Chronic Disease Innovation Center, Seven Oaks General Hospital, Winnipeg, Manitoba, Canada; and.
Section of Nephrology, Department of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
Clin J Am Soc Nephrol. 2018 Mar 7;13(3):457-467. doi: 10.2215/CJN.05390517. Epub 2018 Feb 20.
The safety of intravenous iron dosing in dialysis is uncertain. Higher-dose intravenous iron may be associated with a higher risk of infections, cardiovascular events, hospitalizations, and mortality. This systematic review aimed to determine the safety of higher-dose versus lower-dose intravenous iron, oral iron, or no iron supplementation in adult patients treated with dialysis.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We searched Medline, EMBASE, Cochrane library, and CINAHL from inception to January 6, 2017 for randomized, controlled trials and observational studies comparing higher-dose intravenous iron with lower-dose intravenous iron, oral iron, or no iron in patients treated with dialysis that had all-cause mortality, infection, cardiovascular events, or hospitalizations as outcomes.
Of the 2231 eligible studies, seven randomized, controlled trials and 15 observational studies met inclusion criteria. The randomized, controlled trials showed no association between higher-dose intravenous iron (>400 mg/mo for most studies) and mortality (six studies; =970; pooled relative risk, 0.93; 95% confidence interval, 0.47 to 1.84; follow-up ranging from 35 days to 26 months) or infection (four studies; =743; relative risk, 1.02; 95% confidence interval, 0.74 to 1.41). The observational studies showed no association between higher-dose intravenous iron (>200 mg/mo for most studies) and mortality (eight studies; =241,408; hazard ratio, 1.09; 95% confidence interval, 0.98 to 1.21; follow-up ranging from 3 to 24 months), infection (eight studies; =135,532; pooled hazard ratio, 1.13; 95% confidence interval, 0.99 to 1.28), cardiovascular events (seven studies; =135,675; hazard ratio, 1.18; 95% confidence interval, 0.90 to 1.56), or hospitalizations (five studies; =134,324; hazard ratio, 1.08; 95% confidence interval, 0.97 to 1.19).
Higher-dose intravenous iron does not seem to be associated with higher risk of mortality, infection, cardiovascular events, or hospitalizations in adult patients on dialysis. Strength of this finding is limited by small numbers of participants and events in the randomized, controlled trials and statistical heterogeneity in observational studies.
静脉铁剂在透析中的安全性尚不确定。高剂量静脉铁剂可能与感染、心血管事件、住院和死亡风险增加有关。本系统评价旨在确定高剂量与低剂量静脉铁剂、口服铁剂或不补充铁剂在接受透析治疗的成年患者中的安全性。
设计、设置、参与者和测量方法：我们检索了 Medline、EMBASE、Cochrane 图书馆和 CINAHL，从建库到 2017 年 1 月 6 日，以确定比较高剂量静脉铁剂（大多数研究中 >400mg/mo）与低剂量静脉铁剂、口服铁剂或不补充铁剂在接受透析治疗且全因死亡率、感染、心血管事件或住院为结局的随机对照试验和观察性研究。
在 2231 项符合条件的研究中，有 7 项随机对照试验和 15 项观察性研究符合纳入标准。随机对照试验显示，高剂量静脉铁剂（大多数研究中 >400mg/mo）与死亡率（6 项研究；=970；汇总相对风险，0.93；95%置信区间，0.47 至 1.84；随访时间 35 天至 26 个月）或感染（4 项研究；=743；相对风险，1.02；95%置信区间，0.74 至 1.41）无关。观察性研究显示，高剂量静脉铁剂（大多数研究中 >200mg/mo）与死亡率（8 项研究；=241,408；危险比，1.09；95%置信区间，0.98 至 1.21；随访时间 3 至 24 个月）、感染（8 项研究；=135,532；汇总危险比，1.13；95%置信区间，0.99 至 1.28）、心血管事件（7 项研究；=135,675；危险比，1.18；95%置信区间，0.90 至 1.56）或住院（5 项研究；=134,324；危险比，1.08；95%置信区间，0.97 至 1.19）无关。
高剂量静脉铁剂似乎不会增加接受透析治疗的成年患者的死亡率、感染、心血管事件或住院风险。这一发现的强度受到随机对照试验中参与者和事件数量少以及观察性研究中统计学异质性的限制。
