基于FAERS数据库对替格列汀不良事件的信号挖掘分析  

Signal mining and analysis of adverse events of teneligliptin based on FAERS database

作　　者：方功 李文汐 张杰 白娟 FANG Gong;LI Wenxi;ZHANG Jie;BAI Juan(Department of Pharmacy,Jingmen Central Hospital,Jingmen 448000,China;Department of Pharmacy,Jingmen Central Hospital Affiliated to Jingchu University of Technology,Jingmen 448000,China)

机构地区：[1]荆门市中心医院药学部,荆门448000 [2]荆楚理工学院附属荆门市中心医院药学部,荆门448000

出　　处：《西北药学杂志》2025年第2期1-9,共9页Northwest Pharmaceutical Journal

摘　　要：目的利用报告比值比(reported odds ratio,ROR)法和比例报告比值法(proportional reported odds ratio,PRR)对美国食品药品管理局不良事件报告系统(Food and Drug Administration Adverse Event Reporting System,FAERS)数据库中替格列汀的相关报告进行深入挖掘,旨在发现该药物的不良事件(adverse event,ADE)信号,为临床安全、合理用药提供参考。方法从美国食品药品监督管理局(Food and Drug Administration,FDA)不良事件报告系统数据库提取2012年1月至2023年9月替格列汀的ADE报告,用ROR法和PRR法挖掘潜在的ADE信号,同时与药品说明书和相关个案文献进行比对,并结合欧洲药品管理局制定的指定医疗事件(designated medical event,DME)清单进行筛选和分析。结果获得替格列汀ADE报告1694份,检出阳性信号108个,共涉及15个系统器官分类(systemic organ classifications,SOC),主要为代谢及营养类疾病、感染及侵染类疾病、各类检查、各类神经系统疾病、呼吸系统、胸及纵隔疾病、心脏器官疾病等;脑梗死、糖尿病、感染性肺炎、尿路感染、糖尿病酮症酸中毒、恶性肿瘤进展、呼吸衰竭和横纹肌溶解等ADE未在其药品说明书中提及。检出了4个DME,其中横纹肌溶解未在其药品说明书中提及。结论挖掘出的常见ADE信号与替格列汀的药品说明书基本一致;临床使用中应特别关注横纹肌溶解等替格列汀药品说明书中未提及的DME以及ADE,以降低用药风险。Objective To use the reported odds ratio(ROR)and proportional reported odds ratio(PRR)methods to deeply explore the relevant reports of teneligliptin in the Food and Drug Administration Adverse Event Reporting System(FAERS)database of the US Food and Drug Administration(FDA),with the aim of discovering adverse event(ADE)signals of the drug and providing reference for safe and rational clinical use.Methods The ADE reports for teneligliptin from the US FAERS database from January 2012 to the third quarter of 2023 were extracted.The ROR and PRR methods were used to explore the potential ADE signals,and compare them with drug instructions and relevant case literature.The data were screened and analyzed in conjunction with the designated medical event(DME)list developed by the European Medicines Agency.Results 1694 ADE reports of teneligliptin were obtained,with 108 positive signals detected,involving 15 systemic organ classifications(SOC),mainly metabolic and nutritional diseases,infectious and infectious diseases,various examinations,various neurological diseases,respiratory system,thoracic and mediastinal diseases,and cardiac organ diseases,etc..Brain infarction,diabetes,infectious pneumonia,urinary tract infection,diabetes ketoacidosis,malignant tumor progression,respiratory failure,rhabdomyolysis and other ADEs were not mentioned in the drug package.Four DME were detected,among which rhabdomyolysis was not mentioned in its drug instructions.Conclusion The common ADE signals mined are basically consistent with the drug instructions of teneligliptin.In clinical use,special attention should be paid to DME and ADE not mentioned in the drug instructions,such as rhabdomyolysis,to reduce medication risks.

关 键 词：美国FDA不良事件报告系统数据库 替格列汀 药品不良事件 信号挖掘 比例失衡测量法 指定医疗事件 

分 类 号：R95[医药卫生—药学]