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目的分析保定市2013~2015年疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)的发生特征,初步评价疫苗的安全性。方法通过中国AEFI监测系统收集2013~2015报告的AEFI个案数据,采用描述流行病学方法进行分析。结果保定市2013~2015年共报告AEFI 3 178例,报告发生率为22.65/10万剂,其中严重AEFI报告22例,报告发生率为0.15/10万剂。一般反应和异常反应报告发生率分别为21.64/10万剂、0.82/10万剂。AEFI报告数男、女性别比为1.31∶1,≤1岁占83.10%,主要发生在接种后≤1d。一般反应以发热、红肿、硬结为主,异常反应以过敏性皮疹、卡介苗淋巴结炎为主。96.95%的AEFI治愈。结论保定市AEFI监测系统运转正常,各疫苗异常反应报告发生率在预期范围内。≤1岁儿童与接种疫苗0~1天为AEFI监测重点。
Objective To analyze the characteristics of suspected AECI (Adverse Events Following Immunization) in Baoding from 2013 to 2015 and evaluate the safety of the vaccine initially. Methods The data of AEFI cases collected from 2013 to 2015 were collected through China AEFI monitoring system, and the descriptive epidemiological method was used to analyze the data. Results A total of 3 178 cases of AEFI were reported in Baoding city from 2013 to 2015, with a reported incidence of 22.65 / 10 000 doses. Among them, 22 cases were reported with severe AEFI and the reported incidence was 0.15 / 100 000 doses. The incidences of general reaction and abnormal reaction were 21.64 per 100,000 doses and 0.82 per 100,000 dose, respectively. AEFI reported that male and female ratio was 1.31: 1, accounting for 83.10% of the patients who were less than 1 year old, mainly occurred within 1 day after inoculation. General reaction to fever, redness, induration, abnormal reaction to allergic rash, BCG-based lymphadenitis. 96.95% AEFI cure. Conclusion The AEFI monitoring system in Baoding City is in normal operation. The incidence of abnormal response of each vaccine is within the expected range. ≤ 1 year old children and vaccination 0 ~ 1 days for the AEFI monitoring focus.