Post market trial of hepatitis B immunoglobulin for intravenous administration / 中华肝胆外科杂志

ABSTRACT

Objective To observe the efficacy and adverse reaction of the test drug hepatitis B immunoglobin on the post market.Method Employed by the methods of multiple center's clinical trials and using the recommended dosage of hepatitis B immunoglobulin for intravenous administration,the clinical efficacy of either prevention or treatment for hepatitis B recurrence and drug related adverse reactions were observed.This consisted of 22.1 months,13 hospitals,and 525 patients with hepatitis B related liver transplantation.Result The results showed a contrasting probability of adverse reactions for different doses among the observation period.Within 6 months postoperatively with a greater or equal to recommended drug dose,the infection rate was less than 4％.In contrast,the infection rate was greater than 12％ in the group with less than the recommended drug dose.Conclusion There was an obvious dose effect relationship,and the drug safety and recommended treatment rationality were verified.