基于open FDA数据库挖掘与分析布加替尼上市后的不良反应信号  

Mining and analyzing the adverse reaction signals of brigatinib after marketing based on the open FDA database

作　　者：王晓[1] 丁菊英[1] 刁怀保 宋莹 Wang Xiao;Ding Juying;Diao Huaibao;Song Ying(Department of Pharmacy,Central Hospital of Shengli Oil Field,Dongying 257034,China)

机构地区：[1]胜利油田中心医院药学部,山东东营257034

出　　处：《实用药物与临床》2023年第8期693-698,共6页Practical Pharmacy and Clinical Remedies

摘　　要：目的挖掘布加替尼的不良反应信号,为临床安全用药提供参考。方法从美国FDA不良事件报告系统(FAERS)中下载2017年4月1日至2022年12月31日关于布加替尼的报告,采用报告比值比法(ROR)和比例报告比值法(PRR)进行数据挖掘。结果使用ROR和PRR公式,得到213个布加替尼的不良反应信号,二次筛选并清除考虑肿瘤治疗无效引起的不良反应信号后,最终得到109个完全重合信号。涉及16个系统,不良反应主要集中在全身性疾病及给药部位各种反应、胃肠系统疾病、呼吸道、胸部和纵隔腔疾病、皮肤和皮下组织疾病以及各类神经系统疾病;不良反应信号主要集中在各类检查、内分泌系统疾病、呼吸道、胸部和纵隔腔疾病、皮肤和皮下组织疾病等方面;同时发现了一些未收录于说明书中的不良反应,如癫痫、睡眠障碍、脑膜炎、心包积液和咯血等。结论通过ROR和PRR发现布加替尼药品说明书中未提及的31个新的不良反应信号,应引起重视。临床用药时应考虑其可能引起的不良反应,并采取干预措施。Objective To mine the adverse reaction signals of brigatinib,and provide reference for clinical safety medication.Methods The ADE reports on brigatinib from April 1,2017 to December 31,2022 were downloaded from FAERS,and the reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods were used to data mining.Results Totally 213 adverse reaction signals of brigatinib were obtained after using ROR and PRR methods,and 109 complete coincidence signals were obtained after secondary screening and removing the invalid adverse reaction signals induced by tumor treatment.There were 16 systems involved,and the adverse reactions were mainly concentrated in the systemic disease and the various reactions of the drug,gastrointestinal system disease,respiratory,chest and mediastinal disease,skin and subcutaneous tissue disease and various neurological diseases.The main adverse reaction signals were found in various kinds of examination,endocrine system disease,respiratory tract,chest and mediastinal disease and skin and subcutaneous tissue disease.Some of the adverse reactions that were not included in the instructions were found,such as epilepsy,sleep disorders,meningitis,cardiac fluid and dichotomy.Conclusion Thirty-one new adverse reactions that are not mentioned in brigatinib′s instructions by using ROR and PRR should be paid serious attention.The adverse reactions should be considered and intervened in clinical medication.

关 键 词：布加替尼 药物不良事件 报告比值比法 比例报告比值法 信号挖掘 

分 类 号：R969[医药卫生—药理学]