CONSENSUS研究PPT课件.ppt

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1、CONSENSUS:CooperativeNorthScandinavianEnalaprilSurvivalStudyPurposeTodeterminewhethertheACEinhibitorenalaprilreducesmortalityinpatientswithseverecongestiveheartfailureReferenceTheCONSENSUSTrialStudyGroup.Effectsofenalaprilonmortalityinseverecongestiveheartfailure.ResultsoftheCooperati

2、veNorthScandinavianEnalaprilSurvivalStudy(CONSENSUS).NEnglJMed1987;316:1429–35.CONSENSUS:CooperativeNorthScandinavianEnalaprilSurvivalStudy-TRIALDESIGN-DesignMulticenter,multinational,randomized,double-blind,placebo-controlledPatients253patientswithseverecongestiveheartfailure(NYHAclas

3、sIV)andheartsize>600(men)or>500mL/m2(women),andreceivingadiureticanddigoxin;patientswithMIinprevious2monthsexcludedFollowupandprimaryendpointPrimaryendpoint:all-causemortality.Mean188daysfollowupTreatmentPlaceboorenalaprilinitiatedat5mgtwicedaily;increasedto10mgtwicedailyafter1weekifno

4、sideeffects,thentomaximum20mgtwicedailyaccordingtoclinicalresponseCONSENSUS:CooperativeNorthScandinavianEnalaprilSurvivalStudy-RESULTS-TrialhaltedearlyonrecommendationofEthicalReviewCommitteebecauseofevidentbenefitofenalaprilSignificantreductioninall-causemortalityinenalaprilgroupat6

5、monthsand1year,withoverallrelativeriskreductionof27%(39vs.54%,P=0.003)ReductioninmortalityentirelyattributedtoreductionindeathduetoprogressionofheartfailureNodifferenceinincidenceofsuddencardiacdeathwithinthetwogroupsNYHAclassimprovedinsignificantlyhigherproportionofenalaprilgroup(42

6、vs.22%,P<0.001)Withdrawalduetohypotensionhigherinenalaprilgroup,butoverallwithdrawalratesimilarinthetwogroupsCONSENSUS:CooperativeNorthScandinavianEnalaprilSurvivalStudy-RESULTScontinued-MonthsafterrandomizationProbability024126127789859824773345924421726Placebo:Enalapril:6810120.20.00

7、.60.40.8CumulativeprobabilityofdeathPlaceboEnalaprilCONSENSUSTrialStudyGroup.NEnglJMed1987;316:1429–35.CONSENSUS:CooperativeNorthScandinavianEnalaprilSurvivalStudy-RESULTScontinued-PMortalityat6months(180days)Mortalityat1year(360days)Totalmortality5566684031270.0020.0010.003All-cause