中国药物警戒 ›› 2023, Vol. 20 ›› Issue (1): 96-100.
DOI: 10.19803/j.1672-8629.20210956

• 安全与合理用药 • 上一篇    下一篇

基于美国疫苗不良事件报告系统的肺炎疫苗不良反应信号挖掘与研究

刘砚韬1,2,3, 张伶俐1,2,3,*, 林芸竹1,2,3, 陈力1,2,3, 王丽1,2,3   

  1. 1四川大学华西第二医院药学部,四川 成都 610041;
    2四川大学华西第二医院循证药学中心,四川 成都 610041;
    3出生缺陷与相关妇儿疾病教育部重点实验室,四川 成都 610041
  • 收稿日期:2021-10-29 发布日期:2023-01-19
  • 通讯作者: *张伶俐,女,博士,主任药师·博导,循证药物决策与管理、循证临床药学研究与实践。E-mail: zhanglingli@scu.edu.cn
  • 作者简介:刘砚韬,男,硕士,副主任药师,循证药学研究与实践、医院药事管理。
  • 基金资助:
    四川省科技计划项目重点研发项目（2020YFS0035）

Mining and research of adverse reaction signals of pneumonia vaccines based on US Vaccine Adverse Event Reporting System

LIU Yantao1,2,3, ZHANG Lingli1,2,3,*, LIN Yunzhu1,2,3, CHEN Li1,2,3, WANG Li1,2,3   

  1. 1Department of Pharmacy, West China SecondUniversity Hospital, Sichuan University, Chengdu Sichuan 610041, China;
    2Evidence-Based Pharmacy Center, West China SecondUniversity Hospital, Sichuan University, Chengdu Sichuan 610041, China;
    3Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu Sichuan 610041, China
  • Received:2021-10-29 Published:2023-01-19

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摘要： 目的 通过对肺炎球菌疫苗的不良反应信号进行挖掘与研究,为肺炎疫苗的临床安全合理使用提供参考。方法 采用报告比值比法（ROR）和比例报告比值比法（PRR）对美国疫苗不良事件报告系统（VAERS）2010年1月1日至2019年12月31日收集的药品不良反应（adverse drug reaction, ADR）报告进行分析,挖掘其中有关肺炎球菌疫苗（23价和13价）的ADR信号。结果 23价肺炎疫苗经ROR和PRR法检测得到36个信号,其中7个未在说明书中提及,信号强度最高的ADR是白细胞增多症。13价肺炎疫苗ROR和PRR分别得到103和102个ADR信号,其中36个信号未在说明书中提及,信号强度较高的ADR多为胃肠系统疾病、感染及侵袭类疾病、全身性疾病及给药部位各种反应等。结论 临床使用肺炎疫苗时应密切监测患者的ADR,特别是说明书未提及的,应及时做出干预。

关键词: 肺炎疫苗, 药品不良反应, 美国疫苗不良事件报告系统, 报告比值比法, 比例报告比值比法, 信号挖掘

Abstract: Objective To provide reference for rational and safe use of pneumonia vaccines by mining and studying the adverse reaction signals of pneumonia vaccines. Methods The reporting odds ratio (ROR) and the proportional reporting ratio (PRR) were used to analyze the adverse reaction reports collected by the American Vaccine Adverse Reaction Event Reporting System (VAERS) between January 1, 2010 and December 31, 2019, while adverse reaction signals related to pneumonia vaccines were mined. Results Thirty-six ADR signals associated with 23-valent pneumonia polysaccharide vaccines were obtained using both the ROR and PRR method, seven of which were not mentioned in specifications before, and ADR with the highest signal intensity were related to leukocytosis. A total of 103 ADR signals of 13-valent pneumococcal polysaccharide conjugate vaccines were obtained using ROR, compared with 102 signals by PRR. Thirty-six of the ADR signals were not mentioned in any specifications before, and ADR with relatively high signal intensity centered on gastrointestinal diseases, infections and invasive diseases, systemic diseases, and various reactions at the administration site. Conclusion It is suggested that patients should be closely monitored for adverse reactions, especially new ADR that are not mentioned in specifications, and immediate interventions should be enforced when pneumonia vaccines are used.

Key words: pneumonia vaccine, adverse drug reactions, VAERS, reporting odds ratio, proportional reporting ratio, signal mining

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