基于FAERS的罗米司亭和艾曲泊帕ADE信号挖掘与分析

邵鑫; 蒋先虹; 尤俊; 刘易陇

doi:10.6039/j.issn.1001-0408.2023.19.15

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基于FAERS的罗米司亭和艾曲泊帕ADE信号挖掘与分析

药物与临床 | 更新时间：2023-10-09

- 基于FAERS的罗米司亭和艾曲泊帕ADE信号挖掘与分析
- Mining and analysis of ADE signals of romiplostim and eltrombopag based on FAERS database
- 中国药房 2023年34卷第19期页码：2391-2395
- 作者机构：
  
  1.乐山市人民医院药学部，四川乐山　614000
  2.乐山市人民医院胃肠外科，四川乐山　614000
- 作者简介：
  
  药师，硕士。研究方向：临床药学。E-mail：864649882@qq.com
  主管药师，博士研究生。研究方向：临床药学。 E-mail：1158124292@qq.com
- 基金信息：
  
  四川省医学会静脉血栓栓塞症防治（恒瑞）专项科研课题(2019HR15)
- DOI：10.6039/j.issn.1001-0408.2023.19.15
  中图分类号： R969.3;R973
- 纸质出版日期：2023-10-15，
  
  收稿日期：2023-01-09，
  
  修回日期：2023-08-17，
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邵鑫,蒋先虹,尤俊等.基于FAERS的罗米司亭和艾曲泊帕ADE信号挖掘与分析 ^Δ[J].中国药房,2023,34(19):2391-2395.

SHAO Xin,JIANG Xianhong,YOU Jun,et al.Mining and analysis of ADE signals of romiplostim and eltrombopag based on FAERS database[J].ZHONGGUO YAOFANG,2023,34(19):2391-2395.
邵鑫,蒋先虹,尤俊等.基于FAERS的罗米司亭和艾曲泊帕ADE信号挖掘与分析 ^Δ[J].中国药房,2023,34(19):2391-2395. DOI： 10.6039/j.issn.1001-0408.2023.19.15.

SHAO Xin,JIANG Xianhong,YOU Jun,et al.Mining and analysis of ADE signals of romiplostim and eltrombopag based on FAERS database[J].ZHONGGUO YAOFANG,2023,34(19):2391-2395. DOI： 10.6039/j.issn.1001-0408.2023.19.15.

摘要

目的

为临床安全使用血小板生成素受体激动剂类药物罗米司亭和艾曲泊帕提供参考。

方法

利用美国FDA不良事件报告系统（FAERS）收集罗米司亭和艾曲泊帕从在美国上市至2022年9月30日的药物不良事件（ADE）报告，利用报告比值比（ROR）法与英国药品和健康产品管理局的综合标准法对2种药物的ADE信号进行分析。

结果

共收集到罗米司亭和艾曲泊帕的ADE报告分别为14 021、4 431份，性别构成均为女性多于男性。经信号筛选，得到罗米司亭563个ADE信号，累及25个系统器官分类（SOC）；艾曲泊帕433个ADE信号，累及26个SOC。2种药物发生频次最多的ADE信号均为血小板计数降低（分别为2 060、 1 585例），在其药品说明书中均有记载；按信号强度排序，罗米司亭的血小板生成素水平异常（ROR值为2 268.85）和艾曲泊帕的登革病毒检测阳性（ROR值为954.50）位列第一，且均未被其药品说明书记载。

结论

罗米司亭和艾曲泊帕的ADE主要累及血液及淋巴系统，且新的可疑高风险信号较多。

Abstract

OBJECTIVE

To provide a reference for the safe use of thrombopoietin receptor agonists romiplostim and eltrombopag in clinic.

METHODS

FDA adverse event reporting system （FAERS） in the United States was adopted to collect adverse drug event （ADE） reports of romiplostim and eltrombopag from their launch in the United States to September 30， 2022； the ADE signals of the two drugs were analyzed using the reporting odds ratio （ROR） method and the comprehensive standard method of the UK Medicines and Healthcare Products Regulatory Agency.

RESULTS

A total of 14 021 and 4 431 ADE reports were collected about romiplostim and eltrombopag， respectively， with a gender composition of more females than males. After signal screening， 563 ADE signals were obtained about romiplostim， involving 25 system organ classes （SOC）； eltrombopag had 433 ADE signals， involving 26 SOC. The most frequently reported ADE for both drugs was platelet count decreased （2 060， 1 585 cases）， which was mentioned in their drug instructions. In terms of signal intensity， romiplostim exhibited the highest signal for abnormal thrombopoietin levels （ROR of 2 268.85）， while eltrombopag had the highest signal for positive dengue virus test （ROR of 954.50）， with neither of these signals mentioned in their respective drug instructions.

CONCLUSIONS

The ADE of romiplostim and eltrombopag mainly affects the blood and lymphatic system， and there are many new suspicious high-risk signals.

关键词

罗米司亭艾曲泊帕药品不良事件信号挖掘报告比值比法综合标准法

Keywords

eltrombopagadverse drug eventsignal miningreporting odds ratio methodcomprehensive standard method

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