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静注铁(ferumoxytol)治疗缺铁。

Ferumoxytol for the treatment of iron deficiency.

机构信息

Division of Nephrology, University of Virginia Health System, Charlottesville, VA, USA.

出版信息

Expert Rev Hematol. 2011 Aug;4(4):399-406. doi: 10.1586/ehm.11.31.

Abstract

Intravenous iron is standard for dialysis-associated anemia and its use is rising dramatically in other settings. Except for the dextrans, full iron replacement requires multiple visits. Nonetheless, safety concerns abound. Ferumoxytol, a recently approved modified dextran with a carbohydrate core that tightly binds the iron moiety, decreasing free iron and ostensibly increasing safety, was approved by the US FDA, in June 2009, for the treatment of iron deficiency associated with chronic kidney disease and end-stage renal disease. This formulation, uniquely, can be administered in a large dose as a short intravenous injection of 1 min or less, markedly facilitating care. Recent post-marketing safety issues have been raised resulting in a change in the package insert. This article examines existing clinical data and posits reasons for the labeling change. Potential future use of this formulation is opined.

摘要

静脉铁剂是治疗与透析相关贫血的标准方法,其在其他治疗环境中的应用也在迅速增加。除了葡聚糖外,完全铁替代需要多次就诊。尽管如此,安全性问题仍然存在。Ferumoxytol 是一种最近批准的改良葡聚糖,具有紧密结合铁部分的碳水化合物核心,减少游离铁,表面上增加了安全性,于 2009 年 6 月被美国 FDA 批准用于治疗与慢性肾脏病和终末期肾病相关的缺铁。这种制剂具有独特性,可作为 1 分钟或更短的大剂量短静脉注射给药,显著方便了治疗。最近出现了一些上市后安全性问题,导致了说明书的变更。本文检查了现有的临床数据,并提出了标签变更的原因。对这种制剂的潜在未来用途进行了讨论。

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