基于美国FAERS数据库的恩美曲妥珠单抗和维布妥昔单抗不良反应信号挖掘

Data mining of adverse drug reaction signals for ado-trastuzumab emtansine and brentuximab vedotin based on FAERS database

目的分析恩美曲妥珠单抗和维布妥昔单抗上市后的药品不良反应(ADR)信号,为临床用药安全提供参考。方法利用美国食品药品监督管理局不良事件报告系统(FAERS)数据库,使用OpenVigil 2.1数据平台,收集恩美曲妥珠单抗和维布妥昔单抗从美国上市至2021年9月30日的ADR报告。采用频率法检测恩美曲妥珠单抗和维布妥昔单抗的ADR信号,并分别按照发生频次和信号强度进行排序。结果与结论分别获得恩美曲妥珠单抗和维布妥昔单抗相关的ADR报告2319、3178份,检测到ADR信号分别为215、329个。按发生频次排序,两种药物发生频次最多的ADR分别是血小板计数降低(109例)和发热性中性粒细胞减少症(198例),均可见于其药品说明书;按信号强度排序,恩美曲妥珠单抗的蜘蛛痣(报告比值比为451.46)和维布妥昔单抗的非感染性心内膜炎(报告比值比为304.35)位列首位,均未被其药品说明书提及。建议临床不仅应关注两种药物所致最常见的血液及淋巴系统ADR,还应关注恩美曲妥珠单抗致蜘蛛痣和维布妥昔单抗致非感染性心内膜炎等药品说明书中未报道的ADR。

OBJECTIVE To analyze the adverse drug reaction(ADR)signals of ado-trastuzumab emtansine and brentuximab vedotin,so as to provide reference for clinical medication safety.METHODS Using the FDA adverse drug event reporting system(FAERS)database and OpenVigil 2.1 data platform,the ADR of the two drugs were collected from being approved by FDA to the Sep.30th,2021.The ADR signals were detected by frequency method and sorted according to the occurrence frequency and signal strength respectively.RESULTS&CONCLUSIONS A total of 2319 and 3178 ADR reports related to ado-trastuzumab emtansine and brentuximab vedotin were collected,215 and 329 ADR signals were detected respectively.According to the occurrence frequency,the most frequent ADRs of the two drugs were thrombocytopenia(109 cases)and febrile neutropenia(198 cases),separately,which were consistent with the drug instructions.According to the signal strength,the spider nevus of ado-trastuzumab emtansine(report odds ratio of 451.46)and the noninfectious endocarditis of brentuximab vedotin(report odds ratio of 304.35)ranked first,both of which were not reported in the drug instructions.It is suggested that attention should be paid not only to the most common ADRs of blood and lymphatic system caused by both drugs,but also to the ADRs not reported in the drug instructions such as spider nevus of ado-trastuzumab emtansine and noninfective endocarditis of brentuximab vedotin.