PDF(Pubmed)
Abstract：
Background: Stevens-Johnson syndrome (SJS) has been reported as a serious adverse effect in patients treated with vancomycin or linezolid, and there is currently a lack of real-world studies comparing specific differences in adverse effects of SJS. Methods: According to the FDA\'s Adverse Event Reporting System (FAERS), from January 2004 to July 2021, the data of suspected SJS after the use of vancomycin and linezolid were analyzed by imbalance and Bayesian analysis. The onset time, fatality rate and hospitalization rate of vancomycin-associated SJS and linezolid-associated SJS were also investigated. Results: 276 cases of vancomycin-related SJS reports and 63 cases of linezolid-related SJS reports were identified. These two drugs are more common in middle-aged patients (45-64 years) than other age groups, and less common in underage children (<18). Among them, linezolid-related SJS is more common in middle-aged and elderly patients (45-74 years old) than other groups. Except for unspecified data, in vancomycin-associated SJS cases, there are more men than women (49.28% vs 43.84%), while in linezolid-associated SJS cases, the proportion of men and women is almost equal (44.44%). From the point of view of the areas where adverse reactions were reported, about 1/2 of the reports on Vancomycin-related SJS came from North America, and 1/3 of the reports came from Europe. The median onset time of Linezolid-related SJS was 5 days (interquartile range [IQR] 2-7.75), which was significantly earlier than that of Vancomycin-related SJS (12 days, IQR 4-20) (Mann-Whitney test, p < 0.0001). There were no significant differences in mortality and hospitalization rates after vancomycin and linezolid caused SJS. Conclusion: The analysis of faers data provides a comprehensive overview of the adverse reactions of SJS caused by the use of vancomycin and linezolid, and can warn clinical workers to timely intervene and continuously monitor the patients at risk of SJS when using such drugs.
摘要：
背景：史蒂文斯-约翰逊综合征（SJS）已被报道为万古霉素或利奈唑胺治疗患者的严重不良反应，目前缺乏比较SJS不良反应的具体差异的现实研究。方法：根据FDA的不良事件报告系统（FAERS），2004年1月至2021年7月,对使用万古霉素和利奈唑胺后疑似SJS的数据进行不平衡分析和贝叶斯分析.发病时间，还调查了万古霉素相关SJS和利奈唑胺相关SJS的死亡率和住院率。结果:共发现276例万古霉素相关SJS报告和63例利奈唑胺相关SJS报告。这两种药物在中年患者（45-64岁）比其他年龄组更常见，在未成年儿童中不常见（<18）。其中,利奈唑胺相关的SJS在中老年患者（45-74岁）中比其他人群更常见。除未指定的数据外，在万古霉素相关的SJS病例中，男性多于女性（49.28％vs43.84％），而在利奈唑胺相关的SJS病例中，男女比例几乎相等(44.44%)。从报告不良反应的地区来看,万古霉素相关SJS的报告约有1/2来自北美，1/3的报告来自欧洲。利奈唑胺相关SJS的中位发病时间为5天（四分位距[IQR]2-7.75），明显早于万古霉素相关的SJS（12天，IQR4-20)(曼-惠特尼测试，p<0.0001)。万古霉素和利奈唑胺引起SJS后的死亡率和住院率没有显着差异。结论:通过对faers数据的分析,全面概述了使用万古霉素和利奈唑胺引起的SJS不良反应,并可以警告临床工作者在使用此类药物时及时干预和持续监测有SJS风险的患者。
