Estimation model for the exposure of mycophenolic acid in early renal transplant recipients
- VernacularTitle:肾移植受者早期霉酚酸暴露量估算模型研究
- Author:
Hanjuan ZHANG
1
;
Jianqiang DING
2
;
Wenchao HAN
1
;
Yongyan CHEN
1
;
Gaobiao WANG
1
;
Rui DING
1
;
Dongdong YUAN
1
Author Information
1. Dept. of Pharmacy，Zhengzhou No.7 People’s Hospital，Zhengzhou 450016，China
2. Dept. of Pharmacy，Henan General Hospital of Armed Police，Zhengzhou 450052，China
- Publication Type:Journal Article
- Keywords:
mycophenolic acid;
exposure;
renal transplantation;
pharmacokinetics;
limited sampling strategy;
estimation model
- From:
China Pharmacy
2023;34(20):2530-2534
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To establish the estimation model for the exposure of mycophenolic acid （MPA） in early renal transplant recipients [calculated by the area under the plasma concentration-time curve with 12 h （AUC0－12 h）]. METHODS Twenty kidney transplant recipients， who received triple immunosuppressive therapy of mycophenolate mofetil （MMF）+tacrolimus+ methylprednisolone， were selected and given MMF dispersible tablets （750 mg， q12 h） on the 15th day after the operation； the blood samples were collected from the patients before and 0.5， 1.0， 1.5， 2.0， 3.0， 4.0， 6.0， 8.0， 12.0 hours after the administration， respectively. The blood concentration of MPA was determined， and the pharmacokinetic parameters of MPA were calculated. The multivariate linear stepwise regression analysis method was used to fit an estimation formula for the finite sampling method suitable for MPA-AUC0－12 h of the recipients. Bland-Altman analysis was used to evaluate the agreement between the estimation formula and the classical pharmacokinetic method. RESULTS The main pharmacokinetic parameters of MPA in 20 renal transplant recipients： c0 was （1.53±0.84） μg/mL， cmax was （12.07±5.97） μg/mL， t1/2 was （5.41±3.67） h， tmax was （1.58±0.75） h， and the average AUC0－12 h calculated by the classical pharmacokinetic method was （33.95±13.40） μg·h/mL. MPA-AUC0－12 h was estimated with sampling points of “4.0， 8.0， 12.0 h”； the simplified calculation formula was AUC0－12 h＝12.058+2.819c4.0+7.045c8.0+ 3.879c12.0 （R 2＝0.934）. The predicted value had a good correlation and consistency with the measured value， and 95.0% of predicted values did not exceed the x±1.96SD （standard deviation） range. CONCLUSIONS The estimation model is established successfully for the exposure of MPA in early renal transplant recipients； the model has better prediction accuracy and fewer sampling points.
