Objective: To evaluate the efficacy and safety of Dahuoluo capsules in the treatment of atherosclerotic thrombotic cerebral infarction. Methods: A randomized, double-blind and double-simulation, multi-center, superiority trial was conducted, a total of 336 patients with atherosclerotic thrombotic cerebral infarction consistent with the selective standards were randomly allocated to 2 groups. They were treated with Dahuoluo capsule (n -252) or Naomaitai capsule ( n = 84 , control) for 42 days. The main symptoms were observed before and after treatment. Results: The efficacy analysis based on TCM theory showed a significant efficient rate of 37. 30% and a total efficient rate of 88. 89% in Dahuoluo group, which were higher than those (33. 33% and 72. 62% ) in control group (P<0.01). Efficacy analysis for single TCM symptoms showed significant differences between two groups (P<0.05). However, changes in laboratory indexes before and after treatment were similar in two groups. Conclusion : Dahuoluo capsules have a more satisfactory efficacy than Naomaitai capsules, and an equivalent safety in patients with atherosclerotic thrombotic cerebral infarction.%目的:评价大活络胶囊治疗动脉粥样硬化性血栓性脑梗死恢复期的有效性以及安全性.方法:采用随机、双盲双模拟、多中心、优效性检验的方法,以脑脉泰胶囊为对照药物.将336例符合入选标准的动脉粥样硬化性血栓性脑梗死恢复期患者随机分至试验组和对照组,其中试验组252例,对照组84例.试验组服用大活络胶囊;对照组服用脑脉泰胶囊,疗程42d.治疗前后依据主要症状的积分变化来判定疗效.结果:中医证候疗效分析表明,试验组显效率51.59％,总有效率88.89％;对照组显效率33.33％,总有效率72.62％.两组间显效率、总有效率及等级综合比较均有统计学显著差异(P＜0.01);中医证候单项症状主症(上肢不遂、下肢不遂)疗效分析比较均有统计学显著差异(P＜0.05);对两组受试者实验室指标治疗前后变化情况进行统计分析,差异无统计学意义.结论:大活络胶囊治疗动脉粥样硬化性血栓性脑梗死恢复期(中风中经络风痰瘀阻证)的疗效优于脑脉泰胶囊,安全性方面与脑脉泰胶囊相当.
展开▼
