CAJ | 학술논문

目的了解甲型H1N1流感(pH1N1)疫苗和季节性流感疫苗(SIV)接种后的不良反应和疫苗接种前后的血清抗体水平变化,评价流感疫苗的安全性及免疫原性.方法 760例符合要求人群随机分为pH1N1疫苗免疫组(VH组,460人)和SIV免疫组(VS组,300人),分别接种pH1N1疫苗和SIV,观察接种不良反应；应用微量血凝抑制试验(HI)方法对人群接种前、后进行血清抗体检测.结果 760名疫苗接种者共发生不良反应57例(7.50％),未出现严重的不良反应.其中VH组发生不良反应为29例(6.30％),VS组发生不良反应为28 例(9.33％),两组间不良反应的发生率差异无统计学意义(x2=2.40,P＞0.05).疫苗免疫21 d后,VH组抗-pH1N1流感病毒抗体阳转率为95.65％,几何平均滴度倒数(GMRT)高达1∶424.4(95％CI:325.07～ 523.76).VS组抗-季节性流感病毒GMRT上升至1∶183.8(95％ CI:71.32 ～ 296.28).结论 pH1N1疫苗具有良好的安全性和免疫原性,适宜无接种禁忌症人群的普遍接种.
목적 료해갑형H1N1류감(pH1N1)역묘화계절성류감역묘(SIV)접충후적불량반응화역묘접충전후적혈청항체수평변화,평개류감역묘적안전성급면역원성.방법 760례부합요구인군수궤분위pH1N1역묘면역조(VH조,460인)화SIV면역조(VS조,300인),분별접충pH1N1역묘화SIV,관찰접충불량반응；응용미량혈응억제시험(HI)방법대인군접충전、후진행혈청항체검측.결과 760명역묘접충자공발생불량반응57례(7.50％),미출현엄중적불량반응.기중VH조발생불량반응위29례(6.30％),VS조발생불량반응위28 례(9.33％),량조간불량반응적발생솔차이무통계학의의(x2=2.40,P＞0.05).역묘면역21 d후,VH조항-pH1N1류감병독항체양전솔위95.65％,궤하평균적도도수(GMRT)고체1∶424.4(95％CI:325.07～ 523.76).VS조항-계절성류감병독GMRT상승지1∶183.8(95％ CI:71.32 ～ 296.28).결론 pH1N1역묘구유량호적안전성화면역원성,괄의무접충금기증인군적보편접충.
Objective To understand the antibody levels and adverse reaction (ADR) of healthy people before and after vaccinating pandemic influenza A H1N1 (pH1N1) vaccine and seasonal influenza vaccine(SIV),and then evaluate the immunogenicity and safety of pH1N1 vaccine and SIV.Methods A total of 760 subjects who met the requirements were randomly individed into 2 groups:the pH1N1 vaccine recipients group (VH group,n =460) and the SIV recipients group (VS group,n =300).The ADR after immunization of 2 groups were recorded and analyzed respectively.The sera antibody levels were separately detected before and after immunization with two vaccines by the hemagglutinafion inhibition (HI) test.Results The total ADR rate of 760 cases was 7.50％(57 cases),including 29 cases (6.30％) in VH group and 28 cases (9.33％) in VS group.ADR rate had no significant difference between 2 groups (x2 =2.40,P＞0.05).No serious ADR was observed.Twenty one days after vaccination,anti-pH1N1-positive seroconversion rate was 95.65％,GMRT was estimated as 1∶424.4(95％ CI:325.07-523.76) in VH group; in VS group,the GMRT of anti-seasonal influenza virus increased to 1 ∶ 183.8(95％ CI:71.32-296.28).Conclusions The pH1N1 vaccine shows good safety and immunogenicity.It is suit for the crowd without contraindications of vaccination universally.