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目的 建立癫疒间儿童丙戊酸钠的群体药代动力学 (populationpharmacokinetics ,PPK)模型 ,促进个体化用药。方法 检测 10 0例癫疒间 患儿丙戊酸钠的血药质量浓度 ,用USC PACK软件计算丙戊酸钠PPK参数值 ,建立PPK模型 ;据此预测 36例新癫疒间 患儿 (指未参与PPK模型建立的 )的血药质量浓度 ;将预测值与观测值做配对t检验 ;计算不同预测误差百分比的符合率及其 95 %可信区间 ,判断预测的准确程度 ,验证PPK模型。结果 PPK参数值 :消除速率常数为 (0 0 4 38± 0 0 384 ) /h ,选择吸收速率常数为 (2 5 2 2± 2 74 3) /h ,表观分布容积对体重的斜率为 (0 32 9± 0 4 96 )L/kg。预测值与观测值的配对 t检验没有统计学差异 (P =0 99) ;预测的误差百分比分别为 5 %、10 %、15 %、2 0 %、2 5 %、30 %的符合率分别为 74 %、84 %、89%、92 %、93%、95 %。结论 用USC PACK软件成功建立中国癫疒间儿童丙戊酸钠的PPK模型 ,准确预测丙戊酸钠稳态血药质量浓度 ,为获取个体药代动力学参数 ,设计个体化用药方案 ,提供了新途径。
Objective To establish population pharmacokinetic (PPK) model of epirubicin in children with epilepsy and to promote individualized medication. Methods The plasma concentrations of sodium valproate in children with epilepsy were detected by USC PACK software. The PPK parameters were calculated and the PPK model was established. According to the results, 36 children with new epilepsy PPK model). The paired t-test was performed between the predictive value and the observed value. The coincidence rate and 95% confidence interval of the different forecasting error percentages were calculated to determine the accuracy of the prediction and verify the PPK model. Results PPK parameters: the elimination rate constant was (0 0 4 38 ± 0 0 384) / h, the selective absorption rate constant was (2 5 2 2 ± 2 74 3) / h and the apparent distribution volume to body weight was ( 0 32 9 ± 0 4 96) L / kg. There was no significant difference between the predicted and observed paired t-test (P = 0 99). The coincidence rates of 5%, 10%, 15%, 20%, 25% and 30% were 74%, 84%, 89%, 92%, 93%, 95%. Conclusion The PPK model of sodium valproate in children with epilepsy in China was successfully established by USC PACK software and the steady-state plasma drug concentration of sodium valproate was accurately predicted. In order to obtain individual pharmacokinetic parameters, individualized drug regimens were designed and provided New way.