摘要
目的分析中国2010-2012年水痘减毒活疫苗（Varicella Attenuated Live Vaccine,VarV）上市（未包括香港、澳门特别行政区和台湾地区,下同）后,疑似预防接种异常反应（Adverse Events Following Immunization,AEFI）的发生特征,评价VarV预防接种的安全性。方法通过中国AEFI信息管理系统,收集截至2013年4月18日报告的2010~2012年VarV发生的AEFI个案数据,采用描述流行病学方法进行分析。结果中国AEFI信息管理系统共收到2010~2012年接种VarV发生的AEFI个案4329例,根据中国免疫规划信息管理系统中VarV接种剂次估算,报告发生率为19.16/10万剂。其中严重AEFI 101例,估算报告发生率为0.45/10万剂。不良反应4138例,估算报告发生率为18.31/10万剂;其中一般反应15.16/10万剂,异常反应3.15/10万剂。所有AEFI中,男、女性别比为1.37∶1;主要集中在≤3岁儿童和首剂接种后。在不良反应中,一般反应的主要症状为发热、局部红肿和局部硬结,异常反应的诊断主要为过敏性皮疹。不良反应集中在接种后≤1d。所有严重异常反应均治愈和好转。结论 VarV的不良反应报告发生率在预期范围内,与其他国家类似,但仍需关注预防接种后急性过敏性反应的发生情况。
Objective The study is to analyze the occurrence features of adverse event following immunization （AEFI） with varicella attenuated live vaccine （VarV） in China （Not include Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan Sheng） during 2010- 2012, and to evaluate the immunization safety related to VarY. Methods 2010-2012 VarV AEFI data were collected through the national AEFI information management system, which were reported before April 18, 2013. The descriptive methodology was used in the analysis. Results 4329 cases were collected in 2010-2012 from national AEFI information management system. According to the vaccination doses from national immunization information management system, the estimated incidence rate was 19. 16 per 100 000 doses. 101 cases were serious AEFIs, the estimated incidence rate was 0. 45 per 100,000 doses. In all, 4138 cases was classified as vaccine reactions, the estimated incidence rate was 18.31 per 100,000 doses, in which 15.16 per 100,000 doses for common vaccine reactions and 3.15 per 100,000 doses for rare vaccine reactions. In all AEFIs, ratio of male to female was 1.37 ： 1, and most AEFIs were under 3 years of age and occurred after the first dose vaccination. In the vaccine reactions, the main symptoms of common vaccine reactions were fever, local swelling and durations; the main diagnoses of rare vaccine reactions were anaphylactie rashes. Most vaccine reactions happened within l d after vaccination. All rare vaccine reactions were recovery or got better. Conclusions The reported incidence rate for the vaccine reactions of VarV was less than expected and may be comparable with that in other countries. However, the surveillance should still focus on the anaphylactoid reactions after VarV immunization in future.
出处
《中国疫苗和免疫》
CAS
2014年第1期13-18,35,共7页
Chinese Journal of Vaccines and Immunization
关键词
水痘减毒活疫苗
疑似预防接种异常反应
监测
Varicella attenuated live vaccine
Adverse events following immunization
Surveillance
