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

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2 823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。

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

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 2 823 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.