2011年至2016年河南省乙型脑炎减毒活疫苗预防接种不良反应监测

Surveillance data of adverse reactions for live attenuated Japanese encephalitis vaccine in Henan Province from 2011 to 2016

目的:分析2011年至2016年河南省乙型脑炎减毒活疫苗(JEV-L)预防接种不良反应的流行病学特征,评价JEV-L预防接种的安全性。方法:通过中国免疫规划信息管理系统,收集2011年至2016年河南省报告的JEV-L预防接种不良反应个案数据和JEV-L预防接种数据,采用描述流行病学方法进行分析。结果:2011年至2016年河南省共报告JEV-L预防接种不良反应5 236例,年平均报告发病率为25.74/10万剂。5 236例不良反应中,一般反应5 126例,占97.90%,报告发生率为25.20/10万剂;异常反应110例,占2.10%,报告发生率为0.54/10万剂。不良反应男女性别比为1.22∶1;<1岁者占60.06%;7~9月份不良反应报告最多,占32.75%;报告病例主要集中在洛阳市、郑州市和周口市等地。不良反应主要发生在第1剂次接种后和接种后<1 d。一般反应临床诊断均为发热、红肿、硬结,异常反应以过敏反应性疾病为主,有过敏性休克和脑炎病例报告。所有不良反应中,治愈或好转占99.73%。结论:河南省JEV-L预防接种安全性良好,需关注过敏性休克、脑炎等严重异常反应的发生。

Aim： To analyze the characteristics of adverse reactions for live attenuated Japanese encephalitis vaccine（ JEV-L） in Henan Province from 2011 to 2016,in order to evaluate the immunization safety related to JEV-L. Methods：The adverse reaction data and vaccination doses of JEV-L in Henan Province from 2011 to 2016 were collected through the China Information Management System for Immunization Programming. The descriptive methodology was used for data analysis. Results： A total of 5 236 cases with adverse reactions were reported in Henan Province from 2011 to 2016,the annual average reported incidence rate was 25. 74 per 100 000 doses. Among all cases,5 126 cases was common adverse reaction,accounting for 97. 90%,the reported incidence rate was 25. 20 per 100 000 doses,and 110 cases was rare adverse reaction,accounting for 2. 10%,the reported incidence rate was 0. 54 per 100 000 doses. The ratio of male to female was1. 22∶1; 60. 06% cases occurred under 1 years old; most of cases were reported from July to September; and the reported cases were mainly concentrated in Luoyang,Zhengzhou and Zhoukou. Most cases occurred after the first dose and within 1 d after vaccination. The symptoms of common vaccine reactions were fever,local swelling and indurations,the main diagnosis of rare vaccine reactions were anaphylactic disorders. Anaphylactic shock and encephalitis were reported in rare adverse reaction. 99. 73% cases were recovered or got better. Conclusion： The JEV-L vaccine safety is good in Henan Province.The surveillance should focus on the anaphylactic shock and encephalitis and other serious rare adverse reaction.