper copies of identified articles were then assessed for eligibility by two independent reviewers (agreement was reached)

Each included paper was further assessed by two reviewers working independently and information was extracted on study design patient group intervention outcomes duration of and loss to followup using standard data extraction sheets

9

The Study (研究效度) - 3 Each study was scored for methodological

quality using designspecific scoring based on checklists developed by the Dutch Cochrane Center(RCT score1-9)

The SIGN instrument (1) RCTs and (2) studies with case-control cohort CBA or ITS design Studies were also rated as ++ (high quality with low risk of bias) + (well conducted with low risk of bias) and ndash (low quality with higher risk of bias)

10

The Study (研究效度) - 5

HBO therapy 6 篇 RCT(114 studies identified ) Bioengineered skin and skin grafts 6 篇 RCT(72

papers identified)

Level of Evidence 1A(SR of RCTs)

11

The Study (研究效度) - 6本篇文獻的 PICO (T)

Patient Problem

chronic foot ulcers in people aged 18 years or older with either type 1 or type 2 diabetes Mellitus

Intervention

Dressings Debridement Bioengineered skin and skin grafts Electromagnetic laser and ultrasound Stem cell therapy Abnormalities of wound biology and gene therapy Reduction of tissue oedema Hyperbaric oxygen Resection of the chronic woundsurgical procedures

Comparison

OutcomeThe healing of chronic ulcer ulcer area amputation rate

Time 3 months ndash 1 years

12

The Evidence (研究重要結果) - 1

Topical HBO inclusion of the affected foot into a sealed chamber containing hyperbaric oxygen (HBO)

Systemic HBO the patient spending prolonged periods of time in a large HBO chamber

13

The Evidence (研究重要結果) - 2

HBO-1

14

The Evidence (研究重要結果) - 3

HBO-2

15

The Evidence (研究重要結果) - 4

Bioengineered skin and skin grafts-1

16

The Evidence (研究重要結果) - 5

Bioengineered skin and skin grafts-2

17

Comment amp Discussion -1 Systemic HBO may reduce the incidence

of major amputation While further evidence of effectiveness and cost-effectiveness is required from larger more robust and blinded studies

The benefit of topically administered HBO is not established

18

Comment amp Discussion -2 Bioengineered skin products and skin grafts

are widely used in some areas but their benefit has not been clearly established

Many clinicians will reserve the use of these relatively expensive treatments for ulcers that fail to respond to simpler approaches and yet bioengineered skin products have not been evaluated in such populations

19

Comment amp Discussion -3 本篇 review針對高壓氧植皮等各種糖尿病足部潰瘍

之治療方法進行探討關鍵字及搜尋範圍拉到十分大故各種療法皆有許多篇 paper被 identified(高壓氧114 篇植皮 72 篇 ) 但最後對此兩種療法僅各評值 6篇 RCT雖應可推論這幾篇為證據等級較高之 paper但評值的文章數或許過少而無法充分代表其療法之療效結論

關於自體植皮方面僅有一篇文章被選出並且是兩種植皮方法的比較故未針對植皮本身之療效進行評值而結論提出植皮的益處仍未清楚確立或許是因以其篩選之方法目前關於植皮療效之文章之嚴謹程度仍未達其篩選標準(文章中僅聲稱 Reduction of tissue oedema Hyperbaric oxygen Resection 有療效)

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 5: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

5

Search Terms amp Strategy (搜尋關鍵字與策略)

資料庫 Pubmed搜尋日期 20091023搜尋關鍵字與隅策略

如圖表

6

Best available evidence(挑選可獲得之最佳研究證據)

Citations

A systematic review of the effectiveness of interventions to enhance the healing of chronic ulcers of the foot in diabetes(2008)

Lead authors name

RJHinchliffe GDValk JApelqvist DGArmstrong KBakker FLGame AHartemann-Heurtier MLondahl PEPrice WHvan HoutumW JJeffcoate

7

The Study (研究效度) - 1 Prospective and retrospective controlled studies

published in any language that evaluated interventions for the treatment of chronic foot ulcers in people aged 18 years or older with either type 1 or type 2 diabetes mellitus were considered

Randomized controlled trials (RCTs) case-control studies prospective and retrospective cohort studies control before-and-after (CBA) design and interrupted time series (ITS) designs were included

MEDLINE (1966 - 2006)EMBASE(1980 - 2006)

The Cochrane database of systematic reviews and the Cochrane Central Controlled Trials Register (2006)

8

The Study (研究效度) - 2 One reviewer assessed all identified references by

title and abstract on the basis of patient group intervention and outcome

Full paper copies of identified articles were then assessed for eligibility by two independent reviewers (agreement was reached)

Each included paper was further assessed by two reviewers working independently and information was extracted on study design patient group intervention outcomes duration of and loss to followup using standard data extraction sheets

9

The Study (研究效度) - 3 Each study was scored for methodological

quality using designspecific scoring based on checklists developed by the Dutch Cochrane Center(RCT score1-9)

The SIGN instrument (1) RCTs and (2) studies with case-control cohort CBA or ITS design Studies were also rated as ++ (high quality with low risk of bias) + (well conducted with low risk of bias) and ndash (low quality with higher risk of bias)

