Excavation and evaluation of tocilizumab and infliximab for adverse drug event signals among children
10.13699/j.cnki.1001-6821.2024.05.021
- VernacularTitle: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
- Author:
Yue TAN
1
;
Ning-Ning GE
;
Jing PENG
;
Wen-Shuang QIU
;
Xin ZHANG
;
Lan-Fang LI
Author Information
1. 济宁医学院附属医院临床药学科,山东济宁 272029
- Keywords:
tocilizumab;
infliximab;
adverse drug event;
data mining
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(5):732-736
- CountryChina
- Language:Chinese
-
Abstract:
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 1 39 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.
