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.
ABSTRACT
BACKGROUND: The performance of a target controlled infusion (TCI) system needs to be confirmed in a clinical setting. Aquafol(TM), a microemulsion propofol, can be used for TCI with its pharmacokinetic parameters. The aim of this study is to evaluate the predictive performance of Aquafol(TM) TCI by using a PION TCI(R) pump incorporating the previously established pharmacokinetic parameters and ke0. METHODS: Thirty adult patients were enrolled in the study. General anesthesia was maintained with TCI of Aquafol(TM) and remifentanil using a PION TCI(R) pump. During the maintenance of anesthesia with a constant target effect-site concentration of propofol for at least for 20 minutes, blood was drawn and the propofol plasma concentration was measured. The predictive performance of Aquafol(TM) TCI was evaluated by determining the median performance error (MDPE), median absolute performance error (MDAPE), divergence, and wobble from the intra-individual and pooled performance errors. The acceptability of the TCI system was determined based on the pooled predictive performance. RESULTS: A total of 153 propofol blood samples were analyzed. The estimates of pooled MDPE, MDAPE, divergence and wobble were 8.59% (1.61), 19.1% (1.12), -1.12%/h and 9.87% (1.01), respectively. The MDAPE indicating the accuracy of the TCI infusion system was within the clinically acceptable range (< 20-30%) and the bias (MDPE) was also acceptable (< 10-20%). CONCLUSIONS: The performance of Aquafol(TM) TCI using a PION TCI(R) pump was acceptable for the clinical use.