Signal mining and analysis of adverse events of oseltamivir， zanamivir and baloxavir marboxil

JIANG Tingting; ZHANG Ni; SU Hui; LI Yanping; LIU Yao

doi:10.6039/j.issn.1001-0408.2024.06.18

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Signal mining and analysis of adverse events of oseltamivir， zanamivir and baloxavir marboxil

更新时间：2024-04-09

- Signal mining and analysis of adverse events of oseltamivir， zanamivir and baloxavir marboxil
- ZHONGGUO YAOFANG Vol. 35, Issue 6, Pages: 739-743(2024)
- 作者机构：
  
  陆军军医大学大坪医院药剂科，重庆　400042
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.06.18
  CLC： R969.3
- Published：30 March 2024，
  
  Received：27 September 2023，
  
  Revised：26 February 2024，
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蒋婷婷,张妮,苏辉等.奥司他韦、扎那米韦和玛巴洛沙韦的不良事件信号挖掘与分析 ^Δ[J].中国药房,2024,35(06):739-743.

JIANG Tingting,ZHANG Ni,SU Hui,et al.Signal mining and analysis of adverse events of oseltamivir， zanamivir and baloxavir marboxil[J].ZHONGGUO YAOFANG,2024,35(06):739-743.
蒋婷婷,张妮,苏辉等.奥司他韦、扎那米韦和玛巴洛沙韦的不良事件信号挖掘与分析 ^Δ[J].中国药房,2024,35(06):739-743. DOI： 10.6039/j.issn.1001-0408.2024.06.18.

JIANG Tingting,ZHANG Ni,SU Hui,et al.Signal mining and analysis of adverse events of oseltamivir， zanamivir and baloxavir marboxil[J].ZHONGGUO YAOFANG,2024,35(06):739-743. DOI： 10.6039/j.issn.1001-0408.2024.06.18.

摘要

目的

挖掘3种抗甲型流感病毒药物（奥司他韦、扎那米韦、玛巴洛沙韦）的不良事件（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）2004年第1季度至2022年第3季度上报的奥司他韦、扎那米韦、玛巴洛沙韦ADE数据，采用报告比值比（ROR）法进行数据挖掘，评估指定医疗事件（DME），利用《国际医学用语词典》（25.0版）药物ADE术语集中的系统器官分类（SOC）进行分类统计。

结果

分别检索到奥司他韦、扎那米韦、玛巴洛沙韦ADE报告12 636、1 749、1 283例，分别累及26、16、17个SOC。奥司他韦与睡惊症、异常行为、幻觉、谵妄的关联性较强；扎那米韦涉及的异常行为、谵妄、语无伦次、意识状态改变信号强度突出；玛巴洛沙韦与缺血性结肠炎、出血性膀胱炎、多形性红斑、黑便的关联性较强。3种药物的DME均检出多形性红斑，且信号较强。

结论

临床应用奥司他韦等3种药物时，除关注常见ADE外，还应加强关注药品说明书中未提及的ADE。对于奥司他韦应警惕急性肾损伤、暴发性肝炎，定期监测患者的肝肾功能；对于扎那米韦应警惕与呼吸系统相关的ADE，包括急性呼吸窘迫综合征、呼吸衰竭，并密切关注患者的呼吸状况；对于玛巴洛沙韦应警惕多形性红斑、横纹肌溶解等ADE。

Abstract

OBJECTIVE

To provide reference for safe drug use in clinic by mining the adverse drug events （ADE） of 3 kinds of anti-influenza A virus drugs （oseltamivir， zanamivir， baloxavir marboxil）.

METHODS

The ADE data of oseltamivir， zanamivir and baloxavir marboxil were collected from the FDA adverse event reporting system （FAERS） between the first quarter in 2004 and the third quarter in 2022， and mined by using reporting odds ratio （ROR） method. The designated medical events （DME） were estimated. The system organ class （SOC） in the

Medical Dictionary for Regulatory Activities

（MedDRA， version 25.0） was used for the classification and statistics of drug ADE terminology.

RESULTS

A total of 12 636， 1 749 and 1 283 ADE reports were retrieved for oseltamivir， zanamivir and baloxavir marboxil， involving 26， 16 and 17 SOCs， respectively. Oseltamivir was strongly associated with sleep terror， abnormal behavior， hallucination and delirium. Zanamivir was implicated in abnormal behavior， delirium， incoherence， and altered state of consciousness with prominent signal intensity. Baloxavir marboxil was strongly associated with ischemic colitis， hemorrhagic cystitis， erythema multiforme and melaena. Erythema multiform was detected in the DME of three drugs with strong signals.

CONCLUSIONS

When clinically administering the three drugs， it is crucial to pay close attention to both common adverse reactions and those ADEs that are not explicitly mentioned in the drug instructions. For oseltamivir， clinicians should exercise caution due to the potential risk of acute kidney injury and fulminant hepatitis， necessitating regular monitoring of the patient’s liver and kidney function. When prescribing zanamivir， caution should be exercised due to ADEs related to the respiratory system， including acute respiratory distress syndrome and respiratory failure， necessitating close monitoring of the patient’s respiratory status. Similarly， for baloxavir marboxil， clinicians should be vigilant for potential ADEs such as erythema multiforme and rhabdomyolysis.

关键词

抗甲型流感病毒药物奥司他韦扎那米韦玛巴洛沙韦信号挖掘不良事件

Keywords

oseltamivirzanamivirbaloxavir marboxilsignal miningadverse drug event

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