A randomized trial of intravenous and oral iron in chronic kidney disease.
A randomized trial of intravenous and oral iron in chronic kidney disease.
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DOI：
10.1038/ki.2015.163
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发表时间：
2015-10
影响因子：
19.6
通讯作者：
Pappas MK
中科院分区：
文献类型：
--
作者：
Agarwal R;Kusek JW;Pappas MK
虽然铁通常用于纠正慢性肾脏病（CKD）中的缺铁性贫血（IDA），但其对肾功能的影响尚不清楚。为了评估这一点，我们将患有3期和4期CKD和IDA的患者随机分配至开放标签口服硫酸亚铁（69例患者，325 mg，每日3次，持续8周）或静脉注射蔗糖铁（67例患者，200 mg，每2周，共1 g）。主要结果是两年内测量的肾小球滤过率（mGFR）变化斜率的组间差异。根据独立数据和安全监测委员会的建议，该试验提前终止，因为发现mGFR斜率差异的可能性很小，但静脉铁剂治疗组发生严重不良事件的风险较高。两个治疗组的mGFR在两年内下降相似（口服−3.6 mL/min/1.73m2，静脉注射− 4.0 mL/min/1.73m2，组间差异− 0.35 mL/min/1.73m2（95%置信区间−2.9至2.3）。口服铁剂治疗组的19名受试者中发生了36起严重心血管事件，静脉铁剂治疗组的17名受试者中发生了55起事件（校正后的发生率比为2.51（1.56 - 4.04））。导致住院的感染的校正发生率比值为2.12（1.24−3.64）。因此，在患有CKD和IDA的非透析患者中，静脉铁剂治疗与严重不良事件的风险增加相关，包括心血管原因和感染性疾病。
Although iron is commonly used to correct iron deficiency anemia (IDA) in chronic kidney disease (CKD) its effect on kidney function is unclear. To assess this, we randomly assigned patients with Stage 3 and 4 CKD and IDA to either open-label oral ferrous sulfate (69 patients to 325 mg three times daily for 8 weeks) or intravenous iron sucrose (67 patients to 200 mg every 2 weeks, total 1 gram). The primary outcome was the between group difference in slope of measured glomerular filtration rate (mGFR) change over two years. The trial was terminated early on the recommendation of an independent Data and Safety Monitoring Board based on little chance of finding differences in mGFR slopes, but a higher risk of serious adverse events in the intravenous iron treatment group. mGFR declined similarly over two years in both treatment groups (oral −3.6 mL/min/1.73m2, intravenous − 4.0 mL/min/1.73m2, between group difference − 0.35 mL/min/1.73m2 (95% confidence interval −2.9 to 2.3). There were 36 serious cardiovascular events among 19 participants assigned to the oral iron treatment group and 55 events among 17 participants of the intravenous iron group (adjusted incidence rate ratio 2.51 (1.56−4.04). Infections resulting in hospitalizations had a significant adjusted incidence rate ratio of 2.12 (1.24−3.64). Thus, among non-dialyzed patients with CKD and IDA, intravenous iron therapy is associated with an increased risk of serious adverse events, including those from cardiovascular causes and infectious diseases.