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在新生儿和婴儿中,以模型为基础优化螺旋乳的剂量
Amira Soliman1,2, Leandro F Pippa1, Jana Lass3,4
1Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, University of Florida, Orlando, FL 32827, USA.
Pharmaceuticals (Basel, Switzerland)
|March 27, 2025
概括
开发了基于生理学上的spironolactone (SP) 药物动力学模型,以预测儿科剂量. 模拟表明婴儿的特定mg/kg剂量与成人暴露相匹配,改善了儿童的SP治疗.
科学领域:
- 药理动力学 药理动力学
- 儿科药理学 儿科药理学
- 药物新陈代谢 药物新陈代谢
背景情况:
- 在儿科中使用螺旋 (SP) 是常见的,但缺乏可靠的药理动力学 (PK) 数据.
- 在儿童中有限的PK数据阻碍了最佳的螺旋乳剂量和治疗结果.
研究的目的:
- 开发基于生理学的药理动力学 (PBPK) 模型,用于螺旋和其代谢物.
- 在儿科群体中预测螺旋龙PK,包括婴儿和新生儿.
- 建立一个基础,优化儿童的spironolactone剂量.
主要方法:
- 在成年人中开发了PBPK模型,用于螺旋 (SP),canrenone (CAN) 和7α硫甲基螺旋 (TMS).
- 纳入CES1介导的代谢和CES1和CYP3A4.4的本体发生.
- 整合与年龄相关的生理变化用于儿科PK预测.
主要成果:
- PBPK模型准确地预测了成人SP,CAN和TMS PK,包括食物的影响.
- 儿科PBPK模型模拟建议婴儿剂量为2.5 mg/kg (6mo-2yr) 和2 mg/kg (1-6mo).
- 这些模拟的婴儿剂量与成人系统暴露相匹配,用于治疗.
结论:
- PBPK模型为儿童群体中螺旋诺拉克剂量提供了有价值的见解.
- 优化剂量策略可以改善儿童的治疗结果.
- 该模型对于临床PK研究难以进行的人群特别有用.
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