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目的分析全国(未包括香港、澳门特别行政区和台湾地区,下同)乙型肝炎疫苗(Hepatitis B Vaccines,HepB)疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)的发生特征,评价HepB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AEFI监测信息管理系统,收集全国截至2010年4月28日报告的2005～2009年HepB AEFI个案数据,采用描述性方法对相关指标进行流行病学分析。结果全国2005～2009年共报告HepB AEFI 2836例,报告发生率为16.17/100万;男女性别比为1.27:1,<1岁婴儿占78.81%。HepB不良反应中,一般反应报告发生率为12.01/100万,异常反应报告发生率为2.89/100万;主要临床损害为中度发热[腋温(下同)37.6～38.5℃,4.38/100万]、重度发热(≥38.6℃,2.83/100万)、过敏性皮疹(1.76/100万)、无菌性脓肿(0.43/100万)。HepB不良反应主要集中在第3剂次和接种后≤1d。部分批号HepB AEFI存在聚集性,以发热和过敏性皮疹为主。结论 HepB具有较好的安全性,不良反应和聚集性反应以发热和过敏反应为主;需进一步加强HepB AEFI监测。
Objective To analyze the characteristics of Hepatitis B Vaccines (HepB) suspected to prevent AEFI in Hong Kong, Macao Special Administrative Region and Taiwan, and to evaluate HepB vaccination Security. Methods The data of HepB AEFI cases reported from April 2005 to April 2010 in China were collected through the China Immunization Program Monitoring Information Management System and the National AEFI Monitoring Information Management System. The descriptive method was used to carry out epidemiological analysis on related indicators. Results A total of 2836 HepB AEFI cases were reported in China from 2005 to 2009, with a reported incidence of 16.17 / 1 million. The sex ratio was 1.27: 1 for men and women, and 78.81% for children <1 year old. Among the adverse reactions of HepB, the average reaction report rate was 12.01 / 1 million and the incidence of abnormal reaction reports was 2.89 / 1 million. The main clinical lesion was moderate fever (axillary temperature 37.6-38.5 ℃, 4.38 / 1 million ], Severe fever (≥38.6 ℃, 2.83 / 1 million), allergic rash (1.76 / 1 million), and aseptic abscess (0.43 / 1 million). Adverse reactions of HepB mainly concentrated in the third dose and after inoculation ≤ 1d. Some batches HepB AEFI presence of aggregation, mainly fever and allergic rash. Conclusion HepB has a good safety, adverse reactions and aggregation reactions with fever and allergic reactions; further monitoring of HepB AEFI needs to be strengthened.