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目的了解国产不同剂量重组乙型肝炎(乙肝)疫苗(酵母)阻断乙肝病毒(HBV)母婴传播的效果。方法用5μg/0.5ml和10μg/0.5ml重组乙肝疫苗(酵母)免疫乙肝病毒表面抗原(HBsAg)、乙肝病毒膜抗原(HBeAg)双阳性母亲的新生儿68例,采用0、1、6个月接种程序,用固相放射免疫(SPRIA)法定量检测乙肝病毒表面抗体(抗-HBs)滴度及HBsAg。结果全程免疫后1个月,10μg剂量组新生婴儿HBsAg阳性率为2.86%,保护率为96.43%;5μg剂量组的HBsAg阳性率为3.45%,保护率为95.69%。10μg、5μg剂量组的抗-HBs阳转率分别为97.14%、82.76%,产生的抗-HBs几何平均浓度分别为237.44毫国际单位/毫升(mIU/ml)、150.06mIU/ml。10μg组的抗体阳转率明显高于5μg组。结论重组乙肝疫苗(酵母)母婴阻断效果良好,10μg组的免疫原性高于5μg组。
Objective To understand the effects of different doses of recombinant hepatitis B vaccine (yeast) on the mother-to-child transmission of hepatitis B virus (HBV). Methods Sixty-eight newborns with HBsAg and HBeAg positive mothers were immunized with recombinant hepatitis B vaccine (yeast) at doses of 5μg / 0.5ml and 10μg / 0.5ml for 0,1,6 months Inoculation procedure, the hepatitis B virus surface antibody (anti-HBs) titer and HBsAg were quantitatively detected by solid-phase radioimmunoassay (SPRIA). Results The positive rate of HBsAg in newborn infants was 2.86% and the protective rate was 96.43% in 1μg dose group. The positive rate of HBsAg in 5μg dose group was 3.45% and the protective rate was 95.69%. The positive conversion rates of anti-HBs in 10μg and 5μg dose groups were 97.14% and 82.76%, respectively. The geometric mean concentrations of anti-HBs produced were 237.44 milliUgIU / ml and 150.06 mIU / ml, respectively. The antibody positive rate of 10μg group was significantly higher than that of 5μg group. Conclusion The results showed that the recombinant hepatitis B vaccine (yeast) had a good blocking effect on maternal and infant, and the immunogenicity of 10μg was higher than that of 5μg.