2岁及以上人群接种23价肺炎球菌多糖疫苗的安全性研究  

Safety study of 23-valent pneumococcal polysaccharide vaccine in people aged 2 years old and above

作　　者：郑艳[1] 石峰 杨海涛[1] 陈菁菁 严雪梅 陶思文 赖欣 杨叶梅 岳俊艳 刘晓强[1] 袁琳 Zheng Yan;Shi Feng;Yang Haitao;Chen Jingjing;Yan Xuemei;Tao Siwen;Lai Xin;Yang Yemei;Yue Jun-yan;Liu Xiaoqiang;Yuan Lin(Clinical Research Center,Yunnan Center for Disease Prevention and Control,Kunming,Yunnan 650022,China;Pu′er Center for Disease Prevention and Control,Pu′er,Yunnan 665000,China;Registration and Medical Center,Walvax Biotechnology Co.,Ltd,Kunming,Yunnan 650000,China)

机构地区：[1]云南省疾病预防控制中心疫苗临床研究中心,云南昆明650022 [2]普洱市疾病预防控制中心,云南普洱665000 [3]云南沃森生物技术股份有限公司注册与医学中心,云南昆明650000

出　　处：《中国药物与临床》2025年第5期318-322,共5页Chinese Remedies & Clinics

摘　　要：目的探究≥2岁人群接种23价肺炎球菌多糖疫苗的安全性。方法选取2022年3~5月在云南省疾病预防控制中心下辖的普洱市疾病预防控制中心自愿接种23价肺炎球菌多糖疫苗的≥2岁2995名受种者作为研究对象,接种后30 min现场观察及接种后7 d/30 d电话随访后,对受种者的全身性及局部不良反应进行统计,分析≥2岁人群接种23价肺炎球菌多糖疫苗的安全性。结果23价肺炎球菌多糖疫苗安全性接种共纳入观察者2995名,其中男性1285名(42.90%),女性1710名(57.10%);2~5岁500名(16.69%)、6~17岁499名(16.66%)、≥18岁1996名(66.64%)。2995名中接种后30 d观察期内共发生不良反应748例,占比24.97%,0~7 d不良反应发生率21.99%~30.66%。接种后30 min内共发生17例(0.57%)不良反应,各年龄段发生率分别为0.20%,1.00%和0.55%。全身不良事件总发生率4.31%(129例,137例次),2~5岁、6~17岁及≥18岁发生率分别为8.60%(43例,48例次)、6.81%(34例,36例次)和2.61%(52例,53例次)。主要症状以发热(总占比2.97%)、乏力(0.43%)、头痛(0.43%)为主。共观察到544例570例次局部不良反应,其中2~5岁发生率最低(13.00%),主要症状为疼痛(17.53%)、瘙痒(0.60%)和肿胀(0.50%),6~17岁疼痛(23.05%)和肿胀(1.00%)发生率最高。观察到严重不良事件7例16例次,2~5岁受种者中报告2例(0.07%)6例次,涉及慢性扁桃体炎、支原体肺炎、支气管炎等小儿常见感染性及呼吸系统疾病;≥18岁发生5例(0.17%)10例次,其中1例脑血管意外,1例呼吸系统衰竭、循环系统异常合并脓毒症;6~17岁组未观察到。结论本研究为疫苗上市后安全性观察,证实≥2岁人群接种23价肺炎球菌多糖疫苗具有较高的安全性。Objective To explore the safety of the 23-valent pneumococcal polysaccharide vaccine in in-dividuals aged 2 years and older.Methods A total of 2995 individuals aged 2 years and older who voluntarily received the 23-valent pneumococcal polysaccharide vaccine at Pu′er City Center for Disease Prevention and Con-trol from March 2022 to May 2022 were selected as the research subjects.After on-site visits 30 minutes after vaccination and telephone follow-ups at 7 days and 30 days after vaccination,the systemic and local adverse reac-tions of the vaccinated individuals were counted to analyze the safety of the 23-valent pneumococcal polysaccha-ride vaccine in individuals aged 2 years and older.Results A total of 2995 people were included in the safety observation of the 23-valent pneumococcal polysaccharide vaccine.Among them,1285(42.90%)were male and 1710(57.10%)were female.The age distribution was as follows:500 cases(16.69%)were aged 2-5 years old,499 cases(16.66%)were aged 6-17 years old,and 1996 cases(66.64%)were aged 18 years old and older.A-mong of 2995 individuals who were vaccinated,a total of 748 cases(24.97%)of adverse reactions were reported within the 30-day observation period.The majority of these adverse reactions occurred within 0 to 7 days post-vaccination,with the incidence rate across different age groups ranging from 21.99%to 30.66%.Within the first 30 minutes after vaccination,17 cases(0.57%)of adverse reactions were reported,with the incidence rates in the youngest to oldest age groups being 0.20%,1.00%,and 0.55%,respectively.The overall incidence of systemic ad-verse events was 4.31%(129 cases/137 instances),with some variation observed across different age groups:the incidence rates were 8.60%(43 cases,48 instances)for ages 2-5,6.81%(34 cases,36 instances)for ages 6-17,and 2.61%(52 cases,53 instances)for those aged 18 and above.The primary systemic symptoms were fever(overall prevalence of 2.97%),fatigue(0.43%),and headache(0.43%).A total of 544 cases(570 instances)of local adverse reactions we

关 键 词：2岁及以上人群 接种 23价肺炎球菌多糖疫苗 安全性 

分 类 号：R186[医药卫生—流行病学]