中医药治疗急性缺血中风的多中心随机对照研究

Randomized Multicenter Control Clinical Study on Acute IschemicStroke Treatment with Traditional Chinese Medicine

目的:观察中西医结合综合方案治疗急性缺血性中风的疗效。方法:采用前瞻性、多中心、中央随机、平行对照试验的设计方法,606例患者分别用中西医结合综合(试验组274例)和西医加中药安慰剂(对照组263例)治疗(剔除15例、脱落54例),并观察生活能力水平B I、残障水平mRS。结果:与对照组比较,试验组患者治疗后90天严重致残加病死率(B I<75)降低(P<0.05);90天完全康复和轻微残疾率(B I≥95)提高(P<0.05);90天残障评分(mRS)分段比较,残障程度明显改善(P<0.05)。结论:中西医结合综合治疗方案可改善本病患者90天的生活质量,降低严重致残率,随着随访时间的延长,中西医综合治疗方案有提高患者生存质量的趋势。

Objective ： To observe the effect of a comprehensive protocol of integrated Chinese and Western medicine （ICWM） in treating with acute ischemic stroke. Methods： A multi-center, prospective, random and control clinical trial was adopted with 606 patients of acute ischemic stroke. They were divided into the treatment group （274 cases） treated with ICWM protocol, and the control group （263 cases ）treated with Western medicine plus placebe, and BI, mRS were assessed after treatment. Results： Compared with the control group, the 90th day assessment showed that the severe disability rate was lower （BI 〈 75 ） （P 〈 0. 05 ）, the complete reabilitation and mild disability rate （BI≥95 ,P 〈0. 05 ）, and the disability level （modified Rankin scale mRS） were improved （P 〈 0. 05 ） in the treatment group than those in the control group. Conclusion： The ICWM protocol used in this study may improve neural function and quality of life of acute ischemic stroke patients,and reduce the severe disability rate in those after 90 days＇treatment.