基于FAERS数据库的阿布昔替尼不良事件信号挖掘与分析

Mining and Analysis of Adverse Event Signals of Abrocitinib Based on FAERS Database

目的 通过挖掘真实世界中与阿布昔替尼关联的药物不良事件信号,为其临床安全合理用药提供参考。方法 调取美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)中阿布昔替尼2022年1月1日~2023年9月30日的数据,运用报告比值比法和贝叶斯可信区间递进神经网络法进行信号挖掘,分析其药物不良反应发生情况。结果 共得到药物不良事件信号41个,其中发生频次位居前5位的ADE信号分别为病情恶化、意外的治疗反应、痤疮、血胆固醇升高和带状疱疹;ROR值居前5位的ADE信号分别为疱疹性湿疹、眼单纯疱疹、脂质升高、脓疱病和静脉栓塞;挖掘到21个未收录于说明书中的新发现可疑不良反应,如病情恶化、意外的治疗反应、疱疹性湿疹、肝酶升高、听觉减退、蜂窝织炎等。结论 临床使用阿布昔替尼治疗特应性皮炎时应做好相关预防措施,监测是否出现感染及实验室各类检查指标异常等,减少用药风险。

OBJECTIVE To identify adverse event signals associated with Abrocitinib from the real world and provide a reference for its clinical safe and rational use.METHODS Data on Abrocitinibfrom the Adverse Event Reporting System(FAERS)of the US Food and Drug Administration(FDA)between January 1,2022,and September 30,2023,were retrieved.The signals were analyzed using the Reporting Odds Ratio(ROR)method and a Bayesian confidence interval progressive neural network method.RESULTS A total of 41 adverse drug event signals were obtained.The most frequent ADE signals included worsening of the condition,unexpected treatment response,acne,elevated blood cholesterol,and herpes zoster,respectively.The ADE signals with the top 5 ROR values were herpetic simplex eczema,ocular herpes simplex,lipid elevation,pustulosis,and venous embolism.Additionally,21 new suspected adverse reactions not listed were discovered,including worsening of the condition,unexpected treatment reactions,herpetic eczema,elevated liver enzymes,decreased hearing,and cellulitis.CONCLUSION When using Abrocitinib in the clinical treatment of atopic dermatitis,relevant preventive measures should be taken,monitoring for infection and abnormal laboratory test indicators to reduce minimize the risks associated with its use.