[Dual, triple, and quadruple oral tacrolimus-based immunosuppression regimens after orthotopic liver transplantation: a randomised comparative study of regimens].
OBJECTIVE
To investigate the effects of tacrolimus-based immunosuppression regimens after orthotopic liver transplantation and search a reasonable regimen of combination therapy and suitable blood concentration of tacrolimus.


METHODS
Ninety-four adult recipients of cadaveric livers were randomly divided into 3 groups to undergo different tacrolimus-based immunosuppression regimens: dual (tacrolimus + glucocorticoid), triple [tacrolimus + mycophenolate mofetil (MMF) + glucocorticoid]; quadruple [tacrolimus + MMF + glucocorticoid in addition of induction treatment by daclizumab]. The efficacy and safety of the 3 groups 6 months after the transplantation were compared.


RESULTS
The frequencies of acute rejection were 25.9%, 11.1%, and 7.5% for the dual, triple, and quadruple therapy groups, that of the quadruple therapy group being significantly lower than that of the dual therapy group (P = 0.038). There were no significant differences in the rates Three months after transplantation, the levels of ALT and total cholesterol of the dual therapy groups were significantly higher than those of the quadruple therapy group (P(ALT) = 0.011, P(Tch) = 0.002). Within the first month post-operatively the concentration of tacrolimus of the triple therapy group could be controlled at the level 8 ng x ml(-1)-13 ng x ml(-1).


CONCLUSIONS
Quadruple tacrolimus-based immunosuppression regimen is the most effective and safest, followed by the triple therapy and dual therapy. Low-dose tacrolimus combination therapy provides an effective protection to the liver graft with mild drug toxicity to the patient.
Lu
An-wei
AW
Liver Transplant Unit, The First Affiliated Hospital, Medical College of Zhejiang University, Hangzhou 310003, China.
Zheng
Shu-sen
SS
Wu
Jian
J
Liang
Ting-bo
TB
Wang
Wei-lin
WL
Shen
Yan
Y
Zhang
Min
M
Shi
Shao-hua
SH
Wu
Ying-sheng
YS
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D003131:Combined Modality Therapy; D000077561:Daclizumab; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000627:therapeutic use; D006084:Graft Rejection / Q000517:prevention & control; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use; D007165:Immunosuppression Therapy / Q000379:methods*; D016031:Liver Transplantation / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D011184:Postoperative Period; D011446:Prospective Studies; D016559:Tacrolimus / Q000627:therapeutic use*; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D005938:Glucocorticoids; D007074:Immunoglobulin G; D000077561:Daclizumab; D009173:Mycophenolic Acid; D016559:Tacrolimus