基于FAERS数据库的泽布替尼不良事件信号挖掘与分析
作者:
作者单位:

昆明医科大学附属延安医院 药学部,云南 昆明,650051

作者简介:

谭飞龙,男,硕士,主管药师,研究方向为临床药学、数据挖掘和处理。

通讯作者:

夏洪颖,女,硕士,副主任药师,研究方向为临床药理学。

中图分类号:

R979.1;R969.3

基金项目:

云南省医疗机构药师协会科研专项基金项目(2024YSXH06);云南省教育厅科学研究基金项目(2024J0371);昆明市卫生科技人才培养“千工程”项目(2023-SW(后备)-84);昆明市卫生健康委员会卫生科研课题项目(2023-13-01-017)。


Signal mining and analysis of zanubrutinib-related adverse events based on FAERS database
Author:
Affiliation:

Department of Pharmacy, the Affiliated Yan'an Hospital of Kunming Medical University, Kunming, 650051, Yunnan, China

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    摘要:

    目的 挖掘泽布替尼的风险信号,为临床安全合理用药提供参考。 方法 收集美国FDA不良事件报告系统(FAERS)数据库中2019年10月1日至2023年9月30日的泽布替尼相关不良事件报告数据。采用比例失衡法进行数据挖掘,利用《国际医学用语词典》(26.0版)中药物不良反应术语集的首选系统器官分类(SOC)和首选术语(PT)对挖掘到的风险信号进行分类和描述。 结果 提取以泽布替尼为首要怀疑药物的不良事件报告2 356份,报告国家主要是美国,转归以住院和死亡为主,报告数呈逐年上升趋势。利用比例失衡法检测,共得到不良事件信号49个,累及15个SOC,主要集中于各类损伤、中毒及操作并发症,皮肤及皮下组织类疾病,各类检查等,并挖掘出药品说明书中未收录的20个新的不良事件及欧盟重要医疗事件清单中收录的12个重要不良事件。 结论 临床应用泽布替尼时应密切监测患者的不良事件,及时采取相应措施进行干预。

    Abstract:

    Objective To explore the risk signals of zanubrutinib to provide reference for its clinical rational and safe use. Methods Data on adverse drug events (ADE) related to zanubrutinib from October 1, 2019 to September 30, 2023 were collected from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. Disproportionality measurement was used for data mining. The mined risk signals were classified and described by the preferred system organ class (SOC) and preferred term (PT) of the adverse drug reaction terminology set in the Medical Dictionary for Regulatory Activities (version 26.0). Results A total of 2 356 ADEs with the zanubrutinib as the primary suspected drug were extracted. The majority of reports came from the United States. The outcomes primarily involved hospitalization and death, and the number of reports showed an increasing annual trend. The disproportionality measurement of detection yielded 49 ADEs involving 15 SOCs. These signals mainly focused on injury, poisoning and procedural complications, skin and subcutaneous tissue disorders, and investigations. Additionally, 20 new ADEs were identified that were not included in the label, along with 12 important medical events (IMEs) that are included in the EU list of IMEs. Conclusion When clinically applying zanubrutinib, it is important to closely monitor patients for any adverse events and take appropriate measures to intervene in a timely manner.

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谭飞龙,尹文洁,周丽,游丽娜,王丽,王洋,李翠红,夏洪颖.基于FAERS数据库的泽布替尼不良事件信号挖掘与分析 [J].肿瘤药学,2025,15(4):544-550 ( in Chinese)

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