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1、缺血性卒中抗栓循證治療證據等級I類證據隨機對照試驗,假陽性和假陰性錯誤低II類證據隨機對照試驗,假陽性和假陰性錯誤高III類證據非隨機對列研究IV類證據回顧性非隨機對列研究,V類證據經驗性研究Cooketal.Chest1992102:305S311S急性缺血性卒中溶栓治療概述靜脈溶栓組織纖溶酶原激活物(tPA)NINDSECASSI&IIATLANTIS鏈激酶MASTIMASTEASK動脈溶栓前循環:大腦中動脈(PROACTII)后循

2、環:基底動脈與安慰劑相比,3h內IVrtPA(0.9mgkg)能改善90天時的預后出血發生率為6.4%,安慰劑為0.6%,但死亡率無差異所有亞組預后均優于安慰劑組益處可持續1年rtPA:NINDS隨機多中心雙盲安慰劑對照620例排除CT早期梗塞灶(預后不良)干預rtPA(1.1mgkg)vs.placebo起病6h內主要終點BarthelIndexmodifiedRankinScaleat90daysrtPA與安慰劑組無明顯差別rtPA

3、:ECASSIHackeetal.JAMA.1995274:10171025隨機多中心雙盲安慰劑對照800例排除CT早期明顯梗塞灶干預rtPA(0.9mgkg)vs.placebo起病6h內主要終點modifiedRankinScaleSceof≤1at90daysrtPA與安慰劑組無明顯差別rtPA:ECASSIIHackeetal.Lancet.1998352:12451251隨機多中心雙盲安慰劑對照613例干預rtPA(0.9mg

4、kg)vs.placebo起病35h內主要終點NIHSSof≤1at90daysrtPA與安慰劑組無明顯差別rtPA:ATLANTISAlteplaseThrombolysisfAcuteNoninterventionalRxinIschStrokeClarketal.JAMA.1999282:20192026rtPA:小結與安慰劑相比,3h內IVrtPA(0.9mgkg)能改善90天時的預后.I類證據目前證據顯示,超過3h予IVtPA

5、無效.I類證據鏈激酶(SK)與安慰劑相比,6h內予IVSK1.5MU預后不良(出血和死亡率高).I類證據動脈溶栓前循環大腦中動脈阻塞后循環椎基底動脈阻塞與安慰劑相比6h內予IAProUK經造影證實MCAM1或M2段阻塞的患者有效.I類證據15%絕對有效(numberneededtotreat=7)增加顱內出血,死亡率無差異PROACTII:小結急性椎基底動脈阻塞數項病例報道(IV、V類證據)非隨機化無對照組Brtetal.Cerebro

6、vDis19955:1827小結3h內靜脈用tPA能降低90天時的殘障功能.I類證據靜脈用鏈激酶(1.5MU)增加出血和死亡率.I類證據6h內動脈用尿激酶前體(ProUK未被FDA通過)能降低90天時的殘障功能.I類證據有證據支持在急性椎基底動脈阻塞中應用動脈溶栓.IV、V類證據急性缺血性卒中抗凝治療概述肝素LMWheparinLMWheparinoid作用于抗凝血酶III(抑制凝血因子IIaIXaXa)1?effectonXaredu

7、cedpltinteractionlongerhalflifesimplertoadministerlowerbleedingriskreducedeffectonIIaSummary:trialresults各卒中亞型急性抗凝治療房顫和心源性栓塞大動脈粥樣硬化椎基底動脈阻塞TIA進展性卒中動脈夾層靜脈血栓形成各卒中亞型急性抗凝治療:小結小結急性期抗凝減少深靜脈血栓和肺栓塞發生,不增加顱內出血幾率.I類證據急性缺血性卒中阿司匹林治療In

8、ternationalStrokeStrial(IST)ASA300mgdx2wksbegunwithin48hrsp.01ChineseAcuteStrokeTrial(CAST)Lancet1997349:1641ASA160mgdx4wksbegunwithin48hrsp.05小結基于IST和CAST阿司匹林在急性缺血性卒中后24周內,每1000例患者中有10人可減少死亡和復發。非心源性卒中二級預防:抗栓治療概述抗血小板藥Ant

