Burg M, Säemann M D, Wieser C, Kramer S, Fischer W, Lhotta K
Department of Internal Medicine/Nephrology, Nephrological Center, Hann, Muenden, Germany.
Transplant Proc. 2009 Dec;41(10):4159-64. doi: 10.1016/j.transproceed.2009.08.078.
A main cause for gastrointestinal (GI) complications in graft recipients is the routinely administered inosine monophosphate dehydrogenase inhibitor mycophenolic acid (MPA). MPA is available in two formulations, the prodrug mycophenolate mofetil (MMF) and the enteric-coated sodium salt (EC-MPS). Clinical results point to a better GI tolerability of EC-MPS as compared to MMF. We performed an open surveillance study in 397 organ graft recipients to investigate the clinical tolerability of EC-MPS in renal graft recipients who were converted from MMF to EC-MPS (maintenance) or who received EC-MPS as a new component of their immunsuppressive regimen (de novo). Physicians recorded GI symptoms (nausea, emesis, anorexia, diarrhea, abdominal cramps) at the start of EC-MPS treatment (visit 1) and at the next two visits in the clinic (visits 2 and 3); general tolerability (very good/good/moderate/poor) was assessed at visit 2 and 3. Two hundred seventy-five patients were on maintenance treatment with MMF and were converted to equimolar doses of EC-MPS, and 122 patients received EC-MPS de novo. The mean time since transplantation was 4.2 +/- 4.4 years. Median time until visit 2 was 28 days and until visit 3, 65 days. In 63.0% of patients, tolerability was rated as very good at visit 2 and in 64.7% at visit 3. Most patients who had suffered from GI complications during preceding MMF treatment reported improvement or total disappearance of their symptoms after conversion to EC-MPS. In conclusion, EC-MPS is a useful means to reduce GI complications in MPA-treated patients.
移植受者发生胃肠道（GI）并发症的一个主要原因是常规使用的肌苷单磷酸脱氢酶抑制剂霉酚酸（MPA）。MPA有两种剂型，即前体药物霉酚酸酯（MMF）和肠溶包衣钠盐（EC-MPS）。临床结果表明，与MMF相比，EC-MPS的胃肠道耐受性更好。我们对397名器官移植受者进行了一项开放性监测研究，以调查EC-MPS在从MMF转换为EC-MPS（维持治疗）或接受EC-MPS作为免疫抑制方案新组分（初治）的肾移植受者中的临床耐受性。医生在EC-MPS治疗开始时（访视1）以及在接下来的两次门诊访视时（访视2和3）记录胃肠道症状（恶心、呕吐、厌食、腹泻、腹部绞痛）；在访视2和3时评估总体耐受性（非常好/好/中等/差）。275例患者接受MMF维持治疗并转换为等摩尔剂量的EC-MPS，122例患者初治时接受EC-MPS。移植后的平均时间为4.2±4.4年。到访视2的中位时间为28天，到访视3的中位时间为65天。在63.0%的患者中，访视2时耐受性被评为非常好，访视3时为64.7%。大多数在之前MMF治疗期间出现胃肠道并发症的患者在转换为EC-MPS后报告症状有所改善或完全消失。总之，EC-MPS是减少MPA治疗患者胃肠道并发症的一种有用方法。
