沈金花, 顾士康, 陈文花, 朱祺, 陆红梅. 上海市松江区含b型流感嗜血杆菌成分疫苗预防接种不良反应监测结果分析[J]. 上海预防医学, 2022, 34(11): 1129-1133. DOI: 10.19428/j.cnki.sjpm.2022.22191
引用本文: 沈金花, 顾士康, 陈文花, 朱祺, 陆红梅. 上海市松江区含b型流感嗜血杆菌成分疫苗预防接种不良反应监测结果分析[J]. 上海预防医学, 2022, 34(11): 1129-1133. DOI: 10.19428/j.cnki.sjpm.2022.22191
SHEN Jinhua, GU Shikang, CHEN Wenhua, ZHU Qi, LU Hongmei. Monitoring of adverse reaction of Haemophilus influenzae type b vaccine in Songjiang District, Shanghai[J]. Shanghai Journal of Preventive Medicine, 2022, 34(11): 1129-1133. DOI: 10.19428/j.cnki.sjpm.2022.22191
Citation: SHEN Jinhua, GU Shikang, CHEN Wenhua, ZHU Qi, LU Hongmei. Monitoring of adverse reaction of Haemophilus influenzae type b vaccine in Songjiang District, Shanghai[J]. Shanghai Journal of Preventive Medicine, 2022, 34(11): 1129-1133. DOI: 10.19428/j.cnki.sjpm.2022.22191

上海市松江区含b型流感嗜血杆菌成分疫苗预防接种不良反应监测结果分析

Monitoring of adverse reaction of Haemophilus influenzae type b vaccine in Songjiang District, Shanghai

  • 摘要:
    目的 分析2016—2020年上海市松江区含b型流感嗜血杆菌(Hib)成分疫苗不良反应报告情况,为Hib疫苗纳入儿童免疫规划及做好Hib疫苗的安全性监测提供依据。
    方法 通过中国疾病预防控制信息系统收集预防接种不良事件(AEFI)报告数据,并用描述性方法进行分析。
    结果 2016—2020年松江区各类含Hib成分疫苗的AEFI报告率为747.76/10万剂次,其中一般反应和异常反应报告率分别为734.31/10万剂次、13.45/10万剂次,一般反应报告率显著高于异常反应(χ2=1 400.18,P<0.001)。比较不同性别、不同户籍人群的不良反应报告率,差异无统计学意义;而不同年龄对象的不良反应报告率差异有统计学意义(χ2=366.07,P<0.001),≥12月龄儿童最高,这是由一般反应报告率的差异导致(χ2=360.48,P<0.001),而各年龄段儿童的异常反应报告率无差异。4类含Hib成分疫苗的AEFI报告率差异有统计学意义(χ2=508.51,P<0.001),且DTaP⁃IPV⁃Hib疫苗的AEFI报告率最高,DTaP⁃Hib疫苗次之,Hib疫苗和流脑HI疫苗无差异,而AEFI报告率的差异主要是由一般反应报告率的差异引起(χ2=499.19,P<0.001)。各类含Hib成分疫苗加强免疫的AEFI报告率高于基础免疫(χ2=462.85,P<0.001);DTaP⁃Hib疫苗和DTaP⁃IPV⁃Hib疫苗接种于不同接种部位不良反应报告率有统计学差异(χ2=13.63,P=0.001;χ2=78.48,P<0.001),且接种于大腿部位发生的AEFI报告率低于臀部或上臂部位。报告的1 501例不良反应中,分别有97.21%的一般反应和85.19%的异常反应发生在接种后72 h内。临床诊断以发热、红肿、硬结反应为主,共1 454例,占总报告AEFI的96.87%;其次为过敏性皮疹。
    结论 4类含Hib成分疫苗均有较高的安全性,预防接种门诊工作人员要严格按照规范要求,做好预检、规范操作、充分告知,同时提升AEFI监测和调查处置水平,提高临床救治能力,从而有效降低AEFI的发生率及严重程度。

     

    Abstract:
    Objective To determine the reporting rate of adverse reaction of Haemophilus influenzae type b (Hib) containing vaccine in Songjiang District from 2016 to 2020, so as to provide evidence for the inclusion of Hib vaccine in children's immunization planning and safety monitoring.
    Methods The adverse reaction data of Hib vaccination were collected through the Chinese Disease Prevention and Control Information System and presented by descriptive methods.
    Results From 2016 to 2020, the reporting rate of adverse reaction of various Hib-containing vaccines in Songjiang District was determined to be 747.76/105 doses, among which the rates of general reaction and abnormal reaction were 734.31/105 doses and 13.45/105 doses, respectively. The reporting rate of general reaction was significantly higher than that of abnormal reaction (χ2=1 400.18,P<0.001). Moreover, the reporting rate of adverse reaction did not differ significantly by sex or registered residence, whereas it differed significantly by age groups (χ2=366.07,P<0.001). Children ≥12 months old had the highest reporting rate, which was caused by higher rate of general reaction (χ2=360.48,P<0.001) compared with other age groups; in contrast, there was no difference in the reporting rate of abnormal reactions across age groups. The reporting rate of adverse reaction differed significantly across four Hib-containing vaccines (χ2=508.51,P<0.001), among which the reporting rate of pentavalent vaccine was the highest, followed by tetravalent vaccine, and Hib vaccine and meningococcal HI vaccine. This difference was mainly caused by general reaction (χ2=499.19,P<0.001). The reporting rate of booster Hib-containing vaccines was significantly higher than that of basic immunization (χ2=462.85,P<0.001). Furthermore, the reporting rate differed between DTaP-Hib vaccine and DTaP-IPV-Hib vaccine by injection sites(χ2=13.63,P=0.001;χ2=78.48, P<0.001); the reporting rate on the thigh was lower than that on the hip or upper arm. Among the 1 501 reported adverse reactions, 97.21% of the general reactions and 85.19% of the abnormal reactions occurred within 72 hours following immunization. Principal clinical diagnosis was fever, redness and nodules (n=1 454), accounting for 96.87% of the total reported adverse event following immunization(AEFI), followed by allergic rash.
    Conclusion The four types of Hib-containing vaccines have high safety. Health care practitioners at points of vaccination should improve the pre-examination, standardized operation and full notification in strict accordance with the requirements. It also warrants strengthening the AEFI monitoring, investigation and response, so as to effectively reduce the incidence and severity of adverse reactions.

     

/

返回文章
返回