10

The Study (研究效度) - 5

HBO therapy 6 篇 RCT(114 studies identified ) Bioengineered skin and skin grafts 6 篇 RCT(72

papers identified)

Level of Evidence 1A(SR of RCTs)

11

The Study (研究效度) - 6本篇文獻的 PICO (T)

Patient Problem

chronic foot ulcers in people aged 18 years or older with either type 1 or type 2 diabetes Mellitus

Intervention

Dressings Debridement Bioengineered skin and skin grafts Electromagnetic laser and ultrasound Stem cell therapy Abnormalities of wound biology and gene therapy Reduction of tissue oedema Hyperbaric oxygen Resection of the chronic woundsurgical procedures

Comparison

OutcomeThe healing of chronic ulcer ulcer area amputation rate

Time 3 months ndash 1 years

12

The Evidence (研究重要結果) - 1

Topical HBO inclusion of the affected foot into a sealed chamber containing hyperbaric oxygen (HBO)

Systemic HBO the patient spending prolonged periods of time in a large HBO chamber

13

The Evidence (研究重要結果) - 2

HBO-1

14

The Evidence (研究重要結果) - 3

HBO-2

15

The Evidence (研究重要結果) - 4

Bioengineered skin and skin grafts-1

16

The Evidence (研究重要結果) - 5

Bioengineered skin and skin grafts-2

17

Comment amp Discussion -1 Systemic HBO may reduce the incidence

of major amputation While further evidence of effectiveness and cost-effectiveness is required from larger more robust and blinded studies

The benefit of topically administered HBO is not established

18

Comment amp Discussion -2 Bioengineered skin products and skin grafts

are widely used in some areas but their benefit has not been clearly established

Many clinicians will reserve the use of these relatively expensive treatments for ulcers that fail to respond to simpler approaches and yet bioengineered skin products have not been evaluated in such populations

19

Comment amp Discussion -3 本篇 review針對高壓氧植皮等各種糖尿病足部潰瘍

之治療方法進行探討關鍵字及搜尋範圍拉到十分大故各種療法皆有許多篇 paper被 identified(高壓氧114 篇植皮 72 篇 ) 但最後對此兩種療法僅各評值 6篇 RCT雖應可推論這幾篇為證據等級較高之 paper但評值的文章數或許過少而無法充分代表其療法之療效結論

關於自體植皮方面僅有一篇文章被選出並且是兩種植皮方法的比較故未針對植皮本身之療效進行評值而結論提出植皮的益處仍未清楚確立或許是因以其篩選之方法目前關於植皮療效之文章之嚴謹程度仍未達其篩選標準(文章中僅聲稱 Reduction of tissue oedema Hyperbaric oxygen Resection 有療效)

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 6: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

6

Best available evidence(挑選可獲得之最佳研究證據)

Citations

A systematic review of the effectiveness of interventions to enhance the healing of chronic ulcers of the foot in diabetes(2008)

Lead authors name

RJHinchliffe GDValk JApelqvist DGArmstrong KBakker FLGame AHartemann-Heurtier MLondahl PEPrice WHvan HoutumW JJeffcoate

7

The Study (研究效度) - 1 Prospective and retrospective controlled studies

published in any language that evaluated interventions for the treatment of chronic foot ulcers in people aged 18 years or older with either type 1 or type 2 diabetes mellitus were considered

Randomized controlled trials (RCTs) case-control studies prospective and retrospective cohort studies control before-and-after (CBA) design and interrupted time series (ITS) designs were included

MEDLINE (1966 - 2006)EMBASE(1980 - 2006)

The Cochrane database of systematic reviews and the Cochrane Central Controlled Trials Register (2006)

8

The Study (研究效度) - 2 One reviewer assessed all identified references by

title and abstract on the basis of patient group intervention and outcome

Full paper copies of identified articles were then assessed for eligibility by two independent reviewers (agreement was reached)

Each included paper was further assessed by two reviewers working independently and information was extracted on study design patient group intervention outcomes duration of and loss to followup using standard data extraction sheets

9

The Study (研究效度) - 3 Each study was scored for methodological

quality using designspecific scoring based on checklists developed by the Dutch Cochrane Center(RCT score1-9)

The SIGN instrument (1) RCTs and (2) studies with case-control cohort CBA or ITS design Studies were also rated as ++ (high quality with low risk of bias) + (well conducted with low risk of bias) and ndash (low quality with higher risk of bias)

10

The Study (研究效度) - 5

HBO therapy 6 篇 RCT(114 studies identified ) Bioengineered skin and skin grafts 6 篇 RCT(72

papers identified)

Level of Evidence 1A(SR of RCTs)

11

The Study (研究效度) - 6本篇文獻的 PICO (T)

Patient Problem

chronic foot ulcers in people aged 18 years or older with either type 1 or type 2 diabetes Mellitus

Intervention

Dressings Debridement Bioengineered skin and skin grafts Electromagnetic laser and ultrasound Stem cell therapy Abnormalities of wound biology and gene therapy Reduction of tissue oedema Hyperbaric oxygen Resection of the chronic woundsurgical procedures

Comparison

OutcomeThe healing of chronic ulcer ulcer area amputation rate

Time 3 months ndash 1 years

12

The Evidence (研究重要結果) - 1

Topical HBO inclusion of the affected foot into a sealed chamber containing hyperbaric oxygen (HBO)

