基于openFDA数据库对PD1抑制剂不良反应的信号检测与分析

The signal detection and analysis of adverse reactions to PD-1 inhibitors based on the openFDA database

目的应用openFDA数据库分析帕博利珠单抗和纳武利尤单抗的不良反应报告,为临床安全用药提供参考。方法应用requests库,从API接口获取openFDA数据。检索时间2014年1月至2022年10月。采用报告比值比(ROR)方法,按药物不良反应术语集的首选系统器官分类(SOC)和首选术语(PT)对两种PD1抑制剂的不良反应进行分类并计算风险信号。结果共收到帕博利珠单抗不良反应报告43,160份,纳武利尤单抗67,546份。帕博利珠单抗ROR阳性PT信号120个,纳武利尤单抗124个。在排名前50的PT中,帕博利珠单抗涉及16个SOC,纳武利尤单抗17个。总体上帕博利珠单抗和纳武利尤单抗的不良反应相似:帕博利珠单抗强ROR阳性信号分布在呼吸系统最高,纳武利尤单抗则在内分泌系统阳性信号最高。结论对2种PD1抑制剂的真实世界不良事件数据进行挖掘,有助于获得免疫不良反应发生率,发现潜在不良反应风险,比较PD1抑制剂不良反应的器官系统倾向性,帮助临床尽早发现免疫相关不良反应,及时干预,保障用药安全。

Objective To analyze the adverse reaction reports of pembrolizumab and nivolumab by using the openFDA database,providing evidences for rational drug use in clinic.Methods Used the requests library to obtain openFDA data from the API interface.The data collection period was limited from January 1,2014 to October 1,2022.Adverse reactions of the two PD1 inhibitors were classified by preferred system organ class(SOC)and preferred term(PT),and risk signals were calculated using the reporting odds ratio(ROR)method.Results A total of 43,160 adverse reaction reports for pembrolizumab and 67,546 for nivolumab were received.There were 120 ROR-positive PT signals for pembrolizumab and 124 for nivolumab.Among the top 50 PTs,pembrolizumab involved 16 SOCs and nivolumab 17.Overall,the adverse reactions of pembrolizumab and nivolumab were similar:the strong ROR positive signal distribution of pembrolizumab was the highest in the respiratory system,while the positive signal of nivolumab was the highest in the endocrine system.Conclusion Mining real-world adverse event data for two PD-1 inhibitors to obtain rates of immune adverse reactions,identify potential adverse reaction risks,compare organ system tendencies in adverse reactions to PD-1 inhibitors,and assist in early detection and timely intervention of immune-related adverse reactions in clinical settings,ensuring medication safety.