基于FAERS数据库的维莫非尼不良事件信号挖掘与分析  

Mining and analysis of vemurafenib adverse event signals based on the FAERS database

作　　者：刘敬如 王世恒 陈敏 陆程灿 LIU Jing-ru;WANG Shi-heng;CHEN Min;LU Cheng-can(Department of Pharmacy,the Affiliated Jiangning Hospital of Nanjing Medical University,Nanjing 211100,China;Post-Doctoral Research Center,Nanjing First Hospital,Nanjing Medical University,Nanjing 210006,China)

机构地区：[1]南京医科大学附属江宁医院药学部,南京211100 [2]南京医科大学附属南京医院/南京市第一医院博士后科研工作站,南京210006

出　　处：《中国新药杂志》2025年第4期433-437,共5页Chinese Journal of New Drugs

基　　金：南京市卫生科技发展专项资金一般项目(YKK23223);南京市药学会——常州四药医院药学科研基金资助项目(2023YX004)。

摘　　要：目的:对维莫非尼在上市后的不良事件进行数据挖掘与分析,为临床合理用药提供参考。方法:从美国FDA不良事件报告系统(Food and Drug Administration Adverse Event Reporting System, FAERS)提取维莫非尼上市以来的药品不良事件(adverse drug event, ADE)报告,联合报告比值比法(reporting odds ratio, ROR)和贝叶斯置信传播神经网络法(bayesian confidence propagation neural network, BCPNN)筛选维莫非尼的ADE信号,同时将得到的ADE信号与药品说明书进行比对,挖掘潜在可疑的新的药物不良反应。结果:共获得维莫非尼ADE信号314个,累及25个系统/器官分类(system organ class, SOC),主要包括皮肤及皮下组织类疾病、全身性疾病及给药部位反应、各种肌肉骨骼及结缔组织疾病等。共挖掘到32个说明书中未明确记录的不良反应,主要包括血乳酸脱氢酶升高、痤疮样皮炎、肉状瘤病、发育不良痣等。结论:维莫非尼上市后在真实世界中发生的不良反应与药物说明书具有一致性,但存在部分潜在可疑的新的药物不良反应。在患者接受维莫非尼治疗期间,临床医师对该部分不良反应要给予足够重视。Objective:To mine and analyze the adverse events of vemurafenib after marketing to provide a reference for clinical rational medication.Methods:Adverse drug event(ADE)reports of vemurafenib since its marketing were extracted from the US Food and Drug Administration Adverse Event Reporting System(FAERS)database.Combined reporting odds ratio(ROR)and Bayesian confidence propagation neural network(BCPNN)methods were used to explore and screen the ADE signals of vemurafenib,and the obtained ADE signals were compared with drug instructions.Potentially suspicious newly discovered adverse drug reactions were mined.Results:A total of 314 ADE signals of vemurafenib were mined,involving 25 system organ classes(SOCs),mainly including skin and subcutaneous tissue diseases,systemic diseases and various reactions at the drug administration site,musculoskeletal and connective tissue diseases,etc.Thirty-two adverse reactions that were not recorded in the instructions were obtained,mainly including elevated blood lactate dehydrogenase,acneiform dermatitis,sarcoid disease,and dysplastic nevus.Conclusion:The adverse effects of vemurafenib in the real world are consistent with the drug label.However,there are some potentially suspicious new adverse effects.During the treatment with vemurafenib,clinicians should pay enough attention to these adverse reactions.

关 键 词：维莫非尼 报告比值比法 贝叶斯置信传播神经网络法 不良事件 数据挖掘 

分 类 号：R969.3[医药卫生—药理学]