Systemic HBO the patient spending prolonged periods of time in a large HBO chamber

13

The Evidence (研究重要結果) - 2

HBO-1

14

The Evidence (研究重要結果) - 3

HBO-2

15

The Evidence (研究重要結果) - 4

Bioengineered skin and skin grafts-1

16

The Evidence (研究重要結果) - 5

Bioengineered skin and skin grafts-2

17

Comment amp Discussion -1 Systemic HBO may reduce the incidence

of major amputation While further evidence of effectiveness and cost-effectiveness is required from larger more robust and blinded studies

The benefit of topically administered HBO is not established

18

Comment amp Discussion -2 Bioengineered skin products and skin grafts

are widely used in some areas but their benefit has not been clearly established

Many clinicians will reserve the use of these relatively expensive treatments for ulcers that fail to respond to simpler approaches and yet bioengineered skin products have not been evaluated in such populations

19

Comment amp Discussion -3 本篇 review針對高壓氧植皮等各種糖尿病足部潰瘍

之治療方法進行探討關鍵字及搜尋範圍拉到十分大故各種療法皆有許多篇 paper被 identified(高壓氧114 篇植皮 72 篇 ) 但最後對此兩種療法僅各評值 6篇 RCT雖應可推論這幾篇為證據等級較高之 paper但評值的文章數或許過少而無法充分代表其療法之療效結論

關於自體植皮方面僅有一篇文章被選出並且是兩種植皮方法的比較故未針對植皮本身之療效進行評值而結論提出植皮的益處仍未清楚確立或許是因以其篩選之方法目前關於植皮療效之文章之嚴謹程度仍未達其篩選標準(文章中僅聲稱 Reduction of tissue oedema Hyperbaric oxygen Resection 有療效)

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 7: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

7

The Study (研究效度) - 1 Prospective and retrospective controlled studies

published in any language that evaluated interventions for the treatment of chronic foot ulcers in people aged 18 years or older with either type 1 or type 2 diabetes mellitus were considered

Randomized controlled trials (RCTs) case-control studies prospective and retrospective cohort studies control before-and-after (CBA) design and interrupted time series (ITS) designs were included

MEDLINE (1966 - 2006)EMBASE(1980 - 2006)

The Cochrane database of systematic reviews and the Cochrane Central Controlled Trials Register (2006)

8

The Study (研究效度) - 2 One reviewer assessed all identified references by

title and abstract on the basis of patient group intervention and outcome

Full paper copies of identified articles were then assessed for eligibility by two independent reviewers (agreement was reached)

Each included paper was further assessed by two reviewers working independently and information was extracted on study design patient group intervention outcomes duration of and loss to followup using standard data extraction sheets

9

The Study (研究效度) - 3 Each study was scored for methodological

quality using designspecific scoring based on checklists developed by the Dutch Cochrane Center(RCT score1-9)

The SIGN instrument (1) RCTs and (2) studies with case-control cohort CBA or ITS design Studies were also rated as ++ (high quality with low risk of bias) + (well conducted with low risk of bias) and ndash (low quality with higher risk of bias)

10

The Study (研究效度) - 5

HBO therapy 6 篇 RCT(114 studies identified ) Bioengineered skin and skin grafts 6 篇 RCT(72

papers identified)

Level of Evidence 1A(SR of RCTs)

11

The Study (研究效度) - 6本篇文獻的 PICO (T)

Patient Problem

chronic foot ulcers in people aged 18 years or older with either type 1 or type 2 diabetes Mellitus

Intervention

Dressings Debridement Bioengineered skin and skin grafts Electromagnetic laser and ultrasound Stem cell therapy Abnormalities of wound biology and gene therapy Reduction of tissue oedema Hyperbaric oxygen Resection of the chronic woundsurgical procedures

Comparison

OutcomeThe healing of chronic ulcer ulcer area amputation rate

Time 3 months ndash 1 years

12

The Evidence (研究重要結果) - 1

Topical HBO inclusion of the affected foot into a sealed chamber containing hyperbaric oxygen (HBO)

Systemic HBO the patient spending prolonged periods of time in a large HBO chamber

13

The Evidence (研究重要結果) - 2

HBO-1

14

The Evidence (研究重要結果) - 3

HBO-2

15

The Evidence (研究重要結果) - 4

Bioengineered skin and skin grafts-1

16

The Evidence (研究重要結果) - 5

Bioengineered skin and skin grafts-2

17

Comment amp Discussion -1 Systemic HBO may reduce the incidence

of major amputation While further evidence of effectiveness and cost-effectiveness is required from larger more robust and blinded studies

The benefit of topically administered HBO is not established

18

Comment amp Discussion -2 Bioengineered skin products and skin grafts

are widely used in some areas but their benefit has not been clearly established

Many clinicians will reserve the use of these relatively expensive treatments for ulcers that fail to respond to simpler approaches and yet bioengineered skin products have not been evaluated in such populations

19

Comment amp Discussion -3 本篇 review針對高壓氧植皮等各種糖尿病足部潰瘍

之治療方法進行探討關鍵字及搜尋範圍拉到十分大故各種療法皆有許多篇 paper被 identified(高壓氧114 篇植皮 72 篇 ) 但最後對此兩種療法僅各評值 6篇 RCT雖應可推論這幾篇為證據等級較高之 paper但評值的文章數或許過少而無法充分代表其療法之療效結論

