Signal mining and analysis of selinexor adverse events

CHEN Yaqing; XU Mengdan; GU Hangye; WU Junlin; CHEN Yong

doi:10.6039/j.issn.1001-0408.2024.02.15

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Signal mining and analysis of selinexor adverse events

更新时间：2024-01-24

- Signal mining and analysis of selinexor adverse events
- ZHONGGUO YAOFANG Vol. 35, Issue 2, Pages: 210-213(2024)
- 作者机构：
  
  1.广东药科大学附属第一医院临床药学重点专科，广州　510080
  2.广东药科大学药学院，广州　510006
  3.国家药品监督管理局药物警戒技术研究与评价重点实验室，广州　510006
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.02.15
  CLC： R979.1
- Published：30 January 2024，
  
  Received：09 August 2023，
  
  Revised：28 November 2023，
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陈亚轻,徐梦丹,顾航烨等.塞利尼索不良事件信号挖掘与分析 ^Δ[J].中国药房,2024,35(02):210-213.

CHEN Yaqing,XU Mengdan,GU Hangye,et al.Signal mining and analysis of selinexor adverse events[J].ZHONGGUO YAOFANG,2024,35(02):210-213.
陈亚轻,徐梦丹,顾航烨等.塞利尼索不良事件信号挖掘与分析 ^Δ[J].中国药房,2024,35(02):210-213. DOI： 10.6039/j.issn.1001-0408.2024.02.15.

CHEN Yaqing,XU Mengdan,GU Hangye,et al.Signal mining and analysis of selinexor adverse events[J].ZHONGGUO YAOFANG,2024,35(02):210-213. DOI： 10.6039/j.issn.1001-0408.2024.02.15.

摘要

目的

挖掘塞利尼索的药品不良事件（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）2019年7月3日到2023年3月31日上报的塞利尼索ADE数据。采用报告比值比（ROR）法和比例报告比值（PRR）法进行数据挖掘，利用国际医学用语词典（MedDRA）（26.0版）药物ADE术语集中的系统器官分类（SOC）和首选语（PT）进行分类统计。

结果

共获得塞利尼索ADE报告3 084份，ADE阳性信号共134个；已报告性别中男性127例、女性124例，年龄以≥65岁为主（4.12%）；美国报告数量最多（96.53%），报告者主要为消费者（77.27%）；严重ADE主要为住院/住院时间延长（26.26%），其次为死亡（17.15%）。发生频次排名前3位的ADE分别为恶心（1 162次）、疲劳（790次）、食欲减退（610次），均被塞利尼索说明书提及。信号强度排名前3位分别为装置相关性菌血症（ROR＝115.07，PRR＝114.94）、睑板腺功能障碍（ROR＝106.70，PRR＝106.54）、沙门菌性脓毒症（ROR＝99.90，PRR＝99.81），均未被塞利尼索说明书提及。

结论

临床使用塞利尼索时除需关注说明书提及的恶心等常见ADE外，还应关注装置相关性菌血症、睑板腺功能障碍、沙门菌性脓毒症等未被说明书提及的ADE；建议每周复查患者血常规，对患者的血液指标、感染症状等进行监测，以保障患者安全用药。

Abstract

OBJECTIVE

To mine the adverse drug event （ADE） signals of selinexor， and to provide reference for its clinical safety medication.

METHODS

ADE data for selinexor reported from July 3rd， 2019 to March 31st， 2023 were collected from the FDA adverse event reporting system （FAERS）. Data mining was performed by using the reporting odds ratio （ROR） and proportional reporting ratio （PRR） methods， and categorization statistics were performed by using the system organ class （SOC） and preferred term （PT） from drug ADE terminology set in the MedDRA （version 26.0）.

RESULTS

A total of 3 084 ADE reports were obtained for selinexor， with a total of 134 ADE-positive signals. Among the reported genders， there were 127 males and 124 females， with a predominant age of ≥65 years old （4.12%）； the United States had the highest number of reports （96.53%）， with consumers being the main reporters （77.27%）； severe ADR was mainly characterized by hospitalization/prolonged hospitalization （26.26%）， followed by death （17.15%）. The top 3 ADE in the list of frequency were nausea （1 162 times）， fatigue （790 times） and anorexia （610 times）， all of which were mentioned in the selinexor’s instructions. The top 3 signals in the list of strength were device-associated bacteremia （ROR＝115.07， PRR＝114.94）， blepharospasm dysfunction （ROR＝106.70， PRR＝106.54）， and salmonella sepsis （ROR＝99.90， PRR＝99.81）， all of which were not mentioned in the selinexor’s instructions.

CONCLUSIONS

In addition to the ADE of nausea mentioned in the instruction manual， attention should also paid to device-associated bacteremia， blepharospasm dysfunction， salmonella sepsis， and other ADE not mentioned in the instruction manual when using selinexor in clinical practice； weekly rechecking of the patient’s blood routine should be done to monitor the patient’s blood indexes， symptoms of infection， and so on， to ensure that the safety of drug use.

关键词

塞利尼索药品不良事件信号挖掘FDA不良事件报告系统

Keywords

adverse drug eventsignal miningFDA adverse event reporting system

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