2011—2018年郴州市乙型脑炎减毒活疫苗预防接种不良反应监测分析

Surveillance of adverse reactions following immunization with live attenuated Japanese encephalitis vaccine in Chenzhou city,Hunan province,2011-2018

目的分析2011-2018年郴州市乙型脑炎减毒活疫苗(Japanese encephalitis attenuated live vaccine, JEV-L)预防接种不良反应的发生特征和预防接种安全性。方法通过国家疑似预防接种异常反应(adverse events following immunization, AEFI)信息管理系统收集郴州市2011-2018年报告的JEV-L预防接种不良反应个案数据,采用描述流行病学方法进行分析。结果 2011-2018年郴州市共报告JEV-L预防接种不良反应421例,年平均报告发生率为43.55/10万剂。其中一般反应404例(95.96%,41.79/10万剂);异常反应17例(4.04%,1.76/10万剂);男女性别比为1.38∶1;<3岁的儿童占92.16%;个案报告主要集中在第二季度,占42.99%;第1剂次不良反应发生率高于第2剂次,差异有统计学意义(χ~2=37.22,P<0.01);98.81%的不良反应发生在接种后24 h之内。结论 JEV-L具有较好的安全性,仍需加强JEV-L不良反应监测工作。

Objective To analyze the characteristics of adverse reactions for live attenuated Japanese encephalitis vaccine(JEV-L) and the safety profile of JEV-L in Chenzhou city from 2011 to 2018. Methods The data regarding adverse events following immunization of JEV-L in Chenzhou during 2011-2018 were collected from the National Adverse Events Following Immunization Surveillance System, and then descriptive epidemiological method was used for analysis. Results A total of 421 cases of adverse reactions caused by JEV-L were reported in Chenzhou city during 2011-2018, with an average annual reported incidence rate of 43.55 per 100,000 doses administered. Among the cases reported, 404 cases(95.96 %, 41.79/100,000 doses) were common reactions, and 17(4.04 %, 1.76/100,000 doses) were abnormal reactions. The male to female ratio was 1.38∶1, and children aged < 3 years accounted for 92.16 %. Most of the reported cases occurred in the second quarter, accounting for 42.99%. The incidence rate of adverse reactions of the first dose was significantly higher than that of the second dose, with a statistically significant difference(χ~2=37.22, P<0.01). 98.81 % of adverse reactions occurred within 24 hours after the vaccination. Conclusions JEV-L has a good safety profile;however, surveillance of adverse reactions for JEV-L still should be strengthened.