Kim H C, Hwang E A, Han S Y, Park S B, Kim H T, Cho W H
Department of Internal Medicine, Keimyung University School of Medicine, Keimyung University Kidney Institute, Daegu, Korea.
Transplant Proc. 2004 Sep;36(7):2082-3. doi: 10.1016/j.transproceed.2004.08.006.
The 1-year results of the phase III US Multicenter Trial comparing tacrolimus- and cyclosporine (Sandimmun)-based immunosuppressive therapy in kidney transplantation revealed a significant reduction in the incidence and severity of acute rejection episodes among patients maintained on tacrolimus. This retrospective, nonrandomized, single-center study represented 3-year data for patient and graft survival and safety in the tacrolimus-treated patients.
Among 97 consecutive kidney transplant recipients 41 who received tacrolimus and 56 cyclosporine-based immunosuppression were followed for 3 years for patient and graft survivals and for the incidence of acute rejection episodes as well as serious adverse events.
The 3-year patient and graft survival rates for tacrolimus and cyclosporine were similar (91.0% vs 90.2%, 96.5% vs 95.0%). However, the incidence of acute rejection episodes was significantly lower in the tacrolimus (17.1%) compared with the cyclosporine group (35.7%, P = .043). There was a higher incidence of headache, posttransplant diabetes, and alopecia reported in the tacrolimus group, whereas hypertension, hypercholesterolemia, and hirsutism were more frequent in the cyclosporine group. The incidences of hand tremor, hyperkalemia, and viral infections were comparable in both groups. Two patients in the tacrolimus group were converted to cyclosporine due to nephrotoxicity and posttransplant diabetes, respectively, whereas 12 patients in the cyclosporine group were converted to tacrolimus as rescue therapy for acute rejection (41.7%), gingival hyperplasia (33.3%), nephrotoxicity (8.3%), neurotoxicity (8.3%), and hirsutism (8.3%), respectively.
The 3-year results of tacrolimus treatment show excellent efficacy and safety in kidney transplantation. Due to different side-effect profiles, it is necessary to develop individualized immunosuppressive strategies in kidney transplant recipients.
美国多中心III期试验对肾移植中基于他克莫司和环孢素（山地明）的免疫抑制疗法进行了比较，1年结果显示，接受他克莫司治疗的患者急性排斥反应的发生率和严重程度显著降低。这项回顾性、非随机、单中心研究呈现了他克莫司治疗患者3年的患者和移植物存活情况以及安全性数据。
在97例连续的肾移植受者中，41例接受他克莫司免疫抑制治疗，56例接受基于环孢素的免疫抑制治疗，对其进行3年随访，观察患者和移植物存活情况、急性排斥反应发生率以及严重不良事件。
他克莫司组和环孢素组的3年患者和移植物存活率相似（分别为91.0%对90.2%，96.5%对95.0%）。然而，他克莫司组急性排斥反应的发生率（17.1%）显著低于环孢素组（35.7%，P = 0.043）。他克莫司组报告的头痛、移植后糖尿病和脱发发生率较高，而环孢素组高血压、高胆固醇血症和多毛症更为常见。两组手震颤、高钾血症和病毒感染的发生率相当。他克莫司组有2例患者分别因肾毒性和移植后糖尿病转而使用环孢素，而环孢素组有12例患者分别因急性排斥反应（41.7%）、牙龈增生（33.3%）、肾毒性（8.3%）、神经毒性（8.3%）和多毛症（8.3%）转而使用他克莫司作为挽救治疗。
他克莫司治疗3年的结果显示在肾移植中具有优异的疗效和安全性。由于副作用情况不同，有必要为肾移植受者制定个体化的免疫抑制策略。
