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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 characteristics of suspected immunization inoculation of hepatitis B vaccine in Fujian Province and evaluate the safety of vaccination against hepatitis B vaccine. Methods Through the information system of China’s immunization program monitoring and the national information system of suspected antivirus reaction monitoring, the data of suspected cases of hepatitis B vaccine immunization reported from December 2008 to December 2013 in Fujian Province were collected. Using descriptive Methods, the relevant indicators of epidemiological analysis. Results A total of 377 cases of suspected abnormal vaccination of hepatitis B vaccine were reported in Fujian province from 2008 to 2013 (the reported incidence was 38.90 / 1 million doses). Among them, 303 were general reactions, accounting for 80.37%; 59 were abnormal reactions, accounting for 15.65%; 12 were intercourse, accounting for 3.18%; 2 were psychogenic reactions, accounting for 0.53%; 1 was unknown, accounting for 0.27%. The male / female ratio was 1.43: 1, with <1 year old children accounting for 61.54%. Among the adverse reactions of hepatitis B vaccine, the incidence rate of general reaction was 31.26 / 1 million doses. The main clinical lesions were fever, redness, and induration (the reported incidence was 1.03 / 1 million doses to 8.25 / 1 million doses); abnormal reaction reports The incidence was 6.09 / 1 million doses, the main clinical damage was an allergic skin rash (the reported incidence of 3.71 / 1 million doses). Adverse reactions to hepatitis B vaccine mainly concentrated in the first dose and after vaccination ≤ 1d. Conclusion In general, hepatitis B vaccination in Fujian Province has good safety and adverse reactions are mainly fever, redness, induration and allergic reaction.