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.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Organ Transplant Center, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, People's Republic of China.
authors.forename: H
authors.initials: H
authors.lastname: Zhang
authors.affiliation: Organ Transplant Center, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, People's Republic of China.
authors.forename: L
authors.initials: L
authors.lastname: Liu
authors.affiliation: Organ Transplant Center, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, People's Republic of China.
authors.forename: J
authors.initials: J
authors.lastname: Li
authors.affiliation: Organ Transplant Center, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, People's Republic of China.
authors.forename: Q
authors.initials: Q
authors.lastname: Fu
authors.affiliation: Department of Clinical Laboratory, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, People's Republic of China.
authors.forename: J
authors.initials: J
authors.lastname: Wan
authors.affiliation: Organ Transplant Center, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, People's Republic of China.
authors.forename: R
authors.initials: R
authors.lastname: Deng
authors.forename: H
authors.initials: H
authors.lastname: Wang
authors.affiliation: Organ Transplant Center, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, People's Republic of China.
authors.forename: J
authors.initials: J
authors.lastname: Liao
authors.affiliation: Organ Transplant Center, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, People's Republic of China.
authors.forename: W
authors.initials: W
authors.lastname: Deng
authors.affiliation: Organ Transplant Center, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, People's Republic of China.
authors.forename: S
authors.initials: S
authors.lastname: Deng
authors.affiliation: Organ Transplant Center, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, People's Republic of China.
authors.forename: L
authors.initials: L
authors.lastname: Chen
authors.affiliation: Organ Transplant Center, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, People's Republic of China.
authors.forename: C
authors.initials: C
authors.lastname: Wang
mesh_terms: D000328:Adult; D000368:Aged; D064591:Allografts / Q000503:physiopathology; D065095:Calcineurin Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D065095:Calcineurin Inhibitors; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid