与β-lactaman抗菌药物相关的异常凝血指标:基于FAERS数据库的药监测研究
Xuemei Tian1,2, Tingting Chen1, Lishan Lu2
1Department of Pharmacy, Fujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University, #18 Daoshan Road, Fuzhou, 350001, China.
Naunyn-Schmiedeberg's archives of pharmacology
|July 18, 2025
概括
β-乳酸抗生素可能导致异常凝血,特别是在老年患者中. 塞福拉/苏尔巴克坦对这些药物不良事件显示出最强的风险信号.
科学领域:
- 药物监督 药物监督 药物监督
- 临床药理学 临床药理学
- 药品安全 药品安全
背景情况:
- β-乳酸抗菌药物被广泛使用,但可能导致不良药物事件 (ADEs).
- 异常凝血指标是与这些药物相关的潜在风险.
- 确定特定的药物事件关系和风险因素对于安全的临床实践至关重要.
研究的目的:
- 调查与β-乳糖抗菌药物异常凝血指标相关的不良事件的特征.
- 确定这些药物不良反应的特定风险信号.
- 为在临床环境中合理使用β-乳酸药物提供基于证据的参考资料.
主要方法:
- 从2004年第一季度到2024年第三季度使用了FDA不良事件报告系统 (FAERS) 的数据.
- 采用了统计方法,包括报告几率比率 (ROR),比例报告比率 (PRR),贝叶斯信任传播神经网络 (BCPNN) 和多项马鱼缩小器 (MGPS).
- 分析了与β-lactam药物相关的异常凝血指标的发生时间和特定类型.
主要成果:
- 总共有828个病例报告和902个不良反应被确定.
- 大多数不良药物事件 (95.55%) 发生在药物服用后30天内.
- 塞福拉/苏尔巴克坦表现出最强烈的风险信号,其次是塞夫特里亚和塞福塔西姆,INR升高和PT延长是常见的.
- 老年患者 (≥65岁) 占病例的60.39%,死亡率为10.39%.
结论:
- β-乳酸抗菌药物,特别是诸如 cefoperazone/sulbactam, ceftriaxone 和 cefotaxime 这样的类药物,与各种异常凝血指标有关.
- 对于老年患者,肝/功能障碍患者以及有血凝失调病史的个人,密切监测是必不可少的.
- 这些发现支持在高风险人群中使用β-乳糖药物的安全措施,以防止凝血异常.
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