河北省三种脊髓灰质炎疫苗安全性监测分析

目的比较河北省二价脊髓灰质炎(脊灰)减毒活疫苗(bivalent oral polio attenuated live vaccine,bOPV)、脊灰灭活疫苗(Salk株)(inactivvated poliomyelitis vaccine made from Salk strains,IPV-Salk)和脊灰灭活疫苗(Sabin株)(inactivated poliomyelitis vaccine made from Sabin strains,IPV-Sabin)接种后疑似预防接种异常反应(adverse events following immunization,AEFI)的发生特征,评价脊灰疫苗的安全性。方法通过疑似AEFI信息管理系统收集河北省2016年5月1日—2018年4月30日脊灰疫苗接种后AEFI个案,比较分析三种脊灰疫苗接种后AEFI的报告发生情况。结果bOPV、IPV-Salk和IPV-Sabin的AEFI报告发生率分别为13.53/10万剂、40.50/10万剂和63.70/10万剂。bOPV与IPV-Salk、bOPV与IPV-Sabin、IPV-Salk与IPV-Sabin的AEFI报告发生率(χ2=360.355,P<0.001,χ2=360.247,P<0.001,χ2=34.895,P<0.001)和一般反应报告发生率(χ2=373.009,P<0.001,χ2=564.795,P<0.001,χ2=35.382,P<0.001)差异均有统计学意义,由高到低依次为:IPV-Sabin、IPV-Salk和bOPV;异常反应报告发生率(χ2=3.077,P=0.079,χ2C=1.165,P=0.281,χ2C=0,P=1)差异均无统计学意义。三种脊灰疫苗的AEFI中均以一般反应为主,年龄主要集中在≤1岁组,主要发生在接种后1 d内。结论河北省三种脊灰疫苗总体安全性良好,但仍需加强脊灰疫苗安全性监测。

Monitoring on safety of three types of poliomyelitis vaccines in Hebei province

Objective To compare occurrence features of suspected adverse events following immunization (AEFI) of bivalent oral polio attenuated live vaccine (bOPV), inactivated poliomyelitis vaccine made from Salk strains (IPV-Salk) andinactivated poliomyelitis vaccine made from Sabin strains (IPV-Sabin) in Hebei province, and to evaluate the safety of poliomyelitis vaccines.Methods We collected reported AEFI cases related to vaccination of poliomyelitis vaccines in Hebei province from May 1, 2016 to April 30, 2018 through suspected AEFI information management system, and then compared and analyzed the incidence of reported AEFI cases related to vaccination of the three types of poliomyelitis vaccines. Results The incidence rates of AEFI of bOPV, IPV-Salk and IPV-Sabin were 13.53/100,000 doses, 40.50/100,000 doses, and 63.70/100,000 doses, respectively. Statistically significant differences in the incidence rates of AEFI (χ²=360.355, P<0.001; χ²=360.247, P<0.001; χ²=34.895, P<0.001) and common adverse reaction reported (χ²=373.009, P<0.001; χ²=564.795, P<0.001; χ²=35.382, P<0.001) were seen between bOPV and IPV-Salk,betweenbOPV and IPV-Sabin, and between IPV-Salk and IPV-Sabin. The order from high to low was IPV-Sabin, IPV-Salk and bOPV. No statistically significant differences were found in the incidence rates of reported rare adverse reaction between bOPV and IPV-Salk (χ²=3.077, P=0.079), bOPV and IPV-Sabin (χ²_c= 1.165, P=0.281), and IPV-Salk and IPV-Sabin (χ²_c=0, P=1). Most of the reported AEFI cases caused by the three types of poliomyelitis vaccines were common adverse reactions, were children aged ≤1 year, and occurred within 1 day after vaccination. Conclusions The three types of poliomyelitis vaccines in Hebei province are safe, but the work of monitoring safety of poliomyelitis vaccines still needs to be strengthened.