Mastrobuoni S, Ubilla M, Cordero A, Herreros J, Rabago G
Departamento de Cirugía Cardiovascular, Clinica Universitaria de Navarra, Universidad de Navarra, Pamplona, Spain.
Transplant Proc. 2007 Sep;39(7):2163-6. doi: 10.1016/j.transproceed.2007.06.073.
Tacrolimus (TAC) with mycophenolate mofetil (MMF) and a steroid-free regimen seems to have good efficacy in preventing acute rejection in cardiac transplant recipients, although concern exists about nephrotoxicity. Induction therapy with Daclizumab seems to give protection without side effects. Data are lacking about the outcome of 2-dose Daclizumab+TAC+MMF and a steroid-free regimen.
We retrospectively reviewed 28 consecutive de novo heart transplantations performed at a single center between January 2001 and June 2006. Patients received induction therapy with 2-dose Daclizumab. Maintenance immunosuppression included TAC, MMF, and prednisone during the first 6 months. The endpoints were the incidence of acute rejection, patient and graft survival, and clinical tolerability.
Among 28 patients of mean age 57 +/- 9 years, 2 subjects (7%) died in the perioperative period due to infections. The mean follow-up was 2.8 +/- 1.5 years. There were no late deaths. Six patients experienced acute rejection (International Society of Heart and Lung Transplantation [ISHLT] >or=3A) that required treatment during the first 3 months. At follow-up, only 3 patients (>or=3A) required treatment. Mean creatinine level increased from 1.08 +/- 0.37 at baseline to 1.08 +/- 0.41 at 1 year (n = 23; P = not significant [NS]) to 1.39 +/- 0.68 (n = 13; P < .05) at 4 years, 1.65 +/- 0.51 (n = 8; P < .05) at 5 years. No patient required replacement therapy.
A steroid-free protocol with 2-dose Daclizumab induction therapy and maintenance with TAC and MMF seemed to be safe to prevent acute rejection. Creatinine levels were slightly but significantly increased.
他克莫司（TAC）联合霉酚酸酯（MMF）及无类固醇方案在预防心脏移植受者急性排斥反应方面似乎具有良好疗效，尽管人们对其肾毒性存在担忧。达利珠单抗诱导治疗似乎能提供保护且无副作用。关于两剂达利珠单抗+TAC+MMF及无类固醇方案的结果的数据尚缺乏。
我们回顾性分析了2001年1月至2006年6月在单一中心连续进行的28例首次心脏移植手术。患者接受两剂达利珠单抗诱导治疗。维持免疫抑制在前6个月包括TAC、MMF和泼尼松。终点指标为急性排斥反应的发生率、患者及移植物存活率和临床耐受性。
28例患者平均年龄为57±9岁，2例（7%）在围手术期因感染死亡。平均随访时间为2.8±1.5年。无晚期死亡病例。6例患者在最初3个月内发生急性排斥反应（国际心肺移植学会[ISHLT]≥3A），需要进行治疗。在随访时，仅3例（≥3A）患者需要治疗。平均肌酐水平从基线时的1.08±0.37升至1年时的1.08±0.41（n = 23；P = 无显著差异[NS]），4年时升至1.39±0.68（n = 13；P <.05），5年时升至1.65±0.51（n = 8；P <.05）。无患者需要替代治疗。
两剂达利珠单抗诱导治疗及TAC和MMF维持的无类固醇方案在预防急性排斥反应方面似乎是安全的。肌酐水平有轻微但显著的升高。
