程序性死亡受体1/程序性死亡配体1抑制药相关不良事件的分析

Analysis of adverse drug events of programmed death receptor 1/programmed death receptor ligand 1 inhibitors

目的了解程序性死亡受体1/程序性死亡配体1(programmed death recep⁃tor 1/programmed death receptor ligand 1,PD-1/PD-L1)抑制药相关不良事件(adverse event,AE)的发生特点及规律。方法回顾性分析美国食品药品监督管理局不良事件报告系统中2004年第一季度至2021年第二季度上报的与PD-1/PD-L1抑制药有关的AE。结果共纳入101570份AE报告,涉及PD-1抑制药7个品种,累及器官系统18个;PD-L1抑制药3个品种,累及器官系统12个。报告的患者男女比例为1.62,年龄≥65岁的患者占比最高,为36.28%。AE临床转归主要为治愈,占28.28%。报告者主要为医师,占38.98%。各PD-1/PD-L1抑制药常见AE上报类型较为一致,主要累及胃肠道、呼吸系统、皮肤系统及血液系统。结论PD-1/PD-L1抑制药AE发生率较高,累及器官系统广泛,临床应用时应给予一定重视,对特殊AE应进行监测。

Objective To investigate the characteristics and regularity of adverse events(AEs)associated with programmed death receptor 1(PD-1)and programmed death receptor ligand 1(PD-L1)inhibitors.Methods Retrospective analysis adverse events reported between Q12004 and Q22021 in US Food and Drug Administration adverse event reporting system were connected with PD-1 and PD-L1 inhibitors.Results A total of 101570 adverse event reports were included,18 organ systems were affected by 7 varieties of PD-1 inhibitors and 12 organ systems were affected by 3 varieties of PD-L1 inhibitors.The ratio of male to female patients reported was 1.62,and patients aged≥65 years accounted for the highest proportion(36.28%).The main clinical outcome of adverse events was cure,accounting for 28.28%.The report was mainly from doctors,accounting for 38.98%.The common AE reporting types of PD-1/PD-L1 inhibitors were consistent,and mainly affects the gastrointestinal tract,respiratory,skin system and blood system.Conclusion PD-1/PD-L1 inhibitors have a high incidence of AEs,which involves a wide range of organ systems.Therefore,certain attention should be paid to their clinical application,and special AE should be monitored.