基于美国FAERS数据库的恩美曲妥珠单抗不良事件信号挖掘与分析  

Data-mining and analysis of adverse events signals for ado-trastuzumab emtansine based on US FAERS database

作　　者：黄佳 钟薇[1] 王浩[1] 韩梦婷 陈玲[1] 伏箫燕 陈力[2,3,4] HUANG Jia;ZHONG Wei;WANG Hao;HAN Meng-ting;CHEN Ling;FU Xiao-yan;CHEN Li(Department of Pharmacy,Xindu District People's Hospital of Chengdu,Sichuan Chengdu 610500,China;West China Second University Hospital,Sichuan University Department of Pharmacy,Sichuan Chengdu 610041,China;West China Second University Hospital,Sichuan University Evidence-Based Pharmacy Center,Ministry of Education,Sichuan Chengdu 610041,China;West China Second University Hospital,Sichuan University Key Laboratory of Birth Defects and Related Diseases of Women and Children,Ministry of Education,Sichuan Chengdu 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,四川成都610041 [3]四川大学华西第二医院循证药学中心,四川成都610041 [4]四川大学华西第二医院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：《中国医院药学杂志》2022年第1期49-53,共5页Chinese Journal of Hospital Pharmacy

基　　金：成都市医学科研课题(编号:2020114)。

摘　　要：目的:采用美国FDA不良事件报告系统(FAERS)挖掘恩美曲妥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:采用报告比值比(ROR)法和综合标准(MHRA)法对美国FAERS数据库中2015年第一季度至2020年第四季度共20个季度的恩美曲妥珠单抗相关不良事件报告进行数据挖掘。结果:获得恩美曲妥珠单抗报告数2823个,不良事件信号220个,涉及20个系统器官,发现了如淋巴细胞计数降低、胸腔积液、红细胞计数下降、肺水肿、放射性坏死、脾肿大等多个新的药物不良事件,此外,血液及淋巴系统疾病方面的不良事件也有较多报告。结论:基于FAERS数据库可对恩美曲妥珠单抗上市后的不良事件进行全面的挖掘分析,促进合理用药。OBJECTIVE To provide guidance for the safe and rational use of ado-trastuzumab emtansine through mining and analyzing the adverse events signals of ado-trastuzumab emtansine in the database from US FDA Adverse Event Reporting System(FAERS).METHODS Reporting odds ratio(ROR)method and Medicines and Healthcare Products Regulatory Agency(MHRA)method were applied to analyzing the data in FAERS from the first quarter of 2015 to the fourth quarter of 2020.RESULTS Totally 2823 ado-trastuzumab emtansine related reports were obtained with 220 ADE signals involving 20 system sorgans,and multiple new adverse drug events were discovered such as decreased lymphocyte count and red blood cell count,pleural effusion,pulmonary oedema,radiation necrosis and splenomegaly.In addition,there were many reports on the adverse events in blood and lymphatic disorders.CONCLUSION Based on the FAERS database,the post-marketing adverse events of ado-trastuzumab emtansine can be comprehensively mined and analyzed to promote rational drug use.

关 键 词：恩美曲妥珠单抗 不良事件 信号 数据挖掘 

分 类 号：R979[医药卫生—药品]