重组酵母乙肝疫苗对新生儿免疫效果的评价

Evaluation on the Efficacy of the Recombination Yeast Hepatitis B Vaccine Immunization Program of Infants

目的研究新生儿接种国产5μg重组酵母乙肝疫苗的免疫效果及影响因素。方法从东莞市石碣医院预防接种门诊登记的,2005年7～12月出生的,按规定接种程序完成乙肝疫苗接种的新生儿中随机抽取303名进行横断面调查研究。结果新生儿免疫后抗-HBs几何平均滴度(GMT)为(201.36±14.89)mIU/ml。母亲乙肝HBsAg阳性/阴性、母亲乙肝HBeAg阳性/阴性、男/女、是否出生低体重、是否早产、本地/外地的新生儿之间抗-HBs抗体GMT差别无统计学意义(P>0.05)。抗-HBs阳转率为97.69%,达到卫生部规定的免疫成功率指标(85%)(t=6.19,P<0.001);母亲HBsAg阳性/阴性、HBeAg阳性/阴性的新生儿之间抗-HBs阳转率差别有统计学意义。新生儿HBsAg阳性率0.33%,母亲乙肝HBeAg阳性/阴性的新生儿HBsAg阳性率差别有统计学意义(P<0.05)。免疫后母婴传播阻断保护率为96.16%。结论新生儿接种国产5μg重组酵母乙肝疫苗具有良好的免疫效果,与乙肝免疫球蛋白100 IU联合使用,有良好的母婴传播阻断保护作用。母亲乙肝感染状况(HBsAg、HBeAg阳性)是影响新生儿乙肝抗-HBs阳转率的危险因素;母亲乙肝HBeAg阳性是影响新生儿乙肝疫苗母婴传播阻断保护率的危险因素。

Objective To investigate the protective effect of hepatitis B vaccine among the infants under the immunization program. Method 303 infants who had completed hepatitis B vaccine inoculation and registered in out-patient clinic were selected from Shijie Hospital of Donggnan City from July to December in 2005. Cross-sectional study was carried out. Result After immunization, the anti-HBs GMT of infants was （201.36±14.89）mIU/ml. The anti-HBs GMT of infants showed no significant differences no matter the mothers＇ HBsAg or HBeAg was positive or negative, male or female, low or high birth weight, premature or full term birth, and local or foreign（P〉0.05）. The anti-HBs seroconversion rate was 97.69%, which achieved the index of immune achievement ratio of Department of Health （t=6.19,P〈0.001）. The HBsAg positive rate of infants was 0.33%, which showed a significant difference between the infants whether their mother were HBeAg positive or negative （P〈 0.05）. The mother-infant transmission protection rate was 96.16%. Conclusion The home-made 5μg recombination yeast hepatitis B vaccine had a good immunoprotective effect on infants. When combined with HBIG, it has a favorable mother-infant transmission protection effect. The mothers＇ hepatitis B infection condition （HBsAg, HbeAg positive） was correlated with the HBsAg positive rate of the infants, and the mothers＇ HBeAg positive condition also correlated with the mother-infant transmission protection rate.