不同霉酚酸剂型在儿童肾移植不同年龄段的暴露差异

Exposure difference of various dosage forms of mycophenolic acid in different age groups of pediatric kidney transplantation

    摘要
  • 摘要:
      目的  探讨儿童肾移植术后服用不同霉酚酸（MPA）制剂在≤12岁与 > 12岁年龄段的暴露差异。
      方法  回顾性分析73例接受心脏死亡器官捐献（DCD）儿童肾移植受者的临床资料，术后免疫抑制方案均为MPA+他克莫司+糖皮质激素，按照MPA剂型分为A组（37例，服用吗替麦考酚酯胶囊）、B组（28例，服用麦考酚钠肠溶片）和C组（8例，服用吗替麦考酚酯分散片）。并根据移植时患者年龄分为≤12岁年龄段和 > 12岁年龄段。计算不同药物剂型每日给药剂量，采用酶放大免疫法检测MPA血药浓度（C）与曲线下面积（AUC），比较各组不同时间点和两个年龄段的MPA血药浓度，分析受者术后肾功能恢复情况及并发症发生情况。
      结果  A、B、C组给药剂量和各时间点血药浓度比较，差异均无统计学意义（均为P > 0.05）。≤12岁年龄段MPA-C4 h、AUC均高于 > 12岁年龄段，差异均有统计学意义（均为P < 0.05）。B组≤12岁年龄段MPA-C4 h高于 > 12岁年龄段，差异有统计学意义（P=0.016）。B组≤12岁年龄段MPA-C4 h较A组和C组高，但差异无统计学意义（P=0.080）。3组急性排斥反应和感染发生率差异均无统计学意义（均为P > 0.05）。
      结论  不同年龄段儿童肾移植术后服用不同MPA制剂有不同的暴露率，≤12岁儿童肾移植受者暴露率较 > 12岁儿童有升高的趋势，但主要表现在服用麦考酚钠肠溶片的受者中。因此，监测MPA的暴露水平是必要的，对调整不同剂型药物用量具有较大的指导意义。

     

    Abstract:
      Objective  To investigate the exposure difference of different dosage forms of mycophenolic acid (MPA) between children aged ≤12 and > 12 years old after kidney transplantation.
      Methods  Clinical data of 73 children undergoing kidney transplantation from donation after cardiac death (DCD) were retrospectively analyzed. Postoperative immunosuppressive regimen was MPA+ tacrolimus+glucocorticoid. According to different dosage forms of MPA, all recipients were divided into group A (n=37, mycophenolate mofetil capsules), group B (n=28, enteric-coated mycophenolate sodium) and group C (n=8, mycophenolate mofetil dispersible tablets). All children were divided into ≤12 and > 12 years old groups according to the age of kidney transplantation. The daily dosage of different dosage forms was calculated. The blood concentration (C) of MPA and the area under the curve (AUC) were detected by enzyme-multiplied immunoassay technique. The MPA blood concentration was statistically compared between two age groups at different time points. The recovery of renal function and postoperative complications were assessed.
      Results  No significant differences were observed in the dosage and blood concentration of drug at different time points among groups A, B and C (all P > 0.05). The MPA-C4 h and AUC in the ≤12 years old group were significantly higher than those in the > 12 years old group (both P < 0.05). In group B, the MPA-C4 h of children aged ≤12 years old was significantly higher compared with that in those aged > 12 years old (P=0.016). The MPA-C4 h of children aged ≤12 years old in group B was higher than those in group A and group C, but the differences were not statistically significant (P=0.080). There was no significant difference in the incidence of acute rejection and infection among three groups (both P > 0.05).
      Conclusions  Children of different ages who are given with different dosage forms of MPA after kidney transplantation obtain different exposure rates. The exposure rate of kidney transplant recipients aged ≤12 years old tends to be higher than that of their counterparts aged > 12 years old, mainly seen in the recipients treated with enteric-coated mycophenolate sodium. Therefore, it is necessary to monitor the exposure level of MPA, which provides significant guidance for adjusting the drug dosage of different dosage forms.

     

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