Iaria G, Pisani F, Iorio B, Lucchesi C, De Luca L, Ielpo B, D'Andria D, Tariciotti L, Tisone G
Clinica Chirurgica Università Tor Vergata, Ospedale S. Eugenio Roma, Rome.
Transplant Proc. 2006 May;38(4):1018-9. doi: 10.1016/j.transproceed.2006.04.001.
The aim of the study was to evaluate safety and efficacy of everolimus with cyclosporine (CsA) in de novo renal transplant recipients. The immunosuppressive regimen, including basiliximab, everolimus (3 mg), and low-dose CsA, was administered to 17 patients, of whom 15 were part of a multicenter randomized study that stipulated cessation of steroids at 7 days posttransplantation in 5 recipients. Five patients underwent dialysis after transplantation for delayed graft function (DGF; 29%), all of whom showed a good recovery within 3 weeks. The mean follow-up was 45.7 months (SD +/- 13). The 1-year graft survival was 100%. We observed one acute rejection episode. No patient experienced a cytomegalovirus infection. Increased cholesterol and triglyceride levels were reported in almost all patients. Severe arthralgia (n = 3) was treated by everolimus dose reduction to maintain trough levels at 3 ng/mL. We noted a high rate of switch to mycophenolate mofetil (MMF) throughout follow-up (n = 7), due to everolimus-induced side effects. However, we did not observe normalization of lipids after the switch: patients always required stain treatment, resulting in slightly lower serum cholesterol and triglycerides. Everolimus plus CsA was effective to prevent acute rejection after kidney transplantation. To manage the induced side effects of the drugs C(2) monitoring is mandatory, targeting 350 ng/mL during 1 year and 200 to 250 ng/mL thereafter. Careful reduction of everolimus trough levels to 3 ng/mL is recommended for patients with arthralgia.
本研究的目的是评估依维莫司联合环孢素(CsA)在初发肾移植受者中的安全性和有效性。将包括巴利昔单抗、依维莫司(3mg)和低剂量CsA的免疫抑制方案应用于17例患者,其中15例是一项多中心随机研究的一部分,该研究规定5例受者在移植后7天停用类固醇。5例患者(29%)移植后因移植肾功能延迟恢复(DGF)接受透析,所有患者均在3周内实现良好恢复。平均随访时间为45.7个月(标准差±13)。1年移植肾存活率为100%。我们观察到1次急性排斥反应。无患者发生巨细胞病毒感染。几乎所有患者均报告胆固醇和甘油三酯水平升高。3例严重关节痛患者通过降低依维莫司剂量进行治疗,以使谷浓度维持在3ng/mL。在整个随访期间,我们注意到因依维莫司引起的副作用,改用霉酚酸酯(MMF)的比例较高(n = 7)。然而,我们并未观察到改用MMF后血脂恢复正常:患者始终需要他汀类药物治疗,导致血清胆固醇和甘油三酯略有降低。依维莫司联合CsA可有效预防肾移植后的急性排斥反应。为控制药物引起的副作用,必须进行C₂监测,目标是在1年内达到350ng/mL,此后达到200至250ng/mL。对于关节痛患者,建议将依维莫司谷浓度谨慎降至3ng/mL。