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目的分析浙江省2010~2014年甲型肝炎(甲肝)减毒活疫苗(HepA-L)和甲肝灭活疫苗(HepA-I)的疑似预防接种异常反应(adverse events following immunization,AEFI)监测资料,了解甲肝疫苗AEFI发生和分布情况,初步探讨其预防接种安全性。方法通过中国AEFI信息管理系统和浙江省免疫规划信息系统获取AEFI监测数据及接种数据,对HepA-L和HepA-I的AEFI发生情况进行分析。结果 2010~2014年浙江省HepA-L AEFI报告395例,男女性别比为2.0∶1,<7岁者占99.49%,报告县(区)比例为87.8%;HepA-I AEFI报告108例,男女性别比为1.3∶1,<7岁者占96.30%,报告县(区)比例为45.6%;两种疫苗AEFI报告均以第2、3季度居多。HepA-L AEFI报告发生率为14.39/10万剂,一般反应为9.98/10万剂,异常反应为3.71/10万剂;HepA-I AEFI报告发生率为9.72/10万剂,一般反应为7.74/10万剂,异常反应为1.71/10万剂。HepA-L和HepA-I AEFI报告例数和报告发生率均呈现逐年上升趋势。一般反应以发热、红肿、硬结为主,异常反应以过敏性皮疹为主;均主要集中在接种后≤1d发生。HepA-L和HepA-I AEFI分别有99.2%、100%治愈或好转,均无死亡报告。结论浙江省HepA-L和HepA-I的安全性均在可接受范围内;HepA-L AEFI报告发生率稍高于HepA-I;AEFI监测敏感性逐年提高。
Objective To analyze the suspected AEFI surveillance data of HepA-L and HepA-I from 2010 to 2014 in Zhejiang Province, To understand the occurrence and distribution of hepatitis A vaccine AEFI preliminary study of vaccination safety. Methods The AEFI monitoring data and inoculation data were obtained from China AEFI information management system and Zhejiang immunization planning information system to analyze the AEFI occurrence of HepA-L and HepA-I. Results A total of 395 HepA-L AEFI cases were reported from 2010 to 2014 in Zhejiang Province. The sex ratio was 2.0:1. The percentage of women aged <7 years was 99.49% and that of the reported county (region) 87.8%. HepA-I AEFI was reported in 108 cases, Sex ratio was 1.3: 1, <7.-year-old accounted for 96.30%, reporting county (district) ratio was 45.6%; both vaccines AEFI reports are mostly in the second and third quarter. The incidence of HepA-L AEFI was 14.39 per 100 000 doses, with a general response of 9.98 per 100 000 agents and an anomalous response of 3.71 per 100 000 doses. The reported incidence of HepA-I AEFI was 9.72 per 100,000 doses, with a general response of 7.74 / 100,000 doses, anomalous response of 1.71 / 10 million doses. HepA-L and HepA-I AEFI report the number of cases and report the incidence showed a rising trend year by year. General reaction to fever, redness, induration mainly allergic reaction to allergic rash; are mainly concentrated in the vaccination ≤ 1d occurred. HepA-L and HepA-I AEFI were 99.2%, 100% cured or improved, no death report. Conclusions The safety of HepA-L and HepA-I in Zhejiang Province are within the acceptable range. The incidence of HepA-L AEFI is slightly higher than that of HepA-I. The sensitivity of AEFI is increasing year by year.