Objective: To evaluate the efficacy and safety of hepatitis B immunoglobulin (HBIG) by different medicating ways in patients with liver transplantation and to explore the methods for calculating the intravenous loading dosage of HBIG.
Methods: The patients enrolled were randomized into three groups (i.v group, i.m group and domino group). Under the combined utilization with Lamivudine, HBIG was given in different ways during anhepatic phase and the postoperative six days. The physical examination was done, the serum conversion rate of HBsAg was studied, the serum level of HBsAb titer, WBC, PLT, AST, GGT, TBIL, DBIL, CR, PT and PTA were tested daily within the postoperative seven days. The preoperative body weight, serum HBsAg and HBeAg titer were analyzed with the intravenous loading dosage of HBIG by multiple-factor linear regression (Stepwise).
Results: Both the average negative-conversion rate of serum HBsAg and the average increasing rate of serum HBsAb titer are significantly faster in i.v group and domino group than that in i.m group within the postoperative four days (P < 0.05). The regression equation to calculate the i.v loading dosage of HBIG (IU) by preoperative criteria was drawn as 1123 + 3.4 x serum HBsAg titer (IU/L) +73 x body weight (kg). There was no linear correlation found between the level of HBeAg and the loading dosage of HBIG. There were no significant difference in body temperature, pulse rate, respiratory rate, blood pressure, WBC, PLT, AST, GGT, TBIL, DBIL, CR, PT and PTA among the three groups within the postoperative seven days (P < 0.05). The rate of the second elevation of serum ALT was 10.3% (3/29), 3.4% (1/29) and 6.7% (2/30) in i.v group, i.m group and domino group, respectively (P < 0.05), and the rate of the local complications (sclerosis, edema, pain) at the injection site was 0, 89.6% (26/29) and 0, respectively (P < 0.05).
Conclusions: Based on the combined utilization of lamivudine and HBIG, the qualified intervention efficacy, less complications could be obtained by medicating HBIG in a domino way (i.v first, followed by i.m), which is worthy to be promoted.