基于OpenFDA挖掘与评价司美格鲁肽上市后的不良反应  

Detection and evaluation of post-marking adverse reactions induced by semaglutide base upon Open

作　　者：李波[1] 张科[1] 宋崟 袁恒杰[1] 李正翔[1] FDA LI Bo;ZHANG Ke;SONG Yin;YUAN HengJie;LI Zhengxiang(Department of Pharmacy,Tianjin Medical University General Hospital,Tianjin 300052,China)

机构地区：[1]天津医科大学总医院药剂科,天津市300052

出　　处：《临床合理用药杂志》2023年第17期32-35,39,共5页Chinese Journal of Clinical Rational Drug Use

摘　　要：目的运用美国食品药品监督管理局开放数据库(OpenFDA)挖掘并评价司美格鲁肽上市后的不良反应与安全信号,为临床安全合理用药提供参考。方法采用报告比值比(ROR)法对美国不良事件报告系统(FAERS)中自2017年12月5日—2021年12月22日期间司美格鲁肽的所有不良事件报告数据进行处理分析,挖掘阳性风险信号。结果从与司美格鲁肽相关的10826份不良事件报告中检测到有临床参考意义的阳性信号31个,涉及6个系统/器官。除去说明书中记载的不良反应外,还存在糖化血红蛋白增加、血糖升高、糖尿病酮症酸中毒增加、嗜睡、鼻塞等阳性风险信号。结论通过OpenFDA挖掘与评价得到不良反应阳性风险信号,为临床用药提供参考,保障患者用药安全。Objective Using OpenFDA to analyze the adverse reactions and safety signals of semaglutide,so as to provide reference for safe and rational drug use in clinic.Methods The methods of reporting odds ratio(ROR)was used to analyze the data which included reports from December 5,2017 to December 22,2021 of the FDA adverse event reporting system(FAERS),and analyzed the excavated signals.Results A total of 10826 reports of semaglutide related adverse reactions were retrieved,including 31 adverse reaction risk signals with clinical reference significance,involving 6 system organs,There were also glycosylated haemoglobin increased,blood glucose increased,diabetic ketoacidosis,lethargy,nasal congestion etc,were found that in addition to the adverse reactions contained in the manual.Conclusion Through OpenFDA and evaluation,the positive risk signals of adverse reactions are obtained,which can provide reference for clinical medication and ensure the safety of patients′medication.

关 键 词：司美格鲁肽 美国食品药品监督管理局开放数据库 不良反应 报告比值比 

分 类 号：R977.15[医药卫生—药品]