注射用血塞通治疗脑梗死恢复期瘀血阻滞证的随机对照研究

A Randomized Controlled Trial of Xuesaitong for Injection in the Treatment of Stagnation of Blood Stasis Syndrome during Cerebral Infarction

目的:评价注射用血塞通(冻干)治疗脑梗死恢复期瘀血阻滞证的有效性和安全性。方法:采用区组随机、盲法、阳性药/安慰剂平行对照、多中心临床研究的方法,选取2012年10月至2014年1月北京中医药大学东方医院收治的脑梗死恢复期患者282例,随机分为观察组(高剂量) 105例、阳性药对照组35例、低剂量组71例及安慰剂组71例。疗程均为15d。观察各组患者治疗前后美国国立卫生研究所卒中量表(NIHSS)评分、改良Rankin量表(mRS)评分、Barthel指数、中医证候积分、各项生命体征及相关实验室检查的变化,并观察不良反应。结果:观察组在改善NIHSS评分、mRS评分、Barthel指数及中医证候方面疗效皆优于阳性药物组、低剂量组、安慰剂组,差异有统计学意义(P <0. 05);观察组与其他各组比较,能明显改善中医单项症状中下肢不遂、口舌歪斜、舌强言謇或不语、偏身麻木、头痛、头晕、唇色紫暗(P <0. 05)。各组不良反应发生率差异无统计学意义(P> 0. 05)。结论:注射用血塞通(冻干)用于脑梗死恢复期疗效好,安全性较高。

Objective:To evaluate the efficacy and safety of freeze-dried Xuesaitong injection in the treatment of cerebral infarction with blood stasis syndrome at the recovery stage.Methods:A total of 282 subjects who were selected from October 2012 to January 2014 in Dongfang Hospital affiliated to Beijing University of Chinese Medicine were randomly divided into experimental(high-dose)group,positive drug group,low-dose group and placebo group with a course of treatment of 15 days.Changes in National Institutes of Health Stroke Scale(NIHSS)score,modified Rankin Scale(mRS)score,Barthel index,the efficacy score of traditional Chinese medicine(TCM)syndromes,vital signs,and related laboratory examination of each group were observed.Moreover,adverse reactions were observed.Results:Compared with the positive drug group,low-dose group and placebo group,the efficacy score of NIHSS,mRS,Barthel,and the TCM syndromes in the experimental group improved(P<0.05).The experimental group had an advantage of TCM syndromes include paralysis of lower limb,skew of tongue and mouth,stiff tongue,dysphasia and aphasia,hemianesthesia,headache,dizziness,oral dark purple(P<0.05).The incidence of adverse reactions showed no statistical differences among each group.Conclusion:Application of freeze-dried Xuesaitong injection in the treatment of cerebral infarction with blood stasis syndrome at the recovery stage presents certain efficacy and high safety.