基于FAERS数据库的曲氟尿苷替匹嘧啶的不良事件信号挖掘与分析  

Data Mining of Adverse Drug Event Signals for Trifluridine based on FAERS Database

作　　者：李露禾 任雁飞 杨学英 李丹 LI Lu-He;REN Yan-Fei;YANG Xue-Ying;LI Dan(College of pharmacy,Dali University,Dali 671000,China;Department of Pharmacy,the First Afiliated Hospital of Dali University,Dali 671000,China)

机构地区：[1]大理大学药学院 [2]大理大学第一附属医院药剂科

出　　处：《中国药物经济学》2024年第12期40-46,共7页China Journal of Pharmaceutical Economics

基　　金：大理大学第一附属医院临床医学学科队伍建设项目(DFYYB2024021)。

摘　　要：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)数据库挖掘曲氟尿苷替匹嘧啶药品不良事件(ADE)风险信号,为临床安全用药提供参考。方法收集FAERS数据库2014—2023年的曲氟尿苷替匹嘧啶的ADE数据,利用比例失衡法中的报告比值(ROR)法和比例报告比值比(PRR)法进行数据挖掘。结果以曲氟尿苷替匹嘧啶为怀疑药物的ADE报告有9701份,患者以男性为主(56.40%),上报国家以美国为主(77.00%),大多数病例发生ADE是在给药1个月内(38.4%)。共检测到ADE信号186个,涉及20个系统和器官,报告数较多的为全身性疾病及给药部位各种反应(8517例)、胃肠系统疾病(5140例)、各类检查(2324例)、血液及淋巴系统疾病(1586例)、代谢及营养类疾病(1331例),临床需关注的ADE信号主要集中于血小板、白细胞、中性粒细胞数减少等,同时,还发现一些新的ADE信号,如浆液性视网膜病、皮肤干燥症、阻塞性胰腺炎等。结论临床使用曲氟尿苷替匹嘧啶前应做好患者的用药评估,治疗期间不仅需要关注常见的不良反应,而且应对药品说明书中没有提到的不良反应加以重视,发现异常时应及时干预。Objective To mine the adverse drug event(ADE)signals for trifluridine from the FDA adverse event reporting system(FAERS)database,and provide a reference for the safe clinical use of this medication.Methods The adverse drug event(ADE)signals data of trifluridine from the FAERS database from 2014 to 2023.The data were mined using the reporting odds ratio(ROR)method and the proportional reporting ratio(PRR)method.Results A total of 9701 ADE reports were associated with trifluridine as the suspected medication.The majority of the patients in these reports were male,accounting for 56.40%of the cases,with a significant proportion of reports originating from the United States(77.00%).Most adverse events were observed within one month following administration,representing 38.4%of the total cases.In total,186 ADE signals were identified,encompassing 20different system and organ classifications.The most frequently reported categories included systemic diseases and reactions at the site of administration(8,517 cases),gastrointestinal system diseases(5,140 cases),various laboratory tests(2,324 cases),blood and lymphatic system diseases(1,586 cases),and metabolic and nutritional disorders(1,331 cases).Clinically significant ADE signals were predominantly associated with reductions in platelet,white blood cell,and neutrophil counts.Furthermore,novel ADE signals such as serous retinal disease,dry skin syndrome,and obstructive pancreatitis were also identified.Conclusion Before initiating treatment with trifluridine,a thorough medication evaluation is essential.During the treatment process,it is important to monitor not only the common adverse reactions but also those that may not be specified in the drug's labeling.Any identified abnormalities should be addressed promptly.

关 键 词：曲氟尿苷替匹嘧啶 药品不良事件 美国食品药品监督管理局不良反应事件报告系统 信号挖掘 

分 类 号：R979.1[医药卫生—药品] R926[医药卫生—药学]