脑脉泰胶囊与阿司匹林治疗短暂性脑缺血发作随机对照临床研究.docVIP

脑脉泰胶囊与阿司匹林治疗短暂性脑缺血发作随机对照临床研究 　　摘要：目的 评价脑脉泰胶囊对短暂性脑缺血发作（TIA）病人的治疗作用，探索中药治疗TIA的方法。方法 采用随机、双盲双模拟、1∶1∶1对照、单中心探索性研究，将108例病人分为3组：脑脉泰组、脑脉泰+阿司匹林组、阿司匹林组，每组36例，最终完成103例，脱落5例。观察3组治疗前后症状积分变化及临床疗效。结果 脑脉泰组临床痊愈率、显效率、有效率、无效率分别为20.59%、8.82%、64.71%、5.88%，合并有效率为94.12%；脑脉泰+阿司匹林组临床痊愈率、显效率、有效率、无效率分别为8.57%、37.14%、51.43%、2.86%，合并有效率为97.14%；阿司匹林组临床痊愈率、显效率、有效率、无效率分别为11.76%、14.71%、50.00%、23.53%，合并总有效率为76.47%。3组有效率比较差异有统计学意义（P=0.043 9），PP（符合方案集）分析与ITT（意向性治疗原则）分析结果基本一致。结论 脑脉泰囊胶囊治疗TIA安全有效。 　　关键词：短暂脑缺血发作；脑脉泰胶囊；阿司匹林；症状积分 　　中图分类号：R743 R289.5 文献标识码：A 　　doi：10.3969/j.issn.1672-1349.2014.04.006 　　文章编号：1672-1349（2014）04-0395-04 　　Clinical Observation on Naomaitai Capsule and Aspirin for Treatment of Transient Ischemic Attack 　　Li Qiubing，Yang Xueqing，Tian XinDepartment of Geriatrics，China-Japan Friendship Hospital（Beijing 100029） 　　Abstract：Objective To evaluate the effect of Naomaitai capsule（NMTC） on patients of transient ischemic attack （TIA），and to discover the traditional Chinese medicine（TCM） method on TIA.Methods A random，double-blind，double simulated，and 1∶1∶1 compared and single-center discovery study was adopted.One hundred and eight patients were divided into three groups： NMTC group，NMTC plus aspirin group，aspirin group.Each group has 36 cases.At last，103 cases finished the study，5 cases lost.To observe the change of symptom after treatment of three groups.Results The clinical recovery ratio was 20.59%，remarkable effective ratio was 8.82%，effective ratio was 64.71%，invalid ratio was 5.88%，and total effective ratio was 94.12% in NMTC group.The clinical recovery ratio was 8.57%，remarkable effective ratio was 37.14%，effective ratio was 51.43%，invalid ratio was 2.86%，and total effective ratio was 97.14% in NMTC plus aspirin group.The clinical recovery ratio was 11.76%，remarkable effective ratio was 14.71%，effective ratio was 50.00%，invalid ratio was 23.53%，and total effective ratio was 76.47% in aspirin group.The effective ratio of the three group had remarkable different （P=0.043 9）.An