基于openFDA数据库对奥妥珠单抗不良事件信号的挖掘与分析  

Mining and Analysis of Adverse Event Signals of Obinutuzumab Based on OpenFDA Database

作　　者：尹桂森 刘中秋 薛淑一 张艳华[1] 张关敏[1] Yin Guisen;Liu Zhongqiu;Xue Shuyi;Zhang Yanhua;Zhang Guanmin(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;Department of Pharmacy,Zhongda Hospital Southeast University(Jiangbei);Department of Pharmacy,Qingdao Central Hospital)

机构地区：[1]北京大学肿瘤医院暨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 [2]烟台市中医医院药学部 [3]东南大学附属中大医院江北院区药学部 [4]青岛市中心医院药学部

出　　处：《药物流行病学杂志》2022年第11期744-749,共6页Chinese Journal of Pharmacoepidemiology

摘　　要：目的:对奥妥珠单抗不良事件(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2013年7月3日~2021年9月30日呈报的奥妥珠单抗相关ADE,通过比例失衡法中报告比值比(ROR)法和比例报告比值(PRR)法筛选可疑风险信号。结果:共获得5573例奥妥珠单抗相关ADE,筛选出179个可疑风险信号。报告数前200位的ADE中涉及72个用药风险,这些用药风险涉及11个系统/器官,其中35个风险信号是药品说明书中尚未记载的。结论:通过挖掘奥妥珠单抗真实世界用药后的ADE,提示医师在临床用药中注意不良反应风险,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 obinutuzumab,so as to provide reference for clinical safety application.Methods:The adverse events reported from July 3,2013 to December 31,2021 were extracted based on openFDA database.The suspicious risk signals were screened by reporting ratio(ROR)method and proportional reporting ratio(PRR)method.Results:A total of 5573 adverse drug events(ADE)and 179 suspicious risk signals related to obinutuzumab were obtained.Among the top 200 ADE reported,72 drug risks were involved.These risk signals involved 11 systems and organs,and 35 had not been recorded in the drug instructions.Conclusion:By excavating the ADE after the real-world use of obinutuzumab,it is suggested that doctors should pay attention to the risk of adverse reactions in clinical use,and actively take preventive and therapeutic measures to ensure the drug safety of patients.

关 键 词：奥妥珠单抗 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：R95[医药卫生—药学]