摘要
目的对磷霉素的药品不良事件(ADE)信号进行挖掘分析,为临床安全用药提供参考。方法从美国食品药品监督管理局不良事件报告系统(FAERS)提取2004年第1季度至2024年第1季度共81个季度的ADE报告,数据去重后,利用报告比值比法(ROR)、英国药品和保健产品管理局的综合标准法(MHRA)对磷霉素的ADE报告进行数据筛选与分析,挖掘ADE信号。结果共获得以磷霉素为首要怀疑药物的ADE报告2530份,最终得到ADE信号100个,累及20个系统器官(SOC),主要涉及皮肤及皮下组织类疾病、胃肠系统疾病、感染及侵染类疾病、各类损伤、中毒及操作并发症等。报告数和信号强度前30位的ADE中未在说明书中出现的信号3个。结论本研究挖掘出的常见ADE信号和其累及SOC与说明书一致,但也发现心动过速等新信号,可为临床安全用药提供一定的参考。
OBJECTIVE To explore and analyze the adverse drug event(ADE)signals of fosfomycin,and provide reference for clinical safe drug use.METHODS A total of 81 quarters of ADE reports were extracted from the Adverse Event Reporting System(FAERS)of the US Food and Drug Administration from Q12004 to Q12024.After data deduplication,the reportingodd ratio(ROR)and the comprehensive standards actof the Medicines and healthcare products regulatory agency(MHRA)were used to screen and analyze the ADE reports of fosfomycin,mining the ADE signals.RESULTS A total of 2530 ADE reports were obtained,with fosfomycin as the primary suspected drug.Ultimately,100 ADE signals were obtained,affecting 20 systemic organ classes(SOC),mainly involving skin and subcutaneous tissue diseases,gastrointestinal system diseases,infection and infection diseases,various injuries,poisoning,and operational complications.There are 3 signals in the top 30 ADEs of the number of reports and signal strength that are not listed in the manual.CONCLUSION The common ADE signals and their involvement in SOC discovered in this study are consistent with the instructions,but new signals such as tachycardia were also found,which can provide some reference for safe clinical medication.
作者
林志鸿
LIN Zhi-hong(Department of PIVAS,The First Affiliated Hospital of Xiamen University,Xiaman 361000,China)
出处
《海峡药学》
2025年第6期74-78,共5页
Strait Pharmaceutical Journal
作者简介
林志鸿,男(1987.09-)。职称:主管药师。研究方向:医院药学。
