Signal mining and analysis of adverse drug events for gilteritinib

LIU Yang; HAN Minzhen; XIA Jie; HU Hanshuai; YAO Lei; LAN Xue; LIU Qian; WANG Jinxingyi

doi:10.6039/j.issn.1001-0408.2024.15.15

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Signal mining and analysis of adverse drug events for gilteritinib

更新时间：2025-09-23

- Signal mining and analysis of adverse drug events for gilteritinib
- ZHONGGUO YAOFANG Vol. 35, Issue 15, Pages: 1888-1892(2024)
- 作者机构：
  
  贵州医科大学第二附属医院药剂科，贵州凯里　556000
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.15.15
  CLC： R979.1
- Received：04 March 2024，
  
  Revised：2024-07-09，
  
  Accepted：15 July 2024，
  
  Published：15 August 2024
- 稿件说明：
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刘洋,韩敏珍,夏杰,等.吉瑞替尼的不良事件信号挖掘与分析 [J].中国药房,2024,35(15):1888-1892.

LIU Yang,HAN Minzhen,XIA Jie,et al.Signal mining and analysis of adverse drug events for gilteritinib[J].ZHONGGUO YAOFANG,2024,35(15):1888-1892.
刘洋,韩敏珍,夏杰,等.吉瑞替尼的不良事件信号挖掘与分析 [J].中国药房,2024,35(15):1888-1892. DOI： 10.6039/j.issn.1001-0408.2024.15.15.

LIU Yang,HAN Minzhen,XIA Jie,et al.Signal mining and analysis of adverse drug events for gilteritinib[J].ZHONGGUO YAOFANG,2024,35(15):1888-1892. DOI： 10.6039/j.issn.1001-0408.2024.15.15.

摘要

目的

挖掘吉瑞替尼的不良事件（ADE）信号，为临床安全用药提供参考。

方法

收集美国FDA不良事件报告系统（FAERS）2018年2月1日至2023年12月31日上报的以吉瑞替尼为首要怀疑药物的ADE报告，采用报告比值比（ROR）法和比例报告比值比（PRR）法进行数据挖掘。利用《国际医学用语词典》（24.1版）药物ADE术语集中的首选术语（PT）和系统器官分类（SOC）进行分类统计。

结果

共得到吉瑞替尼ADE报告2 755份，包含676个ADE信号（阳性ADE信号95个），累及313个PT，涉及25个SOC。其中，有9个ADE信号未被其药品说明书提及。信号强度排名前5位的PT分别为肝功能异常、血小板计数降低、发热性中性粒细胞减少症、肺炎和骨髓抑制；阳性信号数排名前6位的SOC分别为各类检查，全身性疾病及给药部位各种反应，呼吸系统、胸及纵隔疾病，感染及侵染类疾病，心脏器官疾病，各类神经系统疾病。其药品说明书未提及的ADE包括肺炎、骨髓抑制、血细胞减少症、败血症、出血、感染（未特指）、感染性休克、呼吸衰竭、曲霉菌感染。

结论

应用吉瑞替尼时，临床除需关注肝功能异常、血小板减少症等常见ADE外，还应监测药品说明书未提及且信号较强的ADE，如肺炎、骨髓抑制、血细胞减少症、败血症、出血、感染（未特指）、感染性休克、呼吸衰竭、曲霉菌感染、血肌酐升高及间质性肺疾病等。

Abstract

OBJECTIVE

To mine the adverse drug events （ADE） signals for gilteritinib， and provide a reference for safe drug use in clinic.

METHODS

ADE reports with gilteritinib as the primary suspected drug were extracted from the FDA Adverse Event Reporting System （FAERS） database from February 1st， 2018 to December 31st， 2023. Reporting odds ratio （ROR） and proportional reporting ratio （PRR） were applied to detect the risk signals from the data in the FAERS database. The classification and statistics of collected signal data were conducted by using the preferred term （PT） and systemic organ class （SOC） in ADE terminology set of the

Medical Dictionary for Regulatory Activities

（24.1 edition）.

RESULTS

Totally， 2 755 gilteritinib-related ADE reports were collected from the database， involving 676 ADE signals （95 positive signals）， 313 PTs and 25 SOCs. Among them， nine signals were not recorded in the package insert. The top 5 PTs consisted of abnormal liver function， decreased platelet count， febrile neutropenia， pneumonia and myelosuppression. The top 6 SOCs for positive signal counts were examinations， general disorders and administration site conditions， respiratory， thoracic and mediastinal disorders， infections and infestations， heart organ disorders， and nervous system disorders. ADEs not recorded in the drug package insert included pneumonia， myelosuppression， decreased blood cell count， sepsis， hemorrhage， infection （not specifically referred to）， septic shock， respiratory failure， and aspergillosis.

CONCLUSIONS

In addition to paying attention to common ADEs such as liver dysfunction and thrombocytopenia， it is necessary to monitor ADEs with strong signals that are not mentioned in the drug instructions when using gefitinib， such as pneumonia， bone marrow suppression， cytopenia， sepsis， bleeding， infection （not specifically referred to）， septic shock， respiratory failure， Aspergillus infection， elevated serum creatinine and interstitial lung disease.

关键词

Keywords

references

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