PMID- 32107364
OWN - NLM
STAT- MEDLINE
DCOM- 20201225
LR  - 20201225
IS  - 2329-0358 (Electronic)
IS  - 1425-9524 (Print)
IS  - 1425-9524 (Linking)
VI  - 25
DP  - 2020 Feb 28
TI  - Efficacy and Safety of a Quadruple Regimen Compared with Triple Regimens in 
      Patients with Mycophenolic Acid-Related Gastrointestinal Complications After 
      Renal Transplantation: A Short-Term Single-Center Study.
PG  - e919875
LID - 10.12659/AOT.919875 [doi]
AB  - BACKGROUND At present, there is no ideal conventional triple regimen that can 
      effectively treat gastrointestinal (GI) complications in patients after kidney 
      transplantation. We aimed to investigate the efficacy and safety of a quadruple 
      regimen including standard-dose tacrolimus, low-dose enteric-coated mycophenolate 
      sodium (EC-MPS), low-dose mizoribine (MZR), and corticosteroids, compared with 
      regimens containing standard-dose tacrolimus, corticosteroids, plus either 
      low-dose EC-MPS or standard-dose MZR in patients with mycophenolic acid 
      (MPA)-related GI complications after renal transplantation. MATERIAL AND METHODS 
      Between August 2016 and October 2018 in Qilu Hospital of Shandong University, 115 
      living donor kidney transplant recipients with MPA-related GI complications were 
      enlisted in a single-center, prospective, randomized, control study. Thirty-six 
      recipients were assigned to the low-dose EC-MPS plus low-dose MZR group, 37 
      recipients were assigned to the low-dose EC-MPS group, and 39 recipients were 
      assigned to the standard-dose MZR group. We analyzed the Gastrointestinal Symptom 
      Rating Scale (GSRS), estimated glomerular filtration rate (eGFR), graft 
      rejection, serum creatinine, human leukocyte antigen (HLA) antibody, and the 
      occurrence of adverse events among the 3 groups. RESULTS Compared with baseline, 
      gastrointestinal symptoms improved significantly in all 3 groups. The reduction 
      in mean subscale scores from baseline to month 3 was more significant in the 
      standard-dose MZR group compared with the other 2 groups. The low-dose EC-MPS 
      plus low-dose MZR group had better renal function. The incidence of graft 
      rejection and cytomegalovirus (CMV) and polyomavirus BK (BKV) infection, as well 
      as the incidence of hyperuricemia, in the low-dose EC-MPS plus low-dose MZR group 
      were all significantly reduced. CONCLUSIONS This quadruple regimen may be 
      equivalent to regimens containing standard-dose tacrolimus, corticosteroids plus 
      either low-dose EC-MPS or standard-dose MZR in improving GI symptoms after kidney 
      transplant, and is also advantageous for kidney function, graft rejection, and 
      the rates of adverse events.
FAU - Peng, Zhiguo
AU  - Peng Z
AD  - Department of Organ Transplantation, Qilu Hospital of Shan Dong University, 
      Jinan, Shandong, China (mainland).
FAU - Xian, Wanhua
AU  - Xian W
AD  - Department of Organ Transplantation, Qilu Hospital of Shan Dong University, 
      Jinan, Shandong, China (mainland).
FAU - Sun, Huaibin
AU  - Sun H
AD  - Department of Organ Transplantation, Qilu Hospital of Shan Dong University, 
      Jinan, Shandong, China (mainland).
FAU - Li, Engang
AU  - Li E
AD  - Department of Organ Transplantation, Qilu Hospital of Shan Dong University, 
      Jinan, Shandong, China (mainland).
FAU - Geng, Lina
AU  - Geng L
AD  - Department of Organ Transplantation, Qilu Hospital of Shan Dong University, 
      Jinan, Shandong, China (mainland).
FAU - Tian, Jun
AU  - Tian J
AD  - Department of Organ Transplantation, Qilu Hospital of Shan Dong University, 
      Jinan, Shandong, China (mainland).
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20200228
PL  - United States
TA  - Ann Transplant
JT  - Annals of transplantation
JID - 9802544
RN  - 0 (Adrenal Cortex Hormones)
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (Ribonucleosides)
RN  - 4JR41A10VP (mizoribine)
RN  - HU9DX48N0T (Mycophenolic Acid)
RN  - WM0HAQ4WNM (Tacrolimus)
SB  - IM
MH  - Adrenal Cortex Hormones/adverse effects/therapeutic use
MH  - Adult
MH  - Drug Therapy, Combination/adverse effects
MH  - Female
MH  - Gastrointestinal Diseases/etiology/*prevention & control
MH  - Graft Rejection/*drug therapy
MH  - Humans
MH  - Immunosuppressive Agents/*adverse effects/therapeutic use
MH  - Kidney Transplantation/*adverse effects
MH  - Male
MH  - Mycophenolic Acid/adverse effects/therapeutic use
MH  - Postoperative Complications/etiology/prevention & control
MH  - Prospective Studies
MH  - Ribonucleosides/adverse effects/therapeutic use
MH  - Tacrolimus/adverse effects/therapeutic use
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC7065508
EDAT- 2020/02/29 06:00
MHDA- 2020/12/29 06:00
PMCR- 2020/02/28
CRDT- 2020/02/29 06:00
PHST- 2020/02/29 06:00 [entrez]
PHST- 2020/02/29 06:00 [pubmed]
PHST- 2020/12/29 06:00 [medline]
PHST- 2020/02/28 00:00 [pmc-release]
AID - 919875 [pii]
AID - 10.12659/AOT.919875 [doi]
PST - epublish
SO  - Ann Transplant. 2020 Feb 28;25:e919875. doi: 10.12659/AOT.919875.