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

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.

An experimental study on target antibody profile and the titer level as well as immune cross reaction of immunoglobulin products / 中国免疫学杂志

Objective:To study on the target antibody composition,the titer,and immune cross reaction of immunoglobulin products.Methods:ELISA kit for IgG antibody against varicella zoster virus,cytomegalovirus,herpes simplex Ⅰ and Ⅱ type virus,rabies virus,tetanus toxoid and IgG RIA kit specific to hepatitis virus surface antigen were utilized.The antibody titer of 5 kinds of specific immunoglobulin,and the IgG injection for either intramuscular or intravenous preparations was detected.Results:There were higher antibody titer against rabies,HBsAg and tetanus in the immunoglobulin preparations,probably due to the blood donors immunized with correspording vaccination.Compared with the antibody preparations of higher efficacy against cytomegalovicrus dotained by screening,there was a narrow disparity for the titer of the target antibody in the blood IgG preparations.In the population,also widespread existence for infection by varicella zoster virus and herpes simplex Ⅰtype virus,the antibody titer level was lower than those against cytomegalovirus,higher than herpes simplex Ⅱtype virus.Conclusion:All of the 7 kinds target antibody can be detected from the samples of immunoglobulin,antibody titer is related with active and passive immunity,higher titer of against cytomegalovirus can be induced by vaccine of varicella zoster virus,there is noticeable difference for antibody titer level between the intramuscular and intravenous injection immunoglobulin.