基于FAERS的阿伐曲泊帕不良事件信号挖掘与分析

熊瑞; 王瑾; 杨振; 罗艳梅; 张宏; 仝永涛; 来小丹

doi:10.16016/j.2097-0927.202305092

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基于FAERS的阿伐曲泊帕不良事件信号挖掘与分析

药学 | 更新时间：2026-01-09

- 基于FAERS的阿伐曲泊帕不良事件信号挖掘与分析
- Signal mining and analysis for adverse events of avatrombopag based on FAERS
- 陆军军医大学学报 2024年46卷第4期页码：369-376
- 作者机构：
  
  1.400020 重庆，中国人民解放军陆军第九五八医院药剂科
  2.860000 西藏林芝，中国人民解放军陆军第九五六医院药剂科
- 作者简介：
  
  [来小丹，E-mail: laixiaodan0926@sina.comLAI Xiaodan, E-mail: laixiaodan0926@sina.com
- 基金信息：
  
  重庆市科卫联合中医药项目(2022MSXM187)
- DOI：10.16016/j.2097-0927.202305092
  中图分类号： R195.1;R969.3;R973.6
- 收稿：2023-05-26，
  
  修回：2023-10-16，
  
  纸质出版：2024-02-28
- 稿件说明：
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熊瑞, 王瑾, 杨振, 等. 基于FAERS的阿伐曲泊帕不良事件信号挖掘与分析[J]. 陆军军医大学学报, 2024,46(4):369-376.

Rui XIONG, Jin WANG, Zhen YANG, et al. Signal mining and analysis for adverse events of avatrombopag based on FAERS[J]. Journal of Army Medical University, 2024, 46(4): 369-376.
熊瑞, 王瑾, 杨振, 等. 基于FAERS的阿伐曲泊帕不良事件信号挖掘与分析[J]. 陆军军医大学学报, 2024,46(4):369-376. DOI： 10.16016/j.2097-0927.202305092.

Rui XIONG, Jin WANG, Zhen YANG, et al. Signal mining and analysis for adverse events of avatrombopag based on FAERS[J]. Journal of Army Medical University, 2024, 46(4): 369-376. DOI： 10.16016/j.2097-0927.202305092.

摘要

目的

基于真实世界数据挖掘血小板减少症治疗药物阿伐曲泊帕的药物不良事件(adverse drug events

ADE)信号

为其临床安全应用提供参考。

方法

通过OpenVigil2.1药物警戒平台获取美国食品药品监督管理局不良事件报告系统中2018年5月至2023年3月阿伐曲泊帕的ADE数据

利用《国际医学用语词典》(26.0版)中ADE术语集的首选系统器官分类(system organ class

SOC)和首选术语(preferred term

PT)对ADE信号进行分类和描述

并采用报告比值比(reporting odds ratio

ROR)法和英国药品和保健品管理局综合标准法对ADE数据进行信号检测。

结果

共获取到阿伐曲泊帕相关ADE报告1 879份

累及24个SOC

在PT层级检测到阳性ADE信号28个

其中信号最强的是肾静脉血栓形成、门静脉血栓形成和移植物抗宿主病

报告数最多的是头痛、疲劳和乏力

新发现了8个ADE信号

分别是季节性过敏、背部疾病、肌肉骨骼不适、肠胃气胀、睡眠过度、斑状皮疹、情绪障碍和流涕。

结论

临床应用阿伐曲泊帕时不仅要关注其血栓形成风险

还应密切关注季节性过敏、背部疾病、肌肉骨骼不适、肠胃气胀、睡眠过度、斑状皮疹、情绪障碍和流涕等说明书尚未记载的ADE信号。

Abstract

Objective

To mine the adverse drug events (ADE) signal of avatrombopag

an effective drug for thrombocytopenia treatment

based on real world data in order to provide reference for its clinical safety application.

Methods

The OpenVigil2.1 pharmacovigilance platform was used to obtain the ADE report data of avatrombopag from May 2018 to March 2023 in the database of FDA adverse event reporting system (FAERS).The ADE signals were classified and described by the system organ class (SOC) and preferred term (PT) of the ADE terminology set in the Medical Dictionary for Regulatory Activities (MedDRA)

and reporting odds ratio (ROR) and UK Medicines and Healthcare Products Regulatory Agency (MHRA) comprehensive standard were used to detect the positive ADE signals.

Results

A total of 1 879 ADE reports related to avatrombopag were obtained

24 SOCs were involved

and 28 positive ADE signals were detected at PT level.Among these signals

the strongest ones were renal vein thrombosis

portal vein thrombosis and graft versus host disease

while the reports accounting for the largest numbers were headache

fatigue and asthenia.There were 8 ADE signals discovered newly

that is

seasonal allergy

back disorder

musculoskeletal discomfort

flatulence

hypersomnia

rash macular

emotional disorder

and rhinorrhoea.

Conclusion

For clinical use of avatrombopag

clinicians should not only concern the risk of thrombosis

but also pay close attention to ADE signals such as seasonal allergy

back disorder

musculoskeletal discomfort

flatulence

hypersomnia

rash macular

emotional disorder

and rhinorrhoea that are not documented in the instructions.

关键词

Keywords

references

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