延长释放皮尔芬尼的药理动力学在肝硬化 GENESIS 研究中得到了修改
Jorge L Poo1, Juan R Aguilar1, Raul Bernal-Reyes2
1Grupo Mexicano para el Estudio de las Enfermedades Hepáticas, Mexico.
Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie
|October 23, 2023
概括
皮尔芬尼的药理动力学在肝硬化患者中发生变化. 与对照组相比,Child-Pugh A和B组的延长释放皮尔芬尼 (PR-PFD) 暴露显著增加,需要在肝功能障碍时考虑剂量.
科学领域:
- 药理学 药理学是指药理学的学科.
- 肝病学 肝病学是一种肝病学.
- 药物新陈代谢 药物新陈代谢
背景情况:
- 皮尔芬尼 (PFD) 具有抗炎和抗纤维素性质.
- 肝硬化严重影响肝功能储备,可能改变药物的药理动力学.
- 研究了一种新的延长释放型 pirfenidone (PR-PFD) 配方.
研究的目的:
- 评估PR-PFD在肝硬化患者中的药理动力学.
- 评估PR-PFD曲线下的面积 (AUC) 和最大度 (Cmax) 的变化.
- 为了比较PR-PFD肝硬化患者和健康对照组之间的药理动力学.
主要方法:
- 招募了24名肝硬化患者 (Child-Pugh A和B) 和8名健康对照.
- 参与者在禁食条件下接受了1200毫克PR-PFD单次口服剂量.
- 用HPLC-MS/MS.在36小时内测量PFD的血度.
主要成果:
- 与对照组相比,PR-PFD暴露 (AUC) 在Child-Pugh A患者中高3.6倍,在Child-Pugh B患者中高4.4倍.
- 与对照组相比,Child-Pugh B患者的Cmax高出1.6倍,Child-Pugh A患者的Cmax高出1.8倍.
- 在所有参与者中,Pirfenidone的耐受性很好.
结论:
- 在肝硬化患者中,PR-PFD的药理动力学参数发生显著变化.
- 在处方PR-PFD时需要考虑肝功能障碍.
- 肝硬化患者可能需要调整剂量,以确保最佳的治疗结果.
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