Objective: To evaluate efficacy and safety on steroid withdrawal at the seventh day after liver transplantation.
Methods: Seventy-six adult patients undergoing first cadaveric liver transplantation from October 2005 to October 2007 were randomly divided into 7 day (n = 40) and 3 month (n = 36) steroid withdrawal groups. All patients received FK506 3 mg and intravenous methylprednisolone 1000 mg during intra-operation and FK506 thereafter was adjusted to predefined 8 - 12 microg/L from day 1 to month 6. Patients in 7 day steroid withdrawal group received 500, 240, 200, 160, 80, 40 and 20 mg intravenous methylprednisolone tapered daily from postoperative day 1 to day 7. In 3 month steroid withdrawal group, patients received the same protocol as 7 day steroid withdrawal group for intravenous methylprednisolone tapered daily from postoperative day 1 to day 7 and thereafter received oral prednisone 48, 40, 32, 24, 16, 8, 4 mg tapered every 3 days and maintained 4 mg to the 3(rd) month. All patients were followed up for 6 months. The incidence of treated acute rejection and side effects were evaluated between two groups.
Results: A total of 69 cases were fully followed up, and 7 cases were discontinued including death (n = 2), server infection (n = 2), protocol violation (n = 2) and retransplantation (n = 1). There were no statistical difference between 2 groups concerning the incidence of acute rejection, hypertension, hyperlipemia and other adverse events (P > 0.05), but significant difference in incidence of diabetes (17.5% vs. 38.9%, P = 0.047).
Conclusion: Steroid withdrawal strategy at day 7 is same safety and efficacy as steroid withdrawal at 3 month.