中国药物警戒 ›› 2025, Vol. 22 ›› Issue (11): 1287-1291.
DOI: 10.19803/j.1672-8629.20240999

• 安全与合理用药 • 上一篇    下一篇

基于美国FAERS数据库的噁拉戈利钠不良事件信号分析

李若涵1, 胡攀伟2, 杨红3, 钱麟2*   

  1. 1上海市浦东新区光明中医医院妇科,上海 201300;
    2上海中医药大学附属曙光医院妇科,上海 201203;
    3上海市中医医院妇科,上海 200040
  • 收稿日期:2024-12-16 出版日期:2025-11-15 发布日期:2025-11-14
  • 通讯作者: *钱麟,男,博士,主任医师·硕导,妇科肿瘤与不孕的中西医结合治疗。E-mail: qqqq19740@vip.sina.com
  • 作者简介:李若涵,女,硕士,妇科肿瘤的中西医诊治。
  • 基金资助:
    国家自然科学基金资助项目（82305284、82274571）

Adverse Drug Reactions of Elagolix Based on the FAERS Database

LI Ruohan1, HU Panwei2, YANG Hong3, QIAN Lin2*   

  1. 1Department of Gynaecology, Shanghai Pudong New District Guangming Traditional Chinese Medicine Hospital, Shanghai 201300, China;
    2Department of Gynaecology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China;
    3Department of Gynaecology, Shanghai Hospital of Traditional Chinese Medicine, Shanghai 200040, China
  • Received:2024-12-16 Online:2025-11-15 Published:2025-11-14

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摘要： 目的 挖掘噁拉戈利钠的不良反应信号,为子宫内膜异位症患者临床安全合理用药提供参考。方法 提取美国食品药品监督管理局（Food and Drug Administration, FDA）不良事件报告系统数据库（Adverse Event Reporting System, FAERS）中2018年7月23日至2024年9月30日噁拉戈利钠所有药品不良事件（ADE）数据,获取以噁拉戈利钠列为“首要怀疑”(PS)的报告,用报告比值比法（ROR）、成比例报告比值比法（PRR）、贝叶斯置信区间神经网络传播法（BCPNN）、多重伽马-泊松收缩估计法（MGPS）进行数据分析。结果 本研究共识别10 005份与噁拉戈利钠相关的ADE报告,涉及3 775名患者。累及27个系统-器官分类（SOC）和145个阳性首选语（PT）。其中同时满足4种算法的阳性SOC是各种手术及医疗操作,生殖系统及乳腺疾病,精神病类,血管与淋巴管类疾病。发生频次最高的PT是潮热、疼痛、恶心、头痛等,与说明书对比还发现了新的ADE,如脱发、贪食、脐出血等。结论 临床上使用噁拉戈利钠治疗子宫内膜异位症患者时,应结合药物ADE特点,密切监测患者不良事件,尽早发现用药风险,保证临床合理用药。

关键词: 噁拉戈利钠, 子宫内膜异位症, 不良事件, 脱发, 贪食, 美国食品药品监督管理局不良事件报告系统数据库, 信号挖掘, 药物警戒

Abstract: Objective To mine signals of adverse drug reactions induced by elagolix and provide references for safe and rational use of drugs in patients with endometriosis. Methods Data on all the adverse drug events (ADEs) of elagolix was retrieved from the U.S. Food and Drug Administration Adverse Event Reporting System database from July 23, 2018 to September 30, 2024, and reports in which elagolix was listed as the “primary suspect” (PS) were obtained. Data was analyzed using the reporting odds ratio (ROR)method, proportional reporting ratio (PRR) method, Bayesian Confidence Propagation Neural Network (BCPNN) method, and the Multiple Gamma-Poisson Shrinkage Estimation (MGPS) method. Results A total of 10 005 reports of ADEs related to elagolix were identified, involving 3 775 patients, 27 System Organ Classes (SOCs) and 145 preferred terms (PTs). Positive SOCs that met all the four algorithms were surgical and treatment procedures, the reproductive system, breast diseases, psychiatric disorders, and vascular and lymphatic diseases. The most frequent PTs were hot flashes, ache, and nausea headache. New ADEs that were never mentioned in drug inserts were discovered, such as alopecia, food craving, umbilical haemorrhage. Conclusion When elagolix is used to treat endometriosis, clinicians need to be alert to adverse events in patients, identify risks as early as possible, and ensure the rational use of drugs in clinical practice.

Key words: Elagolix, Endometriosis, Adverse Events, Alopecia, Food Craving, Food and Drug Administration Adverse Event Reporting System Database（FAERS), Signal Mining, Pharmacovigilance

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