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重组乙型肝炎疫苗在健康人群中的免疫效果及安全性评价
Analysis on Immune Effect and Safety of Recombinant Hepatitis B Vaccine in Healthy Population
【摘要】 目的分析常用的两种国产重组乙肝疫苗在健康人群中接种的免疫效果及安全性。方法选择2010年1月-2011年1月在本门诊接种乙肝疫苗的532例健康人群,按接种疫苗类别分为A组(酵母疫苗10μg)与B组(CHO疫苗20μg),观察两组间的不良反应发生率和发生程度。于第2、3针接种前及3针全程接种后1月和1年时分别应用放射免疫法(RIA)检测血清HBsAb滴度水平,并比较两组抗体的阳性率。结果两组疫苗接种不良反应发生率差异无统计学意义(P>0.05)。全程接种后1月时,B组的HBsAbGMT峰值高于A组(P<0.05)。全程接种后1年B组抗体阳性率和HBsAb滴度均高于A组(P<0.05)。结论在可接受的、等同少而轻的接种不良反应基础上,应用20μg的CHO疫苗可使健康人群获得更大的保护效力。
【Abstract】 Objective To analyze the immune effect and safety of two kinds of homemade recombinant hepatitis B vaccines in healthy people. Methods Altogether 532 cases of healthy people with hepatitis B vaccines in Outpatient Department from January 2010 to January 2011 were divided into group A(yeast vaccine,10μg) and group B(CHO vaccine,20μg) according to the category of vaccines.The incidence and degree of adverse reactions were observed between the two groups.The serum HBsAb titers were detected with radioimmunoassay before the second and third shots,one month and one year after the full course vaccination.The antibody-positive rate was compared between the two groups. Results There was no statistically significant difference in the incidence of adverse reaction between the two groups(P>0.05).One month after the full course vaccination,the HBsAb GMT peak value of group B was significantly higher than that in group A(P<0.05).One year after the full course vaccination,the antibody-positive rate and HBsAb titers in group B were both significantly higher than those in group A(P<0.05). Conclusions On the basis of acceptable,equivalent,less and light adverse reactions following vaccination,the application of recombinant hepatitis B vaccine (CHO cells) with 20 μg will obtain greater protective effect in healthy people.
【Key words】 Hepatitis B; Recombinant vaccine; Adverse reaction; Antibody response;
- 【文献出处】 实用预防医学 ,Practical Preventive Medicine , 编辑部邮箱 ,2012年10期
- 【分类号】R186
- 【被引频次】12
- 【下载频次】119