9、iplatelet.阿司匹林Aspirin抵克立得(噻氯匹啶)Ticlid(Ticlopidine)波力維(氯吡格雷)Plavix(Clopidogrel)艾諾思Aggrenox(aspirinextendedreleasedipyridamole)Warfarinfnoncardioembolicarterialstroke:includinglargevesseldisease.抗磷脂抗體綜合征(ASP).頸椎動脈夾層.Aspiri

10、n高劑量阿司匹林隨機對照試驗Riskofvularevents(deathstrokeMI)inthecontrolgroup低劑量阿司匹林隨機對照試驗Vularevents(deathMIstroke)inplacebo.strokeinplaceboAntiplateletTrialists’100000ptsfrom145trials.Allantiplateletagentswereincluded.Clumpedallvula

11、reventstogether.Overalloddsreductionfvulareventswas25%.FptswithminstrokeTIA(18trials)antiplateletagentsledtooddsreductionof22%fvularevents23%fnonfatalstroke.Didnotanswerquestionsaboutaspirindose.Usedoddsratioinsteadofrel

12、ativerisk.Usedallantiplateletagents.Isthereaconsensus.TheFDAreviewedtrialsofaspirinvsplacebo(includingESPS2SALTUKTIAtrials)toreducetheriskofstrokedeathinpatientswithpriTIAstroke.“Thepositivefindingsatlowerdosages(eg50753

13、00mgdaily)alongwiththehigherincidenceofsideeffectsexpectedatthehigherdosage(eg1300mgdaily)aresufficientreasontolowerthedosageofaspirinfsubjectswithTIAischemicstroke.”F“ischemicstrokeTIA:50to325mg[aspirin]onceaday.Continu

14、etherapyindefinitely.”FDA.FederalRegister.199863:56802.TiclopidineTASSStudy:Efficacy?3yearstudyendpointsN=3069.Endpoint?StrokeStrokeMIvulardeathRRR21%9%(P=0.024)Hassetal.NEnglJMed.1989321:501.Easton.InHassEaston(eds).Tic

15、lopidinePlateletsVularDisease.NewYk:SpringerVerlag1993:141.Ticlopidine(250mgbid)vsASA(650mgbid).(NS)Ticlopidine(%)Aspirin(%)DiarrheaRashNauseaGastritisulcerGIbleedingSevereneutropenia(ANC450mm3)Cerebralhemrhage20.411.911

16、.12.10.90.69.85.210.26.00.00.7P0.05TASSStudy:SideEffectsAdaptedfromHassetal.NEnglJMed.1989321:501.ClopidogrilCAPRIEStudyEfficacyofClopidogrelvs.Aspirin(n=19185)PrimaryOutcome:MIIschemicStrokeVularDeathMonthsofFollowUpCum

17、ulativeEventRate(%)0481216ClopidogrelAspirin0369121518212427303336Aspirin5.83%5.32%ClopidogrelEventRateperYearP=0.043CAPRIESteeringCommittee.Lancet1996348:13291339.ARR=0.51NNT=10.005=196Clopidogrel(%)ASA(%)GIcomplaintsAn

18、ybleedingdisderRashDiarrheaGIbleedingIntracranialhemrhage1.901.200.900.420.520.212.411.370.410.270.930.33P0.05CAPRIESteeringCommittee.Lancet.1996348:13291339.SideEffectscausingdiscontinuationofdrugCAPRIEStudyManagementof

19、AtherothrombosiswithClopidogrelinHighriskpatients(MATCH)氯吡格雷(75mg)阿司匹林(75mg)與單用氯吡格雷(75mg)的療效進行比較,結果是失敗的兩組的主要終點指標,即缺血性卒中、心肌梗死和血管源性死亡發生率與急性缺血事件(心絞痛、周圍動脈癥狀惡化或TIA)無統計學差異聯合治療同時增加了嚴重出血的概率TheSecondEuropeanStrokePreventionStudy:

