新生儿接种不同种类和剂量乙型肝炎疫苗的安全性观察  

Safety of Different Types and Dose amounts of Hepatitis B Vaccines for Infants

作　　者：胡丹标[1] 刘世科[1] 黄美林[1] 葛宝湘[1] 孔志芳[1] 洪因之[1] 

机构地区：[1]宁海县疾病预防控制中心,浙江宁海315600

出　　处：《中国疫苗和免疫》2015年第1期77-79,共3页Chinese Journal of Vaccines and Immunization

基　　金：国家科学技术艾滋病和病毒性肝炎等重大传染病防治重大专项新生儿基础免疫接种不同种类乙型肝炎疫苗效果观察研究课题(编号:2008ZX10002-001)

摘　　要：目的了解新生儿接种10微克（μg）重组乙型肝炎（乙肝）疫苗（汉逊酵母）[Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid（DNA）Techniques in Hansenula Polymorpha Yeast,Hep B-HPY）]和5μg重组Hep B（酿酒酵母,Saccharomyces Cerevisciae Yeast）（HepB-SCY）的安全性。方法选择本县医院产科出生的新生儿分为实验组与对照组,分别接种10μg Hep B-HPY和5μg HepB-SCY,观察两种HepB的安全性。结果 10μg HepB-HPY接种了13988剂,发生不良反应5例,其中1例为发热,3例为接种部位的红肿,1例为接种部位的硬结,不良反应总发生率为35.74/10万剂;5μg HepB-SCY接种了9058剂,发生不良反应4例,其中3例为发热,1例为接种部位红肿,不良反应总发生率为44.16/10万剂,两种HepB不良反应总发生率的差异无统计学意义（χ^2=0.752,P=0.745）。结论接种10μg HepB-HPY和5μg HepB-SCY均有良好的安全性。Objective To determine the safety of 10p, g Hepatitis B vaccine （HepB） made by recombinant deoxyribonucleic acid （DNA） techniques in Hansenula Polymorpha yeast （HepB-HPY）and 5μg HepB made in a different yeast （Saccharomyces Cerevisiae yeast） （HepB-SCY）. Methods Infants born in Ninghai county hospital were divided into 2 groups. The experimental group was administered 10μg HepB-HPY, while the other group received 5μg HepB-SCY. We observed the groups for safety signals. Results Among the 13,988 doses of 10μg HepB-HPY administered, 5 adverse reactions occurred： 1 case of fever, 3 cases of injection site redness and swelling, and 1 case of injection site induration. The incidence of adverse reactions was 35.74/100,000. Among the 9,058 doses of 5μg HepB-SCY, there were 4 adverse reactions ： 3 cases of fever and 1 case of injection site redness. The incidence of adverse reactions was 44.16/100,000. There was no statistical significant difference between the incidence of ad- verse reaction between the HepB-HPY group and the HepB-SCY group （X^2 = 0. 752,P = 0. 745）. Con- clusions The safety of 10μg HepB-HPY was the same as that of 5 μg HepB-HPY.

关 键 词：新生儿 预防接种 重组乙型肝炎疫苗 安全性 

分 类 号：R186[医药卫生—流行病学] R512.62[医药卫生—公共卫生与预防医学]