title: Safety and efficacy of four steroid-minimization protocols in liver transplant recipients: 3-year follow-up in a single center.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of steroid-minimization therapy in liver transplantation (LT) recipients with hepatitis B virus-related diseases in China.
  
  
  METHODS
  From March 2000 to June 2007, 502 adult LT recipients, mostly with hepatitis B (HBV)-related diseases, were enrolled in our study. Four study groups were setup according to the steroid-minimization protocols: tacrolimus (TAC) with 6 months steroids withdrawal (6M SW), TAC with 3 months SW (3M SW), TAC with 14 days SW (14d SW), and TAC with basiliximab induction and steroids avoidance (Bas SA). All patients were followed up for at least 36 months after LT.
  
  
  RESULTS
  There were no significant differences in the overall 3-year survival rates of the patients and graft, and chronic rejection among the four groups (P = 0.092, P = 0.113 and P = 0.684, respectively). There was also no difference in acute rejection within 12 months after LT (P = 0.514). The 3-year recurrence rates of HBV infection and hepatocellular carcinoma (HCC) after LT were significantly different among all the groups (lowest in TAC/Bas SA group; P = 0.037 and P = 0.029, respectively). The overall incidence of infection was significantly higher in the 6M SW group (62.2% vs 56.1% in 3M SW, 30.5% in 14d SW, 20.5% in Bas SA; P < 0.01). By the end of the 3-year follow-up, more than 90% of the surviving patients could safely receive TAC monotherapy.
  
  
  CONCLUSIONS
  Bas SA immunosuppressive protocol can be achieved safely in LT and reduce HBV infection and HCC recurrence and side effects of steroids after LT.
authors.affiliation: Department of General Surgery, Organ Transplantation Center, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong Province, China.
authors.forename: An Bin
authors.initials: AB
authors.lastname: Hu
authors.forename: Lin Wei
authors.initials: LW
authors.lastname: Wu
authors.forename: Qiang
authors.initials: Q
authors.lastname: Tai
authors.forename: Xiao Feng
authors.initials: XF
authors.lastname: Zhu
authors.forename: Xiao Shun
authors.initials: XS
authors.lastname: He
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D001424:Bacterial Infections / Q000209:etiology; D000077552:Basiliximab; D006528:Carcinoma, Hepatocellular / Q000601:surgery*; D016009:Chi-Square Distribution; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control; D006085:Graft Survival; D019694:Hepatitis B, Chronic / Q000150:complications / Q000188:drug therapy; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008103:Liver Cirrhosis / Q000601:surgery / Q000821:virology; D008113:Liver Neoplasms / Q000601:surgery*; D016031:Liver Transplantation / Q000276:immunology / Q000379:methods*; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000276:immunology; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage* / Q000009:adverse effects; D012008:Recurrence; D018709:Statistics, Nonparametric; D015996:Survival Rate; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab; D016559:Tacrolimus; D008775:Methylprednisolone