Histological patterns of rejection using oral microemulsified cyclosporine and tacrolimus (FK506) as monotherapy induction after orthotopic liver transplantation

Liver. 2001 Oct;21(5):329-34. doi: 10.1034/j.1600-0676.2001.210505.x.


Background/aims: We describe the histological patterns of rejection in liver transplant recipients using induction therapies with cyclosporine and tacrolimus monotherapy compared with standard triple therapy as historical control.

Methods: Patients formed part of the initial cohort in an open-labelled, randomised pilot study and were selected consecutively if they had histological rejection and no other confounding diagnoses. There were 13 patients in the cyclosporine monotherapy group (CsA), 11 in the tacrolimus monotherapy group and 13 in the triple therapy group (CAP). The histology of liver biopsies was reassessed blindly and the severity of rejection was recorded.

Results: The total Royal Free Hospital (RFH) rejection scores as well as other histological features (zone 3 haemorrhage, apoptosis in zones 1 and 3, steatosis, cholestasis, nuclear vacuolation, lymphoblasts and ballooning) were comparable in the three groups. There was no difference in individual components of the histological features comprising the diagnosis of rejection, except that the portal inflammation score was significantly lower in the tacrolimus group when compared with the CsA group (p=0.04). There was no significant difference in the number of patients with moderate/severe rejection between the three groups. Overall, there was no significant increase in histological severity of rejection in the monotherapy groups.

Conclusions: The results suggest that the monotherapy may be as effective as the triple therapy in the initial post-transplant phase and that no particular graft histological changes were associated with the type of treatment.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Cyclosporine / administration & dosage*
  • Drug Therapy, Combination
  • Female
  • Graft Rejection / pathology*
  • Graft Rejection / prevention & control
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Intubation, Gastrointestinal
  • Liver / pathology*
  • Liver Transplantation*
  • Male
  • Middle Aged
  • Pilot Projects
  • Tacrolimus / administration & dosage*


  • Immunosuppressive Agents
  • Cyclosporine
  • Tacrolimus