目的 選擇合適的方法評價抗程序性死亡受體1（PD-1）單克隆抗體在體外引起細胞因子釋放的風險。方法 通過抗體與人PBMC細胞共培養(yǎng)6、24 h，并用流式技術評估重組人源化抗PD-1單克隆抗體（F520）和已上市抗PD-1單克隆抗體Opdivo、Keytruda是否存在引起細胞因子釋放綜合征（cytokine release syndrome，CRS）的風險。結果 成功建立了采用人PBMC細胞在體外進行抗PD-1單克隆抗體細胞因子釋放的評價技術。結論 與人PBMC細胞的共培養(yǎng)6、24 h，F520、Opdivo和Keytruda在體外均不存在引起CRS的風險。

Objective Choose the appropriate method to evaluate cytokine release syndrome induced by anti-PD1 monoclonal antibody in vitro. Methods PBMC Cells were cocultured with mAb for 6 and 24 hours. Using FACS, we evaluated the risk of cytokine release syndrome induced by F520, Opdivo and Keytruda.Results Successfully established the method to evaluate cytokine release syndrome induced by anti-PD1 monoclonal antibody in vitro.Conclusion Cocultured with PBMC Cells for 6 and 24 hours, the results strongly emphasized that F520, Opdivo and Keytruda could not induce cytokine release syndrome.