關於自體植皮方面僅有一篇文章被選出並且是兩種植皮方法的比較故未針對植皮本身之療效進行評值而結論提出植皮的益處仍未清楚確立或許是因以其篩選之方法目前關於植皮療效之文章之嚴謹程度仍未達其篩選標準(文章中僅聲稱 Reduction of tissue oedema Hyperbaric oxygen Resection 有療效)

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 8: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

8

The Study (研究效度) - 2 One reviewer assessed all identified references by

title and abstract on the basis of patient group intervention and outcome

Full paper copies of identified articles were then assessed for eligibility by two independent reviewers (agreement was reached)

Each included paper was further assessed by two reviewers working independently and information was extracted on study design patient group intervention outcomes duration of and loss to followup using standard data extraction sheets

9

The Study (研究效度) - 3 Each study was scored for methodological

quality using designspecific scoring based on checklists developed by the Dutch Cochrane Center(RCT score1-9)

The SIGN instrument (1) RCTs and (2) studies with case-control cohort CBA or ITS design Studies were also rated as ++ (high quality with low risk of bias) + (well conducted with low risk of bias) and ndash (low quality with higher risk of bias)

10

The Study (研究效度) - 5

HBO therapy 6 篇 RCT(114 studies identified ) Bioengineered skin and skin grafts 6 篇 RCT(72

papers identified)

Level of Evidence 1A(SR of RCTs)

11

The Study (研究效度) - 6本篇文獻的 PICO (T)

Patient Problem

chronic foot ulcers in people aged 18 years or older with either type 1 or type 2 diabetes Mellitus

Intervention

Dressings Debridement Bioengineered skin and skin grafts Electromagnetic laser and ultrasound Stem cell therapy Abnormalities of wound biology and gene therapy Reduction of tissue oedema Hyperbaric oxygen Resection of the chronic woundsurgical procedures

Comparison

OutcomeThe healing of chronic ulcer ulcer area amputation rate

Time 3 months ndash 1 years

12

The Evidence (研究重要結果) - 1

Topical HBO inclusion of the affected foot into a sealed chamber containing hyperbaric oxygen (HBO)

Systemic HBO the patient spending prolonged periods of time in a large HBO chamber

13

The Evidence (研究重要結果) - 2

HBO-1

14

The Evidence (研究重要結果) - 3

HBO-2

15

The Evidence (研究重要結果) - 4

Bioengineered skin and skin grafts-1

16

The Evidence (研究重要結果) - 5

Bioengineered skin and skin grafts-2

17

Comment amp Discussion -1 Systemic HBO may reduce the incidence

of major amputation While further evidence of effectiveness and cost-effectiveness is required from larger more robust and blinded studies

The benefit of topically administered HBO is not established

18

Comment amp Discussion -2 Bioengineered skin products and skin grafts

are widely used in some areas but their benefit has not been clearly established

Many clinicians will reserve the use of these relatively expensive treatments for ulcers that fail to respond to simpler approaches and yet bioengineered skin products have not been evaluated in such populations

19

Comment amp Discussion -3 本篇 review針對高壓氧植皮等各種糖尿病足部潰瘍

之治療方法進行探討關鍵字及搜尋範圍拉到十分大故各種療法皆有許多篇 paper被 identified(高壓氧114 篇植皮 72 篇 ) 但最後對此兩種療法僅各評值 6篇 RCT雖應可推論這幾篇為證據等級較高之 paper但評值的文章數或許過少而無法充分代表其療法之療效結論

關於自體植皮方面僅有一篇文章被選出並且是兩種植皮方法的比較故未針對植皮本身之療效進行評值而結論提出植皮的益處仍未清楚確立或許是因以其篩選之方法目前關於植皮療效之文章之嚴謹程度仍未達其篩選標準(文章中僅聲稱 Reduction of tissue oedema Hyperbaric oxygen Resection 有療效)

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 9: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

9

The Study (研究效度) - 3 Each study was scored for methodological

quality using designspecific scoring based on checklists developed by the Dutch Cochrane Center(RCT score1-9)

The SIGN instrument (1) RCTs and (2) studies with case-control cohort CBA or ITS design Studies were also rated as ++ (high quality with low risk of bias) + (well conducted with low risk of bias) and ndash (low quality with higher risk of bias)

10

The Study (研究效度) - 5

HBO therapy 6 篇 RCT(114 studies identified ) Bioengineered skin and skin grafts 6 篇 RCT(72

papers identified)

Level of Evidence 1A(SR of RCTs)

11

The Study (研究效度) - 6本篇文獻的 PICO (T)

Patient Problem

chronic foot ulcers in people aged 18 years or older with either type 1 or type 2 diabetes Mellitus

Intervention

Dressings Debridement Bioengineered skin and skin grafts Electromagnetic laser and ultrasound Stem cell therapy Abnormalities of wound biology and gene therapy Reduction of tissue oedema Hyperbaric oxygen Resection of the chronic woundsurgical procedures

