《CONSENSUS研究》PPT课件教案AddtheauthorandtheaccompanyingtitleCONSENSUS研究CONSENSUS:CooperativeNorthScandinavianEnalaprilSurvivalStudy-TRIALDESIGN-DesignMulticenter,multinational,randomized,double-blind,placebo-controlledPatients253patientswithseverecongestiveheartfailure(NYHAclassIV)and...
AddtheauthorandtheaccompanyingtitleCONSENSUS研究CONSENSUS:CooperativeNorthScandinavianEnalaprilSurvivalStudy-TRIALDESIGN-DesignMulticenter,multinational,randomized,double-blind,placebo-controlledPatients253patientswithseverecongestiveheartfailure(NYHAclassIV)andheartsize>600(men)or>500mL/m2(women),andreceivingadiureticanddigoxin;patientswithMIinprevious2monthsexcludedFollowupandprimaryendpointPrimaryendpoint:all-causemortality.Mean188daysfollowupTreatmentPlaceboorenalaprilinitiatedat5mgtwicedaily;increasedto10mgtwicedailyafter1weekifnosideeffects,thentomaximum20mgtwicedailyaccordingtoclinicalresponseCONSENSUS:CooperativeNorthScandinavianEnalaprilSurvivalStudy-RESULTS-TrialhaltedearlyonrecommendationofEthicalReviewCommitteebecauseofevidentbenefitofenalaprilSignificantreductioninall-causemortalityinenalaprilgroupat6monthsand1year,withoverallrelativeriskreductionof27%(39vs.54%,P=0.003)ReductioninmortalityentirelyattributedtoreductionindeathduetoprogressionofheartfailureNodifferenceinincidenceofsuddencardiacdeathwithinthetwogroupsNYHAclassimprovedinsignificantlyhigherproportionofenalaprilgroup(42vs.22%,P<0.001)Withdrawalduetohypotensionhigherinenalaprilgroup,butoverallwithdrawalratesimilarinthetwogroupsCONSENSUS:CooperativeNorthScandinavianEnalaprilSurvivalStudy-RESULTScontinued-MonthsafterrandomizationProbability024126127789859824773345924421726Placebo:Enalapril:6810120.20.00.60.40.8CumulativeprobabilityofdeathPlaceboEnalaprilCONSENSUSTrialStudyGroup.NEnglJMed1987;316:1429–35.CONSENSUS:CooperativeNorthScandinavianEnalaprilSurvivalStudy-RESULTScontinued-PMortalityat6months(180days)Mortalityat1year(360days)Totalmortality5566684031270.0020.0010.003All-causemortalityPlacebo(n=126)No.(%)Enalapril(n=127)No.(%)CONSENSUSTrialStudyGroup.NEnglJMed1987;316:1429–35.(44)(52)(54)334650(26)(36)(39)Reductioninrelativerisk(%)CONSENSUS:CooperativeNorthScandinavianEnalaprilSurvivalStudy-RESULTScontinued-PCardiacdeathwithin24hofnewsymptomsSuddencardiacdeath(within1hofnewsymptoms)ProgressionofcongestiveheartfailureOthercardiacdeath1914441CardiaccausesofdeathPlacebo(n=126)Enalapril(n=127)CONSENSUSTrialStudyGroup.NEnglJMed1987;316:1429–35.2014222>0.25>0.250.001No.ofdeathsAddtheauthorandtheaccompanyingtitle生活图标元素商务图标元素商务图标元素商务图标元素商务图标元素
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