Efficacy of Yangyin Yiqi Huoxue Granule (养阴益气活血颗粒) in Treatment of Ischemic Stroke Patients with Qi-Yin Deficiency and Blood Stasis Syndrome: A Randomized, Double-Blind, Multicenter, Phase-2 Clinical Trial<sup>*</sup>

Yu WANG; Jie-hong YANG; Hai-tong WAN; Yu HE; Bin XU; Chang-shan AI; Hui-fen ZHOU; Li YU; Hao-fang WAN; Xiao-dong BIE

doi:10.1007/s11655-021-2857-0

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Efficacy of Yangyin Yiqi Huoxue Granule (养阴益气活血颗粒) in Treatment of Ischemic Stroke Patients with Qi-Yin Deficiency and Blood Stasis Syndrome: A Randomized, Double-Blind, Multicenter, Phase-2 Clinical Trial^*

Original Article | Updated：2021-11-05

- Efficacy of Yangyin Yiqi Huoxue Granule (养阴益气活血颗粒) in Treatment of Ischemic Stroke Patients with Qi-Yin Deficiency and Blood Stasis Syndrome: A Randomized, Double-Blind, Multicenter, Phase-2 Clinical Trial^*
- Chinese Journal of Integrative Medicine Vol. 27, Issue 11, Pages: 811-818(2021)
- Affiliations：
  
  1.Institute of Cardio-Cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou (310053), China
  2.Neurology Department, Xinhua Hospital of Zhejiang Province, Hangzhou(310005), China
  3.Neurology Department, Integrated Medicine Hospital of Jilin Province, Yanbian, Jilin Province (133001), China
  4.Chinese Medicine Department, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou (310000), China
- Author bio：
  
  Dr. WAN Hai-tong, E-mail: whtong@126.com
- Funds：
- DOI：10.1007/s11655-021-2857-0
  CLC：
- Published：01 November 2021，
  
  Published Online：22 April 2021，
  
  Accepted：19 August 2019
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Yu WANG, Jie-hong YANG, Hai-tong WAN, et al. Efficacy of Yangyin Yiqi Huoxue Granule (养阴益气活血颗粒) in Treatment of Ischemic Stroke Patients with Qi-Yin Deficiency and Blood Stasis Syndrome: A Randomized, Double-Blind, Multicenter, Phase-2 Clinical Trial^*. [J]. Chinese Journal of Integrative Medicine 27(11):811-818(2021)
DOI：

Yu WANG, Jie-hong YANG, Hai-tong WAN, et al. Efficacy of Yangyin Yiqi Huoxue Granule (养阴益气活血颗粒) in Treatment of Ischemic Stroke Patients with Qi-Yin Deficiency and Blood Stasis Syndrome: A Randomized, Double-Blind, Multicenter, Phase-2 Clinical Trial^*. [J]. Chinese Journal of Integrative Medicine 27(11):811-818(2021) DOI： 10.1007/s11655-021-2857-0.

摘要

目的:

评价养阴益气活血颗粒 (YYHG) 治疗缺血性中风气阴两虚、瘀血阻络证的疗效和安全性

并探讨其有效剂量.

方法:

采用竞争性随机区组法

将288例患者随机分为YYHG高剂量

YYHG低剂量

阳性对照 (消栓通颗粒

XSTG) 或安慰剂对照组

每组72例

用药干预28天

随访180天. 主要疗效指标是综合疗效评估

次要疗效指标是美国国立卫生研究院卒中量表评分 (NIHSS)

Barthel日常生活活动指数评分 (ADL)

生活质量指数评分 (QLI) 和中医证候评分 (CMS)

所有指标均采用意向性分析. 本研究同时评估了YYHG的安全性.

结果:

2008年6月1日至2009年9月30日共招募288名参与者

其中287名患者接受了干预. 四组间基线平衡; YYHG高剂量、低剂量

阳性对照组和安慰剂对照组的综合治愈率分别为63.38%

31.94%

36.11% 和6.14% ; 两组之间有统计学差异 (

0.01)

且YYHG高剂量组明显高于其他三组 (

0.01) . YYHG高剂量和低剂量组的NIHSS、ADL、QLI和CMS评分的改善明显优于阳性对照组和安慰剂对照组 (

0.05) . 在改善NIHSS和ADL分级方面

YYHG高剂量组明显优于其他三组 (

0.05)

而YYHG低剂量组优于安慰剂对照组 (

0.01) . 同时

YYHG高剂量组在NIHSS、ADL、CMS评分及改善NIHSS和ADL分级方面组均优于低剂量组 (

0.05) . 安全性方面

YYHG治疗后仅2例 (3.78% ) 出现轻微不良反应

未见严重不良反应.

结论:

YYHG治疗缺血性中风气阴两虚、瘀血阻络证安全、有效.

Abstract

Objective:

To evaluate the efficacy and safety of Yangyin Yiqi Huoxue Granule (养阴益气活血颗粒

YYHG) in the treatment of ischemic stroke (IS) patients with qi-yin deficiency and blood stasis syndrome (QYDBSS)

and to explore its effective dosage.

Methods:

The total of 288 patients were randomly assigned to the YYHG high-dose

YYHG low-dose

positive control (administered Xiaoshuantong Granule

XSTG

消栓通颗粒)

or placebo control (administered inert granule) groups (72 cases per group) by software-drived competitive block randomization. The trial was conducted for a 28-day period

with a 180-day follow-up period. The primary outcome was the comprehensive curative evaluation

and secondary outcomes were the National Institute of Health Stroke Scale (NIHSS) score

Barthel activities of daily living (ADL) index score

the quality of life index (QLI) score

and the Chinese medicine syndrome (CMS) score. All analyses were done on an intention-to-treat basis. The clinical safety was also assessed.

Results:

The total of 288 participants were recruited between June 1

2008 and September 30

2009

and 287 patients received intervention; the treatment groups were well balanced at baseline. The comprehensive cure rates of YYHG high-dose

low-dose

positive and placebo control groups were 63.38%

31.94%

36.11% and 6.14%

respectively; there was a statistical difference between the two groups (

0.01)

while the high-dose YYHG treatment group was significantly higher than the other 3 groups (

0.01). The improvement of NIHSS

ADL

QLI and CMS scores of the YYHG high-dose and low-dose groups was significantly better than that of the positive control group and the placebo control group (

0.05). In terms of improving the classification of the NIHSS scale and the assessment of the ADL scale

the YYHG high-dose group was significantly better than the other three groups (

0.05)

and the YYHG low-dose group was better than the placebo control group (

0.01). At the same time

except for the QLI score

the high-dose group was better than the low-dose group (

0.05). In terms of safety

adverse reactions after YYHG treatment were generally mild (3.78%)

and no serious adverse reactions have been reported.

Conclusion:

YYHG is safe and effective in the treatment of IS patients with QYDBSS.

关键词

Keywords

strokeqi-yin deficiency and blood stasis syndromeChinese medicinerandomized controlled trial

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