缺血性卒中抗栓循证治疗培训课件.ppt
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1、缺血性卒中抗栓循证治缺血性卒中抗栓循证治疗疗证据等级I类证据随机对照试验,假阳性和假阴性错误低II类证据随机对照试验,假阳性和假阴性错误高III类证据非随机对列研究IV类证据回顾性非随机对列研究,V类证据经验性研究Cook et al.,Chest,1992;102:305S-311S缺血性卒中抗栓循证治疗2急性缺血性卒中溶栓治疗缺血性卒中抗栓循证治疗3概述 静脉溶栓 组织纤溶酶原激活物(tPA)NINDS ECASS I&II,ATLANTIS 链激酶 MAST-I,MAST-E,ASK 动脉溶栓 前循环:大脑中动脉(PROACT II)后循环:基底动脉 缺血性卒中抗栓循证治疗4 与安慰剂相
2、比,3h内IV rtPA(0.9 mg/kg)能改善90天时的预后 出血发生率为 6.4%,安慰剂为 0.6%,但死亡率无差异 所有亚组预后均优于安慰剂组 益处可持续1年rt-PA:NINDS 缺血性卒中抗栓循证治疗5 随机,多中心,双盲,安慰剂对照 620例;排除CT早期梗塞灶(预后不良)干预 rtPA(1.1 mg/kg)vs.placebo 起病6h内 主要终点 Barthel Index and modified Rankin Scale at 90 days rtPA 与安慰剂组无明显差别rt-PA:ECASS IHacke et al.,JAMA.1995;274:1017-102
3、5缺血性卒中抗栓循证治疗6 随机,多中心,双盲,安慰剂对照 800 例;排除CT早期明显梗塞灶 干预 rtPA(0.9 mg/kg)vs.placebo 起病6h内 主要终点 modified Rankin Scale Score of 1 at 90 days rtPA 与安慰剂组无明显差别rt-PA:ECASS IIHacke et al.,Lancet.1998;352:1245-1251缺血性卒中抗栓循证治疗7 随机,多中心,双盲,安慰剂对照 613例 干预 rtPA(0.9 mg/kg)vs.placebo 起病3-5h内 主要终点 NIHSS of 1 at 90 days rtP
4、A 与安慰剂组无明显差别rt-PA:ATLANTISAlteplase Thrombolysis for Acute Noninterventional Rx in Isch StrokeClark et al.,JAMA.1999;282:2019-2026缺血性卒中抗栓循证治疗8rt-PA:小结 与安慰剂相比,3h内IV rtPA(0.9 mg/kg)能改善90天时的预后.I 类证据 目前证据显示,超过3h 予IV tPA 无效.I 类证据缺血性卒中抗栓循证治疗9链激酶(SK)研究药物剂量治疗窗结果Multicenter Acute Stroke Trial-Europe(MAST-E)N
5、EJM 1996;335:145-50SK1.5 MU6hSK组出血和死亡率高提前终止试验Multicenter Acute Stroke Trial-Italy(MAST-I)Lancet 1995;346:1509-14SK aspirin1.5 MU300 mg/d6hSK组,尤其是SK+aspirin组出血和死亡率高提前终止试验Australian Streptokinase Trial(ASK)Donnan et al.,Lancet 1995;345:578-9SK1.5 MU4h提前终止;治疗窗4h无明显益处,结果不良与安慰剂相比,6h内予IV SK 1.5 MU 预后不良(出血
6、和死亡率高).I 类证据缺血性卒中抗栓循证治疗10动脉溶栓 前循环 大脑中动脉阻塞 后循环 椎基底动脉阻塞缺血性卒中抗栓循证治疗11 与安慰剂相比,6h内予IA ProUK 经造影证实MCA M1 或M2 段阻塞的患者有效.I 类证据 15%绝对有效(number needed to treat=7)增加颅内出血,死亡率无差异PROACT II:小结缺血性卒中抗栓循证治疗12急性椎基底动脉阻塞 数项病例报道(IV、V 类证据)非随机化 无对照组 Brandt et al.,Cerebrovasc Dis,1995;5:182-7缺血性卒中抗栓循证治疗13小结 3h内静脉用 tPA 能降低90天
7、时的残障功能.I类证据 静脉用链激酶(1.5 MU)增加出血和死亡率.I类证据 6h内动脉用尿激酶前体(Pro-UK,未被FDA通过)能降低90天时的残障功能.I类证据 有证据支持在急性椎基底动脉阻塞中应用动脉溶栓.IV、V类证据缺血性卒中抗栓循证治疗14急性缺血性卒中抗凝治疗缺血性卒中抗栓循证治疗15概述 肝素 LMW heparin LMW heparinoid-作用于抗凝血酶 III(抑制凝血因子 IIa,IXa,and Xa)1 effect on Xa reduced plt interaction longer half-life simpler to administer low
