<italic style="font-style: italic">Qingxin Jieyu Granule</italic> （清心解瘀颗粒） for the Treatment of Acute Coronary Syndrome with Binding of Stasis and Toxin Syndrome：A Multicenter，Double-Blind，Placebo Randomize-Controlled Trial

OUYANG Jiahui; SHI Junhe; JIANG Zhonghui; QU Hua; ZHANG Lijing; HU Zhigeng; CHEN Ailian; LI Dong; SHI Dazhuo; GAO Zhuye

doi:10.13288/j.11-2166/r.2025.22.010

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Qingxin Jieyu Granule （清心解瘀颗粒） for the Treatment of Acute Coronary Syndrome with Binding of Stasis and Toxin Syndrome：A Multicenter，Double-Blind，Placebo Randomize-Controlled Trial

更新时间：2025-11-25

- Qingxin Jieyu Granule （清心解瘀颗粒） for the Treatment of Acute Coronary Syndrome with Binding of Stasis and Toxin Syndrome：A Multicenter，Double-Blind，Placebo Randomize-Controlled Trial
- Journal of Traditional Chinese Medicine Vol. 66, Issue 22, Pages: 2345-2352(2025)
- 作者机构：
  
  1.中国中医科学院西苑医院，北京市海淀区西苑操场1号，100091
  2.中国中医科学院眼科医院
  3.北京中医药大学东直门医院
  4.山西中医药大学附属医院
  5.河南省濮阳市中医医院
  6.北京中医药大学东方医院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2025.22.010
  CLC：
- Received：14 July 2025，
  
  Revised：2025-08-30，
  
  Published：17 November 2025
- 稿件说明：
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欧阳嘉慧,史君鹤,姜众会等.清心解瘀颗粒治疗急性冠脉综合征瘀毒互结证患者的多中心双盲安慰剂随机对照试验[J].中医杂志,2025,66(22):2345-2352.

OUYANG Jiahui,SHI Junhe,JIANG Zhonghui,et al.Qingxin Jieyu Granule （清心解瘀颗粒） for the Treatment of Acute Coronary Syndrome with Binding of Stasis and Toxin Syndrome：A Multicenter，Double-Blind，Placebo Randomize-Controlled Trial[J].Journal of Traditional Chinese Medicine,2025,66(22):2345-2352.
欧阳嘉慧,史君鹤,姜众会等.清心解瘀颗粒治疗急性冠脉综合征瘀毒互结证患者的多中心双盲安慰剂随机对照试验[J].中医杂志,2025,66(22):2345-2352. DOI： 10.13288/j.11-2166/r.2025.22.010.

OUYANG Jiahui,SHI Junhe,JIANG Zhonghui,et al.Qingxin Jieyu Granule （清心解瘀颗粒） for the Treatment of Acute Coronary Syndrome with Binding of Stasis and Toxin Syndrome：A Multicenter，Double-Blind，Placebo Randomize-Controlled Trial[J].Journal of Traditional Chinese Medicine,2025,66(22):2345-2352. DOI： 10.13288/j.11-2166/r.2025.22.010.

摘要

目的

观察清心解瘀颗粒治疗急性冠脉综合征（ACS）瘀毒互结证患者的临床疗效与安全性。

方法

将5个研究中心共100例ACS瘀毒互结证患者随机分为治疗组和对照组各50例。两组均接受西医常规治疗，治疗组同时予清心解瘀颗粒口服，对照组同时予安慰剂颗粒口服，疗程均为4周，治疗结束后随访12周。评估主要结局指标左心室射血分数（LVEF）、主要不良心脑血管事件（MACCE）发生情况；次要结局指标包括左室舒张末期内径（LVEDD）、室间隔厚度（IVS）、西雅图心绞痛量表（SAQ）评分［涉及躯体活动受限程度、心绞痛稳定状态、心绞痛发作情况、治疗满意程度、疾病认知程度共5个维度］和中医证候积分；并进行安全性评价。

结果

与本组治疗前比较，治疗4周后及随访12周后两组SAQ各维度评分升高、中医证候积分降低，治疗组LVEF升高；随访12周后对照组LVEDD增大（

＜0.05）。治疗组随访12周后与治疗前差值方面，LVEF高于对照组，LVEDD低于对照组（

≤0.05）。研究期间两组患者均未发生MACCE及严重不良事件。

结论

清心解瘀颗粒可改善ACS瘀毒互结证患者的心功能和临床症状，且安全性良好。

Abstract

Objective

To evaluate the clinical efficacy and safety of

Qingxin Jieyu Granule

（清心解瘀颗粒， QJG） in acute coronary syndrome （ACS） patients with blood binding of stasis and toxin syndrome.

Methods

A total of 100 ACS patients with binding of stasis and toxin syndrome from five centers were randomized into a treatment group and a control group， with 50 cases in each group. Both groups received standard western medical therapy， while the treatment group additionally received QJG， and the control group received placebo. The treatment period was 4 weeks， with a 12-week follow-up. The primary outcomes were left ventricular ejection fraction （LVEF） and major adverse cardiac and cerebrovascular events （MACCE）. Secondary outcomes included left ventricular end-diastolic diameter （LVEDD）， interventricular septal thickness （IVS）， Seattle Angina Questionnaire （SAQ） scores covering five dimensions， including physical activity limitation， stable angina， angina episodes， treatment satisfaction， and disease awareness， and traditional Chinese medicine （TCM） syndrome scores， along with safety evaluations.

Results

Both groups showed increased SAQ dimension scores and decreased TCM syndrome scores， and the treatment group showed a significant improvement in LVEF after 4-week treatment and at 12-week follow-up； the control group demonstrated an increase in LVEDD at 12-week follow-up （

＜0.05）. In terms of the difference between follow-up and pre-treatment values， the treatment group showed higher LVEF and lower LVEDD than the control group （

≤0.05）. No MACCE or serious events occurred in either group during the study.

Conclusion

QJG can improve cardiac function and clinical symptoms of ACS patients with binding ofstasis and toxin syndrome， with a favorable safety profile.

关键词

Keywords

references

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Qingxin Jieyu Granule （清心解瘀颗粒） for the Treatment of Acute Coronary Syndrome with Binding of Stasis and Toxin Syndrome：A Multicenter，Double-Blind，Placebo Randomize-Controlled Trial

DOI：10.13288/j.11-2166/r.2025.22.010

摘要

Abstract

关键词

Keywords

references