fentanyl口頰貼片(painkyl® ) 是否有更有效的使用方式？ ·...

針對癌症病人的疼痛，fentanyl口頰貼片(Painkyl® ) 是否有更有效的使用方式？

主報人：陳冠儒藥師

引言人：張雅惠副主任

萬芳醫院藥劑部

2018/10/16 1

報告大綱

Step 0 : Background

Step 1 : Ask

Step 2 : Acquire

Step 3 : Appraisal

Step 4 : Apply

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Step 0 : Background 臨床問題與背景資料

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Background

本背景資訊取自於 WHO三階段止痛

Preparation

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Background

• 按時給藥

–長效型鴉片類藥物：定時使用

–短效型鴉片類藥物：疼痛突發出現時使用

• 每次突發疼痛時使用的鴉片類藥物劑量為全日按時給藥劑量的六分之一 (或約 10% - 20%)

• 若每天有超過 3 次的機會需使用藥物來控制突發疼痛時，應該增加每天每次按時給藥的劑量。

Preparation

本背景資訊取自於 NCCN Guideline 5

Background

Preparation

Morphine Fentanyl Hydromorphone Oxycodone

速效藥物 v

長效藥物

Morphine

15 mg

Morphine

Injection

MXL

60 mg

Painkyl

buccal film

Patch 25 mcg/hr

Patch 50 mcg/hr

Jurnista 8 mg OxyContin 10 mg

萬芳醫院強效鴉片類品項 6

Background

取自Painkyl 仿單

Preparation

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Background

取自Painkyl 仿單

Preparation

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Background 其他強效鴉片類用法

每次突發疼痛時使用的鴉片類藥物劑量為全日按時給藥劑量的六分之一 (或約 10% - 20%)

Fentanyl buccal film

仿單用法

起始劑量唯一片200 微克PAINKYL，若使用一片

200 微克PAINKYL 口頰溶片後仍未達到足夠之疼痛緩解，則以 200 微克 PAINKYL 口頰溶片持續進行劑量調整。

使用第一片 200 微克 PAINKYL 後若仍有疼痛事件發生，則在每次疼痛事件發生時再給予一片

200 微克 PAINKYL 口頰溶片，直至劑量達到可提供病患充足的止痛效果且可耐受副作用。

Fentanyl buccal film

仿單注意事項

PAINKYL 相較於其他吩坦尼製劑，在藥物動力學特性上有顯著之不同，導致吩坦尼吸收程度具有臨床上之重大差異，這些重大差異可能

會引發致命的用藥過量。因此開立處方時，請勿以微克數換算之方式將病患的其他經口腔黏膜吩坦尼製劑替換成 PAINKYL。

Background

Pain Med. 2010 Jul;11(7):1017-23. doi: 10.1111

Preparation

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Step 1 : Ask 病人／族群、介入／暴露因子、比較因子、結果

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PICO

Ask：清楚描述病人／族群、介入／暴露因子、比較因子、結果

PICO

P 癌症突發性疼痛

I Painkyl 等比例劑量治療

C Painkyl 仿單建議劑量治療

O 疼痛改善

這是一個 ●治療 ●診斷 ●傷害 ●預後型問題

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Step 2 : Acquire 運用合適的關鍵字與檢索策略，提昇搜尋效率

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關鍵字與搜尋策略

Acquire：合適關鍵字及清楚檢索策略

OR

OR

OR

AND

AND

((Mesh)) ((Mesh))

((Mesh))

((Mesh))

NOT

PICO 可能的檢索詞

P 癌症突發性疼痛 Cancer pain, cancer breakthrough pain, breakthrough

pain, pain related to cancer

I Painkyl 等比例劑量

治療

Fentanyl buccal soluble film proportional dose, fentanyl

buccal soluble film equivalent dose, Fentanyl buccal film

C Painkyl 仿單建議

劑量治療

Fentanyl buccal soluble film

O 疼痛改善 Pain relief, pain change in 30 minutes

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搜尋歷程：PubMed Search Builder

Acquire：利用檢索功能提昇搜尋效率

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先分別population＆intervention 搜尋


（請將「pubmed搜尋結果」貼上來）


再聯集兩個搜尋結果

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先尋找較佳研究設計-meta or RCT

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彙整cancer breakthrough pain的止痛藥藥效

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討論fentanyl buccal film的pharmacokinetics

fentanyl buccal film和placebo相比，fentanyl的用法參照仿單

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以肉眼screen有無符合PICO的研究

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選用文獻

Acquire：清楚地描述挑選文獻的理由

此篇文章納入理由：最符合臨床問題，發表年份新，有全文可評讀，最佳研究設計

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Aim

• To assess the efficacy and safety of proportional doses of fentanyl buccal soluble film (FBSF) in patients with breakthrough cancer pain.

Aim Method Results Limitation

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Method-study design

• An open-label, multicenter, noncomparative study

• Conducted at 3 clinical sites in Taiwan between January 2015 and June 2016. • The study protocol was approved by the institutional review board at each study site and written

informed consent was obtained from all patients.


Method-population

• Aged 20 to 70 y/o cancer patients

• Experiencing 1 to 3 BTP per day

• Receiving regimens equivalent to • 60 to 360 mg/day of oral morphine

• 25 to 150 mcg/h of transdermal fentanyl ≥ 1 week, were prospectively recruited.


Method-population

Population-exclusion criteria

• Rapidly escalating pain

• Hypersensitivity or intolerance to fentanyl

• Cardiopulmonary disease that would increase the risk of respiratory depression

• Moderate to severe mucositis or abnormal oral mucosa

• Alcohol or other drug substance abuse

• Pregnant


Method-intervention

Fentanyl proportional dose • FBSF was administered proportionally based on

their current opioid regimen for baseline pain.

• The treatment of study medication was administered for a maximum period of 2 weeks


Method-intervention

• 每次突發疼痛時使用的鴉片類藥物劑量為全日按時給藥劑量的六分之一 (或約 10% - 20%)

• Fentanyl 貼片 25mcg/hr (600 mcg/day)，1/6 為100 mcg

• 51% rapidly absorbed from buccal mucosa.

• 100 mcg ÷ 51% ≒ 200 mcg


=

Method

Primary Outcome 1. Percentage of patients requiring dose titration.

Secondary Outcome 2. Changes in pain intensity at 30 minutes (PID30)

after dosing (11-point numeric scale)

3. Percentage of episodes requiring rescue medication

4. Patients satisfaction (A 5-point categorical scale )

5. Adverse events


要講評估方式

Results

• Patient disposition and demographics


Results

1. Percentage of patients requiring dose titration：

• 21.4% (6/28) and 12.0% (3/25) in the full analysis set and

per-protocol populations, respectively.


fentanyl口頰貼片(painkyl® ) 是否有更有效的使用方式？ ·...

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