Qin Y, Zhang F, Shen B, Liu Y, Qiu J, Guo Y, Fan Y
Department of Kidney Transplantation, Clinical Centre of Urology, Shanghai Jiaotong University Affiliated First People's Hospital, Shanghai, China.
Int J Clin Pract Suppl. 2014 Apr(181):17-22. doi: 10.1111/ijcp.12402.
To evaluate the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS) in renal transplant patients treated de novo and for maintenance.
The efficacy and safety data of EC-MPS in renal transplant patients treated de novo and for maintenance in our hospital from July 2009 to March 2013 were reviewed.
Thirty-one patients treated with EC-MPS de novo were included: there were 16 male and 15 female patients. The acute allograft rejection rate was 12.9% (4/31) and pneumonia occurred in 25.8% patients (8/31); the allograft survival rate was 96.7% (30/31) with a patient survival rate of 96.7% (30/31). Gastrointestinal side effects occurred in four patients (12.9%). Only one patient discontinued EC-MPS and treatment was converted to bredinin because of gastrointestinal intolerance. Thirty-nine patients receiving mycophenolate mofetil (MMF) de novo treatment served as a control group. Five (13.2%) of 38 patients developed serious acute rejection and 10 patients (26.3%) had pulmonary infection. Eight (21.1%) patients suffered abdominal distention, diarrhoea and other gastrointestinal adverse reactions; the symptoms improved significantly after treatment change to mizoribine. Compared with the MMF de novo group, the allograft function, blood cell counts and urine protein were similar in the EC-MPS de novo treatment group. The incidence of gastrointestinal side effects was obviously lower in the EC-MPS group than in the MMF group, and there was no difference in serious acute rejection and pulmonary infection between the groups. The study also included 23 renal transplantation maintenance patients who suffered from chronic diarrhoea and treatment was changed to EC-MPS treatment. This change to EC-MPS was at 77 months after transplantation. The gastrointestinal symptoms improved significantly in 21 patients after conversion. Compared with the results at 1 week, no obvious deterioration in serum creatinine, cystatin or estimated glomerular filtration rate was found at 1, 3 and 12 months after the change. In addition, there was no marked decline in blood cell counts and no significant increase in urine protein.
The outcome of EC-MPS treatment in clinical practice of de novo kidney transplant patients was good, with high patient and graft survivals. In maintenance patients it induced an improvement in gastrointestinal side effects and a stable allograft function.
评估肠溶型霉酚酸钠（EC-MPS）在初治及维持治疗的肾移植患者中的疗效和安全性。
回顾性分析2009年7月至2013年3月我院使用EC-MPS进行初治及维持治疗的肾移植患者的疗效和安全性数据。
纳入31例初治使用EC-MPS的患者，其中男性16例，女性15例。急性移植肾排斥反应发生率为12.9%（4/31），25.8%的患者（8/31）发生肺炎；移植肾存活率为96.7%（30/31），患者存活率为96.7%（30/31）。4例患者（12.9%）出现胃肠道副作用。仅1例患者因胃肠道不耐受停用EC-MPS，改为布累迪宁治疗。39例初治使用霉酚酸酯（MMF）的患者作为对照组。38例患者中有5例（13.2%）发生严重急性排斥反应，10例患者（26.3%）发生肺部感染。8例患者（21.1%）出现腹胀、腹泻等胃肠道不良反应；改为咪唑立宾治疗后症状明显改善。与初治MMF组相比，初治EC-MPS组的移植肾功能、血细胞计数及尿蛋白情况相似。EC-MPS组胃肠道副作用发生率明显低于MMF组，两组严重急性排斥反应和肺部感染发生率无差异。本研究还纳入23例肾移植维持治疗患者，这些患者患有慢性腹泻，改为EC-MPS治疗。改为EC-MPS治疗是在移植后77个月。转换后21例患者的胃肠道症状明显改善。与转换后1周的结果相比，转换后1、3和12个月时血清肌酐、胱抑素或估计肾小球滤过率无明显恶化。此外，血细胞计数无明显下降，尿蛋白无明显增加。
在初治肾移植患者的临床实践中，EC-MPS治疗效果良好，患者和移植肾存活率高。在维持治疗患者中，它可改善胃肠道副作用并使移植肾功能稳定。
