2010-2014年广东省乙型肝炎疫苗疑似预防接种异常反应监测数据分析  

Analysis of the monitoring data of adverse events following immunization with Hepatitis B vaccine in Guangdong Province between 2010 and 2014

作　　者：赵占杰[1] 刘隽[1] 梁文佳[1] 

机构地区：[1]广东省疾病预防控制中心免疫所,广东广州511430

出　　处：《现代预防医学》2016年第4期718-721,共4页Modern Preventive Medicine

摘　　要：目的了解广东省乙型肝炎疫苗(Hep B)疑似预防接种异常反应(AEFI)发生的流行病学特征,评价其预防接种的安全性。方法通过AEFI信息管理系统和广东省疫苗监测系统,收集广东省2010-2014年报告的Hep B AEFI个案和接种数据,采用描述流行病方法对相关指标进行分析。结果广东省2010-2014年共报告Hep B AEFI 1 850例,报告发生率4.95/10万剂次;年龄分布以<1岁组为主,占73.19%;男女比为1.31∶1。一般反应报告发生率为2.31/10万剂次,以单纯发热(占61.12%)和单纯红肿(占28.46%)为主;异常反应报告发生率为1.81/10万剂次,以过敏性皮疹(占86.51%)为主。58.05%发生在接种后当天,95.78%个案治愈或好转。报告死亡个案27例,报告死亡率为0.07/10万剂次;25例为偶合症,2例不详;13例接种第1剂次,14例接种第2剂次。结论 Hep B具有较好的预防接种安全性,不良反应以单纯发热/红肿和过敏性皮疹为主,死亡个案无1例是异常反应。Objective The objective of the study was to assess the epidemiological characteristics of adverse events following immunization （AEFI） with hepatitis B （HepB） vaccine in Guangdong Province and to evaluate the safety of HepB vaccination. Methods HepB AEFI cases and immunization data reported in Guangdong Province between 2010 and 2014 were obtained from the AEFI Information Management System and Guangdong Vaccine Monitoring System. Descriptive epidemiological methods were used to analyze the related indicators. Results A total of 1850 HepB AEFI cases were reported in Guangdong between 2010 and 2014, with a reported incidence of 4.95 per 100 000 doses. Children under the age of 1 was the most vulnerable population （73.19%）, and the male/female incidence ratio was 1.31：1. The incidence of normal reactions was 2.31 per 100 000 doses, mainly fever （61.12%） or swelling （28.46%） ; and the incidence of abnormal reactions was 1.81 per 100 000 doses, mainly allergic rash （86.51%）. 58.05% of the cases showed AEFI on the day of vaccination, and 95.78% of the cases were cured or improved. 27 cases of death were reported, and the mortality rate was 0.07 per 100 000 doses. Among the death cases, 25 cases were coincidental events and 2 cases were of unknown causes; additionally, 13 cases died after first vaccination and 14 cases died after second vaccination. Conclusion HepB vaccine is considered safe for immunization. The adverse reaction included mainly fever, swelling, and allergic rash; and none of the death cases had abnormal reactions.

关 键 词：乙型肝炎疫苗 疑似预防接种异常反应 分析 

分 类 号：R186[医药卫生—流行病学]