浙江省肠道病毒71型疫苗上市后AEFI监测与评价

Incidence and monitoring of AEFI of EV71 vaccine in Zhejiang province

目的评价肠道病毒71(EV71)型疫苗在浙江省使用后安全性。方法通过主动监测与被动监测相结合的方法,利用中国免疫规划信息管理系统中疑似预防接种异常反应(AEFI)子系统,收集2016年1月1日至2019年12月31日浙江省接种EV71疫苗后发生的AEFI情况,采用描述性流行病学方法进行评价分析。结果浙江省2016年~2019年累计报告接种EV71疫苗后发生的AEFI个案1830例(报告发生率72.23/10万),其中异常反应报告202例(报告发生率7.97/10万),男性多于女性(1.17:1),以6月~24月龄内为主(81.92%),4月~7月份占全年报告总数的51.53%,主要集中在第1剂次(1283例,占70.11%),AEFI发生在接种后1 d内(180例,64.48%),临床损害以发热、红肿、硬结等一般反应较多,异常反应则以过敏性皮疹为主(114例,报告发生率4.50/10万),79.45%的病例最终痊愈。结论浙江省EV71疫苗安全性良好,主动监测报告敏感性优于被动监测,监测方式有待优化。

Objective To evaluate the safety of EV71 vaccine in Zhejiang province.Methods Based on the results of active and passive monitoring and using the AEFI subsystem,the data on AEFI related to EV71 vaccine in Zhejiang province from Jan 1,2016 to Dec 31,2019 was collected and analyzed with descriptive epidemiological methods.Results 1830 cases of AEFI following EV71 vaccination were reported in Zhejiang province over the four years and the estimated incidence was 72.23 per 100000 doses.Among them,202 cases of abnormal reactions were reported and the incidence was estimated to be 7.97 per 100000 doses.The ratio of males to females was 1.17:1 among these cases.81.92% of the cases of AEFI involved patients between 6 and 24 months old.51.53% of the cases occurred between April and July.1283 cases(70.11%)of adverse reactions started after the first dose and 1180 cases(64.48%)within one day of vaccination.The symptoms of common adverse reactions ranged from fever,local swelling,induration to anaphylactic rashes.79.45% of the cases of AEFI eventually recovered.Conclusion EV71 vaccine used in Zhejiang province is safe.Active monitoring is more sensitive than passive monitoring,but monitoring methods need to be optimized.