Efficacy of Getong Tongluo Capsule (葛酮通络胶囊) for Convalescent-Phase of Ischemic Stroke and Primary Hypertension: A Multicenter, Randomized, Double-Blind, Controlled Trial

Qian-yu ZHAO; Rong-hua TANG; Guo-xiong LU; Xu-zheng CAO; Lu-ran LIU; Ji-hua ZHANG; Jin-tao ZHANG; Bin XU; Hong-tao WEI; Miao YANG; Ling WEI; Mei ZHANG; Wen-zong ZHU; Hong WANG; Hong-lin LI; Li-ping MA; Chi ZHONG; Yan-jie GAO; Na ZHANG; Shan REN; Lu CHEN; Yun-hai LIU; Zhi-gang CHEN

doi:10.1007/s11655-020-3320-3

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Efficacy of Getong Tongluo Capsule (葛酮通络胶囊) for Convalescent-Phase of Ischemic Stroke and Primary Hypertension: A Multicenter, Randomized, Double-Blind, Controlled Trial

Original Article | Updated：2021-08-16

- Efficacy of Getong Tongluo Capsule (葛酮通络胶囊) for Convalescent-Phase of Ischemic Stroke and Primary Hypertension: A Multicenter, Randomized, Double-Blind, Controlled Trial
- Efficacy of Getong Tongluo Capsule (葛酮通络胶囊) for Convalescent-Phase of Ischemic Stroke and Primary Hypertension: A Multicenter, Randomized, Double-Blind, Controlled Trial
- Chinese Journal of Integrative Medicine 2021年27卷第4期页码：252-258
- Affiliations：
  
  1.Department of Neurology, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing (100078), China
  2.The Second School of Clinical Medicine, Beijing University of Chinese Medicine, Beijing (100029), China
  3.Department of Neurology, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan (430030), China
  4.Department of Neurology, the Hospital Affiliated to Jiangxi University of Traditional Chinese Medicine, Nanchang (330006), China
  5.Department of Neurology, the 211th Hospital of the People's Liberation Army, Harbin (150000), China
  6.Department of Neurology, the Fourth Hospital Affiliated to Harbin Medical University, Harbin (150000), China
  7.Department of Neurology, the First Hospital of Suihua, Suihua, Heilongjiang Province(152053), China
  8.Department of Neurology, the 88th Hospital of the People's Liberation Army, Tai'an, Shandong Province (271000), China
  9.Department of Neurology, Xinhua Hospital of Zhejiang Province, Hangzhou (310005), China
  10.Department of Neurology, the Second Provincial People's Hospital of Gansu, Lanzhou (730000), China
  11.Department of Neurology, People's Hospital of Bozhou, Bozhou, Anhui Province (236800), China
  12.Department of Neurosurgery, the Third Hospital Affiliated to Shanxi University of Chinese Medicine, Taiyuan (030000), China
  13.Department of Neurology, the First People's Hospital of Huainan, Huainan, Anhui Province (232007), China
  14.Department of Neurology, Wenzhou Hospital of Traditional Chinese Medicine, Wenzhou, Zhejiang Province (325000), China
  15.Department of Neurology, the First Hospital Affiliated to Medical College of Shihezi University, Shihezi, Xinjiang Uygur Autonomous Region(832008), China
  16.Department of Rehabilitation, the Second Hospital Affiliated to Heilongjiang University of Traditional Chinese Medicine, Harbin (150001), China
  17.Department of Neurology, People's Hospital of Xinzhou, Xinzhou, Shanxi Province (034000), China
  18.Department of Neurology, People's Hospital of Weifang, Weifang, Shandong Province(261000), China
  19.Department of Neurology, Xiangya Hospital Affiliated to Central South University, Changsha (410013), China
- Author bio：
  
  Correspondence to: Prof. CHEN Zhi-gang, E-mail: chenzhigang64@126.com
- Funds：
  
  the project of Guangzhou Clinical Medical Research and Transformation Center Pilot Construction
- DOI：10.1007/s11655-020-3320-3
  中图分类号：
- 纸质出版日期：2021-04-01，
  
  网络出版日期：2020-10-10，
  
  录用日期：2020-03-04
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Qian-yu ZHAO, Rong-hua TANG, Guo-xiong LU, 等. Efficacy of Getong Tongluo Capsule (葛酮通络胶囊) for Convalescent-Phase of Ischemic Stroke and Primary Hypertension: A Multicenter, Randomized, Double-Blind, Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2021,27(4):252-258.

Qian-yu ZHAO, Rong-hua TANG, Guo-xiong LU, et al. Efficacy of Getong Tongluo Capsule (葛酮通络胶囊) for Convalescent-Phase of Ischemic Stroke and Primary Hypertension: A Multicenter, Randomized, Double-Blind, Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2021,27(4):252-258.
Qian-yu ZHAO, Rong-hua TANG, Guo-xiong LU, 等. Efficacy of Getong Tongluo Capsule (葛酮通络胶囊) for Convalescent-Phase of Ischemic Stroke and Primary Hypertension: A Multicenter, Randomized, Double-Blind, Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2021,27(4):252-258. DOI： 10.1007/s11655-020-3320-3.

Qian-yu ZHAO, Rong-hua TANG, Guo-xiong LU, et al. Efficacy of Getong Tongluo Capsule (葛酮通络胶囊) for Convalescent-Phase of Ischemic Stroke and Primary Hypertension: A Multicenter, Randomized, Double-Blind, Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2021,27(4):252-258. DOI： 10.1007/s11655-020-3320-3.

摘要

Abstract

Objective:

To evaluate whether the efficacy of Getong Tongluo Capsule (葛酮通络胶囊

GTC

consisted of total flavone of

Radix Puerariae

) on improving patients' quality of life and lowering blood pressure are superior to the extract of

Ginkgo biloba

(EGB) for patients with convalescent-phase ischemic stroke and primary hypertension.

Methods:

This randomized

positive-drug- and placebo-controlled

double-blind trial was conducted from September 2015 to October 2017. Totally 477 eligible patients from 18 hospitals in China were randomly assigned in a 2:1:1 ratio to the following interventions

twice a day for 12 weeks: (1) GTC 250 mg plus EGB-matching placebo 40 mg (237 cases

GTC group)

(2) EGB 40 mg plus GTC-matching placebo 250 mg (120 cases

EGB group) or (3) GTC-matching placebo 250 mg plus EGB-matching placebo 40 mg (120 cases

placebo group). Moreover

all patients were orally administered aspirin enteric-coated tablets 100 mg

once a day for 12 weeks. The primary outcome was the Barthel Index (BI). The secondary outcomes included the control rate of blood pressure and National Institutes of Health Stroke Scale (NIHSS) scores. The incidence and severity of adverse events (AEs) were calculated and assessed.

Results:

The BI relative independence rates

the clinical recovery rates of NIHSS

and the total effective rates of NIHSS in the GTC and EGB groups were significantly higher than the placebo group at 12 weeks after treatment (

0.05)

and no statistical significance was found between the GTC and EGB groups (

0.05). The control rate of blood pressure in the GTC group was significantly higher than the EGB and placebo groups at 12

18 and 24 weeks after treatment (

0.01). There were no statistically significant differences in the incidences of AEs

adverse drug reactions

or serious AEs among the 3 groups (

0.05).

Conclusion:

GTC exhibited significant efficacy in improving patients' quality of life as well as neurological function and controlling hypertension. (Registration No. ChiCTR1800016667)

关键词

Keywords

convalescent-phase of ischemic strokeprimary hypertensionGetong Tongluo Capsuletotal flavone of Radix Puerariaerandomized controlled trialChinese medicine

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