目的：观察中医综合康复方案治疗缺血性中风患者早期康复的临床疗效和安全性，并探索虚拟事实因果模型在实用性RCT疗效评价中的应用。方法：采用实用性RCT，通过中央在线随机系统，将300例缺血性中风患者随机分为试验组200例，对照组100例。试验组采用中医综合康复方案，对照组采用西医综合康复方案，治疗14天。分别于治疗前后观察评价NIHSS、Fugl-Meyer量表、Ashworth痉挛评定量表，并采用虚拟事实因果模型进行中医综合康复方案的疗效评价。结果：试验组改善Fugl-Meyer积分比对照组好7.748分，且有统计学差异（P<0.05）；试验组改善NIHSS积分比对照组好0.757分，改善Ashworth积分比对照组好0.058分，但均无统计学差异（P>0.05）。没有发现严重不良反应。结论：中医综合康复方案对缺血性中风患者的早期康复有一定的治疗作用；虚拟事实因果模型可用于实用性RCT的疗效评价。

This work aimed to study the effect and safety of the TCM synthetic rehabilitation project for the patients with acute cerebral Ischemic stroke and to explore the application of the counterfactual model in clinical effectiveness evaluation of the pragmatic randomized controlled trial. 300 patients were divided into two groups by the central randomization system. The study group, with 200 cases, was treated with the TCM synthetic rehabilitation project, and the control group, with 100 cases, was treated with the synthetic rehabilitation project of western medicine. The patients were treated for 2 weeks. Before the treatment and at the end of the 2-week treatment, the indexes including NIHSS were used for evaluating the neurological deficit degree, the motor function score (Fugl-Meyer) for evaluating the motor function, and the modified Ashworth convulsion rating scale for evaluating the convulsion degree. The safety index was defined by adverse observation events. The score of the amelioration motor function was better in the treatment group than in the control group, with statistical difference between the two groups(P<0.05). The scores of the amelioration neural function and convulsion were better in the treatment group than in the control group, but with no statistical difference between these two groups(P>0.05). The results indicated that the treatment group had the therapeutic strength in improving the motor function. No serious adverse events were observed. Taken together, the TCM rehabilitation project of ischemic stroke shows some superiority to the western medicine rehabilitation program in improving the motor function, while both groups can improve the neural function and spasmodical degree, with no difference between them.

国家高技术研究发展计划“863”计划（2007AA02Z4B2）：缺血性中风早期康复和避免复发中医方案研究，负责人：谢雁鸣。