Takahara S, Ichimaru N, Kojima Y, Namba Y, Toki K, Shi Y, Yoshimura K, Matsumiya K, Nonomura N, Okuyama A
Osaka University, Graduate School of Medicine, Faculty of Medicine, Urology Department, Suita, Japan.
Transplant Proc. 2004 Mar;36(2 Suppl):456S-460S. doi: 10.1016/j.transproceed.2004.01.065.
A crossover administration of Neoral and Sandimmune was performed in 43 renal allograft recipients who had been on cyclosporine maintenance therapy for 2 to 19 years posttransplant to investigate the pharmacokinetics of cyclosporine. Although there was no difference in C0 values (trough values) when Neoral and Sandimmune were administered at the same doses, AUC(0-4) and AUC(0-12) values of Neoral were 1.57- and 1.36-fold greater than those of Sandimmune, respectively. For both Neoral and Sandimmune, there was a high correlation between the C2 value and AUC(0-4). The Pearson's product-moment coefficient for the correlation between the C2 value and AUC(0-4) was R=0.91642. On the other hand, the correlation with the C0 value (trough value) was low (R=0.53181). During the period of the study, there was no acute rejection episode, onset of adverse drug reaction symptoms, or marked change in laboratory test values.
对43名肾移植受者进行了新山地明（Neoral）和环孢素（Sandimmune）的交叉给药，这些受者在移植后接受环孢素维持治疗2至19年，以研究环孢素的药代动力学。尽管新山地明和环孢素以相同剂量给药时C0值（谷值）无差异，但新山地明的AUC(0-4)和AUC(0-12)值分别比环孢素高1.57倍和1.36倍。对于新山地明和环孢素，C2值与AUC(0-4)之间均存在高度相关性。C2值与AUC(0-4)之间相关性的Pearson积矩系数为R=0.91642。另一方面，与C0值（谷值）的相关性较低（R=0.53181）。在研究期间，未发生急性排斥反应、药物不良反应症状发作或实验室检查值的明显变化。
