第十三屆實證醫學競賽文獻查證進階組潛力獎 機構 : 高雄醫學大學附設中和紀念醫院組員 : 內科王俊偉醫師麻醉科陳柏年醫師李佳倫護理師 1
臨床場景 (clinical scenario) 分析 1 李先生 65 歲是個長期菸癮者有 30 年以上的抽菸史, 他因有高血壓及糖尿病且在家附近的診所拿藥已有十來年, 血壓一直控制的不錯, 最近因為常常感到胸口煩悶, 尤其是早晨或工作及動後, 因懷疑是心絞痛被診所醫師轉介至醫院做進一步檢查 到醫院後醫師表示要判斷是否有冠狀動脈阻塞, 最準確的診斷方法為心導管檢查, 不過風險較高, 建議可先做非侵入性檢查, 而檢查項目有運動心電圖, 心肌灌注掃描或費用較昂貴的心臟 64 切電腦斷層掃描 若是確定為冠狀動脈引起的徵兆, 就有做心導管檢查與治療的必要, 且藥物可能要做調整 2
臨床場景 (clinical scenario) 分析 2 另外, 醫師又建議戒菸及好好控制血糖會對身體較好且可降低心血管風險 經過醫師一系列的解釋, 李先生有好幾個疑惑, 就檢查方面, 到底哪一種檢查對李先生是最好判斷冠狀動脈疾病工具? 若真的有問題是否非得做心導管手術才可? 如果現在開始戒菸, 是不是來得及? 並且, 控制血糖到底要控制到什麼程度才是最好? 就在李先生正在為這些問題苦惱的幾天中, 他的好朋友 75 歲王先生因為患急性心肌梗塞到急診就醫, 急診醫師告訴他需要做心導管手術或血栓溶解劑注射擇一, 雖各有優缺點, 由於沒有多少時間考慮, 王先生選擇了心導管手術, 李先生此時又有一個疑惑, 若是他也發生了類似的狀況, 到底哪一種最適合他? 3
STEP 1:Question forming 臨床重要的問題 判斷是否有冠狀動脈阻塞, 運動心電圖, 心肌灌注掃描或費用較昂貴的心臟 64 切電腦斷層掃描何者較佳? 病人關心的問題 哪一種檢查對李先生是最好判斷冠狀動脈疾病工具? 冠狀動脈疾病是否非得做心導管手術才可? 現在開始戒菸, 是不是來得及? 控制血糖到底要控制到什麼程度才是最好? 急性心肌梗塞心導管手術或血栓溶解劑注射哪一種最適合? 4
以 PICO 建構臨床問題 P Patient/Problem I Intervention C Comparison O Outcome Man suffer from AMI 急性心肌梗塞心導管手術 (PCI) 血栓溶解劑注射 (Thrombolysis) Mortality rate, re-infarction rate, complications 問題類型 : 治療 最適合回答此問題的研究設計 : Systematic Review 5
STEP 2:Finding evidence 選擇 Key words 及 Meshterms Key words:ami PCI Thrombolysis Mortality rate re-infarction rate 運用的資料庫 Meshterms:Ischemic heart disease Secondary first Primary second 5S:UpToDate DynaMed ACP journal club Cochrane Library PubMed CEPS Filter & limit 運用 Combine terms with Boollean operators: and or not Filter & limit:human English elderly systematic review 6
選擇 Key words 及 Meshterms 原始關鍵字 布林邏輯 同義字 布林邏輯 P(AMI OR ACS ) AND I (PCI OR PTCA ) AND C(Thrombolysis OR Fibrinolysis ) AND O(Mortality rate OR re-infarction rate ) 7
資料庫搜尋結果 The "5S" levels of organisation of evidence from healthcare research Brian Haynes, R Evid Based Med 2006;11:162-164 Dynamed:4 篇, 與主題相關 1 篇 Uptodate: 與主題相關 3 篇 篇數 :1 篇 Systemic review:1 篇 Trails :178 篇 pubmed:775 篇 CEPS:1 篇 8 Copyright 2006 BMJ Publishing Group Ltd.
