Division of Transplantation, Department of Surgery, University of Cincinnati, Cincinnati, OH, USA.
Clin Transplant. 2010 Jan-Feb;24(1):73-83. doi: 10.1111/j.1399-0012.2009.01127.x. Epub 2009 Nov 20.
This study compared the safety and efficacy of early corticosteroid withdrawal (ECSWD) with rabbit anti-thymocyte globulin (rATG) induction to chronic corticosteroid therapy (CCST) without antibody induction in primary, living-donor renal transplant recipients.
Eligible subjects were randomized 2:1 to receive either an ECSWD (n = 103) or CCST (n = 48) regimen, with all subjects receiving tacrolimus and mycophenolate mofetil (MMF).
Results are reported as ECSWD vs. CCST. No significant differences were observed in the primary composite endpoint of freedom from biopsy-proven acute rejection (BPAR), graft loss, and death at six months (85.4% vs. 85.4%) or 12 months (84.4% vs. 74.4%). At 12 months, no difference was observed in BPAR (13.9% vs. 19.4%); however, ECSWD was associated with lower total cholesterol (159.7 +/- 39.2 vs. 196.5 +/- 56.7 mg/dL, p = 0.012), and trends toward significance were noted in serum triglycerides (151.9 +/- 92.0 vs. 181.4 +/- 78.8 mg/dL, p = 0.073) and weight gain (+3.6 +/- 9.4 vs. +6.4 +/- 9.3 kg, p = 0.069). No differences were observed in serious adverse events or infectious complications, with the exception of a higher incidence of leukopenia with ECSWD.
rATG with tacrolimus and MMF therapy may allow early elimination of corticosteroids, is associated with trends toward lower lipid levels, less weight gain, and a safety profile comparable to CCST therapy.
本研究比较了早期激素撤药（ECSWD）与兔抗胸腺细胞球蛋白（rATG）诱导联合环孢素和霉酚酸酯（MMF）方案与单纯慢性激素治疗（CCST）在原发性活体供肾移植受者中的安全性和疗效。
合格的受试者按 2：1 随机分为 ECSWD 组（n=103）或 CCST 组（n=48），所有患者均接受他克莫司和霉酚酸酯（MMF）治疗。
结果报告为 ECSWD 与 CCST 比较。两组主要复合终点（即 6 个月时无活检证实的急性排斥反应（BPAR）、移植物丢失和死亡，12 个月时无 BPAR、移植物丢失和死亡）发生率无显著差异（85.4%比 85.4%和 84.4%比 74.4%）。12 个月时，BPAR 发生率也无差异（13.9%比 19.4%）；但 ECSWD 组总胆固醇（159.7 +/- 39.2 比 196.5 +/- 56.7 mg/dL，p = 0.012）较低，且血清甘油三酯（151.9 +/- 92.0 比 181.4 +/- 78.8 mg/dL，p = 0.073）和体重增加（+3.6 +/- 9.4 比 +6.4 +/- 9.3 kg，p = 0.069）呈下降趋势。两组严重不良事件或感染并发症发生率无差异，但 ECSWD 组白细胞减少症发生率较高。
rATG 联合他克莫司和 MMF 治疗可早期撤停激素，且具有降低血脂水平、减轻体重增加和与 CCST 治疗相当的安全性。
