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一项关于伏立康唑药物性别相关FDA不良事件报告系统(FAERS)事件的真实世界药物警戒研究。

A Real-world Pharmacovigilance Study Of FDA Adverse Event Reporting System (FAERS) Events For Gender Of Voriconazole Drugs.

作者信息

Xu Qiong, Cheng Hongxia, Sun Xu, Zhao Jing, Chen Yingying, Ji Lingyu, Liang Yan

机构信息

Department of Hematology, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, China.

Department of Orthopedics, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, China.

出版信息

Drug Res (Stuttg). 2025 Jul;75(6):218-224. doi: 10.1055/a-2575-1530. Epub 2025 Apr 28.

Abstract

To detect the gender variations in adverse events (AEs) of voriconazole, promote personalised medicine.A normalized dataset from Q1 2004 to Q4 2022 from the US Food and Drug Administration's Adverse Event Reporting System (FAERS) was analyses. The reporting odds ratio (ROR), proportional reporting ratio (PRR), and P value were used to examine data from the FAERS database to detect risk signals and quantify the presence and extent of gender variations in voriconazole adverse events.A total of 7670 cases (female/male (2785/4885)) of adverse reactions to voriconazole were analysed, and drug interaction (ROR 1.30 (1.10,1.54)), death and sudden death (ROR 1.31 (1.06,1.61)), actinic keratosis (ROR 1.98 (1.10,3.57)) were found to be significantly more frequent in male patients than in female patients.We found that gender was a determinant in voriconazole-related AEs using FAERS. Our results require future validation due to the inherent limits of this open data source, but they also identify potential contributing elements for a customised side effect profiling.

摘要

为检测伏立康唑不良事件(AE)中的性别差异,推动个性化医疗。对美国食品药品监督管理局不良事件报告系统(FAERS)2004年第一季度至2022年第四季度的标准化数据集进行了分析。采用报告比值比(ROR)、比例报告比值比(PRR)和P值来检查FAERS数据库中的数据,以检测风险信号并量化伏立康唑不良事件中性别差异的存在及程度。共分析了7670例伏立康唑不良反应病例(女性/男性(2785/4885)),发现药物相互作用(ROR 1.30(1.10,1.54))、死亡和猝死(ROR 1.31(1.06,1.61))、光化性角化病(ROR 1.98(1.10,3.57))在男性患者中比在女性患者中明显更频繁。我们发现,利用FAERS,性别是伏立康唑相关不良事件的一个决定因素。由于这个开放数据源的固有局限性,我们的结果需要未来进行验证,但它们也确定了定制副作用概况的潜在促成因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9319/12227254/a2f25699bcca/10-1055-a-2575-1530-idr-2025-01-3170-0001.jpg

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