Kaufman D B, Leventhal J R, Gallon L G, Parker M A
Department of Surgery, Division of Transplantation, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
Am J Transplant. 2006 Feb;6(2):331-9. doi: 10.1111/j.1600-6143.2005.01166.x.
This study compared the effects of using two T-cell depleting antibodies, alemtuzumab (anti-CD 52, Campath-1H) and rabbit antithymocyte globulin (Thymoglobulin), as induction immunosuppression for recipients of simultaneous pancreas-kidney transplantation given a prednisone-free maintenance regimen. We used a single-center, nonrandomised, retrospective, sequential study design to evaluate the efficacy and safety of alemtuzumab (n = 50) or antithymocyte globulin (n = 38) induction in combination with a prednisone-free, tacrolimus/sirolimus-based immunosuppression protocol. Kaplan-Meier analyses of long-term patient and graft survivals and rejection rates were determined according to induction agent. Secondary endpoints included the quality of renal allograft function, incidence of infectious and malignant complications, and cost considerations. Overall long-term patient and graft survival rates did not significantly differ between patients treated with alemtuzumab and antithymocyte globulin. Rejection rates were also nearly equivalent at 1 and 2 years. Viral infectious complications were statistically significantly lower in the alemtuzumab group. The cost of alemtuzumab induction was lower than antithymocyte globulin. Alemtuzumab induction followed by steroid-free maintenance therapy with a tacrolimus/sirolimus-based immunosuppression regimen provided an effective, safe and cost-conscious approach to SPK transplantation.
本研究比较了两种T细胞清除抗体,即阿仑单抗(抗CD52,Campath-1H)和兔抗胸腺细胞球蛋白(即胸腺球蛋白),在接受无泼尼松维持方案的同期胰肾联合移植受者中作为诱导免疫抑制的效果。我们采用单中心、非随机、回顾性、序贯研究设计,评估阿仑单抗(n = 50)或抗胸腺细胞球蛋白(n = 38)诱导联合基于他克莫司/西罗莫司且无泼尼松的免疫抑制方案的疗效和安全性。根据诱导药物,采用Kaplan-Meier分析确定长期患者和移植物存活率以及排斥率。次要终点包括肾移植功能质量、感染和恶性并发症的发生率以及成本考量。接受阿仑单抗和抗胸腺细胞球蛋白治疗的患者的总体长期患者和移植物存活率无显著差异。1年和2年时的排斥率也几乎相当。阿仑单抗组的病毒感染并发症在统计学上显著更低。阿仑单抗诱导的成本低于抗胸腺细胞球蛋白。阿仑单抗诱导后采用基于他克莫司/西罗莫司的无类固醇维持治疗方案为同期胰肾联合移植提供了一种有效、安全且具有成本效益的方法。