用于监测抗病毒药物不良事件的主动药物警戒策略比较:系统回顾。

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Drug Safety Pub Date : 2024-12-01 Epub Date: 2024-08-19 DOI:10.1007/s40264-024-01470-0
Renato Ferreira-da-Silva, Joana Reis-Pardal, Manuela Pinto, Matilde Monteiro-Soares, Bernardo Sousa-Pinto, Manuela Morato, Jorge Junqueira Polónia, Inês Ribeiro-Vaz
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引用次数: 0

摘要

简介:抗病毒药物在实际临床环境中的安全性至关重要,因为上市前研究往往无法捕捉到所有不良事件(AE)。积极的药物警戒策略对于全面检测和描述这些不良事件至关重要:本研究旨在识别和描述在实际临床环境中针对使用全身性抗病毒药物的患者所采用的积极药物警戒策略,重点关注不良事件的发生频率和所使用的临床数据来源:我们检索了三个电子文献数据库,针对观察性前瞻性主动药物警戒研究、上市后安全性监测的IV期临床试验以及评估主动药物警戒策略的干预性研究进行了系统综述,重点关注暴露于全身性抗病毒药物的个体:我们纳入了 36 项主要采用药物事件监测 (DEM) 技术的初步研究,少数研究采用了哨点和登记制度。人类免疫缺陷病毒(HIV)是最常见的病症,其中大多数采用 DEM。在药物监测(DEM)中,至少有一种 AE 的患者发生率差异很大,其中大多数研究使用了一种或两种数据源。哨点研究并不常见,其中两项研究涉及丙型肝炎病毒 (HCV),一项涉及艾滋病病毒 (HIV),每项研究都依赖于一种或两种数据源。唯一一项使用登记册的研究报告称,该研究重点关注艾滋病治疗,仅使用了一个数据源。患者访谈是最常见的数据来源,其次是医疗记录和实验室检测。18/36 项研究的质量被认为是 "良好",1/36 项研究的质量被认为是 "一般",17/36 项研究的质量被认为是 "较差":DEM是最主要的药物警戒策略,采用了多种数据来源,似乎增加了发现较高AE发生率的可能性。建立这样一个框架将有助于在不同的研究和环境中采用更详细、更一致的方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review.

A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review.

Introduction: The safety of antiviral agents in real-world clinical settings is crucial, as pre-marketing studies often do not capture all adverse events (AE). Active pharmacovigilance strategies are essential for detecting and characterising these AE comprehensively.

Objective: The aim of this study was to identify and characterise active pharmacovigilance strategies used in real-world clinical settings for patients under systemic antiviral agents, focusing on the frequency of AE and the clinical data sources used.

Methods: We conducted a systematic review by searching three electronic bibliographic databases targeting observational prospective active pharmacovigilance studies, phase IV clinical trials for post-marketing safety surveillance, and interventional studies assessing active pharmacovigilance strategies, focusing on individuals exposed to systemic antiviral agents.

Results: We included 36 primary studies, predominantly using Drug Event Monitoring (DEM), with a minority employing sentinel sites and registries. Human immunodeficiency virus (HIV) was the most common condition, with the majority using DEM. Within the DEM, there was a wide range of incidences of patients experiencing at least one AE, and most of these studies used one or two data sources. Sentinel site studies were less common, with two on hepatitis C virus (HCV) and one on HIV, each relying on one or two data sources. The single study using a registry focusing on HIV therapy reported using just one data source. Patient interviews were the most common data source, followed by medical records and laboratory tests. The quality of the studies was considered 'good' in 18/36, 'fair' in 1/36, and 'poor' in 17/36 studies.

Conclusion: DEM was the predominant pharmacovigilance strategy, employing multiple data sources, and appears to increase the likelihood of detecting higher AE incidence. Establishing such a framework would facilitate a more detailed and consistent approach across different studies and settings.

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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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