恩必普软胶囊治疗中度急性缺血性卒中的多中心开放临床研究

The multicentric randomized study of dl-3-butylphthalide in the treatment of acute moderate ischemic stroke

目的 进一步观察国家一类新药dl 3 正丁基苯酞软胶囊(恩必普软胶囊)对中度急 性缺血性卒中的疗效及安全性。 方法 对144例脑梗患者死进行了多中心、随机、对照、开放研 究(Ⅰ组),其中用药组每次口服dl 3 正丁基苯酞软胶囊200mg,4次/d,1个疗程为20d;对照组用 安慰剂替代dl 3 正丁基苯酞软胶囊。对299例患者进行多中心开放研究(Ⅱ组),服药方法同Ⅰ组用 药组。两组患者基础用药均为复方丹参注射液。 结果 Ⅰ组和Ⅱ组总有效率分别为73.1%和 63.9%,治疗后第11天和第21天的神经功能缺损量表评分和生活能力状态量表的评分较治疗前, 差异均有显著意义(P<0.05)。dl 3 正丁基苯酞软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(AST)轻度和中度升高为主,Ⅰ组肝功能异常的发生率为 1.4%,Ⅱ组为8.7%。停药后,ALT和AST均可恢复至正常水平。1例患者用药3d后出现腹泻,停 药后症状消失。 结论 dl 3 正丁基苯酞软胶囊对中度急性缺血性卒中的急性期疗效显著,不良反 应可逆,临床应用安全。

Objective To assess the efficacy and safety of dl-3-butylphthalinde in the treatment of acute ischemic stroke. Methods There were two groups divided in this study. Multicentric, randomized, parallel controlled and open study was performed in group I (144 patients ) and multicentric opened study was performed in group II (299 patients). Results The national rating scale score (NRSS) and activities of daily living (ADL) were used for evaluation in this study. Remarkable clinical improvement was found in 73.1% patients (group I) and 63.9% (group II) respectively. There was a significant difference between the two groups on NRSS and ADL assessments on the day 11th and 21st after treatment respectively. Increase of ALT and AST were the main side effects in this study. The incidence of abnormal liver function was 1.4% in group I and 8.7% in group II respectively. ALT and AST were returned normal after stop taking the medications. Diarrhea was found in one patient for 3 days after taking medication, which disappeared after 3 days.Conclusion dl-3-butylphthalinde should be regarde as an effective and safe medication in the treatment of acute moderate ischemic stroke without severe side effects.