Recommendations for the selection of nucleoside analogues as antihuman herpesvirus drugs: a real-world analysis of reported cases from the FDA adverse event reporting system.

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2024-07-04 DOI:10.1080/14740338.2024.2374919
Caixia Gao, Xiaomei Dong, Jun Zhang, Lejiao Mao, Changxin Guo, Xia Qin, Zhen Zou
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引用次数: 0

Abstract

Objective: The aim of this study is to provide guidance for refining medication protocols, developing alternative strategies, and enhancing protection against herpesvirus infections in personalized clinical settings.

Methods: Adverse drug events (ADEs) data for anti-herpesvirus from the first quarter of 2004 to the fourth quarter of 2022 were collected from the FDA Adverse Event Reporting System (FAERS). Disproportionality analysis was performed using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN) methods for data mining.

Results: A total of 18,591, 24,206, 6,150, and 419 reports of ADEs associated with acyclovir (ACV), valacyclovir (VACV), ganciclovir (GCV), and famciclovir (FCV) were screened and extracted from the FAERS. In this study, the report summarized the high frequency and strong correlation of ADEs for the four drugs at the Preferred Term (PT) level. Additionally, the analysis also identified the relationship between ADEs and factors such as age, gender, and severity of outcome at the System Organ Class (SOC) level.

Conclusion: The safety reports for the four-nucleoside analogue anti-herpesvirus drugs are diverse and interconnected. Dosing for patients with herpesvirus infections should be tailored to their specific conditions and the potential risk of disease.

选择核苷类似物作为抗人类疱疹病毒药物的建议:对美国食品药物管理局不良事件报告系统所报告病例的实际分析。
目的:本研究旨在为完善用药方案、制定替代策略和加强个性化临床环境中对疱疹病毒感染的防护提供指导:本研究旨在为完善用药方案、制定替代策略以及在个性化临床环境中加强对疱疹病毒感染的防护提供指导:从 FDA 不良事件报告系统 (FAERS) 收集了 2004 年第一季度至 2022 年第四季度抗疱疹病毒药物不良事件 (ADE) 数据。使用报告比值比(ROR)、比例报告比(PRR)和贝叶斯置信度传播神经网络(BCPN)方法进行数据挖掘,进行比例失调分析:从 FAERS 中筛选并提取了与阿昔洛韦 (ACV)、伐昔洛韦 (VACV)、更昔洛韦 (GCV) 和泛昔洛韦 (FCV) 相关的 ADE 报告,数量分别为 18591 份、24206 份、6150 份和 419 份。在这项研究中,报告总结了这四种药物在首选术语 (PT) 级别的 ADE 的高频率和强相关性。此外,分析还确定了 ADE 与年龄、性别和系统器官分级(SOC)结果严重程度等因素之间的关系:结论:四种核苷类似物抗疱疹病毒药物的安全性报告多种多样且相互关联。疱疹病毒感染患者的用药剂量应根据其具体病情和疾病的潜在风险而定。
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来源期刊
CiteScore
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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