Clinical research of domestic tacrolimus in management of rejection following renal transplant

Objective To evaluate the efficacy and safety of domestic taerolimus in the manage-ment of acute rejection in renal transplantation reeipienta. Methods A multieeneter, open and com-parative study for domestic Taerolimua and Prograf was performed. Eighty reeipienta of first allogenie renal transplantation were randomized into 2 groups: ①Experimental group (accepting Fumeixin ad-ministration, n=58) included 23 males and 35 females with the mean age of(39.1±9.6)years. ②Control group(accepting Prograf administration, n=22) included 12 males and 10 females with the mean age of(41.34±8.5)years. There was no significant difference in the volume, warm and cold is-chemia time of donor renal, age and sex of donor. All of the 80 cases accepted tacrolimus (domestic or foreign made, at the dose of 0. 10～0. 15 mg·kg-1·d-1 , q 12 h) treatment that combined with MMF and prednisone posttransplantation. Tacrolimus CO was aimed to 8-12 ng/ml in the first 60 days and 5-10 ng/ml later. The dose of MMF was according to the rule of each transplantation center based on the following recommendation: 1.5-2.0 g/d for the weight above 70 kg, 1.5 g/d for the weight 50-69 kg, and 1.0 g/d for the weight below 49 kg, in two divided doses. Prednisone was ad- ministrated as per ruler of each center. Results Observation termination was 3 months. Morbility of actue rejection was 3.40% (2/58)and 13.6% (3/22) in experimental and control group(P>0.05). Ad-verse events including hypertension, hyperlipemia, hyperglycemia and slight abnormality of liver func-tion occurred in 36. 2%(21/58) and 36. 4% (8/22) cases of experimental and control group(P> 0. 05). The survival rate in the 2 groups was 100%. The dose of tacrolimus in experimental group was significantly lower than that in the control group at 8 and 12 weeks posttransplant, while drug valley concentration in serum was proximal in 2 groups during the whole observation period. Conclusion Domestic tacrolimus capsules can be used effectively and safely in the management of acute rejection in renal transplantation. Key words: Tacrolimus; Kidney transplantation; Rejection