重组乙型肝炎疫苗(酿酒酵母)上市后安全性的临床观察  

Post-marketing study on safety of recombinant hepatitis B vaccine(Saccharomyces cerevisiae)

作　　者：张岷 康国栋[2] 马燕丽 张志兰[3] 翟力军[4] 廉丽华[3] 陈海平 徐斌 杨云凯 马福宝[2] 

机构地区：[1]中国生物技术股份有限公司医学事务部,北京100029 [2]江苏省疾病预防控制中心,江苏南京210009 [3]南通市疾病预防控制中心,江苏南通226006 [4]北京市东城区疾病预防控制中心,北京100009 [5]北京天坛生物制品股份有限公司,北京100176

出　　处：《中国生物制品学杂志》2016年第11期1183-1186,共4页Chinese Journal of Biologicals

摘　　要：目的观察重组乙型肝炎疫苗(酿酒酵母)上市后大规模应用于新生儿的安全性。方法采用观察性队列研究方法,对2015年4月1日~8月30日期间在江苏省南通市辖区内新生儿按国家儿童免疫规划程序,常规接种重组乙型肝炎疫苗(酿酒酵母),分别通过《江苏省儿童预防接种个案信息管理系统》和《疑似预防接种异常反应(AEFI)信息管理系统》收集接种信息及接种后安全性数据,评价该疫苗应用于新生儿的安全性。结果 2015年4月1日~8月30日期间报告发生AEFI共37例,发生率为40.93/10万,无严重不良事件和严重非预期不良事件报告。37例AEFI病例中一般反应32例,异常反应5例,无偶合症与心因性反应报告;一般反应以接种后发热居多,占一般反应的67.57%,第3针接种后发热的发生率达69.84/10万;异常反应中过敏性皮疹2例,荨麻疹及热性惊厥各1例。37例AEFI病例不良反应主要出现在接种后30 min^24 h内,预后均良好。结论重组乙型肝炎疫苗(酿酒酵母)上市后在新生儿中具有良好的安全性。Objective To perform a post-marketing study on the clinical safety of recombinant hepatitis B（r HB）vaccine（Saccharomyces cerevisiae） in newborns. Methods A cohort study on r HB vaccine（S. cerevisiae） was conducted.Newborns from April 1 to August 30, 2015 in Nantong City, Jiangsu Province, China were immunized with the vaccine according to the schedule in national EPI. The data on vaccination and the safety after vaccination were collected through the Individual Information System of Vaccination in Children in Jiangsu Province and the AEFI Information System to evaluate the safety of the vaccine. Results A total of 37 cases of AEFI were reported during the period, indicating an incidence rate of 40. 93 / 100 000. No severe adverse events or severe unexpected events were observed. Of the 37 cases,32 were general reactions, while 5 were abnormal events, and no accidental or psychogenic reactions were reported. A portion of 67. 57% of the general reactions were fever, especially those occurred after the 3rd dose, with an incidence rate of 69. 84 / 100 000. The abnormal reactions included two cases of allergic rash, one case of urticaria and one case of febrile convulsion. The 37 cases of AEFI events mainly occurred within 30 min to 24 h after vaccination, with good prognosis. Conclusion The r HB vaccine（S. cerevisiae）showed good safety in newborns.

关 键 词：重组乙型肝炎疫苗(酿酒酵母) 安全性 异常反应 

分 类 号：R373.21[医药卫生—病原生物学] R186.3[医药卫生—基础医学]