CAJ | 학술논문

目的评价我国新生儿乙型肝炎(乙肝)疫苗免疫后的长期保护效果,为乙肝防控和乙肝疫苗HepB免疫策略提供参考.方法用横断面调查和分层整群抽样的方法,在乙肝疫苗免疫效果观察监测点收集1987-1996年出生(13～22岁)、全程接种乙肝血源疫苗的人群,以及1997-2008年出生(1 ～ 12岁)、全程接种乙肝重组酵母疫苗人群的血清样本和资料；用微粒子酶免疫法检测HBV感染指标,结合本底资料和乙肝疫苗免疫史进行分析.结果在河北正定、广西隆安、上海黄浦、青海同德和湖南湘潭5个监测点共收集1～12岁重组酵母疫苗免疫人群样本8133例,13 ～22岁血源疫苗免疫人群样本4848例,5个监测点的HBsAg平均阳性率均显著低于本底值,疫苗总体保护效果分别为86.04％～96.14％；河北正定、青海同德和湖南湘潭的年龄分布差异无统计学意义,广西隆安和上海黄浦的结果显示19～22岁人群HBsAg阳性率偏高；Anti-HBs阳性率随免疫年龄增长而下降,重组疫苗免疫人群从1～2岁组的86.84％下降至11～12岁组的46.40％,17 ～18岁组的Anti-HBs阳性率处于较低水平,而19～22岁组出现升高；几何平均浓度(GMC) ＜10 mIU/ml(Anti-HBs阴性)的比例随着年龄增长逐渐升高,100～999.99 mIU/ml和≥1000 mIU/ml的比例随着年龄的增长呈现下降趋势.结论血源疫苗免疫后13～ 22年、重组酵母疫苗免疫后1～12年的总体保护效果良好；不必开展加强免疫,建议加强监测18岁以上人群的Anti-HBs水平,对GMC＜10 mIU/ml者开展加强免疫.
목적 평개아국신생인을형간염(을간)역묘면역후적장기보호효과,위을간방공화을간역묘HepB면역책략제공삼고.방법 용횡단면조사화분층정군추양적방법,재을간역묘면역효과관찰감측점수집1987-1996년출생(13～22세)、전정접충을간혈원역묘적인군,이급1997-2008년출생(1 ～ 12세)、전정접충을간중조효모역묘인군적혈청양본화자료；용미입자매면역법검측HBV감염지표,결합본저자료화을간역묘면역사진행분석.결과 재하북정정、엄서륭안、상해황포、청해동덕화호남상담5개감측점공수집1～12세중조효모역묘면역인군양본8133례,13 ～22세혈원역묘면역인군양본4848례,5개감측점적HBsAg평균양성솔균현저저우본저치,역묘총체보호효과분별위86.04％～96.14％；하북정정、청해동덕화호남상담적년령분포차이무통계학의의,엄서륭안화상해황포적결과현시19～22세인군HBsAg양성솔편고；Anti-HBs양성솔수면역년령증장이하강,중조역묘면역인군종1～2세조적86.84％하강지11～12세조적46.40％,17 ～18세조적Anti-HBs양성솔처우교저수평,이19～22세조출현승고；궤하평균농도(GMC) ＜10 mIU/ml(Anti-HBs음성)적비례수착년령증장축점승고,100～999.99 mIU/ml화≥1000 mIU/ml적비례수착년령적증장정현하강추세.결론 혈원역묘면역후13～ 22년、중조효모역묘면역후1～12년적총체보호효과량호；불필개전가강면역,건의가강감측18세이상인군적Anti-HBs수평,대GMC＜10 mIU/ml자개전가강면역.
Objective To evaluate the long-term efficacy and duration of hepatitis B vaccine (HepB) after vaccinated to newborns and to provide information for HBV control and prevention.Methods A cross-sectional investigation was carried out in 5 HepB surveillance sites to collect blood samples and vaccination history information of participants who were born in 1987-1996 and received plasma derived HepB (HepB-P) as newborns,and who were born in 1997-2008 and received recombinant saccharomyces cerevisiae yeast HepB(HepB-SCY)as newborns.The serum samples were taken to test HBV infective markers by the method of microparticle enzyme immunoassay(MEIA).The data was analyzed combined with vaccination information and baseline data.Results Four thousand eight hundred and forty-eight participants who were immunized with HepB-P as newborns and 8133 participants with HepB-SCY were enrolled in 5 sites including Hebei-Zhengding,Guangxi-Longan,Shanghai-Huangpu,Qinghai-Tongde and Hunan-Xiangtan.The average HBV surface antigen (HBsAg) prevalence rates of 5 sites were all significantly lower than their baseline data.The overall vaccine protective efficacy is between 86.04％-96.14％.The age distributions of HBsAg prevalence showed differences in 5 sites.Participants aged 19 to 22 had a relatively high prevalence in Guangxi-Longan and Shanghai-Huangpu,while there was no statistic differences showed in Hebei-Zhengding,Qinghai-Tongde and Hunan-Xiangtan.The positive rate of antibody to HBsAg(Anti-HBs) decreased with immune duration,whose average rate was 54.34％.The Anti-HBs positive rate decrease by the trend of after vaccinated by HepB-SCY from 1 year to 12 years and vaccinated by HepB-P,which of 17-18 age group was low but enhanced at 19-22 age group.Conclusion It shows that the effectiveness of HepB-P and HepB-SCY are fine and stable after HepB-P being used for 22 years and HepB-SCY for 12 years.It is suggested not to carry out large scale booster immunization in people younger than 18 years old,but it is suggested to monitor the GMC of Anti-HBs and give booster for those people whose GMC is lower than 10 mIU/ml.