基于FAERS数据库的肿瘤坏死因子抑制剂不良反应信号的挖掘与分析
Mining and analysis of tumor necrosis factor inhibitors related adverse drug reaction signals based on the FDA Adverse Event Reporting System
张灿华 1苏健芬 2徐朗 1林劲伟 3房瑶 4郭茵 2付喜花 5唐郁宽 6彭新生7
作者信息
- 1. 广东医科大学药学院,东莞 523808;广州市番禺区中心医院 药学部,广州 511400;广州医科大学附属清远医院/清远市人民医院 药学部,清远 511518
- 2. 广州市番禺区中心医院 药学部,广州 511400
- 3. 广州医科大学附属清远医院/清远市人民医院 药学部,清远 511518
- 4. 广州医科大学附属清远医院/清远市人民医院 麻醉科,清远 511518
- 5. 广州市番禺区中心医院 感染科,广州 511400
- 6. 广州市番禺区中心医院 微创介入科,广州 511400
- 7. 广东医科大学药学院,东莞 523808
- 折叠
摘要
目的 基于美国FDA不良事件报告系统(FAERS)数据库对英夫利西单抗、依那西普、阿达木单抗、培塞利珠单抗、戈利木单抗5种肿瘤坏死因子抑制剂(TNFi)进行药物不良反应(ADR)信号挖掘,为临床合理安全使用TNFi提供参考.方法 从FAERS数据库中收集2004年第1季度至2023年第3季度共79个季度的数据,采用报告比值比(ROR)法和比例报告比值(PRR)法对5种TNFi的ADR报告数据进行信号挖掘,利用《国际医学用语词典》25.0版规范进行汉化及系统分类,并对结果进行分析.结果 获得以5种TNFi为首要怀疑药品的共1 325 026例病例,其中英夫利西单抗158 971例,依那西普497 224例,阿达木单抗559 655例,培塞利珠单抗68 365例,戈利木单抗40 811例,共涉及24个系统和器官分类,主要集中于感染及侵染类疾病、全身性疾病和给药部位的各种反应,以及各种肌肉骨骼及结缔组织疾病,同时也发现了多个药品说明书中未收录的ADR,如依那西普导致的胎儿畸形和失眠等.结论 5种TNFi的ADR主要为感染及侵染类疾病(注射部位痛、注射部位红斑和注射部位肿胀等)、全身性疾病和给药部位的各种反应(鼻咽炎、鼻窦炎和尿路感染等),临床使用TNFi时需重点关注.
Abstract
AIM To guide the rational and safe use of tumor necrosis factor inhibitors(TNFi)through mining and analyzing the adverse drug reaction(ADR)signals of TNFi in the FDA Adverse Event Reporting System(FAERS).METHODS A total of 79 quarters of FAERS data were downloaded from the first quarter of 2004 to the third quarter of 2023 and 5 TNFi-related adverse events were extracted.The reporting odd ratio(ROR)and proportional reporting ratio(PRR)methods were used to detect the ADR signals.The Chinese and systematic classification was carried out according to the Medical Dictionary for Regularly Activities version 25.0(MedDRA),and the results were analyzed.RESULTS There were 1 325 026 patients with 5 kinds of TNFi as the primary suspected drugs,including 158 971 of infliximab,497224 of etanercept,559 655 of adalimumab,68 365 of certolizumab pegol and 40 811 of golimumab,involving a total of 24 system organ classes,mainly focusing on infections and infestations,general disorders and administration site conditions,as well as musculoskeletal and connective tissue disorders,and some new ADRs were discovered,such as fetal malformation and insomnia caused by etanercept.CONCLUSION In this study,we found that the ADRs of these 5 TNFi were mainly distributed in infections and infestations(e.g.injection site pain,injection site erythema,injection site swelling,etc.),and general disorders and administration site conditions(e.g.nasopharyngitis,sinusitis,and urinary tract infection,etc.).These findings highlight the importance of paying attention to these potential ADRs when clinically using TNFi.
关键词
肿瘤坏死因子抑制剂/药物不良反应/FAERS数据库/信号挖掘与分析/报告比值法/比例报告比值法Key words
tumor necrosis factor inhibitor/adverse drug reaction/FDA Adverse Event Reporting System/mining and analysis/reporting odd ratio/proportional reporting ratio引用本文复制引用
基金项目
广东省教育厅研究生教育创新计划项目(2023ANLK_046)
广州市科技计划民生科技项目(202103000002)
广州市科技计划基础与应用基础研究项目(201904010065)
广州市民生科技攻关计划项目(201903010016)
广州市番禺区中心医院院内科研基金(2021Y001)
出版年
2024
国家科技期刊平台
NSTL
万方数据