摘要
目的基于美国食品药品管理局不良事件报告系统(FAERS)数据,挖掘苯二氮■类药物(BZDs)及相关药物相关痴呆事件信号,为临床合理用药提供参考。方法下载并清洗2004年第1季度至2019年第4季度FAERS数据,提取BZDs相关痴呆事件,采用报告比值比(ROR)法和比例报告比值(PRR)法进行信号检测。结果共提取到23种BZDs相关痴呆事件报告记录10 324例,其中事件报告数前5的BZDs为唑吡坦2809例(33.21%)、阿普唑仑2 440例(17.02%)、劳拉西泮2157例(35.35%)、地西泮1287例(14.60%)和氧异安定525例(24.18%)。女性痴呆事件占比高于男性(女:男=1.34),中位年龄为51岁。20种BZDs检出"痴呆",信号强度前5的BZDs为氯甲西泮(PRR:15.29)、硝西泮(PRR:9.94)、溴西泮(PRR:7.55)、佐匹克隆(PRR:6.25)和氟硝西泮(PRR:6.02)。短效BZDs检出的信号强度值高于长效BZDs(PRR:4.13和2.77)。结论应加强BZDs临床用药监测,警惕BZDs相关痴呆事件。
Objective To detect and analyze the signals of benzodiazepines(BZDs)related dementia events through data mining methods based on the US FDA Adverse Event Reporting System(FAERS)data,so as to provide a reference for clinical rational drug uses.Methods FAERS data of 64 quarters from the first quarter of 2004 to the fourth quarter of 2019 were downloaded and screened.After data processing,BZDs-related dementia adverse events were extracted and signal detection was performed using proportional reporting ratio(PRR)and reporting odds ratio(ROR).Results A total of 10324 dementia events related to the twenty-three BZDs were gathered,among which the top 5 BZDs in the number of event reports were 2809(33.21%)reports for zolpidem,2440(17.02%),reports for alprazolam,2157(35.35%)reports for lorazepam,1287(14.60%)reports for diazepam,and 525(24.18%)reports for clobazam.The proportion of dementia was higher in female(female:male=1.34),and the median age was 51 years old.Twenty BZDs had signals detected in"dementia",and the top 5 BZDs by signal intensity were lormetazepam(PRR:15.29),nitrazepam(PRR:9.94),bromazepam(PRR:7.55),zopiclone(PRR:6.25),and flunitrazepam(PRR:6.02).Higher signal intensity values were detected from short-acting BZDs(PRR:4.13 vs.2.77).Conclusion The clinical monitoring of BZDs should be strengthened,and BZDs related dementia events should be vigilant.
作者
金子妍
陈晨
杜雨凡
吴斌
徐珽
JIN Ziyan;CHEN Chen;DU Yufan;WU Bin;XU Ting(Department of Pharmacy,West China Hospital,Sichuan University,Chengdu 610041,China;West China School of Pharmacy,Sichuan University,Chengdu 610041,China)
出处
《医药导报》
CAS
北大核心
2021年第10期1356-1360,共5页
Herald of Medicine
基金
科技部国家重点研发计划项目(2020YFC2008302)。
