摘要
目的探讨基于美国疫苗不良事件报告系统(Vaccine Adverse Event Reporting System,VAERS)的疫苗相关性免疫性血小板减少症(vaccine-associated immune thrombocytopenia,VA-ITP)的临床特征,为疫苗安全性监测、预防接种以及临床诊治提供参考。方法通过美国VAERS自1990年建库后至2023年11月7日数据锁定点中,所有接种疫苗后发生免疫性血小板减少症(immune thrombocytopenia,ITP)的报告数据,对接种者性别、年龄、接种疫苗类型和剂次、ITP发生时间等信息进行回顾性分析。结果877例VA-ITP病例中,有效统计疫苗类型数为868例,共涉及43种疫苗类型,排名前10的为新型冠状病毒疫苗(434例,50%)、麻疹-腮腺炎-风疹活疫苗(82例,9.4%)、甲型肝炎疫苗(48例,5.5%)、三价流感病毒疫苗(41例,4.7%)、四价流感病毒疫苗(32例,3.7%)、人乳头瘤病毒四价疫苗(30例,3.5%)、白喉-破伤风-无细胞百日咳疫苗(29例,3.3%)、麻疹-腮腺炎-风疹-水痘活疫苗(32例,3.7%)、水痘-带状疱疹疫苗(17例,2.0%)、人乳头瘤病毒九价疫苗(13例,1.5%)。877例报告病例中,明确统计患者性别共843例,男374例,女469例,男女比例为1∶1.25;377例18岁以下患者VA-ITP发生率为44.7%,不同性别患者在各年龄段发生VA-ITP构成比差异有统计学意义(χ^(2)=10.029,P<0.05);336例患者接种疫苗后8 d内ITP发生率为39.9%,不同性别患者发生ITP时间构成比差异无统计学意义(χ^(2)=3.296,P>0.05);54.9%ITP发生于接种第1剂疫苗后,不同接种疫苗剂次患者在男女受种者中的构成比差异无统计学意义(χ^(2)=5.323,P>0.05),不同接种疫苗剂次患者在各年龄段构成比差异有统计学意义(χ^(2)=30.591,P<0.01)。结论通过从VAERS数据库中提取汇总数据,充分认识了VA-ITP这一不良反应,临床接种疫苗后,应重点关注未成年和老年人群以及8 d内接种人群血小板情况,应持续开展疫苗安全性监测,有助于减少疫苗不良事件(adverse event,AE)漏诊并提高临床诊治效率。
Objective To investigate the clinical characteristics of vaccine-associated immune thrombocytopenia(VA-ITP)based on the US Vaccine Adverse Event Reporting System(VAERS),and to provide a reference for vaccine safety monitoring,vaccination prevention,and clinical diagnosis and treatment.Methods Data from VAERS on all reported cases of immune thrombocytopenia(ITP)after vaccination since the establishment of the database in 1990 to the data lock point of 7th November 2023 were analyzed retrospectively for information on such as sex,age,vaccine type,vaccine dose,and occurrence time of ITP.Results Among the 877 cases of VA-ITP,there were 868 cases of effective statistical vaccine types,involving 43 vaccine types.The top 10 vaccine types were COVID-19 vaccine(434 cases,50%),MMR vaccine(82 cases,9.4%),HEPA vaccine(48 cases,5.5%),FLU3 vaccine(41 cases,4.7%),FLU4 vaccine(32 cases,3.7%),HPV4 vaccine(30 cases,3.5%),DTAP vaccine(29 cases,3.3%),MMRV vaccine(32 cases,3.7%),VARZOS vaccine(17 cases,2.0%)and HPV9vaccine(13 cases,1.5%).Among the 877 reported cases,843 cases with definite sex were counted,including 374 males and469 females,with a male-to-female ratio of 1∶1.25.The 377 cases of patients were under 18 years of age,accounting for about 44.7%of the total,and there was significant difference in the composition ratio of sexes among patients with VA-ITP at different ages(χ^(2)=10.029,P<0.05).The incidence of ITP within 8 days after vaccination,with a total of 336 cases,was39.9%,and there was no significant difference in the occurrence time composition ratio of ITP between different sexes(χ^(2)=3.296,P>0.05).The 54.9%of ITP occurred after the first dose of vaccine,and there was no significant difference in the composition ratio of different vaccination doses between male and female recipients(χ^(2)=5.323,P>0.05),but there was significant difference in the composition ratio of vaccination doses among different age groups(χ^(2)=30.591,P<0.01).Conclusion By analyzing the summary data from VAERS database,the adverse reaction of VA-ITP was fully recognized.After clinical vaccination,attention should be focused on the platelet status of minors and the elderly,as well as those who were vaccinated within 8 days,and the continuous vaccine safety monitoring should be carried out,which is helpful to reduce the missed diagnosis of vaccine adverse events(AE)and improve the efficiency of clinical diagnosis and treatment.
作者
王俊芳
成娟
WANG Junfang;CHENG Juan(First Clinical Medical College of Lanzhou University,Lanzhou 730000,Gansu Province,China)
出处
《中国生物制品学杂志》
2025年第2期161-166,171,共7页
Chinese Journal of Biologicals
基金
甘肃省药品科研项目(2021GSMPA009)
甘肃省疾病预防项目(横20230540)。
关键词
疫苗不良事件报告系统
免疫性血小板减少症
回顾性分析
Vaccine Adverse Event Reporting System(VAERS)
Immune thrombocytopenia(ITP)
Retrospective analysis