20、ESPS2TestedefficacyofASAERDPfsecondarystrokepreventionAddressedclinicalquestionsDoeslowdoseASApreventstrokeDoesERDPpreventstrokeIsASAERDPsuperitoASAaloneToERDPaloneIsASAERDPwelltoleratedTheESPS2Group.JNeurolSci.1997151:S

21、3.Dieneretal.JNeurolSci.1996143:1.ESPS2Results:StrokeRatesat24MonthsPlaceboASAERDPASAERDP048121615.2%12.5%12.8%9.5%Incidence(%)ARR=5.7overPlaceboNNT=10.057=17.5ESPS2:SideEffectProfilePlaceboASAASAEDGIEvent28.1%30.4%32.8%

22、Headache32.3%33.1%38.1%Bleeding4.5%8.2%8.7%(anysite)Lightheadedness30.9%29.1%29.5%=P0.05MetaAnalysis:ASADPvsASAAdaptedfromDiener.Neurology.199851(suppl3):S17.TrialsToulouseTIA(N=284)AICLA(N=400)ACCSG(N=890)ESPS2(N=3299)O

23、verall(N=4873)15%RRRRelativeRisk(ofstrokeMIvulardeath)0.511.522.53ASADPBetterASABetterPreventionRegimenfEffectivelyAvoidingSecondStrokes(PRoFESS)是由30個國家參入,納入18500例患者,為期4年的隨機雙盲多中心試驗,直接比較艾諾思Aggrenox(雙嘧達莫緩釋劑200mg阿司匹林25mg,ER

24、DP200mgASA25mg,2次d)與氯吡格雷(75mg,1次d)在卒中二級預防中的療效,預期結果將在2008年報道。WarfarinAspirinRecurrentStrokeStudy(WARSS)2206patientsfollowedf2yearsISDeathMjrbleed100ptyrsWarfarin17.8%2.22Aspirin16.0%1.49p=.25Nosignificantdifferencebetween

25、warfarinaspirinTheWarfarinAspirinSymptomaticIntracranialDiseasestudy(WASID)多中心前瞻性隨機雙盲試驗華法林INR為2~3,阿司匹林為1300mg兩組的卒中發生率和血管源性病死率無統計學差異華法林組出血并發癥的發生率較高促使試驗提前終止TheWarfarinAspirinSymptomaticIntracranialDiseaseStudy.Neurology.19

26、95Aug45(8):148893.EffectofTreatmentonRecurrentIschemicStrokeDeathAtTwoYearsinAPASSWARSS(BreyRL:presentedatthe27InternationalStrokeConferenceSanAntonioTXFebruary92002)PrimaryEndpoint(%)抗磷脂抗體陽性組與陰性組無差異,阿司匹林與華法林無差異頸動脈和椎動脈夾層

27、Naturalhistyofcarotiddissection:(HartetalNeurolClinNthAm1:1551983)Cerebralinfarctionin33%(23%min10%majfatal.TIAin45Headneckpainin16%Pulsatiletinnitus4%bruitin2%.Propermanagementiscontroversial.Mostptsdowelleitherbecauseo

28、fdespitetreatment.心源性卒中預防:抗血栓治療心源性卒中可能病因Valvularheartdisease心臟瓣膜病Rheumaticmitralvalvedisease風濕性二尖瓣病Prostheticheartvalves人工心臟瓣膜Mitralvalveprolapse二尖瓣脫垂Aticvalvedisease主動脈瓣病Aticarchatherosclerosis主動脈弓粥樣硬化Endocarditis(infec

29、tivenonbacterialthrombotic)心內膜炎(感染性或非細菌性血栓)Atrialfibrillation心房顫動Myocardialinfarction心肌梗死Leftventriculardysfunction左心室功能不全Patentfamenovale卵圓孔未閉Rheumaticmitralvalvedisease:2strokepreventionNoromizedtrialsObservationalstud

