RESULTS OF A RANDOMIZED, PROSPECTIVE, MULTICENTER TRIAL OF MYCOPHENOLATE MOFETIL VERSUS AZATHIOPRINE IN THE PREVENTION OF ACUTE LUNG ALLOGRAFT REJECTION1
RESULTS OF A RANDOMIZED, PROSPECTIVE, MULTICENTER TRIAL OF MYCOPHENOLATE MOFETIL VERSUS AZATHIOPRINE IN THE PREVENTION OF ACUTE LUNG ALLOGRAFT REJECTION1
复制标题
霉酚酸酯与硫唑嘌呤预防急性同种异体肺移植排斥反应的随机、前瞻性、多中心试验结果1
DOI：
10.1097/00007890-200106270-00012
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发表时间：
2001
期刊：
影响因子：
6.2
通讯作者：
R. Duane Davis
中科院分区：
文献类型：
--
作者：
S. Palmer;M. Baz;L. Sanders;A. Miralles;C. Lawrence;J. Rea;D. Zander;L. Edwards;E. Staples;V. Tapson;R. Duane Davis
背景。虽然使用霉酚酸酯（MMF）降低了心脏和肾脏同种异体移植受者的急性排斥反应发生率，但其在肺移植中的作用仍存在争议。因此，我们在肺移植受者中进行了一项随机、前瞻性、开放标签、多中心的研究，以确定MMF与硫唑嘌呤（AZA）相比是否能减少急性同种异体移植排斥反应的发生。方法。1997年3月至1999年1月，来自两个中心的81名连续肺移植受者被前瞻性随机分配接受环孢素、皮质类固醇和每天2mg /kg的AZA或每天两次1g的MMF治疗。主要研究终点是在移植后6个月内活检证实的急性同种异体移植排斥反应。次要终点包括临床排斥反应、巨细胞病毒（CMV）感染、不良事件和生存。在1、3、6个月或临床指征时进行支气管镜检查。解释活检结果的病理学家对随机分组不知情。根据意向治疗对结果进行分析。组间均值和比例的比较分别采用两个样本t检验和Fisher精确检验。6个月生存率采用Kaplan-Meier法计算，log rank检验比较。结果。38名患者前瞻性随机接受AZA和43名MMF治疗。6个月时活检证实II级或以上急性同种异体移植排斥反应的发生率在AZA组为58%，在MMF组为63% （P =0.82）。MMF组和AZA组6个月生存率分别为86%和82% （P =0.57）。两组间巨细胞病毒感染率和不良事件发生率无显著差异。结论。急性排斥反应率和6个月时的总生存率在肺移植受者接受MMF或aza免疫抑制治疗时相似。
Background. Although the use of mycophenolate mofetil (MMF) has reduced the incidence of acute rejection in heart and kidney allograft recipients, its role in lung transplantation remains controversial. Therefore, we conducted a randomized, prospective, open-label, multicenter study in lung transplant recipients to determine whether MMF decreases episodes of acute allograft rejection when compared with azathioprine (AZA). Methods. Between March of 1997 and January of 1999, 81 consecutive lung transplant recipients from two centers were prospectively randomized to receive cyclosporine, corticosteroids, and either 2 mg/kg per day of AZA or 1 g twice daily of MMF. The primary study endpoint was biopsy-proven acute allograft rejection over the first 6 months posttransplant. Secondary endpoints included clinical rejection, cytomegalovirus (CMV) infection, adverse events, and survival. Surveillance bronchoscopies were performed at 1, 3, and 6 months, or if clinically indicated. Pathologists interpreting the biopsy results were blinded to the randomization. Results were analyzed according to intention-to-treat. Between group comparisons of means and proportions were made by using two sample t tests and Fisher’s exact tests, respectively. Six-month survival was calculated by the Kaplan-Meier method and compared by the log rank test. Results. Thirty-eight patients were prospectively randomized to receive AZA, and 43 MMF. The incidence of biopsy proven grade II or greater acute allograft rejection at 6 months was 58% in the AZA group and 63% in the MMF group (P =0.82). The 6-month survival rates in the MMF and AZA groups were 86% and 82%, respectively (P =0.57). Rates of CMV infection and adverse events were not significantly different between the two groups. Conclusions. Acute rejection rates and overall survival at 6 months are similar in lung transplant recipients treated with either MMF- or AZA-based immunosuppression.