基于蒙特卡洛模拟的美罗连续输液的优化,与降解研究相结合
Nguyen Tran Nam Tien1, Vu Ngan Binh2, Pham Thi Thanh Ha2
1National Drug Information and Adverse Drug Reactions Monitoring Centre, Hanoi University of Pharmacy, Hanoi, Vietnam.
连续输注 (CI) 期间的美罗胺稳定性是可行的,在8小时的输注中维持标药物水平. 降解对实现目标 (PTA) 的概率影响最小,但剂量调整可以恢复对具有挑战性的感染的疗效.
科学领域:
- 药理动力学和药理动力学
- 药物的稳定性和配方
- 传染病和抗微生物治疗
背景情况:
- 梅罗胺的降解挑战了持续输液 (CI) 的实施.
- 关于美罗胺降解对目标实现概率 (PTA) 的影响的数据有限.
- 评估美罗胺品牌稳定性和对PTA的降解后果对于优化治疗至关重要.
研究的目的:
- 评估不同品牌的美罗在不同环境条件下的瓶装稳定性.
- 在模拟的临床场景中确定美罗胺降解对PTA的影响.
- 评估美罗胺IC的可行性,以实现治疗目标.
主要方法:
- 七个meropenem仿制品牌在不同度和温度 (25-37°C) 中进行了8小时的测试.
- 一个线性混合效应模型分析了降解率.
- 瓶内稳定性数据为使用危急疾病人口模型进行药理动力学模拟提供了信息.
主要成果:
- 梅罗胺的稳定性受到时间,温度和度的影响,但仿制药之间的降解差异很小.
- 八个小时的美罗胺CI比3小时的输液获得更高的PTA,即使在高降解下.
- 降解对PTA的影响很小,尽管剂量调整 (1.5-2g q8h) 在特定患者群体中恢复了目标.
结论:
- 梅罗胺IC与8小时更新输注是一种可行的策略,以最大限度地提高疗效,即使在热带气候.
- 这种方法对难以治疗的病原体有效.
- 考虑到药物稳定性对于成功实施美罗胺IC至关重要.
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