基于FAERS数据库利拉鲁肽不良反应信号挖掘与分析

目的： 通过对利拉鲁肽不良反应信号的挖掘分析，为临床合理安全用药提供依据。方法： 采用比例失衡法中的报告比值比法（ROR）和比例报告比值比法（PRR）对美国FDA不良事件报告系统（FAERS）利拉鲁肽2010年一季度至2019年一季度共37个季度的不良反应报告进行数据挖掘及分析。结果： 共收集到56 396条药品不良反应（Adverse Drug Reaction，ADR）报告，合并同义词后使用ROR与PRR法，经过二次筛选，得到ADR信号87个，主要集中于胃肠道系统损害、代谢和营养障碍、用药部位损害、内分泌紊乱等方面。结论： 对利拉鲁肽ADR信号进行挖掘和分析，为临床安全用药提供参考，采取相应的预防措施，或避免应用于高风险人群。

Mining and analysis ofADR signals induced by liraglutide based on FAERS database

OBJECTIVE To provide reference for rational and safe clinical practice through adverse drug reaction(ADR)signal mining and analysis of liraglutide.METHODS The methods of reporting odds ratio(ROR)and the proportional reporting ratio(PRR)were used to analyze the data which included 37 quarterly reports from the first quarter of 2010 to the first quarter of 2019 of the united states FDA adverse event reporting system(FAERS).RESULTS A total of 56396 ADR reports were collected,and 88 ADR signals of liraglutide were obtained after secondary screening through the methods of ROR and PRR,mainly focusing on gastrointestinal system disorders,metabolic and nutritional disorders,application site disorders,endocrine disorders and other aspects.CONCLUSION The ADR signal of liraglutide should be mined and analyzed to provide reference for clinical safe medication,and corresponding preventive measures should be taken,or it should be avoided to be applied to high risk population.