稳心颗粒治疗气虚血瘀型不稳定型心绞痛的有效性和安全性的随机对照试验研究方案。
Efficacy and safety of Chinese herbal medicine Wen Xin granules for the treatment of unstable angina pectoris with Yang deficiency and blood stasis syndrome: study protocol for a randomized controlled trial.
机构信息
Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Graduate School Department, Beijing University of Chinese Medicine, Beijing, China.
出版信息
Trials. 2021 Nov 13;22(1):798. doi: 10.1186/s13063-021-05771-y.
INTRODUCTION
Unstable angina pectoris (UAP) is the common type of coronary heart disease with the risk of developing into acute myocardial infarction (AMI). Currently, there are still numerous patients suffering from recurrent angina after revascularization or conventional medication due to the microvascular lesions, endothelial dysfunction, chronic inflammation, in-stent restenosis, and other factors. As an important part of China's medical and health care system, traditional Chinese medicine (TCM) has rich clinical experience in the treatment of UAP. According to the theory of TCM, Yang deficiency and blood stasis syndrome is a common type of UAP. Wen Xin decoction, as a type of Chinese herbal medicine, has been used in the clinic for years and shown great efficacy in the treatment of UAP with Yang deficiency and blood stasis syndrome. This study aims to evaluate the efficacy and safety of Wen Xin granular in patients with UAP.
METHODS AND ANALYSIS
This is a double-blinded, randomized, placebo-controlled clinical trial. A total of 502 participants will be randomly allocated to the intervention group and the placebo group. Based on conventional medication, the intervention group will be treated with Wen Xin granular and the placebo group will be treated with Wen Xin granular placebo. The primary outcomes are major adverse cardiovascular events (MACE). Assessments will be performed 1 year after the treatment. The secondary outcomes include TCM symptom scale score, Seattle angina questionnaire, and thromboelastography. Assessments will be performed at baseline (before randomization) and 4 and 8 weeks after randomization.
DISCUSSION
This trial will provide high-quality data on the benefits and risks of Wen Xin granular in patients with UAP.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04661709 . Registered on 30 November 2020.
简介
不稳定型心绞痛（UAP）是冠心病的常见类型，有发展为急性心肌梗死（AMI）的风险。目前，由于微血管病变、内皮功能障碍、慢性炎症、支架内再狭窄等因素，仍有许多患者在血管重建或常规药物治疗后出现复发性心绞痛。作为中国医疗卫生体系的重要组成部分，中医药在治疗 UAP 方面具有丰富的临床经验。根据中医理论，阳虚心血瘀证是 UAP 的常见证型。稳心颗粒作为一种中药制剂，已在临床上应用多年，对治疗阳虚心血瘀证 UAP 有较好的疗效。本研究旨在评价稳心颗粒治疗 UAP 的疗效和安全性。
方法与分析
这是一项双盲、随机、安慰剂对照的临床试验。共纳入 502 例患者，随机分为干预组和安慰剂组。在常规药物治疗的基础上，干预组给予稳心颗粒治疗，安慰剂组给予稳心颗粒安慰剂治疗。主要结局指标为主要不良心血管事件（MACE）。治疗 1 年后进行评估。次要结局指标包括中医证候量表评分、西雅图心绞痛问卷和血栓弹力图。基线（随机分组前）、随机分组后 4 周和 8 周进行评估。
讨论
本试验将为稳心颗粒治疗 UAP 患者的获益和风险提供高质量的数据。
试验注册
ClinicalTrials.gov NCT04661709 。于 2020 年 11 月 30 日注册。
Zotero 插件