西洛他唑的最新研究及存在的问题_精品文档PPT课件下载推荐.ppt
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试验对象:
采用随机、双盲、安慰剂对照的方法,平均随访2年,病例来自日本183个临床研究所,1052例受试者参与试验。
西洛他唑组:
526例安慰剂组:
526例排除排除标准:
准:
既往有脑出血病史;
既往或未来可能有心源性脑栓塞或任何相关的并发症;
严重的脑梗死导致日常生活能力丧失,生活不能自理者;
痴呆;
对西洛他唑有禁忌证者。
入入选标准:
年龄80岁;
在1992年4月1996年3月患脑梗死的患者,如果该患者在随机入选前16个月发生脑梗死也符合入选标准;
并无严重的并发症;
颈内动脉、基底动脉系统的脑梗死均包括在研究范围中。
方法:
治疗组接受西洛他唑100mg,2/d口服,对照组采用安慰剂口服。
平均随访时间:
治疗组651.8d安慰剂组569.7d主要主要终点事件点事件:
脑梗死复发,其次是心肌梗死、颅内出血、短暂性脑缺血发作(TIA)、心绞痛、肺栓塞、静脉血栓形成以及死亡。
2组人群的基线特征包括年龄、性别、临床资料(卒中的类型、梗死灶大小、糖尿病、高血压、心脏病等病史)相匹配。
结果果:
关于终点事件,西洛他唑组有30例脑梗死复发,安慰剂组有57例,年发病率2组分别为3.37和5.78。
西洛他唑组与安慰剂组相比脑梗死复发的相对危险度显著降低(41.7,可信区间为9.262.5),有显著的统计学意义(P=0.015)。
GUIDELINESFORMODERATESTROKEGUIDELINESFORSEVERESTROKE2.CilostazolStrokePreventionStudyII(CSPSII)Background:
Theefficacyofaspirinandotherantiplateletsinsecondarypreventionofcerebralinfarctionhasbeendemonstratedinvariousstudiesandmeta-analyses,mostlyconductedintheUSandEU.Alongwithaspirin,ticlopidine,andclopidgrel,cilostazolisrecommendedforsecondarypreventionofnoncardiogeniccerebralinfarctionintheJapaneseGuidelinesfortheManagementofStroke.Objective:
Thisstudywasdesignedtodemonstratecilostazolsnon-inferioritytoaspirininsecondarypreventionofstrokeinJapanesepatients.Design:
Thisisamulti-center,randomized,double-blindstudytoconfirmthesafetyandefficacyofcilostazolinJapanesecerebralinfarctionpatientscomparedwithaspirin.cilostazol(100mg,twicedaily)aspirin(81mg,oncedaily).Populationstudied:
Patientswhosufferedcerebralinfarctionwithin26weekspriortoenrollmentandwhosesymptomswerestablethereafterwererandomlyassignedtoreceiveeithercilostazoloraspirin.ThestudyperiodisfromDecember2003December2008,withindividualpatienttreatmentandobservationbeingbetween1and5years.OutcomeMeasures:
Theprimaryendpointisoccurrence:
stroke(cerebralinfarction,cerebralhemorrhage,orsubarachnoidhemorrhage).Thesecondaryendpoints:
recurrenceofcerebralinfarction,occurrenceofischemiccerebraldisorder,occurrenceofall-causedeath,andoccurrenceofcerebralinfarction,cerebralhemorrhage,subarachnoidhemorrhage,transientischemicattack,anginapectoris,myocardialinfarction,cardiacfailure,andhemorrhagerequiringhospitalization.Intherandomized,double-blindstudyofnearly2,700patientswithnon-cardioembolicischemicstroke,thosetreatedwithcilostazolwere25.7%lesslikelytosufferfromastrokethanthosewhoreceivedaspirin.Strokesoccurredin82of1,337cilostazol-treatedpatientsandin119of1,335aspirin-treatedpatients(riskratio1.33).Ahemorrhagicstrokeorhemorrhagethatrequiredhospitalizationoccurredin23patientstakingcilostazoland57ofthosereceivingaspirin-asignificantdifference(p0.001).CombinationManagementofperipheralarterialdisease(PAD)requiresstandardatheroscleroticriskmanagementinterventions.However,PADisoftencomplicatedbywalkingpain(intermittentclaudicationIC),whichrequiressymptom-specifictherapiesaswell.Thus,allPADpatientsareencouragedtotakeantiplateletagentstoreducetheassociatedrisksofmajorcardiovascularevents,andthosewithICmayalsorequiretreatmentwithcilostazol.Effectonplateletfunctionofcilostazol,clopidogrel,andaspirin,eachaloneorincombination.AtherosclerosisSupplements6(2006)1319。
Ascriteriaforinclusioninthetrial,26patients(71.4%males;
meanage65.9years)wereidentifiedwhohadPADwithIC,anABI0.90,andnocontraindicationstothestudydrugs.Announcements解释:
解释:
AntiplateletAgentsSarpogrelateandCilostazolAffectExperimentally-inducedVentricularArrhythmiasandMortalityMaleSpragueDawleyratsCardiovascToxicol(2008)8:
127135pretreatedwitheitherSARorCIL(5mg/kg/day)for2weeksEpigiven4,8,16,32,and64g/kgat10minintervalsoruntildeathoftheanimals;
Saline-treatedanimalsservedascontrolsCoronaryOcclusionResults1outof17SAR-pretreatedratshadanepisodeofsinglePVC4outof17CIL-pretreatedratshadanaverageof1.25episodesofsinglePVCs.Among12controlanimals,2ratsdeveloped1episodeofsinglePVC.SARandCILpretreatmentshadnosignificanteffectsonthebaselineECGvariab