Signal detection and analysis of the adverse events of ustekinumab based on OpenFDA database

XU Ting; CHEN Huiqing

doi:10.6039/j.issn.1001-0408.2023.02.11

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Signal detection and analysis of the adverse events of ustekinumab based on OpenFDA database

更新时间：2023-02-22

- Signal detection and analysis of the adverse events of ustekinumab based on OpenFDA database
- ZHONGGUO YAOFANG Vol. 34, Issue 2, Pages: 185-189(2023)
- 作者机构：
  
  广州中医药大学第二附属医院药学部，广州　510120
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2023.02.11
  CLC： R994.1
- Published：30 January 2023，
  
  Received：18 August 2022，
  
  Revised：21 December 2022，
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徐婷,陈辉清.基于OpenFDA数据库的乌司奴单抗不良事件信号检测与分析 ^Δ[J].中国药房,2023,34(02):185-189.

XU Ting,CHEN Huiqing.Signal detection and analysis of the adverse events of ustekinumab based on OpenFDA database[J].ZHONGGUO YAOFANG,2023,34(02):185-189.
徐婷,陈辉清.基于OpenFDA数据库的乌司奴单抗不良事件信号检测与分析 ^Δ[J].中国药房,2023,34(02):185-189. DOI： 10.6039/j.issn.1001-0408.2023.02.11.

XU Ting,CHEN Huiqing.Signal detection and analysis of the adverse events of ustekinumab based on OpenFDA database[J].ZHONGGUO YAOFANG,2023,34(02):185-189. DOI： 10.6039/j.issn.1001-0408.2023.02.11.

摘要

目的

分析乌司奴单抗的不良反应发生风险，为临床安全合理用药提供参考。

方法

对美国FDA公共数据开放项目（OpenFDA）数据库收录的乌司奴单抗上市后（2009年9月25日至2021年12月30日）的不良事件（AE）报告进行分析。采用报告比值比（ROR）法和比例报告比值（PRR）法对报告例数居前100位的AE进行风险信号挖掘。

结果

共检索到乌司奴单抗相关AE报告62 356份，男性患者（51.79%）多于女性（39.51%）；ROR法和PRR法检测结果显示，共有31个可疑信号生成，主要有感染及侵染类疾病（9个）、全身性疾病及给药部位各种反应（5个）、皮肤及皮下组织类疾病（4个）、各种肌肉骨骼及结缔组织疾病（4个）等；其中说明书未收录的可疑信号14个，如肝酶升高、基底细胞癌、心包炎、天疱疮、脱发、滑膜炎、舌痛等。

结论

临床应用乌司奴单抗时，除说明书已提及的不良反应外，还需密切关注和评估使用过程中患者的肝功能、皮肤状态、脱发情况以及心血管相关风险，及早识别AE，以确保患者安全用药。

Abstract

OBJECTIVE

To analyze the risk of adverse drug reaction of ustekinumab， so as to provide reference for rational drug use in clinic.

METHODS

The adverse events （AE） reports related to ustekinumab included in the FDA public data program（OpenFDA） database were analyzed after marketing （from September 25th 2009 to December 30th 2021）. The risk signals were mined for top 100 AE by the method of reporting odds ratio （ROR） and proportional reporting ratio （PRR）.

RESULTS

A total of 62 356 AE reports related to ustekinumab were retrieved， male patients （51.79%） were more than female patients （39.51%）. Results of ROR method and PRR method showed that 31 suspicious signals were mined， mainly infections and infectious diseases （9 kinds）， general disorders and administration site conditions （5 kinds）， skin and subcutaneous tissue disorders diseases （4 kinds）， musculoskeletal and connective tissue disorders （4 kinds）， etc. Fourteen suspicious signals were not included in the instructions， such as hepatic enzyme increase， basal cell carcinoma， pericarditis， pemphigus， hair loss， synovitis， glossodynia， etc.

CONCLUSIONS

During clinical dosing of ustekinumab， in addition to ADR mentioned in package inserts， great attention should be paid to the patient’s liver function， skin status， hair loss and cardiovascular-related risks，which is helpful to discover AE early and ensure the safety medication of patients.

关键词

乌司奴单抗OpenFDA不良事件数据挖掘

Keywords

OpenFDAadverse eventsdata mining

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