Individualized mycophenolate mofetil therapy based on monitoring of mycophenolic acid trough level in cardiac transplant recipients / 中华器官移植杂志

ABSTRACT

Objective To compare clinical outcomes in cardiac transplant recipients treated with individualized dosing (ID) and fixed dosing (FD) of mycophenolate mofetil (MMF).Methods Fortyeight de novo cardiac transplant patients in ID group received MMF (2.0 g/day) in combination with calcineurin inhibitors and prednisone.The MMF dosages were adjusted individually based on clinical events and MPA trough levels (MPA-C0).The target range of C0 was maintained within 2.0-4.0rng/L.The FD group included 55 recipients retrospectively from the transplant database who were also treated with MMF (2.0 g/day).In this group,the MMF dose adjustment was performed empirically according to clinical events only.All of the follow-up data were collected up to 12 months post-transplantation.Results The follow-up rate was 95.8％ and the mean MPA-AUC0-12 was (54.37± 17.03) rng h-1 L-1 in the ID group.The mean MPA-C0 on the day 7 post-transplantation was significantly higher in the ID group than that at 12th month [(3.44 ± 0.58) mg/L vs.(2.79 ± 0.54)mg/L] (P＜0.05).The dose of MMF was significantly lower in the ID group at 4th week posttransplantation than in control group [(1.49± 0.48) g/day vs.(1.96 ± 0.39) g/d] (P＜0.05),while there was no significant difference at 12 th month post-transplantation [(1.61 ± 0.77) g/day vs.(1.68 ± 0.84) g/day] (P＞ 0.05).No significant difference was found in the incidence of acute rejection episode between two groups (8.7％ vs.9.1％,P＞0.05).57.6％ of overall side effects were observed within one month postoperatively,and the incidence of MPA-related side effects was significantly lower in the ID group than in the control group (47.8％ vs.67.3％,P＜0.05).Conclusion It was demonstrated that individualized use of MMF based on therapeutic drug monitoring may prevent MMF-related side effect and appears to be valuable to optimize the treatment of cardiac transplantation.