基于美国食品药品监督管理局不良事件报告数据库大环内酯类抗生素致听力受损的相关性分析  

Correlation between Hearing Impairment and Use of Macrolide Antibiotics Based on FAERS Reports

作　　者：付中华 申庆利 赵成龙 FU Zhonghua;SHEN Qingli;ZHAO Chenglong(Department of Pharmacy,Henan Provincial People's Hospital,People's Hospital of Zhengzhou University,Zhengzhou 450003,China)

机构地区：[1]河南省人民医院药学部,郑州大学人民医院药学部,郑州450003

出　　处：《中华耳科学杂志》2025年第1期54-58,共5页Chinese Journal of Otology

摘　　要：目的借助美国食品药品监督管理局不良事件报告系统(U.S.food and drug administration adverse event reporting system,FAERS)对大环内酯类抗生素与听力受损之间的相关性进行探讨。方法借助OpenVigil平台,检索2004年1月至2023年3月听力受损不良反应,怀疑药物为大环内酯类药物的报告。采用报告比值比(reporting odds ratio,ROR)、比例报告比(proportional reporting ratio,PRR)及贝叶斯置信度神经网络法(bayesian confidence propagation neural network,BCPNN)评价大环内酯类药物与听力受损的相关性及差异。结果共检索到84088份听力受损相关报告,其中阿奇霉素、克拉霉素、红霉素的报告数分别为428、415、64份,致残率分别为2.34%、10.84%、1.56%。听力受损与阿奇霉素、克拉霉素相关性强,其ROR值分别为3.74、3.59,与红霉素有弱相关性,其ROR值为1.28。3种药物与耳毒性、双侧耳聋、感音神经性耳聋、耳聋有强相关性。结论大环内酯类抗生素与听力受损之间存在相关性。临床实践中应加强不良事件评估,保障患者用药安全。Objective To determine the correlation between macrolide antibiotics usage and hearing impairment using the FDA Adverse Event Reporting System(FAERS).Methods The OpenVigil platform was used to search for FAERS reports of hearing impairment adverse reactions suspected to be linked to macrolides from January 2004 to January 2023.Reporting odds ratio(ROR),proportional reporting ratio(PRR)and Bayesian confidence neural network(BCPNN)were used to evaluate the correlation between macrolides and hearing impairment as well as differences among macrolids.Results The A total of 84,088 reports on macrolide-related hearing impairment were retrieved,involving azithromycin(n=428,2.34%),clarithromycin(n=415,10.84%)and erythromycin(n=64,1.56%).Hearing impairment was significantly correlated with azithromycin and clarithromycin(ROR=3.74 and 3.59,respectively),and weakly with erythromycin(ROR=1.28).All three drugs showed strong correlation to ototoxicity,bilateral deafness,sensorineural deafness and deafness.Conclusion This study shows an association between macrolide antibiotics and hearing impairment.Evaluation of ototoxicity adverse events is important in clinical practice to ensure safety medication use for patients.

关 键 词：大环内酯类抗生素 听力受损 耳毒性 美国食品药品监督管理局不良事件报告系统 

分 类 号：H31[语言文字—英语]