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Objective: To study the effect of tacrolimus (Prograf, FK506) in preventing renal allograft rejection. Methods: The curative effect, therapy index, toxicity and side effects of FK506 were observed in 294renal transplant recipients among whom 268 received FK506 24 h after the operation and the other 26 with cyclosporine (CsA) developed acute rejection after transplantation and were given FK506 to replace methylprednisolone (MP) when the latter did not result. All the patients were given oral mycophenolate mofetil (MMF, 1.0 g/d) and meticorten (Pred, 30 mg/d) 24 h later after operation. Results: In the 268 recipients previously mentioned, the incidence of acute rejection was 10. 45%, glycometabolism disorder 9.33%, nervous system disturbance 1.59%, liver function abnormality 2.99%, nephrotoxicity 1.87%, gastrointestinal disorder 17. 5%, cytomegalovirus (CMV) viremia 2.99%, and non-CMV pulmonary infection 1. 59%(4/268), with 1 fatal case for cerebral hemorrhage with normal allograft function and another 2 non-fatal cases in which function loss resulted in removal of the allografts. The blood trough concentrations of FK506were between 5 and 20μg/L. In the 26 cases of steroid-resistant rejection, 23 (88. 46%, 23/26) were reversed and the rest 3 required plasma exchange and application of OKT3 before recovery. Conclusion: As a safe and effective immunosuppressant, FK506 can reduce the incidence of allograft rejection in kidney transplant recipients with little side effects or toxicity, which is particularly applicable in patients with steroid-resistant rejection or CsA nephrotoxicity. Attention should to be paid to glycometabolism disorder due to FK506, however, the long-term effects of FK506 need further investigation.