摘要
目的挖掘分析左炔诺孕酮宫内节育系统的不良事件(ADEs)信号,为临床安全用药提供参考。方法采用报告比值比法(ROR)和比例报告比值法(PRR)对美国食品药品管理局(FDA)ADEs报告系统(FAERS)2016年第一季度至2021年第一季度ADEs进行数据挖掘。结果得到以左炔诺孕酮宫内节育系统为首要怀疑药品的ADEs报告病例39306例,检测获得ADEs信号438个,共涉及系统器官分类24个。二次筛选后得到信号81个,其中新的ADEs信号14个,涉及器官系统分类8个,病例年龄主要集中于18~50岁。结论新的ADEs信号可能与左炔诺孕酮宫内节育系统有关,需加强临床用药监测。
Objective To explore and analyze the adverse events(ADEs)signals of levonorgestrel intrauterine system(LNG-IUS).Furthermore,to provide a reference for its clinical safety.Methods The reporting odds ratio(ROR)method and the proportional reporting ratio(PRR)method were adopted to conduct data-mining adverse events in the US Food and Drug Administration Adverse Event Reporting System(FAERS),from the first quarter of 2016 to the first quarter of 2021.Results A total of 39306 ADEs reported cases with the levonorgestrel intrauterine system as the first suspected drug were found,and 438 ADEs signals were detected,involving 24 system organ classifications.Fourteen of the 81 ADEs signals were not mentioned in the labels after the second screening,which involved eight system organ classifications and happened to patients mainly between the ages of 18 to 50.Conclusion New ADEs signals may be related to LNG-IUS,and clinical monitoring of LNG-IUS should be strengthened.
作者
唐芙蓉
黄兴
陈力
王丹青
TANG Furong;HUANG Xing;CHEN Li;WANG Danqing(Department of Obstetrics and Gynecology,West China Second Hospital,Sichuan University,Chengdu 610041,China;Key Laboratory of Obstetric & Gynecologic and Pediatric Diseases and Birth Defects of Ministry of Education,Chengdu 610041,China;Department of Pharmacy /Evidence-based Pharmacy Center,West China Second Hospital,Sichuan University,Chengdu 610041,China)
出处
《医药导报》
CAS
北大核心
2022年第7期963-968,共6页
Herald of Medicine
基金
四川省科技厅项目(2020YFS0131)。