基于美国FAERS数据库的阿特珠单抗不良事件信号挖掘研究  

Data mining for atezolizumab-related adverse events signals based on FAERS database

作　　者：钟薇[1] 黄佳 陈力[2,3] ZHONG Wei;HUANG Jia;CHEN Li(Department of Pharmacy,Xindu District People's Hospital,Chengdu,Sichuan,610500,China;Department of Pharma-cy/Evidence-Based Pharmacy Center,West China Second University Hospital,Sichuan University,Chengdu,Sichuan,610041,China;Key Laboratory of Birth Defects and Related Diseases of Women and Children(Sichuan University),Minis-try of Education,Chengdu,Sichuan,610041,China)

机构地区：[1]成都市新都区人民医院药剂科,四川成都610500 [2]四川大学华西第二医院药学部/循证药学中心,四川成都610041 [3]出生缺陷与相关妇儿疾病教育部重点实验室,四川成都610041

出　　处：《肿瘤药学》2021年第4期413-419,共7页Anti-Tumor Pharmacy

基　　金：四川省科技计划项目(2019JDR0163);成都药学会赞邦药学科研基金(201919)。

摘　　要：目的挖掘和分析阿特珠单抗的不良事件信号,为其安全风险控制和临床合理用药提供参考。方法采用比例失衡法对美国FDA不良事件报告系统(FAERS)中2017年第一季度至2020年第一季度共13个季度的阿特珠单抗相关不良事件报告进行数据挖掘分析。结果获得阿特珠单抗报告数11140个,不良事件信号440个,涉及23个系统器官分类,发现了如卵巢静脉血栓症、子宫积水、超进展肿瘤、回肠穿孔等多个新的药物不良事件。结论阿特珠单抗发生不良事件的信号主要集中在全身性反应和呼吸、胃肠及血液等系统,建议临床用药时注意监测患者的不良事件,及时采取干预措施。Objective To excavate and analyze the adverse events signals of atezolizumab,so as to provide guidance for the safe and rational use of atezolizumab.Methods Disproportionality measurements were applied to analyze the atezolizumab-related adverse events reported in the US FDA adverse event reporting system(FAERS)from the first quarter of 2017 to the first quarter of 2020.Results Totally 11140 atezolizumab-related reports were obtained,with 440 adverse event signals,involving 23 system organ classes.In addition,several new adverse drug events were discovered,including ovarian venous thrombosis,hydrometra,hyperprogressive tumor,ileal perforation and so on.Conclusion The signals of adverse events of atezolizumab mainly focused on systemic reaction and respiratory,gastrointestinal and blood systems.It is suggested that we should pay attention to monitoring the adverse events of patients and take timely preventive measures in clinical medication.

关 键 词：阿特珠单抗 不良事件信号 比例失衡法 

分 类 号：R979.1[医药卫生—药品]