Thomas Philip G, Woodside Kenneth J, Lappin Jacqueline A, Vaidya Smita, Rajaraman Srinivasan, Gugliuzza Kristene K
Department of Surgery, University of Texas Medical Branch, Galveston, TX 77555-0533, USA.
Transplantation. 2007 Jun 15;83(11):1509-12. doi: 10.1097/01.tp.0000263344.53000.a1.
Immunosuppression for immunologically high-risk renal transplant patients usually involves antithymocyte globulin induction with triple drug maintenance therapy. Alemtuzumab, a humanized anti-CD52 antibody, has shown promise in tolerogenic induction protocols, requiring minimal maintenance immunosuppression. In this prospective, open-label, randomized, controlled trial, we enrolled 21 high immunological risk patients (i.e., panel reactive antibody>20% or previous transplant). Patients received either single-dose alemtuzumab given before graft reperfusion, with tacrolimus monotherapy, or four doses of Thymoglobulin with tacrolimus, mycophenolate, and steroids. Median follow-up was 377 days. One patient in the Thymoglobulin group who suffered primary graft nonfunction died. One-year cumulative graft survival was 85.7% for the alemtuzumab group and 87.5% for the Thymoglobulin group. Two alemtuzumab and three Thymoglobulin patients suffered rejection episodes. Infection rates were similar. Early results of this ongoing study indicate that a tolerogenic protocol with alemtuzumab induction and tacrolimus maintenance monotherapy is safe in immunologically high-risk renal transplant patients.
对于免疫高风险肾移植患者，免疫抑制通常包括使用抗胸腺细胞球蛋白诱导治疗并联合三联药物维持治疗。阿仑单抗是一种人源化抗CD52抗体，在诱导免疫耐受方案中显示出前景，所需的维持免疫抑制最少。在这项前瞻性、开放标签、随机对照试验中，我们纳入了21例高免疫风险患者（即群体反应性抗体>20%或曾接受过移植）。患者在移植肾再灌注前接受单剂量阿仑单抗联合他克莫司单药治疗，或接受四剂抗胸腺细胞球蛋白联合他克莫司、霉酚酸酯和类固醇治疗。中位随访时间为377天。抗胸腺细胞球蛋白组中有1例发生原发性移植肾功能丧失的患者死亡。阿仑单抗组1年移植肾累积生存率为85.7%，抗胸腺细胞球蛋白组为87.5%。阿仑单抗组有2例患者和抗胸腺细胞球蛋白组有3例患者发生排斥反应。感染率相似。这项正在进行的研究的早期结果表明，在免疫高风险肾移植患者中，采用阿仑单抗诱导和他克莫司维持单药治疗的免疫耐受方案是安全的。
