Abstract:

BACKGROUND: Pharmacokinetics of healthy volunteers and patients undergoing renal transplantation shows that Mycophenolate Mofetil enteric coating tablets, dispersible tablets, and capsule display identical biological effects. However, the clinical effects remain unclear.
OBJECTIVE: To observe the effects and safety of cycopin (Mycophenolate Mofetil Dispersible Tablets) in combination with Cyclosporine A (CsA) and prednisone (Pred) as triple regimen for immunosuppressive therapy after living related renal transplantation.
METHODS: A total of 90 recipients of living related renal transplantation were randomized into two groups. In the study group, 45 patients were treated with cycopin, CsA and Pred. In the control group, 45 patients were treated with Cellcept (Mycophenolate mofetil capsule), CsA and Pred. The same concentration ranges of CsA were controlled in two groups. The use of prednisone was the same in two groups. Cycopin and Cellcept (body mass ≤ 70 kg, 0.5 g; body mass > 70 kg, 0.75 g) was taken two times a day. Any adverse event and the laboratory results were recorded and analyzed.
RESULTS AND CONCLUSION: All patients finished this study. The 6-month patient and graft survival rates in two groups were 100%. Only one case suffered from acute rejection respectively in each group. But the rejections were reversed by methylprednisolone. The difference of adverse event, the blood concentrations of triglyceride, total cholesterol and the level of serum creatinine in two groups were not significant. Cycopin is an effective and safe immunosuppressive drug for in vivo kidney transplantation and allows reducing the cost of drug.