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Is it appropriate to conduct a disproportionality analysis using a spontaneous reporting database to investigate whether drug-related adverse events are dose-dependent?

作者信息

Noguchi Yoshihiro, Tachi Tomoya, Yoshimura Tomoaki

机构信息

Laboratory of Clinical Pharmacy, Gifu Pharmaceutical University, Gifu, Japan.

Department of Clinical Pharmacy, Graduate School of Pharmaceutical Sciences, Nagoya City University, Nagoya, Aichi, Japan.

出版信息

Front Pharmacol. 2025 Aug 29;16:1563524. doi: 10.3389/fphar.2025.1563524. eCollection 2025.

DOI:10.3389/fphar.2025.1563524
PMID:40949121
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12425998/
Abstract
摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eb7f/12425998/036f7f5b4d2d/fphar-16-1563524-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eb7f/12425998/849d1db62406/fphar-16-1563524-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eb7f/12425998/036f7f5b4d2d/fphar-16-1563524-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eb7f/12425998/849d1db62406/fphar-16-1563524-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eb7f/12425998/036f7f5b4d2d/fphar-16-1563524-g002.jpg

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J Diabetes Metab Disord. 2025 Jan 2;24(1):33. doi: 10.1007/s40200-024-01552-x. eCollection 2025 Jun.
2
Is ibrutinib-related atrial fibrillation dose dependent? Insights from an individual case level analysis of the World Health Organization pharmacovigilance database.伊布替尼相关房颤与剂量有关吗?来自世界卫生组织药物警戒数据库的个体病例水平分析的见解。
Leukemia. 2024 Dec;38(12):2628-2635. doi: 10.1038/s41375-024-02413-5. Epub 2024 Sep 19.
3
Caveats of Covariate Adjustment in Disproportionality Analysis for Best Practices.
最佳实践中不成比例分析协变量调整的注意事项。
Drug Saf. 2025 Jan;48(1):1-5. doi: 10.1007/s40264-024-01473-x. Epub 2024 Aug 17.
4
The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement.使用个体病例安全报告在药物警戒中进行药物安全性信号检测的不均衡分析报告:方法学开发与声明。
Drug Saf. 2024 Jun;47(6):575-584. doi: 10.1007/s40264-024-01421-9. Epub 2024 May 7.
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Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting Systems.基于自发呈报系统的简单两组比较检测算法。
Drug Saf. 2024 Jun;47(6):535-543. doi: 10.1007/s40264-024-01404-w. Epub 2024 Feb 22.
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Analysis of clozapine-induced seizures using the Japanese Adverse Drug Event Report database.利用日本不良药物事件报告数据库分析氯氮平引起的癫痫发作。
PLoS One. 2023 Jun 12;18(6):e0287122. doi: 10.1371/journal.pone.0287122. eCollection 2023.
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A Comparative Safety Analysis of Medicines Based on the UK Pharmacovigilance and General Practice Prescribing Data in England.基于英国药物警戒和英格兰一般实践处方数据的药品比较安全性分析。
In Vivo. 2022 Mar-Apr;36(2):780-800. doi: 10.21873/invivo.12765.
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Verification of the "Upward Variation in the Reporting Odds Ratio Scores" to Detect the Signals of Drug-Drug Interactions.验证“报告比值比分数的上升变化”以检测药物相互作用信号
Pharmaceutics. 2021 Sep 22;13(10):1531. doi: 10.3390/pharmaceutics13101531.
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Leveraging Case Narratives to Enhance Patient Age Ascertainment from Adverse Event Reports.利用病例叙述来增强从不良事件报告中确定患者年龄的能力。
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