麝香保心丸（MUSKARDIA）治疗稳定型冠状动脉疾病患者的疗效与安全性：一项多中心、双盲、安慰剂对照的IV期随机临床试验。
Efficacy and safety of Shexiang Baoxin pill (MUSKARDIA) in patients with stable coronary artery disease: a multicenter, double-blind, placebo-controlled phase IV randomized clinical trial.
作者信息
Ge Jun-Bo, Fan Wei-Hu, Zhou Jing-Min, Shi Hai-Ming, Ji Fu-Sui, Wu Yang, Zhao Yu-Lan, Qian Jun, Jin Yuan-Zhe, Liu Ying-Wu, Wang Sheng-Huang, He Sheng-Hu, Yang Ping, Wu Jie, Lu Feng, Hou Zi-Shan
机构信息
Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Department of Cardiology, Huashan Hospital, Fudan University, Shanghai 200040, China.
出版信息
Chin Med J (Engl). 2021 Jan 20;134(2):185-192. doi: 10.1097/CM9.0000000000001257.
BACKGROUND
The Shexiang Baoxin Pill (MUSKARDIA) has been used for treating coronary artery disease (CAD) and angina for more than 30 years in China. Nevertheless, methodologically sound trials on the use of MUSKARDIA in CAD patients are scarce. The aim of the study is to determine the effects of MUSKARDIA as an add-on to optimal medical therapy (OMT) in patients with stable CAD.
METHODS
A total of 2674 participants with stable CAD from 97 hospitals in China were randomized 1:1 to a MUSKARDIA or placebo group for 24 months. Both groups received OMT according to local tertiary hospital protocols. The primary outcome was the occurrence of a major adverse cardiovascular event (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal stroke. Secondary outcomes included all-cause mortality, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or heart failure, peripheral revascularization, angina stability and angina frequency.
RESULTS
In all, 99.7% of the patients were treated with aspirin and 93.0% with statin. After 2 years of treatment, the occurrence of MACEs was reduced by 26.9% in the MUSKARDIA group (MUSKARDIA: 1.9% vs. placebo: 2.6%; odds ratio = 0.80; 95% confidence interval: 0.45-1.07; P = 0.2869). Angina frequency was significantly reduced in the MUSKARDIA group at 18 months (P = 0.0362). Other secondary endpoints were similar between the two groups. The rates of adverse events were also similar between the two groups (MUSKARDIA: 17.7% vs. placebo: 17.4%, P = 0.8785).
CONCLUSIONS
As an add-on to OMT, MUSKARDIA is safe and significantly reduces angina frequency in patients with stable CAD. Moreover, the use of MUSKARDIA is associated with a trend toward reduced MACEs in patients with stable CAD. The results suggest that MUSKARDIA can be used to manage patients with CAD.
TRIAL REGISTRATION
chictr.org.cn, No. ChiCTR-TRC-12003513.
背景
麝香保心丸在中国用于治疗冠状动脉疾病（CAD）和心绞痛已有30多年。然而，关于麝香保心丸用于CAD患者的方法学严谨的试验却很匮乏。本研究的目的是确定麝香保心丸作为优化药物治疗（OMT）的附加治疗对稳定型CAD患者的疗效。
方法
来自中国97家医院的2674例稳定型CAD患者按1:1随机分为麝香保心丸组或安慰剂组，治疗24个月。两组均根据当地三级医院方案接受OMT。主要结局是主要不良心血管事件（MACE）的发生，定义为心血管死亡、非致死性心肌梗死（MI）或非致死性卒中的复合事件。次要结局包括全因死亡率、非致死性MI、非致死性卒中、因不稳定型心绞痛或心力衰竭住院、外周血管重建、心绞痛稳定性和心绞痛发作频率。
结果
总体而言，99.7%的患者接受了阿司匹林治疗，93.0%的患者接受了他汀类药物治疗。治疗2年后，麝香保心丸组MACE的发生率降低了26.9%（麝香保心丸组：1.9% vs. 安慰剂组：2.6%；优势比=0.80；95%置信区间：0.45 - 1.07；P = 0.2869）。在18个月时，麝香保心丸组的心绞痛发作频率显著降低（P = 0.0362）。两组之间的其他次要终点相似。两组的不良事件发生率也相似（麝香保心丸组：17.7% vs. 安慰剂组：17.4%，P = 0.8785）。
结论
作为OMT的附加治疗，麝香保心丸安全且能显著降低稳定型CAD患者的心绞痛发作频率。此外，使用麝香保心丸使稳定型CAD患者的MACE有降低趋势。结果表明麝香保心丸可用于CAD患者的治疗。
试验注册
chictr.org.cn，编号ChiCTR - TRC - 12003513。
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