8、er bleeding risk reduced effect on IIa缺血性卒中抗栓循证治疗16Summary:trial resultsNdrugresultsCanadian225Hep IVno differenceIST19,435Hep scno differenceTOAST1281heparinoidno differencelarge art better at 3 mo?HK308LMWH dead/dep at 6 moFISS767LMWHno differenceTAIST1486LMWHno differenceTOPAS404LMWHno difference
9、 among doses缺血性卒中抗栓循证治疗17各卒中亚型急性抗凝治疗 房颤 和心源性栓塞 大动脉粥样硬化 椎基底动脉阻塞 TIA 进展性卒中 动脉夹层 静脉血栓形成缺血性卒中抗栓循证治疗18各卒中亚型急性抗凝治疗:小结CCTsubgrpNresults心源性栓塞123618no diff大动脉硬化0413,2851+(?)/3-后循环032318no diffTIA1055no diff进展性卒中20204no diff夹层00286no diff静脉血栓20791+/1-缺血性卒中抗栓循证治疗19小结急性期抗凝减少深静脉血栓和肺栓塞发生,不增加颅内出血几率.I类证据 缺血性卒中抗栓循证治
10、疗20急性缺血性卒中阿司匹林治疗急性缺血性卒中阿司匹林治疗缺血性卒中抗栓循证治疗21International Stroke Strial(IST)ASA 300 mg/d x 2 wks begun within 48 hrs2 wk endptsASAN=9720No ASAN=9715Recurrent ischemic2.8%*3.9%All recurrent stroke3.7%4.6%Major extracranial bleed1.1%*0.6%Death9.0%9.4%*p.01缺血性卒中抗栓循证治疗22Chinese Acute Stroke Trial(CAST)Lan
11、cet 1997;349:1641ASA 160 mg/d x4 wks begun within 48 hrs4 wk endptsASAN=10335PlaceboN=10320Recurrent ischemic1.6%*2.1%All recurrent stroke3.2%3.4%Major extracran bleed0.8%*0.6%Death3.3%*3.9%*p.05缺血性卒中抗栓循证治疗23小结小结基于 IST 和 CAST,阿司匹林在急性缺血性卒中后2-4周内,每1000例患者中有10人可减少死亡和复发。缺血性卒中抗栓循证治疗24非心源性卒中二级预防:非心源性卒中二级预
12、防:抗栓治疗抗栓治疗缺血性卒中抗栓循证治疗25概述 抗血小板药Antiplatelet.阿司匹林Aspirin抵克立得(噻氯匹啶)Ticlid(Ticlopidine)波力维(氯吡格雷)Plavix(Clopidogrel)艾诺思Aggrenox(aspirin+extended-release dipyridamole)Warfarin for non-cardioembolic arterial stroke:including large vessel disease.抗磷脂抗体综合征(ASP).颈椎动脉夹层.缺血性卒中抗栓循证治疗26Aspirin缺血性卒中抗栓循证治疗27高剂量阿司匹
13、林随机对照试验#StudyASA dose#of ptsAgef/u Prim.Endpoint%of RR1AITIA 1977Medical group1300mgA 88;P 9060.237mTIA,CI,RI,death20 only with TIA.*P(15.7)2AITIA 1977 surgical group650mgA 65;P 6060.3?TIA,CI,RI,deathSame as medical*P(15.7)3CCSG 1978ASA+SP1300mgA 144;P 139?26mTIA,S,death-6 to 31%*P(7.6)4Reuther 1978
14、1500mgA 29;P 295924mTIA,SNS*P(8.3)5AICLA 1983ASA+DP990mgA 198;P 20463.536mFatal;nonfatal CI no TIA included41*P(7.5)6Danish CS 19831000mgA 101;P 1025925mS or Death-77*P(9.6)7Swedish CS 19871500mgA 253;P 2526824mS or Death0*P(10.9)*Risk of vascular events(death,stroke,MI)in the control group缺血性卒中抗栓循证
15、治疗28低剂量阿司匹林随机对照试验#Study ASA dose in mg.#of ptsAgeF/uPrim.Endpoint%in RR1Danish Low 1988(post CEA)50-100A150P15158.925TIA,S,MI,vascular death11%(NS)*P(7.3)2UK TIA 19911200300Placebo81580681459.848Major S,MI,Vasc.Death 15%vs P;NS between doses*P(5.7)3SALT 199175A676P68466.932S or death16%*P(10.6)4ESPS
