2018—2022年陕西省国产口服轮状病毒减毒活疫苗安全性监测分析  

Safety analysis of oral live attenuated rotavirus vaccine,Shaanxi,2018-2022

作　　者：吕亚可 马悦章 张少白[1] 胡伟军[1] LV Ya-ke;MA Yue-zhang;ZHANG Shao-bai;HU Wei-jun(Shaanxi Provincial Center for Disease Control and Prevention,Xi’an,Shaanxi 710054,China)

机构地区：[1]陕西省疾病预防控制中心,陕西西安710054

出　　处：《现代预防医学》2024年第22期4206-4211,共6页Modern Preventive Medicine

基　　金：陕西省创新能力支撑计划项目(项目编号:2022PT-26)。

摘　　要：目的分析陕西省2018—2022年国产口服轮状病毒减毒活疫苗(Rotavirus(Live)Vaccine,Oral,RVVO)疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)的特征,评价RVVO预防接种的安全性。方法通过国家AEFI信息管理系统,收集陕西省2018—2022年接种RVVO发生的AEFI个案信息,通过陕西省免疫规划信息管理系统收集全省RVVO接种情况,采用描述性流行病学方法进行分析。结果陕西省2018—2022年接种RVVO共计461102剂次,首剂接种有63.69%年龄在12月龄后。共报告发生AEFI 48例,发生率10.41/10万剂,其中一般反应43例(9.33/10万剂)、异常反应3例(0.65/10万剂),偶合症2例,未见报告严重AEFI病例。3例异常反应分别为过敏性皮疹(0.22/10万剂),急性腹泻(0.22/10万剂)和轮状病毒腹泻(0.22/10万剂)各1例。报告的AEFI经随访97.92%病例治愈或好转,无后遗症和死亡病例报告。报告AEFI发病年龄均小于1岁,发生时间均为接种当天;接种首剂、二剂次和三剂次AEFI发生率分别为12.65/10万剂、10.64/10万剂和3.61/10万剂;RVVO与其他疫苗联合接种报告AEFI中一般反应发生率10.16/10万剂次,异常反应发生率0.97/10万剂次。结论国产口服轮状病毒减毒活疫苗具有良好的安全性,应进一步加强儿童疫苗及时接种率。Objective To analyze the characteristics of Adverse Events Following Immunization(AEFI)of domestic rotavirus(live)vaccine(RVVO)in Shaanxi province from 2018 to 2022,and to evaluate the safety of RVVO vaccination.Methods The AEFI case data on RVVO vaccination in Shaanxi Province between 2018 and 2022 was gathered from the China AEFI Information Management System.,and the vaccination situation of RVVO in Shaanxi province was collected through the immunization planning information management system of Shaanxi province.The analysis was conducted using the descriptive epidemiological technique.Results A total of 461102 doses of RVVO were inoculated in Shaanxi province from 2018 to 2022,and 48 cases of AEFI were recorded,with an incidence of 10.41 cases per 100000 doses,including 43 cases of normal reactions(9.33 cases per 100000 doses)and 3 cases of abnormal reactions(0.65 cases per 100000 doses).2 cases of coupling disease and No serious AEFI cases recorded.The three abnormal reactions were allergic rash(0.22/100000 doses),acute diarrhea(0.22/100000 doses)and rotavirus diarrhea(0.22/100000 doses).97.92%of the reported AEFI cases were cured or improved after follow-up,and no sequelae and death cases were reported.The age of onset of AEFI was less than 1 year old and occurred on the day of inoculation.The incidence of AEFI at the first,second and third doses was 12.65 cases per 100000 doses,10.64 cases per 100,000 doses and 361 cases per 100000 doses,respectively.RVVO combined with other vaccines reported a general reaction rate of 10.16 per 100000 doses and an abnormal reaction rate of 0.97 per 100000 doses in AEFI.Conclusion The domestic oral live attenuated rotavirus vaccine has good safety,and the timely vaccination rate of children should be further strengthened.

关 键 词：轮状病毒疫苗 疑似预防接种异常反应 

分 类 号：R186[医药卫生—流行病学] R512.5[医药卫生—公共卫生与预防医学]