与诺基诺相关的低血糖:基于FDA不良事件报告系统的2014年至2023年的药监测分析
Dan Li1, Yuan Zhang1, Yu Qi Wang1
1Department of Pharmacy, Zhejiang Provincial People' s Hospital Bijie Hospital, Bijie, China.
Frontiers in medicine
|May 19, 2025
概括
基诺 (FQ) 诱导的低血糖症,特别是用西普洛素 (CPR),是一个显著的不良事件. 早期监测至关重要,因为这些事件可以在一周内发生,并导致严重的结果,特别是口服时.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 临床药理学 临床药理学
背景情况:
- 诺基诺 (FQs) 是广泛使用的抗生素.
- 包括低血糖症在内的不良事件 (AE) 是FQ治疗的挑战.
- 低血糖是临床实践中与FQ使用相关的公认的AE.
研究的目的:
- 综合分析和总结与FQs相关的低血糖AE.
- 专注于莫西弗洛克萨 (MOX),西普罗夫洛克萨 (CPR) 和莱沃弗洛克萨 (LEV).
- 评估FQ相关低血糖和安全信号之间的关联强度.
主要方法:
- 使用FDA FAERS数据 (2014 Q12023 Q4) 的不成比例性分析.
- 使用标准化MedDRA查询 (SMQ) 和首选术语 (PT).
- 计算报告几率比 (ROR) 来识别安全信号和分析的临床特征,发病,服用途径和结果.
主要成果:
- 确定了242,509份FQAE报告,其中16,306份显示出低血糖信号.
- 低血糖主要影响女性 (52.55%) 和年龄在18-64岁之间的患者.
- 齐普罗夫洛克萨 (CPR) 显示出与低血糖的最强相关性 (ROR 99.02),而莱沃弗洛克萨 (LEV) 的相关性较弱 (ROR 82.78). 所有FQ在1周内都显示出低血糖症,口服显示出更强烈的信号. 莫西弗洛克萨辛 (MOX) 具有最严重的副作用.
结论:
- 由FQ诱导的低血糖症可能在治疗开始后一周内发生.
- 这些事件可能会导致严重后果,包括死亡率和残疾.
- 在FQ治疗期间,建议加强低血糖的监测.
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