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目的:应用非线性混合效应模型计算国人老年心衰患者口服地高辛(digxion)群体药动学参数,以促进个体化给药。方法:采用荧光偏振免疫法(FPIA)测定84例老年患者120例次地高辛的血清浓度并收集相关临床指标,运用NONMEM软件建立群体药动学模型。结果:地高辛的药动学符合一室线性开放模型,固定效应参数中,体质量、剂量、血肌酐及尿素氮对参数有影响。最终回归模型中地高辛血药浓度估算值与实测浓度间线性关系良好。结论:用群体药动学模型分析常规监测数据可为老年患者个体化给药提供依据。
OBJECTIVE: To calculate the pharmacokinetic parameters of oral digoxin in elderly patients with heart failure by using the non-linear mixed-effects model to promote individualized administration. Methods: Serum concentrations of 120 cases of digoxin in 84 elderly patients were measured by fluorescence polarization immunoassay (FPIA). Relevant clinical indexes were collected. Population pharmacokinetic model was established by NONMEM software. RESULTS: The pharmacokinetics of digoxin was in line with the linear model of one-compartment open-label. In the fixed effect parameters, body weight, dose, serum creatinine and urea nitrogen had influence on the parameters. The linear regression between the estimated concentration of digoxin in the final regression model and the measured concentration was good. CONCLUSIONS: The analysis of routine monitoring data using population pharmacokinetic models may provide evidence for individualized drug delivery in elderly patients.