静脉铁剂治疗左室射血分数保留性心力衰竭伴铁缺乏患者的疗效

Outcomes of patients with left ventricular ejection fraction preserved heart failure and iron deficiency treated with intravenous iron

目的评估长期静脉铁剂治疗对左室射血分数保留性心力衰竭(HFp EF)伴铁缺乏患者的意义。方法选取61例射血分数保留性心力衰竭伴铁缺乏的患者,随机分为静脉铁剂(FCM)治疗组(n=31)和安慰剂对照组(n=29)进行为期24周的随机、双盲、对照试验,首要观察终点为24周时6MWT的显著变化,次要观察终点为NYHA心功能分级及健康相关生命质量评分(HRQo L)的变化,同时检测NT-proBNP变化情况。结果铁剂治疗组与对照组相比,两组患者16周和24周的6MWT、RQo L差异有统计学意义,铁剂治疗组6MWT更长,HRQo L更高(P<0.05)。16周NT-proBNP水平、NYHA心功能分级在两组间的差异不明显(P>0.05),但24周两组间差异均有统计学意义(P<0.05)。结论对HFp EF患者进行补铁治疗,有利于改善患者症状、运动能力和生活质量。

Objective The aim of this study was to evaluate the benefits of i.v. iron therapy in iron-deficient patients with left ventricular ejection fraction preserved heart failure （HFpEF）. Methods 61 HFpEF patients with iron deficiency were randomized to treatment with or without i.v. iron, as ferric earboxymaltose （FCM, n = 31） or placebo （saline, n = 29） for 24 weeks of a double-blind, placebo-controlled trial. The primary end- point was the change in 6-min-walk-test （6MWT） distance from baseline to Week 24. Secondary end-points included changes in New York Heart Association （NYHA） class, health-related quality of life （QoL）, with NT-proBNP under observation. Results Compared with the control group at week 16 and 24, the iron treatment group has much more improve in 6MWT and the health-related quality of life （HRQoL） （P 〈 0.05 ）. The changes in NT-proB- NP level and NYHA heart function classification only show significance at week 24 （P 〈 0.05 ） but not at week 16 （P 〉 0.05）. Conclusion In this study, Treatment with intravenous ferric carboxymaltose can improve symptoms, functional capacity, and quality of life.