Department of Cardiology, Campus Virchow-Klinikum, Charité Universitätsmedizin, Berlin.
N Engl J Med. 2009 Dec 17;361(25):2436-48. doi: 10.1056/NEJMoa0908355. Epub 2009 Nov 17.
Iron deficiency may impair aerobic performance. This study aimed to determine whether treatment with intravenous iron (ferric carboxymaltose) would improve symptoms in patients who had heart failure, reduced left ventricular ejection fraction, and iron deficiency, either with or without anemia.
We enrolled 459 patients with chronic heart failure of New York Heart Association (NYHA) functional class II or III, a left ventricular ejection fraction of 40% or less (for patients with NYHA class II) or 45% or less (for NYHA class III), iron deficiency (ferritin level <100 microg per liter or between 100 and 299 microg per liter, if the transferrin saturation was <20%), and a hemoglobin level of 95 to 135 g per liter. Patients were randomly assigned, in a 2:1 ratio, to receive 200 mg of intravenous iron (ferric carboxymaltose) or saline (placebo). The primary end points were the self-reported Patient Global Assessment and NYHA functional class, both at week 24. Secondary end points included the distance walked in 6 minutes and the health-related quality of life.
Among the patients receiving ferric carboxymaltose, 50% reported being much or moderately improved, as compared with 28% of patients receiving placebo, according to the Patient Global Assessment (odds ratio for improvement, 2.51; 95% confidence interval [CI], 1.75 to 3.61). Among the patients assigned to ferric carboxymaltose, 47% had an NYHA functional class I or II at week 24, as compared with 30% of patients assigned to placebo (odds ratio for improvement by one class, 2.40; 95% CI, 1.55 to 3.71). Results were similar in patients with anemia and those without anemia. Significant improvements were seen with ferric carboxymaltose in the distance on the 6-minute walk test and quality-of-life assessments. The rates of death, adverse events, and serious adverse events were similar in the two study groups.
Treatment with intravenous ferric carboxymaltose in patients with chronic heart failure and iron deficiency, with or without anemia, improves symptoms, functional capacity, and quality of life; the side-effect profile is acceptable. (ClinicalTrials.gov number, NCT00520780).
铁缺乏可能会损害有氧运动能力。本研究旨在确定静脉铁（羧基麦芽糖铁）治疗是否会改善患有心力衰竭、左心室射血分数降低且存在铁缺乏（铁蛋白水平＜100μg/L 或 100-299μg/L 但转铁蛋白饱和度＜20%）、无论是否伴贫血的 NYHA 心功能 II 或 III 级患者的症状。
我们纳入了 459 例 NYHA 心功能 II 或 III 级、左心室射血分数＜40%（NYHA II 级）或＜45%（NYHA III 级）、铁缺乏（铁蛋白水平＜100μg/L 或 100-299μg/L 但转铁蛋白饱和度＜20%）且血红蛋白水平 95-135g/L 的慢性心力衰竭患者。患者以 2:1 的比例随机接受 200mg 静脉铁（羧基麦芽糖铁）或生理盐水（安慰剂）治疗。主要终点为 24 周时的自我报告的患者整体评估和 NYHA 心功能分级。次要终点包括 6 分钟步行距离和健康相关生活质量。
根据患者整体评估，与接受安慰剂的患者（28%）相比，接受羧基麦芽糖铁的患者中有 50%报告症状有很大或中度改善（改善的优势比，2.51；95%置信区间[CI]，1.75 至 3.61）。在接受羧基麦芽糖铁治疗的患者中，24 周时 NYHA 心功能 I 或 II 级的患者比例为 47%，而接受安慰剂的患者比例为 30%（心功能改善一个级别，优势比为 2.40；95%CI，1.55 至 3.71）。贫血和非贫血患者的结果相似。羧基麦芽糖铁在 6 分钟步行试验和生活质量评估中均显著改善。两组患者的死亡率、不良事件和严重不良事件发生率相似。
在伴有或不伴有贫血的慢性心力衰竭合并铁缺乏的患者中，静脉给予羧基麦芽糖铁可改善症状、功能能力和生活质量；副作用可接受。（临床试验.gov 编号，NCT00520780）。
