神经复原方预防轻型缺血性卒中复发的多中心随机双盲对照研究  

A multi-center,randomized,double-blind,controlled study on Shenjing Fuyuan Formula in prevention of minor ischemic stroke recurrence

作　　者：张华廷 赵彪绩 胡佳利 李文娟 张瑞[4] 韩世友 赵超蓉 张梅 蔡丽[1] 李文涛[1] ZHANG Huating;ZHAO Biaoji;HU Jiali;LI Wenjuan;ZHANG Rui;HAN Shiyou;ZHAO Chaorong;ZHANG Mei;CAI Li;LI Wentao(Department of Neurology,Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200071,China;Department of Neurology,North Station Hospital of Shanghai Jing'an District,Shanghai 200071,China;Department of Neurology,Shanghai Jing'an District Hospital of Traditional Chinese Medicine,Shanghai 200072,China;Department of Neurology,Shanghai Jiading District Hospital of Traditional Chinese Medicine,Shanghai 201800,China;Department of Neurology,Shanghai Fengxian District Hospital of Traditional Chinese Medicine,Shanghai 201499,China;Department of Neurology,Shanghai Putuo District Hospital of Traditional Chinese Medicine,Shanghai 200062,China;Department of Traditional Chinese Medicine,Shanghai Zhabei Center Hospital of Jing'an District,Shanghai 200070,China)

机构地区：[1]上海中医药大学附属市中医医院脑病科,上海200071 [2]上海市静安区北站医院神经内科,上海200071 [3]上海市静安区中医医院脑病科,上海200072 [4]上海市嘉定区中医医院脑病科,上海201800 [5]上海市奉贤区中医医院脑病科,上海201499 [6]上海市普陀区中医医院脑病科,上海200062 [7]上海市静安区闸北中心医院中医科,上海200070

出　　处：《上海中医药大学学报》2022年第5期17-21,26,共6页Academic Journal of Shanghai University of Traditional Chinese Medicine

基　　金：上海市科委“科技创新行动计划”项目(19401970500);上海市“十三五”临床重点专科建设项目(shslczdzk04901)。

摘　　要：目的:观察神经复原方预防轻型缺血性卒中(IS)复发的临床疗效。方法:采用多中心、随机、双盲、安慰剂对照的研究方法,纳入气阴不足、痰瘀阻滞型轻型IS患者180例,随机分为治疗组和对照组,每组各90例。两组患者均给予西医常规治疗,在此基础上,治疗组患者给予神经复原方颗粒剂口服,对照组患者给予神经复原方颗粒安慰剂口服,两组治疗周期均为270 d。治疗90、180、270 d后,记录IS、短暂脑缺血发作(TIA)及其他缺血性疾病(包括心肌梗死、急性冠脉综合征等)的发生情况,统计并比较两组患者的IS复发率、TIA发生率等。结果:研究过程中,治疗组10例患者、对照组10例患者剔除或脱落,最终纳入统计分析者治疗组80例、对照组80例。(1)治疗90、180、270 d后,治疗组患者的IS复发率分别为3.75%、3.75%、5.00%,对照组患者的IS复发率分别为2.50%、13.75%、16.25%,治疗180、270 d后治疗组患者的IS复发率明显低于对照组(P<0.05);(2)治疗90、180、270 d后,治疗组患者的TIA发生率分别为5.00%、6.25%、6.25%,对照组患者的TIA发生率分别为6.25%、16.25%、17.50%,治疗180、270 d后治疗组患者的TIA发生率明显低于对照组(P<0.05);(3)治疗过程中,对照组2例患者发生新发急性心肌缺血,治疗组无其他缺血性疾病发生;(4)治疗90、180、270 d后,治疗组患者的总体缺血性事件发生率分别为8.75%、10.00%、11.25%,对照组患者的总体缺血性事件发生率分别为10.00%、28.75%、31.25%,治疗180、270 d后治疗组患者的总体缺血性事件发生率明显低于对照组(P<0.05)。结论:神经复原方能够有效预防轻型IS复发及TIA发生,降低总体缺血性事件的发生率,且随着治疗时间延长,治疗效果更明显。Objective:To observe the clinical effect of Shenjing Fuyuan Formula in preventing the recurrence of minor ischemic stroke(IS).Methods:A multi-center,randomized,double-blind,controlled study was applied. A total of 180 patients of minor IS with Qi-yin deficiency and phlegm-stasis stagnation type were included,and randomly divided into the treatment group and control group,90 cases in each group. The patients in the two groups were treated with conventional western medicine. Based on above,the patients in the treatment group were orally treated with Shenjing Fuyuan Formula granules,and the patients in the control group were orally treated with Shenjing Fuyuan Formula granule placebo,with a course of 270 d. After 90,180 and 270 d of treatment,the occurrences of IS,transient ischemic attack(TIA)and other ischemic events(including myocardial infarction,acute coronary syndrome and so on)were recorded,and the recurrence rate of IS,the incidence of TIA and so on were calculated and compared in the two groups.Results:In the course of study,10patients in the treatment group and 10 patients in the control group were eliminated and shed off,finally 80 patients in the treatment group and 80 patients in the control group were included in the statistical analysis.(1)After 90,180 and 270 d of treatment,the recurrence rates of IS in the treatment group were 3.75%,3.75% and 5.00% respectively,and the recurrence rates of IS in the control group were 2.50%,13.75% and 16.25% respectively. After 180 and 270 d of treatment,the recurrence rates of IS in the treatment group were significantly lower than those in the control group(P<0.05).(2)After 90,180 and 270 d of treatment,the incidences of TIA in the treatment group were5.00%,6.25% and 6.25% respectively,and the incidences of TIA in the control group were 6.25%,16.25% and 17.50% respectively.After 180 and 270 d of treatment,the incidences of TIA in the treatment group were significantly lower than those in the control group(P<0.05).(3)In the course of treatment,new-onset acute myocar

关 键 词：缺血性卒中 神经复原方 二级预防 

分 类 号：R743.3[医药卫生—神经病学与精神病学]