国产与进口重组乙型肝炎疫苗安全性的研究  

Study of Domestic and Imported Recombinant Hepatitis B Vaccine Safety

作　　者：杨海云[1] 陈乐锋[1] 黄金凤[1] 梁小媚[1] 陈雪玲[1] 

机构地区：[1]广东省茂名市疾病预防控制中心,525000

出　　处：《医学理论与实践》2015年第2期141-142,158,共3页The Journal of Medical Theory and Practice

基　　金：广东省茂名市2014年科技计划项目;专题编号:20140335

摘　　要：目的：了解国产和进口两种乙肝疫苗安全性的差异,促进乙肝疫苗接种,提高免疫覆盖率。方法：在茂名市市区内选择0-1岁的健康儿童共300例,以自愿为原则分为国产疫苗组与进口疫苗组,分别接种国产重组乙型肝炎疫苗和进口重组乙型肝炎疫苗,在接种后的7d内追踪观察全身反应和局部反应。结果：国产重组乙型肝炎疫苗与进口重组乙型肝炎疫苗相比具有相似的安全性。300例接种者中均无局部反应发生,全身反应的发生率分别为在4.67%、3.33%,两者在安全性方面差异没有统计学意义（χ^2=0.35,P值〉0.05）。在发生的12例不良反应中,83.33%（10/12）发生于接种后1d内,16.67%（2/12）发生于接种后2-3d;男女比例为1.40∶1。25.00%（3/12）发生在接种第1剂时,41.67%（5/12）发生在接种第2剂时,33.33%（4/12）发生在接种第3剂时。国产疫苗组与进口疫苗组发生的不良反应在时间分布、人群分布、接种针次分布上的趋势一致。结论：无论国产乙肝疫苗还是进口乙肝疫苗接种后均有部分儿童发生不良反应,可能与儿童个体差异因素有关,经干预后无严重后果发生,安全性较高,而国产疫苗为国家免疫规划疫苗,儿童免费接种3剂次,与价格偏高的进口疫苗相比,更适用于我国乙型肝炎防控工作。Objective：Understand the difference between domestic and imported vaccines the safety of both the two hepatitis B,hepatitis Bvaccination to promote and improve immunization coverage.Methods：In Maoming City area choose healthy children aged 0-1total 300,a voluntary set of principles into domestic and imported vaccines vaccine group were vaccinated with a recombinant hepatitis B vaccine and recombinant hepatitis B vaccine imported in vaccination 7days after the follow-up observation of systemic reactions and local swelling reactions.Results：Compared with domestic recombinant vaccine and imported recombinant hepatitis B vaccine has a similar safety profile.300 cases of recipients had no local reaction,the incidence was 3.33%in 4.67%,systemic reaction,the difference in the aspect of safety was not statistically significant（χ^2=0.35,P0.05）.In 12 cases of adverse reactions occurred in 83.33%（10/12）,occurs within 1days after inoculation,16.67%（2/12）occurred in 2-3days after inoculation;the male to female ratio was 1.40∶1 25.00%（3/12）,occurred in inoculated first agents,41.67%（5/12）occurred within second agents,33.33%（4/12）occurred in third when the inoculation agent.Domestic vaccine group and imported vaccines group had adverse reactions in the time distribution,population distribution,the distribution of the inoculating needle on the same trend.Conclusion：Whether domestic or imported hepatitis B vaccine hepatitis B vaccination are part of the children after the occurrence of adverse reactions may be related to factors related to children＇s individual differences,without serious consequences occur after the intervention,the security is high,while the domestic vaccine vaccines for national immunization programs,children free vaccinated three times,compared with the high price of imported vaccines,more suitable for the prevention and control of hepatitis.

关 键 词：国产 进口 重组乙型肝炎疫苗 安全性 

分 类 号：R18[医药卫生—流行病学]