| 张丽,翟祥军,李艳萍,张卫,朱凤才,黄腾,颜丙玉,刘甲野,李立秋,龚晓红,崔富强,梁晓峰,徐爱强.中国4省(区市)早产儿和足月儿乙型肝炎疫苗免疫应答多中心比较研究[J].Chinese journal of Epidemiology,2012,33(2):185-188 |
| 中国4省(区市)早产儿和足月儿乙型肝炎疫苗免疫应答多中心比较研究 |
| Multi-center matching study on antibody response between preterm and full-term infants after primary immunization of hepatitis B vaccine |
| Received:September 19, 2011 |
| DOI： |
| KeyWord: 乙型肝炎疫苗 抗体应答 早产儿 多中心研究 |
| English Key Word: Hepatitis B vaccine Antibody response Preterm infants Multi-center study |
| FundProject:国家“十一五”科技重大专项(2008ZX10002-001, 2009ZX10002-028) |
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| Abstract: |
| 目的 分析早产儿和足月儿乙型肝炎(乙肝)疫苗(HepB)抗体免疫应答。方法 按照多中心研究方法, 以北京、山东、江苏、广西4省(区市)为研究现场, 选取按照0-1-6程序、使用5ng重组HepB(酿酒酵母)(HepB-SC)或10ng重组HepB(汉逊酵母)(HepB-HP)完成HepB初免的7~12月龄婴儿;以其中全部早产儿作为早产儿组, 按照I:1随机选择其中Hq>B种类、月龄、性别和居住地相同的足月儿作为足月儿组。对所有研究对象进行问卷调查, HepB免疫史根据接种卡确定；同时采集静脉血2ml, 使用化学发光微粒子免疫分析法检测血清HBV表面抗体(抗-HBs);比较两组婴儿抗体应答率和抗体水平。结果 4省(区市)共调査648对婴儿。早产儿组初免无应答率、低应答率、正常应答率和髙应答率分别为1.39%, 8.64%、45.83%和44.14%, 足月儿组分别为1.08%、9.26%、44.91%和44.75%, 两组4项指标差异均无统计学意义(口>0.05);两组初免后抗-HBs几何平均浓度(GMT)分别为755.14和799.47mlU/ml, 差异无统计学意义(P>0.05)。多因素条件logistic回归分析显示, 排除出生体重、分娩方式、胎次、产程损伤和父母乙肝病毒表面抗原状态后, 是否早产与HepB抗体应答率无关(P>0.05)。结论 早产儿和足月儿HepB免后抗体应答无明显差异.可以按照相同的HepB免疫策略进行接种。 |
| English Abstract: |
| Objective To compare the antibody response between preterm and full-term infants after primary immunization of hepatitis B vaccine(HepB). Methods Infants who were aged 7-12 months and had completed primary immunization with 5 [ig HepB made by recombinant dexyribonucleic acid techniques in saccharomyces cerevisiae(HepB-SC) or 10 |xg HepB made by recombinant dexyribonucleic acid techniques in Hansenula polymorpha(HepB-HP) on 0-1-6 schedule were investigated in four provinces(municipality) including Beijing, Shandong, Jiangsu and Guangxi of China. Among them, all preterm infants were selected to form the preterm group and the 1 ?? 1 matching full-term infants with the same month-age, gender and residence were randomly selected to form the full-term group. Their HepB history was determined by immunization certificate and all of their parents were interviewed with standard questionnaire to get their birth information. Blood samples were obtained from all anticipants and were tested for Anti-HBs by chemiluminescence microparticle immuno-assay(CMIA). Results Total anticipants were 648 pairs of infants. The rates of non-response, low-response, normal-response and high-response after the primary immunization were 1.39%, 8.64%, 45.83% and 44.14% in the preterm group, respectively. The corresponding rates were 1.08%, 9.26%, 44.91% and 44.75% in the full-term group. The above four rates did not show significant differences between the two groups(尸>0.05). The geometric mean concentrations(GMC) of anti-HBs in the pre-term and full-term group were 755.14 and 799.47 mlU/ml respectively. There was no significantly difference in the GMCs between the two groups(P>0.05). Results from multivariable conditional logistic analysis showed that preterm was not an influencing factor to the antibody response after HepB primary immunization among newborns even after debugging the other influencing factors. Conclusion The autibody response after HepB primary immunization were similar among the preterm and full-term infants. The preterm newborns could be immunized under the same HepB immunization strategy. |
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