基于美国食品和药物管理局不良事件报告系统 (FAERS) 数据库的聚密辛相关不良事件的药监测研究
Tingxi Wu1, Yanfeng Shi2, Chang Xu3
1Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Expert opinion on drug safety
|April 27, 2024
概括
与Polymyxin B相比,素使用与损伤风险增加和神经毒性降低有关.Polymyxin B可能会导致皮肤多颜色,需要对不良事件进行警监测.
科学领域:
- 药理学 药理学是指药理学的学科.
- 传染性疾病 传染性疾病
- 临床毒理学 临床毒理学
背景情况:
- 聚米克辛是对多药耐药性格拉姆阴性感染的关键最后一线药物.
- 对于素和多素B (PMB) 的毒性概况存在持续的担忧.
- 对素和PMB之间的不良事件的比较分析对于优化患者安全至关重要.
研究的目的:
- 为了比较与素和多素B (PMB) 治疗相关的潜在不良事件 (AE).
- 为了确定每个多胺剂的特定毒性信号.
- 为了为临床决策提供有关多素选择的信息.
主要方法:
- 从FDA不良事件报告系统 (2004-2022) 中对聚胺相关的副作用进行了回顾性分析.
- 使用报告几率比率 (ROR) 来估计AE不成比例.
- 进行了子组分析,以调整显著AE信号中的混因素.
主要成果:
- 胆固醇在和尿路疾病 (ROR 1.62) 和急性损伤 (ROR 1.75) 中显示出较高的不成比例.
- 与PMB相比,素与较低的神经毒性风险 (ROR 0.47) 有关.
- 与PMB一起报告了7例皮肤色素增多病例,没有与胆固醇一起报告;大多数副作用发生在两周内.
结论:
- 胆固醇治疗具有较高的毒性风险,但神经毒性风险较低.
- 临床医生必须监测PMB诱导的多发色素障碍.
- 了解差异性毒性概况有助于更安全地使用聚胺.
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