신장이식에 있어서 Tacrolimus 용량 감량의 효용성과 임상결과

Abstract

Background: Immunosuppressive regimens with the fewest possible toxic effects are desirable for transplant recipients. This study evaluated the efficacy and relative toxic effects of four immunosuppressive regimens. Methods: We assigned 299 renal-transplant recipients to receive group A (standard-dose cyclosporine, mycophenolate mofetil, and corticosteroids), group B (low-dose cyclosporine, basiliximab induction, mycophenolate mofetil, and corticosteroids), group C (standard-dose tacrolimus, mycophenolate mofetil, and corticosteroids), or group D (low-dose tacrolimus, basiliximab induction, mycophenolate mofetil, and corticosteroids) regimens. We compared the groups according to graft function through estimated glomerular filtration rate (GFR), acute rejection, and allograft survival. Results: The mean calculated GFR in patients receiving low-dose tacrolimus (76.4 mL per minute) was higher than in the other three groups (range, 66.3 to 73.8 mL per minute). The rate of biopsy-proven acute rejection was lower in patients receiving low-dose tacrolimus (14.3%) than in those receiving standard-dose cyclosporine (29.6%), low-dose cyclosporine (19.8%), or standard-dose tacrolimus (23.8%). Allograft survival rates differed significantly among the four groups (P=0.006) and were highest in the low-dose tacrolimus group (99.9%). Serious adverse events were more common in the standard-dose tacrolimus group than in the other groups (51.2% vs a range of 41.4 to 42.3%), although a similar proportion of patients in each group had at least one adverse event during treatment (81.1 to 90.5%). Conclusions: A regimen of basiliximab, mycophenolate mofetil, and corticosteroids in combination with low-dose tacrolimus may be advantageous for renal function, allograft survival, and acute rejection rates, compared with regimens containing basiliximab induction plus either low-dose cyclosporine or standard-dose tacrolimus or with standard-dose cyclosporine without induction.