Effects of dl-3-butylphthalide soft capsules on treatment of acute ischemlC stroke: multi-center, randomized, double-blind, double-dummy and aspirin-control study
- VernacularTitle:dl-3-正丁基苯酞软胶囊与阿司匹林治疗急性缺血性脑卒中的多中心、随机、双盲双模拟对照研究
- Author:
Liying CUI
;
Shunwei LI
;
Weiwei ZHANG
;
Guoguang PENG
;
Li HE
;
Dongsheng FAN
;
Yang SHEN
;
Yongjun WANG
;
Xuguang GAO
;
Jianping JIA
;
Jinsheng ZENG
;
En XU
;
Chengyan LI
;
Jia HE
- Publication Type:Journal Article
- Keywords:
Cerebrovascular accident;
Brain iachemia;
Benzofurans;
Randomized controlled trials
- From:
Chinese Journal of Neurology
2008;41(11):727-730
- CountryChina
- Language:Chinese
-
Abstract:
Objective To assess the efficacy and safety of dl-3-butylphthalide on the treatment of acute ischemic stroke. Methods A total of 197 patients who were in the period of 72 hours of first attack of ischemic stroke of internal carotid artery with NIHSS from 5 to 25 scores were enrolled in this multi-center, randomized, double-blind and aspirin-control study. Compound " Dan Shen" was used as a baseline therapy. Results Basical recovery plus significant improvement was seen in 74.7% of the patients in dl-3-butylphthalide group and 60.9% in aspirin group (CMH value 4.0,P=0.047);There was a significant improvement for dl-3-butylphthalide group regarding NIHSS total score, total score difference value and Barthel index on the day 11th and 21st after treatment compared with control group. The main adverse reaction of dl-3-butylphthalide was increased aminotransferase and mainly the slight increase of aspartate aminotransferase, by 4.34% and 0 respectively. Conclusion dl-3-butyiphthalide should be regarded as an effective and safe treatment for ischemic stroke and a treatment without severe side effects.