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器官移植中的原装和通用保存液。一种新范式?

Original and generic preservation solutions in organ transplantation. A new paradigm?

作者信息

Roselló-Catafau Joan, Panisello-Roselló Arnau, Pasut Gianfranco, Navasa Miquel, Pirenne Jacques, Adam René

机构信息

PhD, Experimental Pathology Department, Institute of Biomedical Research (IIBB-CSIC), Catalonia, Barcelona, Spain. Manuscript writing, final approval.

PhD, Department of Pharmaceutical and Pharmacological Sciences, Padova, Italy. Manuscript writing, final approval.

出版信息

Acta Cir Bras. 2020 Mar 9;35(1):e202000101. doi: 10.1590/s0102-865020200010000001. eCollection 2020.

Abstract

Solid organ transplantation is a very complex process, in which the storage of the graft in a preservation solution is mandatory in order to extend ischemic times and contain further damage. The condition in which the organ is transplanted is critical for the outcome of the organ recipient. The recent emergence of generic versions of organ preservation solutions (solutions with the same composition and under the same legislation as the original versions, but with different brands) compelled us to study whether the standards are maintained when comparing the original and its generic counterpart. Along these lines, we discuss and comment on some aspects concerning this issue of general interest in the organ transplantation field.

摘要

实体器官移植是一个非常复杂的过程,在此过程中,必须将移植物保存在保存液中,以延长缺血时间并防止进一步损伤。器官移植时的状况对器官接受者的预后至关重要。最近出现了器官保存液的仿制药(成分与原产品相同且符合相同法规,但品牌不同的溶液),这促使我们研究在比较原产品及其仿制药时其标准是否得以维持。基于此,我们讨论并评论了器官移植领域中这个普遍感兴趣的问题的一些方面。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ec8/7065442/a827b5f609fa/1678-2674-acb-35-1-e201901201-gf01.jpg

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