铁性碳酸在缺铁心力衰竭中的作用
Robert J Mentz1, Jyotsna Garg1, Frank W Rockhold1
1From the Division of Cardiology, Department of Medicine (R.J.M., J.H., A.F.H.), and the Department of Biostatistics and Bioinformatics (F.W.R.), Duke University School of Medicine, and Duke Clinical Research Institute (R.J.M., J.G., F.W.R., L.S., J.H., A.F.H.) - both in Durham, NC; Baylor Scott and White Research Institute, Dallas (J.B.); the Department of Medicine, University of Mississippi, Jackson (J.B.); Flinders Medical Centre, Flinders University, Adelaide, SA (C.G.D.P.), and the Department of Cardiology, Prince Charles Hospital and Faculty of Medicine, University of Queensland, Brisbane (Y.W.W.) - both in Australia; Canadian VIGOUR Centre, University of Alberta, Edmonton (J.A.E.), and Montreal Heart Institute and Université de Montréal, Montreal (E.O.) - both in Canada; the Cardiology Division and Cardiovascular Research Center, Massachusetts General Hospital, Boston (G.D.L.); the Center for Heart Diseases, University Hospital, Wroclaw Medical University, Wroclaw, Poland (P.P.); Christchurch Heart Institute, University of Otago, Christchurch, New Zealand (R.W.T.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (Y.W.W.); and American Regent, Shirley, NY (R.A., N.B.).
铁性碳酸盐并没有显著减少心力衰竭患者的临床事件,减少喷射分数和缺铁. 该研究发现与安慰剂相比,死亡,心力衰竭住院或6分钟步行距离没有明显的差异.
科学领域:
- 心脏病学 心脏病学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 铁缺乏症常见于心力衰竭患者,心力衰竭患者的射出分数减少 (HFrEF).
- 铁炭酸糖 (FCM) 用于治疗铁缺乏症并改善HFrEF患者的症状.
- 需要进一步证实FCM对HFrEF临床事件的影响.
研究的目的:
- 与安慰剂相比,评估静脉注射铁性碳酸盐糖在减少HFrEF和铁缺乏症的门诊患者的临床事件方面的疗效.
- 评估重复注射铁碳酸盐和马尔托的安全性和耐受性.
主要方法:
- 这是一项双盲随机试验,涉及3065名患有HFrEF和铁缺乏症的门诊患者.
- 根据需要,患者被分为1:1接受每6个月一次静脉注射铁糖糖醇或安慰剂.
- 主要结局是死亡,心力衰竭住院或6个月后6分钟步行距离的变化等级组合.
主要成果:
- 对于初级复合结果,铁性碳酸和安慰剂组之间没有显著差异.
- 12个月死亡发生在FCM组的8.6%,与安慰剂组的10.3%相比.
- 副作用的概况相似,严重不良事件发生在FCM组的27.0%和安慰剂组的26.2%中.
结论:
- 铁性碳酸与安慰剂相比,在减少死亡,心力衰竭住院的复合情况或改善铁缺乏HFrEF患者的6分钟步行距离方面没有显著的好处.
- 在这个患者群体中,铁性碳酸被发现是安全的,具有可接受的不良事件概况.
- HEART-FID试验没有达到其主要终点,这表明目前的证据不支持常规使用FCM来预防铁缺乏HFrEF的临床事件.
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