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新生儿乙型肝炎疫苗免疫低应答的影响因素分析
Influencing factors for low response to hepatitis B vaccination in neonates
文章发布日期:2018年05月07日  来源:  作者:文思敏,王崇,潘雨辰,等  点击次数:348次  下载次数:64次

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【摘要】:目的探索HBsAg阳性母亲分娩的新生儿在接受乙型肝炎疫苗(HepB)后发生免疫低应答的相关影响因素。方法招募了2012年7月-2015年7月参加HBV母婴传播阻断项目的1152例HBsAg阳性母亲分娩的新生儿,剔除了96例后,共1056例研究对象纳入分析,其中包含HBsAg阳性/HBeAg阴性母亲分娩的新生儿714例,HBsAg阳性/HBeAg阳性母亲分娩的新生儿342例。HBsAg阳性/HBeAg阴性和HBsAg阳性/HBeAg阳性母亲分娩的新生儿采用不同剂量的免疫接种方案,分别在其出生后2 h内注射10 μg或20 μg重组酵母HepB,并联合100 IU乙型肝炎免疫球蛋白(HBIG),于1月龄及6月龄时再分别注射一剂10 μg或20 μg的HepB。采集末次免疫后1个月的静脉血检测HBsAg及抗-HBs水平。抗-HBs水平<100 mIU/ml为低应答者,抗-HBs水平≥ 100 mIU/ml为高应答者。对计量资料应用两独立样本t检验进行组间比较,计数资料应用χ2检验或Fisher精确检验进行组间比较。采用非条件logistic回归来分析新生儿HepB免疫低应答的相关影响因素。采用协方差分析比较组间的抗-HBs水平。 结果10 μg方案组的免疫低应答率高于20 μg方案组(5.7% vs 2.0%,χ2=7.278,P=0.007);10 μg方案组母体HBV DNA 载量及母亲孕期接受抗病毒治疗的比例均低于20 μg方案组[( 2.90±1.50)log10 IU/ml vs (7.73±1.07)log10 IU/ml,t=-50297,P<0001;0.7% vs 7.0%, χ2=34.552,P<0.001];10 μg方案组新生儿的早产率高于20 μg方案组(3.2% vs 1.2%, χ2=3.907,P=0.048)。10 μg方案组新生儿人工喂养的比例低于20 μg方案组(37.8% vs 66.4%,χ2=75.703,P<0.001)。在10 μg方案组中,非条件logistic回归分析结果显示早产(比值比=3.31,95%可信区间:1.05~10.40)和人工喂养(比值比=2.67,95%可信区间:138~5.07)是新生儿HepB免疫低应答的独立危险因素(P值均<0.05)。协方差分析结果显示与足月儿相比,早产儿的抗-HBs水平较低(P=0004);与母乳喂养和混合喂养相比,人工喂养的新生儿抗-HBs水平较低(P=0.001)。在20 μg方案组中,母体因素及新生儿的各项资料与HepB的免疫应答水平没有关系(P值均>0.05)。结论早产及人工喂养是新生儿HepB免疫低应答的危险因素,识别具有免疫低应答风险的新生儿可以为制订个体化HepB接种方案提供依据。
【Abstract】:ObjectiveTo investigate the influencing factors for low response to hepatitis B (HepB) vaccination in neonates born to HBsAg-positive mothers. MethodsA total of 1152 neonates born to HBsAg-positive mothers who participated in the project of prevention of mother-to-child transmission of HBV from July 2012 to July 2015 were enrolled. After 96 neonates were excluded, 1056 neonates were included in the final analysis, including 714 neonates born to HBsAg-positive/HBeAg-negative mothers and 342 neonates born to HBsAg-positive/HBeAg-positive mothers. These two groups of neonates were given immunization at different doses, i.e., 10 μg or 20 μg HepB derived in Saccharomyces cerevisiae and 100 IU hepatitis B immunoglobulin within 2 hours after birth, followed by the injection of 10 μg or 20 μg HepB at the ages of 1 and 6 months. Venous blood samples were collected at one month after the last immunization to measure the levels of HBsAg and anti-HBs. The neonates with anti-HBs <100 mIU/ml were classified as low responders, and those with anti-HBs ≥100 mIU/ml were classified as high responders. The two-independent-samples t test was used for comparison of continuous data between groups, and the chi-square test or the Fisher′s exact test was used for comparison of categorical data between groups. An unconditional logistic regression analysis was used to identify the influencing factors for low response to HepB in neonates. An analysis of covariance was used for comparison of the level of anti-HBs between groups. ResultsCompared with the 20 μg group, the 10 μg group had a significantly higher rate of low response (5.7% vs 2.0%, χ2=7.278, P=0.007), significantly lower maternal HBV DNA load [(2.90±1.50)log10 IU/ml vs (7.73±1.07)log10 IU/ml, t=-50.297, P<0.001)] and proportion of the mothers who received antiviral therapy during pregnancy (0.7% vs 7.0%, χ2=34.552, P<0.001), and a significantly higher rate of preterm birth (3.2% vs 1.2%, χ2=3.907, P=0048). The 10 μg group had a significantly lower proportion of neonates with artificial feeding than the 20 μg group (37.8% vs 66.4%, χ2=75.703, P<0.001). In the 10 μg group, the unconditional logistic regression analysis showed that preterm birth (odds ratio [OR]=3.31, 95% confidence interval [CI]: 1.05-10.40, P<0.05) and artificial feeding (OR=2.67, 95%CI: 1.38-5.07, P<0.05) were independent risk factors for low response to HepB vaccination. The analysis of covariance showed that compared with the full-term infants, the preterm infants had a significantly lower level of anti-HBs (P=0.004); compared with those given breastfeeding or mixed feeding, the neonates given artificial feeding had a significantly lower level of anti-HBs (P=0.001). In the 20 μg group, no maternal factors or infantile factors were found to be associated with the response to HepB vaccination (all P>0.05). ConclusionPreterm birth and artificial feeding are risk factors for low response to HepB vaccination in neonates. Identification of neonates at risk of low response to HepB vaccination will provide a basis for developing individualized HepB vaccination schemes.
【关键字】:肝炎疫苗, 乙型; 婴儿, 新生
【Key words】:hepatitis B vaccines; infant, newborn
【引证本文】:
WEN SM, WANG C, PAN YC, et al. Influencing factors for low response to hepatitis B vaccination in neonates[J]. J Clin Hepatol, 2018, 34(6): 1198-1203. (in Chinese) 文思敏, 王崇, 潘雨辰, 等. 新生儿乙型肝炎疫苗免疫低应答的影响因素分析[J]. 临床肝胆病杂志, 2018, 34(6): 1198-1203.

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