五水头孢唑林钠群体药代动力学研究

发布时间：2018-11-22 14:26

【摘要】：目的研究注射用五水头孢唑林钠在感染患者中的群体药代动力学(PPK)。方法 PPK研究在感染患者或者需要手术前预防感染的患者中进行,采集每个患者在静脉滴注五水头孢唑林钠2 g后0~48 h内的4~5个血样,用液相色谱法测定血药浓度,以非线性混合效应模型(NONMEN)程序建立并验证五水头孢唑林钠的群体药代动力学模型。结果根据文献资料及所测定血药浓度数据建立二室PPK模型,五水头孢唑啉钠清除率(CL)、中央室分布容积(V1)及外周室分布容积(V2)分别为3.24 L·h~(-1)、10.78 L、8.62 L,患者体重对CL具有显著影响,性别、年龄和给药剂量均不影响其药代动力学参数。结论用NONMEM软件拟合建立的五水头孢唑林钠PPK模型是稳定、有效的,可用于感染患者个体化药代动力学参数估算。
[Abstract]:Objective to study the pharmacokinetic (PPK). Of cefazolin sodium pentahydrate for injection in infected patients. Methods the PPK study was carried out in the infected patients or patients who needed to prevent infection before operation. The blood samples of each patient were collected within 48 hours after intravenous drip of cefazolin pentahydrate sodium 2 g. The blood concentration of cefazolin pentahydrate was determined by liquid chromatography. The population pharmacokinetic model of cefazolin sodium pentahydrate was established and verified by (NONMEN) program. Results the two-compartment PPK model was established according to the literature data and the measured blood concentration data. The (CL), central ventricular distribution volume (V1) and the peripheral ventricular distribution volume (V2) were 3.24 L h-1, respectively, the clearance rates of cefazolin sodium pentahydrate were 3.24 L / h ~ (-1). The weight of the patients had a significant effect on CL, and gender, age and dosage had no effect on the pharmacokinetic parameters. Conclusion the PPK model of cefazolin sodium pentahydrate fitted by NONMEM software is stable and effective and can be used to estimate the individual pharmacokinetic parameters of infected patients.
【作者单位】：北京大学第一医院医学统计室;清华大学附属北京清华长庚医院普通内科;中国医科大学附属第一医院药学部;中国医科大学附属盛京医院肾内科;南方医科大学南方医院药物临床试验中心;
【分类号】：R969.1

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