聚乙二醇化重组人粒细胞集落刺激因子免疫原性的研究进展  

Research progress on immunogenicity of PEGylated recombinant human granulocyte-colony stimulating factor

作　　者：王丹阳 徐婷婷(综述) 邱云良(审校) WANG Danyang;XU Tingting;QIU Yunliang(School of Chemistry and Chemical Engineering,Shanghai University of Engineering Science,Shanghai 201620,China)

机构地区：[1]上海工程技术大学化学化工学院,上海201620 [2]上海益诺思生物技术股份有限公司,上海201203 [3]中国医药工业研究总院,上海201203

出　　处：《中国生物制品学杂志》2024年第8期1002-1007,共6页Chinese Journal of Biologicals

基　　金：上海市科委工程技术研究中心专项(17DZ2252900)。

摘　　要：重组人粒细胞集落刺激因子(recombinant human granulocyte-colony stimulating factor,rhG-CSF)能够有效防治化疗引起的中性粒细胞减少症,其主要通过肾脏代谢,药物半衰期短,需重复注射以维持药效。聚乙二醇(polyethylene glycol,PEG)与rhG-CSF经共价结合制备为PEG-rhG-CSF,可延长药物半衰期,但其在临床应用中可出现由免疫原性介导的不良反应,是需要关注的安全性问题。本文就PEG-rhG-CSF免疫原性引发的不良反应及免疫原性的影响因素、检测方法、产生机制等作一综述,以期为PEG-rhG-CSF的临床安全应用提供参考。Recombinant human granulocyte-colony stimulating factor(rhG-CSF)can effectively prevent and treat febrile neutropenia caused by chemotherapy,which mainly metabolizes through the kidneys and has a short half-life,requiring repeated injections to maintain its effect.PEG-rhG-CSF formed by combining polyethylene glycol(PEG)with rhG-CSF can prolong the half-life of drugs.However,there have been immunogenicity mediated adverse reactions in clinical use of PEG-rhG-CSF,and the safety is still the focus of attention.This paper discusses the adverse reactions induced by PEG-rhG-CSF immunogenicity,as well as the influencing factors,detection methods and production mechanism of immunogenicity with the aim of providing reference for the safe clinical application of PEG-rhG-CSF.

关 键 词：重组人粒细胞集落刺激因子 聚乙二醇 免疫原性 抗药抗体 不良反应 

分 类 号：R96[医药卫生—药理学]