Calcineurin inhibitor avoidance with daclizumab, mycophenolate mofetil, and prednisolone in DR-matched de novo kidney transplant recipients
Calcineurin inhibitor avoidance with daclizumab, mycophenolate mofetil, and prednisolone in DR-matched de novo kidney transplant recipients
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DOI：
10.1097/01.tp.0000225803.04995.2b
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发表时间：
2006-07-15
期刊：
影响因子：
6.2
通讯作者：
Hartmann, Anders
中科院分区：
文献类型：
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作者：
Asberg, Anders;Midtvedt, Karsten;Hartmann, Anders
背景在肾移植受者中，移植后不使用钙调磷酸酶抑制剂（CNI）的治疗方案除了能降低心血管疾病和恶性疾病的危险因素外，还能保护移植物功能。这项前瞻性、开放标签、随机、平行组、单中心研究的主要目的是比较移植后完全避免CNI的效果（达克珠单抗+吗替麦考酚酯+泼尼松龙：达克组，n = 27）与标准CNI为基础的免疫抑制方案在我们的移植单位（环孢素A +吗替麦考酚酯+泼尼松龙：CsA组27例（肾小球滤过率[GFR]测定为Cr-51-EDTA的血浆清除率）（DR匹配，PRA阴性从头尸体移植受者）。第10周时GFR无显著差异（P = 0.61），但第12个月时Dac组（52 +/- 20 ml/min）的GFR显著（P = 0.029）低于CsA组（69 +/- 29 ml/min）。两组患者和移植物的一年存活率没有差异。Dac组总的急性排斥反应发生率为70.4%（19/27），CsA组为29.6%（8/27）（P = 0.006）。选择DR匹配、PRA阴性的从头尸体移植受者进行CNI避免方案的策略并不成功。急性排斥反应的发生率是不可接受的高，即使抗CD 25抗体诱导以及初始较高的霉酚酸酯剂量（3 g/天），并在1年的CNI避免患者的肾功能显着降低。需要检查其他策略以避免移植后早期CNI。
Background. Calcineurin inhibitor (CNI)-free regimens posttransplantation have been claimed to conserve graft function in addition to reduce the risk factors for cardiovascular and malignant disease in renal transplant recipients.Methods. The primary aim of this prospective, open-label, randomized, parallel-group, single-center study was to compare the effect of complete CNI-avoidance posttransplant (daclizumab + mycophenolate mofetil + prednisolone: Dac-group, n = 27) with the standard CNI-based immunosuppressive protocol at our transplant unit (cyclosporine A + mycophenolate mofetil + prednisolone: CsA-group, n = 27) on renal function (glomerular filtration rate [GFR] determined as plasma clearance of Cr-51-EDTA) in a selected low immunogenic risk population (DR-matched, PRA-negative de novo cadaveric transplant recipients).Results. There were no significant difference in GFR at week 10 (P = 0.61), but GFR was significantly (P = 0.029) lower in the Dac-group (52 +/- 20 ml/min) at month 12 than in the CsA-group (69 +/- 29 ml/min). One-year patient and graft survival did not differ between the two groups. Overall acute rejection rate was 70.4% (19/27) in the Dac-group and 29.6% (8/27) in the CsA-group (P = 0.006).Conclusions. The strategy to select DR-matched, PRA-negative de novo cadaveric transplant recipients for a CNI-avoidance protocol was not successful. The incidence of acute rejection was unacceptable high even though anti-CD25 antibody induction as well as initial higher mycophenolate mofetil doses (3 g/day) were applied, and renal function was significantly lower in the CNI-avoidance patients at 1 year. Other strategies need to be examined for avoidance of CNI's in the early posttransplant period.