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外科實證醫學課程 Somatostatin Analogues for Acute Bleeding Esophageal Varices 外科 莊世昌 醫師 執行EBM的五個步驟 ( I ) 1.問問題（可以回答的問題） vConverting the need for information into an answerable question. 2.找資料（可獲得最好的證據資訊） vSearch the database and tracking down the best evidence. 3.分析判斷（文獻的效度與重要性） vCritical appraising that evidence for its validity and importance. 執行EBM的五個步驟 ( II ) 4.臨床應用（整合三大層面） vIntegrating the critical appraising with our clinical expertise and our patients unique biology, values and circumstances. 5.評估成果（執行EBM的效率） vEvaluating our effectiveness and efficiency in executing step 1- 4 and seeking ways to improve them both for next time. Case v王xx 56 y/o male vHepatitis B Hx for 20+ years vLiver cirrhosis since 3+ years vUGI bleeding 2 episodes = Gastroendoscope: EV bleeding vAdmission due to 3rd GI bleeding Background Knowledge Portal pressure (5-8mmHg) 1.Esophagogastric varices : coronary e.g., 80% follow-up) Retrospective cohort study or follow-up untreated control patients in an RCT; or CPG not validated in a test set. B2c “Outcomes” Research“Outcomes” Research B3a SR (with homogeneity*) of case- control studies B3b Individual Case-Control Study C4 Case-series (and poor quality cohort and case-control studies) Case-series (and poor quality prognostic cohort studies) D5 Expert opinion without explicit critical appraisal, or based on physiology bench research or “first principles” Expert opinion without explicit critical appraisal, or based on physiology bench research or “first principles” Seach Result Cochrane標誌及其意義 Cochrane協作網標誌（見圖）由一個圓形圖以及圍繞圓形 圖的兩個粗體同心半環圖共同構成。 每一橫線代表一個試驗結果的可信區間，橫線越短則試 驗精度越高，結果越肯定 垂直線（代表OR=1）將圓一分為二，可用於判斷結果差 別有無統計學意義，以區別治療效果，一般來說具有療 效的試驗結果分佈於垂直線左側;若橫線落在垂直線右 側,則表明治療結果無效。 橫線與垂直線相接觸或相交，則表明該RCT中的不同治 療措施間差異無統計學意義。 圓形圖內下方的菱形符號代表7個RCT的綜合結果。符號 位於左邊表明治療措施有效，位於右邊則表明治療措施 弊大於利。 該圓形圖展示了一項短程價廉的激素類藥物 Hydrocortisone治療可能早產的孕婦療效的隨 機對照試驗系統評價結果。第一個試驗於1972 年報導。至1991年，另外6項試驗結果也相繼報 導，但7個試驗結果不一致，該療法是否利大於害，根據 單個的臨床試驗結果難以確定。而系統評價結果明確肯定 ：Hydrocortisone的確可降低新生兒死於早產併發症的危 險，使早產兒死亡率下降30%-50%。直至1989年，由於沒 有進行相關的系統評價分析和報導，多數產科醫師並未認 識到該項治療措施的效果,成千上萬的早產兒可能因其母 親未接受相應治療而死亡（還耗費更多不必要的治療費用 ）。在臨床醫學中,由於未能根據RCTs製作出及時的、不 斷更新的系統評價而導致以生命為代價的這類例子，不勝 枚舉。 Seach Strategy vMEDLINE (PubMed) from 1966 to Feb 2004 vKey word: (somatostatin or octreotide or vapreotide or lanreotide) combined with (varic* or bleed* or hemorrhag* or hematemesis or melena) vThe Cochrane library vKey word: (somatostatin explode all trees (mesh) or somatostatin* or octreotide or vapreotide or lanreotide) and (varic* or bleed* or hemorrhag* or hematemesis or melena ) Selection Criteria vAll randomised trials comparing somatostatin or analogues with placebo or no treatment in patients suspected of acute or recent bleeding from oesophageal varices. Description of Studies vIncluded 20 trials (2518 patients, average of about 100 patients per trial) vThe dose schedules and length of treatment were quite variable Methodological Quality vDouble-blind: nine trials vBlinding during data analysis: four trials vAll or nearly all (90%) of the randomised patients in the analysis: seven trials vIn four trials, some of the randomised patients were excluded because the source of bleeding was judged to be non-variceal vIn the remaining trials it was not clear whether there had been additional patients that were not accounted for. vThe trials were divided in two groups vHigh-quality group: the allocation of patients to treatment groups had to be concealed and the trials had to be double-blind vLow-quality group Types of Outcome Measures vMortality. vNumber of blood transfusions. vNumber with balloon tamponade. vNumber failing initial haemostasis. vNumber with rebleeding. Results (1) vThe drugs did not reduce mortality signicantly vRelative risk 0.96 (95% condence interval (CI) 0.74 to 1.24) for the high-quality trials v0.79 (95% CI 0.61 to 1.02) for other trials Mortality Results (2) vUnits of blood transfused vRelative risk: 0.7 (0.3 to 1.2) less with drugs in the high-quality trials v1.5 (0.9 to 2.0) less in the low-quality trials. Number of Transfusions Results (3) vNumber of patients failing initial hemostasis was reduced, relative risk 0.67 (0.53 to 0.86). Number Failing Initial Hemostasis Results (4) vRebleeding was not signicantly reduced vRelative risk 0.82 (0.45 to 1.49) in the high- quality trials vRelative risk 0.35 (0.18 to 0.67) in the low- quality trials, Number With Rebleeding Results (5) vUse of balloon tamponade was rarely reported. 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