单抗诱发性细胞因子释放综合征和体外细胞因子释放实验的研究进展

Research development of cytokine release syndrome induced by monoclonal antibody and cytokine release assays in vitro

单克隆抗体引发的细胞因子释放综合征(CRS)具有发病迅速、危害严重、难以预测和控制等特点。近年来,建立可靠的体内动物模型和体外细胞因子释放实验(CRA)预测CRS的发生成为临床前安全性评价的研究热点。该文着重从CRA的适用对象、方法设计考虑因素、方法优化等方面进行综述,为CRA预测平台的优化提供建议。

Cytokine-release syndrome(CRS)triggered by monoclonal antibodies(mAbs)is characterized by rapid onset and severe damage,and difficulty in prediction and control.Recent years,it has been a research focus on establishing a reliable animal model in vivo and cytokine release assay(CRA)in vitro to predict CRS for preclinical safety evaluation.In this paper we summarize matters related to CRA applicable objects,considerations of method design and method optimization,aiming to provide suggestions for the optimization of CRA prediction platform.