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目的 分析河北省脊髓灰质炎减毒活疫苗疑似预防接种异常反应信息管理系统(Adverse events following immunization Information Management System,AEFIIMS)监测数据,初步评价上市后二价脊髓灰质炎疫苗(Bivalent oral poliovirus vaccines,bOPV)的安全性.方法 通过中国AEFIIMS收集2015年和2016年接种三价脊髓灰质炎减毒活疫苗(Trivalent oral poliovirus vaccines,tOPV)、bOPV的AEFI个案数据,中国免疫规划信息管理系统(National Immunization Program Information Management System,NIPIMS)收集疫苗接种数据.采用描述性方法对相关指标进行流行病学分析,计算构成比和AEFI估算报告发生率等指标.结果 河北省2015年tOPV估算报告发生率为88.29/100万,2016年5～12月bOPV估算报告发生率为155.97/100万;不良反应估算报告发生率分别为151.62/100万、155.00/100万,以一般反应为主.2015年和2016年一般反应估算报告发生率分别为86.43/100万、147.74/100万;异常反应估算报告发生率分别为4.27/100万、7.27/100万.异常反应中过敏性皮疹报告例数最多,估算报告发生率2015年和2016年分别为1.49/100万、2.91/100万;反应主要发生在接种后1d内,过敏性皮疹等反应集中在3d内,预后均良好.结论 bOPV的AEFI报告发生率和一般反应报告发生率均高于tOPV,高于国家OPV的相关报道,异常反应报告发生率差异无统计学意义.应进一步加强bOPV的安全性监测,以获得更加全面科学的数据.“,”Objective To analyze adverse events following immunization (AEFI) with OPV in Hebei Province,and to evaluate the safety of bOPV.Methods We collected reported tOPV AEFIs in 2015,and bOPV AEFIs between May to Dec 2016,the vaccine doses administered from NIPIMS.Descriptive epidemiological methods were used in the study.Results AEFI reporting incidence and vaccine reactions incidence were 155.97/1 000 000,155.00/1 000 000,between May and Dec 2016,more than 88.29/1 000 000,151.62/1 000 000,in 2015.Common vaccine reactions reported incidence was 86.43/1 000 000,147.74/ 1 000 000 respectively.Rare vaccine reactions was 4.27/1 000 000,7.27/1 000 000 respectively.Most of rare vaccine reactions were allergic rashes(1.49/1 000 000 in 2015,2.91/1 000 000 in 2016).Vaccine reactions usually occurred within 1 d after vaccination,anaphylactic rash after 3 d,most cases recovered.Conclusion AEFI reporting incidence and common reactions of bOPV were higher than tOPV,higher than the OPV of China related report.There was no significant difference in the incidence of rare response.More security monitoring work of bOPV should to be done,to obtain more comprehensive scientific data.