摘要
目的 评价Sabin株脊髓灰质炎灭活疫苗(Vero细胞)(inactivated poliomyelitis vaccine made from Sabin strain,IPV-Sabin)上市后的安全性。方法 选择2017年9月29日~2018年1月25日于河北省接种IPV-Sabin的人群为研究对象,通过疑似预防接种异常反应(adverse event following immunization,AEFI)信息管理系统收集不良反应发生情况,回顾性分析该疫苗AEFI分类构成、报告发生率等相关指标。结果 共接种IPV-Sabin 545 256剂次,报告AEFI 378例(发生率69. 33/10万剂),其中一般反应364例(发生率66. 76/10万剂),异常反应7例(发生率1. 28/10万剂),偶合症5例(报告发生率0. 92/10万剂),不明原因2例(报告发生率0. 37/10万剂)。一般反应主要包括发热、红肿、硬结,均发生在接种后0及1 d;异常反应包括过敏性皮疹、血管性水肿、血小板减少性紫癜和热性惊厥,均发生在接种后0 d。356例AEFI治愈或好转。结论 IPV-Sabin具有良好的安全性,可用于适龄人群脊髓灰质炎的预防接种。
Objective To evaluate the post-marketing safety of inactivated poliovirus vaccine(Vero cells)made from Sabin strain(IPV-Sabin).Methods The data of adverse events following immunization(AEFI)with IPV-Sabin in population in Hebei Province from September 29,2017 to January 25,2018 were collected from Hebei Centers for Disease Control AEFI Information System,and the class and reported incidence of AEFI were analyzed retrospectively.Results A total of 378 cases of AEFI were reported after vaccination with IPV-Sabin among the 545256 doses of IPVSabin vaccine,378 cases(incidence 69.33/100000 doses)of AEFI were reported,including 364 cease of general reaction(incidence 66.76/100000 doses),7 cases of abnormal reaction(incidence 1.28/100000 doses),5 cases of coincidental events(reported incidence 0.92/100000 doses)and 2 cases of undefined situation(reported incidence 0.37/100000 doses).The general reactions mainly included fever,redness and swelling,and induration,all of which appeared 0 and 1 d after vaccination.However,the abnormal reactions mainly included allergic rash,angioedema,thrombocytopenic purpura and febrile convulsion,all of which appeared 0 d after vaccination.A total of 356 cases of AEFI were cured or improved.Conclusion IPV-Sabin showed high safety,which was suitable for the prevention of poliomyelitis in the population at appropriate ages.
作者
刘小琴
陈海平
张振国
韩莎莎
石煊雯
孙丽
LIU Xiao-qin;CHEN Hai-ping;ZHANG Zhen-guo;HAN Sha-sha;SHI Xuan-wen;SUN Li(China National Biotec Group Company Limited,Beijing 100029,China)
出处
《中国生物制品学杂志》
CAS
CSCD
2019年第12期1386-1389,共4页
Chinese Journal of Biologicals
关键词
脊髓灰质炎灭活疫苗
疑似预防接种异常反应
安全性
Inactivated poliovirus vaccine
Suspected adverse events following immunization
Safety
