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[目的]探讨重组乙型肝炎疫苗对16岁以上农村居民的免疫效果及安全性。[方法]采用整群抽样的方法选择我县3个镇对近期无急、慢性严重疾病患者及对酵母成份无过敏、腋温﹤37.1℃,无乙肝疫苗接种史的16岁以上农村居民,按0、1、6个月程序,剂量依次为10μg、10μg、10μg,全程3针,接种深圳康泰生物制品股份有限公司生产的重组乙型肝炎疫苗。[结果]全程免疫后1个月时,抗-HBs阳转率为96.56%,各年龄组之间抗-HBs阳性率的差异无统计学意义(χ2=8.23,P﹥0.05);男性抗-HBs阳性率为96.55%,女性为96.55%,男女间抗-HBs阳性率的差异无统计学意义(χ2=0.00002,P﹥0.05);有26人发生接种反应,总反应率为0.16%,其中25人在72h内恢复正常,1人发生全身血管性水肿,1周后治愈。[结论]深圳康泰生物制品股份有限公司生的重组乙型肝炎疫苗对16岁以上农村居民具有良好的免疫原性和安全性。
[Objective] To investigate the immune effect and safety of recombinant hepatitis B vaccine for rural residents over the age of 16. [Methods] The method of cluster sampling was used to select three towns in our county for the recent no acute and chronic severe diseases in patients with no allergy to yeast components, axillary temperature <37.1 ℃, no hepatitis B vaccination history of rural residents over the age of 16 according to 0,1,6 months program, the dose was followed by 10μg, 10μg, 10μg, full three-needle, inoculated with Shenzhen Kangtai Biological Products Co., Ltd. recombinant hepatitis B vaccine. [Results] The positive rate of anti-HBs was 96.56% at 1 month after the whole immunization. The positive rate of anti-HBs was not significantly different among all age groups (χ2 = 8.23, P> 0.05) The positive rate of HBs was 96.55% and the rate of female was 96.55%. There was no significant difference in the anti-HBs positive rate between male and female (χ2 = 0.00002, P> 0.05). There were 26 inoculation reactions with the total response rate of 0.16% 25 returned to normal within 72 hours, 1 had systemic angioedema and were cured after 1 week. [Conclusion] The recombinant hepatitis B vaccine produced by Shenzhen Kangtai Biological Products Co., Ltd. has good immunogenicity and safety for rural residents over the age of 16.