搜尋到的文章標題及文獻等級 Title: Primary percutaneous coronary intervention versus fibrinolysis in acute ST elevation myocardial infarction: Clinical trials Overview of the acute management of ST elevation myocardial infarction Overview of the acute management of unstable angina and non-st elevation myocardial infarction Level of evidence:ia
搜尋到的文章內容摘要 PCI 較 Thrombolysis30 天內死亡率 再梗塞率 中風較低
搜尋到的文章內容摘要 Thrombolysis 容易出血 且易復發 建議病人接受 PCI
搜尋到的文章標題及文獻等級 Title: Percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) Level of evidence:ia
搜尋到的文章內容摘要 PCI 降低死亡率 再梗塞率 中風率
搜尋到的文章內容摘要 PCI( 不延遲 >60-90 分 ) 較 Thrombolysis 死亡率低
搜尋到的文章內容摘要 PCI 較 Thrombolysis 能降低死亡率及再梗塞率
搜尋到的文章標題及文獻等級 Title: Review: Transfer for PCI reduces 30-day mortality more than on-site thrombolysis in STEMI Level of evidence:ia
搜尋到的文章內容摘要 Conclusion: In patients with ST-segment elevation myocardial infarction, transfer for percutaneous coronary intervention reduces 30-day mortality more than on-site thrombolysis
PCI 較 Thrombolysis30 天內死亡率 再梗塞率 中風較低
搜尋過程與結果 Summaries Synopses Syntheses Stidies UpToDate 與主題相關 3 篇 DynaMed4 篇, 與主題相關 1 篇 ACP Journal club 1 篇 The Cochrane Library Systemic review:1 篇 PubMed 775 篇 CEPS 1 篇 Trails :178 篇 因 SR 為最適合治療性問題之文獻類型, 在鎖定文獻類型並經三位組員逐篇進入摘要閱讀後, 選定 PubMed 中的 1 篇 Systematic review 進行評讀, 因其臨床情境符合 可下載全文 研究方法符合且最近年代 (2012) 20
比對 PICO 此項研究與我們的 PICO 是否符合? 此項研究我們的 PICO YES NO P patients with stable CAD Man suffer from AMI V I PCI 急性心肌梗塞心導管手術 (PCI) V C Optimal medicine treatment (OMT) 血栓溶解劑注射 (Thrombolysis) V O Mortality rate, reinfarction rate, revascularization, freedom from angina Mortality rate, re-infarction rate, complications V 21
http://www.casp-uk.net/ STEP 3:Critical appraisal Systematic Review Checklist
1. Did the review address a clearly focused question? 此篇綜論問題明確? Yes Cannot tell No Systematic Review Checklist
2. Did the authors look for the appropriate sort of papers? 作者有找尋適當類別之文獻? Yes Cannot tell No 納入 12 篇 Systematic Review Systematic Review Checklist
3. Do you think the important, relevant studies were included? 重要 相關的研究都有被納入? Yes Cannot tell No 搜尋 PUBMED EMBASE 及 Cochrane Central, 共納入 12 篇 Systematic Review Systematic Review Checklist
4. Did the review s authors do enough to assess the quality of the included studies? 綜論作者是否對納入之研究有做足夠之評估? Yes Cannot tell No Two independent reviewers (S.P., F.K.) abstracted data from included studies using a uniform data abstraction form for each study, with the second reviewer reentering data using double-data entry. Data abstracted included study characteristics, patient characteristics, details regarding the intervention and comparison group, and outcome measures. For the primary (all-cause mortality) and each of the secondary (cardiovascular death, nonfatal MI, repeat revascularization, and freedom from angina) outcomes, crude data was collected for the PCI and OMT groups. Where available, outcome data were abstracted at multiple follow-up time points. For trials using survival analysis design, 1-year event rates were extrapolated from the Kaplan-Meier survival curves using the Kaplan-Meier rates, in addition to the final time point data. Systematic Review Checklist
5. If the results of the review have been combined, was it reasonable to do so? 若此綜論之結果有被綜合, 合理嗎? Yes Cannot tell No All-cause mortality: PCI vs OMT RR: 0.85 (95%CI: 0.71, 1.01) Systematic Review Checklist
