Hematological adverse events associated with anti-MRSA agents: a real-world analysis based on FAERS.

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Expert Opinion on Drug Safety Pub Date : 2024-10-01 Epub Date: 2024-01-25 DOI:10.1080/14740338.2024.2309225
Xiuheng Yu, Xiaodan Zhou, Min Li, Yu Zhao
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Abstract

This study investigated the patterns of hematological adverse events related to daptomycin (DAP), tigecycline (TIG), vancomycin (VAN) and linezolid (LIN) in the FDA Adverse Event Reporting System (FAERS). Adverse event associations were analyzed through calculating reporting odds ratio (ROR), proportional reporting ratio (PRR), multiple gamma Poisson shrinkage (MGPS), and Bayesian confidence propagation neural network (BCPNN). A comprehensive descriptive analysis was also conducted considering factors such as age, gender, daily dose, cumulative dose, and time to onset. The leading hematologic adverse events were eosinophilia for daptomycin, coagulation abnormalities and thrombocytopenia for tigecycline, thrombocytopenia, neutropenia, and anemia for linezolid, and thrombocytopenia, eosinophilia, and neutropenia for vancomycin. Most of the affected patients were over 55 years old. Daily doses for the tigecycline and daptomycin groups exceeded the standard daily dose. The times to onset were 14.00 days for daptomycin (interquartile range [IQR], 4.00-21.00), 6.00 days for tigecycline (IQR, 2.00-9.00), 10.00 days for linezolid (IQR, 4.00-16.5), and 10.00 days for vancomycin (IQR,5.00-20.00). It is essential to intensify early monitoring and identification of these adverse events, especially in the context of off-label dosages and for elderly patients and individuals taking medication for over one week.

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与抗 MRSA 药物相关的血液学不良事件:基于 FAERS 的真实世界分析。
本研究调查了 FDA 不良事件报告系统 (FAERS) 中与达托霉素 (DAP)、替加环素 (TIG)、万古霉素 (VAN) 和利奈唑胺 (LIN) 相关的血液学不良事件的模式。通过计算报告几率比(ROR)、比例报告比(PRR)、多伽马泊松收缩(MGPS)和贝叶斯置信传播神经网络(BCPN)分析了不良事件的关联性。考虑到年龄、性别、日剂量、累积剂量和发病时间等因素,还进行了综合描述性分析。主要的血液学不良事件是:达托霉素引起嗜酸性粒细胞增多;替加环素引起凝血异常和血小板减少;利奈唑胺引起血小板减少、中性粒细胞减少和贫血;万古霉素引起血小板减少、嗜酸性粒细胞增多和中性粒细胞减少。大多数患者年龄超过 55 岁。替加环素和达托霉素组的日剂量超过了标准日剂量。达托霉素的发病时间为 14.00 天(四分位数间距 [IQR],4.00-21.00),替加环素为 6.00 天(IQR,2.00-9.00),利奈唑胺为 10.00 天(IQR,4.00-16.5),万古霉素为 10.00 天(IQR,5.00-20.00)。必须加强对这些不良事件的早期监测和识别,尤其是在标签外剂量、老年患者和服药超过一周的患者中。
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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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