基于FAERS数据库挖掘与分析利格列汀上市后的安全警戒信号

Data mining and safety analysis of ligrestin based upon FAERS

目的:基于美国食品药品监督管理局不良事件报告系统(FAERS)对利格列汀安全警戒信号进行挖掘分析,为临床安全用药提供参考。方法:运用报告比值比(ROR)法、比例报告比(PRR)法对FAERS中2011年5月2日-2021年12月31日利格列汀的药物不良事件(ADE)报告进行数据挖掘分析。结果:共收集利格列汀ADE 8666条,经合并同义词、删除非ADE后使用ROR和PRR法进行数据挖掘,得到197个安全警戒信号,其中药品说明书记载18个,未记载179个,主要集中在代谢和营养失调、胃肠系统损害、肾脏和泌尿系统疾病、中枢及外周神经系统紊乱等15个器官和系统。结论:使用利格列汀期间应加强安全监测,以减少用药风险。

Objective:To mine and analyze the safety warning signals of ligliptin based on FDA adverse event Reporting System(FAERS),so as to provide reference for clinical safe drug use.Methods:Adverse drug eventade(Adverse drug eventade)reports in FAERS May 2,2011 to December 31,2021 were analyzed by using ROR and PRR 2021.Results:A total of 8666 data were collected,and 197 safety warning signals were obtained by combining synonyms and deleting non-ADE.Of these,18 were listed in the drug descriptions and 179 were not.Most of them focused on metabolic and nutritional disorders,gastrointestinal disorders,kidney and urinary system diseases,central and peripheral nervous system disorders.Conclusion:Safety monitoring should be strengthened to reduce the risk of drug use.