基于FAERS对靶向HER2抗体偶联药品不良反应/事件的分析  

Adverse events caused by HER2 conjugated antibodies via FAERS

作　　者：何雄 马俊龙 阳国平[2] HE Xiong;MA Junlong;YANG Guoping(Hunan Center for Drug Evaluation and ADR Monitoring,Changsha Hunan 410013,China;Center of Clinical Pharmacology,Third Xiangya Hospital,Central South University,Changsha Hunan 410013,China)

机构地区：[1]湖南省药品审评与不良反应监测中心,湖南长沙410013 [2]中南大学湘雅三医院临床药理中心,湖南长沙410013

出　　处：《中国药物警戒》2023年第8期915-920,共6页Chinese Journal of Pharmacovigilance

基　　金：湖南省科技重点专项(2020SK2010)。

摘　　要：目的基于美国食品药品监督管理局不良事件报告系统(FAERS),对靶向HER2的抗体偶联药品T-DM1和T-DXd进行药品不良反应/事件(ADR/ADE)信号挖掘分析,为临床安全用药提供参考。方法从FAERS提取2020年1月1日至2022年6月30日的药物ADR/ADE报告,合并去除重复报告,并对ADR/ADE信号进行筛选分析。结果获得以T-DM1或T-DXd为首要怀疑药物的ADR/ADE报告共2806例,筛选后得到ADR/ADE信号3979个。对ADR/ADE信号分类发现,2种药ADR/ADE累及系统-器官分类(SOC)基本相同,T-DM1还累及生殖系统及乳腺疾病以及血管类疾病。T-DM1所关联的ADR/ADE信号强度较高的有肝肺综合征、蜘蛛痣和结节状再生性增生,T-DXd则为kL-6升高、癌性淋巴管炎和间质性肺疾病。在报告信号强度前20位的ADR/ADE中,T-DM1药品说明书中未提及的有蜘蛛痣、感觉减退和感觉异常,T-DXd有角膜炎和股骨颈骨折。结论挖掘的真实世界ADR/ADE报告与说明书中记载一致,还报告了新的ADR/ADE,为T-DM1和T-DXd的临床使用提供参考。Objective To provide reference for clinical drug safety by mining and analyzing adverse drug reaction/event(ADR/ADE)signals of T-DM1 and T-DXd which are antibody-conjugated drugs targeting HER2.Methods ADR/ADE reports submitted between January 1,2020 and June 30,2022 were retrieved from the Adverse Event Reporting System of the United States Food and Drug Administration(FAERS)before signals were screened and analyzed after removal of duplicate reports.Results A total of 2806 ADR/ADE reports were collected with T-DM1 or T-DXd as the primary suspected drug,and 3979 ADR/ADE signals were obtained after screening.The classification of ADR/ADE signals found that the signals of the two drugs were of a similar system organ class(SOC).However,T-DM1 was additionally involved in the reproductive system and breast disorders and vascular disorders.Furthermore,ADR/ADE signal intensities associated with T-DM1 were higher for hepatopulmonary syndrome,sideroblastic nevus and nodular aplastic hyperplasia,while T-DXd was more significantly correlated with elevated kL-6,carcinomatous lymphadenopathy and interstitial lung diseases.Among the top 20 ADR/ADE in terms of signal intensities,spider naevus,hyperalgesia and sensory abnormality were not mentioned in the instructions of T-DM1,while keratitis and femoral neck fracture were not mentioned in T-DXd instructions.Conclusion The real-world ADR/ADE mined conform with those specified in drug instructions.New ADR/ADE are also reported that can provide reference for clinical use of T-DM1 and T-DXd.

关 键 词：恩美曲妥珠单抗 德喜曲妥珠单抗 人表皮生长因子受体-2 抗体偶联药物 肿瘤 乳腺癌 美国食品药品监督管理局不良事件报告系统 药品不良反应/事件 

分 类 号：R979.1[医药卫生—药品] R994.11[医药卫生—药学]