中国合理用药探索2026，Vol.23Issue(8)：6-12,7.DOI:10.3969/j.issn.2096-3327.2026.08.002
基于FAERS数据库分析奥马珠单抗治疗儿童与成人哮喘的安全性差异
Analysis of the Safety Differences of Omalizumab Treatment in Children and Adults with Asthma Based on the FAERS Database
摘要
Abstract
Objective:Based on the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS),this study compared the occurrence characteristics and risk signal differences of adverse drug event(ADE)associated with omalizumab between pediatric and adult asthma patients,aiming to provide more specific guidance for clinical safe medication.Methods:ADE reports related to omalizumab used for asthma treatment from January 2004 to March 2025 were retrieved from the FAERS database.ADE were described and classified using preferred term(PT)and system organ category(SOC)according to the Medical Dictionary for Regulatory Activities,version 28.0.Risk signal mining was performed using the reporting odds ratio(ROR),proportional reporting ratio(PRR),Bayesian confidence propagation neural network(BCPNN),and multi-item gamma Poisson shrinker(MGPS).Results:A total of 15 141 ADE reports were included.At the SOC level,omalizumab-related ADE in both pediatric and adult patients involved 27 SOC.Positive signals meeting all four algorithms were identified for"immune system disorders"and"respiratory,thoracic and mediastinal disorders,"and the signal values for"immune system disorders"were higher in children than in adults across all four algorithms.At the PT level,the most significant differences in ROR positive signals were observed for"anaphylactic reaction,immediate"in children and"blood pressure increased"in adults.The median time to ADE onset was 54 days in children and 97 days in adults.Conclusion:There are differences in the signal characteristics and time to onset of ADE associated with omalizumab between pediatric and adult asthma patients.Children exhibit stronger signals in immune system-and respiratory system-related ADE,with an earlier onset time,suggesting that early safety monitoring should be strengthened for pediatric patients after medication administration.关键词
奥马珠单抗/儿童/成人/药物不良事件/FAERS数据库/哮喘Key words
omalizumab/children/adults/adverse drug reactions/FAERS database/asthma分类
医药卫生引用本文复制引用
杨蕾,樊长娥,蔡惠娇,甄华,常海良,冯海先..基于FAERS数据库分析奥马珠单抗治疗儿童与成人哮喘的安全性差异[J].中国合理用药探索,2026,23(8):6-12,7.基金项目
内蒙古自治区首府地区公立医院高水平临床专科建设科技项目(2024SGGZ139) （2024SGGZ139）
内蒙古医学科学院公立医院科研联合项目(2024GLLH0414) （2024GLLH0414）
