Three-year results of a randomized, double-blind, controlled trial of mycophenolate mofetil versus azathioprine in cardiac transplant recipients
Three-year results of a randomized, double-blind, controlled trial of mycophenolate mofetil versus azathioprine in cardiac transplant recipients
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DOI：
10.1016/j.healun.2005.02.002
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发表时间：
2005-05-01
影响因子：
8.9
通讯作者：
Johnson, J
中科院分区：
文献类型：
--
作者：
Eisen, HJ;Kobashigawa, J;Johnson, J
背景：本研究报告了心脏移植患者中霉酚酸酯 (MMF) 与硫唑嘌呤 (AZA) 的随机、双盲、主动对照试验的 36 个月结果。方法：患者在移植时随机接受 MMF（1,500 毫克，每天两次，N = 327）或 AZA（1.5 至 3 毫克/公斤，每天 4 次） 剂量，N = 323）除环孢素和皮质类固醇外；每组 289 名患者接受研究药物。对随机患者（登记）和接受研究药物（治疗）的患者的数据进行了分析。临床和移植评估持续 36 个月。 结果：对于共同主要终点，289 名接受 AZA 治疗的患者中有 53 名 (18.3%) 死亡或接受了另一次移植，而 289 名接受 MMF 治疗的患者中有 34 名 (11.8%) (p < 0.01)。 AZA 治疗的患者再移植或患者死亡的时间明显短于 MMF 治疗的患者 (P = 0.029)。在接受血管内超声检查的患者中，MMF 组的平均最大内膜厚度变化小于 AZA 组（分别为 0.06 +/- 0.03 mm 和 0.13 +/- 0.03 mm；p = 0.056）。在移植冠状动脉血管病变的定量冠状动脉造影测量中，未观察到治疗之间存在显着差异。充血性心力衰竭、房性心律失常和白细胞减少在 AZA 组中更常见，而腹泻、食管炎、单纯疱疹、带状疱疹和巨细胞病毒 (CMV) 组织侵袭在 MMF 治疗的患者中更常见。结论：MMF 可以降低移植后 36 个月内的死亡率和移植物丢失。国际心肺移植协会版权所有 (c) 2005。
Background: This study reports the 36-month results of a randomized, double-blind, active-controlled trial of mycophenolate mofetil (MMF) vs azathioprine (AZA) in heart transplant patients.Methods: Patients were randomized at the time of transplant to receive MMF (1,500 mg twice a day, N = 327) or AZA (1.5 to 3 mg/kg in 4 daily doses, N = 323) in addition to cyclosporine and corticosteroids; 289 patients in each group received study drug. Data were analyzed in an randomized patients (enrolled) and in patients who received study medications (treated). Clinical and graft assessments continued for 36 months.Results: For the co-primary end-point, 53 of 289 (18.3%) AZA-treated patients either died or received another transplant compared with 34 of 289 (11.8%) MMF-treated patients (p < 0.01). Time to retransplantation or patient death was significantly shorter for AZA- than MMF-treated patients (P = 0.029). In patients undergoing intravascular ultrasound, the change in mean maximal intimal thickness was less for the MMF group than for the AZA group (0.06 +/- 0.03 mm vs 0.13 +/- 0.03 mm, respectively; p = 0.056). No significant differences between treatments were observed in quantitative coronary angiographic measurements of transplant coronary vasculopathy. Congestive heart failure, atrial arrhythmia and leukopenia were more common in the AZA group, whereas diarrhea, esophagitis, Herpes simplex, Herpes zoster and cytomegalovirus (CMV) tissue invasion were more common in MMF-treated patients.Conclusion: MMF reduces mortality and graft loss up to 36 months after transplantation. Copyright (c) 2005 by the International Society for Heart and Lung Transplantation.