Data mining and analysis of adverse drug events signals for guselkumab based on FAERS database

YANG Li; WANG Hao; LIU Xiaoying; ZHOU Yue; FU Xiaoyan

doi:10.6039/j.issn.1001-0408.2022.22.16

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Data mining and analysis of adverse drug events signals for guselkumab based on FAERS database

更新时间：2023-02-22

- Data mining and analysis of adverse drug events signals for guselkumab based on FAERS database
- ZHONGGUO YAOFANG Vol. 33, Issue 22, Pages: 2766-2769(2022)
- 作者机构：
  
  成都市新都区人民医院，成都　610500
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2022.22.16
  CLC： R969.3;R979.5
- Published：30 November 2022，
  
  Received：27 May 2022，
  
  Revised：08 November 2022，
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阳丽,王浩,刘小英等.基于FAERS数据库的古塞奇尤单抗ADE信号挖掘与分析 ^Δ[J].中国药房,2022,33(22):2766-2769.

YANG Li,WANG Hao,LIU Xiaoying,et al.Data mining and analysis of adverse drug events signals for guselkumab based on FAERS database[J].ZHONGGUO YAOFANG,2022,33(22):2766-2769.
阳丽,王浩,刘小英等.基于FAERS数据库的古塞奇尤单抗ADE信号挖掘与分析 ^Δ[J].中国药房,2022,33(22):2766-2769. DOI： 10.6039/j.issn.1001-0408.2022.22.16.

YANG Li,WANG Hao,LIU Xiaoying,et al.Data mining and analysis of adverse drug events signals for guselkumab based on FAERS database[J].ZHONGGUO YAOFANG,2022,33(22):2766-2769. DOI： 10.6039/j.issn.1001-0408.2022.22.16.

摘要

目的

为古塞奇尤单抗临床使用的安全性提供参考依据。

方法

采用报告比值比法和贝叶斯可信区间递进神经网络法对美国FAERS数据库中2017年第4季度至2022年第2季度古塞奇尤单抗相关不良事件（ADE）报告进行数据挖掘。结果与

结论

共筛选得到古塞奇尤单抗ADE报告29 951份，获得197个（3 871例）ADE信号，涉及21个系统器官。古塞奇尤单抗的主要ADE信号体现在感染及侵染类疾病、全身性疾病及给药部位各种反应、皮肤及皮下组织类疾病上，这与其说明书记载基本一致。其新的ADE信号包括眼眶肿瘤、胆囊腺癌、汗腺疾病、血尿酸降低、眼睑回缩、血管免疫母细胞性T细胞淋巴瘤、非酒精性脂肪肝、增生性胆囊病、气管软化、内耳疾病等。其严重的ADE信号包括全身各部位的严重感染、肝胆疾病、肿瘤疾病等。

Abstract

OBJECTIVE

To provide a reference for the safety of guselkumab in clinical use.

METHODS

The reporting odds ratio and the Bayesian confidence propagation neural network were used to mine the data of adverse drug events （ADE） related to guselkumab in FAERS database from the fourth quarter of 2017 to the second quarter of 2022.

RESULTS &

CONCLUSIONS

A total of 29 951 ADE reports related to guselkumab were screened， involving 197 （3 871 cases） ADE signals and 21 system organs. The major ADE signals of guselkumab manifested as infectious and invasive diseases， systemic disease and various reactions at the site of administration， and skin and subcutaneous tissue　diseases， which were basically consistent with the instructions. The new ADE signals were found， such as neoplasm of orbit， gallbladder adenocarcinoma， sweat gland disorder， decreased blood uric acid， eyelid retraction， angioimmunoblastic T-cell lymphoma， nonalcoholic fatty liver disease， hyperplastic cholecystopathy， tracheomalacia， inner ear disorder， etc. And the severe ADE signals included severe infections in various parts of the body， liver and gallbladder diseases， tumor， etc.

关键词

古塞奇尤单抗药品不良事件药品不良反应据挖掘

Keywords

adverse drug eventsadverse drug reactiondata mining

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