Comparison

OutcomeThe healing of chronic ulcer ulcer area amputation rate

Time 3 months ndash 1 years

12

The Evidence (研究重要結果) - 1

Topical HBO inclusion of the affected foot into a sealed chamber containing hyperbaric oxygen (HBO)

Systemic HBO the patient spending prolonged periods of time in a large HBO chamber

13

The Evidence (研究重要結果) - 2

HBO-1

14

The Evidence (研究重要結果) - 3

HBO-2

15

The Evidence (研究重要結果) - 4

Bioengineered skin and skin grafts-1

16

The Evidence (研究重要結果) - 5

Bioengineered skin and skin grafts-2

17

Comment amp Discussion -1 Systemic HBO may reduce the incidence

of major amputation While further evidence of effectiveness and cost-effectiveness is required from larger more robust and blinded studies

The benefit of topically administered HBO is not established

18

Comment amp Discussion -2 Bioengineered skin products and skin grafts

are widely used in some areas but their benefit has not been clearly established

Many clinicians will reserve the use of these relatively expensive treatments for ulcers that fail to respond to simpler approaches and yet bioengineered skin products have not been evaluated in such populations

19

Comment amp Discussion -3 本篇 review針對高壓氧植皮等各種糖尿病足部潰瘍

之治療方法進行探討關鍵字及搜尋範圍拉到十分大故各種療法皆有許多篇 paper被 identified(高壓氧114 篇植皮 72 篇 ) 但最後對此兩種療法僅各評值 6篇 RCT雖應可推論這幾篇為證據等級較高之 paper但評值的文章數或許過少而無法充分代表其療法之療效結論

關於自體植皮方面僅有一篇文章被選出並且是兩種植皮方法的比較故未針對植皮本身之療效進行評值而結論提出植皮的益處仍未清楚確立或許是因以其篩選之方法目前關於植皮療效之文章之嚴謹程度仍未達其篩選標準(文章中僅聲稱 Reduction of tissue oedema Hyperbaric oxygen Resection 有療效)

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 10: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

10

The Study (研究效度) - 5

HBO therapy 6 篇 RCT(114 studies identified ) Bioengineered skin and skin grafts 6 篇 RCT(72

papers identified)

Level of Evidence 1A(SR of RCTs)

11

The Study (研究效度) - 6本篇文獻的 PICO (T)

Patient Problem

chronic foot ulcers in people aged 18 years or older with either type 1 or type 2 diabetes Mellitus

Intervention

Dressings Debridement Bioengineered skin and skin grafts Electromagnetic laser and ultrasound Stem cell therapy Abnormalities of wound biology and gene therapy Reduction of tissue oedema Hyperbaric oxygen Resection of the chronic woundsurgical procedures

Comparison

OutcomeThe healing of chronic ulcer ulcer area amputation rate

Time 3 months ndash 1 years

12

The Evidence (研究重要結果) - 1

Topical HBO inclusion of the affected foot into a sealed chamber containing hyperbaric oxygen (HBO)

Systemic HBO the patient spending prolonged periods of time in a large HBO chamber

13

The Evidence (研究重要結果) - 2

HBO-1

14

The Evidence (研究重要結果) - 3

HBO-2

15

The Evidence (研究重要結果) - 4

Bioengineered skin and skin grafts-1

16

The Evidence (研究重要結果) - 5

Bioengineered skin and skin grafts-2

17

Comment amp Discussion -1 Systemic HBO may reduce the incidence

of major amputation While further evidence of effectiveness and cost-effectiveness is required from larger more robust and blinded studies

The benefit of topically administered HBO is not established

18

Comment amp Discussion -2 Bioengineered skin products and skin grafts

are widely used in some areas but their benefit has not been clearly established

Many clinicians will reserve the use of these relatively expensive treatments for ulcers that fail to respond to simpler approaches and yet bioengineered skin products have not been evaluated in such populations

19

Comment amp Discussion -3 本篇 review針對高壓氧植皮等各種糖尿病足部潰瘍

之治療方法進行探討關鍵字及搜尋範圍拉到十分大故各種療法皆有許多篇 paper被 identified(高壓氧114 篇植皮 72 篇 ) 但最後對此兩種療法僅各評值 6篇 RCT雖應可推論這幾篇為證據等級較高之 paper但評值的文章數或許過少而無法充分代表其療法之療效結論

關於自體植皮方面僅有一篇文章被選出並且是兩種植皮方法的比較故未針對植皮本身之療效進行評值而結論提出植皮的益處仍未清楚確立或許是因以其篩選之方法目前關於植皮療效之文章之嚴謹程度仍未達其篩選標準(文章中僅聲稱 Reduction of tissue oedema Hyperbaric oxygen Resection 有療效)

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 11: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

11

The Study (研究效度) - 6本篇文獻的 PICO (T)

Patient Problem

chronic foot ulcers in people aged 18 years or older with either type 1 or type 2 diabetes Mellitus

Intervention

Dressings Debridement Bioengineered skin and skin grafts Electromagnetic laser and ultrasound Stem cell therapy Abnormalities of wound biology and gene therapy Reduction of tissue oedema Hyperbaric oxygen Resection of the chronic woundsurgical procedures

Comparison

OutcomeThe healing of chronic ulcer ulcer area amputation rate

Time 3 months ndash 1 years

12

The Evidence (研究重要結果) - 1

Topical HBO inclusion of the affected foot into a sealed chamber containing hyperbaric oxygen (HBO)

