Shexiang Tongxin Dropping Pill Improves Stable Angina Patients with Phlegm-Heat and Blood-Stasis Syndrome: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

ZHAO Ying-qiang; XING Yong-fa; ZOU Ke-yong; JIANG Wei-dong; DU Ting-hai; CHEN Bo; YANG Bao-ping; QU Bai-ming; WANG Li-yue; GONG Gui-hong; SUN Yan-ling; WANG Li-qi; ZHOU Gao-feng; DONG Yu-gang; CHEN Min; ZHANG Xue-juan; YANG Tian-lun; ZHANG Min-zhou; ZHAO Ming-jun; DENG Yue; XIAO Chang-jiang; WANG Lin; WANG Bao-he

doi:10.1007/s11655-025-4014-7

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Shexiang Tongxin Dropping Pill Improves Stable Angina Patients with Phlegm-Heat and Blood-Stasis Syndrome: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Original Article | Updated：2025-07-30

- Shexiang Tongxin Dropping Pill Improves Stable Angina Patients with Phlegm-Heat and Blood-Stasis Syndrome: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
- Chinese Journal of Integrative Medicine Vol. 31, Issue 8, Pages: 685-693(2025)
- Affiliations：
  
  1.Department of Cardiology, the Second Affiliated Hospital of Tianjin University of Chinese Medicine, Tianjin (300143), China
  2.Department of Cardiology, Nanshi Hospital of Nanyang, Nanyang, Henan Province (473000), China
  3.Department of Cardiology, Nantong Hospital of Traditional Chinese Medicine, Nantong, Jiangsu Province (226001), China
  4.Department of Cardiology, the First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou (450000), China
  5.Department of Cardiology, the First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine, Haerbin (150000), China
  6.Department of Cardiology, Gansu Provincial Hospital of Traditional Chinese Medicine, Lanzhou (730000), China
  7.Department of Cardiology, Zhejiang Provincial People's Hospital, Hangzhou (314408), China
  8.Department of Cardiology, Wuhan University of Science and Technology Affiliated Wuchang Hospital, Wuhan (430000), China
  9.Department of Cardiology, the First Affiliated Hospital of Henan University, Kaifeng, Henan Province (475000), China
  10.Department of Cardiology, Luoyang Hospital of Traditional Chinese Medicine, Luoyang, Henan Province (471000), China
  11.Department of Cardiology, Kaifeng People's Hospital, Kaifeng, Henan Province (475000), China
  12.Department of Integrated Traditional Chinese and Western Medicine, West China Hospital of Sichuan University, Chengdu (610000), China
  13.Department of Cardiology, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou (510000), China
  14.Department of Geratology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang (110000), China
  15.Department of General Medicine, the Affiliated Hospital of Qingdao University, Qingdao, Shandong Province (266000), China
  16.Department of Cardiology, Xiangya Hospital of Central South University, Changsha (410008), China
  17.Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou (510120), China
  18.Department of Cardiology, Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi Province (712000), China
  19.Department of Cardiology, Affiliated Hospital of Changchun University of Traditional Chinese Medicine, Changchun (130000), China
  20.Department of Cardiology, the Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine, Changsha, (410000), China
  21.Department of Cardiology, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan (430000), China
  22.Department of Cardiology, the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin (300041), China
- Author bio：
  
  Prof. WANG Bao-he, E-mail: wangbaohe2024@ 163.com
- Funds：
- DOI：10.1007/s11655-025-4014-7
  CLC：
- Accepted：14 February 2025，
  
  Published Online：13 June 2025，
  
  Published：2025-08
- Accepted：
Scan QR Code
ZHAO Ying-qiang, XING Yong-fa, ZOU Ke-yong, et al. Shexiang Tongxin Dropping Pill Improves Stable Angina Patients with Phlegm-Heat and Blood-Stasis Syndrome: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial[J]. Chinese journal of integrative medicine, 2025, 31(8): 685-693.
DOI：

ZHAO Ying-qiang, XING Yong-fa, ZOU Ke-yong, et al. Shexiang Tongxin Dropping Pill Improves Stable Angina Patients with Phlegm-Heat and Blood-Stasis Syndrome: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial[J]. Chinese journal of integrative medicine, 2025, 31(8): 685-693. DOI： 10.1007/s11655-025-4014-7.

