急性脑出血中西医结合综合治疗方案研究

Treatment of Acute Intracerebral Hemorrhage with a Comprehensive Protocol of Integrated Chinese and Western Medicine

目的观察中西医结合综合方案治疗急性脑出血的疗效。方法采用多中心、单盲随机对照试验的设计方法,404例患者分别用中西医结合综合(结合组199例)和西医加中药安慰剂(对照组205例)治疗,并观察相关指标。结果与对照组比较,结合组患者治疗后28天和90天时神经功能缺损评分均改善(P<0·05);90天严重致残加病死率(BI<75)降低(P<0·05);90天完全康复和轻微残疾率(BI≥95)提高(P<0·05);90天社会功能活动(FAQ)改善(P<0·01)。不良反应为非感染性腹泻(发生率为5·53%)。结论中西医结合综合治疗方案可改善本病患者90天的神经功能和生活质量,降低严重致残+病死率;其不良反应主要为非感染性腹泻。

Objective To observe the effect and safety of a comprehensive protocol of integrated Chinese and Western medicine （ICWM） in treating acute intracerebral hemorrhage （AICH）. Methods A multi-center, single blinded, random and control clinical trial was adopted with 404 patients with AICH, they were divided into the treatment group （199 cases） treated with ICWM protocol, and the control group （205 cases） treated with Western medicine plus placebo, and AICH related indexes were assessed after treatment. Results Compared with the control group, the neurological deficit score （National Institute of Health Stroke Scale, NIHSS） determined on the 28th and the 90th day after treatment was ameliorated in the treatment group （P 〈 0.01）. Moreover, the 90th day assessment showed that the mortality and severe disability rate was lower （BI〈 75） （P 〈0.05）, the complete rehabilitation and mild disability rate （BI ≥ 95, P 〈 0.05）, and the sociability rate （Functional Assessment Questionnaire,FAQ） were higher （P〈 0.01） in the treatment group than those in the control group. The incidence of adverse reaction was 5.53%, manifested as non-infective diarrhea. Conclusion The ICWM protocol used in this study may improve neural function and quality of life of AICH patients, and reduce the mortality and severe disability rate in those after 90 days＇ treatment, with only non-infective diarrhea as the adverse reaction.