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

ZHANG Huating; ZHAO Biaoji; HU Jiali; LI Wenjuan; ZHANG Rui; HAN Shiyou; ZHAO Chaorong; ZHANG Mei; CAI Li; LI Wentao

doi:10.16306/j.1008-861x.2022.05.004

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

Clinical Research | 更新时间：2022-11-01

- A multi⁃center， randomized， double⁃blind， controlled study on Shenjing Fuyuan Formula in prevention of minor ischemic stroke recurrence
- Academic Journal of Shanghai University of Traditional Chinese Medicine Vol. 36, Issue 5, Pages: 17-21(2022)
- 作者机构：
  
  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）
- 作者简介：
- 基金信息：
- DOI：10.16306/j.1008-861x.2022.05.004
  CLC：
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张华廷,赵彪绩,胡佳利等.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[J].上海中医药大学学报,2022,36(05):17-21.

ZHANG Huating,ZHAO Biaoji,HU Jiali,et al.A multi⁃center， randomized， double⁃blind， controlled study on Shenjing Fuyuan Formula in prevention of minor ischemic stroke recurrence[J].Academic Journal of Shanghai University of Traditional Chinese Medicine,2022,36(05):17-21.
张华廷,赵彪绩,胡佳利等.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[J].上海中医药大学学报,2022,36(05):17-21. DOI： 10.16306/j.1008-861x.2022.05.004.

ZHANG Huating,ZHAO Biaoji,HU Jiali,et al.A multi⁃center， randomized， double⁃blind， controlled study on Shenjing Fuyuan Formula in prevention of minor ischemic stroke recurrence[J].Academic Journal of Shanghai University of Traditional Chinese Medicine,2022,36(05):17-21. DOI： 10.16306/j.1008-861x.2022.05.004.

摘要

目的,2,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,2,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,2,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,2,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。

Abstract

Objective： To observe the clinical effect of Shenjing Fuyuan Formula in preventing the recurrence of minor ischemic stroke （IS）.,Methods,2,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,2,In the course of study， 10 patients 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. ①After 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）. ②After 90， 180 and 270 d of treatment， the incidences of TIA in the treatment group were 5.00%， 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）. ③In the course of treatment， new-onset acute myocardial ischemia occurred in 2 patients in the control group and no other ischemic diseases occurred in the treatment group. ④After 90， 180 and 270 d of treatment， the incidences of total ischemic events in the treatment group were 8.75%， 10.00% and 11.25% respectively， and the incidences of total ischemic events in the control group were 10.00%， 28.75% and 31.25% respectively. After 180 and 270 d of treatment， the incidences of total ischemic events in the treatment group were significantly lower than those in the control group （,P,<,0.05）.,Conclusion,2,Shenjing Fuyuan Formula can effectively prevent the recurrence of minor IS and the occurrence of TIA， reduce the incidence of total ischemic events， and the effect becomes more obvious with the prolongation of the treatment time.

关键词

缺血性卒中神经复原方二级预防

Keywords

ischemic strokeShenjing Fuyuan Formulasecondary prevention

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