Abstract:

Objective To investigate the effects of pharmacokinetic intra-variability of cyclosporin A (CsA) on early clinical outcomes of recipients after renal transplantation. Methods Forty-four recipients undergoing triple immunosuppressive therapy of CsA, mycophenolate mofetil (MMF) and corticosteroid early after allogeneic renal transplantation were selected. The plasma concentration of mycophenolic acid (MPA), which was the active component of CsA and MMF, was measured with enzymemultiplied immunoassay technique (EMIT), including the valley value before medication (C0) and peak value 2 h after medication (C2), and the linear correlation of CsA C0 with CsA C2 was analysed. Correlation group and non-correlation group were divided according to the results of correlation analysis, the prevalences of clinical events (infection, acute rejection, acute rejection combined with infection, dysfunction of transplanted kidney, liver and renal toxic reaction to CsA) and qualification rates of area under the curve of plasma concentration of MPA-time （AUCMPA）early after transplantation were compared between groups. Results There was non-linear correlation of CsA C0 with CsA C2 in 31 patients (70.45%), and there was linear correlation in 13 patients (29.55%). Statistic analysis revealed that there were significant differences in the prevalences of all clinical events 2 to 4 weeks after transplantation, prevalence of acute injection 2 to 4 weeks after transplantation and qualification rate of AUCMPA 2 to 4 weeks after translplantation between correlation group and noncorrelation group (P≤0.05). Conclusion The linear correlation of C0 with C2 of pharmacokinetic parameters of CsA may predict the early clinical outcomes of recipients after renal transplantation.

Key words: cyclosporin A, pharmacokinetic, plasma drug concentration, valley value, peak value, linear correlation, renal transplantation