摘要
目的:本研究旨在观察darbepoetin α(一种红细胞生成刺激蛋白,ESP)能否改善有症状性慢性心力衰竭(CHF)伴贫血患者的运动耐量。背景:贫血在CHF患者中较为常见。方法:在此项多中心、随机、双盲、安慰剂对照研究中,伴有贫血(血红蛋白90~120g/L)的CHF患者接受安慰剂(n=22)或darbepoetind(n=19)皮下注射,初始剂量为0.75μg/kg,每2周1次,持续26周。主要终点是从基线到27周时以峰值耗氧量[ml/(min·kg体重)】测量的运动耐量的变化。其他终点包括:绝对峰值耗氧量、运动持续时间以及健康相关生活质量的变化。
Objectives: This study sought to investigate whether darbepoetin alfa, an erythropoiesis-stimulating protein(ESP), improves exercise capacity in patients with symptomatic chronic heart failure(CHF) and anemia. Background: Anemia is common in patients with CHF. Methods: In a multicenter, randomized, double-blind, placebo-controlled study, CHF patients with anemia(hemoglobin ≥9.0 to ≤ 12.0 g/dl) received subcutaneous placebo(n=22) or darbepoetin alfa(n = 19) at a starting dose of 0. 75 p,g/kg every 2 weeks for 26 weeks. The primary end point was change in exercise tolerance from baseline to week 27 as measured by peak oxygen uptake(ml/min/kg body weight) .