出凝血功能的常用检测方法.ppt

****FRAXIS对速避凝和赛诺菲来说都不是一个有利的研究。Dr.Leizorovicz代表FRAXIS研究组在1999年ESC上发表了全部结果。其结论最为令人关注和惊讶。在14天三重复合终点(研究的主要终点)各治疗组的疗效相似。三个治疗组为5天静脉普通肝素组；和两个治疗方案，即6或14天的速避凝组(静脉推注，而后皮下注射87units/kg/BID)。对于延长的14天治疗组，Dr.Leizorovicz的结论是：相对于6天组没有附加的临床收益，而且大的出血的风险增加了。**相反，对于FRAXIS研究，两个介绍者和听众都表现出明显的失望。介绍结束后的问题集中在两个研究中的肝素治疗组，特别是在FRAXIS中普通肝素使用了5天，而在TIMI11B中使用了3天。虽然在ESC中并未发表亚组研究的结果，但我们现在知道3天时的亚组分析在TIMI11B研究中是有显著性差异的。**WecansaywithconfidencethatClexane/Lovenoxisnowpoisedtobecomethenewstandard-of-careinthetreatmentofunstableanginaandnon-QwaveMI.WewillbeworkingcloselywithyouoverthenextseveralweeksandmonthstogetthismessageouttoourcustomersandtodifferentiateourselvesfurtheramongtheLMWHs.Clexane/LovenoxistheonlyLMWHtohavedemonstratedasignificantclinicaleffectininTWOwell-controlledclinicalstudies.************Duringtheacutephase,alleligiblepatientsweretreatedwithaspirinandwerethenrandomizedtodouble-blindtreatmenteitherwithUFHforaminimumof3daysbeginningwithabolusof70units/kgandaninitialinfusionof15units/kg/hourtotargetaPTTof1.5-2.5xcontrol(coordinatedthroughanunblindedthirdparty)orenoxaparingivenasanintravenousbolusof30mgfollowedbysubcutaneousinjectionsof1mg/kgevery12hrs.

Theprimaryefficacyendpointwasacompositeofallcausemortality,recurrentmyocardialinfarctionbasedonstandardECGandserummarkercriteria,andurgentrevascularizationdefinedasanepisodeofrecurrentanginapromptingrevascularizationontheindexhospitalizationoronreadmission.

Theprimarysafetyendpointwasmajorbleedingresultingeitherindeath,ableedinaretroperitoneal,intracranial,orintraocularlocation,ahemoglobindropofatleast3grams/decliterortherequirementoftransfusionofatleast2unitsofblood.

Double-blindtreatmentduringtheacutephasecontinueduntilhospitaldischargeor8dayswhic