2010—2020年北京市丰台区含无细胞百白破成分联合疫苗预防接种安全性评价

Evaluation of the safety of diphtheria, tetanus and acellular pertussis containing combination vaccines in Fengtai district, Beijing,2010—2020

目的 评价北京市丰台区含无细胞百日咳、白喉及破伤风(DTaP)成分的联合疫苗预防接种安全性。方法 通过中国免疫规划信息管理系统疑似预防接种异常反应信息管理系统,收集丰台区2010—2020年报告的DTaP、DTaP-Hib及DTaP-IPV-Hib疫苗疑似预防接种异常反应监测数据,进行描述性流行病学分析。结果 2010—2020年北京市丰台区累计接种3种含DTaP成分疫苗1 171 348剂次,报告AEFI 311例(26.55/10万剂);其中一般反应、异常反应、偶合症、心因性反应分别报告217例(18.53/10万剂)、63例(5.38/10万剂)、30例(2.56/10万剂)、1例(0.09/10万剂)。DTaP、DTaP-Hib、DTaP-Hib-IPV的AEFI报告发生率比较差异有统计学意义(P<0.01)。基础免疫AEFI发生数为131例(11.18/10万剂),加强免疫共报告AEFI发生数180例(15.37/10万剂),加强免疫AEFI报告发生率显著高于基础免疫,差异有统计学意义(P<0.01)。3种含DTaP成分疫苗不良反应报告总数为280例,其中一般反应AEFI发生数217例(18.53/10万剂)、异常反应AEFI报告数63例(5.38/10万剂)。DTaP、DTaP-Hib、DTaP-Hib-IPV不良反应报告发生率比较差异有统计学意义(P<0.01)。报告的AEFI主要发生于接种疫苗后0~1 d内,发生数为293例(94.21%),2~3 d发生数为15例(4.82%),4~7 d发生数为2例(0.64%),>7 d发生数为1例(0.32%)。结论 北京市丰台区使用的3种含DTaP成分联合疫苗均具有良好的安全性,但仍需继续加强AEFI监测。

Objective This paper aimed to evaluate the safety of the combined vaccine containing acellular pertussis, diphtheria and tetanus(DTaP) in Fengtai district. Methods A descriptive epidemiological study was used to analyze adverse event following immunization(AEFI) data of DTaP, Diphtheria, DTaP-Hib, DTaP-IPV-Hib reported in 2010—2020 through the national AEFI Information System.Results A total of 311 AEFIs were reported during 2010—2020, for an incidence of 26.55 per 100 000 doses. Among all the AEFI cases, 217(18.53 per 100 000) were common adverse reactions;63(5.38 per 100 000) were rare adverse reactions;30 cases of coincidence reactions(2.56 per100 000) and 1 case of psychogenic reaction(0.09 per100 000), respectively. There was significant difference in the report rate of AEFI among the three vaccines: DTaP, DTaP-Hib, and DTaP-Hib-IPV(P<0.01).The incidence of AEFI inbooster immunization of DTaP vaccine was higher than that of basic immunization(P<0.01). The incidence of AEFI in basic immunization was 131 cases(11.18/100 000 doses), and a total of 180 cases(15.37/100 000 doses) were reported in enhanced immunization. The incidence of AEFI in enhanced immunization was significantly higher than that in basic immunization, and the difference was statistically significant(P<0.01). The total number of adverse reactions of the three vaccines was 280, including 217 cases of general reaction AEFI(18.53/100 000 doses) and 63 cases of abnormal reaction AEFI(5.38/100000 doses). There was significant difference in the reported incidence of adverse reactions among DTaP, DTaP Hib and DTaP Hib IPV(P<0.01). The reported 293 cases(94.21%)of AEFI occurred within 0-1 days after vaccination, 15 cases(4.82%) within 2-3 days, 2 cases(0.64%) within 4-7 days, and 1 case(0.32%) in more than 7 days.Conclusion The three DTaP-containing combined vaccines used in Fengtai District of Beijing are safe, and the monitoring of AEFI needs to be further strengthened.