【医学课件】isis-2研究ppt课件.ppt

,ISIS-2:SecondInternationalStudyofInfarctSurvival,PurposeToassesstheeffectsofintravenousstreptokinase(SK)andoralaspirin,aloneandincombination,shortlyaftersuspectedacuteMIReferenceTheISIS-2collaborativegroup.Randomizedtrialofintravenousstreptokinase,oralaspirin,both,orneitheramong17,187casesofsuspectedacutemyocardialinfarction:ISIS-2.Lancet1988;ii:34960.,天马行空官方博客：,ISIS-2:SecondInternationalStudyofInfarctSurvival-TRIALDESIGN-,Design:Multicenter,multinational,randomized,double-blind,placebo-controlledPatients:17,187patientswithsuspectedMIinprevious24h;patientswithhistoryofstrokeorGIhemorrhage/ulcerwereexcludedFollowupandprimaryendpoint:Median15monthsfollowup.PrimaryendpointvascularmortalityTreatmentPatientsrandomizedtooneoffourgroupsSK(1.5millionUover60min)andaspirin(160mg/dayfor1month)SK(1.5millionUover60min)andplacebomatchingaspirinPlacebomatchingSKandaspirin(160mg/dayfor1month)PlacebomatchingSKandplacebomatchingaspirin,ISIS-2:SecondInternationalStudyofInfarctSurvival-RESULTS-,Significantreductionin5-weekvascularmortalityfor:SKoraspirincomparedwithmatchedplacebo,regardlessoftherapywiththeotheragentoritsplaceboCombinationtherapycomparedwithSKalone,aspirinaloneorcombinationplaceboEffectsofSKandaspirinon5-weekvascularmortalityappearedadditiveandindependentReductioninall-causemortalitysignificantatmedian15monthsforeachagentandforcombination(2P0.001)WithSK,greaterbenefitiftherapygivenearly(04h)ratherthanlate(524h)WithSK,excessreinfarctionandmajor/minorbleeds;withaspirin,excessminorbleedsbutreducedreinfarctionandstrokeCombinationassociatedwithexcessmajor/minorbleedsbutwithgreaterreductioninreinfarctionandstrokethaneitheragentalone,ISIS-2:SecondInternationalStudyofInfarctSurvival-RESULTScontinued-,Daysafterrandomization,Cumulative,no.of,vascular,deaths,0,7,14,21,28,35,50,600,400,200,800,1000,Vascularmortalityover35days:individualtherapies,Oddsreduction:,25%,SD4,2P0.00001,1029,(12.0%),Placebo,infusion,SK,TheISIS-2collaborativegroup.,Lancet1988;ii:34960.,791,(9.2%),0,7,14,21,28,35,50,600,400,200,800,1000,Oddsreduction:,23%,SD4,2P0.00001,1016,(11.8%),Placebo,tablets,Aspirin,804,(9.4%),ISIS-2:SecondInternationalStudyofInfarctSurvival-RESULTScontinued-,Vascularmortalityat35daysinfourtreatmentarmsandcombination,TheISIS-2collaborativegroup.,Lancet1988;ii:34960.,Streptokinase,8.0,Vascularmortality(%)at35days,Aspirin,Placebo,Placebo,13.2,ISIS-2:SecondInternationalStudyofInfarctSurvival-RESULTScontinued-,Monthsafterrandomization,Estimated%surviving,0,12,24,70,100,95,90,85,80,Estimatesof12-and24-monthsurvival,Placebo,infusion,SK,TheISIS-2collaborativegroup.,Lancet1988;ii:34960.,0,12,24,70,100,95,90,85,80,0,12,24,70,100,95,90,85,80,Placebo,tablets,Aspirin,Placebo,infusion,andtablets,ISIS-2:SecondInternationalStudyofInfarctSurvival-RESULTScontinued-,Reductioninoddsofvasculardeathindays035,bytimefrompainonset,Oddsratioand95%CI*,01,2,3,4,Subtotalfor04,512,1324,Subtotalfor524,Totalfor024,TheISIS-2collaborativegroup.,Lancet1988;ii:34960.,0.5,1.0,1.5,0.5,1.0,1.5,Timeofrandomization,(hoursfrompainonset),SK,better,Placebo,better,Aspirin,better,Placebo,better,ISIS-2:SecondInternationalStudyofInfarctSurvival-RESULTScontinued-,Reinfarction,Majorbleed,(transfused),Minorbleed,(nottransfused),Stroke,(excludingTIA),202,18,81,67,238,46,297,61,284,33,163,81,156,31,215,47,123,11,33,45,77,24,167,25,EffectsofSKandaspirinonclinicalevents,TheISIS-2collaborativegroup.,Lancet1988;ii:34960.,Placebo,infusion,(n=8595),SKallocation,Clinical,event,Placebo,tablets,(n=8600),SK,(n=8592),Aspirin,(n=8587),Both,placebos,(n=4300),SKand,aspirin,(n=4292),Aspirinallocation,Combinationtherapy,ISIS-2:SecondIntern