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
路支超 1孟艳丽 1张霞 1邹静雯 1张歆 2许莉莉3
作者信息
- 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
- 折叠
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:1 056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,1 672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.
Abstract
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 Moni-toring Center from April 2019 to May 2023 were retrieved.Statistical analysis was performed on types of adverse reactions,sever ity,unintended or not,patient gender,age,outcome and involved organs/systems.RESULTS Among 1 056 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 1 672 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-1 inhibitors 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Key words
PD-1 inhibitor/adverse reactions/serious adverse drug reactions/drug safety引用本文复制引用
出版年
2024
NETL
NSTL
万方数据