30、ies:OACreducerecurrentemboliceventsfataleventsby23me13Extrapolationfrom1largeromizedstudyinNVAF(EAFT)providesadditionaldatafpatientswithRHDAF(butRHDexcluded)1SzekelyPBMJ19641:209122AdamsGFetalJNNP197437:378833Fleming47:5

31、99604LevelIIIIV:BenefitofOACProstheticheartvalves:mechanicalvalves1strokepreventionObservationaldata:APAmaybesufficienttopreventembolisminabsenceofAFbutOACneededtopreventvalvethrombosis12RCT:additionofASA100mgtowarfarin(

32、INR34.5)?cerebralembolism(4186vs.12184)3NonRCT:additionofASA500mgtripledriskofmajhemrhage(14%vs.5%)4LevelIevidence:benefitofOACASAoverOACalone1HartzRetalJThacCVSurg198692:684902RibeiroPetalJThacCVSurg198691:9283TurpieAet

33、alNEJM1993329:52494ChesebroJetalAmJCard198351:153741Prostheticheartvalves:mechanicalvalves2strokepreventionNodirectdataACCPrecommendations:OACbabyASAbasedonextrapolationof1preventiondata6thACCPConsensusConferenceonAntith

34、romboticTherapy2001Prostheticheartvalves:bioprostheticvalves1NunezetalAnnThacSurg198233:3548ButnodifferenceinembolicratewithOAC(4.6%7260)incomparisontoASA(3.7%5135)significantlyhigherrateofhemrhagiccomplications(5.5%vs.0

35、.4%)1(InterestinglylowrateoflateembolisminptswithAFdespitelackofchronicACinbothofthesestudies1prevention:LevelIVevidence:benefitofearlyOACovernoOACLevelVevidence:nodifferencebetweenOAC&ASA2prevention:noevidenceMitralValv

36、eProlapse:2strokepreventionLevelVevidence:neitherASAnACcompletelyeffectiveStrokerecurrenceinMVP:caseseriesMVPAF:extrapolatedatafromEAFT1WatsonRTNeurol197929:88692HansonMetalStroke198011:499506Atherosclerosisofthethacicat

37、a:benefitofOAC50patientswithatheroma4mmLevelIII:benefit34patientswithmobileatheromaLevelIII:benefitFerrariEetalJACC199933:131722主動脈弓粥樣硬化TunickPetalAmJCardiol200290:13205LevelIIIevidence:benefitofstatins主動脈弓粥樣硬化:OACTunick

38、PetalAmJCardiol200290:13205LevelIIIevidence:nobenefitofOAC主動脈弓粥樣硬化:APATunickPetalAmJCardiol200290:13205LevelIIIevidence:nobenefitofAPA主動脈弓粥樣硬化:他汀類TunickPetalAmJCardiol200290:13205LevelIIIevidence:benefitofstatins1strokep

39、reventionRetrospectivedatashownobenefitofOACfnativevalveendocarditis?benefitfprostheticvalveendocarditis152strokeprevention:Nodata感染性心內膜炎1DavenptetalStroke199021:99392PhalisetalEurNeurol199030:8793YehetalCirculation19673

40、5:I77814DelahayeetalEurHeartJ199011:107485WilsonetalCirculation197857:10047LevelVevidencePathogenesis:fibrinthrombidepositsonvalvesassocwithcoagulopathy(usuallyDIC)Reptedincidenceofembolismvaries(1491%)Rx:Retrospectiveda

41、tasuggestbenefitofheparinbutnotOAC1368%withrecurrentemboliwhenheparindc’dICHrisklowerthanininfectiveendocarditis1RogersetalAmJMed198783:746562LopezetalAmHeartJ1987113:773843SacketalMedicine197756:137非細菌性血栓性心內膜炎LevelVevid

42、ence:nobenefitofOACbenefitofheparininTrousseausyndrome(mainlywithDIC)EuropeanAtrialFibrillationTrial:EAFT(Lancet1993342:12551262)alanticoagulants(225)vs.Aspirin(230)HR(95%CI)1Endpoint0.60(.41.87)Allstroke0.38(.23.64)Blee

