Clinical Study Of Tacrolimus In Kidney Transplant Recipients Of End-Stage Diabetic Nephropathy

OBJECTIVE:In order to observe the efficacy of the renal transplantation in ESDN and compared the efficacy and safety of FK506-based versus CsA-based immunosuppression in renal transplant recipients of ESDN. METHODS:A total of 64 patients were randomized to FK506(n=33) or CsA(n=31) after cadaveric renal transplantation. The small dose tacrolimus was adapted.The survival of patients and grafts , the incidence of acute rejection > and the influences on the glucose metabolism, blood pressure x lipid metabolism and liver function were evaluated and compared between two groups. RESULTS: 1. The efficacy of the renal transplantation in ESDN1) The 1 year survival rate of recipients/grafts were 96.88%/92.19%: the incidence of acute rejection was 23.44%;2) Compared with the pre-transplantation, There were more patients (28.13% vs 74.19%, PO.001) need the isulin and more dose ofisulin (8.25 + 14.63u vs 32.32?8.43u, PO.001) were used 1 month after transplantation. After that the glucose metabolism recovered slowly. 1 year after operation, the percent of patients need insulin (28. 13% vs 45.76%, P<0. 05) and the he average dose of isulin (8. 25+14. 63u vs 15. 29+ 18. 1 lu, P<0. 001) were still significantly higher than that before operation;3) Compared with the pre-transplantation, 1 year after transplantation the incidence of hypertension (98.44% vs 76.27%, P<0.05 )was less; the incidence of hyperlipidemia (28.13 % vs 38. 98%, P>0.05 ) was the same as before.2. The compare between two FK506 and CsA.1) The 1 year survival of recipients/grafts were 96.97%/93.94% in FK506 group and 96.77%/90.32% in CsA group. There were no significant difference(P>0.05);2) The incidence of acute rejection were 12.12%in the FK506 group and 35.48% in the CsA group during the first year after the operation. There were significant difference(P<0.05);3) Glucose metabolism:The average insulin dose of the patients required insulin pre-operation between FK506 group and CsA group has no significant difference from the 1st month(55.56+18.27u vs 49.11+20.52u, P>0.05 ) till the 12th month(33.11+12.69u vs 29.56+13.48u, P>0.05)after the transplantation.The percemt of the patients need isulin who didn't requir insulin pre-operation between FK506 group and CsA group has no significant difference fron the 1st month(66. 67% vs 60%, P>0.05) till the 12th month(27. 27% vs 15. 79%, P>0. 05)after the transplantation.4) 1 year after transplantation, the percent anti-hypertension treatment (64.52% vs 89.29%, PO.05), the percent anti-hyperlipidemia group (25.81% vs 53.57%, PO.05 X the incidence of abnormal liverfunction ( 9.68% vs 39.29% , PO.05 ) of FK506 group weresignificantly less than those of CsA group. CONCLUSIONS:Renal transplantation for ESDN is effective. The small dose low concentration FK506 is effective for renal transplant recipients of ESDN, the side effect incidence of which was low and has almost the same influence on the glucose metabolism as the CsA.