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目的探讨母亲乙型肝炎(乙肝)病毒表面抗原(HBsAg)阴性婴儿,应用国产重组乙肝疫苗(酵母)常规接种后的乙肝病毒表面抗体(抗-HBs)应答状况及其特征。方法在河南省开封市筛选母亲HBsAg阴性的7～24月龄婴幼儿8 093例,按0、1、6个月程序接种5μg国产重组乙肝疫苗(酵母),用固相放射免疫法检测抗-HBs,对<10mIU/ml者的性别、城乡、不同月龄等特点进行分析。结果2 970例7～10月龄婴儿中,56例抗-HBs<10mIU/ml,无应答率为1.89%。其中1 911例城市婴儿中7例无应答(0.37%),1 059例农村婴儿中无应答者49例(4.63%),城乡婴儿抗-HBs无应答率的差异有非常显著的统计学意义(χ2=66.87,P<0.01),不同性别婴儿抗-HBs无应答率的差异无显著的统计学意义。城乡婴儿抗-HBs无应答率的差异与疫苗管理及接种质量综合评估呈显著负直线相关。婴儿11～24月龄间抗-HBs下降速度快,至22～24月龄时,已有15.53%抗-HBs阴转,较7～10月龄时增加8.22倍。结论母亲HBsAg阴性的婴儿常规接种5μg国产重组乙肝疫苗(酵母)后,抗-HBs无应答率为1.89%。城市低于农村。全程免疫后婴儿抗-HBs的下降速度快,提示应加大新生儿期疫苗的剂量,重组乙疫苗(酵母)可由5μg/剂提高到10μg/剂。
Objective To investigate the status and characteristics of hepatitis B virus surface antibody (anti-HBs) response in maternal hepatitis B virus (HBsAg) negative infants after routine inoculation of domestic recombinant hepatitis B vaccine (yeast). Methods A total of 8 093 HBsAg-negative infants aged 7-24 months were screened in Kaifeng City, Henan Province. 5 μg domestic recombinant hepatitis B vaccine (yeast) was inoculated every 0, 1 and 6 months according to the method of solid phase radioimmunoassay. HBs, <10mIU / ml of gender, urban and rural areas, different months of age and other characteristics were analyzed. Results Among 2 970 infants aged 7 to 10 months, 56 cases had anti-HBs <10 mIU / ml, with no response rate of 1.89%. There were 7 911 non-responders (0.37%) in 1 911 urban infants and 49 (4.63%) non-responders in 1 059 rural infants. There was a significant difference in the non-responsive rate of anti-HBs in urban and rural areas χ2 = 66.87, P <0.01). There was no significant difference in the non-response rate of anti-HBs among different sexes. The difference in non-HBs response rates among urban and rural infants was significantly negatively correlated with the overall assessment of vaccine administration and vaccination quality. Anti-HBs decreased rapidly in 11 to 24 months of age in infants, and 15.53% of anti-HBs were negative in 22 to 24 months of age, 8.22 times more than those in 7 to 10 months of age. Conclusion The non-response rate of anti-HBs in infants with HBsAg negative mothers was 1.89% after routine inoculation of 5μg domestic recombinant hepatitis B vaccine (yeast). The city is lower than the countryside. The rapid decline of anti-HBs in infants after full immunization indicates that the dose of neonatal vaccine should be increased. The recombinant vaccine (yeast) can be increased from 5μg / dose to 10μg / dose.