摘要
目的分析福建省乙型肝炎疫苗疑似预防接种异常反应的发生特征,评价乙肝疫苗预防接种的安全性。方法通过中国免疫规划监测信息管理系统和全国疑似预防接种异常反应监测信息管理系统,收集福建省截止2013年12月31日报告的2008-2013年乙肝疫苗疑似预防接种异常反应个案数据,采用描述性方法,对相关指标进行流行病学分析。结果福建省2008-2013年共报告乙肝疫苗疑似预防接种异常反应377例（报告发生率为38.90/100万剂次）。其中,一般反应303例,占80.37%;异常反应59例,占15.65%;偶合症12例,占3.18%;心因性反应2例,占0.53%;不明原因1例,占0.27%。男女性别比为1.43∶1,〈1岁婴儿占61.54%。乙肝疫苗不良反应中,一般反应报告发生率为31.26/100万剂次,主要临床损害为发热、红肿、硬结（报告发生率1.03/100万剂次-8.25/100万剂次）;异常反应报告发生率为6.09/100万剂次,主要临床损害为过敏性皮疹（报告发生率3.71/100万剂次）。乙肝疫苗不良反应主要集中在第1剂次和接种后≤1d。结论总体上,福建省乙肝疫苗接种具有良好的安全性,不良反应以发热、红肿、硬结和过敏反应为主。
Objective To analyze the occurrence features of Adverse Events Following Immunization（AEFI）of Hepatitis B Vaccines（HepB）in Fujian province,and evaluate the safety of HepB. Methods The HepB AEFI data in 2008-2013 were collected through the China Information System for AEFI Surveillance reported before December 31,2013.The descriptive methodology was used in the study. Results A total of 377 HepB AEFI cases were reported during 2008-2013,with a reporting rate of 38.90 per million doses.In these AEFI cases,80.37%（303cases）were common adverse reactions;15.65%（59cases）were rare adverse reactions;3.18%（12cases）were coincidental events;0.53%（2cases）were psychogenic reactions;0.27%（1cases）were unexplained reactions.The ratio of male and female was 1.43∶1.61.54% of the cases were children younger than one year old.In vaccine reactions,the reporting rate of common adverse reactions and rare adverse reactions was 31.26 per million doses and 6.09 per million doses respectively.The main clinical manifestation were fever,swelling and induration in the common adverse reactions cases,the reported incidence rate ranged from 1.03 per million to 8.25 per million doses.And the main diagnosis in rare adverse reactions was anaphylactic rash,the reported rate was 3.71 per million doses.HepB adverse reactions mainly happened after the 1st dose and within 1day after vaccination. Conclusion HepB has good immunization safety.Fever,swelling,induration and anaphylactic rash are the predominant diagnosis following immunization.In general,the sensibility of National HepB AEFI surveillance need to be improved as well.
出处
《预防医学论坛》
2015年第2期97-101,110,共6页
Preventive Medicine Tribune
关键词
乙型肝炎疫苗
疑似预防接种异常反应
监测
Hepatitis B vaccine
Adverse events following immunization
Surveillance
