【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。更多还原

【Abstract】 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.MethodsEstablished prospective cohort study with the HBsA g-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 prevent 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.ResultsThe 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 significant differences were noticed in efficacy of the two groups(P=0.962).Respectively,hepatitis B surface antibody geometric mean titer(GMT)was 1238.91mI U/mL and 886.91mI U/mL,Seroprotection rates(anti-HBs≥10mI U/mL)were detected in 96.81%and 96.86%.The difference of GMT and the HBsAg positive rates between the two groups were not significant(P=0.108,0.976).ConclusionsCombined with10μg yeast recombinant hepatitis B vaccine’the passive-active immunoprophylaxis using 100 IU HBIG was more costeffective than 200 IU HBIG.更多还原