郭晴, 刘滔滔, 经力, 庞惠媚, 农光民, 唐双意, 陈峋. 中国儿童万古霉素群体药代动力学模型的外部验证与分析J. 药学学报, 2019,54(3): 528-532. doi: 10.16438/j.0513-4870.2018-0853
引用本文: 郭晴, 刘滔滔, 经力, 庞惠媚, 农光民, 唐双意, 陈峋. 中国儿童万古霉素群体药代动力学模型的外部验证与分析J. 药学学报, 2019,54(3): 528-532. doi: 10.16438/j.0513-4870.2018-0853
GUO Qing, LIU Tao-tao, JING Li, PANG Hui-mei, NONG Guang-min, TANG Shuang-yi, CHEN Xun. Predictive performance and analysis of a vancomycin population pharmacokinetic model in Chinese pediatric patientsJ. Acta Pharmaceutica Sinica, 2019,54(3): 528-532. doi: 10.16438/j.0513-4870.2018-0853
Citation: GUO Qing, LIU Tao-tao, JING Li, PANG Hui-mei, NONG Guang-min, TANG Shuang-yi, CHEN Xun. Predictive performance and analysis of a vancomycin population pharmacokinetic model in Chinese pediatric patientsJ. Acta Pharmaceutica Sinica, 2019,54(3): 528-532. doi: 10.16438/j.0513-4870.2018-0853

中国儿童万古霉素群体药代动力学模型的外部验证与分析

Predictive performance and analysis of a vancomycin population pharmacokinetic model in Chinese pediatric patients

  • 摘要: 本文旨在外部验证前期建立的0~10岁中国儿童万古霉素群体药动学(population pharmacokinetics,PPK)模型。本研究经广西医科大学第一附属医院伦理委员会批准,通过回顾性收集2013年8月至2017年5月期间在广西医科大学第一附属医院静脉应用万古霉素治疗的≤ 10岁的患者,根据前期建立的儿童万古霉素PPK模型,运用贝叶斯分析法求出给定剂量下的万古霉素浓度个体预测值,与实测值比较,评估模型的预测性能。结果共纳入191例患者371个血药浓度值。万古霉素个体预测值与实测值的平均预测误差(ME)、平均相对预测误差(ME%)、平均绝对误差(MAE)和均方根误差(RMSE)分别为-0.50 mg·L-1、6.03%、1.84 mg·L-1和2.86 mg·L-1;个体预测值与实测值的相关系数为0.95;相对预测误差在±30%以内的血药浓度值约占82.75%;拟合优度(goodness-of-fit)、直观预测检验法(VPC)和Bland-Altman一致性评价显示最终模型稳定,预测结果可靠。结果表明前期建立的0~10岁儿童万古霉素PPK模型具有较高的预测性能,可用于万古霉素初始治疗方案的制定和药物暴露程度的预测。

     

    Abstract: This study aimed to evaluate the predictive performance of a vancomycin population pharmacokinetic model in 0-10 year Chinese pediatric patients. This study was approved by the Ethics Research Committee of the First Affiliated Hospital of Guangxi Medical University, data from hospitalized children ≤ 10 years of age who receiving vancomycin were collected retrospectively. Individual predictive values (IPRED) were estimated by Bayesian Analysis based on a previous published population pharmacokinetic model, and compared with the observed steady state trough concentration. As results, a total of 371 vancomycin serum concentrations from 191 patients were taken for the external validation. The mean error (ME), the mean relative prediction error (ME%), the mean absolute error (MAE) and the root mean square error (RMSE) in individual prediction method for the total patients were -0.50 mg·L-1, 6.03%, 1.84 mg·L-1, 2.86 mg·L-1 respectively. The correlation coefficient between individual predictions and detection values was 0.95. The stability and the predictive performance of model were accepted by goodness-of-fit, visual predictive check (VPC) and Bland-Altman. The percentage of individual prediction error within ±30% was 82.75%. The above results suggest that, this Chinese pediatric population pharmacokinetic model in 0-10 years old has a good prediction performance. It can be applied to the design of initial treatment plan and predicting the extent of drug exposure.

     

/

返回文章
返回