大连市二价脊髓灰质炎减毒活疫苗安全性分析

Safety of bivalent oral live attenuated poliomyelitis vaccine in Dalian City,Liaoning Province,China

目的分析二价脊髓灰质炎减毒活疫苗(bivalent oral live attenuated poliomyelitis vaccine,bOPV)、三价脊髓灰质炎减毒活疫苗(trivalent oral live attenuated poliomyelitis vaccine,t OPV)及脊髓灰质炎灭活疫苗(inactivated polio-virus vaccine,IPV)疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)发生情况,评价bOPV安全性。方法收集大连市2009～2017年所有疫苗(包括第一类和第二类疫苗)的AEFI报告病例数和疫苗接种剂次,采用描述性流行病学方法进行统计分析。结果 bOPV发生AEFI 19例(男性8例,女性11例,男女发病比例为0. 73∶1),报告发生率为6. 88/10万,低于全部疫苗的平均报告发生率,高于t OPV,差异均有统计学意义(P <0. 05),与IPV-Salk相比,差异无统计学意义(P> 0. 05);11例发生在接种1 d内,7例发生在接种1 d后,1例发生在接种15 d后,其中一般反应18例,异常反应1例,发生严重异常反应的报告发生率为0. 36/10万,与全部疫苗和t OPV发生严重异常反应的报告发生率相比,差异无统计学意义(P> 0. 05)。结论 b OPV的AEFI发生率高于t OPV,低于全部疫苗,疫苗有较高的安全性。

Objective To compare the incidence rates of Adverse Events Following Immunization(AEFI)of bivalent oral live attenuated poliomyelitis vaccine(bOPV),trivalent oral live attenuated poliomyelitis vaccine(t OPV)and inactivated poliovirus vaccine(IPV)and evaluate the vaccine safety. Methods Cases and doses of AEFI caused by all the vaccines(including those of classesⅠandⅡ)reported from 2009 to 2017 in Dalian City,Liaoning Province,China were collected and subjected to statistical analysis by descriptively epidemiologic method. Results Nineteen cases of AEFI caused by bOPV was reported,8 in males and 11 in females,indicating an incidence of 6. 88/100 000,which were significantly lower than the reported mean incidence of AEFI caused by all the vaccines but significantly higher than that by t OPV(each P < 0. 05),and showed no significant difference with that by IPV-Salk(P > 0. 05). Eleven cases appeared within1 d,while 7 cases 1 d and one case 15 d after vaccination,including 18 cases of general reaction and one case of abnormal reaction. The reported incidence rate of severe abnormal reaction was 0. 36/100 000,which showed no significant difference with those caused by all the vaccines and by t OPV(P > 0. 05). Conclusion The incidence rate of AEFI caused by bOPV was higher than that by t OPV and lower than that by all the vaccines,indicating a high safety.