口服补铁对心力衰竭患者运动能力的影响:IRONOUT HF随机临床试验
Gregory D Lewis1, Rajeev Malhotra1, Adrian F Hernandez2
1Massachusetts General Hospital, Boston.
JAMA
|May 17, 2017
概括
高剂量的口服铁并没有改善心力衰竭和铁缺乏症患者的运动能力. 这些发现不支持HFrEF患者口服铁补充剂.
科学领域:
- 心脏病学
- 血液学
- 临床试验
背景情况:
- 缺铁影响大约50%的心力衰竭患者,左心室喷射率 (HFrEF) 降低.
- 铁缺乏与HFrEF患者的功能能力下降和死亡率增加有关.
- 在HFrEF缺乏铁的患者中,口服铁补充剂的有效性以前是未知的.
研究的目的:
- 评估口服铁疗法是否能改善诊断为HFrEF和铁缺乏症的患者的峰值运动能力.
主要方法:
- 一个双盲,安慰剂控制的2期随机临床试验.
- 包括225名患有HFrEF (<40%的射出分数) 和铁缺乏症的患者.
- 参与者每天两次服用150毫克口服铁多糖或安慰剂,持续16周.
主要成果:
- 在16周后,口服铁和安慰剂组之间,氧气摄取峰值 (V·o2) 的变化没有显著差异.
- 二级终点,包括6分钟步行距离,NT-proBNP水平和KCCQ得分,也没有显著改善口服铁.
- 这项研究包括225名随机参与者,其中203人完成了16周的试验.
结论:
- 在16周的时间内,高剂量的口服铁补充剂没有提高HFrEF和铁缺乏症患者的运动能力.
- 这项研究的结果不支持在这种患者群体中常规使用口服铁.
- 可能需要进一步研究以探索替代铁配方或治疗持续时间.
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