Ao Jianhua(敖建華，Dept Urol，301st Hosp PLA，Beijing 100853)… ∥Chin J Transplant.－2011，32(7).－99～40

Tacrolimus once daily(Advagraf)vs twice daily(Prograf)in De Novo renal transplantation:a multicentre，randomized，open label，parallel control phaseⅢ study

Ao Jianhua(敖建華，Dept Urol，301st Hosp PLA，Beijing 100853)… ∥Chin J Transplant.－2011，32(7).－99～40

ObjectiveTo compare the efficacy and safety of twice－daily tacrolimus(Tacrolimus BID;Prograf)vs once－daily prolonged release tacrolimus(Tacrolimus QD;Advagraf)，combined with steroids and mycophenolate mofetil in preventing acute rejection in De Novo renal transplantation patients.Methods241 patients from 11 centers were randomized into two groups with 3 months observation period post－transplantation.Advagraf was administered as a single oral dose in the morning(initially 0.1－0.15 mg/kg every day)and Prograf was administered in two equal oral doses 12 h apart(initially 0.l－0.15 mg/kg).Study visits were scheduled for days 1，3，7，14，28，56，84 post－transplantion.The efficacy， safety， compliance and adverse effects were compared between two groups.ResultsTotally 223 patients completed the study.The two groups were comparable in age，gender and primary disease.There were 12 episodes of acute rejection in each group.There was no graft loss or patient death in both groups.The incidence of drug related adverse events was 32.1 and 33.3%respectively in the control and experimental groups.Dosage was decreased in both groups and there was significant difference in each group.The trough level was similar at the initiate period.Twenty－eight days post－transplantation the trough level in Advagraf group was lower than in Prograf group.ConclusionAdvagraf has the same efficacy，safety and drug related adverse effects as Prograf.It is practical and feasible substituting Prograf with Advagraf in clinical practice.8 refs，2 tabs.

(Authors)