资源描述：
《事与愿违的大型临床试验结果告诉了我们什麽》由会员上传分享，免费在线阅读，更多相关内容在教育资源-天天文库。
1、WhatWehaveLearnedfromtheFailureofLargeClinicalTrials?事与愿违的大型临床试验结果告诉了我们什麽?HUIRutai惠汝太BeijingFuWaiHospital,China北京阜外医院高血压中心主任prioritizestargetlevelsofsomeriskfactors:plasmasugarbloodpresurecholestrolWomen'sHealthInitiativeRCTrevealedthathormone-replacementtherapy,whichreducesLDLcholesterollev
2、els,increasedtheriskofcardiovasculardisease.(Andersonetal.Effectsofconjugatedequineestrogeninpostmenopausalwomenwithhysterectomy:theWomen'sHealthInitiativeRandomizedControlledTrial.JAMA2004;291:1701-1712)ENHANCEENHANCE:EffectofCombinationEzetimibeandHigh-DoseSimvastatinversusSimvastatinAlone
3、ontheAtheroscleroticProcessinPatientswithHeterozygousFamilialHypercholesterolemiaKasteleinetal:NEJM2008,358:1431-1443;Correction:NEJM2008,358:1977ENHANCEshowedthatezetimibedidnotreducetheprogressionofarteriosclerosiswhencombinedwithsimvastatin,ascomparedwithsimvastatinalone,eventhoughthecomb
4、inationdidresultinagreaterreductionofLDLcholesterol.Kasteleinetal:NEJM2008,358:1431-1443;Correction:NEJM2008,358:1977Post-trialStudyUKPDS(UKProtectiveDiabetesStudy)Type-2DM:lowplasmaglucose,Reductioninmicrovascularcomplications.Whetherthetherapycanreducemacrovascularcomplications?降糖治疗试验停止后，持
5、续随访10年的结果HolmanetalNEJM2008:359:AnyDM-relatedEndpoints：suddendeath，deathfromhyperglycemia,hypoglycemia,fatal,non-fatalMI,angina,heartfailure,fatal,non-fatalStroke,renalfailure,amputation,vitreoushemorrhage,retinalphoto-coagulation,blindnessinoneeye,hyperglycemia,Hypoglycemia.Microvasculardis
6、ease:vitreous(玻璃体)hemorrhage,retinalphoto-Coagulation(视网膜光凝术),renalfailure,Follow-up10yearsSulfonylurea-InsulinMetoforminAnyDM-relatedEndpoints9%(P=0.04)21%(P=0.01)MicrovasDis24%(P=0.001)MI15%(P=0.01)33%(P=0.005)DeathfromAnycause13%(P=0.007)27%(P=0.002)与传统限制饮食治疗比较，药物强化治疗HolmanetalNEJM2008:35
7、9:ADVANCETheADVANCE：actionindiabetesandvasculardisease--preteraxanddiamicronMRcontrolledevaluation.Diabetologia2001;44:1118-1120CollaborativeGroupNEJM2008,358:2560-2572ADVANCE11,140patientswithtype2diabetes;Grouped:1.standardglucosecontrol2.intensi
