Höcker Britta, Weber Lutz T, Bunchman Timothy, Rashford Michelle, Tönshoff Burkhard
Division of Pediatric Nephrology, University Children's Hospital Heidelberg, Heidelberg, Germany.
Pediatr Transplant. 2005 Aug;9(4):504-11. doi: 10.1111/j.1399-3046.2005.00335.x.
Mycophenolate mofetil (MMF) is widely used to prevent acute rejection in adult solid organ transplant recipients, but data in children and adolescents are scarce. This prospective, multicenter, open-labeled, single-arm study investigated the efficacy and safety of an MMF-based immunosuppressive regimen in 100 pediatric renal transplant recipients over a 3-yr period of time. Three age groups were formed (<6 yr, n = 33; 6 to <12 yr, n = 34; 12-18 yr, n = 33). Basic immunosuppression consisted of MMF (600 mg/m(2) b.i.d), cyclosporin A microemulsion and corticosteroids. Seventy-three percent of patients were given anti-lymphocyte antibody induction therapy, of whom 74% received anti-thymocyte globulin. Patient and graft survival 3 yr after transplantation amounted to 98 and 95%, respectively. Twenty-five percent of all patients suffered a biopsy-proven acute rejection episode in the first 6 month post-transplant. Children undergoing induction therapy exhibited a numerically lower rejection rate (21 vs. 37%, p = 0.11). Three years after transplantation, the acute rejection rate added up to 30% (26% with induction therapy vs. 41% without induction therapy, p = 0.21). The number of patients with acute rejection was lowest in the youngest age group (18%), in comparison with 39% in the 6 to <12 yr and 33% in the 12-18 yr age group, respectively. For the entire patient population, the rate of patients who withdrew prematurely because of adverse events was low (12%). The present study shows that MMF therapy in pediatric renal transplant recipients leads to an excellent patient and graft survival 3 yr post-transplant with an acceptable safety profile.
霉酚酸酯（MMF）被广泛用于预防成人实体器官移植受者的急性排斥反应，但关于儿童和青少年的数据却很匮乏。这项前瞻性、多中心、开放标签、单臂研究在3年时间里调查了基于MMF的免疫抑制方案在100名小儿肾移植受者中的疗效和安全性。研究分为三个年龄组（<6岁，n = 33；6至<12岁，n = 34；12 - 18岁，n = 33）。基础免疫抑制包括MMF（600 mg/m²，每日两次）、环孢素A微乳剂和皮质类固醇。73%的患者接受了抗淋巴细胞抗体诱导治疗，其中74%接受了抗胸腺细胞球蛋白治疗。移植后3年患者和移植物存活率分别为98%和95%。所有患者中有25%在移植后的前6个月发生了经活检证实的急性排斥反应。接受诱导治疗的儿童排斥率在数值上较低（21%对37%，p = 0.11）。移植后3年，急性排斥率总计为30%（诱导治疗组为26%，未诱导治疗组为41%，p = 0.21）。急性排斥反应患者数量在最年幼的年龄组中最低（18%），相比之下，6至<12岁年龄组为39%，12 - 18岁年龄组为33%。对于整个患者群体，因不良事件过早退出的患者比例较低（12%）。本研究表明，小儿肾移植受者接受MMF治疗后，移植后3年患者和移植物存活率良好，安全性也可接受。
