b型流感嗜血杆菌结合疫苗预防接种不良事件报告与分析  

Adverse Event Following Immunization Report and Analysis of Haemophilus Influenzae Type B Conjugate Vaccine

作　　者：李宏涛 李强 张汉青 杜晓琴 李洪光 Li Hong-tao;Li Qiang;Zhang Han-qing;Du Xiao-qing;Li Hong-guang(Chengdu Olymvax Biopharmaceuticals Inc.,Chengdu,Sichuan 611700,China)

机构地区：[1]成都欧林生物科技股份有限公司,四川成都611700

出　　处：《中国社区医师》2022年第31期155-157,共3页Chinese Community Doctors

摘　　要：目的:观察b型流感嗜血杆菌结合疫苗的疑似预防接种不良反应(AEFI)发生率。方法:选取2018年12月-2022年03月成都欧林生物科技股份有限公司出库的1162433支Hib结合疫苗接种者为研究对象,通过中国AEFI监测信息管理系统收集AEFI 266例。观察不同年份、年龄段、性别及联合应用其他疫苗发生AEFI情况。结果:2018年12月-2022年3月,出库的1162433支Hib结合疫苗,发生AEFI共266例,发生率2.288/万支;266例AEFI中,痊愈212例,好转44例,不详10例。1岁发生AEFI 99例,占37.22%;6~11个月发生AEFI 93例,占34.96%。266例AEFI中,男155例,女111例,性别占比男:女=1.40:1。AEFI的临床表现发生率由高到低依次为发热、接种部位肿胀、接种部位硬结。266例AEFI中,单独使用Hib结合疫苗235例,占88.34%,联合其他药品31例,占11.66%。联合用药发生的不良反应单独用药时也可能发生,无新的药品-药品之间的相互作用。结论:Hib结合疫苗具有较好的免疫效果,AEFI发生率较低,且多为一般反应,提倡在适龄儿童群体应用并予以推广。Objective:To observe the incidence of adverse event following immunization(AEFI)of Haemophilus influenzae type B conjugate vaccine.Methods:From December 2018 to March 2022,the recipients of 1162433 Hib conjugate vaccine released from Chengdu Olymvax Biopharmaceuticals Inc.were selected as the study subjects,and 266 cases of AEFI were collected through Chinese National AEFI Information System.The occurrence of AEFI in different years,age groups,genders,and combination with other vaccines.Results:From December 2018 to March 2022,1162433 Hib conjugate vaccines were released from the warehouse,and there were a total of 266 cases of AEFI,with the incidence of 2.288/10000 vaccines.Among the 266 cases of AEFI,212 cases were cured,44 cases were improved,and 10 cases were unknown.99 cases occurred AEFI at the age of 1 year,accounting for 37.22%;93 cases occurred AEFI at the age of 6-11 months,accounting for 34.96%.Among the 266 cases of AEFI,there were 155 males and 111 females,with a gender ratio of male:female=1.40:1.The incidence of clinical manifestations of AEFI was ranked in descending order as follows:fever,swelling at the vaccination site,and induration at the vaccination site.Among the 266 cases of AEFI,235 cases received Hib conjugate vaccine alone,accounting for 88.34%,and 31 cases received the combination with other drugs,accounting for 11.66%.Adverse effects due to the combined drugs may also occur when the drug was used alone,with no new drug-drug interactions.Conclusion:Hib conjugate vaccine has a good immune effect and a low incidence of AEFI,most of which are general reactions.It is recommended to promote the application in children of appropriate age.

关 键 词：B型流感嗜血杆菌结合疫苗 预防接种不良事件 临床表现 联合使用疫苗 

分 类 号：R186[医药卫生—流行病学]