2012-2016年山东省烟台市乙型脑炎减毒活疫苗疑似预防接种异常反应监测分析

Surveillance of adverse events following immunization with Japanese encephalitis attenuated live vaccine in Yantai city of Shandong province,2012-2016

目的分析山东省烟台市乙型脑炎减毒活疫苗（Japanese encephalitis attenuated live vaccine，JEV-L）疑似预防接种异常反应（Adverse events following immunization，AEFI）的特征，评价JEV-L预防接种的安全性。方法通过全国AEFI信息管理系统和山东省免疫规划监测信息管理系统，收集烟台市2012-2016年报告的AEFl个案数据和疫苗接种数据，采用描述流行病学方法进行分析。结果烟台市2012-2016年报告JEV-L的AEFI651例，报告发生率为11．19／万剂。一般反应643例（98．77％，11．05／万剂），其中发热618例（96．11％，10．63／万剂）、局部红肿55例（8．55％，0．95／万剂）；异常反应7例（1．08％，0．12／万剂），均为过敏性皮疹。在不良反应中，第1剂次、接种后0-1d发生分别占70．oo％（455／650）、93．85％（610／650）。结论JEV-L具有较好的预防接种安全性，不良反应以发热和局部反应为主。

Objective To characterize adverse events following immunization （AEFI） of Japanese en- cephalitis attenuated live vaccine （JEV-L） in Yantai city of Shandong province, and to evaluate the safe- ty of JEV-L. Methods JEV-L AEFi reports during 2012-2016 were obtained through the National AEFIs Information System; vaccination data were collected through the Shandong Children Immunization Information System. We analyzed data with descriptive epidemiological methods. Results 651 JEV-L AEFIs were reported, for an incidence of 11.19 per 10 000 doses. Among AEFIs, 643 （98.77% , 11.05 per 10 000） were common vaccine reactions, of which 618 （96. 11% , 10. 63 per 10 000） were fever and 55 （8.55%, 0. 95 per 10 000） were injection-site redness/swelling. Seven AEFIs （ 1.08%, 0. 12 per 10 000） were rare vaccine reactions, all of which were anaphylactic reactions. Seventy percent （455/650） of AEFIs occurred after the first dose of vaccine, and 93.85% （610/650） occurred within one day after vaccination. Conclusions JEV-L had a good safety profile; most reported AEFIs were fever or local reactions.