Department of Pediatrics I, University Children's Hospital Heidelberg, 69120 Heidelberg, Germany.
Nephrol Dial Transplant. 2010 Feb;25(2):617-24. doi: 10.1093/ndt/gfp506. Epub 2009 Sep 30.
Long-term corticosteroid treatment impairs growth and increases cardiovascular risk factors. Hence, steroid withdrawal constitutes a major topic in paediatric renal transplantation and maintenance immunosuppression.
The lack of data from randomised controlled trials caused us to conduct the first prospective, randomised, multicentre study on late steroid withdrawal among paediatric kidney allograft recipients treated with standard-dose cyclosporine microemulsion (CsA) and mycophenolate mofetil (MMF) for 2 years. Forty-two low- or regular-immunologic risk patients were randomly assigned, >or=1 year post-transplant, to continue taking or to withdraw steroids over 3 months.
Two years after steroid withdrawal, they showed a longitudinal growth superior to controls [mean height standard deviation score (SDS) gain, 0.6 +/- 0.1 SDS versus -0.2 +/- 0.1 SDS (P < 0.001)]. The prevalence of the metabolic syndrome declined significantly (P < 0.05), 2 years after steroid withdrawal, from 39% (9/23) to 6% (1/16). Steroid-free patients had less frequent arterial hypertension (50% versus 93% (P < 0.05)) and required fewer antihypertensive drugs [0.6 +/- 0.2 versus 1.5 +/- 0.3 (P < 0.05 versus control)]. Additionally, they had a significantly improved carbohydrate and lipid metabolism with fewer hypercholesterolaemia and hypertriglyceridaemia (P < 0.05 versus control). Patient and graft survival amounted to 100%. Allograft function remained stable 2 years after steroid withdrawal. The incidence of acute rejections was similar in the steroid-withdrawal group (1/23, 4%) and controls (2/19, 11%).
Late steroid withdrawal in selected CsA- and MMF-treated paediatric kidney transplant recipients improves growth, mitigates cardiovascular risk factors and reduces the prevalence of the metabolic syndrome, at no increased risk of acute rejection or unstable graft function.
长期使用皮质类固醇治疗会影响生长并增加心血管危险因素。因此，皮质类固醇的撤药是儿科肾移植和维持免疫抑制的主要课题。
由于缺乏随机对照试验的数据，我们进行了第一项前瞻性、随机、多中心研究，以评估接受标准剂量环孢素微乳剂（CsA）和吗替麦考酚酯（MMF）治疗 2 年的儿童肾移植受者中晚期撤药的情况。42 例低或中免疫风险患者在移植后>或=1 年时随机分为继续服用或在 3 个月内撤药两组。
撤药 2 年后，他们的纵向生长优于对照组[平均身高标准差评分（SDS）增加，0.6 +/- 0.1 SDS 与-0.2 +/- 0.1 SDS（P < 0.001）]。撤药 2 年后，代谢综合征的患病率显著下降（P < 0.05），从 39%（9/23）降至 6%（1/16）。无激素组的高血压发生率较低（50%与 93%（P < 0.05）），所需降压药物较少[0.6 +/- 0.2 与 1.5 +/- 0.3（P < 0.05 与对照组）]。此外，他们的糖脂代谢得到改善，高胆固醇血症和高三酰甘油血症的发生率较低（P < 0.05 与对照组）。患者和移植物的存活率均为 100%。撤药 2 年后，移植物功能保持稳定。撤药组（1/23，4%）和对照组（2/19，11%）急性排斥反应的发生率相似。
在选定的 CsA 和 MMF 治疗的儿童肾移植受者中，晚期撤药可改善生长，减轻心血管危险因素，降低代谢综合征的患病率，且不会增加急性排斥反应或移植物功能不稳定的风险。
