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目的评价甲型H1N1流行性感冒裂解疫苗(简称甲流疫苗)大规模接种的安全性。方法通过儿童预防接种信息管理系统和全国疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)信息管理系统,收集邯郸市2009年10月29日～2010年5月4日接种甲流疫苗个案信息和接种后AEFI个案信息,采用描述性方法对相关指标进行流行病学分析。结果邯郸市共接种甲流疫苗717 288人,发生AEFI 105例,发生率14.64/10万,其中不良反应102例(含一般反应93例、异常反应9例),偶合症2例,心因性反应1例,无严重不良反应和接种事故发生。一般反应中主要为发热61例(65.59%),且以38.5℃以下的低热为主(44例,70.97%)。报告AEFI有地区差异,无年龄和性别差异。报告AEFI主要在接种后24h内发生。3个生产企业生产的甲流疫苗的AEFI报告发生率差异有统计学意义(χ2=85.6,P单侧<0.01)。结论接种甲流疫苗后不良反应报告发生率低,无严重不良反应,较安全。接种后AEFI的发生与年龄、性别无关系。不同生产企业报告AEFI发生率差异有统计学意义。
Objective To evaluate the safety of large-scale inoculation of influenza A (H1N1) influenza vaccine (abbreviated as Influenza A). Methods AEFI information management system was used to collect information on cases of vaccination of A flu vaccine in Handan City from October 29, 2009 to May 4, 2010 through the information system of children’s vaccination information and the National AEFI (Information Management System of Infectious Diseases) Post-vaccination AEFI case information, using descriptive methods for epidemiological analysis of relevant indicators. Results A total of 717 288 A flu vaccines were received in A total of 105 cases of AEFI in Handan City. The incidence rate was 14.64 / 100 000, of which 102 were adverse reactions (including 93 cases of general reaction and 9 cases of abnormal reaction), 2 cases of complications, Response in 1 case, no serious adverse reactions and vaccination accidents. The general reaction was mainly fever in 61 cases (65.59%), and the low fever below 38.5 ℃ (44 cases, 70.97%). There are regional differences in reporting AEFI and no age and gender differences. The report AEFI occurred mainly within 24h after inoculation. The incidences of AEFI reported by the three manufacturing enterprises were statistically different (χ2 = 85.6, P <0.01). Conclusion The incidence of adverse reactions after vaccination with A H1N1 vaccine is low, no serious adverse reactions, safer. The incidence of AEFI after vaccination has nothing to do with age and sex. The difference in the incidence of AEFI between different manufacturers was statistically significant.