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

1、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

2、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）。GUIDELINES FOR MODERATE STROKEGUIDELINES FOR

3、 SEVERE STROKE2.Cilostazol Stroke Prevention Study II（CSPS II）Background:The efficacy of aspirin and other antiplatelets in secondary prevention of cerebral infarction has been demonstrated in various studies and meta-analyses,mostly conducted in the US and EU.Along with aspirin,ticlopidine,and clop

4、idgrel,cilostazol is recommended for secondary prevention of noncardiogenic cerebral infarction in the Japanese Guidelines for the Management of Stroke.Objective:This study was designed to demonstrate cilostazols non-inferiority to aspirin in secondary prevention of stroke in Japanese patients.Desig

5、n:This is a multi-center,randomized,double-blind study to confirm the safety and efficacy of cilostazol in Japanese cerebral infarction patients compared with aspirin.cilostazol（100mg,twice daily）aspirin（81mg,once daily）.Population studied:Patients who suffered cerebral infarction within 26 weeks pr

6、ior to enrollment and whose symptoms were stable thereafter were randomly assigned to receive either cilostazol or aspirin.The study period is from December 2003 December 2008,with individual patient treatment and observation being between 1 and 5 years.Outcome Measures:The primary endpoint is occur

7、rence：stroke（cerebral infarction,cerebral hemorrhage,or subarachnoid hemorrhage）.The secondary endpoints：recurrence of cerebral infarction,occurrence of ischemic cerebral disorder,occurrence of all-cause death,and occurrence of cerebral infarction,cerebral hemorrhage,subarachnoid hemorrhage,transien

8、t ischemic attack,angina pectoris,myocardial infarction,cardiac failure,and hemorrhage requiring hospitalization.In the randomized,double-blind study of nearly 2,700 patients with non-cardioembolic ischemic stroke,those treated with cilostazol were 25.7%less likely to suffer from a stroke than those

9、 who received aspirin.Strokes occurred in 82 of 1,337 cilostazol-treated patients and in 119 of 1,335 aspirin-treated patients（risk ratio1.33）.A hemorrhagic stroke or hemorrhage that required hospitalization occurred in 23 patients taking cilostazol and 57 of those receiving aspirin-a significant di

10、fference（p0.001）.CombinationManagement of peripheral arterial disease（PAD）requires standard atherosclerotic risk management interventions.However,PAD is often complicated by walking pain（intermittent claudication IC）,which requires symptom-specific therapies as well.Thus,all PAD patients are encoura

11、ged to take antiplatelet agents to reduce the associated risks of major cardiovascular events,and those with IC may also require treatment with cilostazol.Effect on platelet function of cilostazol,clopidogrel,and aspirin,each alone or in combination.Atherosclerosis Supplements 6（2006）1319。As criteri

12、a for inclusion in the trial,26 patients（71.4%males;mean age 65.9 years）were identified who had PAD with IC,an ABI 0.90,and no contraindications to the study drugs.Announcements解释：解释：Antiplatelet Agents Sarpogrelate and Cilostazol AffectExperimentally-induced Ventricular Arrhythmias and MortalityMal

13、e SpragueDawley ratsCardiovasc Toxicol（2008）8:127135pretreated with either SAR or CIL（5 mg/kg/day）for 2 weeksEpi given4,8,16,32,and 64 g/kg at 10 min intervals oruntil death of the animals；Saline-treated animals served as controlsCoronary OcclusionResults1 out of 17 SAR-pretreated rats had an episode of single PVC4 out of 17 CIL-pretreated rats had an average of 1.25 episodes of single PVCs.Among 12 control animals,2 rats developed 1 episode of single PVC.SAR and CIL pretreatments had no significant effects on the baseline ECG variab