目的 基于美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）数据库，挖掘和分析乌司奴单抗不良事件（ADE）信号，为临床安全用药提供参考。方法 运用报告比值比法（ROR）联合综合标准法（MHRA）对FAERS数据库2017年第1季度—2021年第4季度中以乌司奴单抗为首要怀疑药品的ADE报告进行信号挖掘，所得信号利用MedDRA规范进行汉化和系统归类并分析。结果 2017—2021年的药物ADE中首要怀疑药物为乌司奴单抗的ADE报告共39 650份，其中女性占多数（52.67%）；年龄多集中在18～64岁（46.84%）；报告者以医务专业人员总计上报（55.95%）较高；报告国家前5位分别是美国、加拿大、英国、澳大利亚、巴西，近5年以2020年上报数量最多，2021年出现下降趋势。对以乌司奴单抗为首要怀疑药品的不良反应信号进行筛除后，最终获得乌司奴单抗ADE信号报告数38 733个，共496个信号。根据MedDRA的系统器官分类（SOC）分类，对有信号的PT进行SOC分类排序，共发现有信号的SOC 22个。发现了说明书未提及的一些新的ADE，如良性、恶性及性质不明的肿瘤、各种手术及医疗操作、肝胆系统疾病等。结论 乌司奴单抗常见ADE信号与说明书具有一致性，但累计SOC分类与说明书具有差异性，可为临床安全用药提供参考。

Objective Based on the FDA adverse event reporting system (FAERS) database, the ADE signal of ustekinumab was mined and analyzed to provide reference for clinical safe drug use. Methods Reports ratio method (ROR) and comprehensive standard method (MHRA) were used to mine ADE reports of ustekinumab as the primary suspected drug in FAERS database from the first quarter of 2017 to the fourth quarter of 2021. The obtained signals were sinicized and systematically classified and analyzed using MedDRA standards. Results Among ADE reports from 2017 to 2021, a total of 39 650 suspected drugs were ustekinumab, of which women accounted for the majority (52.67%). Most of them were aged from 18 to 64 (46.84%). The total number of medical professionals reported higher (55.95%). The top five reporting countries are the United States, Canada, the United Kingdom, Australia, and Brazil. In the past five years, the number of reported countries is the largest in 2020, and the trend will decline in 2021. After screening the adverse reaction signals of ustekinumab as the primary suspected drug, 38 733 ADE signals were obtained, a total of 496 signals. According to MedDRA's systematic organ classification (SOC) classification, the PT with signal was sorted by SOC classification, and 22 SOC with signal were found. Some new ADE not mentioned in the instructions were found, such as benign, malignant and unknown tumors, various surgical and medical procedures, hepatobiliary diseases, etc. Conclusion Common ADE signals of ustekinumab were consistent with the instructions, but the cumulative SOC classification was different from the instructions, which could provide reference for clinical drug safety.

R986

四川省医学科学院·四川省人民医院科研基金资助项目(2018LY09);成都市金牛区科研课题(JNKY2021-48)