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- Title
The efficacy and safety of intensified enteric-coated mycophenolate sodium with low exposure of calcineurin inhibitors in Chinese de novo kidney transplant recipients: a prospective study.
- Authors
Zhang, H.; Liu, L.; Li, J.; Fu, Q.; Wan, J.; Deng, R.; Wang, H.; Liao, J.; Deng, W.; Deng, S.; Chen, L.; Wang, C.
- Abstract
<bold>Aims: </bold>The aim of this study was to investigate the efficacy and safety of a transient intensified enteric-coated mycophenolate sodium (EC-MPS) dosing regimen with low exposure of calcineurin inhibitors (CNIs) in Chinese de novo kidney transplantation.<bold>Methods: </bold>In a 6-month prospective study, a total of 97 recipients were enrolled and assigned to either an intensified EC-MPS dosing (IS) regimen or a standard EC-MPS dosing (SD) regimen. The area under the curve (AUC) of MPA was assessed at week 1 post transplant. The incidences of acute rejection, patient and graft survival, renal allograft function and adverse events were analysed.<bold>Results: </bold>The IS regimen displayed a trend of acute rejection risk reduction (IS 2.7% vs. SD 13.3%, p = 0.061) and allograft function improvement (IS 62.8 ± 14.0 ml/min per 1.73 m(2) vs. SD 56.6 ± 18.3 ml/min per 1.73 m(2) , p = 0.084) after 6-month follow-up. MPA-AUC0-12 h was substantially higher in the intensified EC-MPS group than the standard EC-MPS group, though without a significant difference (71.4 ± 41.7 vs. 53.0 ± 27.0 mg·h/l, p = 0.107). The IS regimen did not increase the incidence of adverse effects (IS 54.1% vs. 45.0%, p = 0.39), including diarrhoea or leucopenia.<bold>Conclusions: </bold>The intensified EC-MPS dosing regimen maintaining low-dose CNIs in this study may be beneficial for Chinese adult de novo kidney transplant recipients in terms of acute rejection and allograft function and is safe within 6 months post transplant.
- Subjects
COMBINATION drug therapy; CLINICAL trials; GRAFT rejection; GRAFT versus host reaction; HOMOGRAFTS; IMMUNOSUPPRESSIVE agents; KIDNEY transplantation; LONGITUDINAL method; SURGICAL complications; TREATMENT effectiveness; MYCOPHENOLIC acid; DRUG administration; DRUG dosage
- Publication
International Journal of Clinical Practice, 2016, Vol 70, p22
- ISSN
1368-5031
- Publication type
journal article
- DOI
10.1111/ijcp.12813