静注乙肝人免疫球蛋白Ⅳ期临床研究报告  

Post market trial of hepatitis B immunogiobulin for intravenous administration

作　　者：魏宪义[1] 栾荣生[2] 严律南[3] 张艳兰[1] 张云娜[2] 孙喆[1] 蒋德席 

机构地区：[1]四川远大蜀阳药业股份有限公司,成都610214 [2]四川大学华西公共卫生学院 [3]四川大学华西医院肝胆外科

出　　处：《中华肝胆外科杂志》2013年第4期282-286,共5页Chinese Journal of Hepatobiliary Surgery

摘　　要：目的观察广泛使用条件下受试药物乙肝免疫球蛋白的疗效和不良反应。方法采用推荐的静注乙肝人免疫球蛋白使用剂量、多中心临床研究方法，在13家医院对525例乙肝相关性肝移植患者进行了（22．1±8．8）个月的防治乙肝复发临床的效果与药物相关不良反应观察。结果观察期内所有研究对象均未发现存在可能或肯定相关类型的药物不良反应；术后6个月内采用≥推荐药物剂量时，观察期内的再感染率低于4％；〈推荐药物剂量时，再感染率大于12％。结论受试药物的剂量与疗效存在明显的量效关系，药物的安全性及推荐用药方法的合理性再次得到了验证。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 tri- als 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 reac- tions 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.

关 键 词：免疫球蛋白 乙肝病毒 临床研究 

分 类 号：R51[医药卫生—内科学]