中国药物警戒 ›› 2024, Vol. 21 ›› Issue (5): 580-586.
DOI: 10.19803/j.1672-8629.20240131

• 安全与合理用药 • 上一篇    下一篇

基于美国FAERS数据库的乳腺癌患者使用阿贝西利不良事件分析

苏小涵1,2, 曾姣1,2, 李雪3, 刘礼鑫4, 侯令密1,2, 李金穗1,2,*   

  1. 1川北医学院附属医院甲状腺乳腺外科,乳腺癌生物靶向研究室,院士(专家)工作站 四川 南充637000;
    2四川省医学影像重点实验室,四川 南充637000;
    3川北医学院检验医学院,四川 南充637000;
    4川北医学院附属医院胃肠外科, 四川 南充637000
  • 收稿日期:2024-02-03 出版日期:2024-05-15 发布日期:2024-05-13
  • 通讯作者: *李金穗,女,硕士,副主任医师,甲状腺乳腺外科。E-mail：lijinsui7@163.com
  • 作者简介:苏小涵,女,在读硕士,甲状腺乳腺外科。
  • 基金资助:
    四川省自然科学基金资助项目（2022NSFSC0775）

Adverse events of abemaciclib in breast cancer patients based on US FAERS database

SU Xiaohan1,2, ZENG Jiao1,2, LI Xue3, LIU Lixin4, HOU Lingmi1,2, LI Jinsui1,2,*   

  1. 1Department of Breast and Thyroid Surgery, Biological targeting Laboratory of Breast Cancer, Affiliated Hospital of North Sichuan Medical College, Nanchong Sichuan 637000, China;
    2Sichuan Key Laboratory of Medical Imaging, Nanchong Sichuan 637000, China;
    3Department of Laboratory Medicine, North Sichuan Medical College, Nanchong Sichuan 637000, China;
    4Department of Gastrointestinal Surgery, Affiliated Hospital of North Sichuan Medical College, Nanchong Sichuan 637000, China
  • Received:2024-02-03 Online:2024-05-15 Published:2024-05-13

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摘要： 目的 分析美国食品药品监督管理局不良事件报告系统（FAERS数据库）的乳腺癌患者使用阿贝西利的药品不良事件（ADE）,为乳腺癌患者合理使用阿贝西利提供参考。方法 通过检索FAERS 2017年10月1日至 2023年9月30日乳腺癌患者使用阿贝西利相关的ADE,按《监管活动医学词典》（medical dictionary for regulatory activities, MedDRA）、系统-器官分类（system organ class, SOC）和首选术语（preferred term, PT）进行分类,采用报告比值比法（reporting odds ratio, ROR）、比例报告比值法（proportional reporting ratio, PRR）、贝叶斯置信区间神经传播网络法（bayesian confidence interval neural propagation network method, BCPNN）和多重伽马-泊松收缩估计法(multi-item gamma poisson shrinker, MGPS)挖掘并分析可疑风险信号。结果 排除重复后,检索时段中使用阿贝西利的ADE共5 579份,通过筛选分析,共计得到46个有效信号,主要涉及16个SOC。发生频次前3位ADE分别为腹泻、药物无效和脱水;信号强度前3位ADE分别为治疗反应丧失、乳品不耐受和皮下气肿。此外,还发现说明书未提及的肾小管坏死、肾损伤、睡眠障碍（失眠型）、纵隔积气、多形性红斑、弥散性血管内凝血和短暂性脑缺血发作等19个可疑信号需给予关注。结论 在使用该药时,除密切观察患者可能出现说明书提及的ADE外,还应针对可能会出现的肾小管坏死、肾损伤等说明书中未提及的 ADE进行重点监测,保障患者用药安全。

关键词: 阿贝西利, 乳腺癌, 药品不良反应, FAERS, 主动监测, 用药安全

Abstract: Objective To analyze adverse drug events (ADE) of abemaciclib used in breast cancer patients that were reported in FAERS (FDA Adverse Event Reporting System) database in order to provide clinical data for rational use of this drug among breast cancer patients. Methods Adverse event reports of breast cancer patients using abemaciclib between October 1, 2017 and September 30, 2023 were retrieved from the FAERS before being categorized based on the Medical Dictionary for Regulatory Activities (MedDRA), System Organ Class (SOC), and Preferred Term (PT). Suspected risk signals were analyzed using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence interval neural propagation network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS). Results After duplicates were excluded, a total of 5 579 ADE of abemaciclib were retrieved. Following screening and analysis, 46 valid signals were identified that were of 16 SOC. The top three ADE were diarrhea, drug ineffectiveness, and dehydration. The top three signal strengths were treatment response loss, milk intolerance, and subcutaneous emphysema. Additionally, 19 suspicious signals, including renal tubular necrosis, kidney injury, sleep disorders (insomnia type), mediastinal emphysema, erythema multiforme, disseminated intravascular coagulation, and transient ischemic attack not mentioned in the product label deserved attention. Conclusion When this medication is adopted, clinicians should also watch for potential ADEs such as renal tubular necrosis and kidney injury that are not listed in the instructions to ensure the safety of the patients.

Key words: abemaciclib, breast cancer, drug adverse reactions, FAERS, active monitoring, drug safety

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