福建省2015—2016年乙肝疫苗接种异常反应分析

Analysis on adverse events with Vaccintion of hepatitis B in Fujian(2015-2016)

目的分析福建省乙肝疫苗(HepB)疑似预防接种异常反应(AEFI)的发生特征,评价HepB预防接种的安全性。方法通过全国AEFI监测信息系统,收集福建省2015—2016年乙肝疫苗的AEFI数据,用描述性流行病学方法进行分析。结果福建省2015—2016年共报告AEFI 268例,发生率60.41/100万剂。病例男女性别比1.11,<1岁占88.4%。一般反应202例(45.54/100万剂)、异常反应53例(发生率11.95/100万剂)。主要临床表现以发热和过敏性皮疹为主。AEFI主要集中在第3剂次和接种后≤24h。2016年乙肝疫苗不良反应发生率(64.70/100万剂)高于2015年(50.70/100万剂)。结论福建省使用的乙肝疫苗安全、可靠。应加强AEFI监测,对公众开展健康教育,巩固对预防接种、免疫规划的信心。

Objective To analyze the features of adverse events following immunization（AEFI）of hepatitis B vaccine（HepB）in Fujian during 2015-2016 and evaluate the safety of HepB.Methods The data of AEFI with HepB in Fujian were from National AEFI Information System.The features of AEFI cases were analyzed by descriptive epidemiology method.Results Totally 268 AEFI cases of HepB were reported during 2015-2016 in Fujian and with incidence rate of 60.41.The ratio of male to female was 1.1∶1.Most of the cases were aged 〈1（88.4%）.There were 202 cases with common adervse reaction（45.54 per million doses）and 53 cases with abnormal adverse reaction（11.95 per million doses）.The main clinical features were fever（≥37.6 ℃）and anaphylactic rash.AEFI of HepB mainly happened after the 3 rd dose and within 24 hours after vaccination.The incidence rate of HepB AEFI in 2016（64.70 per million doses）was higher than that in 2015（50.70 per million doses）.Conclusion The HepB vaccine for immunization is safe and reliable product in Fujian.HepB AEFI surveillance and health education should be carried out and improved for the public confidence in national immunization program.