實證醫學文獻查證

胸腔內科第四年住院醫師：簡暐倫

背景

一位54歲男性，抽煙25年，最近常常覺得走路會喘，過去沒有類似的不舒服，因此到胸腔內科求診。肺功能結果為FEV1 65％，病人問有沒有治療喘比較好的藥

COPD group B patient� LABA or LAMA

形成PICO問題及預估理想文獻

問題型態問題型態問題型態問題型態 這是一個治療型問題這是一個治療型問題這是一個治療型問題這是一個治療型問題 理想文獻理想文獻理想文獻理想文獻

Patients COPD, group B P COPD, moderate to severe

Intervention

LABA I indacaterol

Comparison

LAMA C tiotropium

Outcomes For benefit: dyspnea improved

O For benefit: TDI

Time At least 3 months

Design For benefit: RCT, systematic review

Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence

Searching strategy

� Database: PubMed� Searching Keyword: indacaterol tiotropium

COPD� Limits: Full text available,5 years,Meta-

Analysis,Randomized Controlled Trial, Systematic Reviews,English

搜 尋關鍵字 COPD indacaterol tiotropium TDI

MeSH COPDChronic Obstructive Pulmonary DiseaseCOADChronic Obstructive Airway DiseaseChronic Obstructive Lung DiseaseAirflow Obstruction, ChronicAirflow Obstructions, ChronicChronic Airflow ObstructionsChronic Airflow Obstruction

QAB-149Onbrezindacaterol

Spirivatiotropium bromideBA 679 BRBA-679 BR

搜 尋#1 COPD

#2:tiotropium

#3: Indacaterol

COPD tiotropim indacaterol有26篇Filters : English

Searching resultMeta-analysis

RCT

Once-Daily Bronchodilators for Chronic Obstructive Pulmonary Disease Indacaterol Versus Tiotropium James F. Donohue1, Charles Fogarty2, Jan Lo¨tvall3, Donald A. Mahler4, Heinrich Worth5, Arzu Yorganciog˘lu6,Amir Iqbal7, James Swales7, Roger Owen7, Mark Higgins7, and Benjamin Kramer8, for the INHANCE* Study InvestigatorsAMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE VOL 182 2010

Randomized Control TrialStudy: Once-Daily Bronchodilators for Chronic ObstructivePulmonary Disease

Patients Patients with moderate-to-severe COPD

Interventions Intervention group:indacaterol 150 or 300 mgControl group: placebo or tiotropium

Outcomes TDI

TIme 26 Weeks

Validity: bias checklist for RCTsSource of bias

RCTs Yes/Unclear/No

判斷依據判斷依據判斷依據判斷依據

Selection bias

Randomisation yes P155,line 16 : A total of 1,683 patients were randomized to the four treatment arms

Performance bias

Blinding:Participants

Investigators

yes

yes

P155,line 8

Attrition bias

Completeness of follow-up

no 1,683 were involved in stage 2 and 1,291 (77%) completed the study.

Detection bias

Blinded outcome assessment

unclear

Reporting bias

Selective reporting no

Systematic Review/Meta-analysisStudy: COMPARISON OF INDACATEROL WITH TIOTROPIUM OR TWICE-DAILY LONG-ACTING BETA-AGONISTS FOR STABLE COPD

Participants 5,920 subjects (3,377 in the indacaterol arms and 2,543 in the comparators arms)

Interventions Intervention: indacaterolComparison(s) placebo,TD-LABA,tiotropium

Target Outcomes trough FEV 1, TDI

Time 12-52 weeks

Validity: Bias checklist for SRSource of bias

Systematic review Yes/Unclear/No

判斷依據

Eligibility criteria: appropriate & relevant to the Review question?

yes P3 line 5

Search design: comprehensive & systematic? important, relevant studies were missed (publication bias)?

yes P6 line 6

Search process: study selection, extraction of data & assessment of validity done independently by at least 2 reviewers?

yes P7 line 9

Validity of included studies: Did reviewers do enough to assess the validity of included studies?

yes P7 line 15

Combining studies: reasonable to consider combining the studies ( heterogenicity)

yes P8 line 3

Reporting bias

Selective reporting no

Importance [NUMBERS] (reported from paper): Summary Effects & Precision estimates

Gustavo 2012 Syst Rev

Donohue et al. 2010RCT

Outcome for benefit OR 1.43NNT:10

OR 2.16

P<0.00001, 95% CI 1.22

P:<0.001, 95% CI 1.55

Final Level of Evidence

Level I Level I

Quality of the evidence (GRADE)

For benefit outcome 1 ⊕⊕⊕⊕ ⊕⊕⊕⊕For benefit outcome 2 ⊕⊕⊕⊕ ⊕⊕⊕⊕

應用

2011/8/7

藥品/處置成本：

5. 應應應應用用用用Apply：：：：Back to PICO20%

風險考量 低風險/高療效族群:

成本效益

副作用(患者成本)

Hypokalemia, arrhythmia,

臨床應用 我們的病患屬低風險低風險低風險低風險/高療效高療效高療效高療效族群:。這項治療在我所處的環境，要做這處置的可行性(feasibility):是否有其他更好的選擇：tiotropium (相對成本差異)。1514好處是否多於壞處：好是否符合病人的期望(value):是

醫療建議 綜合上面討論，我們的臨床建議

使用onbrez 1 cap QD

這樣建議的建議強度

A

以去學術化術語(plain language)回答病人

Indacaterol每天只要使用一次，可能可以改善你喘的症狀，以後也不比較不會急性發作

藥品名稱藥品名稱藥品名稱藥品名稱 成份成份成份成份 成份含量成份含量成份含量成份含量 規格量規格量規格量規格量 單複方單複方單複方單複方 價格價格價格價格 劑型劑型劑型劑型

Onbrez indacaterol 150mcg/cap 30 capsules 單單單單 NT$:955 breezhaler

應用到病患 (醫學倫理四象限)

Take Home Messages(Comments)

� In moderate-severe COPD patients treated with indacaterol have better effects on clinical outcomes than those treated with tiotropium.

� In group B COPD patients � need further study