肠道病毒71型灭活疫苗上市后安全性主动与被动监测

目的：评价肠道病毒71型灭活疫苗（EV71疫苗）上市后人群使用安全性，为制定EV71疫苗免疫策略提供科学依据。方法：采用主动监测和被动监测相结合的研究方法，收集温州市EV71疫苗不良反应资料，使用SPSS23.0软件进行统计分析。结果：2017年EV71疫苗被动监测不良反应发生率为4.2/万剂，其中异常反应发生率0.5/万剂；主动监测不良反应发生率为156.7/万剂，其中异常反应发生率12.0/万剂；主动监测不良反应及异常反应发生率均高于被动监测，差异均有统计学意义（P＜0.05）。主动监测不良反应主要发生在接种后30 min～3 d（占62.4%），临床表现以发热为主。不良反应发生率随年龄增加呈下降趋势，女性高于男性，差异有统计学意义（P＜0.05）。结论：EV71疫苗不良反应发生率处于较低水平，症状常较轻微，总体安全性良好，主动监测比被动监测更灵敏和准确。

Active and passive surveillance on post-marketing safety of enterovirus 71 inactivated vaccine

Objective: To evaluate post-marketing safety of enterovirus 71 inactivated vaccine (EV71 vaccine), and provide scientific basis for formulating immunization strategy. Methods: The adverse reactions of EV71 vaccine in Wenzhou city were collected by a combination of active and passive surveillance methods and analyzed statistically by SPSS23.0 software. Results: The incidence of adverse reactions of EV71 vaccine was 4.2/10 000 doses in passive surveillance, of which the incidence of abnormal reactions was 0.5/10 000 doses. The incidence of adverse reactions was 156.7/10 000 doses in active surveillance, of which the incidence of abnormal reactions was 12.0/10 000 doses. The incidence of adverse reactions and abnormal reactions in active surveillance were both higher than those in passive surveillance, with statistical difference (P<0.05). Active surveillance showed that adverse reactions mainly occurred within 30 min-3 d (62.4%) after immunization, and the main clinical symptom was fever. With the increase in age, the incidence of adverse reactions showed a downward trend (P<0.05). There was a significant difference in the rate of adverse reactions between different genders, i.e. higher in women than in men (P<0.05). Conclusion: The incidence of adverse reactions of EV71 vaccine was low, the symptoms were common and mild, and the overall safety was good. Active surveillance was more sensitive and accurate than passive surveillance.