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聚乙二醇化促红细胞生成素β治疗慢性肾衰竭相关性贫血

Methoxy polyethylene glycol-epoetin beta for the treatment of anemia associated with chronic renal failure.

作者信息

Schmid Holger

机构信息

a Clinic and Policlinic IV, Section of Nephrology , Munich University Hospital , Munich , Germany.

b KFH Nierenzentrum Muenchen Laim , Munich , Germany.

出版信息

Expert Rev Hematol. 2016 Jan;9(1):5-20. doi: 10.1586/17474086.2016.1112734. Epub 2015 Nov 17.

Abstract

Since more than two decades erythropoiesis-stimulating agents are the main pillar for treatment of anemia associated with chronic kidney disease. Methoxy polyethylene glycol-epoetin beta (MPG-EPO), also called continuous erythropoietin receptor activator, is the longest acting erythropoiesis-stimulating agent currently available. MPG-EPO is characterized by an elimination half-life of approximately 137 h and offers extended dosing intervals up to 4 weeks. Numerous phase I/II studies and a comprehensive clinical phase III program demonstrated the feasibility of MPG-EPO therapy for anemia correction and maintenance of stable hemoglobin levels in adult chronic kidney disease patients. Due to patent disputes MPG-EPO was only available outside the US market so far. In view of a prevailing US market introduction, this review focuses on efficacy and safety data from pivotal trials, summarizes recent clinical research and finally tries to substantiate potential benefits associated with the use of this anti-anemic drug.

摘要

二十多年来,促红细胞生成素一直是治疗慢性肾脏病相关性贫血的主要支柱药物。甲氧基聚乙二醇化促红细胞生成素β(MPG-EPO),也称为持续促红细胞生成素受体激活剂,是目前可用的作用时间最长的促红细胞生成素。MPG-EPO的消除半衰期约为137小时,给药间隔可延长至4周。众多I/II期研究和一项全面的III期临床研究表明,MPG-EPO疗法对于纠正成年慢性肾脏病患者的贫血和维持稳定的血红蛋白水平是可行的。由于专利纠纷,MPG-EPO迄今为止仅在美国市场以外可用。鉴于其即将进入美国市场,本综述重点关注关键试验中的疗效和安全性数据,总结近期临床研究,并最终试图证实使用这种抗贫血药物的潜在益处。

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