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期 刊 ：中国中药杂志 2008年 33卷 22期 页码：2692.

关键词：三七通舒胶囊；缺血性脑卒中；

Keywords:Sanqi Tongshu capsule, ischemic stroke,

摘 要 ：目的：观察三七通舒胶囊对轻、中度缺血性脑卒中患者的临床疗效和安全性。方法：采用多中心、无对照、开放试验的方法，1 753例入组患者口服三七通舒胶囊治疗28 d后，观察治疗前后欧洲卒中评分(Europe Stroke Score，ESS)、巴塞尔指数评分(Barthel Index，BI)及不良反应。结果：实际入组患者中有1 742例符合全分析数据集(Full analysis set FAS)，1 676例符合方案数据集(Per Protocol set，PPS)。经三七通舒胶囊治疗后，患者的ESS评分和BI评分均数均分别高于治疗前，差异有显著统计学意义(P<005)。根据ESS和BI评分进行总疗效分析显示，FAS及PPS的有效率分别为8186%和8443%。全组不良反应发生率为344%，反应大多轻微，勿需治疗或停药。结论：三七通舒胶囊治疗缺血性脑卒中疗效确切，安全可靠，未见明显不良反应。

Abstract:Objective: To observe the clinical effect and security of Sanqi Tongshu capsule in treating ischemic strkoe. Method: A multicenter, no dummy, open labeled clincal trail was conducted. 1 753 patient were enrolled in this clinical trial. All patients were treated with the Sanqi Tongshu capsule (200 mg, three times a day) for 28 days. The score of Europe Stroke Score (ESS) and Barthel Index (BI) were evaluated before and after treatment. The adverse reaction occurred in the therapeutic course was also observed. Result: Finally, 1 742 cases and 1 676 cases were respectively assessable by Full analysis set (FAS) analysis and Full analysis set (FAS) analysis. Clinical symptoms markedly improved in patients after treatment, and the score of ESS and BI had significantly improved (P<005). According to the score of ESS and BI, the total effect analysis indicated that the total effective rate in FAS and PPS were 8186% and 8443% respectively. The rate of adverse reaction was 344%, and the raction was so slight that didn’t need to receive therapy or withdral drug. Conclusion: Sanqi Tongshu capsule is effect and secure in treating ischemic stroke without obvious adverse reaction.

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