肠道病毒71型灭活疫苗上市后安全性主动监测

发布时间：2018-02-07 11:03

本文关键词： 肠道病毒型灭活疫苗不良反应安全性主动监测被动监测　出处：《中国公共卫生》2017年07期 　论文类型：期刊论文

【摘要】：目的初步评价肠道病毒71型(EV71)灭活疫苗(EV71疫苗)上市后常规接种的安全性,比较疑似预防接种不良反应(AEFI)主动及被动监测的差异。方法 2016年8—11月在北京市朝阳区对3 162名儿童开展EV71疫苗上市后安全性监测,其中对770名受种儿童采用手机应用(APP)信息化平台进行主动监测AEFI,对2 392名受种儿童通过家长上报方式进行被动监测AEFI。结果主动监测组AEFI总发生率为42.33%(326/770),以全身反应为主,未见罕见和极罕见不良反应;被动监测组AEFI总发生率为0.67%(16/2 392),明显低于主动监测组(χ~2=51 274.285,P0.001),主要表现为一般反应。结论该EV71疫苗安全性良好;主动监测能够更敏感地获得疫苗接种后不良反应,可为疫苗的安全性评价提供可靠的数据支持。
[Abstract]:Objective to evaluate the safety of routine inoculation of enterovirus 71 (EV71) inactivated vaccine (EV71) after marketing. Methods from August to November, 2016, 3 162 children were monitored for the safety of EV71 vaccine in Chaoyang District, Beijing. Among them, 770 children were monitored by the mobile phone application app) information platform, and 2 392 children were passively monitored by parent report. Results the total incidence of AEFI in the active monitoring group was 42.3326 / 770g, which was mainly systemic reaction. The total incidence of AEFI in the passive monitoring group was 0.67 / 2392%, which was significantly lower than that in the active monitoring group (蠂 ~ (2 +)) 51 274.285 (P 0.001). Conclusion the EV71 vaccine is safe and safe. Active monitoring can more sensitively obtain adverse reactions after vaccination, and can provide reliable data support for vaccine safety evaluation.
【作者单位】：北京市朝阳区疾病预防控制中心生物制品科;包头医学院;北京市朝阳区卫生人才中心;
【分类号】：R186

【相似文献】