Efficacy and safety of enteric-coated mycophenolate sodium in patients withde novoand maintenance renal transplantation

Abstract

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 77months after transplantation. The gastrointestinal symptoms improved significantly in 21 patients after conversion. Compared with the results at 1week, no obvious deterioration in serum creatinine, cystatin or estimated glomerular filtration rate was found at 1, 3 and 12months 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.