Objective  To compare clinical efficacy and safety between standard double-and single-dose of basiliximab in renal transplantation.

  Methods  A total of 121 patients undergoing allogeneic cadaveric renal transplantation in Department of Urology of Renmin Hopsital of Wuhan University from January 2008 to May 2011 were recruited as study subjects. Among them, 53 patients were assigned into the double-dose of basiliximab group and they were intravenously administered with 20 mg of basiliximab before and 4 d after surgery according to product description. Sixty-eight cases were allocated in the single-dose of basiliximab group and they were given with 20 mg of basiliximab before renal transplantation. The changes of immune function in two groups during perioperative period were monitored. The incidence of adverse reactions including delayed graft function (DGF), acute rejection, pulmonary infection and the survival of patients and renal grafts were statistically compared between two groups.

  Results  There was no significant difference in preoperative humoral immune and cellular immune function between two groups. Compared with preoperative period, cellular and humoral immune function in both groups were inhibited by varying degree at 5 d after surgery (both in P < 0.05). Compared with patients in the single-dose group, cellular and humoral immune functions were evidently suppressed in the double-dose group (both in P < 0.05). Compared with the parameters assessed at 5 d after surgery, cellular and humoral immune functions were restored to varying degree at 15 d after surgery, whereas still significantly lower than preoperative levels (CD3, CD4, IgM and IgA). Partial parameters (CD8 and IgG) were persistently inhibited and continued to decline compared with the levels at 5 d after surgery. The incidence of DGF was 8% in the double-dose group, and 7% in the single-dose group. During 1-year follow-up, the rejection rates in the double-and single-dose groups were 13% and 12%, and the incidence of pulmonary infection was 9% and 10%. No statistical significance was noted between two groups in terms of these parameters (all in P>0.05). The 1-year survival of patients in the double-and single-dose groups was 94% and 98%, 93% and 96% for the survival of renal grafts. No statistical significance was found between two groups (both in P>0.05).

  Conclusions  Both double-and single-dose of basiliximab are efficacious in renal transplantation and do not increase the incidence of adverse reaction. The 1-year survival rates of patients and renal grafts between two groups are almost equivalent. Detection of immune function during perioperative period effectively guides individualized immune induction therapy.