Systemic HBO the patient spending prolonged periods of time in a large HBO chamber

13

The Evidence (研究重要結果) - 2

HBO-1

14

The Evidence (研究重要結果) - 3

HBO-2

15

The Evidence (研究重要結果) - 4

Bioengineered skin and skin grafts-1

16

The Evidence (研究重要結果) - 5

Bioengineered skin and skin grafts-2

17

Comment amp Discussion -1 Systemic HBO may reduce the incidence

of major amputation While further evidence of effectiveness and cost-effectiveness is required from larger more robust and blinded studies

The benefit of topically administered HBO is not established

18

Comment amp Discussion -2 Bioengineered skin products and skin grafts

are widely used in some areas but their benefit has not been clearly established

Many clinicians will reserve the use of these relatively expensive treatments for ulcers that fail to respond to simpler approaches and yet bioengineered skin products have not been evaluated in such populations

19

Comment amp Discussion -3 本篇 review針對高壓氧植皮等各種糖尿病足部潰瘍

之治療方法進行探討關鍵字及搜尋範圍拉到十分大故各種療法皆有許多篇 paper被 identified(高壓氧114 篇植皮 72 篇 ) 但最後對此兩種療法僅各評值 6篇 RCT雖應可推論這幾篇為證據等級較高之 paper但評值的文章數或許過少而無法充分代表其療法之療效結論

關於自體植皮方面僅有一篇文章被選出並且是兩種植皮方法的比較故未針對植皮本身之療效進行評值而結論提出植皮的益處仍未清楚確立或許是因以其篩選之方法目前關於植皮療效之文章之嚴謹程度仍未達其篩選標準(文章中僅聲稱 Reduction of tissue oedema Hyperbaric oxygen Resection 有療效)

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 12: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

12

The Evidence (研究重要結果) - 1

Topical HBO inclusion of the affected foot into a sealed chamber containing hyperbaric oxygen (HBO)

Systemic HBO the patient spending prolonged periods of time in a large HBO chamber

13

The Evidence (研究重要結果) - 2

HBO-1

14

The Evidence (研究重要結果) - 3

HBO-2

15

The Evidence (研究重要結果) - 4

Bioengineered skin and skin grafts-1

16

The Evidence (研究重要結果) - 5

Bioengineered skin and skin grafts-2

17

Comment amp Discussion -1 Systemic HBO may reduce the incidence

of major amputation While further evidence of effectiveness and cost-effectiveness is required from larger more robust and blinded studies

The benefit of topically administered HBO is not established

18

Comment amp Discussion -2 Bioengineered skin products and skin grafts

are widely used in some areas but their benefit has not been clearly established

Many clinicians will reserve the use of these relatively expensive treatments for ulcers that fail to respond to simpler approaches and yet bioengineered skin products have not been evaluated in such populations

19

Comment amp Discussion -3 本篇 review針對高壓氧植皮等各種糖尿病足部潰瘍

之治療方法進行探討關鍵字及搜尋範圍拉到十分大故各種療法皆有許多篇 paper被 identified(高壓氧114 篇植皮 72 篇 ) 但最後對此兩種療法僅各評值 6篇 RCT雖應可推論這幾篇為證據等級較高之 paper但評值的文章數或許過少而無法充分代表其療法之療效結論

關於自體植皮方面僅有一篇文章被選出並且是兩種植皮方法的比較故未針對植皮本身之療效進行評值而結論提出植皮的益處仍未清楚確立或許是因以其篩選之方法目前關於植皮療效之文章之嚴謹程度仍未達其篩選標準(文章中僅聲稱 Reduction of tissue oedema Hyperbaric oxygen Resection 有療效)

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 13: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

13

The Evidence (研究重要結果) - 2

HBO-1

14

The Evidence (研究重要結果) - 3

HBO-2

15

The Evidence (研究重要結果) - 4

Bioengineered skin and skin grafts-1

16

The Evidence (研究重要結果) - 5

Bioengineered skin and skin grafts-2

17

Comment amp Discussion -1 Systemic HBO may reduce the incidence

of major amputation While further evidence of effectiveness and cost-effectiveness is required from larger more robust and blinded studies

The benefit of topically administered HBO is not established

18

Comment amp Discussion -2 Bioengineered skin products and skin grafts

are widely used in some areas but their benefit has not been clearly established

Many clinicians will reserve the use of these relatively expensive treatments for ulcers that fail to respond to simpler approaches and yet bioengineered skin products have not been evaluated in such populations

19

Comment amp Discussion -3 本篇 review針對高壓氧植皮等各種糖尿病足部潰瘍

之治療方法進行探討關鍵字及搜尋範圍拉到十分大故各種療法皆有許多篇 paper被 identified(高壓氧114 篇植皮 72 篇 ) 但最後對此兩種療法僅各評值 6篇 RCT雖應可推論這幾篇為證據等級較高之 paper但評值的文章數或許過少而無法充分代表其療法之療效結論

關於自體植皮方面僅有一篇文章被選出並且是兩種植皮方法的比較故未針對植皮本身之療效進行評值而結論提出植皮的益處仍未清楚確立或許是因以其篩選之方法目前關於植皮療效之文章之嚴謹程度仍未達其篩選標準(文章中僅聲稱 Reduction of tissue oedema Hyperbaric oxygen Resection 有療效)

