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培格司亭治疗慢性肾脏病贫血的新方法:是否如流星划过?

Peginesatide as a new approach for treating anemia of CKD patient: is it like a falling star?

出版信息

Expert Opin Pharmacother. 2013 Jul;14(10):1277-80. doi: 10.1517/14656566.2013.799139. Epub 2013 May 16.

Abstract

Any scientific innovation needs to translate into a significant benefit. Peginesatide is noninferior to other erythropoiesis stimulating agents (ESAs) in terms of efficacy, and it shares the advantages of other long-acting ESAs: delayed administration frequency and no changes in dose needs according to the administration route. The molecular structure of peginesatide does not require the use of recombinant DNA technology during the manufacturing process, making its synthesis simpler and likely economically cheaper. During clinical development, its safety profile seemed to be safe, excepting the potential increase in the risk of safety end-point events in nondialysis CKD patients. However postmarketing serious hypersensitivity reactions have completely changed the scenario and urgently needs in-depth clarification. This promising drug seems to have prematurely finished its prospects.

摘要

任何科学创新都需要转化为显著的效益。培高利特在疗效方面不劣于其他促红细胞生成素刺激剂(ESA),并且具有其他长效 ESA 的优点:给药频率延迟,并且根据给药途径不需要改变剂量需求。培高利特的分子结构在制造过程中不需要使用重组 DNA 技术,因此其合成更简单,并且可能在经济上更便宜。在临床开发过程中,其安全性似乎是安全的,除了非透析慢性肾脏病患者的安全性终点事件风险可能增加。然而,上市后严重的过敏反应完全改变了这种情况,迫切需要深入澄清。这种有前途的药物似乎过早地结束了它的前景。

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