重组酵母乙肝疫苗联合不同剂量乙肝免疫球蛋白母婴阻断效果研究  

Effect of yeast recombinant hepatitis B vaccine combined with different doses of hepatitis B immunoglobulin to prevent mother to child transmission of hepatitis B

作　　者：徐兰英[1] 常战军[1] 刘建勋[1] 李杰[2] 孙奎霞[2] 庄辉[2] 程桂芝 魏红霞 陈炜卿 王莉敏[6] 胡志敏 

机构地区：[1]郑州市疾病预防控制中心院士工作站,郑州450007 [2]北京大学医学部病原生物学系,北京100088 [3]新密市妇幼保健院,河南新密452370 [4]巩义市妇幼保健院,河南巩义451200 [5]中牟县妇幼保健院,河南中牟451450 [6]郑州市妇幼保健院,郑州450012 [7]郑州市金水区总医院,郑州450003

出　　处：《医药论坛杂志》2016年第11期1-3,共3页Journal of Medical Forum

基　　金：国家科技重大专项资助(2008ZX10002-001)

摘　　要：目的通过随机双盲对照试验,评价10μg重组酵母乙肝疫苗联合不同剂量乙肝免疫球蛋白(HBIG)预防乙肝病毒母婴传播效果,为制定符合我国乙型肝炎母婴阻断的最佳免疫策略提供科学依据。方法以HBs Ag阳性母亲及其出生的新生儿为研究对象,建立前瞻性研究队列。新生儿出生后6h内注射10μg重组酵母乙肝疫苗和100IU或200IU乙肝免疫球蛋白,第2针和第3针乙肝疫苗分别于1月龄和6月龄接种,于接种第3针后1个月±7d采血,用雅培试剂检测乙肝五项,评价乙肝母婴阻断成功率。结果 100IU组和200IU组母婴阻断失败率分别为2.13%(4/188)和2.69%(6/223),抗-HBs阳转率分别为96.81%和96.86%,乙肝表面抗体几何平均滴度(GMT)分别为1238.91m IU/m L和886.91m IU/m L,差异均无统计学意义(P=0.962,0.976,0.108)。结论 10μg重组酵母乙肝疫苗联合100IU HBIG比联合200IU HBIG的母婴阻断效果更加经济有效。Objective To evaluate the immune - effect on 10μg hepatitis B vaccine made by recombinant DNA techniques in hansenula polymorpha yeast combined with different doses of hepatitis B immunoglobulin （HBIG） to prevent mother to child transmission of hepatitis B virus, using the double - blind randomized controlled trial, to provide a scientific basis for developing the best immunization strategy for prevent mother to child transmission of hepatitis B. Methods Established prospective cohort study with the HBsAg -positive mothers and their newborns, 6 hours after birth injection of 10μg of yeast recombinant hepatitis B vaccine and hepatitis B immuno - globulin（HBIG） 100IU or 200IU, the second and third doses of hepatitis B vaccine was vaccinated at 1 month and 6 month after birth respectively. Evaluated success rate of pre- vent mother to child transmission of hepatitis B, Serum samples were collected at one month ±7 day after the third dose of vaccination. Anti - HBs level was detected by Abbott reagent method. Results The failure rate of blocking perinatal transmission in newborns of 100 IU and 200 IU group were 2. 13% （4/188）and 2. 69% （6/223）respectively. No signifi- cant differences were noticed in efficacy of the two groups （P = 0. 962）. Respectively, hepatitis B surface antibody geomet-ric mean titer （GMT） was 1238. 91mIU/mL and 886. 91mIU/ mL, Seroproteetion rates （anti -HBs ≥ 10mIU/mL） were detected in 96. 81% and 96. 86%. The difference of GMT andthe HBsAg positive rates between the two groups were not significant （P = 0. 108,0. 976）. Conclusions Combined with 10 μg yeast recombinant hepatitis B vaccine＇ the passive - active immunoprophylaxis using 100 IU HBIG was more cost - effective than 200 IU HBIG.

关 键 词：乙型肝炎疫苗 乙肝免疫球蛋白 母婴阻断 

分 类 号：R512.62[医药卫生—内科学]