Wyzgał J, Niemczyk M, Ziółkowski J, Durlik M, Wiecek A
Department of Immunology, Transplant Medicine and Internal Diseases, Transplantation Institute, Medical University of Warsaw, Warsaw, Poland.
Transplant Proc. 2007 Nov;39(9):2730-2. doi: 10.1016/j.transproceed.2007.08.071.
Mycophenolate sodium (MPS) was designed to reduce the gastrointestinal side effects of mycophenolic acid. The aim of our study was to determine the safety and efficacy of MPS in de novo renal transplant recipients.
This 6-month, multicenter, open-label, single-arm, prospective study was carried out in three centers in Poland. Thirty patients were recruited. Immunosuppressive regimen contained of MPS and cyclosporine (CsA) with or without steroids.
The 6-month graft and patient survival was 100%. The incidence of suspected acute rejection episodes (ARE) was 5/30 (16.7%), including biopsy-proven ARE in 2 (6.7%) cases. ARE reversed after therapy. At month 6, the mean serum creatinine level was 1.4 mg/dL, and the mean creatinine clearance (according to the Cockroft-Gault formula) was >70 mL/min. The most frequent adverse effects included diarrhea, delayed graft function, anemia, and lymphocele. Among infections, most common were infections of urinary tract, cytomegalovirus infections, and infections of respiratory tract. Only three patients (10.0%) terminated the study prematurely, including two who discontinuated because of an adverse event, and one because of noncompliance.
An immunosuppressive regimen, including MPS and CsA, with or without steroids, provided effective antirejecton prophylaxis and was well tolerated.
吗替麦考酚酯钠（MPS）旨在减少霉酚酸的胃肠道副作用。我们研究的目的是确定MPS在初次肾移植受者中的安全性和有效性。
这项为期6个月的多中心、开放标签、单臂前瞻性研究在波兰的三个中心进行。招募了30名患者。免疫抑制方案包括MPS和环孢素（CsA），加或不加类固醇。
6个月时移植物和患者存活率为100%。疑似急性排斥反应（ARE）的发生率为5/30（16.7%），其中2例（6.7%）经活检证实为ARE。治疗后ARE逆转。在第6个月时，平均血清肌酐水平为1.4mg/dL，平均肌酐清除率（根据Cockcroft-Gault公式）>70mL/min。最常见的不良反应包括腹泻、移植肾功能延迟、贫血和淋巴囊肿。在感染中，最常见的是尿路感染、巨细胞病毒感染和呼吸道感染。只有3名患者（10.0%）提前终止了研究，其中2名因不良事件停药，1名因不依从停药。
包括MPS和CsA、加或不加类固醇的免疫抑制方案提供了有效的抗排斥预防，且耐受性良好。
