Post market trial of hepatitis B immunoglobulin for intravenous administration / 中华肝胆外科杂志
Chinese Journal of Hepatobiliary Surgery
;
(12): 282-286, 2013.
Article
Dans Chinois
| WPRIM
| ID: wpr-436136
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.
Texte intégral:
Disponible
Indice:
WPRIM (Pacifique occidental)
langue:
Chinois
Texte intégral:
Chinese Journal of Hepatobiliary Surgery
Année:
2013
Type:
Article
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