基于FAERS数据库的阿昔替尼ADE信号挖掘与分析

夏茹楠; 应婷; 梁海; 戴加惠; 王亚东; 解雪峰

doi:10.6039/j.issn.1001-0408.2023.23.14

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基于FAERS数据库的阿昔替尼ADE信号挖掘与分析

药物与临床 | 更新时间：2023-12-08

- 基于FAERS数据库的阿昔替尼ADE信号挖掘与分析
- ADE signal mining and analysis of axitinib based on FAERS database
- 中国药房 2023年34卷第23期页码：2896-2900
- 作者机构：
  
  1.安徽医科大学药学院，合肥　230031
  2.安徽医科大学附属亳州医院药学部，安徽亳州　236800
  3.公共健康社会治理安徽省哲学社会科学重点实验室，合肥　230031
- 作者简介：
  
  药师，硕士研究生。研究方向：临床药学。E-mail：xiarunan312@163.com
  教授，硕士生导师，博士。研究方向：临床药学、药事管理。E-mail：xuefengxie@ahmu.edu.cn
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2023.23.14
  中图分类号： R969.3;R979.1
- 纸质出版日期：2023-12-15，
  
  收稿日期：2023-04-05，
  
  修回日期：2023-10-08，
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夏茹楠,应婷,梁海等.基于FAERS数据库的阿昔替尼ADE信号挖掘与分析 ^Δ[J].中国药房,2023,34(23):2896-2900.

XIA Runan,YING Ting,LIANG Hai,et al.ADE signal mining and analysis of axitinib based on FAERS database[J].ZHONGGUO YAOFANG,2023,34(23):2896-2900.
夏茹楠,应婷,梁海等.基于FAERS数据库的阿昔替尼ADE信号挖掘与分析 ^Δ[J].中国药房,2023,34(23):2896-2900. DOI： 10.6039/j.issn.1001-0408.2023.23.14.

XIA Runan,YING Ting,LIANG Hai,et al.ADE signal mining and analysis of axitinib based on FAERS database[J].ZHONGGUO YAOFANG,2023,34(23):2896-2900. DOI： 10.6039/j.issn.1001-0408.2023.23.14.

摘要

目的

为临床安全使用阿昔替尼提供参考。

方法

收集美国FDA不良事件报告系统（FAERS）数据库2012年第1季度至2022年第4季度的阿昔替尼药品不良事件（ADE）数据，利用比值失衡测量法中的报告比值比（ROR）法与英国药品和健康产品管理局（MHRA）的综合标准法进行数据挖掘与分析。

结果

共获得阿昔替尼相关ADE报告13 962份，患者年龄集中于65～85岁（43.25%），性别以男性为主（65.23%），上报国家以美国为主（60.01%），严重ADE结局多为住院或延长住院（31.51%）。共检测到ADE风险信号172个，涉及18个系统和器官分类（SOC），主要为全身性疾病及给药部位各种反应（3 749例次，30.84%）和胃肠系统疾病（2 067例次，17.00%）。发生频次较多的ADE风险信号与该药的药品说明书基本一致，如腹泻、疲劳及高血压；需临床关注的、新的ADE风险信号主要为死亡，免疫介导性肾炎和各种良性、恶性及性质不明的肿瘤（包括囊肿和息肉）等SOC包含的PT信号。

结论

对于阿昔替尼发生频次多且其药品说明书已载入的ADE（如高血压、腹泻等），在用药前应充分做好评估，尤其是针对联合使用免疫检查点抑制剂及伴有基础高血压的患者；对于其信号较强、新的ADE（如死亡、疾病进展、肿瘤进展等），在治疗期间应密切关注患者的疾病进展情况，关注可能致死的ADE；对于其罕见的ADE（如免疫介导性肾炎、阴囊溃疡、非感染性脑炎等），应进一步加强临床验证。

Abstract

OBJECTIVE

To provide references for the clinical safe use of axitinib.

METHODS

Adverse drug event （ADE） data for axitinib were collected from the US FDA Adverse Event Reporting System （FAERS） database from the first quarter of 2012 to the fourth quarter of 2022. The data were mined and analyzed by utilizing the ratio-of-reporting-ratio （ROR） method and comprehensive standard method of the United Kingdom’s Medicines and Healthcare Products Regulatory Agency （MHRA） of proportional imbalance measurement.

RESULTS

A total of 13 962 reports of axitinib-related ADEs were obtained， with patients’ age concentrated in 65-85 years （43.25%）， gender predominantly male （65.23%）， country of reporting predominantly US （60.01%）， and serious ADE outcomes mostly hospitalization or prolonged hospitalization （31.51%）. A total of 172 ADE risk signals were detected， involving 18 system and organ classifications （SOC）， mainly systemic diseases and various reactions at the site of administration （3 749 cases， 30.84%） and gastrointestinal system diseases （2 067 cases， 17.00%）. ADE risk signals that occurred more frequently were generally consistent with the drug instruction， such as diarrhea， fatigue， and hypertension； new ADE risk signals requiring clinical attention were death， immune-mediated nephritis， and PT signals contained in the SOC of various benign， malignant， and tumors of undetermined nature （including cysts and polyps）.

CONCLUSIONS

For ADEs that occur frequently with axitinib and are already contained in the drug instruction （e.g. hypertension， diarrhea）， they should be adequately evaluated before administration， especially for patients with combined use of immune checkpoint inhibitors and patients with underlying hypertension； for ADEs with stronger signals and newer ADEs （e.g. death， disease progression， tumor progression）， the patient’s disease progression should be closely monitored during the treatment period for potentially fatal ADEs； for its rare ADEs （e.g. immune-mediated nephritis， scrotal ulcer， non-infectious encephalitis）， clinical validation should be further strengthened.

关键词

阿昔替尼药品不良事件信号挖掘比值失衡测量法美国FDA不良事件报告系统数据库

Keywords

adverse drug eventdata miningproportional imbalance measurementUS FDA Adverse Event Reporting System database

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