[Clinical study of tacrolimus in postoperative treatment of patients with renal transplantation for diabetic end-stage renal disease].
OBJECTIVE
To compare the efficacy and safety of tacrolimus (FK506)- versus cyclosporine (CsA)-based immunosuppression protocol in the treatment of patients with renal transplantation for diabetic end-stage renal disease.


METHODS
A total of 64 patients with end-stage renal disease were randomized into FK506 (n=33) and CsA (n=31) group after cadaveric renal transplantation, the former group adopting small-dose FK506 therapy with low trough concentration, and the latter receiving CsA therapy. The dose of insulin was adjusted according to blood glucose level of the patients after the operation. The incidence of acute rejections, blood glucose level, the dose of insulin and changes in blood pressure, lipid metabolism and liver function were compared between the two groups.


RESULTS
The 1-year patient/graft survival rates were 96.97%/93.94% in FK506 group and 96.77%/90.32% in CsA group. Four patients (12.12%) developed acute rejection in the FK506 group, while 11 (35.48%) did in the CsA group during the first year after the operation (P<0.05). The dose of the insulin of the FK506 group (34.35 U/d, 14.09 U/d) was not significantly different from that in the CsA group (28.15 U/d, 13.05 U/d) at the first month and 1 year after the operation (P>0.05). One year after the operation, 21 patients (63.63%) required anti-hypertension treatment, 5 (15.15%) needed anti-hyperlipidemia treatment and 3 (9.09%) had abnormal liver function in FK506 group, while in the CsA group, 28 patients (90.32%) needed anti-hypertension therapy, 13 (41.94%) received anti-hyperlipidemia treatment and 11 (35.48%) showed signs of abnormal liver function, with significant differences between the two groups.


CONCLUSIONS
Small-dose FK506 therapy with low concentrations is effective in the postoperative management of patients with renal transplantation for diabetic end-stage renal disease, with only mild adverse effect. FK506 is comparable with CsA in terms of the effect on glucose metabolism of the patients.
Yu
Li-xin
LX
Department of Kidney Transplantation, Nanfang Hospital, First Military Medical University, Guangzhou 510515, China.
Shan
Hai-tao
HT
Fu
Shao-jie
SJ
Du
Chuan-fu
CF
Ma
Jun-jie
JJ
Xu
Jian
J
Deng
Wen-feng
WF
Wang
Yi-bin
YB
D000368:Aged; D003928:Diabetic Nephropathies / Q000601:surgery*; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007515:Islets of Langerhans / Q000503:physiopathology; D007676:Kidney Failure, Chronic / Q000601:surgery*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology; D016559:Tacrolimus / Q000009:adverse effects / Q000627:therapeutic use*
D007166:Immunosuppressive Agents; D016559:Tacrolimus