Mourad Georges, Karras Alexandre, Kamar Nassim, Garrigue Valérie, Legendre Christophe, Lefrançois Nicole, Charpentier Bernard, Bourbigot Bernard, Pouteil-Noble Claire, Bayle François, Lebranchu Yvon, Mariat Christophe, Le Meur Yann, Kessler Michèle, Moulin Bruno, Ducloux Didier, Delahousse Michel, Lang Philippe, Merville Pierre, Chaouche-Teyara Kamel, Rostaing Lionel
Department of Nephrology-Transplantation, Hôpital Lapeyronie, Montpellier, France.
Clin Transplant. 2007 May-Jun;21(3):295-300. doi: 10.1111/j.1399-0012.2007.00660.x.
In the multicenter, open-label Myriade study, renal transplant patients were randomized to early cyclosporine microemulsion (CsA-ME, day 0) or delayed CsA-ME (day 6) with enteric-coated mycophenolate sodium (EC-MPS), steroids and interleukin-2 receptor induction. One-yr results have been published previously. We now report the results of an extension study in which patients were followed up for a period of three yr post-transplant.
All patients completing the one-yr core study on-treatment were eligible to enter the extension study.
Of the 203 patients, 153 completed the core trial on-treatment; 144 (94%) entered the extension study with a minimum follow-up of one yr (73 early CsA-ME, 71 delayed CsA-ME). In 75% of patients receiving EC-MPS during the extension, the recommended dose was administered (1440 mg/d). Median creatinine clearance remained constant (57 mL/min) at 12, 24 and 30 months post-transplant and was similar in the early and delayed CsA-ME groups as well as in subpopulations with or without delayed graft function. One patient in the early CsA-ME group died. No grafts were lost. The incidence of BPAR from time of transplant to the end of the extension study was 17% (24/139). Seven patients (5%) discontinued the extension study prematurely because of adverse events.
These results suggest that a regimen of CsA-ME, EC-MPS and steroids results in excellent survival rates with stable renal function over a mean follow-up of 30 months. Immediate introduction of CsA-ME has no deleterious effect on long-term renal function, even among patients with delayed graft function.
在多中心、开放标签的Myriade研究中，肾移植患者被随机分为早期环孢素微乳剂组（CsA-ME，第0天）或延迟CsA-ME组（第6天），同时使用肠溶包衣的霉酚酸钠（EC-MPS）、类固醇和白细胞介素-2受体诱导剂。1年的研究结果已在之前发表。我们现在报告一项延长研究的结果，该研究中患者在移植后随访了3年。
所有完成1年核心治疗研究的患者均有资格进入延长研究。
203例患者中，153例完成了核心治疗试验；144例（94%）进入延长研究，最短随访1年（73例早期CsA-ME组，71例延迟CsA-ME组）。在延长研究期间，75%接受EC-MPS治疗的患者接受了推荐剂量（1440 mg/d）。移植后12、24和30个月时，肌酐清除率中位数保持恒定（57 mL/min），在早期和延迟CsA-ME组以及有或无移植肾功能延迟的亚组中相似。早期CsA-ME组有1例患者死亡。无移植肾丢失。从移植时到延长研究结束时BPAR的发生率为17%（24/139）。7例患者（5%）因不良事件提前终止了延长研究。
这些结果表明，CsA-ME、EC-MPS和类固醇方案在平均30个月的随访中可实现优异的生存率，肾功能稳定。即使在移植肾功能延迟的患者中，立即引入CsA-ME对长期肾功能也没有有害影响。
