单唾液酸四己糖神经节苷脂治疗急性脑梗死随机双盲对照多中心研究

A randomized double-blind controlled multicenter study on monosialotetrahexosylganglioside in treatment of acute cerebral infarction

目的:评价国产单唾液酸四己糖神经节苷脂钠注射液(GM1注射液)治疗急性脑梗死的有效性和安全性。方法:本研究采用多中心、随机双盲对照的方法,分别给予试验组(n=67)和对照组(n=70)病人国产和进口GM1注射液100 mg,iv,qd,连续使用14 d。结果:国产及进口GM1注射液对急性脑梗死NIHSS评分及Barthel指数评分治疗前后有显著差异(P<0.05);2组治疗前后NIHSS评分及Barthel指数评分的差值及变化率组间比较无显著差异(P>0.05)。试验组在整个试验过程中没有发生不良反应,实验室检查结果与治疗前及对照组比较没有临床意义。结论:国产GM1注射液对急性脑梗死具有显著的疗效,并且安全性好。

AIM：To evaluate the efficacy and safety of monosialotetrahexosylganglioside sodium （ GM1 ） in the treatment of acute cerebral infarction. METHODS ： A muhicenter, randomized, double-blind, parallel compared study was carried out to compare the efficacy and safety of domestic group （ n = 67 ） and imported group （n =70） after using GM1 100 mg, iv, qd for 14 d in the treatment of acute cerebral infarction. RESULTS：Demestic and imported GM1 before and after treatment showed significant differences of NIHSS score and Barthel exponent score on acute cerebral infarction （P 〈 0.05 ）. The changes of NIHSS score and Barthel exponent score between two groups showed no statistically significant difference （P 〉 0.05 ）. There were no serious adverse drug reactions in the clinical trial of domestic group and the laboratory tests before and after the treatment together with comparison to the imported group showed no clinical significance. CONCLUSION： The domestic GM1 possesses high efficacy and safety in the treatment of acute cerebral infartion.