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在儿童自闭症谱系障碍治疗窗口的外部验证

Rebecca A Hermans^1,2,3, Kathalijne Bruens¹, Karin M Egberts⁴

¹Department of Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, the Netherlands.

British journal of clinical pharmacology

|August 29, 2025

概括

这项研究验证了患有自闭症谱系障碍的儿童里斯佩里的群体药理学 (popPK) 模型. 虽然该模型适用于治疗药物监测 (TDM),但建议使用3.5-7.0 ng/mL的窗口.

科学领域:

药理学
神经发育障碍
临床药房

背景情况:

在自闭症谱系障碍 (ASD) 中,瑞斯佩里有效地控制了破坏性行为.
代谢副作用是瑞斯佩里治疗的一个问题.
种群药动力学 (popPK) 模型有助于优化药物治疗.

研究的目的:

在外部验证之前开发的risperidone和9-OH-risperidone的popPK模型.
重新评估瑞斯佩里及其活性代谢物的治疗窗口.
评估该模型在治疗药物监测 (TDM) 中的有用性.

主要方法:

使用非线性混合效应建模来对popPK模型进行外部验证.
使用接收器操作曲线 (ROC) 分析以确定治疗窗口.
分析了德国治疗药物监测 (TDM) 服务和TDM- VIGIL研究的数据.

主要成果:

人口预测显示度低于预测,但个体预测是准确的.
在ROC分析中,治疗窗口为5. 0- 8. 0ng/ ml.
popPK模型证明适用于TDM应用.

结论:

经过验证的popPK模型适用于与RISPERIDONE治疗的自闭症儿童的TDM.
由于有限的最低度数据,建议治疗窗口为3. 5 - 7. 0 ng/ ml.
进一步的研究可能会完善最佳治疗窗口和模型预测.

关键词:

儿童医学药学动力学药物动力学里斯佩里治疗药物监测

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