在儿科炎性肠病中使用infliximab:对人口药动力学模型的外部评估
Omnia Salah Heikal1, Patrick F van Rheenen2, Daan J Touw1,3
1Department of Clinical Pharmacy and Pharmacology, University Medical Centre Groningen and University of Groningen, Groningen, The Netherlands.
在儿科炎性肠病 (IBD) 中评估因弗利西马布 (IFX) 种群药动力学模型至关重要. 范德·卡斯蒂尔模型显示了诱导的希望,但在维护IFX水平方面遇到了困难.
科学领域:
- 药理动力学和药理动力学
- 儿科胃肠病学 儿科胃肠病学
- 药物的有效性和安全性.
背景情况:
- 伊弗利西马布 (IFX) 改善了儿科炎性肠病 (IBD) 的结果.
- 很大一部分患者要么没有对IFX的反应,要么随着时间的推移失去反应.
- 种群药动力学 (PopPK) 建模为IFX剂量优化提供了一条途径,需要严格的模型评估.
研究的目的:
- 在一组儿科IBD患者中验证现有的IFX PopPK模型的预测性能.
- 进行贝叶斯估计,以确定最适合用于预测后续IFX度的模型.
- 评估IFX PopPK模型对优化IBD儿童治疗的实用性.
主要方法:
- 在PubMed的系统搜索中,发现了9个针对儿童的IFX PopPK模型.
- 模型被重建并使用R进行分析,通过适合性图表,余量,预测错误和视觉预测检查来评估性能.
- 使用了73名儿科IBD患者和340个IFX测量的验证队列.
主要成果:
- 范德·卡斯蒂尔和其他人. 模型在初始评估中表现出优异的表现,个人预测偏差为2.13%,人口预测偏差为-6.11%.
- 贝叶斯估计显示,该模型预测了诱导低谷水平,平均误差为12.95%.
- 然而,该模型在预测维护度时显示出 -69%的实质性中位数误差.
结论:
- 范德·卡斯蒂尔和其他人. 该模型显示,预测儿科IBD患者的infliximab水平初步有希望.
- 它在估计维持度时的高误差限制了其实际应用.
- 该模型目前最适合仅用于预测诱导水平.
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