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EBM

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EBM

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  1. EBM 98.10.22 報告:沈智偉醫師 指導老師:董淳武醫師

  2. 情境

  3. 王爸爸今年65歲,因糖尿病腎病變於今年八月份因為尿毒症引起的噁心嘔吐和食慾不振,開始接受血液透析治療.目前的透析管路是右側內頸靜脈的Permanent Catheter,透析的狀況良好,食慾已經有很明顯的改善.為了避免管路感染的問題,他聽從了查房的主治醫師的建議,已於三周前在他的左手前臂接受了動靜脈人工廔管(arteriovenous graft)的植入手術.目前graft的功能還不錯預計在一周後會開始嘗試使用.

  4. 隔壁床的70歲的龐媽媽,今天早上要來醫院透析前突然發現自己的人工血管沒有聲音了,所幸在急診室經由心臟內科醫師緊急的利用導管將狹窄處以氣球擴張(ballon angioplasty)並將血栓清除(thrombectomy)後,目前已可正常使用.但是卻也因為這一項導管手術造成手臂嚴重瘀青而疼痛不已.

  5. 王爸爸因為聽到龐媽媽因為疼痛發出的呻吟聲而感到煩惱不已.因為王爸爸和龐媽媽一樣都是graft而且龐媽媽也是今年一月才新做的arteriovenous graft,今天已是她第二次接受導管血栓清除手術了.女兒王小姐很關心的詢問醫師說除了熱敷和握球運動以外,難道不用吃藥來避免人工血管阻塞嗎?你是否可以提供相關資訊給他??

  6. AVG stenosis • Dialysis access:The most common cause of arteriovenous failure is thrombosis,which is most commonly secondary to progressive venous outflow stenosis followed by occlusion

  7. 5As of EBM • Ask : ask an answerable question • Acquire : track down the best evidence • Appraisal : validity, impact, applicability • Apply : to patient’s problem • Audit : effectiveness

  8. Ask • Patient: • DM with nephropathy and progressed to ESRD • Had arteriovenous graft created • Intervention:any medication • Comparison:placebo • Outcome: arteriovenous graft thrombosis

  9. Acquire

  10. Acquire Pubmed • Main serch: • Arteriovenous graft • Antithrombosis • Advanced Search: • randomised trials or meta-analysis

  11. Acquire

  12. Acquire allEBM review • Main serch: • Arteriovenous • antithrombosis

  13. Acquire • Antiplatelet Agents Reduce Risks for Death, Stroke, Myocardial Infarction, Deep Venous Thrombosis, and Arterial Occlusion • Double-blind randomized trial of the effect of ticlopidine in arteriovenous fistulas for hemodialysis • Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial • No suitable paper for our PICO

  14. Appraisal • 選擇的文獻是否適當 • 選擇的文獻能有效回答問題 • 各研究的結果是否相似

  15. Appraisal • Selection criteria:RCTs of active drug versus placebo in patients with ESRD undergoing haemodialysis via an A-V fistula or prosthetic interposition AV graft • level IA • Outcome:measure analysed was the long-term fistula or graft patency rate

  16. 是否有遺漏重要文獻 • All randomised trials from electronic searches of MEDLINE (1966 to date), EMBASE (1980 to date) and CINAHL (1982 to date)

  17. Andrassy 1974 Crowther 2002 Fiskerstrand 1984 Grontoft 1985 Grontoft 1998 Harter 1979 Michie 1977 Schmitz 2002 Sreedhara 1994 Trimarche 2006 All randomised controlled studies Characteristics of included studies

  18. Quality of trials A (low risk of bias) B (moderate risk of bias) C(high risk of bias)

  19. Andrassy 1974 Data base 92 Aspirin 500mg VS placebo

  20. Harter 1979 Data base 44 Aspirin 160 mg VS placebo

  21. Crowther 2002 Data base 107 Warfarin VS placebo

  22. Fiskerstrand 1984 Data base 18 Ticlopidine 250mg VS placebo

  23. Grontoft 1985 Data base 42 Ticlopidine 250 mg VS placebo

  24. Grontoft 1998 Data base 254 Ticlopidine 250mg VS placebo

  25. Michie 1977 No show data base Sulfinpyrazone 200 mg VS placebo

  26. Schmitz 2002 Data base 24 fish oil VS placebo

  27. Sreedhara 1994 Data base 108 1.Dipyridamole 75 mg +aspirin 325mg 2.Dipyridamole 75mg 3.Aspirin 325 mg 4.placebo

  28. Trimarche 2006 Clopidogrel VS placebo

  29. Characteristics of excluded studies

  30. Mata-analysis

  31. Aspirin versus placebo Aspirin 500 Aspirin 160 Aspirin 325 Reduce thrombosis by 58% Cochran Q ( P < 0.1 ) (Q/df) > 1 確定有差異

  32. Ticlopidine versus placebo All use ticlopidine 250 mg Reduce thrombosis at one month by 53% Cochran Q is not statistically significant But (Q/df) > 1,可能有差異

  33. Dipyridamole versus placebo 無顯著差異

  34. Dipyridamole + aspirin versus placebo 無顯著差異

  35. Warfarin versus placebo 無顯著差異

  36. Fish oil versus placebo 有顯著差異

  37. Clopidogrel versus placebo 有顯著差異

  38. NEJM N ENGL J MED 360;21 NEJM.ORG May 21, 2009

  39. Method

  40. Include • > 18 y/o • a new arteriovenous graft placed for the purpose of hemodialysis • Currently undergoing long-term hemodialysis • Expected to undergo it within 6 months

  41. Exclude • Pregnant or breast-feeding • Increased risk of bleeding or a known bleeding disorder • Active esophagitis, gastritis, or peptic ulcer disease • Platelet count of less than 75,000 • Advanced liver disease; or required an anticoagulant or antiplatelet agent other than aspirin • Allergy to aspirin or dipyridamole

  42. Study Design and Procedures • Randomization • One capsule contain 200 mg of extended-release dipyridamole plus 25 mg of immediate-release aspirin • identical-looking placebo • Followed monthly by ultrasound • From July 31,2003~Jaunary 31,2008

  43. Randomization • According to the center and access location(forearm or alternative site) with the use of a random permuted-block design • Patients were unaware of the treatment assignments

  44. Outcome • Primary outcome: • Loss of primary unassisted graft patency, defined as the first occurrence of graft thrombosis, an access procedure performed to correct a stenosis of 50% or more of the diameter of the adjacent normal vessel, or other surgical modification of the graft

  45. Outcome • Referred to Angiography: • flow <600ml per minute • less than 1000 ml per minute and the reduction from the baseline rate was more than 25%

  46. Outcome • Secondary outcomes: • Cumulative graft failure • Death from any cause • Combined outcome of death from any cause

  47. Statistical Analysis • Cox proportional-hazards • Basis: • clinical center • Access location (forearm or other site) • Adjustment • serum albumin level • use of ACEI of ARB

  48. Statistical Analysis • Aimed to enroll 1056 patients for statistical power • provide a statistical power of 85% to detect a 25% reduction in the incidence of the primary outcome, with a two-sided type I error rate of 5%.