中国药物警戒 ›› 2025, Vol. 22 ›› Issue (1): 29-36.
DOI: 10.19803/j.1672-8629.20240968

• 药源性血小板减少研究专栏 • 上一篇    下一篇

疫苗诱导的免疫性血栓性血小板减少症安全性监测系统综述

孙一鑫1,2, 王晨3, 于玥琳4, 郭鹏1,2,5#, 聂晓璐6,*   

  1. 1国家儿童医学中心,首都医科大学附属北京儿童医院,临床研究中心,北京 100045;
    2国家儿童医学中心,首都医科大学附属北京儿童医院药学部,北京 100045;
    3国家儿童医学中心,首都医科大学附属北京儿童医院门诊部,北京 100045;
    4复旦大学附属华山医院科研处,上海 200040;
    5儿科重大疾病研究教育部重点实验室,北京 100045;
    6国家儿童医学中心,首都医科大学附属北京儿童医院,临床流行病学与循证医学中心,北京 100045
  • 收稿日期:2024-12-09 出版日期:2025-01-15 发布日期:2025-01-22
  • 通讯作者: *聂晓璐,女,博士,副研究员,药物流行病学与循证医学。E-mail: niexiaolu@ccmu.edu.cn#为共同通信作者。
  • 作者简介:孙一鑫,女,博士,助理研究员,药物流行病学。
  • 基金资助:
    国家自然科学基金资助项目（82204149、72404198）; 药品监管科学全国重点实验室第二批课题（2024SKLDRS-0232）; 北京市医院管理中心“青苗”计划专项经费资助（QML- 20231204）

Safety Surveillance for Vaccine-Induced Immune Thrombotic Thrombocytopenia: a Systematic Review

SUN Yixin1,2, WANG Chen3, YU Yuelin4, GUO Peng1,2,5#, NIE Xiaolu6,*   

  1. 1Clinical Research Center, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China;
    2Department of Pharmacy, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China;
    3Outpatient Department, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China;
    4Department of Scientific Research, Huashan Hospital, Fudan University, Shanghai 200040, China;
    5Key Laboratory of Major Diseases in Children,Ministry of Education, Beijing 100045, China;
    6Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China
  • Received:2024-12-09 Online:2025-01-15 Published:2025-01-22

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摘要： 目的 系统梳理疫苗诱导的免疫性血栓性血小板减少症（VITT）发生的安全性监测研究现况。方法 采用循证医学方法,制定检索策略,系统检索PubMed（含Medline）、Embase、Cochrane图书馆、中国知网、万方数据、维普网与SinoMed等中英文数据库,纳入各数据库建库至2024年9月30日公开发表的有关VITT安全性监测的文章。使用定性系统综述方法对文献中报告数据进行整理汇总,描述与分析VITT发生率（包括报告率）与发生风险的研究现状。结果 最终纳入24篇文献,按照安全性监测的研究类型可分为：①基于自发上报系统的被动监测研究（15篇）;②基于人群或医疗保健数据库的主动监测研究（9篇）。结果 显示VITT主要发生于新型冠状病毒感染（COVID-19）腺病毒载体疫苗接种后（尤其是第1剂次）,报告率范围在0.2/100万剂次~19.9/100万剂次,发生率范围在2.11/10万人年~311/10万人年;其他类型COVID-19疫苗的报告数相对较低,但已有研究发现mRNA疫苗可能导致VITT发生风险增加。此外,麻疹-腮腺炎-风疹三联疫苗、乙型肝炎疫苗、轮状病毒疫苗、脑炎疫苗与甲型肝炎疫苗等8种疫苗也被观察到与VITT发生相关。在纳入文献中,有9项研究报告了VITT诊断标准,主要涉及5方面内容,包括近期疫苗接种史、血栓形成、并发血小板减少、特异的实验室检查结果,以及临床专家综合评估意见。结论 VITT是一种需要引起广泛重视、可涉及多种疫苗类型的潜在免疫接种后不良事件,其发病机制、临床表现与实验室检查特征尚未明确,需进一步深入研究。

关键词: 疫苗, 免疫接种后不良事件, 疫苗诱导的免疫性血栓性血小板减少症, 伴有血小板减少的血栓综合征, 安全性监测

Abstract: Objective To review the safety surveillance of vaccine-induced immune thrombotic thrombocytopenia (VITT). Methods The evidence-based medicine method was used in this research. PubMed (including Medline), Embase, Cochrane Library, CNKI, Wanfang, VIP and SinoMed were searched for eligible studies on the safety surveillance for VITT published between the inception of each database and September 30, 2024. Two researchers independently screened the literature and retrieved data. Qualitative methods of systematic review were used to summarize information from the literature, and the incidence rates (including reporting rates) and risks of VITT were analyzed. Results A total of 24 articles were included, which could be divided into two categories: 15 passive surveillance studies based on spontaneous reporting systems, and 9 active surveillance studies based on population or electronic healthcare databases. The results showed that VITT mostly occurred after the COVID-19 adenovirus-vectored vaccination (especially the first dose). The reporting rates ranged from 0.2/million doses to 19.9/million doses, and the incidence rates ranged from 2.11/100 000 person-years to 311/100 000 person-years. There were fewer reports on other types of COVID-19 vaccines, but some studies found that mRNA vaccines might also lead to an increased risk of VITT. Additionally, eight vaccines, including the measles-mumps-rubella vaccine, hepatitis B vaccine, rotavirus vaccine, encephalitis vaccine and hepatitis A vaccine, were also observed to be associated with VITT. In the included literature, nine studies reported the diagnostic criteria for VITT, involving five primary factors: recent vaccination history, thrombosis, concurrent thrombocytopenia, specific laboratory findings, and a comprehensive assessment by clinical experts. Conclusion VITT is a potential adverse event following immunization that requires extensive attention and can occur after multiple vaccine types. Its pathogenesis, clinical manifestations, and laboratory test characteristics have not yet been clarified and need to be understood and explored in depth by further studies.

Key words: Vaccine, Adverse Event Following Immunization, Vaccine-Induced Immune Thrombotic Thrombocytopenia, Thrombosis with Thrombocytopenia Syndrome, Safety Surveillance

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