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维持性血液透析患者的静脉补铁
Intravenous Iron in Patients Undergoing Maintenance Hemodialysis


Iain C. Macdougall ... 其他 • 2019.01.31
相关阅读
• 慢性肾疾病的营养管理

摘要


背景

静脉补铁是血液透析患者的标准治疗,但关于临床有效方案的比较数据有限。

 

方法

在一项采用盲法终点评估的多中心、开放标签试验中,我们将接受维持性血液透析的成人随机分组,分别接受主动大剂量静脉补充蔗糖铁(每月400 mg,除非铁蛋白浓度>700 μg/L或转铁蛋白饱和度≥40%)或被动(reactive)小剂量静脉补充蔗糖铁(每月0~400 mg,铁蛋白浓度<200 μg/L或转铁蛋白饱和度<20%是补铁的触发条件)。主要终点是由非致死性心肌梗死、非致死性卒中、心力衰竭住院或死亡构成的复合终点,在至首起事件发生时间的分析中进行评估。还对上述终点的复发性事件进行了评估。其他次要终点包括死亡、感染发生率以及红细胞生成刺激剂的剂量。如果主要终点风险比的95%置信区间(CI)上限不超过1.25,则证实大剂量组与小剂量组相比具有非劣效性。

 

结果

共有2,141例患者被随机分组(大剂量组1,093例,小剂量组1,048例)。中位随访时间为2.1年。大剂量组和小剂量组患者补铁的中位月剂量分别为264 mg(四分位距[第25至第75百分位数],200~336)和145 mg(四分位距,100~190)。在大剂量组和小剂量组中,红细胞生成刺激剂的中位月剂量分别为29,757 IU和38,805 IU(中位差异,-7,539 IU;95% CI,-9,485~-5,582)。共有大剂量组320例患者(29.3%)和小剂量组338例患者(32.3%)发生了主要终点事件(风险比,0.85;95% CI,0.73~1.00;对于非劣效性,P<0.001;对于优效性,P=0.04)。在使用复发性事件方法进行的分析中,大剂量组和小剂量组分别发生了429起和507起事件(率比,0.77;95% CI,0.66~0.92)。两组的感染发生率相同。

 

结论

在血液透析患者中,主动大剂量静脉补铁方案优于被动小剂量静脉补铁方案,前者所需的红细胞生成刺激剂的剂量较小(由英国肾脏研究组织[Kidney Research UK]资助;PIVOTAL在EudraCT注册号为20-002267-25)。





作者信息

Iain C. Macdougall, M.D., Claire White, B.Sc., Stefan D. Anker, M.D., Sunil Bhandari, Ph.D., F.R.C.P., Kenneth Farrington, M.D., Philip A. Kalra, M.D., John J.V. McMurray, M.D., Heather Murray, M.Sc., Charles R.V. Tomson, D.M., David C. Wheeler, M.D., Christopher G. Winearls, D.Phil., F.R.C.P., and Ian Ford, Ph.D. for the PIVOTAL Investigators and Committees*
From the Department of Renal Medicine, King’s College Hospital (I.C.M., C.W.), and University College London (D.C.W.), London, Hull and East Yorkshire Hospitals NHS Trust and Hull York Medical School, Hull (S.B.), Lister Hospital, Stevenage (K.F.), and University of Hertfordshire, Hertfordshire (K.F.), the Department of Renal Medicine, Salford Royal NHS Foundation Trust, Salford (P.A.K.), the British Heart Foundation Cardiovascular Research Centre (J.J.V.M.) and the Robertson Centre for Biostatistics (H.M., I.F.), University of Glasgow, Glasgow, Freeman Hospital, Newcastle upon Tyne (C.R.V.T.), and the Oxford Kidney Unit, Churchill Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford (C.G.W.) — all in the United Kingdom; and the Division of Cardiology and Metabolism, Department of Cardiology, Berlin–Brandenburg Center for Regenerative Therapies, German Center for Cardiovascular Research partner site Berlin, Charité Universitätsmedizin Berlin, Berlin (S.D.A.). Address reprint requests to Dr. Ford at the Robertson Centre for Biostatistics, University of Glasgow, Level 11, Boyd Orr Bldg., Glasgow G12 8QQ, United Kingdom, or at ian.ford@glasgow.ac.uk. *A complete list of the Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL) investigators and committee members is provided in the Supplementary Appendix, available at NEJM.org.

 

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