中国药业2025，Vol.34Issue(4)：119-124,6.DOI:10.3969/j.issn.1006-4931.2025.04.029
基于FAERS的妥布霉素不良事件信号挖掘
Data Mining of Adverse Event Signals of Tobramycin Based on FAERS
摘要
Abstract
Objective To promote the safe use of tobramycin in clinical practice.Methods Clinical data related to the use of tobramycin in the FDA Adverse Event Reporting System(FAERS)from the first quarter of 2004 to the fourth quarter of 2023 were extracted,and the reporting odds ratio(ROR),proportional reporting ratio(PRR)in the disproportionality method,and the Medicines and Healthcare Products Regulatory Agency(MHRA)method were used for signal mining.The preferred terms(PTs)for positive signals of adverse drug events(ADEs)were standardized by the Medical Dictionary for Regulatory Activities(MedDRA),the systematic organ classification(SOC)was performed on PTs,and PTs wre sorted and analyzed according to signal frequency and signal strength.Results A total of 27 394 ADE reports were obtained with tobramycin as the primary suspected drug,involving 11 339 patients,with more males than females(46.94%vs.38.23%),mainly aged 18 to<45 years(2 002 cases,17.66%).In the ADE reports,the main reporting groups were consumers(39.44%),pharmacists(26.29%),and physicians(16.54%);the main route of administration was inhalation(49.18%);the main reporting country was the United States(64.84%).A total of 355 ADE positive signals were found,the top five PTs in terms of signal frequency were the death(1 393 times),off-label drug use(1 127 times),infectious pneumonia(928 times),cough(816 times),and dyspnea(786 times);the top five PTs in terms of signal intensity were the Cronobacter infection(ROR=1 876.89,PRR=1 876.48),cystic fibrosis liver disease(ROR=511.82,PRR=511.77),single bacteria infection(ROR=441.59,PRR=441.52),primary ciliary dyskinesia(ROR=388.32,PRR=388.24),and pulmonary cystic fibrosis(ROR=346.96,PRR=346.74).A total of 24 SOCs were involved,mainly respiratory system,chest and mediastinal diseases,infectious and contagious diseases,and various examinations.Conclusion Tobramycin-related ADEs are more common in males,young adults,and patients receiving inhaled medication;the majority of reporters are consumers;the PTs with the highest frequency and strongest signal strength are death and Cronobacter infection,respectively.This study can further provide a reference for the safe use of the drug in clinical practice.关键词
妥布霉素/药品不良事件/信号挖掘/美国食品和药物管理局不良事件报告系统/比例失衡法Key words
tobramycin/adverse drug event/signal mining/FDA Adverse Event Reporting System/disproportionality method分类
医药卫生引用本文复制引用
陈璐,万建伟,王翠红,陈敏..基于FAERS的妥布霉素不良事件信号挖掘[J].中国药业,2025,34(4):119-124,6.基金项目
上海市浦东新区卫生健康委员会优秀青年医学人才培养计划[PWRq2021-46]. （）
