山东医药Issue(18):10-13,4.DOI:10.3969/j.issn.1002-266X.2015.18.004
霉酚酸钠肠溶片用于国人肾移植受者的药代动力学监测
Pharmacokinetics monitoring of EC-MPS in Chinese renal allograft recipients
摘要
Abstract
Objective To observe the pharmacokinetics features of mycophenolic acid ( MPA) in Chinese renal al-lograft recipients who took Myfortic ( EC-MPS) and to establish a calculation for the abbreviated MPA area under the curve (AUC) of plasma concentration and time .Methods Thirty renal-transplant recipients were treated with EC-MPS (1.44 g/d) in combination with cyclosporine ( CsA) and prednisone ( Pred) .Plasma MPA concentrations were determined by E-MIT method at pre-medication, 0.5, 1, 1.5, 2, 4, 6, 8, 10 and 12 hours (C0.5,C1,C1.5,C2,C4,C6,C8,C10 and C12) af-ter oral administration .The MPA AUC0-12 h were calculated by using the trapezoidal rule and the abbreviated MPA AUC model equation fitted to 30 MPA AUC0-12 h profiles was generated by the multiple regression analysis .Results The phar-macokinetics of EC-MPS in 30 renal-transplant recipients manifested great inter-patient difference . The mean MPA AUC0-12 h was (47.64 ±25.14) mg· h/L.We selected C1.5, and C2 at two different time points and C2, C4, C6 and C8 at four different time points.Then, the abbreviated MPA AUC model equations were recommended:AUC=27.41+0.87 ×C1.5 +0.88 ×C2(r2 =0.67), or AUC=3.98+2.03 ×C2 +2.18 ×C4 +1.91 ×C6 +5.08 ×C8(r2 =0.86);the abso-lute prediction error was (28.8 ±24.8)%and (12.8 ±10.1)%, respectively.In 30 recipients, the absolute prediction error between estimated MPA AUC and full MPAAUC 0-12 h was within ±15%.Conclusions EC-MPS pharmacokinetics in Chinese renal allograft recipients manifests a substantial inter-individual variability .We get the MPA AUC simplified calcu-lation formula, which needs less sampling point and has good predictive effect .关键词
肾移植/霉酚酸/药代动力学/中国人Key words
kidney transplantation/mycophenolic acid/pharmacokinetics/Chinese分类
医药卫生引用本文复制引用
师天明,杨洋,周佩军,徐达,王祥慧,邵琨..霉酚酸钠肠溶片用于国人肾移植受者的药代动力学监测[J].山东医药,2015,(18):10-13,4.基金项目
卫生部国际交流与合作中心2012年度器官移植科研项目( IHECC08-201212)。 ()