Yan Xin, Ma Junlong, Guo Chengxian, Yang Guoping
Xiangya School of Pharmaceutical Sciences, Central South University, Changsha, Hunan, China.
Clinical Pharmacology Center, The Third Xiangya Hospital of Central South University, Changsha, Hunan, China.
Int J Antimicrob Agents. 2025 Aug;66(2):107524. doi: 10.1016/j.ijantimicag.2025.107524. Epub 2025 Apr 25.
Recent reports suggest antibiotics may cause severe allergic reactions, such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), exacerbating concerns about antibiotic safety.
Given the limited real-world evidence, this study aims to analyse the FDA Adverse Event Reporting System to investigate the association between various antibiotics and SJS/TEN risk.
Reports from infected patients (Q1 2014-Q4 2023) were extracted from the FDA Adverse Event Reporting System. Disproportionality analysis using information component identified risk signals of antibiotics associated with SJS/TEN. Subgroup analyses investigated the impact of age and gender on antibiotic-associated SJS/TEN. Also, a time of onset analysis was performed.
Among 78 593 infected patients, 1221 cases of SJS/TEN were identified from 30 369 antibiotic administrations. The median age of patients with SJS was 63 y, and with TEN was 60 y. Eleven positive signal drugs were detected through disproportionality analysis. Amoxicillin, piperacillin, ceftriaxone, cefuroxime, cefotaxime, azithromycin, sulfamethoxazole, trimethoprim, vancomycin, doxycycline, and gentamicin exhibited significant risk associations with SJS/TEN. Sulfamethoxazole had the highest risk. Patients with pneumonia, urinary tract infections, and sepsis had higher risks than those with respiratory tract infections. Male patients using specific antibiotics may have a higher risk than females, with no significant age difference.
Antibiotics including penicillins, cephalosporins, azithromycin, sulfamethoxazole, trimethoprim, vancomycin, doxycycline, and gentamicin are associated with an increased risk of SJS/TEN, with sulfamethoxazole presenting the highest risk. Patients with pneumonia, urinary tract infections, and sepsis are particularly vulnerable. These findings highlight the need for personalized antibiotic regimens based on infection site and patient gender.
近期报告表明抗生素可能会引发严重过敏反应，如史蒂文斯-约翰逊综合征（SJS）和中毒性表皮坏死松解症（TEN），这加剧了人们对抗生素安全性的担忧。
鉴于现实世界中的证据有限，本研究旨在分析美国食品药品监督管理局（FDA）不良事件报告系统，以调查各种抗生素与SJS/TEN风险之间的关联。
从FDA不良事件报告系统中提取2014年第一季度至2023年第四季度感染患者的报告。使用信息成分进行不成比例分析，以确定与SJS/TEN相关的抗生素风险信号。亚组分析调查了年龄和性别对抗生素相关SJS/TEN的影响。此外，还进行了发病时间分析。
在78593例感染患者中，从30369次抗生素给药中识别出1221例SJS/TEN病例。SJS患者的中位年龄为63岁，TEN患者的中位年龄为60岁。通过不成比例分析检测到11种阳性信号药物。阿莫西林、哌拉西林、头孢曲松、头孢呋辛、头孢噻肟、阿奇霉素、磺胺甲恶唑、甲氧苄啶、万古霉素、多西环素和庆大霉素与SJS/TEN存在显著风险关联。磺胺甲恶唑风险最高。肺炎、尿路感染和败血症患者的风险高于呼吸道感染患者。使用特定抗生素的男性患者可能比女性风险更高，年龄差异不显著。
包括青霉素类、头孢菌素类、阿奇霉素、磺胺甲恶唑、甲氧苄啶、万古霉素、多西环素和庆大霉素在内的抗生素与SJS/TEN风险增加相关，磺胺甲恶唑风险最高。肺炎、尿路感染和败血症患者尤其易患。这些发现凸显了根据感染部位和患者性别制定个性化抗生素治疗方案的必要性。
