Arns Wolfgang, Sommerer Claudia, Glander Petra, Ariatabar Toofan, Porstner Martina, May Christoph, Paulus Eva-Maria, Shipkova Maria, Fischer Wolfgang, Liefeldt Lutz, Hackenberg Ruth, Schemmer Peter, Domhan Sophie, Zeier Martin, Budde Klemens
Department of Nephrology, Medical Clinic Köln-Merheim, Cologne, Germany.
Clin Nephrol. 2013 Jun;79(6):421-31. doi: 10.5414/CN107908.
In a 6-month prospective, openlabel, multicenter study, 128 de novo kidney transplant patients receiving cyclosporine (CsA) and steroids were randomized to an intensified regimen of enteric-coated mycophenolate sodium (EC-MPS) or to a standard EC-MPS regimen to Week 6 posttransplant, after which the regimen was identical. In a follow-up study to Month 12 post-transplant (49 intensified regimen, 52 standard regimen), the reduced rate of BPAR observed at Month 6 (intensified regimen 3.2%, standard regimen 16.9%, p = 0.016) was maintained at Month 12 (4.8% vs. 18.5%, p = 0.026). Estimated GFR (Cockcroft-Gault) at Month 12 was comparable in the intensified group (mean (SD) 54.8 (22.9) ml/min) vs. the standard group (mean (SD) 57.5 (23.6) ml/min, p = 0.83). The incidence of adverse events and serious adverse events at Month 12 was similar in both treatment groups, although adverse events with a suspected relation to study drug were reported in 69.8% and 50.8% of patients in the intensified and standard regimen groups, respectively (p = 0.032). Infections and hematological parameters were similar between groups. In conclusion, an early regimen of intensified EC-MPS with CsA and steroids achieves a low rate of BPAR over the first year after kidney transplantation with similar renal function to a standard regimen, and without a clinically relevant impact on safety.
在一项为期6个月的前瞻性、开放标签、多中心研究中，128例接受环孢素（CsA）和类固醇治疗的初发肾移植患者被随机分为强化肠溶性霉酚酸钠（EC-MPS）方案组或标准EC-MPS方案组，移植后第6周前采用不同方案，之后方案相同。在一项移植后12个月的随访研究中（强化方案组49例，标准方案组52例），移植后第6个月观察到的BPAR降低率（强化方案组3.2%，标准方案组16.9%，p = 0.016）在第12个月时得以维持（4.8%对18.5%，p = 0.026）。强化组移植后第12个月的估计肾小球滤过率（Cockcroft-Gault）（均值（标准差）54.8（22.9）ml/分钟）与标准组（均值（标准差）57.5（23.6）ml/分钟，p = 0.83）相当。两个治疗组在第12个月时不良事件和严重不良事件的发生率相似，尽管强化方案组和标准方案组分别有69.8%和50.8%的患者报告了与研究药物可能相关的不良事件（p = 0.032）。两组间感染情况和血液学参数相似。总之，肾移植后第一年，早期采用强化EC-MPS联合CsA和类固醇的方案可实现较低的BPAR发生率，肾功能与标准方案相似，且对安全性无临床相关影响。
