Kandus Aljosa, Grego Katarina, Bren Andrej F
Department of Nephrology, University Medical Center Ljubljana, University of Ljubljana, Slovenia.
Ther Apher Dial. 2005 Jun;9(3):262-4. doi: 10.1111/j.1774-9987.2005.00268.x.
We carried out a prospective study of the safety and efficacy of daclizumab combined with triple immunosuppression in adult recipients of at least one HLA-mismatched cadaveric renal allograft. All studied patients received the same immunosuppression: a daclizumab infusion of 1 mg/kg immediately before transplantation, and at 2, 4, 6, and 8 weeks following the transplantation. Infusion of cyclosporine (CsA) (0.08 mg/kg/h) was started at the time of the operation and continued by CsA microemulsion (CsA-Neoral), 3 mg/kg twice daily on day 2, methylprednisolone, 0.4 mg/kg intravenously at operation, and mycophenolate mofetil started on day 1. The dose of CsA-Neoral was adjusted to maintain target blood trough levels. Oral methylprednisolone was tapered by 4 mg per week to achieve a maintenance dose of 0.08 mg/kg/day. Fifty-five patients, with a mean age of 48 +/- 11 years, were studied. Six of them received a second renal allograft. The mean donor age was 38 +/- 14 years. Mean cold ischemia time was 19.5 +/- 6.5 h, mean value of HLA-antigen mismatches was 2.7 +/- 0.9, mean latest PRA value was 3 +/- 7%. Fifteen patients experienced delayed graft function. During a follow-up period of 3 months three acute rejection episodes occurred. One patient died because of systemic aspergillosis. After 3 months mean serum creatinine was 104 +/- 38 micromol/L. Five renal allografts failed, one of them due to rejection. Patient and graft survival was 98.2% and 90.9%, respectively. Daclizumab with this triple therapy represents safe and efficient immunosuppression strategy, demonstrated with low incidence of early acute rejection episodes and an acceptable adverse event profile in cadaveric renal allograft recipients.
我们对达利珠单抗联合三联免疫抑制方案在至少接受一个HLA错配尸体肾移植的成年受者中的安全性和有效性进行了一项前瞻性研究。所有研究患者均接受相同的免疫抑制方案：移植前即刻静脉输注1mg/kg达利珠单抗，并在移植后第2、4、6和8周各输注一次。手术时开始静脉输注环孢素（CsA）（0.08mg/kg/h），并于术后第2天开始改用环孢素微乳剂（CsA-Neoral），每日两次，每次3mg/kg；术中静脉注射甲泼尼龙0.4mg/kg；霉酚酸酯于术后第1天开始使用。根据目标血药谷浓度调整CsA-Neoral的剂量。口服甲泼尼龙每周减量4mg，直至维持剂量为0.08mg/kg/天。共研究了55例患者，平均年龄为48±11岁。其中6例接受了第二次肾移植。供者平均年龄为38±14岁。平均冷缺血时间为19.5±6.5小时，HLA抗原错配的平均值为2.7±0.9，末次PRA值的平均值为3±7%。15例患者发生移植肾功能延迟恢复。在3个月的随访期内，发生了3次急性排斥反应。1例患者因全身性曲霉病死亡。3个月后，平均血清肌酐为104±38μmol/L。5例肾移植失败，其中1例因排斥反应。患者和移植肾的存活率分别为98.2%和90.9%。达利珠单抗联合这种三联疗法是一种安全有效的免疫抑制策略，在尸体肾移植受者中早期急性排斥反应发生率低，不良事件情况可接受。