摘要

目的:

通过运动时间和代谢当量评估麝香通心滴丸 (STDP) 治疗痰热瘀阻型稳定型心绞痛患者的疗效和安全性.

方法:

这是一项多中心、随机双盲、安慰剂对照临床试验

在22家医院招募了稳定型心绞痛患者 (痰热瘀阻型) . 按 1:1 的比例随机接受 STDP (35 mg/片

每天6片) 或安慰剂治疗

共56天. 主要结果是治疗 56 天后通过运动平板试验运动总时间和代谢当量 (METs) . 次要结果包括心绞痛症状总分、中医证候 (CM) 评分、西雅图心绞痛问卷 (SAQ) 评分、心电图 ST-T 变化和不良事件 (AEs).

结果:

共招募309患者

其中 STDP 组155名

安慰剂组154名. 结果表明STDP显著延长了患者的运动时间

增加了51.0 秒

而安慰剂减少了 12.0 秒 (变化率: -11.1% VS.3.2%

0.01) . STDP 组的 METs 增长率明显高于安慰剂组 (变化率: -0.4 VS.0.0

变化率: -5.0% VS.0.0%

0.01) . STDP 对心绞痛症状总评分 (25.0% vs. 0.0%) 、中医证候得分 (38.7% vs. 11.8%) 、硝酸甘油使用减少量 (100.0% vs. 11.3%) 以及 SAQ 各方面的改善均显著高于安慰剂 (均

0.01) . 与基线相比

两组患者在28天和56天时的Q-T 间期变化相似 (均

0.05) . 接受 STDP 治疗的25名参与者 (16.3%) 和接受安慰剂治疗的16名参与者 (10.5%) 出现了不良事件 (

=0.131)

没有观察到严重不良事件.

结论:

STDP 可改善稳定型心绞痛患者 (痰热瘀阻型) 的运动耐量

且具有良好的安全性. (注册号: ChiCTR-IPR-15006020)

Abstract

Objective:

To evaluate the efficacy and safety of Shexiang Tongxin Dropping Pill (STDP) in treating stable angina patients with phlegm-heat and blood-stasis syndrome by exercise duration and metabolic equivalents.

Methods:

This multicenter

randomized

double-blind

placebo-controlled clinical trial enrolled stable angina patients with phlegm-heat and blood-stasis syndrome from 22 hospitals. They were randomized 1:1 to STDP (35 mg/pill

6 pills per day) or placebo for 56 days. The primary outcome was the exercise duration and metabolic equivalents (METs) assessed by the standard Bruce exercise treadmill test after 56 days of treatment. The secondary outcomes included the total angina symptom score

Chinese medicine (CM) symptom scores

Seattle Angina Questionnaire (SAQ) scores

changes in ST-T on electrocardiogram and adverse events (AEs).

Results:

This trial enrolled 309 patients

including 155 and 154 in the STDP and placebo groups

respectively. STDP significantly prolonged exercise duration with an increase of 51.0 s

compared to a decrease of 12.0 s with placebo (change rate: –11.1%

. 3.2%

0.01). The increase in METs was significantly greater in the STDP group than in the placebo group (change: –0.4

. 0.0

change rate: –5.0%

. 0.0%

0.01). The improvement of total angina symptom scores (25.0%

. 0.0%)

CM symptom scores (38.7%

. 11.8%)

reduction of nitroglycerin consumption (100.0%

. 11.3%)

and all domains of SAQ

were significantly greater with STDP than placebo (all

0.01). The changes in Q-T intervals at 28 and 56 days from baseline were similar between the two groups (both

0.05). Twenty-five participants (16.3%) with STDP and 16 (10.5%) with placebo experienced AEs (

=0.131)

with no serious AEs observed.

Conclusion:

STDP could improve exercise tolerance in patients with stable angina and phlegm-heat and blood stasis syndrome

with a favorable safety profile. (Registration No. ChiCTR-IPR-15006020)

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