中华医学杂志（英文版）2012，Vol.125Issue(23)：4226-4232,7.DOI:10.3760/cma.j.issn.0366-6999.2012.23.012
Pharmacokinetics of enteric-coated mycophenolate sodium in Chinese renal transplantation recipients
Pharmacokinetics of enteric-coated mycophenolate sodium in Chinese renal transplantation recipients
QIU Kui 1YIN Hang 2TIAN Hui 2WANG Wei 2HU Xiao-peng 2LI Xiao-bei 2GONG Li-li 1LUO Wei 1LIU Li-hong 1ZHANG Xiao-dong2
作者信息
- 1. Department of Pharmacology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing 100020,China
- 2. Kidney Transplantation Program, Department of Urology Beijing Chao-Yang Hospital, Capital Medical University, Beijing 100020,China
- 折叠
摘要
Abstract
Background Mycophenolic acid (MPA) as an anti-proliferative immune-suppressive agent is used in the majority of immunosuppressive regimens in solid organ transplantation.This study aimed to investigate the pharmacokinetic (PK)characteristics of enteric-coated mycophenolate sodium (EC-MPS) and area under the curve (AUC) from 0 to 12 hours with limited sampling strategies (LSSs) in Chinese renal transplant recipients.Methods This study was conducted in 10 Chinese renal transplant patients receiving living donor and treated with EC-MPS,cyclosporine,and corticosteroids.MPA concentrations were measured by enzyme multiplied immunoassay technique (EMIT).Whole 12-hour PK profiles were obtained on Day 4 after operation.LSSs with jackknife technique,multiple stepwise regression analysis,and Bland-Altman analysis were developed to estimate MPA AUC.Results The mean maximum plasma concentration,the mean time for it to reach peak (Tmax),and the mean MPA AUC were (11.38±2.49) mg/L,(4.85±3.32) hours,and (63.19±13.54) mg.h.L-1,respectively.Among the 10 profiles,MPA AUC of four patients was significantly higher than that of the other six patients,and the corresponding Tmax was significantly longer than that of the other six patients.No patient exhibited a second peak caused by enterohepatic recirculation.The best models were as follows: 27.46+0.94C3+3.24C8+2.81C10 (r2=0.972),which was used to predict AUC of fast metabolizer with a mean prediction error (MPE) of-0.21％ and a mean absolute prediction error (MAE) of 2.59％;36.65+3.08C8+5.30C10-4.04C12 (r2=0.992),which was used to predict AUC of slow metabolizer with a MPE of 0.58％ and a MAE of 1.95％.Conclusions The PKs of EC-MPS had a high variability among Chinese renal transplant recipients.The preliminary PK data indicated the existence of slow and fast metabolizer.These findings may be associated with the enterohepatic recirculation.关键词
enteric-coated mycophenolate sodium/pharmacokinetics/limited sampling strategy/Chinese renal transplant recipientsKey words
enteric-coated mycophenolate sodium/pharmacokinetics/limited sampling strategy/Chinese renal transplant recipients引用本文复制引用
QIU Kui,YIN Hang,TIAN Hui,WANG Wei,HU Xiao-peng,LI Xiao-bei,GONG Li-li,LUO Wei,LIU Li-hong,ZHANG Xiao-dong..Pharmacokinetics of enteric-coated mycophenolate sodium in Chinese renal transplantation recipients[J].中华医学杂志（英文版）,2012,125(23):4226-4232,7.
