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...
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Transcript of 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...
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EBM98.10.22::
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65,,.Permanent Catheter,,.,,(arteriovenous graft).graft.
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70,,(ballon angioplasty)(thrombectomy),..
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. graftarteriovenous graft,.,???
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AVG stenosisDialysis access:The most common cause of arteriovenous failure is thrombosis,which is most commonly secondary to progressive venous outflow stenosis followed by occlusion
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5As of EBMAsk : ask an answerable questionAcquire : track down the best evidenceAppraisal : validity, impact, applicabilityApply : to patients problemAudit : effectiveness
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Ask Patient:DM with nephropathy and progressed to ESRDHad arteriovenous graft created Intervention:any medicationComparison:placeboOutcome: arteriovenous graft thrombosis
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Acquire
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AcquirePubmed Main serch:Arteriovenous graftAntithrombosisAdvanced Search:randomised trials or meta-analysis
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Acquire
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AcquireallEBM reviewMain serch:Arteriovenousantithrombosis
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AcquireAntiplatelet Agents Reduce Risks for Death, Stroke, Myocardial Infarction, Deep Venous Thrombosis, and Arterial OcclusionDouble-blind randomized trial of the effect of ticlopidine in arteriovenous fistulas for hemodialysisEffect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trialNo suitable paper for our PICO
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Appraisal
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AppraisalSelection criteria:RCTs of active drug versus placebo in patients with ESRD undergoing haemodialysis via an A-V fistula or prosthetic interposition AV graftlevel IAOutcome:measure analysed was the long-term fistula or graft patency rate
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All randomised trials from electronic searches of MEDLINE (1966 to date), EMBASE (1980 to date) and CINAHL (1982 to date)
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Characteristics of included studies
Andrassy 1974Crowther 2002Fiskerstrand 1984Grontoft 1985Grontoft 1998Harter 1979
Michie 1977Schmitz 2002Sreedhara 1994Trimarche 2006All randomised controlled studies
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A (low risk of bias) B (moderate risk of bias) C(high risk of bias)
Quality of trials
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Andrassy 1974
Aspirin 500mg VS placeboData base 92
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Harter 1979
Aspirin 160 mg VS placeboData base 44
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Crowther 2002Warfarin VS placeboData base 107
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Fiskerstrand 1984Ticlopidine 250mg VS placeboData base 18
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Grontoft 1985
Ticlopidine 250 mg VS placeboData base 42
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Grontoft 1998
Ticlopidine 250mg VS placeboData base 254
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Michie 1977
Sulfinpyrazone 200 mg VS placeboNo show data base
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Schmitz 2002
fish oil VS placebo
Data base 24
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Sreedhara 1994
1.Dipyridamole 75 mg +aspirin 325mg2.Dipyridamole 75mg3.Aspirin 325 mg4.placebo
Data base 108
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Trimarche 2006
Clopidogrel VS placebo
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Characteristics of excluded studies
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Mata-analysis
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Aspirin versus placebo
Cochran Q ( P < 0.1 )(Q/df) > 1
Reduce thrombosis by 58%Aspirin 500Aspirin 160Aspirin 325
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Ticlopidine versus placebo
Cochran Q is not statistically significantBut (Q/df) > 1,Reduce thrombosis at one month by 53%All use ticlopidine 250 mg
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Dipyridamole versus placebo
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Dipyridamole + aspirin versus placebo
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Warfarin versus placebo
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Fish oil versus placebo
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Clopidogrel versus placebo
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NEJMN ENGL J MED 360;21 NEJM.ORG May 21, 2009
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Method
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Include > 18 y/oa new arteriovenous graft placed for the purpose of hemodialysisCurrently undergoing long-term hemodialysisExpected to undergo it within 6 months
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Exclude Pregnant or breast-feedingIncreased risk of bleeding or a known bleeding disorderActive esophagitis, gastritis, or peptic ulcer diseasePlatelet count of less than 75,000Advanced liver disease; or required an anticoagulant or antiplatelet agent other than aspirinAllergy to aspirin or dipyridamole
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Study Design and ProceduresRandomizationOne capsule contain 200 mg of extended-release dipyridamole plus 25 mg of immediate-release aspirinidentical-looking placebo Followed monthly by ultrasoundFrom July 31,2003~Jaunary 31,2008
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RandomizationAccording to the center and access location(forearm or alternative site) with the use of a random permuted-block designPatients were unaware of the treatment assignments
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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
- OutcomeReferred to Angiography:flow
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OutcomeSecondary outcomes:Cumulative graft failureDeath from any causeCombined outcome of death from any cause
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Statistical Analysis
Cox proportional-hazardsBasis:clinical centerAccess location (forearm or other site)Adjustmentserum albumin leveluse of ACEI of ARB
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Statistical Analysis
Aimed to enroll 1056 patients for statistical powerprovide 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%.
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Result
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Study Population
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Baseline Characteristics
Female,Black race And DM history
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Efficacy
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EfficacyPrimary unassisted patency at 1 year:23% VS 28%Median duration of patency:5.8 months VS 4.3 months
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Hazard ratio
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Secondary outcomeAll had no difference in the two group
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Side effect
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Side effectno significant difference between the two study groups with regard to any adverse-event category
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Bias patient in this study,loss of graft patency in one year,higher than 54% originally predictedMay due to our study population;more woman,black race and DM historyMonthly follow up flow of graft,may increase the loss of graft patency incidence
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Apply Aspirin or Ticlopidine or could decrease short term thrombosis;however There is no long term dataFish oil or Clopidogrel or Sulfinpyrazone could decrease decrease short term thrombosis;however data number was small and there is no long term dataWarfarin had no benefit
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Suggestion Could use Aspirin(500mg or 160mg) or Ticlopidine(250mg) or dipyridamole (200mg)+aspirin (25mg) if patient has no bleeding tendency
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Discussion If there is no obvious side effect,why not try antiplatelet?short term thrombosishemodialysis?