托珠单抗和英夫利昔单抗在儿童患者中药物不良事件信号的挖掘与评价

Excavation and evaluation of tocilizumab and infliximab for adverse drug event signals among children

目的分析托珠单抗与英夫利昔单抗儿科临床应用药物不良事件的发生风险。方法收集美国食品药品监督管理局不良事件报告系统数据库中2013年第一季度至2023年第一季度儿童人群的托珠单抗与英夫利昔单抗的不良事件(AE)报告数据。用报告比值比(ROR)法和比例报告比值比(PRR)法进行AE风险信号挖掘,并按国际医学用语词典的首选系统器官分类和首选术语(PT)对AE进行分类统计分析。结果数据经提取和清洗后纳入以托珠单抗为怀疑药物的AE报告1052份,阳性PT信号198个,以英夫利昔单抗为怀疑药物的AE报告9139份,阳性PT信号387个。分析提示2种药物比较强的阳性风险信号均集中在胃肠系统疾病、感染及侵染类疾病、实验室检查、肌肉骨骼及结缔组织疾病、血液、血管及淋巴系统疾病。英夫利昔单抗风险信号主要集中在胃肠系统疾病、感染及侵染类疾病,而托珠单抗的风险信号主要集中在肌肉骨骼肌系统。结论儿童临床应用这2种药物均对多系统有影响,托珠单抗可能对生长发育有影响,英夫利昔单抗对儿童胃肠道有影响。

Objective To analyze the risk of adverse drug events in pediatric clinical applications of tocilizumab versus inflixima.Methods Adverse event(AE) reporting data for tocilizumab versus infliximab in the U.S.Food and Drug Administration Adverse Event Reporting System database for the pediatric population from Q1 2013 to Q1 2023 were collected.AE risk signal mining was performed using the reporting odds ratio(ROR) method and the proportional reporting ratio(PRR) method.AEs were also classified and statistically analyzed according to the preferred system organ classification and preferred terminology(PT) of the International Dictionary of Medical Terminology.Results Data were extracted and cleaned to include 1 052 AE reports with 198 positive PT signals for tocilizumab as the suspected drug and 9 139 AE reports with 387 positive PT signals for infliximab as the suspected drug.The analyses suggested that the stronger positive risk signals for both drugs were focused on gastrointestinal disorders,infectious and invasive diseases,laboratory tests,musculoskeletal and connective tissue disorders,and blood,vascular,and lymphatic disorders.The risk signals for infliximab were focused on gastrointestinal disorders,infections,and infectious diseases,while the risk signals for tocilizumab were focused on the musculoskeletal muscle system.Conclusion Clinical use of both drugs in children has multi-system effects,tocilizumab may have effects on growth and development,and infliximab has effects on the gastrointestinal tract in children.