使用自发报告系统进行简单两组比较的检测算法。

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Drug Safety Pub Date : 2024-06-01 Epub Date: 2024-02-22 DOI:10.1007/s40264-024-01404-w
Yoshihiro Noguchi, Tomoaki Yoshimura
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引用次数: 0

摘要

医学界通常以成年男性为标准来确定病理状况、病理转归、诊断方法和治疗方法。然而,近来人们已经清楚地认识到,在风险因素如何导致同一种疾病方面存在着性别差异,而在同一种药物的疗效方面也存在着这些差异。此外,老年人和儿童的新陈代谢功能低于成年男性,对成年男性的临床试验结果不能直接应用于这些患者。自发报告系统已成为安全性评估的重要信息来源,从而反映了药物在特定人群和临床环境中的实际使用情况。然而,自发报告系统只登记与药物相关的不良事件(AEs),因此无法准确记录使用这些药物的患者总数。因此,尽管已经开发出了各种算法来利用比例失调现象和搜索 AE 信号,但目前还没有系统的文献介绍如何检测老年人和儿童特有的 AE 信号或性别特异性信号。本综述介绍了利用数据挖掘进行信号检测的传统方法和最新知识及其局限性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting Systems.

Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting Systems.

Medical science has often used adult males as the standard to establish pathological conditions, their transitions, diagnostic methods, and treatment methods. However, it has recently become clear that sex differences exist in how risk factors contribute to the same disease, and these differences also exist in the efficacy of the same drug. Furthermore, the elderly and children have lower metabolic functions than adult males, and the results of clinical trials on adult males cannot be directly applied to these patients. Spontaneous reporting systems have become an important source of information for safety assessment, thereby reflecting drugs' actual use in specific populations and clinical settings. However, spontaneous reporting systems only register drug-related adverse events (AEs); thus, they cannot accurately capture the total number of patients using these drugs. Therefore, although various algorithms have been developed to exploit disproportionality and search for AE signals, there is no systematic literature on how to detect AE signals specific to the elderly and children or sex-specific signals. This review describes signal detection using data mining, considering traditional methods and the latest knowledge, and their limitations.

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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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