基于FAERS数据库挖掘儿童应用万古霉素药品不良事件信号  

Mining of adverse drug event signal of vancomycin in children based on FAERS database

作　　者：温雪 张金红[1] 冯鑫[1] WEN Xue;ZHANG Jinhong;FENG Xin(Department of Pharmacy,Tianjin Hospital,Tianjin 300211,China)

机构地区：[1]天津医院药学部,天津300211

出　　处：《天津药学》2025年第2期236-241,共6页Tianjin Pharmacy

基　　金：医学科学研究基金项目(YWJKJJHKYJJ-YX2023007)。

摘　　要：目的 挖掘儿童使用万古霉素的药品不良事件(ADE)信号,为临床安全用药提供参考。方法 收集美国食品药品监督管理局不良事件报告系统(FAERS)数据库从2004年第1季度至2024年第3季度以“万古霉素”为首要怀疑药物的儿童ADE数据。采用报告比值比法、英国药品和保健品管理局法、贝叶斯置信度递进神经网络法进行信号挖掘。结果 共收集万古霉素ADE报告946份,挖掘到105个ADE信号,涉及18个系统器官(SOC)。0~1岁患儿的报告数最多;女性报告数少于男性。报告数量前3位的SOC依次为皮肤及皮下组织类、全身性疾病及给药部位各种反应、肾脏及泌尿系统类。报告频次前5位ADE信号依次为急性肾损伤、药物无效、药物反应伴嗜酸粒细胞增多和全身性症状(DRESS)、药物相互作用、红人综合征;信号强度前5位ADE信号依次为红人综合征、DRESS、急性肾损伤、万古霉素输液反应、念珠菌感染。万古霉素说明书未记载的新的可疑的ADE信号有念珠菌感染、心肌炎、全身性念珠菌病、新生儿念珠菌感染、唇部红斑等。结论 儿童临床使用万古霉素时,应重点关注报告频次与信号强度排名靠前的ADE,如:急性肾损伤、DRESS、药物相互作用、红人综合征等;还应关注念珠菌感染等新的可疑的ADE,以保障儿童用药安全。Objective To mine adverse drug event(ADE)signals of vancomycin in children,and to provide references for clin-ical medication.Methods The ADE data related to vancomycin as the primary suspected drug in children from Q12004 to Q32024 in the Food and Drug Administration Adverse Event Reporting System(FAERS)database were collected.Signal mining was conducted by using the Reporting Odds Ratio method,the Medicines and Healthcare Products Regulatory Agency comprehensive standard method,and the Bayesian Confidence Propagation Neural Network method.Results A total of 946 ADE reports of vancomycin were collected,containing 105 ADE signals,across 18 system organ classes(SOC).Infants were most frequently reported,and the ADE reports of fe-male were more than that in male.The top three SOC in terms of the report were Skin and subcutaneous tissue disorders,General dis-orders and administration site conditions,and Renal and urinary disorders.The top five ADE signals ranked by report frequency were acute kidney injury,drug ineffective,drug reaction with eosinophilia and systemic symptoms(DRESS),drug interaction,red man syn-drome;the top five ADE signals ranked by signal strength were red man syndrome,DRESS,acute kidney injury,vancomycin infusion reaction,candida infection.The ADE signals not recorded in the drug label of vancomycin were candida infection,myocarditis,sys-temic candida,neonatal candida infection,lip erythema,etc.Conclusion When using vancomycin in clinical for children,it is essen-tial to focus on the ADE with high occurrence frequency and strong signal strength,such as acute kidney injury,DRESS,drug interac-tion,and red man syndrome.In addition,the ADE not recorded in the drug label of vancomycin,such as candida infection,should be take seriously for the safety of children medication.

关 键 词：万古霉素 儿童 药品不良事件 信号挖掘 

分 类 号：R994.1[医药卫生—毒理学]