University Children's Hospital Heidelberg, Germany.
Nephrol Dial Transplant. 2011 Mar;26(3):1073-9. doi: 10.1093/ndt/gfq450. Epub 2010 Jul 28.
Mycophenolate mofetil (MMF) is widely used for immunosuppressive therapy in renal transplantation, but comparative data regarding efficacy and safety in paediatric vs. adult kidney allograft recipients in one and the same study are lacking.
We therefore performed this subgroup analysis of the FDCC trial, a 12-month, prospective, randomised study, comparing fixed-dose (FD) with concentration-controlled (CC) MMF dosing in paediatric and adult renal transplant recipients. Sixty-two paediatric and 839 adult de novo patients in 19 countries were randomised 1:1 to receive fixed-dose or concentration-controlled MMF therapy in combination with calcineurin inhibitors and corticosteroids.
Both patient and allograft survival proved to be excellent in paediatric patients (98.4% and 90.3%) and adults (96.8% and 95.0%). The rates of biopsy-proven acute rejections (BPAR) and treated acute rejection episodes (ARE) were comparable between paediatric (12.9% and 17.7%) and adult patients (15.5% and 20.7%). Transplant function at 12 months post-transplant was similar in paediatric (67.8 ± 45.6 mL/min/1.73 m2;) and adult recipients (64.7 ± 23.3 mL/min/1.73 m2;). Children < 6 years (n = 10) exhibited a numerically higher frequency of leucocytopaenia (20%), diarrhoea (40%) and weight loss (10%) than older children (6-18 years; 5.8%, 28.8% and 1.9%) and adults (16.1%, 24.7% and 1.5%). On the whole, the percentage of patients who experienced adverse events causing interruption of MMF therapy were numerically lower in children (4.8%) than in adults (12.5%). Conclusions. The overall efficacy and tolerability of MMF appear to be comparable between paediatric and adult patients. Further studies are needed to validate these results.
霉酚酸酯（MMF）广泛用于肾移植的免疫抑制治疗，但在一项研究中比较儿童和成人肾移植受者的疗效和安全性的对照数据尚缺乏。
我们对 FDCC 试验进行了亚组分析，该试验是一项 12 个月前瞻性随机研究，比较了儿童和成人肾移植受者固定剂量（FD）与浓度控制（CC）MMF 剂量。19 个国家的 62 例儿科和 839 例成人初治患者以 1:1 比例随机接受固定剂量或浓度控制 MMF 联合钙调磷酸酶抑制剂和皮质类固醇治疗。
儿童患者（98.4%和 90.3%）和成人患者（96.8%和 95.0%）的患者和移植物存活率均极佳。儿童（12.9%和 17.7%）和成人患者（15.5%和 20.7%）的活检证实的急性排斥反应（BPAR）和治疗性急性排斥反应（ARE）发生率相似。移植后 12 个月的移植功能在儿童（67.8±45.6mL/min/1.73m2）和成人受者中相似（64.7±23.3mL/min/1.73m2）。＜6 岁的儿童（n=10）白细胞减少症（20%）、腹泻（40%）和体重减轻（10%）的发生率高于年龄较大的儿童（6-18 岁；5.8%、28.8%和 1.9%）和成人（16.1%、24.7%和 1.5%）。总的来说，儿童（4.8%）发生导致 MMF 治疗中断的不良事件的患者比例低于成人（12.5%）。
MMF 的总体疗效和耐受性在儿童和成人患者中似乎相似。需要进一步的研究来验证这些结果。
