世界中医药

作者	单位
田文杨1，李楠楠2，孟繁兴2，高芳2，李学军2，马丽珍2，蔡英丽2，陈志刚2	1 北京中医药大学，北京，100029； 2 北京中医药大学东方医院脑病一科，北京，100078

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中文摘要:

目的：评价注射用血塞通（冻干）治疗脑梗死后遗症瘀血阻滞证的安全性和有效性。方法：本研究以灯盏细辛注射液为阳性对照，采用随机、盲法、阳性药对照、多中心临床研究，选取2015年1月至2017年1月7个分中心收治的脑梗死后遗症期瘀血阻滞证患者108例作为研究对象，随机分为观察组（n＝72）和对照组（n＝36）。2组均使用阿司匹林作为基础用药，给药周期为15 d。分别在基线点和试验终点对安全性及有效性指标进行评定。结果：观察组不良事件发生率为4.17%，对照组不良事件发生率为5.71%。2组间不良事件发生率比较差异无统计学意义（P>0.05）。主要疗效指标：1）观察组中医证候疗效、总有效率和愈显率均优于对照组，2组比较差异有统计学意义（P<0.05）；2）美国国立卫生研究所卒中量表（NIHSS）评分疗效：2组试验前后患者肢体功能均有所改善，但2组比较差异均无统计学意义（P>0.05）；3）2组间改良Rankin量表评分比较差异均无统计学意义（P>0.05）。次要疗效指标，1）单项症状疗效统计分析显示：口舌歪斜、舌强言謇或不语、偏身麻木、头晕等症状比较，组间比较差异均有统计学意（P<0.05），观察组疗效优于对照组；上肢不遂、下肢不遂、头痛、口唇紫暗等组间比较，差异均无统计学意义（P>0.05）；2）Barthel指数疗效分析结果显示，用药后Barthel指数及基线与用药后Barthel指数差值和变化率，2组比较差异均无统计学意义（P>0.05）。结论：注射用血塞通（冻干）治疗脑梗死（后遗症期）（瘀血阻滞证）疗效确切，能有效改善患者的中医症状及单项症状，疗效优于灯盏细辛注射液，且本品能有效改善患者的肢体功能和生命质量；临床使用安全，临床不良反应为轻度，无严重的不良事件发生。

English Summary:

To evaluate the efficacy and safety of freeze-dried Xuesaitong Injection in the treatment of sequelae cerebral infarction with blood stasis syndrome.Methods:In this study, Dengzhan Xixin Injection was used as a positive control.A randomized, blind method, a positive drug control, and a multicenter clinical study were used.A total of 108 cases of patients with sequelae cerebral infarction with blood stasis syndrome from 7 centers during January 2015 to January 2017 were selected and randomly divided into an experimental group(Xuesaitong Injection)and a control group(Dengzhan Xixin Injection).Aspirin was used as a base drug in both groups, with a course of treatment of 15 days.Safety and efficacy indexes were evaluated at baseline and at the end of the test.Results:In terms of safety evaluation, the incidence of adverse events was 4.17% in the experimental group and 5.71% in the control group.The incidence of adverse reactions showed no statistical differences among each group(P>0.05).In terms of efficacy evaluation, the primary outcome:The efficacy of TCM syndromes(efficacy of TCM syndromes, total effective rate and increasing apparent rate)in the experiential group was better than that in the control group, and there was statistically significant difference in both groups(P<0.05).The results in National Institutes of Health Stroke Scale(NIHSS)score showed that the limb function of patients in both groups improved, but no statistical differences between two groups(P>0.05).Modified Rankin Scale(mRS)score showed that there was no statistically significant difference between the 2 groups(P>0.05).The secondary outcome:The results of single symptom efficacy showed that comparing the secondary symptom of dizzy and the main symptom of hemianesthesia, deviation of the eye and mouth, stiff tongue of the 2 groups, the difference was statistically significant(P<0.05), and the efficacy of the experimental group was better than that of the control group.Comparing the primary symptoms of motor impairment of the upper/lower limbs and secondary symptoms of headache, purple lips of the 2 groups, the differences were not statistically significant(P>0.05).The results of the Barthel index efficacy analysis showed that there was no statistically significant difference in the Barthel index and the difference and change rate between the baseline and post-dose Barthel index after treatment(P>0.05).Conclusion:Application of freeze-dried Xuesaitong Injection in the treatment of sequelae cerebral infarction with blood stasis syndrome presents certain efficacy in the improvement of TCM syndromes and single symptoms.The efficacy was better than the control group of Dengzhan Xixin Injection.It can effectively improve the limb function and life of quality, and it has high safety in clinical use, with mild adverse reactions and no serious adverse events.

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