参附注射液联合呋塞米治疗冠心病慢性心力衰竭随机对照试验方案
Shenfu injection combined with furosemide in the treatment of chronic heart failure in patients with coronary heart disease: A protocol of randomized controlled trial.
机构信息
Department of Emergency Medicine, The Second Affiliated Hospital of Nanjing Medical University, Nanjing 210011, Jiangsu Province, China.
出版信息
Medicine (Baltimore). 2021 Jan 22;100(3):e24113. doi: 10.1097/MD.0000000000024113.
BACKGROUND
Coronary heart disease (CHD) is an important cause of chronic heart failure, and chronic heart failure is also a serious complication in the end stage of coronary heart disease. At present, there is no specific treatment plan. Shenfu injection has advantages in the treatment of heart failure in patients with coronary heart disease, but there is a lack of standard clinical study to verify this. Therefore, the purpose of this randomized controlled trial is to evaluate the efficacy and safety of Shenfu injection combined with furosemide in the treatment of chronic heart failure in patients with coronary heart disease.
METHODS
This is a prospective randomized controlled trial to study the efficacy and safety of Shenfu injection combined with furosemide in the treatment of coronary heart disease and chronic heart failure. This study will be approved by the clinical research ethics committee of our hospital. The patients will be randomly divided into two groups according to 1:1:(a) Shenfu injection combined with furosemide group and (b) simple furosemide group. Standard treatment for 7 days followed up for 30 days at the same time, pay attention to its efficacy and safety indicators. The total effective rate of cardiac function improvement, left ventricular ejection fraction (LVEF), N-terminal pro-brain natriuretic peptide (NT-pro BNP), 6-minute walk test (6-MWTD), and adverse reactions will be observed. Data will be analyzed using the statistical software package SPSS version 25.0 (Chicago, IL).
DISCUSSION
This study will evaluate the efficacy and safety of Shenfu injection combined with furosemide in the treatment of coronary heart disease with chronic heart failure. The results of this experiment will provide a clinical basis for Shenfu injection combined with furosemide in the treatment of coronary heart disease and chronic heart failure.
OSF REGISTRATION NUMBER
doi: 10.17605/OSF.IO/27FPM.
背景
冠心病(CHD)是慢性心力衰竭的重要病因,慢性心力衰竭也是冠心病终末期的严重并发症。目前尚无特异性治疗方案。参附注射液在冠心病心力衰竭患者的治疗中有优势,但缺乏规范的临床研究加以验证。因此,本随机对照试验旨在评价参附注射液联合呋塞米治疗冠心病慢性心力衰竭的疗效和安全性。
方法
这是一项前瞻性随机对照试验,研究参附注射液联合呋塞米治疗冠心病合并慢性心力衰竭的疗效和安全性。本研究将获得我院临床研究伦理委员会的批准。患者将按照 1:1 分为两组:(a)参附注射液联合呋塞米组和(b)单纯呋塞米组。同时给予标准治疗 7 天,随访 30 天,注意其疗效和安全性指标。观察心功能改善总有效率、左心室射血分数(LVEF)、N 末端脑利钠肽前体(NT-pro BNP)、6 分钟步行试验(6-MWTD)和不良反应。数据采用统计软件包 SPSS 版本 25.0(芝加哥,IL)进行分析。
讨论
本研究将评价参附注射液联合呋塞米治疗冠心病合并慢性心力衰竭的疗效和安全性。该实验的结果将为参附注射液联合呋塞米治疗冠心病和慢性心力衰竭提供临床依据。
OSF 注册号:doi:10.17605/OSF.IO/27FPM。