Clinical comparison of tacrolimus and CsA in end stage renal disease of diabetic renal allograft recipients

Objective To compare the efficacy and safety of tacrolimus (FK506)-based versus cyclosporine (CsA)-based immunosuppression in end stage renal disease of diabetic renal allograft recipients. Methods A total of 64 patients were randomized to FK506 ( n =33) or CsA ( n =31) after cadaveric renal transplantation. The small dose low concentration tacrolimus was adapted. The dose of insulin was adjusted according to the level of the blood glucose. The incidence of acute rejection, the level of the glucose, the dose of insulin and the influences on blood pressure, lipid metabolism and liver function were compared and evaluated. Results The 1-year survival rate of recipients/grafts was 96.97 %/ 93.94 % in FK506 group and 96.77 %/ 90.32 % in CsA group. Four patients ( 12.12 %) had acute rejection in the FK506 group, and 11 patients ( 35.48 %) had acute rejection in the CsA group during the first year after the operation. The dose of the insulin in the FK506 group ( 34.35 ± 12.14 )U/d, ( 14.09 ± 4.22 )U/d had no significant difference ( P 0.05 ) with the CsA group ( 28.15 ± 8.33 )U/d, ( 13.05 ± 2.17 )U/d at the first month and 1 year after the operation. One year after the operation, 21 patients ( 63.63 %) were subjected to anti-hypertensiom, 5 patients ( 15.15 %) to anti-hyperlipidemia treatment and 3 patients ( 9.09 %) to liver protection treatment due to abnormal liver function in FK506 group, while in the CsA group 28 patients ( 90.32 %) were subjected to anti-hypertension, 13 patients ( 41.94 %) to anti-hyperlipidemia treatment and 11 patients ( 35.48 %) to liver protection treatment due to abnormal liver function. There were significant differences between the two groups.Conclusion The small dose low concentration FK506 is effective in the end stage renal disease of diabetic renal allograft recipients and side effect incidence of it was low, and it has almost the same influence on the glucose metabolism as the CsA.