2015-2019年成都市武侯区老年人群肺炎球菌疫苗接种安全性分析

Safety Evaluation of Pneumococcal Polysaccharide Vaccine in the Elderly People in Wuhou District of Chengdu 2015 to 2019

目的评价国产23价肺炎球菌多糖疫苗在成都市武侯区60岁及以上老年人群中大规模使用的安全性,为肺炎防治中相关免疫接种提供科学依据。方法通过中国疑似预防接种异常反应(AEFI)信息管理系统,收集2015-2019年成都市武侯区老年人群接种国产23价肺炎球菌多糖疫苗后发生AEFI个案数据,采用SPSS 21.0软件进行数据分析,分类资料采用χ^(2)检验,等级资料用秩和检验,检验水准α=0.05。结果共接种73 610人,累计报告22例AEFI,AEFI发生率为29.89/10万。全身不良反应的发生率为19.02/10万,局部反应发生率为27.17/10万,未见罕见和极罕见不良反应。结论由成都市生物制品研究所生产的23价肺炎球菌多糖疫苗在老年人群中大规模使用具有良好的安全性。

Objective To evaluate the safety of 23-valent pneumococcal polysaccharide vaccine(PPV23)in large-scale use in the elderly people of Wuhou district,Chengdu,and to provide scientific basis for related immunization in the prevention and treatment of pneumonia.Methods The data of individual AEFI cases of elderly people aged 60 years old and above after they had inoculated 23-valent pneumococcal polysaccharide vaccine in Wuhou district of Chengdu city from 2015 to 2019 were collected through the AEFI Information Management System of China.Software SPSS 21.0 was adopted to analyze the data.The chi-square test was used for classification data and ran sum test was used for grade data.The test level was α=0.05.Results Total 73 610 people were vaccinated,and 22 cases of AEFI were reported.The incidence of AEFI was 29.89/105.The incidence of systemic adverse reactions was 19.02/105 and partial adverse reactions was 27.17/105.There was no rare adverse reactions observed.Conclusion The 23-valent pneumococcal polysaccharide vaccine produced by Chengdu Institute of Biological Products has good safety for large-scale use in the elderly people.