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Tacrolimus and mycophenolate mofetil are effective drugs characterized by specific toxicity profiles that may compromise their long‐term use in renal transplant recipients. Clinicians, therefore, need reliable drug monitoring tools for relating efficacy and toxicity to drug exposure.

We conducted a prospective 12‐month pharmacokinetic study of tacrolimus and mycophenolic acid in 100 de novo recipients. The aim was to examine whether tacrolimus and mycophenolic acid exposure parameters (predose trough blood concentration [C₀], area under the concentration curve from 0 to 12 hours [AUC_0–12], maximum blood or plasma concentration [C_max], and dose) would reflect clinical efficacy and toxicity at different time points after transplantation (7 days, 6 weeks, and 3, 6, and 12 months).

Initially, after grafting, the tacrolimus AUC_0–12 was higher in recipients with infection (P = .01 …