Kamar N, Garrigue V, Karras A, Mourad G, Lefrançois N, Charpentier B, Legendre C, Rostaing L
Department of Nephrology-Transplantation, Hôpital Rangueil, Toulouse, France.
Am J Transplant. 2006 May;6(5 Pt 1):1042-8. doi: 10.1111/j.1600-6143.2006.01291.x.
The benefit of delayed cyclosporine in reducing risk of delayed graft function (DGF) is not clearly established. This study compared early vs. delayed cyclosporine microemulsion (CsA-ME) inde novorenal transplant patients. Patients were randomized to early (day 0, n=97) or delayed (day 6, n=100) CsA-ME at an initial dose of 8 mg/kg/day with dose adjusted according to C2 level. All patients received enteric-coated mycophenolate sodium (EC-MPS), steroids and an anti-interleukin-2 receptor antibody. In both groups, 33% of patients were at high risk of DGF; 26 patients (26.8%) in the early CsA-ME group and 23 patients (23.0%) in the delayed CsA-ME group experienced DGF (n.s.). Renal function at 3 months was comparable (creatinine clearance 51.1 mL/min with early CsA-ME and 53.8 mL/min with delayed CsA-ME), and remained similar to 12 months. Treatment failure, defined as biopsy-proven acute rejection, graft loss or death, did not differ significantly at 12 months (23.7% with early CsA-ME vs. 29.0% with delayed CsA-ME). Biopsy-proven acute rejection occurred in 15.5% of early CsA-ME and 26.5% of delayed CsA-ME patients (n.s.). Both regimens were well tolerated. These data suggest that early or delayed introduction of CsA-ME results in similar renal function in renal transplant patients regardless of DGF risk level.
环孢素延迟使用在降低移植肾功能延迟（DGF）风险方面的益处尚未明确确立。本研究比较了初发肾移植患者中早期与延迟使用环孢素微乳剂（CsA-ME）的情况。患者被随机分为早期（第0天，n = 97）或延迟（第6天，n = 100）使用CsA-ME组，初始剂量为8 mg/kg/天，并根据C2水平调整剂量。所有患者均接受肠溶包衣的霉酚酸钠（EC-MPS）、类固醇和抗白细胞介素-2受体抗体治疗。两组中，33%的患者有发生DGF的高风险；早期CsA-ME组有26例患者（26.8%）发生DGF，延迟CsA-ME组有23例患者（23.0%）发生DGF（无统计学差异）。3个月时的肾功能相当（早期CsA-ME组的肌酐清除率为51.1 mL/分钟，延迟CsA-ME组为53.8 mL/分钟），且至12个月时仍保持相似。治疗失败定义为经活检证实的急性排斥反应、移植肾丢失或死亡，12个月时两组无显著差异（早期CsA-ME组为23.7%，延迟CsA-ME组为29.0%）。经活检证实的急性排斥反应在早期CsA-ME组患者中的发生率为15.5%，在延迟CsA-ME组患者中的发生率为26.5%（无统计学差异）。两种治疗方案耐受性均良好。这些数据表明，无论DGF风险水平如何，早期或延迟引入CsA-ME在肾移植患者中导致的肾功能相似。
