Lebranchu Yvon, Bridoux Frank, Büchler Matthias, Le Meur Yannick, Etienne Isabelle, Toupance Olivier, Hurault de Ligny Bruno, Touchard Guy, Moulin Bruno, Le Pogamp Patrick, Reigneau Olivier, Guignard Michel, Rifle Gérard
Service Nephrologie Immunologie Clinique Hĵpital Bretonneau/Tours, France.
Am J Transplant. 2002 Jan;2(1):48-56. doi: 10.1034/j.1600-6143.2002.020109.x.
Acute graft rejection remains a major problem in renal transplant recipients, and there is no consensus on the optimal immunosuppressive strategy. Immunoprophylaxis with Thymoglobulin or basiliximab has significantly reduced the incidence of acute rejection episodes and graft loss following kidney transplantation. This open, randomized, multicenter study investigated the efficacy and tolerability of basiliximab (20mg day 0-day 4) plus early cyclosporine from day 0 (n = 50) compared with Thymoglobulin plus delayed cyclosporine (n = 50) in adult kidney transplant patients. In addition, all patients received steroids and mycophenolate mofetil (MMF) at standard doses from day 0. Patient and graft survival rates at 12 months were 98 and 94% in the basiliximab group, respectively, compared with 100 and 96% in the Thymoglobulin' group. The incidences of biopsy-confirmed acute rejection (8.0% in each group) and treatment failure (14% in the basiliximab group vs. 8% in the Thymoglobulin group) were comparable in the two groups. There was a non-significant tendency to more dialysis (14 vs. 6%), and fewer cytomegalovirus (CMV) infections (p = 0.005) in the basiliximab group, but the percentage of clinical CMV was not different between the two groups (6 vs. 12%). Both strategies give excellent results, despite the differences in patterns, in nonhyperimmunized patients receiving their first cadaveric renal allograft.
急性移植物排斥反应仍是肾移植受者面临的主要问题，对于最佳免疫抑制策略尚无共识。使用抗胸腺细胞球蛋白或巴利昔单抗进行免疫预防已显著降低了肾移植后急性排斥反应发作和移植物丢失的发生率。这项开放性、随机、多中心研究调查了巴利昔单抗（第0天至第4天，每日20mg）联合从第0天开始使用早期环孢素（n = 50）与抗胸腺细胞球蛋白联合延迟使用环孢素（n = 50）在成年肾移植患者中的疗效和耐受性。此外，所有患者从第0天起均接受标准剂量的类固醇和霉酚酸酯（MMF）。巴利昔单抗组12个月时的患者和移植物存活率分别为98%和94%，而抗胸腺细胞球蛋白组为100%和96%。两组活检证实的急性排斥反应发生率（每组8.0%）和治疗失败率（巴利昔单抗组为14%，抗胸腺细胞球蛋白组为8%）相当。巴利昔单抗组有更多透析的非显著趋势（14%对6%），以及更少的巨细胞病毒（CMV）感染（p = 0.005），但两组临床CMV的百分比无差异（6%对12%）。在接受首次尸体肾移植的非高免疫患者中，尽管模式不同，但两种策略都取得了优异的结果。
