抄録
【Objective】The purpose of this study was to evaluate pharmacokinetic (Pk) profile of newly developed modified release tacrolimus (MR-TAC) in pediatric kidney transplant recipients.
【Methods】According to our current immunosuppressive protocol, tacrolimus (TAC) was initially given and converted to MR-TAC in 13 pediatric patients who received kidney transplantation from April 2010 to April 2011. The switch dose ratio was 1:1, and the 24hour full Pk study was assessed before and after the conversion from TAC to MR-TAC.
【Results】The mean total daily dose at baseline upon enrollment was 5.4±3.3 mg. There was no significant correlation between the oral dose and the trough concentration (C0) of TAC/MR-TAC. The consecutive Pk studies revealed no significant difference in the mean time to maximum concentration (Tmax) / maximum concentration (Cmax) and the area under the time-concentration curve (AUC0-24) of both reagents; the mean C0 of MR-TAC was 18% lower than those of TAC. A better correlation between AUC0-24 and C0 was observed in MR-TAC compared to that in TAC (r2＝0.912, for MR-TAC; r2＞0.555, for TAC).
【Conclusion】In the conversion from TAC to MR-TAC, AUC0-24 was equivalent despite the 18% reduction of C0, even in the pediatric kidney transplant recipients. The trough concentration might be an excellent predictor in the therapeutic drug monitoring of MR-TAC because of its better correlation of C0 and AUC0-24.
