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干血斑采样和人口药动力学建模,以优化中国新生儿piperacillin的剂量

Pei Li¹, Quanyao Chen², Yao Chen²

¹Division of Biopharmaceutics and Pharmacokinetics, Xiangya School of Pharmaceutical Sciences, Central South University, Changsha, China.

Journal of clinical pharmacology

|October 7, 2024

概括

抽取干血斑 (DBS) 样本使中国新生儿中皮佩拉西林的种群药理动力学成为可能. 经月经后的年龄为改善治疗和降低毒性风险提供了最佳的剂量方案.

科学领域:

新生儿的药理动力学新生儿的药理动力学
优化抗生素治疗的优化.
干燥的血液斑点微量采样.

背景情况:

皮佩拉西林经常被用于新生儿细菌感染的非标签.
在新生儿中优化皮佩拉西林剂量对于疗效和安全至关重要.
干血斑 (DBS) 是一种微创的采样方法.

研究的目的:

评估基于DBS的微抽样策略,对中国新生儿中皮佩拉西林群体药理动力学进行评估.
开发一个药理动力学/药理动力学 (PK/PD) 模型,用于该群体中的piperacillin.
根据月经后年龄 (PMA) 确定最佳的皮佩拉西林剂量方案.

主要方法:

从新生儿患者中采集DBS样本,时间间隔设定.
使用超高性能液体染色学-并联质谱法量化piperacillin度的量化.
使用非线性混合效应建模开发一个人口药理动力学模型.

主要成果:

总共分析了来自24名新生儿的45个piperacillin样本.
皮佩拉西林的药理动力学被用一个单间模型描述.
经月经后的年龄被确定为一个关键的共同变量,影响皮佩拉西林清除.
模拟确定了不同PMA范围的最佳剂量方案,以实现>90%的PK/PD目标达到低毒性风险.

结论:

在新生儿中进行 piperacillin 种群药动力学研究中,DBS 微量采样是一种可行的策略.
在中国新生儿中成功开发了一种包含PMA的种群药理动力学模型.
基于PMA提出了基于PMA的优化piperacillin剂量方案,以提高治疗结果并最大限度地降低毒性.

关键词:

优化剂量优化剂量优化干燥的血液斑点干燥的血液斑点新生儿们的新生儿皮佩拉西林 (Piperacillin) 是一种药物.人口的药理动力学

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