Limited Sampling Strategy for Mycophenolic Acid in Chinese Kidney Transplant Recipients Receiving Enteric-Coated Mycophenolate Sodium and Tacrolimus During the Early Posttransplantation Phase

作者：Yao, Xi; Huang, Hongfeng; Wei, Chunchun; Chen, Ying; Peng, Wenhan; Xie, Wenqing; Chen, Jianghua^*

来源：Therapeutic Drug Monitoring, 2015, 37(4): 516-523.

DOI：10.1097/FTD.0000000000000170

• UNDER-THE-CURVE
• RENAL-ALLOGRAFT RECIPIENTS
• CONCENTRATION-TIME CURVE
• POPULATION PHARMACOKINETICS
• CLINICAL PHARMACOKINETICS
• CALCINEURIN INHIBITOR
• PLASMA-CONCENTRATION
• EMIT IMMUNOASSAY
• AFRICAN-AMERICAN
• DOUBLE-BLIND

Background: @@@ Mycophenolic acid (MPA), a potent immunosuppressant, is widely used in solid organ transplantations. This study aimed to investigate the pharmacokinetics of enteric-coated mycophenolate sodium (EC-MPS) in Chinese adult renal allograft recipients and to generate optimal model equations for estimation of the MPA area under the concentration-time curve from 0 to 12 hours (AUC(0-12 h)), using a limited sampling strategy (LSS). @@@ Methods: @@@ Serial blood samples were collected over 12 hours from 38 recipients of a primary living-related donor kidney graft treated with EC-MPS, tacrolimus, and corticosteroid. MPA concentrations were evaluated using an enzyme-multiplied immunoassay technique. The LSSs were developed and validated by multiple regression analysis using a 2-group method (test group, n = 19; validation group, n = 19). @@@ Results: @@@ The best algorithms obtained from the test group were the following: 15.09 + 1.05 x C-1.5 + 1.8 x C-4 + 4.18 x C-6 (for 3 time points, r(2) = 0.902) and 10.44 + 0.7 x C-1 + 1.22 x C-2 + 1.75 x C-4 + 4.36 x C-6 (for 4 time points, r(2) = 0.941). When these algorithms were tested in the validation group, there were no significant differences in prediction errors. @@@ Conclusions: @@@ LSSs using time points of 1.5, 4, and 6 hours or 1, 2, 4, and 6 hours after dose provide effective and reliable estimations of the MPA AUC(0-12 h) in Chinese renal allograft recipients treated concomitantly with EC-MPS and tacrolimus during the early posttransplantation phase.

• 出版日期2015-8
• 单位浙江大学