Predictive performance of JPKD software on carbamazepine steady-state trough concentration
Objective To estimate the predictive performance of the population pharmacokinetics software JPKD on predicting the vancomycin steady-state trough concentration,and and to analyze its influencing factors.Methods The information of inpatients who were treated with CBZ from January 2017 to December 2022 and admitted therapeutic drug monitoring(TDM)at the same time were collected.Based on the JPKD software,the initial dosage regimen of CBZ is determined and the steady-state trough concentration is predicted or adjusted.The weight residual(WRES)between the predicted steady-state trough concentration(Cpre)and the measured steady-state trough concentration(Creal)was used to evaluate the ability of the JPKD software for predicting the CBZ steady-state trough concentration.The TDM results of initial regimen were divided into accurate prediction group(WRES＜20%)and the inaccurate prediction group(WRES≥20%)according to the WRES value.Patient characteristics including age,gender,weight,carbamazepine therapy,other concomitant medications therapy and TDM results were collected from electronic medical records.The difference analysis method was adopted to compare the differences between the two groups of variables and multivariate Logistic regression analysis was used to screen the related factors that influence the predictive performance of JPKD software.Results A total of 170 patients were enrolled,and 209 steady-state trough concentrations of CBZ were collected,including 170 concentrations of initial regimen and 39 concentrations of adjustment regimen.Compared with the initial regimen,the WRES of adjusted regimen was significantly reduced[10.48%(9.01%,15.85%)vs.15.55%(12.15%,20.56%),P＜0.01],and the proportion of WRES＜20%increased significantly[84.62%(33/39)vs.57.65%(98/170),P＜0.01].These results indicated that JPKD software had a better accuracy prediction for steady-state trough concentration of the adjusted regimen than the initial regimen.There were 98 concentrations in the accurate prediction group and 72 in the inaccurate prediction group.Correlation analysis showed that the prediction accuracy of the group with and without clonazepam was 1.02%and 98.98%,respectively.There was a statistical difference in the prediction accuracy between the two groups(the difference was 0.98,and 95%CI was 0.78～1.17,P＜0.05).Multivariate Logistic regression analysis indicated that clonazepam(OR=9.17,95%CI 1.04～80.78,P=0.046)were independent risk factors for inaccurate prediction of JPKD software.Conclusion JPKD software had a better predictive performance for the CBZ steady-state trough concentrations of adjustment regimen than initial regimen.JPKD software had a poor predictive performance while the patient was given clonazepam.
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