Department of Pediatrics, Stanford University, Stanford, CA, USA.
Transplantation. 2010 Dec 27;90(12):1516-20. doi: 10.1097/TP.0b013e3181fc8937.
Given the recent withdrawal of daclizumab (DAC), the safety and efficacy of thymoglobulin (TMG) was tested as an alternative induction agent for steroid-free (SF) immunosuppression in pediatric kidney transplant recipients.
Thirteen pediatric renal transplant recipients meeting defined high-risk criteria at transplantation were offered TMG induction and SF immunosuppression with maintenance mycophenolate mofetil and tacrolimus between October 2008 and January 2010. Patients were closely monitored at baseline, 3, 6, 9, and 12 months posttransplant for protocol biopsy and clinical outcomes. Outcomes were compared with 13 consecutively transplanted low-risk patients receiving an established DAC-based SF protocol (Sarwal et al., WA, American Transplant Congress 2003).
There was a significant trend for overall decrease in the absolute lymphocyte counts in TMG group (F=5.86, mixed model group effect P=0.02), predominately at 3 months compared with DAC group (0.7±0.6 vs. 2.1±1.0, P=0.0004); however, lymphocyte count was recovered and was back to reference range by 6 months in TMG. There was trend toward more subclinical cytomegalovirus (15% vs. 0%) and BK viremia (17% vs. 0%) in the TMG group, with no differences in the incidence of subclinical Epstein Barr virus viremia (23% vs. 31%) or clinical viral disease. Mean graft function was excellent, and with a minimum follow-up of 6 months, there were no episodes of acute rejection.
TMG seems to be a safe alternative induction strategy in patients for SF immunosuppression in pediatric renal transplantation. Extended follow-up and greater enrollment are necessary to fully explore the impact of TMG dosing on viral replication posttransplantation.
鉴于达昔珠单抗（DAC）的近期撤市，我们测试了胸腺球蛋白（TMG）作为一种替代诱导剂，用于儿科肾移植受者的无类固醇（SF）免疫抑制。
2008 年 10 月至 2010 年 1 月，我们为 13 名符合移植时定义的高危标准的儿科肾移植受者提供 TMG 诱导和 SF 免疫抑制治疗，方案为霉酚酸酯和他克莫司维持治疗。移植后基线、3、6、9 和 12 个月时，对患者进行密切监测，进行方案活检和临床结局评估。结果与接受既定 DAC 为基础的 SF 方案（Sarwal 等人，WA，美国移植大会 2003 年）的 13 例连续移植的低危患者进行比较。
TMG 组的绝对淋巴细胞计数呈显著下降趋势（F=5.86，混合模型组效应 P=0.02），主要在 3 个月时与 DAC 组相比（0.7±0.6 与 2.1±1.0，P=0.0004）；然而，淋巴细胞计数在 TMG 组在 6 个月时恢复并回到参考范围。TMG 组有更多的亚临床巨细胞病毒（15%与 0%）和 BK 病毒血症（17%与 0%）的趋势，但亚临床 EBV 病毒血症（23%与 31%）或临床病毒病的发生率没有差异。移植物功能良好，在至少 6 个月的随访中，没有急性排斥反应的发生。
TMG 似乎是儿科肾移植患者 SF 免疫抑制的一种安全替代诱导策略。需要进行更长时间的随访和更大规模的招募，以充分探讨 TMG 剂量对移植后病毒复制的影响。
