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霉酚酸在活体供肝移植中的药代动力学

Pharmacokinetics of mycophenolic acid in living donor liver transplantation.

作者信息

Shin M, Moon J I, Kim J M, Choi G-S, Kwon C H, Kim S-J, Joh J-W, Lee S-K, Lee S-T, Jung H, Lee S-Y

机构信息

Division of Transplantation, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

出版信息

Transplant Proc. 2010 Apr;42(3):846-53. doi: 10.1016/j.transproceed.2010.03.004.

Abstract

PURPOSE

This study sought to define the pharmacokinetics of mycophenolic acid (MPA) in Korean living donor liver transplant recipients.

METHODS

Thirty-two liver transplant recipients (29 males, 3 females) were administered 750 mg mycophenolate mofetil (MMF) twice daily with concomitant tacrolimus. Plasma MPA concentrations were measured by liquid chromatography with tandem mass spectrometry detection assay from samples drawn before dosing (C0) and after dosing at 0.5 hours (C1/2) and 2 hours (C2), providing a total of 114 pharmacokinetic profiles at various periods from 3 days to 6 months posttransplantation (D3, D7, D14, M1, M3, and M6).

RESULTS

The mean area-under-the-curve from 0 to 2 hours (AUC0-2) was 30.0+/-11.6 microg.h/mL (range, 7.8-60.7). Of 114 pharmacokinetic profiles, 40 (35%) AUC and 7 (6.1%) trough values were within the target value (30-60 microg.h/mL and 1.7-4.0 microg/mL, respectively). The C0, C1/2, and C2 concentrations showed large interindividual variability: C0 (0.01-4.46 microg/mL), C1/2 (0.14-36.86 microg/mL), and C2 (0.79-18.19 microg/mL). A positive correlation was observed between AUC and C0 (r=.6374; P<.0001), and C2 (r=.7460; P<.0001). When analyzed according to the date posttransplant, a positive correlation between AUC and C0 was shown on day 7, day 14, and at month 1. There was no difference in any pharmacokinetic parameter relative to age, weight, or albumin level.

CONCLUSION

This study demonstrated that C0 values on day 7, day 14, and at month 1 provided valuable information for MPA monitoring. C0 was shown to be the most reliable monitoring time in relation to AUC. However, results from a larger randomized trial with more time intervals are eagerly awaited.

摘要

目的

本研究旨在确定霉酚酸(MPA)在韩国活体供肝移植受者体内的药代动力学。

方法

32例肝移植受者(29例男性,3例女性)接受每日两次750毫克吗替麦考酚酯(MMF)治疗,并同时服用他克莫司。通过液相色谱-串联质谱检测法,在给药前(C0)、给药后0.5小时(C1/2)和2小时(C2)采集的样本中测量血浆MPA浓度,共获得114份移植后3天至6个月不同时间段(D3、D7、D14、M1、M3和M6)的药代动力学图谱。

结果

0至2小时的平均曲线下面积(AUC0-2)为30.0±11.6微克·小时/毫升(范围为7.8至60.7)。在114份药代动力学图谱中,40份(35%)AUC值和7份(6.1%)谷值在目标值范围内(分别为30至60微克·小时/毫升和1.7至4.0微克/毫升)。C0、C1/2和C2浓度显示出较大的个体间差异:C0(0.01至4.46微克/毫升)、C1/2(0.14至36.86微克/毫升)和C2(0.79至18.19微克/毫升)。观察到AUC与C0(r = 0.6374;P < 0.0001)以及C2(r = 0.7460;P < 0.0001)之间呈正相关。根据移植后的日期进行分析,在第7天、第14天和第1个月时,AUC与C0之间呈正相关。在任何药代动力学参数方面,年龄、体重或白蛋白水平之间均无差异。

结论

本研究表明,第7天、第14天和第1个月时的C0值为MPA监测提供了有价值的信息。就AUC而言,C0被证明是最可靠的监测时间。然而,迫切期待来自更大规模、具有更多时间间隔的随机试验结果。

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