Safety of Intravenous Iron in Hemodialysis: Longer-term Comparisons of Iron Sucrose Versus Sodium Ferric Gluconate Complex.
Safety of Intravenous Iron in Hemodialysis: Longer-term Comparisons of Iron Sucrose Versus Sodium Ferric Gluconate Complex.
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DOI：
10.1053/j.ajkd.2016.10.031
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发表时间：
2017-06
期刊：
影响因子：
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通讯作者：
Fishbane S
中科院分区：
文献类型：
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作者：
Winkelmayer WC;Goldstein BA;Mitani AA;Ding VY;Airy M;Mandayam S;Chang TI;Brookhart MA;Fishbane S
对于血液透析（HD）患者常用的不同静脉铁制剂的长期安全性是否存在差异存在争议。我们利用一项自然实验，比较了在主要（≥90%的患者）使用蔗糖铁（IS）与葡萄糖酸铁钠复合物（FG）的机构中开始HD的患者的结局。HD患者的回顾性队列研究。使用美国肾脏数据系统，我们对主要使用FG的HD设施与使用IS的类似设施的地理区域和中心特征进行了严格匹配。随后，将事件HD患者分配给其机构铁制剂暴露。设施级IS与FG的使用。随访患者的任何心血管或感染原因的死亡率。对医保患者进行了感染性和心血管（中风、心肌梗死）住院治疗以及相应原因特异性死亡的复合结局随访。风险比。我们将2，015家IS机构与2，015家FG机构进行了匹配，其中51，603例患者（IS：24，911; FG：26，692）随后开始HD。所有记录的患者特征在组间均衡。在49,989人-年中，发生了10,381例死亡（3908例心血管死亡; 1209例感染性死亡）。IS和FG机构之间校正的全因（HR，0.98; 95% CI，0.93-1.03）、心血管（HR，0.96; 95% CI，0.89-1.03）和感染性死亡率（HR，0.98; 95% CI，0.86-1.13）无差异。在医疗保险受益人中，FG和IS机构之间的致命或非致命心血管事件无差异（HR，1.01; 95% CI，0.93-1.09）。IS与FG机构相比，复合感染终点的发生频率较低（HR，0.92; 95% CI，0.88-0.96）。来自非随机治疗分配的未观察到的选择偏倚。在几乎完全使用IS与FG的机构中开始HD的患者具有相似的长期结局。然而，在主要使用IS的设施中进行透析的患者的感染性住院和死亡略有下降。这种差异可能是由于残余混杂、随机机会或因果效应。
Controversy exists about any differences in longer-term safety across different intravenous iron formulations routinely used in hemodialysis (HD) patients. We exploited a natural experiment to compare outcomes of patients initiating HD in facilities that predominantly (in ≥90% of their patients) used iron sucrose (IS) versus sodium ferric gluconate complex (FG). Retrospective cohort study of incident HD patients. Using the US Renal Data System, we hard-matched on geographic region and center characteristics HD facilities predominantly using FG with similar ones using IS. Subsequently incident HD patients were assigned their facility iron formulation exposure. Facility-level use of IS versus FG. Patients were followed up for mortality from any, cardiovascular, or infectious cause. Medicare-insured patients were followed for infectious and cardiovascular (stroke, myocardial infarction) hospitalizations and for composite outcomes with the corresponding cause-specific deaths. Hazard ratios. We matched 2,015 IS facilities with 2,015 FG facilities, in which 51,603 patients (IS: 24,911; FG: 26,692) subsequently initiated HD. All recorded patient characteristics were balanced between groups. Over 49,989 person-years, 10,381 deaths (3908 cardiovascular; 1209 infectious) occurred. Adjusted all-cause (HR, 0.98; 95% CI, 0.93–1.03), cardiovascular (HR,0.96; 95% CI, 0.89–1.03), and infectious mortality (HR, 0.98; 95% CI, 0.86–1.13) did not differ between IS and FG facilities. Among Medicare beneficiaries, no differences between FG and IS facilities were observed in fatal or non-fatal cardiovascular events (HR, 1.01; 95% CI, 0.93–1.09). The composite infectious end point occurred less frequently in IS versus FG facilities (HR, 0.92; 95% CI, 0.88–0.96). Unobserved selection bias from non-random treatment assignment. Patients initiating HD in facilities almost exclusively using IS versus FG had similar longer-term outcomes. However, there was a small decrease in infectious hospitalizations and deaths in patients dialyzing in facilities predominantly using IS. This difference may be due to residual confounding, random chance, or a causal effect.