醒脑通脉胶囊治疗气虚血瘀型脑梗死恢复期有效性的临床研究

Xingnao Tongmai capsule in the treatment of Qi deficiency and blood stasis type of ischemic stroke in convalescence

目的:观察分析醒脑通脉胶囊治疗气虚血瘀型脑梗死恢复期的有效性和安全性。方法:选取150例气虚血瘀型脑梗死恢复期的患者,随机分为醒脑通脉胶囊组、血栓通胶囊组、安慰剂组各50例。对所有患者治疗前后的NIHSS评分、Barthel指数(BI)、改良Rankin量表及中医临床疗效进行观察,比较组间指标差异,并且检测患者治疗前后三大常规、肝肾功能等指标的变化以观察治疗的安全性。结果:治疗后,醒脑通脉胶囊组的NIHSS评分、BI、改良Rankin量表及中医临床疗效评价均优于血栓通胶囊组及安慰剂组(P<0.05或P<0.01),而观察其安全性未见明显不良反应。结论:醒脑通脉胶囊治疗气虚血瘀型脑梗死恢复期疗效显著,且安全性理想。

Objective：To observe and analyse the clinical curative effectiveness and security of Xingnao Tongmai capsule in the treatment of qi deficiency and blood stasis type of ischemic stroke in convalescence.Methods：150cases of patients who were randomly divided into three groups：the Xingnao Tongmai capsule group（50cases）,the Xueshuantong capsule group（50cases）and the placebo group.To observe NIH stroke scale（NIHSS）,Barthel ADL index,modified Rankin scale and the clinical curative effect of traditional Chinese medicine of all the patients before and after the treatment,and compare the differences among the groups.To research the security of the treatment according to the changes of the index about routine blood,urine and faeces examination,liver and kidney function and more.Results：After treatment,all of the NIH stroke scale（NIHSS）,Barthel ADL index,modified Rankin scale and the clinical curative effect of traditional Chinese medicine of the Xingnao Tongmai capsule group were better than the Xueshuantong capsule group and the placebo group（P〈0.05 or P〈0.001）,and the obvious adverse reactions were not found.Conclusion：The curative effect of Xingnao Tongmai capsule in the treatment of Qi deficiency and blood stasis type of ischemic stroke in convalescence is significantly with the ideal security.