基于FAERS数据库对女性使用坦索罗辛不良事件的研究

A Study on Adverse Events in Women Using Tamsulosin Based on the FAERS Database

关键词:  FAERS数据库，坦索罗辛，女性患者，不良事件

Key words:  FAERS database, tamsulosin, female patients, adverse events

摘要:

目的 坦索罗辛主要用于治疗男性良性前列腺增生引起的排尿困难，但其在女性患者中的超说明书应用逐渐增多。然而，女性使用坦索罗辛的安全性数据有限，缺乏系统性研究。本研究旨在基于美国FDA不良事件报告系统（FAERS）数据库，分析女性患者使用坦索罗辛的不良事件特征，识别潜在风险信号。方法 提取FAERS数据库中2003年4季度~2024年3季度共84个季度所有女性患者使用坦索罗辛的数据，采用报告比值比（ROR）法和比例报告比法（PRR）对ADE报告进行信号检测，采用《国际医学用语词典》（MedDRA）对已筛选出的ADE名称进行首选术语（Preferred terms，PT）标准化，并使用器官系统分类（system organ class，SOC）将ADE归类至不同系统。结果 共纳入511份女性患者的不良事件报告，筛选后得到74个阳性信号，涉及系统器官分类SOC 19个。报告数量前5位的SOC为精神病类、各类神经系统疾病、各类损伤、中毒及操作并发症、眼器官疾病、各类检查；发生频次前五的PT主要为超说明书使用、头晕、低血压、妊娠过程中暴露、产品用于未经批准的适应症；发生强度排名前5位的PT为残余尿量增加、中枢神经系统刺激、红细胞减少症、心身耗竭综合征、虹膜疾病。结论 本研究首次系统揭示了女性患者使用坦索罗辛的不良事件特征，研究结果为女性患者的用药安全提供了重要参考，提示临床医生在超说明书用药时应谨慎评估风险，并加强监测。

Abstract:

Objective Tamsulosin is primarily used to treat dysuria caused by benign prostatic hyperplasia in men, but its off-label use in female patients has been gradually increasing. However, safety data on the use of tamsulosin in women are limited, and systematic research is lacking. This study aims to analyze the characteristics of adverse events (AEs) associated with tamsulosin use in female patients based on the FDA Adverse Event Reporting System (FAERS) database and to identify potential risk signals.?Methods Data on female patients using PDE-5 inhibitors from the 4th quarter of 2003 to the 3rd quarter of 2024 (84 quarters in total) were extracted from the FAERS database. The reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods were used for signal detection of adverse drug event (ADE) reports. The Medical Dictionary for Regulatory Activities (MedDRA) was used to standardize the preferred terms (PTs) of the screened ADEs, and the system organ class (SOC) was used to categorize ADEs into different systems.?Results A total of 511 adverse event reports from female patients were included, and 74 positive signals involving 19 SOCs were identified. The top 5 SOCs by report count were psychiatric disorders, nervous system disorders, injuries, poisonings, and procedural complications, eye disorders, and various investigations. The top 5 PTs by frequency were off-label use, dizziness, hypotension, exposure during pregnancy, and product use for unapproved indications. The top 5 PTs by signal strength were residual urine volume increased, central nervous system stimulation, erythrocytopenia, psychogenic fatigue syndrome, and iris disorders.?Conclusion This study systematically reveals the characteristics of adverse events associated with tamsulosin use in female patients for the first time. The findings provide important insights into the safety of tamsulosin use in women, suggesting that clinicians should carefully assess risks and strengthen monitoring when prescribing off-label use.