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 14: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

14

The Evidence (研究重要結果) - 3

HBO-2

15

The Evidence (研究重要結果) - 4

Bioengineered skin and skin grafts-1

16

The Evidence (研究重要結果) - 5

Bioengineered skin and skin grafts-2

17

Comment amp Discussion -1 Systemic HBO may reduce the incidence

of major amputation While further evidence of effectiveness and cost-effectiveness is required from larger more robust and blinded studies

The benefit of topically administered HBO is not established

18

Comment amp Discussion -2 Bioengineered skin products and skin grafts

are widely used in some areas but their benefit has not been clearly established

Many clinicians will reserve the use of these relatively expensive treatments for ulcers that fail to respond to simpler approaches and yet bioengineered skin products have not been evaluated in such populations

19

Comment amp Discussion -3 本篇 review針對高壓氧植皮等各種糖尿病足部潰瘍

之治療方法進行探討關鍵字及搜尋範圍拉到十分大故各種療法皆有許多篇 paper被 identified(高壓氧114 篇植皮 72 篇 ) 但最後對此兩種療法僅各評值 6篇 RCT雖應可推論這幾篇為證據等級較高之 paper但評值的文章數或許過少而無法充分代表其療法之療效結論

關於自體植皮方面僅有一篇文章被選出並且是兩種植皮方法的比較故未針對植皮本身之療效進行評值而結論提出植皮的益處仍未清楚確立或許是因以其篩選之方法目前關於植皮療效之文章之嚴謹程度仍未達其篩選標準(文章中僅聲稱 Reduction of tissue oedema Hyperbaric oxygen Resection 有療效)

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 15: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

15

The Evidence (研究重要結果) - 4

Bioengineered skin and skin grafts-1

16

The Evidence (研究重要結果) - 5

Bioengineered skin and skin grafts-2

17

Comment amp Discussion -1 Systemic HBO may reduce the incidence

of major amputation While further evidence of effectiveness and cost-effectiveness is required from larger more robust and blinded studies

The benefit of topically administered HBO is not established

18

Comment amp Discussion -2 Bioengineered skin products and skin grafts

are widely used in some areas but their benefit has not been clearly established

Many clinicians will reserve the use of these relatively expensive treatments for ulcers that fail to respond to simpler approaches and yet bioengineered skin products have not been evaluated in such populations

19

Comment amp Discussion -3 本篇 review針對高壓氧植皮等各種糖尿病足部潰瘍

之治療方法進行探討關鍵字及搜尋範圍拉到十分大故各種療法皆有許多篇 paper被 identified(高壓氧114 篇植皮 72 篇 ) 但最後對此兩種療法僅各評值 6篇 RCT雖應可推論這幾篇為證據等級較高之 paper但評值的文章數或許過少而無法充分代表其療法之療效結論

關於自體植皮方面僅有一篇文章被選出並且是兩種植皮方法的比較故未針對植皮本身之療效進行評值而結論提出植皮的益處仍未清楚確立或許是因以其篩選之方法目前關於植皮療效之文章之嚴謹程度仍未達其篩選標準(文章中僅聲稱 Reduction of tissue oedema Hyperbaric oxygen Resection 有療效)

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 16: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

16

The Evidence (研究重要結果) - 5

Bioengineered skin and skin grafts-2

17

Comment amp Discussion -1 Systemic HBO may reduce the incidence

of major amputation While further evidence of effectiveness and cost-effectiveness is required from larger more robust and blinded studies

The benefit of topically administered HBO is not established

18

Comment amp Discussion -2 Bioengineered skin products and skin grafts

are widely used in some areas but their benefit has not been clearly established

Many clinicians will reserve the use of these relatively expensive treatments for ulcers that fail to respond to simpler approaches and yet bioengineered skin products have not been evaluated in such populations

19

Comment amp Discussion -3 本篇 review針對高壓氧植皮等各種糖尿病足部潰瘍

之治療方法進行探討關鍵字及搜尋範圍拉到十分大故各種療法皆有許多篇 paper被 identified(高壓氧114 篇植皮 72 篇 ) 但最後對此兩種療法僅各評值 6篇 RCT雖應可推論這幾篇為證據等級較高之 paper但評值的文章數或許過少而無法充分代表其療法之療效結論

關於自體植皮方面僅有一篇文章被選出並且是兩種植皮方法的比較故未針對植皮本身之療效進行評值而結論提出植皮的益處仍未清楚確立或許是因以其篩選之方法目前關於植皮療效之文章之嚴謹程度仍未達其篩選標準(文章中僅聲稱 Reduction of tissue oedema Hyperbaric oxygen Resection 有療效)

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 17: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

17

Comment amp Discussion -1 Systemic HBO may reduce the incidence

of major amputation While further evidence of effectiveness and cost-effectiveness is required from larger more robust and blinded studies

The benefit of topically administered HBO is not established

18

Comment amp Discussion -2 Bioengineered skin products and skin grafts

are widely used in some areas but their benefit has not been clearly established

Many clinicians will reserve the use of these relatively expensive treatments for ulcers that fail to respond to simpler approaches and yet bioengineered skin products have not been evaluated in such populations

