Li Chen-Sui-Zi, Han Mei-Fen, Yu Bing, Gao Qian, Dong Hong-Liang, Li Zhi-Ling
Department of Pharmacy, Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Expert Opin Drug Saf. 2024 Dec 22:1-8. doi: 10.1080/14740338.2024.2442023.
Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and Acute Generalized Exanthematous Pustulosis (AGEP), pose significant therapeutic challenges. Vancomycin and linezolid have been linked to these life-threatening conditions, necessitating a better understanding of their associated risks.
We conducted a retrospective analysis using data from the FDA Adverse Event Reporting System (FAERS) database. Disproportionality and Bayesian statistical analyses were applied to evaluate the associations between vancomycin, linezolid, and SCARs, comparing the outcomes induced by these drugs.
Of the 11,737,133 data, there were a total of 1024 vancomycin-associated SCARs and 125 cases of linezolid-associated SCARs. Vancomycin was strongly associated with DRESS, showing a Reporting Odds Ratio (ROR) of 53.79 (95% CI: 49.75-58.16), Proportional Reporting Ratio (PRR) of 50.38, and Empirical Bayesian Geometric Mean (EBGM) of 2.32. For SJS and TEN, vancomycin reported RORs of 8.04 and 15.63, respectively. Linezolid demonstrated lower associations, with RORs of 5.14 for DRESS and 2.36 for SJS.
Vancomycin presents a higher risk of SCARs compared to linezolid, particularly for DRESS. Underscoring the need for cautious use and the potential benefit of personalized medicine practices to improve patient safety.
严重皮肤不良反应(SCARs),包括史蒂文斯-约翰逊综合征(SJS)、中毒性表皮坏死松解症(TEN)、伴有嗜酸性粒细胞增多和全身症状的药物反应(DRESS)以及急性泛发性脓疱病(AGEP),带来了重大的治疗挑战。万古霉素和利奈唑胺与这些危及生命的病症有关,因此有必要更好地了解它们的相关风险。
我们使用美国食品药品监督管理局不良事件报告系统(FAERS)数据库中的数据进行了一项回顾性分析。采用不成比例分析和贝叶斯统计分析来评估万古霉素、利奈唑胺与SCARs之间的关联,比较这些药物引起的结果。
在11737133条数据中,共有1024例与万古霉素相关的SCARs和125例与利奈唑胺相关的SCARs。万古霉素与DRESS密切相关,报告比值比(ROR)为53.79(95%置信区间:49.75 - 58.16),比例报告比值(PRR)为50.38,经验贝叶斯几何均值(EBGM)为2.32。对于SJS和TEN,万古霉素的ROR分别为8.04和15.63。利奈唑胺的关联性较低,DRESS的ROR为5.14,SJS的ROR为2.36。
与利奈唑胺相比,万古霉素出现SCARs的风险更高,尤其是对于DRESS。这突出了谨慎使用的必要性以及个性化医疗实践对提高患者安全性的潜在益处。