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