肠道病毒71型灭活疫苗上市后安全性主动与被动监测

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

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。

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 4.2/10000 doses in passive surveillance,of which the incidence of abnormal reactions was 0.5/10000 doses.The incidence of adverse reactions was 156.7/10000 doses in active surveillance,of which the incidence of abnormal reactions was 12.0/10000 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.