救心丸治疗稳定型心绞痛患者的疗效与安全性：一项随机、双盲、安慰剂对照、多中心临床试验方案

Efficacy and Safety of Jiuxin Pill in the Treatment of Patients with Stable Angina Pectoris: A Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial.

作者信息

Liu Tongzuo, Zhang Jingyi, Zhao Zhiqiang, Bi Yingfei, Zheng Ying, Wang Shuai, Dai Xiaohua, Li Jun, Lin Qian, Ni Daimei, Wang Chenglong, Wu Jianguang, Xue Yitao, Zhu Mingjun, Wang Xianliang, Mao Jingyuan

机构信息

Cardiovascular 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.

Graduate School, Tianjin University of Traditional Chinese Medicine, Tianjin, People's Republic of China.

出版信息

Int J Gen Med. 2024 Oct 15;17:4711-4722. doi: 10.2147/IJGM.S485329. eCollection 2024.

DOI:10.2147/IJGM.S485329

PMID:39429963

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11490257/

Abstract

BACKGROUND

Stable angina pectoris (SAP), as a common type of coronary heart disease (CHD), is characterized by transient retrosternal squeezing pain or suffocation induced by exercise, mood swings, or other stress. Most patients with stable angina pectoris do not benefit from interventional therapy and medication, so optimizing treatment plans has important clinical significance. Jiuxin pill is a Chinese patent medicine developed by Huatuo Chinese Medicine Co. Ltd. (Bozhou, China) to relieve the symptoms of stable angina pectoris (SAP). However, there is a lack of evidence support from high-quality clinical studies.

METHODS

In this randomized, double-blind, placebo-controlled, multicenter clinical trial, 170 patients with SAP were recruited from 11 centers in China. The patients were randomized to either the treatment group (Jiuxin pill, 2 pills, bid) or the control group (Jiuxin pill simulant, 2 pills, bid) without changing the original conventional western medicine. The trial was set up with a run-in period of 7 days, a treatment period of 28 ± 2 days, and a follow-up period of 28 ± 2 days. Total exercise time (TED) in the treadmill test and Seattle Angina Questionnaire (SAQ) scores were set as the main efficacy outcomes, and the 1-minute heart rate recovery (HRR1), metabolic equivalents (METs), maximum ST segment depression, Borg perceived exertion after exercise, the average number of angina attacks per week, usage of nitroglycerin, drug withdrawal and reduction rate, information scoring of four diagnostic methods in traditional Chinese medicine and incidence of major adverse cardiovascular events were set as the secondary efficacy outcomes. Adverse events were monitored throughout the trial.

DISCUSSION

In China, the use of Chinese patent medicine in the treatment of stable angina pectoris is more common. This trial evaluated the efficacy and safety of the Jiuxin pill in the treatment of patients with SAP, and the trial results provide high-quality research evidence for its clinical application.

TRIAL REGISTRATION

This trial has been registered in the China Clinical Trial Registry on 11 June 2022 (Registration No.: ChiCTR2200060780, https://www.chictr.org.cn/showproj.html?proj=172352).

摘要

背景

稳定型心绞痛（SAP）作为冠心病（CHD）的常见类型，其特征为运动、情绪波动或其他应激因素诱发的短暂性胸骨后压榨性疼痛或憋闷感。大多数稳定型心绞痛患者无法从介入治疗和药物治疗中获益，因此优化治疗方案具有重要的临床意义。救心丸是华佗国药股份有限公司（中国亳州）研发的一种用于缓解稳定型心绞痛（SAP）症状的中成药。然而，缺乏高质量临床研究的证据支持。

方法

在这项随机、双盲、安慰剂对照、多中心临床试验中，从中国11个中心招募了170例SAP患者。患者被随机分为治疗组（救心丸，2丸，每日2次）或对照组（救心丸模拟剂，2丸，每日2次），且不改变原有的常规西药治疗。试验设置了7天的导入期、28±2天的治疗期和28±2天的随访期。将平板运动试验中的总运动时间（TED）和西雅图心绞痛问卷（SAQ）评分设定为主要疗效指标，将1分钟心率恢复（HRR1）、代谢当量（METs）、最大ST段压低、运动后伯格主观用力程度、每周心绞痛发作平均次数、硝酸甘油使用情况、撤药和减药率、中医四种诊断方法的信息评分以及主要不良心血管事件发生率设定为次要疗效指标。在整个试验过程中监测不良事件。