基于FDA不良事件报告系统数据库的德曲妥珠单抗致呼吸系统不良事件信号挖掘  

Signal mining of respiratory adverse events caused by trastuzumab deruxtecan based on the FDA adverse event reporting system database

作　　者：唐雨辰 易彬[1] 杨健[1] 张子祥[1] TANG Yu-chen;YI Bin;YANG Jian;ZHANG Zi-xiang(Department of General Surgery,the First Affiliated Hospital of Soochow University,Jiangsu Suzhou 215000,China)

机构地区：[1]苏州大学附属第一医院普外科,江苏苏州215000

出　　处：《临床药物治疗杂志》2024年第3期73-77,共5页Clinical Medication Journal

基　　金：国家自然科学基金青年科学基金项目(81902385)。

摘　　要：目的基于FDA不良事件报告系统(FAERS)数据库挖掘并分析德曲妥珠单抗致呼吸系统不良事件信号,为临床安全用药提供参考。方法采用比例失衡法中的报告比值比法和英国药品和健康产品管理局的综合标准法,检索FAERS数据库中2020年第1季度至2023年第1季度报告的德曲妥珠单抗相关不良事件的真实世界数据,并分析呼吸系统不良事件信号。结果共检索到德曲妥珠单抗相关不良事件信号4944条,筛选呼吸系统不良事件信号702条(14.20%)。间质性肺病、肺部炎症、胸腔积液、肺部疾病、肺栓塞等信号较强,而KL-6增加、细菌性肺炎、COVID-19等在说明书中虽未提及,但仍有较高的相关性。结论德曲妥珠单抗相关呼吸系统不良事件较常见,其中以间质性肺病具有较高的死亡率,临床还应关注KL-6增高、细菌性肺炎等呼吸系统相关不良事件,用药期间需加强肺部监测。Objective To mine and analyze respiratory adverse event signals caused by trastuzumab deruxtecan based on the FDA adverse event reporting system(FAERS)database,and to provide reference for clinical safety of drug use.Methods This study analyzed real-world data on respiratory adverse events associated with trastuzumab deruxtecan reported in the FAERS database from Q12020 to Q12023.The reported odds ratio of the proportional disequilibrium method,and the United Kingdom's Medicines and Healthcare Products Regulatory Agency(MHRA)were used to identify adverse event signals.Results A total of 4944 signals for adverse events associated with trastuzumab deruxtecan were retrieved,of which 702(14.20%)were related to respiratory adverse events.Stronger signals were observed for interstitial lung disease,lung inflammation,pleural effusion,lung disease,and pulmonary embolism.Although elevated KL-6,bacterial pneumonia,and COVID-19 were not mentioned in the specification,they still had a high correlation.Conclusion Respiratory adverse events associated with trastuzumab deruxtecan are common,with interstitial lung disease having a high mortality rate.Clinical attention should also be paid to respiratory-related adverse events such as elevated KL-6 and bacterial pneumonia.Lung monitoring needs to be strengthened during medication.

关 键 词：德曲妥珠单抗 FDA不良事件报告系统数据库 呼吸系统不良事件 报告比值比法 综合标准法 

分 类 号：R969.3[医药卫生—药理学] R979.1[医药卫生—药学]