Knechtle Stuart J, Fernandez Luis A, Pirsch John D, Becker Bryan N, Chin L Thomas, Becker Yolanda T, Odorico Jon S, D'alessandro Anthony M, Sollinger Hans W
Department of Surgery, University of Winsconsin Medical School, Madison 53792-7375, USA.
Surgery. 2004 Oct;136(4):754-60. doi: 10.1016/j.surg.2004.06.015.
Immune cell depletion is known to prevent renal allograft rejection and injury. We evaluated the humanized monoclonal antibody Campath-1H (alemtuzumab; ILEX Oncology, San Antonio, Texas) in renal transplant recipients for its safety and efficacy in preventing rejection when used in combination with a calcineurin inhibitor, mycophenolate mofetil, and low-dose steroid therapy.
One hundred twenty-six consecutive renal allograft recipients received 2 doses of Campath-1H antibody on days 0 and 1. Outcomes were compared to patients who received an anti-CD25 antibody (n=799), Thymoglobulin (n=160), or other antibody treatment (n=156) in combination with a calcineurin inhibitor, mycophenolate mofetil, and higher dose steroids.
The Campath-1H group overall experienced less rejection than the other 3 groups (P=.037). Patients with delayed graft function experienced less rejection with Campath-1H than control groups (P=.0096) and improved graft survival (P=.0119). There was no difference in infection or malignancies between the 4 groups.
Campath-1H was well tolerated in renal transplant patients and led to significant reductions in incidence of rejection. Patients with delayed graft function experienced significantly improved graft survival.
已知免疫细胞清除可预防肾移植排斥反应和损伤。我们评估了人源化单克隆抗体Campath-1H(阿仑单抗;ILEX Oncology公司,得克萨斯州圣安东尼奥)在肾移植受者中与钙调神经磷酸酶抑制剂、霉酚酸酯和低剂量类固醇疗法联合使用时预防排斥反应的安全性和有效性。
126例连续肾移植受者在第0天和第1天接受2剂Campath-1H抗体。将结果与接受抗CD25抗体(n = 799)、胸腺球蛋白(n = 160)或其他抗体治疗(n = 156)并联合钙调神经磷酸酶抑制剂、霉酚酸酯和更高剂量类固醇的患者进行比较。
Campath-1H组总体上比其他3组经历的排斥反应更少(P = 0.037)。移植肾功能延迟的患者使用Campath-1H比对照组经历的排斥反应更少(P = 0.0096),移植肾存活率提高(P = 0.0119)。4组之间在感染或恶性肿瘤方面无差异。
Campath-1H在肾移植患者中耐受性良好,并导致排斥反应发生率显著降低。移植肾功能延迟的患者移植肾存活率显著提高。