Efficacy and Safety of Shenqisuxin Granule for Non-ST-segment Elevation Acute Coronary Syndrome: Study Protocol for a Randomized, Double-Blinded, Placebo-Controlled Trial.
Efficacy and Safety of Shenqisuxin Granule for Non-ST-segment Elevation Acute Coronary Syndrome: Study Protocol for a Randomized, Double-Blinded, Placebo-Controlled Trial.
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DOI：
10.3389/fcvm.2022.888724
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发表时间：
2022
影响因子：
3.6
通讯作者：
Chen, Keji
中科院分区：
文献类型：
--
作者：
Wu, Xiaoping;Guo, Ming;Shi, Shihua;Shi, Shengnan;Deng, Yanping;Wang, Shenglan;Wang, Yabing;Wang, Peili;Chen, Keji
关键词：
现代药学研究显示，中药复方参芪素心颗粒（SQSX）可促进新生血管形成并预防支架内再狭窄，有望为治疗非ST段抬高急性冠状动脉综合征（NSTEACS）提供有效策略。因此，本研究旨在检验SQSX对NSTEACS的有效性和安全性，并初步揭示其机制。该研究是一项随机、双盲、安慰剂对照试验。总共 66 名参与者将被随机分配到以下两组之一。 SQSX 组的参与者将接受常规治疗加 SQSX，而安慰剂组将接受常规治疗加安慰剂，均持续 14 天。主要结局 hs-CRP 和次要结局西雅图心绞痛问卷 (SAQ) 将在基线、7 ± 3 天和 14 ± 3 天时进行评估。所有访视窗口均检测肌酸激酶（CK）、肌酸激酶心肌带（CK-MB）、心肌肌钙蛋白I（cTnI）、12导联心电图、气虚血瘀证评分等指标，并进行肠道菌群宏基因组测序。将在基线和 14 ± 3 天时进行超声心动图检查和安全评估。试验期间将监测不良事件。该研究的目的是检验SQSX改善NSTEACS的有效性和安全性，并初步揭示其机制。中国临床试验注册中心，ChiCTR2000029226。注册日期：2020年1月19日。
The Chinese herbal compound formula, Shenqisuxin granule (SQSX), promotes neovascularization and prevents in-stent restenosis in modern pharmaceutical studies and is expected to provide an effective strategy for non-ST-segment elevation acute coronary syndrome (NSTEACS). Thus, this study aims to examine the efficacy and safety of SQSX for NSTEACS and initially reveal its mechanism. The study is a randomized, double-blinded and placebo-controlled trial. A total of 66 participants will be randomly allocated to one of the following two groups. Participants in the SQSX group will receive conventional treatment plus SQSX, while the placebo group will receive conventional treatment plus placebo, both for 14 days. The primary outcome, hs-CRP, and secondary outcome the Seattle Angina Questionnaire (SAQ) will be assessed at baseline, 7 ± 3 days and 14 ± 3 days. At all visit windows, other indicators including creatine kinase (CK), creatine kinase-myocardial band (CK-MB), cardiac troponins I (cTnI), 12-lead electrocardiograph and the syndrome scores of Qi deficiency and blood stasis will be tested and metagenomic sequencing for intestinal flora will be performed. Echocardiography and safety assessment will be performed at baseline and 14 ± 3 days. Adverse events will be monitored during the trial. The purpose of the study is to examine the efficacy and safety of SQSX to improve NSTEACS and initially reveal its mechanism. China Clinical Trial Registry, ChiCTR2000029226. Registered on January 19, 2020.
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DOI：
10.1056/nejmoa1109400
发表时间：
2013-04-25
期刊：
The New England journal of medicine
影响因子：
--
作者：
Tang WH;Wang Z;Levison BS;Koeth RA;Britt EB;Fu X;Wu Y;Hazen SL
通讯作者：
Hazen SL
影响因子：
24
作者：
Baber, Usman;Mehran, Roxana;Pocock, Stuart
通讯作者：
Pocock, Stuart
西洋参皂苷减轻慢性缺血引起的心肌功能障碍
影响因子：
--
作者：
Guo, Ming;Liu, Jiangang;Shi, Dazhuo
通讯作者：
Shi, Dazhuo
肠道微生物组和代谢随冠状动脉疾病严重程度的变化
影响因子：
15.5
作者：
Liu, Honghong;Chen, Xi;Zhang, Chenhong
通讯作者：
Zhang, Chenhong
影响因子：
24
作者：
Valina, Christian;Neumann, Franz-Josef;Kastrati, Adnan
通讯作者：
Kastrati, Adnan