基于真实世界监测数据分析山东省PD-1抑制剂不良反应发生特点  

Analysis of adverse reaction characteristics of PD-1 inhibitors in Shandong Province based upon real-world monitoring data

作　　者：路支超 孟艳丽 张霞 邹静雯 张歆 许莉莉[3] LU Zhichao;MENG Yanli;ZHANG Xia;ZOU Jingwen;ZHANG Xin;XU Lili(Department of pharmacy,Zibo Municipal Hospital,Shandong Zibo 255400,China;Zibo Drug Alert Center,Shandong Zibo 255086,China;Department of Drug Monitoring,Shandong Medicine Adverse Reaction Monitoring Center,Shandong Jinan 250014,China)

机构地区：[1]淄博市市立医院临床药学办公室,山东淄博255400 [2]山东省淄博市药物警戒中心,山东淄博255086 [3]山东省药品不良反应监测中心药品监测科,山东济南250014

出　　处：《中国医院药学杂志》2024年第23期2779-2783,共5页Chinese Journal of Hospital Pharmacy

基　　金：山东省药品不良反应监测中心委托项目(编号:2022SDADRKY19);2021年度山东省医学会临床科研资金--齐鲁专项(编号:YXH2022ZX02074)。

摘　　要：目的:挖掘PD-1抑制剂不良反应发生规律及特点,为使用PD-1抑制剂的患者用药安全提供依据。方法:调取2019年4月至2023年5月山东省药品不良反应监测管理系统收集的PD-1抑制剂相关不良反应,对不良反应的类型、严重程度、是否非预期及患者性别、年龄、转归情况、累及器官/系统等进行统计学处理。结果:1056例PD-1抑制剂相关不良反应报道中,以男性患者为主(74.91%),年龄主要分布在大于65岁(49.53%),涉及18个系统器官分类,1672个首选术语,其中窒息感为所有药品均未报道过的首选术语。发生严重不良反应的患者为609例,占比57.67%,对导致严重不良反应不同因素比较发现,发生严重不良反应组超说明书/指南用药情况及既往药品不良反应/事件发生情况与一般不良反应组相比差异有统计学意义(P<0.05)。结论:临床医师在使用PD-1抑制剂时应关注其不良反应发生规律及特点,加强不良反应监测,保障用药安全。OBJECTIVE To excavate the patterns and characteristics of adverse reactions of PD-1 inhibitors and provide rationales for patient medication safety.METHODS The adverse reactions of PD-1 inhibitor collected by Shandong ADR Monitoring Center from April 2019 to May 2023 were retrieved.Statistical analysis was performed on types of adverse reactions,severity,unintended or not,patient gender,age,outcome and involved organs/systems.RESULTS Among 1056 reports of adverse reactions related to PD-1 inhibitors,males dominated(74.91%)with age mostly over 65 year(49.53%).A total of 18 system organ classifications(SOCs)and 1672 preferred terms(PTs)were involved,with choking sensation as a PT not reported for any of the drugs.And 609 patients with severe ADR occurred,accounting for 57.67%.A comparison of different factors leading to severe adverse drug reaction revealed a significant statistical difference between group with serious adverse drug reactions and group with general adverse drug reaction during off-label drug uses and the previous of adverse drug reaction/event.CONCLUSION Clinicians should pay a high alert for the occurring patterns and characteristics of adverse reactions of PD-1inhibitors and strengthen the monitoring of adverse drug reactions to ensure the safety of drug dosing.

关 键 词：PD-1抑制剂 不良反应 严重不良反应 用药安全 

分 类 号：R979.1[医药卫生—药品]