中国临床药理学杂志2012,Vol.28Issue(9):677-679,3.
比伐卢定在中国健康人群的药代动力学/药效学模型研究
PK/PD model of bivalirudin injection in Chinese healthy population
柴栋 1王睿 2白楠 3蔡芸 3梁蓓蓓2
作者信息
- 1. 解放军总医院海南分院药剂科,海南三亚572013
- 2. 解放军总医院药品保障中心,北京100853
- 3. 解放军总医院药物临床试验中心,北京100853
- 折叠
摘要
Abstract
Objective To establish the PK/PD model of bivalirudin in-jection in Chinese healthy population. Methods Thirty - six Chinese healthy volunteer were selected and enrolled in 3 groups randomly. Each group was administrated bivalirudin by 0. 50,0. 75,1. 05 mg · kg'iv bo-lus once respectively. Plasma drug concentration and activated clotting time (ACT) were measured at different time ,and then PK/PD model of bivalirudin was established by WinNonlin program. Results According to the stimulating of the bivalirudin compartment model, the value of AIC is minimum in the two - compartment model. The pharmacodynamic model fit the M - M equation model. The parameters of the PK/PD model are as follows: Vc = 0. 12, k10 = 3. 54, k12 = 0. 75 , k2l = 1. 44, Eo = 126. 87, Emax =340. 03, EC50 =4258. 03. All the model value lies in the 95% confidence interval. Conclusion The developed PK/PD model of bivalirudin can predict the clinical effect accurately in Chinese.关键词
比伐卢定/药代动力学/药效学模型Key words
bivalirudin/ PK/PD model分类
医药卫生引用本文复制引用
柴栋,王睿,白楠,蔡芸,梁蓓蓓..比伐卢定在中国健康人群的药代动力学/药效学模型研究[J].中国临床药理学杂志,2012,28(9):677-679,3.