华佗再造丸治疗斯拉夫人缺血性脑卒中患者的随机对照试验

A Randomized Controlled Study of Huatuo Zaizao Pill in the Treatment of Ischemic Stroke in Slavic Population

目的:探索华佗再造丸治疗斯拉夫人缺血性脑卒中的有效性和安全性,为华佗再造丸治疗东欧地区的缺血性脑卒中提供研究证据。方法:采用前瞻性的随机对照试验设计,选取2012年11月至2015年8月白俄罗斯明斯克第11临床医院收治的缺血性脑卒中恢复期患者44例作为研究对象,随机分为对照组和观察组。对照组给予常规治疗,观察组在对照组的治疗基础上加用华佗再造丸,8 g/次,2次/d;疗程3个月。治疗结束后,比较2组美国国立卫生研究院卒中量表(NIHSS)评分、巴塞尔指数(BI)评分、改良Rankin量表(mRS)评分、血常规、尿常规、糖化血红蛋白和凝血四项变化,评价华佗再造丸临床应用的有效性和安全性。结果:2组患者人口学特征差异均无统计学意义(均P>0.05)。2组患者治疗1、3个月的NIHSS评分、BI评分和mRS评分差异均无统计学意义(均P>0.05)。与对照组比较,观察组患者治疗1、3个月的NIHSS量表上肢运动项评分下降更多,差异有统计学意义(P<0.05)。2组患者治疗1、3个月的血常规、尿常规、糖化血红蛋白和凝血四项差异均无统计学意义(均P>0.05)。结论:华佗再造丸能改善斯拉夫人缺血性脑卒中上肢运动功能,且安全性良好。华佗再造丸在斯拉夫人中治疗缺血性脑卒中的有效性和安全性得到初步验证,为华佗再造丸在东欧地区缺血性脑卒中患者中的应用提供了研究证据。

Objective:To explore the efficacy and safety of Huatuo Zaizao Pill in the treatment of ischemic stroke in Slavic population, and to provide evidence for the treatment of ischemic stroke with Huatuo Zaizao Pill in Eastern Europe.Methods:In this prospective randomized controlled study, 44 patients with convalescent ischemic stroke at the 11 th Clinical Hospital in Minsk, Belarus, were randomly divided into a control group and an experimental group.The control group was given conventional treatment, while the experimental group was given Huatuo Zaizao Pill, 8 grams each time, twice a day, in addition to the treatment of the control group.After 3 months of treatment, comparison was made between two groups with regard to the National Institutes of Health Stroke Scale(NIHSS) score, Barthel index(BI) score, modified Rankin scale(mRS) score, blood routine, urine routine, glycated hemoglobin and coagulation factors [prothrombin time(PT),activated partial thromboplastintime(APTT),thrombin time(TT),thrombin time(TT)] to evaluate the efficacy and safety of clinical application of Huatuo Zaizao Pill.Results:No significant differences were observed regarding the demographic characteristics and in NIHSS score, BI score and mRS score between the two groups at 1 and 3 months after treatment(all P>0.05).Compared with the control group, the experimental group underwent a remarkable decrease in the NIHSS upper limb exercise score at 1 and 3 months after treatment(P<0.05).There was no significant difference in blood routine, urine routine, glycosylated hemoglobin and coagulation factors between the two groups at 1 and 3 months after treatment(P>0.05).Conclusion:The study suggested that Huatuo Zaizao Pill could significantly improve motor function of the upper limbs of the patients, with good clinical safety.The efficacy and safety of Huatuo Zaizao Pill in the treatment of ischemic stroke in Slavic population have been verified, which provided research evidence for the application of the prescription in patients with ischemic stroke in Eastern Europe.