中国药物警戒 ›› 2022, Vol. 19 ›› Issue (11): 1233-1237.
DOI: 10.19803/j.1672-8629.20210561

• 安全与合理用药 • 上一篇    下一篇

基于FDA不良事件报告系统数据库对仑伐替尼不良反应的信号挖掘

赵晓红, 郭明星, 王晓剑, 蔺建蕊, 崔向丽*   

  1. 首都医科大学附属北京友谊医院药学部,北京 100050
  • 收稿日期:2021-06-07 发布日期:2022-11-17
  • 通讯作者: *崔向丽,女,博士,主任药师,临床药学和药事管理。E-mail：cui10@163.com
  • 作者简介:赵晓红,女,硕士,初级药师,不良反应数据挖掘。
  • 基金资助:
    国家自然科学基金资助项目（82004038）; 国家卫健委卫生技术评估重点实验室2019年度开放基金（FHTA2019-02）; 北京市医院管理中心2020年培育项目（PG2020002）

Risk signal mining related to lenvatinib based on the US FDA adverse event reporting system

ZHAO Xiaohong, GUO Mingxing, WANG Xiaojian, LIN Jianrui, CUI Xiangli*   

  1. Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
  • Received:2021-06-07 Published:2022-11-17

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摘要： 目的 挖掘仑伐替尼相关药品不良反应（ADR）风险信号,为其临床安全应用提供参考。方法 采用报告比值比（ROR）法和比例报告（PRR）法对美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）2015年1月1日至2019年12月31日收到的仑伐替尼为首要怀疑药物的ADR进行挖掘。检测阈值为报告数大于10,ROR与PRR值均>2,且95%置信区间（CI）下限均大于1的ADR。结果 设定时段内FAERS共收到以仑伐替尼为首要怀疑药物的ADR报告7 922例,风险信号191个,涉及18个系统-器官分类（SOC）。说明书未提及的风险信号有52个,主要有胃肠道系统8个,肝胆疾病7个,良性、恶性和未指明的肿瘤（包括囊肿和息肉）6个,实验室检查异常6个,感染5个。仑伐替尼ADR信号强度前50位中,共有12个不良信号未在说明书中提及,其中分布在良性、恶性和未指明的肿瘤中有4个,肝胆疾病中有3个。结论 仑伐替尼可疑ADR信号的挖掘,可以为国内肝癌、肾癌等抗肿瘤安全用药提供参考。

关键词: 仑伐替尼, FDA不良事件报告系统, 药品不良反应, 数据挖掘

Abstract: Objective To explore the risk signals of lenvatinib related adverse drug reactions (ADR) and provide reference for clinical safe applications. Methods The report odds ratio (ROR) and proportional reporting ratio (PRR) methods were used to mine the adverse reactions of the suspected drug-lenvatinib-from the FDA’s adverse event reporting system (FAERS) between the first quarter of 2015 and the fourth quarter of 2019. The detection threshold for these adverse reactions was that the number of reports was larger than 10, both ROR and PRR exceeded 2 and the 95% confidence interval (CI) lower limit of the ROR and PRR was above 1. Results During the given period of time, the FAERS database received 7 922 reports of adverse reactions with lenvatinib as the PS, and detected 191 risk signals, involving 18 SOC(systems on chips). There were 52 risk signals that were not mentioned in the manual, which were mainly concentrated in 8 signals of the gastrointestinal system, 7 signals of hepatobiliary diseases, 6 signals of benign, malignant and unspecified tumors (including cysts and polyps), 6 signals of abnormal laboratory examination, and 5 signals of infection and invasion. Among the top 50 adverse reaction signals of lenvatinib in terms of intensity, 12 adverse signals were not mentioned in the manual, mainly distributed in benign, malignant and unspecified tumors (4 signals), hepatobiliary diseases (3 signals). Conclusion The discovery of suspicious ADR signals of lenvastinib can provide reference for the safe use of this drug in treating hepatocellular carcinoma and renal cancer in China.

Key words: lenvatinib, FDA adverse event reporting system, adverse drug reaction, data mining

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