中西医结合治疗方案对急性缺血中风阴类证患者预后影响的研究

Effect of Integrative Medical Therapy on the Prognosis of Patients Suffering from Yin Syndrome Type Acute Ischemic Stroke

目的观察中西医结合治疗方案对急性缺血性中风(阴类证)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(剔除15例、脱落54例)分为试验组(274例)和对照组(263例),分别用中西医结合疗法和西药加中药安慰剂疗法治疗,并使用中风病专门化生活质量量表(SS-QOL)评价患者生活质量水平,使用改良Rankin量表(modified Rankin Scale,mRS)评价患者残障水平。结果两组在治疗后21天、随访60天mRS评分比较差异均无统计学意义(P>0.05);与对照组比较,试验组随访90天残障程度明显改善(P<0.05);两组不同时间SS-QOL评分比较差异无统计学意义(P>0.05),但试验组有改善患者生活质量的趋势,并且随着随访日期的延长,差异越显著。结论中西医结合治疗方案可降低急性缺血性中风(阴类证)的严重致残率,有改善患者90天生活质量的趋势。

Objective To observe the effect of integrative medical therapy on the prognosis of patients suffering from yin syndrome type acute ischemic stroke （YS-AIS）. Methods A multi-center,prospective,random and parallel controlled clinical trial was carried on 606 patients of YS-AIS. Excepting the 15 patients being excluded and dropped out in the trial period,all patients were assigned to the treatment group （274 patients） treated with integrated medical protocol （i.e. Chinese medical therapy plus conventional Western medical treatment）,and the control group （263 patients） treated with conventional Western medical treatment plus placebo. Patients＇ quality of life （QOL） and their disability level were assessed by scoring based on SS-QOL and modified Rankin scale （mRS） respectively at the terminal of the 21-day treatment （T1） and at the ends of 60-day （T2） and 90-day （T3） following-ups. Results Patients＇ disability level,showed by mRS scores,was not significantly different between the two groups at T1 and T2 （P0.05）,but with significant difference at T3 （P0.05）. The recovery in the treatment group were more significant. Although the SS-QOL scores showed no statistical significant difference between groups （P0.05）,improvement of QOL could be seen in the treatment group and the difference between groups was more significant as the time went by. Conclusion Integrative medical therapy could reduce the severe disability rate in patients after YS-AIS,and showed an improving trend on patients＇ QOL at T3.