基于FAERS数据库对塞来昔布不良事件信号的分析

Adverse event signals for celecoxib based on FAERS database

目的基于美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)数据库,挖掘塞来昔布的不良事件(ADE)信号,为临床安全用药提供参考。方法采用报告比值比法、综合标准法和信息成分法挖掘FAERS数据库2004年第1季度至2022年第4季度的报告数据。结果ADE报告人主要为45岁以上人群,以女性居多,上报国家主要是美国。获得塞来昔布ADE报告37020例,涉及ADE 4068种,挖掘ADE信号406个,经筛选后得到有效信号285个,累及23个系统-器官(SOC)。根据信号强度,排名前5位的信号分别为:食管纤维化、与性活动有关的原发性头痛、脑血管疾病、胃肠道腺癌、心血管障碍。说明书未载明的ADE信号主要有:视网膜静脉血栓形成、失明、健忘、过敏性休克等。结论所得ADE信号基本与说明书一致;信号提示塞来昔布ADE主要集中在心脏疾病、神经系统疾病、免疫系统疾病、胃肠道疾病等;说明书黑框警告心血管血栓事件,胃肠道出血、溃疡和穿孔均有相关ADE信号检出。在使用该药时,除注意患者心脑血管、胃肠道不适症状以外,还应关注患者视网膜病变,并做好相关监护,以保证临床用药的安全。

Objective To mine the signals of adverse drug events(ADE)related to celecoxib based on the US FDA Adverse Event Reporting System(FAERS)database,and to provide reference for safe use of drugs in clinic.Methods The reporting odds ratio method,MHRA and the information component method were used to mine ADE signals of celecoxib from the FAERS database between the first quarter of 2004 and the fourth quarter of 2022.Results A total of 37020 cases of celecoxib-related ADE were retrieved,involving 4068 types of ADE.After screening,285 signals were obtained,which involved 23 different system organ classes(SOC).According to signal intensity,the top 5 signals were related to oesophageal fibrosis,primary headache associated with sexual activity,cerebrovascular disorders,gastrointestinal adenocarcinoma and cardiovascular disorders.The ADE signals not stated in instructions on celecoxib included retinal vein thrombosis,blindness,amnesia and anaphylactic shock.Conclusion Those who Adverse event reported ADE were mostly over 45 years old and female.Most of the reports came from the United States.signals were basically consistent with the instructions.The ADE of celecoxib mainly involved cardiac disorders,nervous system disorders,immune system disorders,and gastrointestinal disorders.ADE signals related to myocardial infarction,cardiovascular disorders,gastric ulcer,gastric haemorrhage and gastric ulcer perforation as described in black box warnings in the instructions were all detected.When celecoxib is used,clinicians should be alert to cardiovascular and cerebrovascular symptoms,gastrointestinal disorders and retinal diseases of patients while ensuring effective monitoring.