关于利奈唑胺(LZD)和其他抗生素之间与药物-药物相互作用(DDI)相关的安全性的详细数据有限。本研究旨在探讨与DDI相关的安全性信号,为临床相关药物不良事件监测提供参考。从2004年1月1日至2022年6月16日单独使用或与LZD联合使用的目标抗生素(包括LZD)的不良事件(AE)信息从OpenVigilFDA数据平台中提取用于安全性信号分析。组合风险比模型,报告比率法,Ω收缩测量模型,采用卡方统计模型分析与DDI相关的安全性信号。同时,我们评估了药物与检测到的目标AE之间的相关性以及性别和年龄的影响。有18991个与LZD相关的不良事件。当LZD与阿米卡星联合使用时,有2293、1726、4449、821、2431、1053和463例AE报告。伏立康唑,美罗培南,克拉霉素,左氧氟沙星,哌拉西林他唑巴坦,和阿奇霉素,分别。除了阿奇霉素,LZD和这些抗生素之间存在与DDI相关的正安全性信号.这些DDI可能会影响13、16、7、7、6和15种类型的AE的发生率,分别,与单独使用相比,与较高的AE报告率相关。此外,性别和年龄可能影响不良事件的发生。我们发现LZD和其他抗生素的组合与多个不良事件有关,如肝毒性,耐药性和心电图QT延长,但仍需进一步研究以探讨其潜在机制。本研究可为临床上LZD联合其他抗生素的安全性监测提供新的参考。
Detailed data on safety associated with drug-drug interactions (DDIs) between Linezolid (LZD) and other antibiotics are limited. The aim of this study was to investigate the safety signals related to these DDIs and to provide a reference for clinically related adverse drug event monitoring. Adverse event (AE) information from 1 January 2004 to 16 June 2022 of the target antibiotics including LZD using alone or in combination with LZD was extracted from the OpenVigil FDA data platform for safety signal analysis. The combined risk ratio model, reporting ratio method, Ω shrinkage measure model, and chi-square statistics model were used to analyze the safety signals related to DDIs. Meanwhile, we evaluated the correlation and the influence of sex and age between the drug(s) and the target AE detected. There were 18991 AEs related to LZD. There were 2293, 1726, 4449, 821, 2431, 1053, and 463 AE reports when LZD was combined with amikacin, voriconazole, meropenem, clarithromycin, levofloxacin, piperacillin-tazobactam, and azithromycin, respectively. Except for azithromycin, there were positive safety signals related to DDIs between LZD and these antibiotics. These DDIs might influence the incidence of 13, 16, 7, 7, 6, and 15 types of AEs, respectively, and is associated with higher reporting rates of AEs compared with use alone. Moreover, sex and age might influence the occurrence of AEs. We found that the combinations of LZD and other antibiotics are related to multiple AEs, such as hepatotoxicity, drug resistance and electrocardiogram QT prolonged, but further research is still required to investigate their underlying mechanisms. This study can provide a new reference for the safety monitoring of LZD combined with other antibiotics in clinical practice.