甲型肝炎疫苗H_2减毒株的流行病学效果考核  

A field evaluation of the epidemiological efficacy of an attenuated live hepatitis A vaccine (H_2 strain)

作　　者：张勇 刘新立[2] 马景臣 夏建铃 侯通[2] 韩长全 张世勇[2] 张英林 刘洪斌 邢占春 徐志一[6] 

机构地区：[1]石家庄市河北医科大学公共卫生学院流行病学教研室,050017 [2]石家庄市卫生防疫站 [3]正定县卫生防疫站 [4]石家庄郊区卫生防疫站 [5]河北省卫生防疫站 [6]复旦大学公共卫生学院

出　　处：《中华预防医学杂志》2001年第6期387-389,共3页Chinese Journal of Preventive Medicine

基　　金："九五"国家科技攻关项目 ( 96 90 6 0 3 0 1)

摘　　要：目的　考核病毒性甲型肝炎 (简称甲肝 )减毒活疫苗 (H2 减毒株 )的流行病学效果。方法　以正定县的 3个乡和石家庄郊区全部 10个乡为研究现场 ,以其适龄儿童约 3 7万人为观察对象 ,进行随机、对照试验。观察对象按其出生的单、双月份随机分为疫苗组和空白对照组 ,疫苗组接种1ml 10 6 5/ml半数细胞培养感染量 (TCID50 )的甲肝疫苗 ,空白对照组不做任何处理。接种后严格随访观察对象中甲肝病例的发生情况。结果　在 3 5年的随访中 ,易感的对照组出现甲型肝炎 2 0例 ,发病率为 136 4/ 10万 ;疫苗组出现 1例 ,发病率 8 1/ 10万。 2组发病率差异有显著性。疫苗的保护率为94 1% ,95 %可信限 :6 7 1%～ 10 0 %。结论　每毫升 10 6 5TCID50 的甲肝减毒活疫苗保护效果良好 ,可以满足人群免疫的需要。Objective To evaluate the epidemiological efficacy of an attenuated live hepatitis A vaccine (H 2 strain) Methods A randomized and controlled field trial was carried out in part of Zhengding County and the Jiaoqu District of Shijiazhuang city There were about 37 000 children in these areas involved in the study and they were randomly divided into a vaccine group and a control group according to the months they were born Children in the vaccine group were given a dose of 10 6 5 TCID 50 /ml attenuated live hepatitis A vaccine while those in the control group were given nothing As soon as the children in the vaccine group had been vaccinated, all the subjects were carefully followed up for hepatitis A cases Results In the 3 5 years of follow up, there were 20 hepatitis A cases in the control group and the incidence rate was 136 4 per 100 000 population There was only one hepatitis A case in the vaccine group and the incidence rate was 8 1 per 100 000 population The difference of the incidence rates between the two groups was highly significant ( P <0 001) and the protective efficacy of the vaccine was 94 4% (95% CI : 67 1% 100%) Conclusion The protective efficacy of the vaccine was excellent and the vaccine is suitable to be widely used

关 键 词：病毒性肝炎疫苗 流行病学 随机对照试验 甲型肝炎 H2减毒株 

分 类 号：R181.3[医药卫生—流行病学]