19

Comment amp Discussion -3 本篇 review針對高壓氧植皮等各種糖尿病足部潰瘍

之治療方法進行探討關鍵字及搜尋範圍拉到十分大故各種療法皆有許多篇 paper被 identified(高壓氧114 篇植皮 72 篇 ) 但最後對此兩種療法僅各評值 6篇 RCT雖應可推論這幾篇為證據等級較高之 paper但評值的文章數或許過少而無法充分代表其療法之療效結論

關於自體植皮方面僅有一篇文章被選出並且是兩種植皮方法的比較故未針對植皮本身之療效進行評值而結論提出植皮的益處仍未清楚確立或許是因以其篩選之方法目前關於植皮療效之文章之嚴謹程度仍未達其篩選標準(文章中僅聲稱 Reduction of tissue oedema Hyperbaric oxygen Resection 有療效)

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 18: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

18

Comment amp Discussion -2 Bioengineered skin products and skin grafts

are widely used in some areas but their benefit has not been clearly established

Many clinicians will reserve the use of these relatively expensive treatments for ulcers that fail to respond to simpler approaches and yet bioengineered skin products have not been evaluated in such populations

19

Comment amp Discussion -3 本篇 review針對高壓氧植皮等各種糖尿病足部潰瘍

之治療方法進行探討關鍵字及搜尋範圍拉到十分大故各種療法皆有許多篇 paper被 identified(高壓氧114 篇植皮 72 篇 ) 但最後對此兩種療法僅各評值 6篇 RCT雖應可推論這幾篇為證據等級較高之 paper但評值的文章數或許過少而無法充分代表其療法之療效結論

關於自體植皮方面僅有一篇文章被選出並且是兩種植皮方法的比較故未針對植皮本身之療效進行評值而結論提出植皮的益處仍未清楚確立或許是因以其篩選之方法目前關於植皮療效之文章之嚴謹程度仍未達其篩選標準(文章中僅聲稱 Reduction of tissue oedema Hyperbaric oxygen Resection 有療效)

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 19: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

19

Comment amp Discussion -3 本篇 review針對高壓氧植皮等各種糖尿病足部潰瘍

之治療方法進行探討關鍵字及搜尋範圍拉到十分大故各種療法皆有許多篇 paper被 identified(高壓氧114 篇植皮 72 篇 ) 但最後對此兩種療法僅各評值 6篇 RCT雖應可推論這幾篇為證據等級較高之 paper但評值的文章數或許過少而無法充分代表其療法之療效結論

關於自體植皮方面僅有一篇文章被選出並且是兩種植皮方法的比較故未針對植皮本身之療效進行評值而結論提出植皮的益處仍未清楚確立或許是因以其篩選之方法目前關於植皮療效之文章之嚴謹程度仍未達其篩選標準(文章中僅聲稱 Reduction of tissue oedema Hyperbaric oxygen Resection 有療效)

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 20: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

20

Comment amp Discussion -4 回顧以 (foot ulcer or diabetic foot) AND (skin graft or skin transplantation) 搜尋出的8 篇相關 randomized controlled trial文章中雖大部分支持植皮之療效但仍有少部份認為無明顯助益(2 篇)

(autologous dermal and epidermal grafts versus nonadherent paraffin gauze)

The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing For plantar ulcers the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 21: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

21

Comment amp Discussion -5 針對此本次的臨床問題未能搜尋到高壓氧及植皮兩者之療效比較的直觀研究僅能由本篇review對兩者各自的療效性以較迂迴的方式對臨床個案作出外推性的決策底線

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 22: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

22

回到臨床個案情境Clinical bottom line 臨床決策底線

對於糖尿病足部潰瘍患者單純接受高壓氧治療仍可提高傷口復原能力降低截肢機率

證據等級 1A 建議等級 B

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 23: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

23

References 1 Belov VV [Effects of short-term immunosuppression on the

engraftment of skin transplants at syndrome of the diabetic foot] Vestn Khir Im I I Grek 2007166(5)32-5

2 Puttirutvong P Meshed skin graft versus split thickness skin graft in diabetic ulcer coverage J Med Assoc Thai 2004 Jan87(1)66-72

3 Caravaggi C HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers a prospective multicenter controlled randomized clinical trial Diabetes Care 2003 Oct26(10)2853-6

4 Hanft JR Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis J Foot Ankle Surg 2002 Sep-Oct41(5)291-9

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 24: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

24

References

5 Veves A Diabetic Foot Ulcer Study Graftskin a human skin equivalent is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial Diabetes Care 2001 Feb24(2)290-5

6 Chang DWCan a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization Ann Vasc Surg 2000 Jan14(1)44-9

7 Naughton GA metabolically active human dermal replacement for the treatment of diabetic foot ulcers Artif Organs 1997 Nov21(11)1203-10

8 Sabolinski ML Cultured skin as a lsquosmart materialrsquo for healing wounds experience in venous ulcers Biomaterials 1996 Feb17(3)311-20

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 25: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

25

結 論 (標題 Title)Systemic HBO may improve the healing of of DM foot ulcer and reduce the incidence of major amputation

Update By (下次更新日期) Oct 29 2010

26

  • Slide 1
Page 26: 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading

26

  • Slide 1