已发表论文

芪参益气滴丸对缺血性心力衰竭患者临床结局的影响:CACT-IHF 随机试验的事后分析

 

Authors Zhou Z, Wang S, Du Y, Zhao Z, Bi Y, Su Q, Hou Y, Wang X, Mao J

Received 26 July 2025

Accepted for publication 6 November 2025

Published 15 November 2025 Volume 2025:19 Pages 10163—10174

DOI https://doi.org/10.2147/DDDT.S556373

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Tuo Deng

Zhou Zhou,1,2,* Shuai Wang,1,* Yijia Du,1,2 Zhiqiang Zhao,1 Yingfei Bi,1 Quan Su,1 Yazhu Hou,1 Xianliang Wang,1 Jingyuan Mao1 

1Cardiovascular Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine/National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, People’s Republic of China; 2Graduate School, Tianjin University of Traditional Chinese Medicine, Tianjin, People’s Republic of China

*These authors contributed equally to this work

Correspondence: Jingyuan Mao, Cardiovascular Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine/ National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, No. 88 Changling Road, Xiqing District, Tianjin, 300381, People’s Republic of China, Email jymao@126.com Xianliang Wang, Cardiovascular Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine/ National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, No. 88 Changling Road, Xiqing District, Tianjin, 300381, People’s Republic of China, Email xlwang1981@126.com

Purpose: This study aimed to evaluate whether the effect of Qishen Yiqi dropping pills (QSYQ) on the clinical outcome of patients with chronic ischemic heart failure (IHF) is related to the history of revascularization.
Patients and Methods: An exploratory post-hoc analysis was conducted using data from the CACT-IHF trial, a multicenter, randomized, double-blind, placebo-controlled study involving 640 patients with chronic IHF. Participants were randomized to receive either QSYQ or placebo for a duration of 6 months in addition to standard therapy, with a minimum follow-up period of 12 months.
Results: Among 638 patients (319 QSYQ, 319 placebo) in modified Intention-to-Treat (mITT) population (patients receive at least one trial drug or placebo treatment after randomization), 54.5% had prior revascularization. In the revascularized subgroup, QSYQ significantly reduced the risk of major adverse cardiac events (MACEs) (HR: 0.55, 95% CI: 0.36 to 0.82; P=0.003), second composite endpoint (HR: 0.60, 95% CI: 0.39 to 0.92; P=0.02) and hospitalization for heart failure (HHF) (HR: 0.57, 95% CI: 0.36 to 0.91; P=0.018) compared to placebo, while no significant difference was observed in non-revascularized patients. A significant interaction between revascularization and QSYQ treatment was noted (Pinteraction=0.009). It is suggested that the effect of QSYQ on the outcome of IHF patients is related to the history of revascularization. Adverse event rates were similar between groups.
Conclusion: QSYQ reduces MACEs risk in revascularized chronic IHF patients without increasing adverse events, suggesting its potential as a safe and effective adjunct therapy.
Registration: Clinical Trial Registry Identifier: NCT01555320.

Keywords: ischemic heart failure, Qishen Yiqi Dripping Pills, traditional Chinese medicine, major adverse cardiac events, revascularization