Clinical application of sirolimus in renal post-transplant patients

Objective:To investigate the clinical application of sirolimus (SRL) in renal post-transplant patients. Methods: From January 2003 to December 2004, we adopted a protocol for renal transplantation which included sirolimus in place of mycophenolale mofetil. Their clinical course was evaluated during the first 6 months after surgery. Maintenance immunosupprcssion included sirolimus. corticosteroid and cy-closporine. Sirolimus dosing was initiated at 6 mg on the first day, from then on 1. 2-1. 5 mg as a single daily dose and adjusted to maintain the levels at 5-15 ng/ml. 25 cases were treated with SRL combined with low dose of CsA (4. 5-5 mg/kg·d) and prednisone(SRL group). Another 35 cases were treated with mycophenolate mofefil (MMF 1. 5-2. 0 g/d)combined with CsA (4. 5-5 mg/kg·d) and prednisone(MMF group). Results: Patients’ graft survival rate was 100%. There was no significant difference in average serum creatinine level and incidence of acute rejection between SRL group and MMF group[10. 0% (2/20) vs 11. 4% (4/35), P>0. 05], During the follow-up period, the incidence of side effect was similar in SRL group or MMF group, except for hyperlipidemia in SRL group. Sirolimus was discontinued in 5 patients for adverse events predominantly for numbness of oral lip, delayed renal allograft function, poor wound healing, liver or kidney function injury and pneumonitis. Conclusion: Early outcomes with sirolimus were acceptable with 100% graft survival and 10. 0% incidence of acute rejection. However, because of adverse events including poor wound healing and pneurnonitis, the immunosuppression regimen of SRL combined with low dose of CsA has been limited to clinical application in some degree in early transplant recipients. As one of therapeutical choices, it has been a long way to investigate SRL in clinical extension.