基于FAERS数据库的氘可来昔替尼不良事件信号挖掘与分析  

Signals mining and analysis of deucravacitinib adverse drug events based on FAERS database

作　　者：胡晔 龚奇能 张琳琳 王阿明 祁旺 缪阳 HU Ye;GONG Qineng;ZHANG Linlin;WANG Aming;QI Wang;MIAO Yang(Department of Pharmacy,the First people's Hospital of Yancheng,Yancheng 224000,Jiangsu Province,China;Medical Research Center,the First People's Hospital of Nantong,Nantong 226001,Jiangsu Province,China)

机构地区：[1]盐城市第一人民医院药学部,江苏盐城224000 [2]南通市第一人民医院临床医学研究中心,江苏南通226001

出　　处：《药物流行病学杂志》2025年第4期419-427,共9页Chinese Journal of Pharmacoepidemiology

基　　金：南通市卫生健康委员会科研课题(MSZ2023016)。

摘　　要：目的挖掘氘可来昔替尼的不良事件(ADE)信号,为临床安全用药提供参考。方法收集2022年第3季度至2024年第3季度上报至美国食品药品管理局不良事件报告系统(FAERS)数据库的ADE报告,选择以氘可来昔替尼为首要怀疑药物的ADE报告。采用报告比值比法和贝叶斯置信区间递进神经网络法对ADE信号进行挖掘。结果共获取氘可来昔替尼为首要怀疑药物的ADE报告1777份,涉及3258例次ADE。筛选获得信号62个,涉及14个系统/器官分类。报告例次数排名前5位的ADE信号为痤疮、口腔溃疡、毛囊炎、荨麻疹和口腔疼痛。信号强度前5位的ADE信号为囊肿性痤疮、甲型肝炎、痤疮、脓疱性痤疮和毛囊炎。色素尿、甲型肝炎和牙龈肿胀等ADE信号未被药品说明书记载。氘可来昔替尼相关ADE发生时间中位数为22 d,58.33%的患者ADE发生在服用药物后第1个月内。女性发生痤疮的风险可能高于男性。结论医务人员使用氘可来昔替尼时,应重点关注皮肤及皮下组织类疾病、胃肠系统疾病、感染及侵染类疾病等方面,监测女性患者的痤疮发生。还应警惕未被说明书记载的潜在ADE,保障患者安全用药。Objective To mine adverse drug event(ADE)signals of deucravacitinib,and to guide its rational clinical use.Methods ADE reports reported to the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database from the third quarter of 2022 to the third quarter of 2024 were collected,ADE reports with deucravacitinib as the primary suspect drug were selected for analysis.ADE signals were identified using reporting adds ratios method and Bayesian confidence propagation neural networks method.Results A total of 1,777 ADE reports were collected involving 3,258 ADEs.Sixty-two ADE signals were identified,spanning 14 system-organ classifications.The top five ADE signals based on the number of reported cases were acne,oral ulcers,folliculitis,urticaria,and oral pain.The top five ADE signals based on signal intensity were cystic acne,hepatitis A,acne vulgaris,pustular acne,and folliculitis.ADE signals such as pigmenturia,hepatitis A,and gingival swelling were not included in the drug instructions.The median duration of ADEs associated with deucravacitinib was 22 days,with 58.33%occurring within the first month of treatment.Women may have a higher risk of developing acne than men.Conclusions When using deutericolaxitinib,healthcare professionals should focus on skin and subcutaneous tissue disorders,gastrointestinal system disorders,and infections and infestations to monitor the occurrence of acne in female patients.The latent ADEs that are not mentioned in the instructions should be remained vigilant to ensure safe drug use.

关 键 词：氘可来昔替尼 药品不良事件 FAERS数据库 银屑病 信号挖掘 药物警戒 

分 类 号：R986[医药卫生—药品]