【作者】 昌思思；

【导师】 陆林；

【作者基本信息】 昆明医科大学 ， 流行病与卫生统计学， 2012， 硕士

【摘要】 目的：评价重组乙型肝炎疫苗(Hepatitis B vaccines, HepB)单纯免疫及其与乙型肝炎免疫球蛋白(Hepatitis B Immune Globulin, HBIG)联合免疫阻断乙肝病毒(Hepatitis B Virus, HBV)母婴传播效果,并分析阻断HBV母婴传播的影响因素。研究方法：采用前瞻性队列研究的方法,选择云南省2011年1月-2011年2月期间住院分娩HBsAg阳性母亲及新生儿为研究对象,将出生24小时内接种10μg重组HepB和HBIG的新生儿作为联合免疫组,接种10gg重组HepB的新生儿作为单纯免疫组,各组均按照0、1、6个月的免疫程序接种10μg重组HepB,定期对各组母亲及婴儿进行个案调查,婴儿全程免疫结束后1月(7-12月龄)随访采集静脉血检测乙肝感染标志物,随访时间截止到2011年12月。用疫苗的保护率来评价重组HepB(酵母)与HBIG联合免疫阻断HBV母婴传播效果,并分析母亲感染状态、分娩方式、分娩医院级别、母乳喂养、婴儿是否联合免疫等因素对阻断HBV母婴传播的影响。结果：双阳母亲,婴儿联合免疫和单纯免疫HBsAg阳性率分别为5.1%、14.1%(x2=4.422,P=0.035),保护率分别为94%、83.4%；单阳母亲婴儿是否联合免疫HBsAg阳性率差异无统计学意义(校正χ2=1.287,P=0.257)；单纯免疫下双阳和单阳母亲其婴儿HBsAg阳性率分别为14.1%、4.1%(χ2=4.227,P=0.04),保护率分别为83.4%、89.7%,而联合免疫下双阳和单阳母亲其婴儿HBsAg阳性率差异无统计学意义(校正χ2=3.28,P=0.07)。影响阻断HBV母婴传播的主要因素为母亲感染状态(OR=5.01,95％CI:1.714～14.669)和婴儿是否联合免疫(OR=3.605,95％CI:1.385～9.381),母亲孕期使用HBIG、分娩方式、分娩医院级别、喂养方式、婴儿性别等因素对阻断HBV母婴传播的无影响。结论：双阳母亲的婴儿采用联合免疫阻断HBV母婴传播效果更佳,而单阳母亲的婴儿是否联合免疫其阻断效果相同；在单纯免疫下,双阳母亲其婴儿感染风险高于单阳；母亲HBV感染状态和婴儿是否联合免疫是影响婴儿HBsAg阳性率的两个主要因素。更多还原

【Abstract】 Objectives:To evaluate the protective efficacy in preventing mother-to-infant transmission of Hepatitis B Virus(HBV) with immunization of Recombinant Yeast Hepatitis B vaccines(HepB)(10μg) and HepB(10μg)combination with Hepatitis B immune globulin(HBIG), And to explore the factors in preventing mother-to-infant transmission of HBV.Methods:This study was a prospective cohort study. In Yunnan Province, we selected mothers whose infants were born from January through February2011, and HBsAg were positive when they were pregnant or child-bearing.The newborns were divided into groups A and B, which infants in groups A were immuned with HepB within24hours after their birth, and infants in groups B were immuned with HepB and HBIG within24hours after their birth. The regular schedule of HepB immunization was0,1st, and6th month with the dose was10μg. The information about HBV infection of mothers and infants, and recodes of HepB immunization of infants, were collected by the fixed questionnaires. The Serum of the children in cohort would be collected in one month after the full dose immunization following a laboratory test of the HBV infection indicators. The end point of this research was on December31,2011. Protective efficacy was estimated using series of formulas. The factors, such as mother’s HBV infecting status, delivery mode, breast feeding, and immuned with HepB and HBIG or with HepB only, were analysed with Logistic regression.Results:For mothers whose both HBsAg and HBeAg were positive, the HBsAg positive rate and the protective rate was14.1%and83.4%for the infants vaccinated with HBIG, and5.1%and94%for the infants vaccinated without HBIG (χ2=4.422,P value=0.035).For mothers with only the HBsAg positive,the difference was no significant between the group combination with HBIG and without HBIG(continuity correctionχ2=1.287,P value=0.257). For the children vaccinated with HepB only, the HBsAg positive rate and the protective rate was14.1%and83.4%for the infants whose mother both HBsAg and HBeAg positive, and was4.1%and89.7%for the mother only HBsAg positive (χ2=4.227,P value=0.04). For the children vaccinated with HepB and HBIG, the difference was no significant between the mother both HBsAg and HBeAg were positive and only HBsAg (continuity correctionχ2=3.28, P value=0.07).Results from multi-factors analysis showed that mother’s HBV infecting status(OR=5.01,95%CI:1.714-14.669)and combination with HBIG (OR=3.605,95%CI:1.385～9.381) were the important influencing factors of recombinant yeastderived HepB in preventing mother-to-infant transmission of HBV. While HBIG inoculation in pregnant women, delivery mode, level of hospital, breast feeding and gender were not the factors.Conclusions:For mothers both HBsAg and HBeAg positive, the protective efficacy are better for the infants vaccinated with HepB and HBIG, while the protective efficacy had no difference for the infants whose mother was only HBsAg positive. For infants vaccinated with only HepB, they had high risk whose mother both HBsAg and HBeAg were positive.更多还原