2018—2021年扬州市无细胞百白破联合疫苗预防接种安全性评价

Analysis on the Adverse Events Following Immunization with DPT Vaccine in Yangzhou from 2018 to 2021

目的:分析扬州市无细胞百白破联合疫苗(DTap)接种后出现疑似预防接种异常反应(AEFI)的发生特征及分布情况,为进一步评价DTaP疫苗预防接种的安全性提供依据。方法:通过中国免疫规划信息管理系统的AEFI监测系统收集2018年1月1日—2021年12月31日扬州市报告的DTaP疫苗相关AEFI个案数据,采用描述流行病学方法进行分析。结果:2018—2021年扬州市共接种DTaP疫苗365215剂次,共报告DTaP疫苗相关AEFI个案1055例,年均报告发生率为288.87/10万剂次,其中,一般反应1015例,占96.21%,报告发生率为277.92/10万剂次,临床表现主要为发热、红肿、硬结;异常反应38例,占3.60%,报告发生率为10.40/10万剂次,主要为过敏性皮疹和荨麻疹;偶合症最少,共2例,占0.19%,报告发生率为0.55/10万剂次,均为热性惊厥;无心因性反应、疫苗质量事故及预防接种事故发生。9个县(市、区)各年度均有DTaP疫苗相关AEFI个案报告,其中,报告发生例数最多的为江都区,为232例;各月份均有DTaP疫苗相关AEFI个案报告,其中5、6、7月份报告例数较多。1055例AEFI个案中,男性621例,女性434例,男女性别比为1.43∶1;年龄分布主要以0岁组(271例)和1岁组(731例)病例为主;97.91%的病例随访结果为好转或痊愈。结论:扬州市DTap疫苗预防接种安全性较好,监测系统敏感性较高。

OBJECTIVE To analyse the characteristics of diphtheria tetanus and acellular pertussis combined vaccine(DTap)adverse events following immunization(AEFI)reported by Yangzhou in order to assess the safety of DTap.METHODS The AEFI surveillance information system of China Immunization Program was used to derive the AEFI report case data occurred from January 1,2018 to December 31,2021 in Yangzhou.The descriptive methods were used for epidemiological analysis.RESULTS From 2018 to2021,a total of 365215 doses of DTap vaccine were administered in Yangzhou,a total of 1055 cases of AEFI related to DTap vaccine were reported,The annual reported incidence of 288.87/10000 doses,among,1015 general reactions,accounting for 96.21%,reported incidence of 277.92/10000 doses,clinical manifestations are mainly fever,redness,swelling,and induration;38 abnormal reactions,at 3.60%,reported incidence of 10.40/10000 doses,mainly for allergic rash and urticaria;the least coincidence,a total of2 cases,of 0.19%,reported incidence rate of 0.55/100000 doses,all are febrile convulsions;unintentional sexual reactions,vaccine quality accidents and preventive vaccination accidents occurred.Nine counties(cities and districts)had DTap vaccine related AEFI case reports,including the largest number of cases in Jiangdu district,with 232 cases in each month,among which more cases were reported in May,June and July.Among the 1055 AEFI cases,621 were male and 434 were female,and the gender ratio was 1.43:1;the age distribution was mainly the cases of 0(271)and 1(731);97.91%of cases had follow-up results were improved or recovery.CONCLUSION The safety of DTap vaccine is good,and the AEFI monitoring system works well.