基于openFDA的维泊妥珠单抗和德曲妥珠单抗不良事件分析  

Analysis of adverse events of polatuzumab vedotin and fam-trastuzumab deruxtecan-nxki based on OpenFDA database

作　　者：林茂 张关敏[2] 尹桂森 凌彩色 肖洪涛 张艳华[2] LIN Mao;ZHANG Guan-min;YIN Gui-sen;LING Cai-se;XIAO Hong-tao;ZHANG Yan-hua(Department of Pharmacy,Sichuan Clinical Research Center for Cancer,Sichuan Cancer Hospital&Institute,Sichuan Cancer Center,Affiliated Cancer Hospital of University of Electronic Science and Technology,Chengdu 610041,Sichuan Province,China;Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing),Department of Pharmacy,Peking University Cancer Hospital&Institute,Beijing 100142,China;Department of Pharmacy,Yantai Hospital of Traditional Chinese Medicine,Yantai 264000,Shandong Province,China;Department of Pharmacy,The Affiliated Hospital of Youjiang Medical University for Nationalities,Baise 533000,Guangxi Zhuang Autonomous Region,China)

机构地区：[1]四川省肿瘤临床医学研究中心·四川省肿瘤医院研究所·四川省癌症防治中心.电子科技大学附属肿瘤医院药学部,四川成都610041 [2]北京大学肿瘤医院、北京市肿瘤防治研究所药剂科.恶性肿瘤发病机制及转化研究教育部重点实验室,北京100142 [3]烟台市中医医院药学部,山东烟台264000 [4]右江民族医学院附属医院药学部,广西壮族自治区百色533000

出　　处：《中国临床药理学杂志》2024年第6期904-908,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的对维泊妥珠单抗(Pola)与德曲妥珠单抗(T-Dxd)不良事件(ADE)进行数据挖掘与分析,为临床安全用药提供参考。方法基于美国食品药品管理局公开数据项目(openFDA)数据库,提取2004-01-01—2023-06-07呈报的以Pola/T-Dxd为首要怀疑药物的ADE。用OpenVigil 2.1数据平台筛选可疑风险信号按信号强度和发生频次排序,并参照《国际医学用语词典》(MedDRA 26.0)进行ADE分类。结果分别获得Pola和T-Dxd相关ADE报告7164和22870份,检查到可疑ADE信号分别为104和95个。按信号强度排序,Pola的巨细胞病毒肠炎[比值比(ROR)=416.94]和T-Dxd的间质性肺病(ROR=82.55)位列首位,均可见其药品说明书;按发生频次排序,2种药物最常发生的ADE分别是死亡(n=111)、恶心(n=285)。Pola用药风险涉及12个系统/器官,其中26个风险信号是药品说明书中尚未记载的;T-Dxd用药风险涉及13个系统/器官,其中18个风险信号是药品说明书中尚未记载的。结论通过挖掘Pola和T-Dxd真实世界用药后的ADE,提示医师在临床用药中注意药物不良反应的发生风险,积极采取预防与治疗措施,保障患者用药安全。Objective To mine and analyze the adverse event data of polatuzumab vedotin(Pola)and fam-trastuzumab deruxtecan-nxki(T-Dxd),so as to provide reference for clinical medication safety.Methods The adverse events reported from January 1,2004 to June 7,2023 were extracted based on openFDA database.The suspicious risk signals were screened by the OpenVigil 2.1 data platform and ranked by signal strength and frequency of occurrence;then ADEs were classified by reference to the MedDRA 26.0.Results A total of 7164 and 22870 ADE reports related to Pola and T-Dxd were obtained,and 104 and 95 suspicious ADE signals were detected,respectively.According to the signal intensity,cytomegalovirus enterocolitis(ROR=416.94)for Pola and interstitial lung disease[reporting odds ratio(ROR)=82.55]for T-Dxd ranked first,both of which were recorded in the drug instructions.According to the frequency of occurrence,the two drugs were most frequently associated with death(n=111)and nausea(n=285),respectively.The risk of Pola was associated with 12 systems/organs,of which 26 risk signals were not documented in the drug instruction,and the risk of T-Dxd was associated with 13 systems/organs,of which 18 risk signals were not documented in the drug instruction.Conclusion By tapping the ADE after real-world administration of Pola and T-Dxd,physicians are prompted to pay attention to the risk of adverse reactions in clinical use and actively take preventive and therapeutic measures to ensure the safety of patients’medication.

关 键 词：维泊妥珠单抗 德曲妥珠单抗 药品不良事件 比例报告比值法 报告比值比法 数据挖掘 

分 类 号：R979.1[医药卫生—药品]