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目的 对比不同剂量重组酵母乙型肝炎疫苗的免疫效果。 方法 选择 2 0 0名一般健康状况良好、乙肝标志物阴性、谷丙转氨酶正常的 2 0～ 60岁学校工作人员随机被分为 A、B、C、D四组 ,四组的免疫程序同为 0、1、6个月 ,免疫剂量分别为 3针 5 μg、3针 10 μg、3针 15 μg、3针 2 0 μg重组酵母乙型肝炎疫苗。 结果 全程免疫后 1个月时四组抗 - HBs阳转率分别是 75 .0 0 %、91.84%、95 .65 %、97.87% ,四组间差别有显著性 (P<0 .0 1) ;四组抗 - HBs平均滴度 (GMT)分别是 197.4、3 15 .6、40 3 .6和 477.8m IU/ ml,四组间差别有显著性 (P<0 .0 1)。年龄、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 0μg组注射部位疼痛发生率为 7.5 9% ,5μg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 我国健康成人应用重组酵母乙型肝炎疫苗免疫 ,同按 0、1、6个月免疫程序 ,3针 2 0 μg优于 3针10 μg,3针 10 μg优于 3针 5 μg。 建议 应用重组酵母乙型肝炎疫苗免疫 ,健康成人的免疫剂量是 3针 10 μg;3 5岁以上乙肝高危男性的免疫剂量是 3针 2 0 μg
Objective To compare the immune effects of different doses of recombinant yeast Hepatitis B vaccine. Methods Two hundred and twenty school staff members from 20 to 60 years old with good general health, negative HBeAg and normal alanine aminotransferase (ALT) were randomly divided into four groups: A, B, C and D. Four groups of immunization procedures were the same At 0, 1 and 6 months, immunization doses were 3 μg 5 μg, 3 μg 10 μg, 3 μg 15 μg, and 3 μg 20 μg recombinant yeast Hepatitis B vaccine respectively. Results The positive rates of anti - HBs in the four groups were 75.0%, 91.84%, 95.65% and 97.87% respectively at 1 month after the whole immunization. The differences among the four groups were significant (P <0.01) . The mean anti-HBs titer (GMT) of the four groups were 197.4, 316. 6, 40 3 .6 and 477.8 m IU / ml, respectively. There was a significant difference between the four groups (P <0.01). Age, sex have an impact on the immune effect. With the increase of immunization dose, the rate of adverse reactions increased. The incidence of pain in the injection site of 20 μg was 7.5 9%. The incidence of pain in the injection site of 5 μg group was 2.03%. There was a significant difference (P <0.05). 0 5). Conclusion Immunization of recombinant yeast Hepatitis B vaccine in healthy adults in China is as same as 0, 1 and 6 months’ immunization program. The 3-pin 20 μg is better than the 3-pin 10 μg, the 3-pin 10 μg is better than the 3-pin 5 μg. Recombinant yeast Hepatitis B vaccine is recommended for immunization, healthy adults immunization dose is 3 needles 10 g; 3 5 years old high-risk hepatitis B men immunization dose is 3 needles 20 g