成人乙型肝炎疫苗无（弱）应答者不同剂量复种效果分析  

Revaccination efficacy of different dosages of hepatitis B vaccine among adult non- and hyporesponders

作　　者：林潮双[1] 王舜钦[2] 凌小强[1] 王向阳[2] 崇雨田[1] 高志良[1] 

机构地区：[1]中山大学附属第三医院感染病科,广州510630 [2]广东出入境检验检疫局附属广东国际旅行卫生保健中心

出　　处：《中华传染病杂志》2009年第2期109-113,共5页Chinese Journal of Infectious Diseases

基　　金：广东省科技计划资助项目（2008B030301048）;国家质检总局广东出入境检验检疫局科技计划项目（2005GDK44）

摘　　要：目的探讨成人乙型肝炎（乙肝）疫苗接种后无（弱）应答者不同方案再免疫的效果，以提高乙肝疫苗预防接种的保护率。方法采用随机、开放性的研究方法，对2年内至少完成1个标准乙肝疫苗免疫接种程序、复查HBV标志物均为阴性的健康人群，随机接受4种接种方案，按常规程序（0、1、6个月）在上臂三角肌予肌内注射。国产10μg组73例，国产基因重组乙肝疫苗复种，每次剂量为10μg；国产20μg组69例，国产基因重组乙肝疫苗复种，每次剂量为20μg；进口20μg组70例，基因重组酵母乙肝疫苗（商品名：安在时）复种，每次剂量为20μg；进口40μg组48例，基因重组酵母乙肝疫苗，每次剂量为40μg。在复种首针乙肝疫苗前及复种首针后第1、2、8、12个月采血检测抗-HBs。均数比较采用单因素方差分析，率的比较采用Х^2检验。结果接种后8个月，国产20μg、进口20μg、进口40μg组抗-HBs阳性率最高，分别为68．1％、70．0％和77．1％，均高于国产10μg组的53．4％（Х^2=21．465，P〈0．01）。国产20μg、进口20μg、进口40μg组随接种次数增加及时间延长，抗-HBs阳性率有所增加，但差异无统计学意义，12个月时有所下降；国产10μg组首次接种后1、2、8、12个月，抗-HBs阳性率依次为8．2％、19．2％、53．4％和43．8％，差异有统计学意义（Х^2=53．07，P〈0．01）。12个月时，国产20μg、进口20μg、进口40μg组抗-HBs效价均高于国产10μg组（F=7．551，P〈0．05）。国产20μg、进口20μg、进口40μg组不同时间点抗-HBs效价比较，差异无统计学意义。结论对乙肝疫苗无（弱）应答者复种疫苗仍能产生免疫应答，增加疫苗剂量可提高疗效。Objective To investigate the revaccination efficacy of different dosages of hepatitis B vaccine among adult non-and hyporesponders so as to improve the protection rate of hepatitis B vaccination. Methods The healthy adults who were immunized with hepatitis B vaccine at least one standard scheme in two years and negative for hepatitis B markers were enrolled in this randomized and open-label study. The hepatitis B vaccine was injected intramuscularly in the deltoid muscle on an upper arm according to routine schedule （month 0, 1, 6）. The adults were randomly given four different dosages： 73 in group A were given hepatitis B vaccine 10 μg （made in China） each time; 69 in group B were given hepatitis B vaccine （made in China） 20 μg each time; 70 in group C were given gene recombinant yeast hepatitis B vaccine （Engerix） 20 μg each time and 48 in group D were given gene recombinant yeast hepatitis B vaccine 40 μg each time. The serum anti-HBs was tested before and 1, 2, 8, 12 months after the first injection. The comparison of means was done by one-factor analysis of variance and the comparison of rates was done by chi square test. Results The anti-HBs positive rates were the highest at months 8 of re-immunization in group B, C and D, which were 68. 1%, 70.0% and 77.1%, respectively, and were all higher than that in group A （53.4%） （Х^2 =21. 465, P^0.01）. The anti-HBs positive rate increased in group B, C and D with increasing immunized times and over time, but there was no significant differenee. it went down at 12 months after re-immunization. The anti-HBs positive rates at 1, 2, 8 and 12 months after re-immunization in group A were 8.2%, 19.2%, 53.4% and 43.8%, respectively and differences were significant（Х^2=53.07, P〈0.01）. The anti-HBs levels in group B, C and D were all higher than that of group A（F=7. 551, P〈0.05） at month 12 of re-immunization. There were no significant differences of anti-HBs levels at different re-immunization time points in group B, C and D. Conc

关 键 词：肝炎疫苗 乙型 肝炎表面抗原 乙型 接种 

分 类 号：R186[医药卫生—流行病学]