Objective  To evaluate the clinical efficacy and safety of reduced-dose tacrolimus(FK506) in combination with increased-dose mycophenolate mofetil (MMF) after renal transplantation.

  Methods  In this prospective study, 52 patients undergoing renal transplantation for over 12 months in the Department of Organ Transplantation, Anhui Provincial Hospital from January 2011 to January 2013 were recruited. All participants were randomly divided into the intervention group and control group(n=26 in each group). In the intervention group, blood trough concentration of FK506 was adjusted to 2.0-4.5 ng/ml and oral dose of MMF was adjusted to 1.5 g/d during 15 d after study. And in control group, blood trough concentration of FK506 was kept in 5.5-10.0 ng/ml and oral dose of MMF was 1.0 g/d constantly. The changes of the glomerular filtration rate (GFR) and serum creatinine (Scr) at 0 d, 15 d, and 2-, 4-, 6-, 8-, 10-, 12-month after corresponding treatment were statistically compared between two groups. At 1 year after therapy, triglyceride, total cholesterol and 24 h urinary protein levels were measured and compared between two groups. Moreover, the incidence of adverse reactions was also statistically compared.

  Results  During the period from 0 d to 12 months after treatment, GFR did not significantly change in the control group (P > 0.05), whereas the value in the intervention group was considerably elevated (P < 0.05). The changes in terms of the GFR at 8-, 10-and 12-month after treatment significantly differed between two groups (all in P < 0.05). From 0 d to 12 months after therapy, the levels of Scr were significantly decreased in two groups (both in P < 0.05), and more apparent decline was noted in the intervention group. The changes in the Scr levels at 10 and 12 months after corresponding treatment significantly differed between two groups (both in P < 0.05). At 12 months after therapy, there was no significant difference in the levels of total cholesterol, triglyceride and mean 24 h urinary protein between the control and intervention groups (all in P > 0.05). No acute rejection or renal allograft dysfunction occurred in two groups. And there was no significant difference in the incidence of adverse reactions between the intervention and control groups (P > 0.05).

  Conclusions  Combined therapy of reduced-dose FK506 and increased-dose MMF is an efficacious and safe immunosuppressive therapy.