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目的了解健康人群接种甲型H1N1流感疫苗后的免疫效果及抗体水平。方法观察接种甲型H1N1流感疫苗人群中不良反应的发生情况;按照不同的年龄组随机抽取350人,采用描叙性流行病学方法,对疫苗的安全性和有效性进行评价;微量血凝抑制试验检测接种者甲型H1N1流感病毒抗体,SPSS16.0统计学软件对接种30 d后甲型H1N1流感与普通流感的发病率、就诊率及HI抗体阳转率进行比较。结果接种组接种甲型H1N1流感疫苗30 d后甲型H1N1流感与普通流感的发病率与就诊率均低于对照组,差异有统计学意义(P<0.05);接种甲型H1N1流感疫苗人群中共出现不良反应1 891例,总不良反应率为4.35%;接种组总体HI抗体阳转率显著高于对照组(χ2=4.27,P<0.05),达到欧盟药品评价委员会的标准,各年龄组间HI抗体阳转率差异无统计学意义。结论国产甲型H1N1流感疫苗具有较高的安全性与较好的免疫原性,适合在健康人群中普遍接种。
Objective To understand the immune effect and antibody level of healthy people after inoculation of influenza A (H1N1) influenza vaccine. Methods To observe the incidence of adverse reactions in people vaccinated with influenza A (H1N1) vaccine. 350 randomly selected persons of different ages were used to evaluate the safety and efficacy of the vaccine by means of the narrative epidemiology. Antibody of influenza A (H1N1) virus was tested in vaccines. SPSS16.0 statistical software was used to compare the incidence of H1N1 influenza and common flu 30 days after vaccination with the rate of visiting and HI antibody positive rate. Results The incidence and visiting rate of Influenza A (H1N1) and common influenza in vaccinated group were lower than those in control group after 30 days of inoculation of influenza A (H1N1) vaccine (P <0.05) There were 1 891 adverse reactions, with a total adverse reaction rate of 4.35%. The positive rate of HI antibody in inoculation group was significantly higher than that of control group (χ2 = 4.27, P <0.05), which reached the standard of EU Drug Evaluation Committee. HI antibody positive rate difference was not statistically significant. Conclusion The domestic influenza A H1N1 influenza vaccine has high safety and good immunogenicity, suitable for universal inoculation in healthy population.