Department of General Surgery, Organ Transplantation Center, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong Province, China.
To evaluate the safety and efficacy of steroid-minimization in liver transplantation (LT) recipients with hepatitis B virus related deceases in China.
Between March 2000 and June 2007, 502 adult LT recipients mostly with hepatitis B related primary diseases were enrolled in a prospective open-label nonrandomized single-centre study. Four study groups were setup according to steroid-minimization protocols: Tacrolimus (TAC) with 6 months steroids withdraw (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 at least 36 months after LT.
There were no significant differences in 3-year survival rates, graft survival rates and chronic rejection (CR) among the four groups (P = 0.092, P = 0.113 and P = 0.684, respectively). There was also no difference in acute rejection (AR) within the 12 months after LT (P=0.514). The 3-year recurrence of HBV and HCC after LT was significantly different among all groups (lowest in TAC/Bas SA group; P = 0.037 and P = 0.029, respectively). The overall incidence of infections were 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 post-LT year 3, more than 90% of survival patients after LT could safely receive TAC monotherapy.
Bas SA immunosuppressive protocol can be achieved safely in LT and can reduce the hepatitis B and tumor recurrences, side effects of steroids after LT.