A Limited Sampling Strategy to Estimate the Area Under the Concentration-Time Curve of Tacrolimus Modified-release Once-daily Preparation in Renal Transplant Recipients
A Limited Sampling Strategy to Estimate the Area Under the Concentration-Time Curve of Tacrolimus Modified-release Once-daily Preparation in Renal Transplant Recipients
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DOI：
10.1097/ftd.0b013e31827efe37
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发表时间：
2013-04
影响因子：
2.5
通讯作者：
T. Niioka;M. Miura;H. Kagaya;M. Saito*;K. Numakura;T. Habuchi;S. Satoh
中科院分区：
文献类型：
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作者：
T. Niioka;M. Miura;H. Kagaya;M. Saito*;K. Numakura;T. Habuchi;S. Satoh
目的：本研究的目的是开发一种有限的采样策略，以估计日本肾移植患者中他克莫司（Advagraf，日本商品名Graceptor）每日一次缓释制剂的浓度-时间曲线下面积（AUC）。方法：43例患者中，23例患者继续服用Graceptor 1年。将43名患者在第28天和第365天的总共66个曲线随机分为训练组（N = 33）和验证组（N = 33），没有任何重叠。结果：使用单个C12 h时间点的AUC 0 -24预测公式与观察到的AUC 0 -24相关性最高（r2 = 0.9057）。当采用2个采样时间点时，C 0 h-C12 h为估算AUC 0 -24的最佳时间点（AUC 0 -24 = 26.8 + 8.0C0h + 17.8C12h，r2 = 0.9221，P < 0.0001）。C 0 h-C12 h组合的预测公式在CYP 3A 5基因型间的预测误差无显著性差异。使用C 0 h-C12 h的预测公式的%平均预测误差、%平均绝对误差和%均方根预测误差分别为0.1%、7.6%和8.8%。结论：在医院环境中，使用C 0 h-C12 h的有限采样策略适用于估计他克莫司每日一次的AUC 0 -24。
Objectives: The aim of this study was to develop a limited sampling strategy to estimate the area under the concentration-time curve (AUC) of a modified-release, once-daily formulation of tacrolimus (Advagraf, Japanese trade name Graceptor) with Japanese renal transplant patients. Methods: Among the 43 enrolled patients, 23 patients continued to take Graceptor for 1 year. A total of 66 profiles on day 28 and day 365 from the 43 patients were randomly divided into a training group (N = 33) and a validation group (N = 33) without any overlap. Results: The prediction formula for the AUC0–24 using the single C12h time point gave the highest correlation with the observed AUC0–24 (r2 = 0.9057). When 2 sampling times were used, C0h–C12h were the best time points for the estimation of the AUC0–24 (AUC0–24 = 26.8 + 8.0C0h + 17.8C12h, r2 = 0.9221, P < 0.0001). There was no significant difference in the prediction error for the prediction formulas with the C0h–C12h combination between CYP3A5 genotypes. The % mean prediction error, % mean absolute error, and % root mean squared prediction error of the prediction formula using C0h–C12h were 0.1%, 7.6%, and 8.8%, respectively. Conclusions: In a hospital setting, a limited sampling strategy using C0h–C12h would be applicable to estimating the AUC0–24 of tacrolimus once daily.