儿科药学杂志2025，Vol.31Issue(4)：4-8,5.DOI:10.13407/j.cnki.jpp.1672-108X.2025.04.002
基于美国食品药品监督管理局不良事件报告系统数据库儿童应用乌司奴单抗安全信号挖掘与分析
Safety Signal Mining and Analysis for Ustekinumab Used in Children Based on the U.S.Food and Drug Administration Adverse Event Reporting System Database
摘要
Abstract
Objective:To probe into the potential adverse drug events(ADE)of ustekinumab in children,and to provide reference for clinical rational drug use.Methods:Based on the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,the reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods were used to mine and analyze the data on ustekinumab as the primary suspect ADE reported in the system from 2015 to 2023.Statistical analysis was performed according to the preferred terms(PT)and system organ class(SOC)of the International Dictionary of Medical Terms(MedDRA).Results:A total of 1,050 reports of ADE related to ustekinumab in children were retrieved,with ADE reports predominantly from females(568 cases,54.1％),and the majority of reports were children aged from 0 to 5 years(81 cases,7.7％),＞5 to 11 years(129 cases,12.3％),and＞11 to 17 years(840 cases,80.0％).The top reporting countries were the United States(774 cases,73.7％),with healthcare professionals being the main reporters(295 cases,28.1％),and the highest number of reports was reported in 2019.A total of 554 ustekinumab PT were retrieved,and 66 ADE signals were obtained by ROR and PRR methods,including 15 SOC.The PT with signals were sorted by signal intensity and occurrence frequency.The most common ADE were rapid severe allergic reactions(ROR=3.25,95％CI 1.95 to 5.41),Clostridium difficile infection(ROR=11.88,95％CI 7.00 to 20.18),and decreased therapeutic response(ROR=5.79,95％CI 3.42 to 9.81).The ADE with the highest signal intensity was intestinal abscess intestinal(ROR=46.03,95％CI 16.70 to 126.88),photopsia(ROR=31.28,95％CI 9.82 to 99.61),decreased blood iron(ROR=12.36,95％CI 3.94 to 38.73).New potential ADE included photopsia,alopecia,C.difficile infection,night sweats,infectious mononucleosis,and premature infants.Conclusion:The common ADE signals of ustekinumab in children is consistent with the drug instructions,yet there are still new SOC and new ADE signals.The results suggest that there is a difference in the occurrence of ADE between children and adults using ustekinumab,and more studies are needed to determine the medication safety.关键词
乌司奴单抗/药品不良事件/美国/食品药品监督管理局不良事件报告系统/信号挖掘/儿童/银屑病Key words
ustekinumab/adverse drug events/the U.S.A/Food and Drug Administration Adverse Event Reporting System/signal mining/children/psoriasis分类
医药卫生引用本文复制引用
张玄羿,孔文强,周义录,钟红..基于美国食品药品监督管理局不良事件报告系统数据库儿童应用乌司奴单抗安全信号挖掘与分析[J].儿科药学杂志,2025,31(4):4-8,5.基金项目
自贡市重点科技计划项目,编号2022ZCYKY04. （）
