中国临床药理学与治疗学2024，Vol.29Issue(7)：768-774,7.DOI:10.12092/j.issn.1009-2501.2024.07.006
四种生物制剂治疗克罗恩病相关淋巴瘤风险:一项上市后监测数据的真实世界研究
Lymphoma risk in the treatment of Crohn's disease with four biologi-cal agents:a real world analysis of post-marketing surveillance data
摘要
Abstract
AIM:To determine the link between infliximab,adalimumab,vedolizumab,ustekinumab and risk of lymphoma in order to provide reference for the safety of clinical application.METHODS:Dis-proportionality analysis and Bayesian analysis were used in data mining to screen the suspected lym-phoma after the use of four biological agents based on the FAERS data from October 2012 to June 2023.The fatality and hospitalization rates of this four biological agents associated lymphoma were also investigated.RESULTS:Totally 705 cases of four biological agents associated lymphoma were collected.Four biological agents associated lymphoma appeared to influent more young pa-tients and middle-aged patients than elderly pa-tients(25.11％vs.22.41％vs.12.2％).There were slightly more male than females(42.84％vs.35.60％).Infliximab has the highest reporting odds ratio[ROR3.40,95％CI=(3.03,3.82)],proportional ratio[PRR3.38,95％CI=(3.01,3.79)],information component(IC1.14,IC-2SD=1.02)and empirical Bayes geometric mean(EBGM2.21,EBGM05=2.01).Significant difference in the fatality rate and hospi-talization rate among four biological agents were not found.CONCLUSION:Infliximab showed a strongest lymphoma association than the other three biological agents.Lymphoma risk should be vigilant when using infliximab.关键词
英夫利西单抗/阿达木单抗/维得利珠单抗/乌司奴单抗/淋巴瘤/美国食品药品监督管理局不良事件报告系统Key words
infliximab/adalimumab/vedolizum-ab/ustekinumab/lymphoma/FDA adverse event re-porting system分类
医药卫生引用本文复制引用
宋尧,潘晨,赵晓红,杨鸿鸽,李泽,崔向丽..四种生物制剂治疗克罗恩病相关淋巴瘤风险:一项上市后监测数据的真实世界研究[J].中国临床药理学与治疗学,2024,29(7):768-774,7.基金项目
北京市医院管理中心创新梦工厂经费资助项目(202101) （202101）
