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欣母沛注射液治疗慢性心力衰竭有效性和安全性的多中心随机双盲安慰剂对照临床试验

The Efficacy and Safety of Xinmailong Injection in Patients with Chronic Heart Failure: A Multicenter Randomized Double-Blind Placebo-Controlled Trial.

机构信息

1Department of Cardiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.

2Department of Cardiology, The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.

出版信息

J Altern Complement Med. 2019 Aug;25(8):856-860. doi: 10.1089/acm.2019.0030. Epub 2019 Jul 11.

Abstract

Chronic heart failure (CHF) is a chronic and progressive disease with high incidence. The aim of this study was to evaluate the effectiveness and safety of Xinmailong injection (XI) on CHF patients with B-type natriuretic peptide (BNP) ≥200 ng/mL and left ventricular ejection fraction (LVEF) of ≤45%. This is a randomized double-blind placebo-controlled trial. Hospitals. One hundred patients with CHF were randomly divided into XI ( = 50) and control groups ( = 50). The XI group was treated with standard treatment plus XI (100 mg/2 mL, intravenous drip infusion). The control group was treated with standard treatment plus equal amounts of XI placebo. The course of treatment was 5 days. New York Heart Association (NYHA) functional class, LVEF, BNP, and 6-min walking distance were assessed for therapeutic effect. NYHA functional classes and LVEF were better in the XI group than in the control ( 0.01). BNP was significantly different after the treatments in both groups ( < 0.01), and compared with the control, BNP was reduced after XI treatment ( < 0.01). No deaths occurred in the course of this study. The number of adverse events between the two groups was not statistically different ( > 0.05). XI can alleviate the symptoms, improve heart function, and exercise tolerance in patients with CHF and is safe to use.

摘要

慢性心力衰竭(CHF)是一种发病率较高的慢性进行性疾病。本研究旨在评估新麦龙注射液(XI)对 B 型利钠肽(BNP)≥200ng/ml 和左心室射血分数(LVEF)≤45%的 CHF 患者的有效性和安全性。这是一项随机、双盲、安慰剂对照试验。医院。100 例 CHF 患者随机分为 XI 组(n=50)和对照组(n=50)。XI 组给予标准治疗加 XI(100mg/2mL,静脉滴注)。对照组给予标准治疗加等量 XI 安慰剂。疗程为 5 天。评估治疗效果的指标包括纽约心脏协会(NYHA)功能分级、LVEF、BNP 和 6 分钟步行距离。XI 组的 NYHA 心功能分级和 LVEF 均优于对照组(P<0.01)。两组治疗后 BNP 均有显著差异(P<0.01),与对照组相比,XI 治疗后 BNP 降低(P<0.01)。本研究过程中无死亡病例。两组不良反应发生率无统计学差异(P>0.05)。XI 可缓解 CHF 患者的症状,改善心功能和运动耐量,使用安全。

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