药物警戒不均衡性分析的有效性、相关性及解读 - Suppr

Validity, relevance and interpretation of pharmacovigilance disproportionality analyses.

作者信息

Cortes Benjamin, Jambon-Barbara Clément, Cracowski Jean-Luc, Khouri Charles

机构信息

Pharmacy Department, Grenoble Alpes University Hospital, F-38000 Grenoble, France.

Pharmacovigilance Unit, Grenoble Alpes University Hospital, F-38000 Grenoble, France; Univ. Grenoble Alpes, HP2 Laboratory, Inserm U1300, Grenoble, France.

出版信息

Bone. 2023 May;170:116685. doi: 10.1016/j.bone.2023.116685. Epub 2023 Feb 8.

DOI:10.1016/j.bone.2023.116685

PMID:36764505

Abstract

摘要

相似文献

Validity, relevance and interpretation of pharmacovigilance disproportionality analyses.药物警戒不均衡性分析的有效性、相关性及解读

Bone. 2023 May;170:116685. doi: 10.1016/j.bone.2023.116685. Epub 2023 Feb 8.

Response to Letter to the editor regarding, "Validity, relevance and interpretation of pharmacovigilance disproportionality analyses".对关于“药物警戒不均衡性分析的有效性、相关性及解读”的致编辑信的回复

Bone. 2023 May;170:116704. doi: 10.1016/j.bone.2023.116704. Epub 2023 Feb 11.

Disproportionality Analysis for Pharmacovigilance Signal Detection in Small Databases or Subsets: Recommendations for Limiting False-Positive Associations.药品不良反应信号检测中小数据库或子数据集的不均衡性分析：限制假阳性关联的建议。

Drug Saf. 2020 May;43(5):479-487. doi: 10.1007/s40264-020-00911-w.

A meta-epidemiological study found lack of transparency and poor reporting of disproportionality analyses for signal detection in pharmacovigilance databases.一项荟萃流行病学研究发现，药物警戒数据库中信号检测的不均衡分析缺乏透明度和报告质量较差。

J Clin Epidemiol. 2021 Nov;139:191-198. doi: 10.1016/j.jclinepi.2021.07.014. Epub 2021 Jul 27.

Case-non-case studies: Principle, methods, bias and interpretation.病例-非病例研究：原理、方法、偏倚与解读

Therapie. 2019 Apr;74(2):225-232. doi: 10.1016/j.therap.2019.01.006. Epub 2019 Jan 31.

Adverse drug reaction risks obtained from meta-analyses and pharmacovigilance disproportionality analyses are correlated in most cases.从荟萃分析和药物警戒不稳定性分析中获得的药物不良反应风险在大多数情况下是相关的。

J Clin Epidemiol. 2021 Jun;134:14-21. doi: 10.1016/j.jclinepi.2021.01.015. Epub 2021 Jan 26.

Contribution of Causality Assessment for an Automated Detection of Safety Signals: An Example Using the French Pharmacovigilance Database.因果关系评估对自动检测安全信号的贡献：用法语药物警戒数据库举例。

Drug Saf. 2020 Mar;43(3):243-253. doi: 10.1007/s40264-019-00887-2.

Conceiving, conducting, reporting, interpreting, and publishing disproportionality analyses: A call to action.构思、开展、报告、解读及发表不均衡性分析：行动呼吁。

Br J Clin Pharmacol. 2022 Jul;88(7):3535-3536. doi: 10.1111/bcp.15269. Epub 2022 Feb 17.

The Role of Disproportionality Analysis of Pharmacovigilance Databases in Safety Regulatory Actions: a Systematic Review.药物警戒数据库的不均衡性分析在安全监管行动中的作用：一项系统评价

Curr Drug Saf. 2015;10(3):234-50. doi: 10.2174/1574886310666150729112903.

High prevalence of spin was found in pharmacovigilance studies using disproportionality analyses to detect safety signals: a meta-epidemiological study.在使用不成比例分析来检测安全信号的药物警戒研究中发现自旋的高患病率：一项元流行病学研究。

J Clin Epidemiol. 2021 Oct;138:73-79. doi: 10.1016/j.jclinepi.2021.06.022. Epub 2021 Jun 26.

引用本文的文献

Are Causal Statements Reported in Pharmacovigilance Disproportionality Analyses Using Individual Case Safety Reports Exaggerated in Related Citations? A Meta-epidemiological Study.在使用个体病例安全报告的药物警戒性不成比例分析中报告的因果陈述在相关引用中是否被夸大？一项元流行病学研究。

Drug Saf. 2025 Jun;48(6):679-688. doi: 10.1007/s40264-025-01524-x. Epub 2025 Feb 22.

The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration.《使用药物警戒中的个体病例安全报告进行药物安全性信号检测的不适当性分析报告（READUS-PV）：解释与说明》。

Drug Saf. 2024 Jun;47(6):585-599. doi: 10.1007/s40264-024-01423-7. Epub 2024 May 7.

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Validity, relevance and interpretation of pharmacovigilance disproportionality analyses.

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