43、ding2.8(1.74.8)MajbleedingOAC2.8%yrvs.ASA0.9%yrLevelIEvidence:benefitofOACOptimumINRfpreventionof2strokeassociatedwithatrialfibrillation(EAFTNEJM1995333:510)“ThetargetvalueftheINRshouldbesetat3.0”StrokePreventionwiththea

44、ldirectThrombinInhibitinpatientswithnonvalvularatrialFibrillation(SPTIF)SPTIFIII是一項開放試驗SPTIFV期是隨機雙盲多中心試驗;比較了口服直接凝血酶抑制劑西美加群(ximelagatran)與華法林(INR2~3)對心房顫動罹患卒中的影響;兩組預防缺血性卒中的療效無統計學差異,華法林組并發出血的概率較高,西美加群組肝酶升高發生率為6%,比華法林組(0.8%

45、)高很多,這也是尚未獲得美國FDA批準的原因。心肌梗死后一級預防:短期抗凝PrethrombolyticeraHeparindecreasesstrokeincidence13Heparindecreasesmuralthrombus41MedResearchCouncilBMJ19691:335422Drapkin22:1009心肌梗死后一級預防:短期抗凝Postthrombolyticerabaselineratesofdeathr

46、einfarctionstroke&PEmarkedlylowerwiththrombolytics&ASAadditionofheparinLMWHmaydecreasemuralthrombusfmationbutincreasesriskofmajbleedingwithoutfurtherreducingstrokerisk1CollinsetalBMJ1996313:65292CollinsetalNEJM1997336:84

47、7603FRAMIKontnyetalJACC199730:96294SCATILancet19892:18265Gissi2VecchioetalCirculation199184:5129心肌梗死后一級預防:長期抗凝Relativetocontrolcoumarinsinmoderatehighdose(INR24.8)SignificantlydecreasestrokeincidenceSignificantlyincrease

48、incidenceofmajbleedingAn282:205867ModifiedfromAn282:205867…ButnobenefitrelativetoASAIncidenceofstrokesignificantincreaseinmajbleedingRR(95%CI)Anticoagulation.19(.13.27)Aspirin#.44(.29.65)LevelIIIevidence:benefitofACASAf1

49、prevention左心室功能不全:卒中危險因子多變量分析(LohEetalNEJM1997336:251257)similar?riskatalllevelsofEF40%#similar?riskatalllevelsofEF35%Rate(Events100PtYr)Anticoagulation0(040)NoAnticoagulation0.35(1288)LowRiskfPrimaryOccurrence慢性室壁瘤系統栓塞(

50、LapeyreACetalJACC19856:534538)PatentFamenOvaleinCryptogenicStrokeStudy(PICSS)(HommaSetalCirculation2002105:262531)Design:ProspectiveromizeddoubleblindmulticenterclinicaltrialEligibility:EnrolledinWARSSAgreetohaveaddition

51、alTEETreatment:Warfarin(targetINR1.42.8mean2.1)vs.aspirin325mg1endpoint:Recurrentischemicstrokedeathwithin2years601patients42%withcryptogenicstrokeasqualifyingevent34%withPFOPICSSLevelIIEvidence:Nodifferencefromaspirinov

52、erallinanysubgroupNoincreasedeventrateinPFOASAvs.PFOonlyNoincreasedratewithlargerPFOsizeRheumaticMVdz:LevelIIIBenefitovernoOACAticarchatheroma:LevelIIIBenefitoverAPAin1studyNobenefitofOACAPAinanother(butbenefitofstatins)

53、Infectiveendocarditis:Nativevalve:LevelVNobenefitProstheticvalve:LevelV?benefitNBTE:LevelVNobenefit(benefitofheparin)Atrialfibrillation:LevelIBenefitoverASA[INR2.9(2.54.0)]PFO:LevelIINobenefitoverASA(INR1.4–2.8)MVP:Level

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