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Freedom from rejection and stable kidney function are excellent criteria for steroid withdrawal in tacrolimus-treated kidney transplant recipients.
Ann. Transplant. 2002: 7 (3) s.28-31, il., tab., bibliogr. 5 poz.
Hasła klasyfikacyjne GBL:
dorośli 19-44 r.ż.
Objectives: This prospective, randomized, multicentre study investigated the efficacy and safety of two tacrolimus-based regimens and their potential to withdraw steroids. Methods: In total 489 patients were randomised to receive either tacrolimus and MMF (n=243) or tacrolimus and azathioprine (n=246) concomitantly with steroids in both treatment groups. The initial oral dose of tacrolimus was 0.2 mg/kg/day, MMF dose was 1 g/day, azathioprine was administered at 1-2 mg/day. Steroids were tapered from 20 mg/day to 5 mg/day. From month 3 onwards, steroids were withdrawn in patients who were free from steroid-resistant rejection and who had serum creatinine concentrations 160 ćmol/L. Study duration was 6 months. Results: Patient survival at month 6 was 98.3 p.c. (Tac/MMF/S) and 98.4 p.c. (Tac/AzaS), graft survival at 6 month was 95.0 p.c. (Tac/MMF/S) and 93.5 p.c. (Tac/Aza/S). The 6-month incidences of biopdy-proven acute rejection were 18.9 p.c. (Tac/MMF/S compared with 28.8 p.c. (Tac/Aza/S), p=0.038. The 6-month incidence of steroid-resistant acute rejection were 2.1 p.c. (Tac/MMF/S) and 4.9 p.c. (Tac/Aza/S), p=ns. At the end of month 3, steroid withdrawal was performed in 60.5 p.c. (Tac/MMF/S) and 48.8 p.c. (Tac/Aza/S) of patients, p 0.01. During months 4-6, 2.7 p.c. of patients in the Tac/MMF group had a biopsy-confirmed acute rejection compared with 0.8 p.c. of patients in the Tac/Aza group. In patients who continued to receive steroids, the incidences of biopsy-proven acute rejection during months 4-6 were 3.5 p.c. (Tac/MMF/S) and 132,8 ćmol/L (Tac/Aza/S). Conclusion: Both tacrolimus regimens are efficacious and safe. The combination of Tacrolimus and MMF achieved a lower rejection rate and permitted a higher proportion of steroid-free patients. Ther overall incidence of acute rejection was low and kidney function was good.
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