应用循证医学的方法和理念系统评价甲型肝炎疫苗免疫程序相关因素

Evaluation on the Influential Factor of Making Hepatitis A Vaccine Immunization Schedule Using Evidence-based Medicine

目的评价甲型肝炎(甲肝)疫苗(Hepatitis A Vaccine,HepA)免疫程序相关影响因素,为HepA免疫程序的制定提供依据。方法用循证医学系统评价的方法,对中国甲肝的主要流行病学特征和目前应用的HepA的安全性、免疫原性、保护效果、免疫持久性等进行评价。结果①≥2岁病例占中国甲肝病例的98%以上,中国甲肝发病的高发人群分别为5～9岁、20～34岁。②目前中国应用的HepA分别为减毒活疫苗(HepA,Live)和灭活疫苗(HepA,Inactivated),减毒活疫苗接种1剂次抗体阳转率为79.8%～100.0%,保护率为93%～98%,免疫持久性>10年;灭活疫苗接种2剂次抗体阳转率为100%,保护率为79%～99%,免疫持久性>9年。③灭活疫苗免疫应答受胎传抗体影响较小;减毒活疫苗免疫应答受胎传抗体影响较大,但出生16个月后影响已降到很低的程度。④免疫4年后,用酶联免疫吸附试验检测甲肝抗体阴性的标本,用中和试验测定,>60%有中和作用,即有预防感染的能力。⑤减毒活疫苗和灭活疫苗的临床试验观察,有发热、皮疹等一般反应发生,大规模接种后极个别受种者有异常反应发生。结论甲肝减毒活疫苗常规免疫的起始月龄为16～24月龄;灭活疫苗为12～24月龄。减毒活疫苗采用1剂次免疫程序,灭活疫苗采用2剂次免疫程序,均有较好的安全性、免疫原性、保护效果、免疫持久性。

Objective To evaluate the influential factor of making hepatitis A vaccine immunization schedule, and provide evidence for making the immunization of hepatitis A vaccine. Methods To evaluate the epidemiology of hepatitis A and the immunity,protective efficacy,duration and safety systematic review. Results ①98% cases of hepatitis A are ≥ years old and above two years,the two high-risk groups are 5-9 years group and 20-34 years group. ②Two kinds of vaccines,attenuated live hepatitis A vaccine and inactivated hepatitis A vaccine,are used in China. The seroconversion of attenuated live of hepatitis A by one dose is 79.8-100% ,protective efficacy is 93%-98%, the induration is above 10 years; the seroconversion of inactivated hepatitis A vaccine by two doses is 100% ,protective efficacy is 79%-99% ,induration is above 9 years. ③Maternal antibody has little effect on the immune efficacy of inactivated hepatitis A vaccine and has much effect on the immune efficacy of attenuated live hepatitis A vaccine, but the effect after 16 months is very low. ④Four years after immunization, the specimen of hepatitis A vaccine whose antibody is negative tested by ELISA is still 60% neutral tested by Neutralization Test,and has ability to prenvent infection ⑤There is common, minor, vaccine reaction such as fever,rash and so on,at large group of immunization. Conclusions The first dose of attenuated live hepatitis A vaccine is after 16 months and before 24 months;the first dose of inactivated hepatitis A vaccine is after 12 and before 24 months. Attenuated live hepatitis A vaccine by 1 dose and inactivated hepatitis A vaccine by two doses both have good immunity,protective efficacy,induration, and safety.