中国药物警戒 ›› 2019, Vol. 16 ›› Issue (8): 478-486.

• 法规与管理研究 • 上一篇    下一篇

基于美国疫苗不良事件报告系统九价人乳头瘤病毒疫苗上市后安全警戒信号检测与评价

龚莉1,2, 潘玲云1,2, 刘颜1, 季欢欢2, 唐学文3, 贾运涛2,*   

  1. 1 重庆医科大学药学院,重庆400016;
    2 重庆医科大学附属儿童医院药学部/儿童发育疾病研究教育部重点实验室/儿童发育重大疾病国家国际科技合作基地/儿科学重庆市重点实验室,重庆400014;
    3 嘉兴太美医疗科技有限公司,上海200233
  • 收稿日期:2019-09-09 修回日期:2019-09-09 出版日期:2019-08-20 发布日期:2019-09-09
  • 通讯作者: *贾运涛,男,主任药师,临床药学。E-mail: jiayuntaomail@hospital.cqmu.edu.cn
  • 作者简介:龚莉,女,在读硕士,药师,临床药学。

Detection and Evaluation of Post-marketing Safety Alert Signals for Human Papillomavirus 9-valent Vaccine Based on US Vaccine Adverse Event Reporting System (VAERS)

GONG Li1,2, PAN Lingyun1,2, LIU Yan1, JI Huanhuan2, TANG Xuewen3, JIA Yuntao2,*   

  1. 1 School of Pharmacy, Chongqing Medical University, Chongqing 400016, China;
    2 Department of Pharmacy, Children's Hospital of Chongqing Medical University/Ministry of Education Key Laboratory of Child Development and Disorders/China International Science and Technology Cooperation Base of Child Development and Critical Disorders/Chongqing Key Laboratory of Pediatrics, Chongqing 400014, China;
    3 TAIMEI Technology,Shanghai 200233, China
  • Received:2019-09-09 Revised:2019-09-09 Online:2019-08-20 Published:2019-09-09

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摘要： 目的 检测与评价单独接种九价人乳头瘤病毒疫苗上市后的安全警戒信号,为后续研究和预防接种提供参考。方法 提取2015年1月至2018年12月美国疫苗不良事件报告系统中单独接种九价人乳头瘤病毒疫苗的不良事件报告,采用比例报告比法进行安全警戒信号检测与评价。结果 检测获得39个安全警戒信号,共涉及14个系统器官分类,每类信号数量前三的有：神经系统疾病、生殖系统及乳腺疾病、各类检查,其中新的、临床需关注的信号有：月经不规律（PRR=12.11,χ2=48.94）、闭经（PRR=4.43,χ2=14.41）、不孕（PRR=8.86,χ2=32.54）、卵巢囊肿（PRR=7.85,χ2=16.31）、月经延迟（PRR=8.56,χ2=17.81）、月经量过多（PRR=4.96,χ2=9.42）、过早绝经（PRR=4.43,χ2=5.93）、脱发（PRR=3.02,χ2=19.27）。结论 本文通过比例报告比法对美国疫苗不良事件报告系统中相关数据进行挖掘,最终检测出多个新的安全警戒信号,为九价人乳头瘤病毒疫苗下一步的安全性研究奠定了基础。

关键词: 疫苗不良事件报告系统, 九价人乳头瘤病毒疫苗, 信号检测, 数据挖掘

Abstract: Objective To detect and evaluate the post-marketing safety warning signals of separate vaccination of human papillomavirus 9-valent vaccine (9vHPV), so as to provide references for follow-up studies and vaccinations. Methods 9vHPV-related (alone) AE reports from January 2015 to December 2018 were collected from the VAERS and comprehensive standard method was adopted to detect and evaluate the safety warning signals. Results A total of 39 safety warning signals were obtained through detection, involving 14 SOCs in total, the first three signals in each class were nervous system diseases, reproductive system diseases and breast diseases, and investigations, among which, the new signals of clinical concern included irregular menstruation (PRR=12.11,χ2=48.94), amenorrhea (PRR=4.43,χ2=14.41), infertility (PRR=8.86,χ2=32.54), ovarian cyst (PRR=7.85,χ2=16.31), opsomenorrhea (PRR=8.56,χ2=17.81), menorrhagia (PRR=4.96, χ2=9.42), premature menopause (PRR=4.43,χ2=5.93), alopecia (PRR=3.02,χ2=19.27). Conclusion In this paper, comprehensive standard method was adopted to mine relevant data from VAERS and many new safety signals were detected at last, which lays a foundation for the follow-up safety studies on 9vHPV.

Key words: VAERS, human papillomavirus 9-valent vaccine, signal detection, data mining

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