近日，美国旧金山退伍军人事务医疗中心教授John R. Teerlink及其研究小组分析了Serelaxin治疗急性心力衰竭患者的效果。 2019年8月22日，国际知名学术期刊《新英格兰医学杂志》发表了这一成果。

Serelaxin是一种重组人松弛素-2，也是一种血管扩张激素，有助于在怀孕期间心血管和肾脏的适应。此前的研究表明，使用serelaxin治疗可能会减轻急性心力衰竭患者的症状，且预后良好。

在这项多中心、双盲、安慰剂对照、事件驱动的试验中，课题组招募了因急性心力衰竭而住院的患者，这些患者呼吸困难，胸部X线造影显示充血，血浆钠尿肽浓度升高，轻中度肾功能不全，收缩压高于125毫米汞柱。这些患者在发病16小时内随机接受48小时静脉输注serelaxin或安慰剂，并进行标准治疗。

该意向治疗分析共纳入6545名患者。在第180天，serelaxin组3274名患者有285名（8.7%）死于心血管疾病，安慰剂组3271名患者中为290人（8.9%），风险比为0.98。在第5天，serelaxin组中有227名患者（6.9%）出现心力衰竭恶化，安慰剂组为252名（7.7%），风险比为0.89。 两组患者在180天时的总死亡率、心血管原因导致的死亡率、因心力衰竭或肾衰竭再住院率以及住院时间相比，均无显著性差异。 两组患者的不良反应发生率亦相差无几。

综上，与安慰剂相比，注射serelaxin并没有降低急性心力衰竭住院患者的180天心血管原因死亡率和5天心力衰竭恶化率。

附：英文原文

Title: Effects of Serelaxin in Patients with Acute Heart Failure

Author: Marco Metra, M.D., John R. Teerlink, M.D., Gad Cotter, M.D., Beth A. Davison, Ph.D., G. Michael Felker, M.D., M.H.S., Gerasimos Filippatos, M.D., Barry H. Greenberg, M.D., Peter S. Pang, M.D., Piotr Ponikowski, M.D., Ph.D., Adriaan A. Voors, M.D., Ph.D., Kirkwood F. Adams, M.D., Stefan D. Anker, M.D., Ph.D., et al

Issue&Volume: Vol 381 No 7, 22 August 2019

Abstract: 

BACKGROUND
Serelaxin is a recombinant form of human relaxin-2, a vasodilator hormone that contributes to cardiovascular and renal adaptations during pregnancy. Previous studies have suggested that treatment with serelaxin may result in relief of symptoms and in better outcomes in patients with acute heart failure.

METHODS
In this multicenter, double-blind, placebo-controlled, event-driven trial, we enrolled patients who were hospitalized for acute heart failure and had dyspnea, vascular congestion on chest radiography, increased plasma concentrations of natriuretic peptides, mild-to-moderate renal insufficiency, and a systolic blood pressure of at least 125 mm Hg, and we randomly assigned them within 16 hours after presentation to receive either a 48-hour intravenous infusion of serelaxin (30 μg per kilogram of body weight per day) or placebo, in addition to standard care. The two primary end points were death from cardiovascular causes at 180 days and worsening heart failure at 5 days.

RESULTS
A total of 6545 patients were included in the intention-to-treat analysis. At day 180, death from cardiovascular causes had occurred in 285 of the 3274 patients (8.7%) in the serelaxin group and in 290 of the 3271 patients (8.9%) in the placebo group (hazard ratio, 0.98; 95% confidence interval [CI], 0.83 to 1.15; P=0.77). At day 5, worsening heart failure had occurred in 227 patients (6.9%) in the serelaxin group and in 252 (7.7%) in the placebo group (hazard ratio, 0.89; 95% CI, 0.75 to 1.07; P=0.19). There were no significant differences between the groups in the incidence of death from any cause at 180 days, the incidence of death from cardiovascular causes or rehospitalization for heart failure or renal failure at 180 days, or the length of the index hospital stay. The incidence of adverse events was similar in the two groups.

CONCLUSIONS
In this trial involving patients who were hospitalized for acute heart failure, an infusion of serelaxin did not result in a lower incidence of death from cardiovascular causes at 180 days or worsening heart failure at 5 days than placebo.

DOI: 10.1056/NEJMoa1801291

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1801291