脉络通治疗动脉粥样硬化性血栓性脑梗死(气虚血瘀证)的临床研究

Clinical research on treating thrombotic cerebral infarction with atherosclerosis (Qi deficiency and blood stasis syndrome) with mailoutong

关键词:  脉络通  动脉粥样硬化  血栓性脑梗死  气虚血瘀证  临床试验

Key words:  Mailuotong  atherosclerosis  thrombotic cerebral infarction  Qi deficiency and blood stasis syndrome  clinical trial

摘要:

[目的]评价脉络通治疗动脉粥样硬化性血栓性脑梗死(气虚血瘀证)的有效性与安全性。[方法]采用随机、阳性药平行对照、非劣效检验的方法进行临床研究。[结果]试验组疗效的总有效率为71.4%;对照组总有效率为69.3%。采用中心分层的CMHχ²统计法,两组差异无显著性统计学意义;非劣结果显示:两组疾病疗效总有效率的非劣效检验成立,全分析集(FAS)与PPS分析结论一致。治疗28d后,试验组、对照组分别有51.5%、43.2%患者生活能力状态有所改善,日常生活自理能力评分分别平均增加11.8分、9.35分,两组比较,差异无显著性统计学意义。未发现不良反应。[结论]脉络通对动脉粥样硬化性血栓性脑梗死(气虚血瘀证)有较好疗效,其疗效不劣于临床常用的步长中风回春胶囊,临床使用安全。

Abstract:

[Objective] To evaluate the effect and safety of Mailuotong in treating atherosclerotic thrombosis of cerebral infarction with Qi deficiency and blood stasis syndrome.[Methods] The clinical research was done with random,positive-medicine paralleled and non-inferiority trial.[Results] There was no significant difference between treatment group and control group.The total effective rate of treatment group was 71.4% while that of control group was 69.3%.The non-inferiority trial on the total effective rate of these two groups established and had a consistent conclusion of FAS and PPS analysis.The 51.5% patients of treatment group and 43.2% patients of control group improved their life quality after treating for 28 days and the scores for daily life abilities increased by 11.8 and 9.35.There was no significant difference and no adverse reaction.[Conclusion] Mailuotong has a better effect in treating atherosclerotic thrombosis of cerebral infarction with Qi deficiency and blood stasis syndrome,compared with the clinical commonly used capsule of Buchang Zhongfeng Huichun capsule.