Deierhoi M H, Kauffman R S, Hudson S L, Barber W H, Curtis J J, Julian B A, Gaston R S, Laskow D A, Diethelm A G
Department of Surgery and Medicine, University of Alabama, Birmingham 35294-0007.
Ann Surg. 1993 May;217(5):476-82; discussion 482-4. doi: 10.1097/00000658-199305010-00007.
Mycophenolate mofetil (MM) is a new immunosuppressive agent that reversibly inhibits guanine nucleotide synthesis and DNA replication. Its activity is highly selective for T and B lymphocytes. Two open-label multicenter trials of MM in renal transplantation have been performed. This report summarizes the results from one center involved in these two trials.
The initial trial of MM was an open-label dose-ranging trial in primary cadaveric renal transplantation. Mycophenolate mofetil was included in the maintenance immunosuppression regimen from the day after transplantation. Of the 21 patients enrolled in this trial, one (5%) was withdrawn for side effects. There was one graft loss due to recurrent renal disease and two patients were withdrawn for difficulty with follow-up. Mean follow-up is 26 months, and patient and graft survival at 2 years are 100 and 95% respectively. The second trial was designed to study the efficacy of mycophenolate in reversing refractory renal allograft rejection. Patients enrolled in the trial had biopsy-proven acute rejection and had previously received at least one course of high-dose corticosteroids and/or OKT3. Of the 26 patients enrolled in this trial, one (4%) was withdrawn for side effects. There were two deaths. Mean follow-up is 20 months, and patient and graft survival at 12 months was 91 and 54%. The incidence of infections in the two groups was 38% and there were no deaths in either group attributable to infection.
The results of these two studies indicate that mycophenolate mofetil could be administered safely to renal allograft recipients for periods up to 2 years. It appears to be effective in reversing acute rejection in a high percentage of patients refractory to other forms of therapy.
霉酚酸酯（MM）是一种新型免疫抑制剂，可可逆性抑制鸟嘌呤核苷酸合成及DNA复制。其活性对T和B淋巴细胞具有高度选择性。已开展了两项关于MM在肾移植中应用的开放性多中心试验。本报告总结了参与这两项试验的一个中心的结果。
MM的初始试验是一项针对初次尸体肾移植的开放性剂量范围试验。从移植后次日起，霉酚酸酯被纳入维持免疫抑制方案。在该试验纳入的21例患者中，1例（5%）因副作用退出。有1例因复发性肾病导致移植肾失功，2例因随访困难退出。平均随访26个月，2年时患者和移植肾存活率分别为100%和95%。第二项试验旨在研究霉酚酸在逆转难治性肾移植排斥反应中的疗效。该试验纳入的患者经活检证实为急性排斥反应，且此前至少接受过一个疗程的大剂量皮质类固醇和/或OKT3治疗。在该试验纳入的26例患者中，1例（4%）因副作用退出。有2例死亡。平均随访20个月，12个月时患者和移植肾存活率分别为91%和54%。两组感染发生率均为38%，两组均无因感染导致的死亡。
这两项研究结果表明，霉酚酸酯可安全地给予肾移植受者长达2年。在很大比例的对其他形式治疗难治的患者中，它似乎对逆转急性排斥反应有效。
