参元丹胶囊用于经皮冠状动脉介入治疗后围手术期心肌损伤的有效性和安全性：一项随机、双盲、安慰剂对照试验的研究方案
Efficacy and safety of Shen-Yuan-Dan capsules for peri-procedural myocardial injury following percutaneous coronary intervention: study protocol for a randomized, double-blind, placebo-controlled trial.
作者信息
Li Xiang, Lai Xiao-Lei, Fei Yu-Tong, Shang Ju-Ju, Zhou Qi, Sun Xue-Yan, Xing Wen-Long, Jia Si-Han, Liu Hong-Xu
机构信息
Cardiovascular Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.
Centre for Evidence-Based Chinese Medicine, Beijing University of Traditional Chinese Medicine, Beijing 100029, China.
出版信息
Ann Transl Med. 2019 Mar;7(6):119. doi: 10.21037/atm.2018.09.44.
BACKGROUND
Peri-procedural myocardial injury (PMI) during percutaneous coronary intervention (PCI) will result in an unfavorable clinical prognosis in patients, thus urgently necessitating effective drug treatment measures. Shen-Yuan-Dan (SYD) capsules are a traditional Chinese medicine (TCM) preparation that have been found to have potential myocardial protection effects during the peri-procedural phase of PCI in previous clinical and basic research; however, there is a lack of rigorous, randomized, and controlled studies. The aim of this study is to evaluate the efficacy and safety of SYD in decreasing PMI.
METHODS
This is a randomized, double-blind, placebo-controlled clinical trial. A total of 284 patients with unstable angina will be randomized into test and control groups. The two groups will be given SYD or a placebo (three times each day, four capsules each time) 3 days before PCI on the basis of conventional treatment. Twelve hours before PCI, an additional 4 capsules will be given, and drug treatment is planned to be maintained for 1 month after surgery. Dynamic changes in the myocardial enzyme in four time-points (before PCI, and 4, 24, 48 hours after PCI) in both groups of patients that will be observed. The follow-up period will be 1 month. The primary observation markers are planned to evaluate the efficacy and safety of SYD in decreasing PMI. The secondary observation markers will be to evaluate the major adverse cardiovascular events (MACEs) status at day 30 after PCI, (all-cause mortality, non-fatal myocardial infarction, repeated revascularization of target blood vessel) and Seattle Angina Questionnaire scores. GRACE scores will be used for risk stratification, and the intervention efficacy of SYD on PMI patients with different risks will be retrospectively evaluated.
DISCUSSION
This study will provide a rigorous clinical evidence to evaluate the efficacy and safety of SYD in decreasing PMI and the results are worth anticipating.
TRIAL REGISTRATION
The design of this trial has been registered with the Chinese Clinical Trial Registry (No. ChiCTR-IPR-17011069).
背景
经皮冠状动脉介入治疗（PCI）期间的围手术期心肌损伤（PMI）会导致患者临床预后不良，因此迫切需要有效的药物治疗措施。参元丹（SYD）胶囊是一种中药制剂，在先前的临床和基础研究中发现其在PCI围手术期具有潜在的心肌保护作用；然而，缺乏严格的随机对照研究。本研究的目的是评估SYD在降低PMI方面的疗效和安全性。
方法
这是一项随机、双盲、安慰剂对照的临床试验。总共284例不稳定型心绞痛患者将被随机分为试验组和对照组。两组在PCI术前3天在常规治疗基础上给予SYD或安慰剂（每日3次，每次4粒）。PCI术前12小时额外给予4粒，术后计划维持药物治疗1个月。观察两组患者在四个时间点（PCI术前、PCI术后4、24、48小时）心肌酶的动态变化。随访期为1个月。主要观察指标计划用于评估SYD在降低PMI方面的疗效和安全性。次要观察指标将是评估PCI术后30天的主要不良心血管事件（MACE）状态（全因死亡率、非致命性心肌梗死、靶血管再次血运重建）和西雅图心绞痛问卷评分。GRACE评分将用于风险分层，并回顾性评估SYD对不同风险PMI患者的干预疗效。
讨论
本研究将为评估SYD在降低PMI方面的疗效和安全性提供严格的临床证据，结果值得期待。
试验注册
本试验设计已在中国临床试验注册中心注册（注册号：ChiCTR-IPR-17011069）。
Zotero 插件