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机构地区:[1]解放军第一五二医院,河南平顶山467000 [2]河南省平顶山市卫生防疫站 [3]河南省卫生防疫站
出 处:《解放军预防医学杂志》2003年第3期176-179,共4页Journal of Preventive Medicine of Chinese People's Liberation Army
摘 要:目的 :对比不同剂量重组酵母乙型肝炎疫苗的免疫效果 ,为探讨适合于我国成人的合适免疫剂量提供依据。方法 :2 0 0名符合要求的研究对象随机分为A、B、C、D共 4个剂量组 ,均按 0、1、6个月免疫程序接种 3次重组酵母乙型肝炎疫苗 ,4组剂量分别为每次 5 μg、10 μg、15 μg和 2 0 μg。 结果 :全程免疫后 1个月时 ,4个组抗 -HBs阳转率分别为 75 .0 0 %、91.84 %、95 .6 5 %、97.87%,组间差别有显著性 (P <0 .0 1) ;抗 -HBs几何平均滴度 (GMT)分别是 197.4mIU·mL 1、315 .6mIU·mL 1、4 0 3.6mIU·mL 1和 4 77.8mIU·mL 1,组间差别亦有显著性 (P <0 .0 1)。年龄、体重指数、性别对免疫效果有影响。随着免疫剂量的增加 ,不良反应率随之增加 ,2 0 μg组注射部位疼痛发生率为 7.5 9%,5 μg组注射部位疼痛发生率为 2 .0 3%,差别有显著性 (P <0 .0 5 )。 结论 :我国健康成人按 0、1、6个月方案接种 3次不同剂量重组酵母乙型肝炎疫苗 ,结果表明 ,每次接种2 0 μg的免疫效果最好 ,但不良反应率也最高。故推荐 ,在健康成人以 10 μg而 35岁以上乙肝高危人群以 2 0 μg的免疫剂量较为适宜。Objective:To compare the immunogenicity and safety of different dosages of recombinant yeast-derived hepatitis B vaccines (YDV) in adults, so as to provide the basis for seeking proper vaccination dose for adults.Methods:200 healthy school staff members of 20~60 years old were randomly divided into four groups. Their HBsAg, anti-HBs and anti-HBc were negative and their liver functions were normal. The four groups were vaccinated with 5 μg, 10 μg, 15 μg, 20 μg YDV respectively for 3 times in 0, 1, 6 months. Results: The seroprotection rates (SPR) of four groups were 75.00%, 91.84%, 95.65%, 97.87% respectively one month after whole course vaccination. There were significant differences among the four groups (P<0.01). The anti-HBs geometric mean titers (GMTs) of four groups (197.4, 315.6, 403.6, 477.8 mIU·mL -1 respectively), were also significanty different (P<0.01). Age, body mass index and sex had effect on immunogenicity. The result also showed the more dosages, the higher rates of side reaction. The rates of injection site pain were significantly different between Group A (2.03%) and Group D (7.59%, P<0.05). Conclusion: The immunogenicity of vaccination with 20 μg of YDV is the best, but the side effect is also increased. It is suggested that 3 dosages of 10 μg for healthy adults and 3 dosages of 20μg for men over 35 years of ages with high risk of hepatitis B may be the proper vaccination dosages.
关 键 词:重组酵母乙型肝炎疫苗 抗体阳转率 抗体几何平均滴度 免疫剂量
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