Clinical efficacy and safety of reduced-dose tacrolimus combined with increased-dose mycophenolate mofetil after renal transplantation / 器官移植

ABSTRACT

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 1 2 months in the Department of Organ Transplantation,Anhui Provincial Hospital from January 201 1 to January 201 3 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 1 5 d after study.And in control group, blood trough concentration of FK506 was kept in 5.5-1 0.0 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,1 5 d,and 2-,4-,6-,8-,1 0-,1 2-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 1 2 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-,1 0-and 1 2-month after treatment significantly differed between two groups (all in P <0.05).From 0 d to 1 2 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 1 0 and 1 2 months after corresponding treatment significantly differed between two groups (both in P <0.05).At 1 2 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.