摘要
目的评价国产口服轮状病毒减毒活疫苗(简称轮状病毒疫苗)的安全性。方法检索中国知网(CNKI)、中文期刊服务平台、万方数据库、PubMed、Medline和Embase,筛选2020年1月1日—2023年7月31日发表的关于中国疑似预防接种异常反应(adverse event following immunization,AEFI)的研究,从中抽取有关国产轮状病毒疫苗AEFI监测数据。采用R语言对轮状病毒疫苗接种后的安全性进行Meta分析,并对不同区域和不同时间段的AEFI报告发生率进行亚组分析。结果共纳入36篇文献,涉及样本2533.2万剂。国产轮状病毒疫苗AEFI发生率为19/10万剂(95%CI:15/10万剂~24/10万剂);北方和南方地区AEFI发生率分别为26/10万剂(95%CI:17/10万剂~39/10万剂)和16/10万剂(95%CI:11/10万剂~23/10万剂);2017年前为24/10万剂[95%CI:12/10万剂~45/10万剂],2017年后为27/10万剂[95%CI:18/10万剂~39/10万剂]。结论国产轮状病毒疫苗AEFI发生率在预期范围内,真实世界应用中安全性良好。
Objective To evaluate the real-world safety of the domestic rotavirus attenuated live vaccine in China.Methods Studies on the incidence of adverse event following immunization(AEFI)published from January 1,2020 to July 31,2023 were retrieved from National Knowledge Infrastructure(CNKI),CQVIP,Wanfang Database,PubMed,Medline,and Embase.Surveillance data about AEFI reports related to the domestic rotavirus vaccine rotavirus were collected.A meta-analysis on the safety of the rotavirus vaccine after vaccination was conducted using R software,and subgroup analyses were conducted on the incidence of AEFI in different regions and time periods.Results A total of 36 articles were included involving 25.332 million doses of vaccine.The incidence of AEFI associated with the domestic rotavirus vaccine was 19/100000 doses[95%CI:15/100000-24/100000 doses];the incidence was 26/100000 doses[95%CI:17/100000-39/100000 doses]in the northern regions and 16/100000 doses[95%CI:11/100000-23/100000 doses]in the southern regions;it was 24/100000 doses[95%CI:12/100000-45/100000 doses]before 2017 and 27/100000 doses[95%CI:18/100000-39/100000 doses]after 2017.Conclusions The incidence of AEFI related to the domestic rotavirus vaccine is within the expected range,and the safety of the vaccine is good based on the real-world data.
作者
苏峰
时云志
徐敏
黎慕
陈军
霍怡菲
陈毅锋
赵杰
苏锦锋
Su feng;Shi Yunzhi;Xu Min;Li Mu;Chen Jun;Huo Yifei;Chen Yifeng;Zhao Jie;Su Jinfeng(Department of Human Vaccines,China National Biotec Group Company Limited,Beijing 100024,China)
出处
《中华微生物学和免疫学杂志》
CAS
CSCD
北大核心
2024年第5期431-440,共10页
Chinese Journal of Microbiology and Immunology
