dl-3-正丁基苯酞治疗中度急性缺血性脑卒中的多中心、随机、双盲和安慰剂对照研究

Effects of dl-3-Butylphthalide on treatment of acute ischemic stroke with moderate symptoms: a multi-center, randomized, double-blind, placebo-control trial

目的 观察国家一类新药dl 3 正丁基苯酞胶囊治疗中度急性缺血性脑卒中的疗效以及安全性。方法 在使用复方丹参静脉点滴的基础上,对201例首次发作的72h以内的颈内动脉系统急性脑梗死患者进行了多中心、随机、双盲和安慰剂对照研究。神经系统功能评分采用的是全国第四届脑卒中会议制定的标准。结果 总有效率(基本痊愈+显著进步)为70 3% (64 /91),对照组为40 4% (40 /99) (P<0 01);神经功能缺损量表评分在治疗后第11天和第21天分别为12 62±7 73和8 98±7 55,明显优于对照组的15 63±7 25和12 42±7 35 (P<0 01);生活能力状态量表的评分在治疗后第11天和第21天分别为3 42±1 46和2 51±1 65,改善的程度明显优于对照组的3 83±1 29和3 20±1 48(P<0 01)。dl 3 正丁基苯酞胶囊的主要不良反应是肝功能异常,以丙氨酸氨基转移酶(ALT)和天冬氨酸氨基转移酶轻和中度升高为主,两者的异常率分别为17 5%和6 2%。1例受试者ALT升高持续最长时间为40d;其他少见的副作用是消化道症状等,以上副作用均随停药而消失。结论 dl 3 正丁基苯酞胶囊对中度缺血性脑卒中的急性期治疗是有效的,副作用是可逆的,临床应用是安全的。

Objective To assess the efficacy and safety of dl-3-butylphthalide in the treatment of acute ischemic stroke.Methods Totally 201 patients fulfilled the following criteria: first attack of ischemic stroke from internal carotid artery; time window in 72 hours after onset. Compound “Dan Shen” was used as the baseline therapy. The national rating scale score (NRSS) was used for evaluation in this multi-center, randomized, double-blind and placebo-control study.Results Out of the 91 patients, 64 (70.3%) showed a clinical improvement in the treatment group and 40 (40.4%) of the 99 patients in the control group. There was a significant difference between the two groups on NRSS, which was 12.62±7.73 and 8.98±7.55 in treatment group and 15.63±7.25 and 12.42±7.35(P<0.01)in the control group on the day 11th and 21st respectively.Activity of daily living was 3.42±1.46 and 2.51±1.65 in treatment group and 3.83±1.29 and 3.20±1.48(P<0.01)in the control group on the day 11th and 21st respectively. Increased alanine aminotransferase(ALT) and aspartate aminotransferase were found in 17.5% and 6.2% respectively. 40 days increased ALT was only found in 1 patient. Nausea and vomiting were found in a few patients which did not discontinue the therapy.Conclusion dl-3-butylphthalide should be regarded as an effective and safety treatment for ischemic stroke with moderate symptoms and a treatment without severe side effects since.