16、 250A1649P164966.724S,death or both18%*P(15.8)*Vascular events(death,MI,stroke)in placebo.*stroke in placebo缺血性卒中抗栓循证治疗29Antiplatelet Trialists 100,000 pts from 145 trials.All antiplatelet agents were included.Clumped all vascular events together.Overall odds reduction for vascular events was 25%.Fo
17、r pts with minor stroke or TIA(18 trials)antiplatelet agents led to odds reduction of 22%for vascular events and 23%for nonfatal stroke.Did not answer questions about aspirin dose.Used odds ratio instead of relative risk.Used all antiplatelet agents.缺血性卒中抗栓循证治疗30Is there a consensus.The FDA reviewed
18、 trials of aspirin vs placebo(including ESPS-2,SALT,and UK-TIA trials)to reduce the risk of stroke and death in patients with prior TIA or stroke.“The positive findings at lower dosages(eg,50,75,and 300 mg daily),along with the higher incidence of side effects expected at the higher dosage(eg,1,300
19、mg daily),are sufficient reason to lower the dosage of aspirin for subjects with TIA and ischemic stroke.”For“ischemic stroke and TIA:50 to 325 mg aspirin once a day.Continue therapy indefinitely.”FDA.Federal Register.1998;63:56802.缺血性卒中抗栓循证治疗31Ticlopidine 缺血性卒中抗栓循证治疗32TASS Study:Efficacy*3-year stu
20、dy endpoints,N=3,069.EndpointStrokeStroke,MI,orvascular deathRRR21%9%(P=0.024)Hass et al.N Engl J Med.1989;321:501.Easton.In Hass and Easton(eds).Ticlopidine,Platelets and Vascular Disease.New York:Springer-Verlag;1993:141.*Ticlopidine(250 mg bid)vs ASA(650 mg bid).(NS)缺血性卒中抗栓循证治疗33Ticlopidine(%)Asp
21、irin(%)DiarrheaRashNauseaGastritis,ulcer,GI bleedingSevere neutropenia (ANC 450/mm3)Cerebral hemorrhage20.4*11.9*11.1 2.10.9*0.69.85.210.2 6.0*0.00.7*P 0.05TASS Study:Side EffectsAdapted from Hass et al.N Engl J Med.1989;321:501.缺血性卒中抗栓循证治疗34Clopidogril缺血性卒中抗栓循证治疗35CAPRIE StudyEfficacy of Clopidogre
22、l vs.Aspirin(n=19,185)Primary Outcome:MI,Ischemic Stroke,or Vascular DeathARR=0.51NNT=1/0.005=196缺血性卒中抗栓循证治疗36Clopidogrel(%)ASA(%)GI complaintsAny bleeding disorderRashDiarrheaGI bleedingIntracranial hemorrhage1.901.200.90*0.420.520.212.41*1.370.410.270.93*0.33*P 0.05Side Effects causing discontinua
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