非达霉素与蔗糖铁治疗慢性肾脏病患者缺铁性贫血的随机对照研究

A randomized comparison of ferumoxytol and iron sucrose for treating iron deficiency anemia in patients with CKD.

作者信息

Macdougall Iain C, Strauss William E, McLaughlin Justin, Li Zhu, Dellanna Frank, Hertel Joachim

机构信息

Department of Renal Medicine, King's College Hospital, London, United Kingdom;, †AMAG Pharmaceuticals, Inc., Lexington, Massachusetts;, ‡Nephrology Center Karlstr, Dusseldorf, Germany, §Greenville Kidney Care, LLC, Greenville, South Carolina.

出版信息

Clin J Am Soc Nephrol. 2014 Apr;9(4):705-12. doi: 10.2215/CJN.05320513. Epub 2014 Jan 23.

DOI:10.2215/CJN.05320513

PMID:24458078

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3974353/

Abstract

BACKGROUND AND OBJECTIVES

Few randomized controlled trials have compared intravenous iron products head to head in CKD patients with iron deficiency anemia. This study compared the efficacy and safety of two intravenous iron products (ferumoxytol [Feraheme injection] and iron sucrose [Venofer]) in patients with CKD and iron deficiency anemia.

DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In this phase II, randomized, open-label, active-controlled, multicenter clinical trial, patients were randomized 1:1 to either 1.02 g ferumoxytol (2 × 510-mg injections) or 1.0 g iron sucrose administered as either a slow injection or infusion (10 doses for dialysis patients and 5 doses for nondialysis patients). Inclusion criteria included hemoglobin<11.0 g/dl, transferrin saturation<30%, and eGFR<60 ml/min per 1.73 m(2) or a diagnosis of underlying CKD (e.g., nephropathy or nephritis). The primary end point was change in hemoglobin from baseline to week 5.

RESULTS

In total, 162 patients were randomized. Demographics were balanced between the treatment groups. Adverse event profiles of the two regimens were fairly similar: overall adverse events, 48% ferumoxytol versus 65% iron sucrose; related adverse events, 10% ferumoxytol versus 16% iron sucrose; and adverse events leading to study discontinuation, 1% ferumoxytol versus 5% iron sucrose. Rates of serious adverse events and related serious adverse events were similar between the ferumoxytol and iron sucrose groups: serious adverse events, 9% versus 7%, respectively and related serious adverse events, 1% versus 1%, respectively. Overall, increases in hemoglobin were similar between treatment groups. Based on an ANOVA model adjusted for baseline hemoglobin level and dialysis status, the least squares mean change from baseline to week 5 was 0.8 ± 0.1 g/dl in the ferumoxytol-treated group and 0.7 ± 0.1 g/dl in the iron sucrose group. The difference in the mean change from baseline between the two treatment groups was 0.1 g/dl (95% confidence interval, -0.2 to 0.4).

CONCLUSION

In this randomized, controlled trial, ferumoxytol and iron sucrose showed comparable efficacy and adverse events rates.

摘要

背景与目的

很少有随机对照试验对缺铁性贫血的慢性肾脏病（CKD）患者使用的静脉铁剂进行直接比较。本研究比较了两种静脉铁剂（多聚麦芽糖铁[Feraheme注射剂]和蔗糖铁[Venofer]）在CKD合并缺铁性贫血患者中的疗效和安全性。

设计、地点、参与者及测量指标：在这项II期随机、开放标签、活性药物对照、多中心临床试验中，患者按1:1随机分组，分别接受1.02 g多聚麦芽糖铁（2次510 mg注射）或1.0 g蔗糖铁，蔗糖铁采用缓慢注射或输注给药（透析患者10剂，非透析患者5剂）。纳入标准包括血红蛋白<11.0 g/dl、转铁蛋白饱和度<30%、估算肾小球滤过率（eGFR）<60 ml/min/1.73 m²或患有基础CKD（如肾病或肾炎）。主要终点是从基线到第5周血红蛋白的变化。

结果

总共162例患者被随机分组。各治疗组的人口统计学特征均衡。两种治疗方案的不良事件谱相当相似：总体不良事件，多聚麦芽糖铁组为48%，蔗糖铁组为65%；相关不良事件，多聚麦芽糖铁组为10%，蔗糖铁组为16%；导致研究中止的不良事件，多聚麦芽糖铁组为1%，蔗糖铁组为5%。多聚麦芽糖铁组和蔗糖铁组的严重不良事件及相关严重不良事件发生率相似：严重不良事件分别为9%和7%；相关严重不良事件均为1%。总体而言，各治疗组血红蛋白的升高情况相似。基于对基线血红蛋白水平和透析状态进行校正的方差分析模型，多聚麦芽糖铁治疗组从基线到第5周的最小二乘均值变化为0.8±0.1 g/dl，蔗糖铁组为0.7±0.1 g/dl。两个治疗组从基线开始的平均变化差异为0.1 g/dl（95%置信区间，-0.2至0.4）。