静脉注射免疫球蛋白在治疗各种免疫系统疾病的患者中的人口药理动力学模型
Jian Lynn Lee1, Noraida Mohamed Shah2, Mohd Makmor-Bakry3
1Centre for Quality Management of Medicines, Faculty of Pharmacy, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia; Department of Pharmacy, Hospital Tunku Azizah, Ministry of Health Malaysia, Kuala Lumpur, Malaysia.
体重会影响静脉注射免疫球蛋白 (IVIG) 的剂量,但Fc受体基因变异不会. 疾病类型显著影响IVIG分布,建议针对免疫疾病量身定制剂量.
科学领域:
- 药理学 药理学是指药理学的学科.
- 免疫学 免疫学 免疫学
- 临床药房 临床药房
背景情况:
- 静脉注射免疫球蛋白 (IVIG) 对于治疗免疫系统疾病至关重要.
- 了解影响IVIG处置的因素对于优化治疗至关重要.
- 遗传和临床因素对IVIG药理动学的影响需要进一步研究.
研究的目的:
- 为了估计IVIG的种群药动力学参数.
- 评估FCGRT基因多态化对IVIG药理动学的影响.
- 评估临床变异性对免疫障碍患者IVIG倾向的影响.
主要方法:
- 使用非线性混合效应建模 (Monolix) 进行人口药理动力学分析.
- 包括重量,疾病类型和FCGRT基因型等共变量.
- 通过合适度图和预测检查进行模型评估.
主要成果:
- 一个具有线性消除的2个分区模型最好地描述了IVIG度.
- 体重是分布量 (中央和外围) 和中央清除量的重要共变量.
- 疾病类型显著影响了外周分布量 (Vp);FCGRT基因型没有影响IVIG的药理动力学.
结论:
- 目前基于体重的IVIG剂量得到支持.
- 疾病类型显著影响IVIG外周分布 (Vp),可能是由于炎症.
- 炎症和自身免疫性疾病可能会改变组织透性,影响IVIG保留.
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