Early Withdrawal of Calcineurin Inhibitors and Everolimus Monotherapy in de novo Liver Transplant Recipients Preserves Renal Function
Early Withdrawal of Calcineurin Inhibitors and Everolimus Monotherapy in de novo Liver Transplant Recipients Preserves Renal Function
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DOI：
10.1111/j.1600-6143.2010.03128.x
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发表时间：
2010-10-01
影响因子：
8.8
通讯作者：
Gerunda, G. E.
中科院分区：
文献类型：
--
作者：
Masetti, M.;Montalti, R.;Gerunda, G. E.
我们设计了一项随机试验，以评估与以环孢素A为基础的免疫抑制方案相比，首次肝移植（LT）患者早期停用环孢素（CsA）后开始依维莫司（Evr）单药治疗是否会导致上级肾功能改善。所有患者在前10天接受CsA治疗，然后随机接受Evr联合CsA治疗至第30天，然后继续接受Evr单药治疗（Evr组）或在慢性肾脏疾病（CKD）的情况下维持CsA联合/不联合吗替麦考酚酯（CsA组）。78例患者接受随机化（Evr n = 52; CsA n = 26）。Evr组的1年无疗效失败率为75%，CsA组为69.2%，p = 0.36。两组患者的生存率无统计学显著差异。在12个月时，Evr组的平均肾脏疾病饮食改良（MDRD）显著更好（87.7 +/- 26.1 vs. 59.9 +/- 12.6 mL/min; p < 0.001）。CsA组1年时CKD分期≥ 3（估计肾小球滤过率< 60 mL/min）的发生率较高（52.2% vs. 15.4%，p = 0.005）。结果表明，在原发LT患者中，早期停用CsA，随后进行Evr单药治疗与肾功能改善相关，排斥反应和主要并发症的发生率相似。
We designed a randomized trial to assess whether the early withdrawal of cyclosporine (CsA) followed by the initiation of everolimus (Evr) monotherapy in de novo liver transplantation (LT) patients would result in superior renal function compared to a CsA-based immunosuppression protocol. All patients were treated with CsA for the first 10 days and then randomized to receive Evr in combination with CsA up to day 30, then either continued on Evr monotherapy (Evr group) or maintained on CsA with/without mycophenolate mofetil (CsA group) in case of chronic kidney disease (CKD). Seventy-eight patients were randomized (Evr n = 52; CsA n = 26). The 1-year freedom from efficacy failure in Evr group was 75% versus 69.2% in CsA group, p = 0.36. There was no statistically significant difference in patient survival between the two groups. Mean modification of diet in renal disease (MDRD) was significantly better in the Evr group at 12 months (87.7 +/- 26.1 vs. 59.9 +/- 12.6 mL/min; p < 0.001). The incidence of CKD stage >= 3 (estimated glomerular filtration rate < 60 mL/min) was higher in the CsA group at 1 year (52.2% vs. 15.4%, p = 0.005). The results indicate that early withdrawal of CsA followed by Evr monotherapy in de novo LT patients is associated with an improvement in renal function, with a similar incidence of rejection and major complications.