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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 To understand the epidemiological characteristics of suspected immunization in Hepatitis B vaccine (AEFI) in Guangdong Province and evaluate the safety of vaccination. Methods AEFI information management system and Guangdong vaccine surveillance system were used to collect Hep B AEFI cases and inoculation data of Guangdong Province reported from 2010 to 2014. Epidemiological methods were used to analyze the related indicators. Results A total of 1 850 cases of Hep B AEFI were reported in Guangdong Province during 2010-2014, with a reported incidence of 4.95 / 100 000 doses. The age distribution was mainly in the group of <1 year old, accounting for 73.19%. The ratio of male to female was 1.31: 1. The incidence of the general reaction was 2.31 per 100 000 doses, with fever (61.12%) and simple erythema (28.46%). The incidence of anomalous reaction was 1.81 per 100 000 doses, with an allergic skin rash Accounting for 86.51%) based. 58.05% occurred on the day after inoculation, 95.78% of cases were cured or improved. Twenty-seven deaths were reported, with a reported mortality rate of 0.07 / 100,000 doses. 25 were incidental and 2 were unknown. Thirteen patients received the first dose and 14 received the second dose. Conclusion Hep B has good vaccination safety. Adverse reactions were mainly fever / irritation and allergic skin rash. None of the deaths were abnormal.