All-cause mortality: PCI vs OMT RR: 0.85 (95%CI: 0.71, 1.01)
Cardiac death: PCI vs OMT RR: 0. 71 (95%CI: 0.47, 1.06)
Nonfatal MI: PCI vs OMT RR: 0. 93 (95%CI: 0.70, 1.24)
Revascularization: PCI vs OMT RR: 0. 93 (95%CI: 0.76, 1.14)
Freedom from angina: PCI vs OMT RR: 1.20 (95%CI: 1.06, 1.37)
6. What are the overall results of the reviews? 主要結果如何呈現? Conclusions In this most rigorous and comprehensive analysis in patients with stable coronary artery disease, PCI, as compared with OMT, did not reduce the risk of mortality, cardiovascular death, nonfatal myocardial infarction, or revascularization. PCI, however, provided a greater angina relief compared with OMT alone, larger studies with sufficient power are required to prove this conclusively. Systematic Review Checklist
7. How precise are the results? 結果之精確度如何? All cause mortality: Chi 2 =3.98, df=2 (p=0.14,) I 2 =49.7% Systematic Review Checklist
Cardiac death: Chi 2 =2.86, df=1 (p=0.09,) I 2 =65.1%
Nonfatal MI: Chi 2 =0.27, df=2 (p=0.88,) I 2 =0%
Revascularization: Chi 2 =1.13, df=2 (p=0.57,) I 2 =0%
Freedom from angina: Chi 2 =2.27, df=2 (p=0.32,) I 2 =11.8%
8. Can the results be applied to the local population? 結果可應用在本土的族群對象嗎? Yes Cannot tell No 一篇包含歐洲及亞洲另一篇研究對象為日本人 Systematic Review Checklist
9. Were all important outcomes considered? 重要結果是否都納入考量? Yes Cannot tell No All cause mortality Cardiac death Nonfatal MI Revascularization Freedom from angina 皆納入考量 Systematic Review Checklist
10. Are the benefits worth the harms and costs? 是否提出傷害與成本的利益價值? 文獻內並未強調傷害與成本的利益價值 Systematic Review Checklist
Yes Can t tell No A. Are the results of the review valid? 1 Did the review address a clearly focused question V 2 Did the authors look for the appropriate sort of papers V Is it worth continuing? 3 Do you think the important, relevant studies were included V 4 Did the review s authors do enough to assess the quality of the included studies 5 If the results of the review have been combined, was it reasonable to do so V V B. What are the results? 6 What are the overall results of the reviews PCI 優於適當藥物治療, 病人較無 angina 的問題 7 How precise are the results 部分文章異質性高 C. Will the results help locally? 8 Can the results be applied to the local population V 9 Were all important outcomes considered V 10 Are the benefit worth the harms and costs No description
Oxford Centre for EBM 2011 LOE ( 證據等級 ) :Level I 43
STEP 4 :Evidence application 臨床問題 : 急性心肌梗塞心導管手術是否較血栓溶解劑注射能降低心肌梗塞病人的死亡率 復發率? 找到的證據 : 證據來源 : Circ Cardiovasc Interv. 2012;5:1-15. 證據等級 :Level I 44
STEP 4 :Evidence application Evidence( 研究的證據 ) 研究證據的結果顯示 PCI 較藥物治療能減緩病人心絞痛 研究的病患屬性部分與個案的屬性相符合 PCI 併支架治療健保給付約莫 1 萬多元, 如使用自費之塗藥支架費用可能高達 7 萬元, 藥物治療費用約 2000 元左右, 然出血可能性較高, 但多數研究證據仍認為病人接受 PCI 治療之再梗塞率 中風率及死亡率較低, 就長期而言仍具有成本效益 45
STEP 4 :Evidence application Expectation( 病人的選擇及期待 ) 建議此檢查時宜考量病人的經濟狀況 病人可能贊成的理由為可藉由藥物即可治療心肌梗塞, 但也可能因為導致出血的危險性而反對 與病人討論兩種治療的優缺點及對治療結果的期待, 並建議病人考量自身經濟負擔進行選擇 46
STEP 4 :Evidence application Experience( 臨床的經驗 ) 研究的證據並未與臨床的經驗相衝突 此實證結果可提供醫療人員向病人及家屬解釋其選擇方案時的考量 Environment( 環境因素 ) 推行上須考量醫院專科醫師是否有熟練的技術執行 PCI 治療, 以使治療過程中的合併症發生率降到最低 建議各醫療院所應致力於相關專科醫師之 PCI 培訓, 以增進病人治療的成功率 比較不同之血栓溶解劑對病人的效益, 並建議醫院採購效果較佳之藥物, 以增加病人的選擇性 47
結合實證醫學的結果與臨床專業經驗給予病人建議 我們的臨床建議是 : 可利用心導管手術治療急性心肌梗塞, 其死亡率 再梗塞率及中風率較血栓溶解術低, 且病人較無心絞痛問題, 生活品質能有所改善 此項建議之證據等級 :Level I
謝謝聆聽 請多多指教 49