在接受肝脏或肾脏移植的儿童和青少年中，使用普乐可复（Prograf®）和新普乐可复（Advagraf®）后预测他克莫司暴露量（AUC0-24）的有限采样策略
Limited sampling strategies for tacrolimus exposure (AUC0-24) prediction after Prograf(®) and Advagraf(®) administration in children and adolescents with liver or kidney transplants.
作者信息
Almeida-Paulo Gonzalo N, Lubomirov Rubin, Alonso-Sanchez Nazareth Laura, Espinosa-Román Laura, Fernández Camblor Carlota, Díaz Carmen, Muñoz Bartola Gema, Carcas-Sansuán Antonio J
机构信息
Department of Pharmacology, School of Medicine, Autonomous University of Madrid, Madrid, Spain.
出版信息
Transpl Int. 2014 Sep;27(9):939-48. doi: 10.1111/tri.12362. Epub 2014 Jun 24.
To develop limited sampling strategies (LSSs) to predict total tacrolimus exposure (AUC0-24 ) after the administration of Advagraf(®) and Prograf(®) (Astellas Pharma S.A, Madrid, Spain) to pediatric patients with stable liver or kidney transplants. Forty-one pharmacokinetic profiles were obtained after Prograf(®) and Advagraf(®) administration. LSSs predicting AUC0-24 were developed by linear regression using three extraction time points. Selection of the most accurate LSS was made based on the r(2) , mean error, and mean absolute error. All selected LSSs had higher correlation with AUC0-24 than the correlation found between C0 and AUC0-24 . Best LSS for Prograf(®) in liver transplants was C0_1.5_4 (r(2) = 0.939) and for kidney transplants C0_1_3 (r(2) = 0.925). For Advagraf(®) , the best LSS in liver transplants was C0_1_2.5 (r(2) = 0.938) and for kidney transplants was C0_0.5_4 (r(2) = 0.931). Excluding transplant type variable, the best LSS for Prograf(®) is C0-1-3 (r(2) = 0.920) and the best LSS for Advagraf(®) was C0_0.5_4 (r(2) = 0.926). Considering transplant type irrespective of the formulation used, the best LSS for liver transplants was C0_2_3 (r(2) = 0.913) and for kidney transplants was C0_0.5_4 (r(2) = 0.898). Best LSS, considering all data together, was C0_1_4 (r(2) = 0.898). We developed several LSSs to predict AUC0-24 for tacrolimus in children and adolescents with kidney or liver transplants after Prograf(®) and/or Advagraf(®) treatment.
为制定有限采样策略（LSS），以预测在向肝或肾移植稳定的儿科患者施用安斯泰来（Advagraf®）和普乐可复（Prograf®）（西班牙马德里安斯泰来制药公司）后他克莫司的总暴露量（AUC0 - 24）。在施用普乐可复（Prograf®）和安斯泰来（Advagraf®）后获得了41个药代动力学曲线。通过使用三个采血时间点进行线性回归来制定预测AUC0 - 24的LSS。基于r(2)、平均误差和平均绝对误差来选择最准确的LSS。所有选定的LSS与AUC0 - 24的相关性均高于C0与AUC0 - 24之间的相关性。肝移植中普乐可复（Prograf®）的最佳LSS是C0_1.5_4（r(2) = 0.939），肾移植的最佳LSS是C0_1_3（r(2) = 0.925）。对于安斯泰来（Advagraf®），肝移植的最佳LSS是C0_1_2.5（r(2) = 0.938），肾移植的最佳LSS是C0_0.5_4（r(2) = 0.931）。排除移植类型变量后，普乐可复（Prograf®）的最佳LSS是C0 - 1 - 3（r(2) = 0.920），安斯泰来（Advagraf®）的最佳LSS是C0_0.5_4（r(2) = 0.926）。不考虑使用的制剂，考虑移植类型时，肝移植的最佳LSS是C0_2_3（r(2) = 0.913），肾移植的最佳LSS是C0_0.5_4（r(2) = 0.898）。综合所有数据，最佳LSS是C0_1_4（r(2) = 0.898）。我们制定了几种LSS，以预测在接受普乐可复（Prograf®）和/或安斯泰来（Advagraf®）治疗的肾或肝移植儿童及青少年中他克莫司的AUC0 - 24。
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