Objective: Carpal tunnel syndrome (CTS) is a prevalent compression neuropathy with multiple well-documented mechanical and systemic risk factors. However, the role of pharmacological agents in the development of CTS remains underexplored. This study aims to identify drugs disproportionately associated with CTS reports using data from the Food and Drug Administration Adverse Event Reporting System (FAERS).

Methods: A retrospective pharmacovigilance analysis was conducted using OpenVigil 2.1 to evaluate adverse event (AE) reports of CTS from the FAERS database from October 2003 to September 2024. Only drugs identified as the primary suspect in at least 10 AE reports were included. Disproportionality analysis, including reporting odds ratios (RORs), was used to assess associations between CTS and specific drugs. Positive signals were validated using Bayesian confidence propagation neural network algorithms, with drugs having ROR ≥10 and significant Bayesian confidence intervals (IC025 > 0) considered strongly associated with CTS.

Results: Of 12,929,504 AEs reported during the study period, 6,837 (0.05%) involved CTS. Female patients comprised 69.5% of CTS cases, with a mean age of 57.0±14.9 years. Ten drugs were found to have significant overreporting of CTS, including idursulfase (ROR=51.2, 95% CI=39.0-67.2), galsulfase (ROR=26.8, 95% CI=17.2-41.7), laronidase (ROR=20.9, 95% CI=14.4-30.3), tesamorelin (ROR=20.7, 95% CI=13.7-31.3), anastrozole (ROR=20.6, 95% CI=17.0-24.9), alendronic acid (ROR=17.1, 95% CI=14.5-20.1), gamma-hydroxybutyric acid (GHB) (ROR=16.3, 95% CI=9.6-27.6), rofecoxib (ROR=16.1, 95% CI=14.3-18.2), alendronate (ROR=12.9, 95% CI=11.0-15.2), and tafamidis (ROR=12.0, 95% CI=9.2-15.7).

Conclusions: Several drugs were disproportionately associated with CTS in the FAERS database, including enzyme replacement therapies (ERTs), aromatase inhibitors, bisphosphonates, growth hormone (GH)-releasing factor analogs, GHB, rofecoxib, and tafamidis. These findings highlight the critical need for increased vigilance and monitoring of new-onset or worsening CTS in high-risk populations prescribed the aforementioned medications. Clinicians should carefully scrutinize pharmacological history when evaluating patients in this context.

Keywords: carpal tunnel syndome; drugs; faers; neuropathy; pharmacovigilance.

Copyright © 2025, Mihalache et al.

目标: 腕管综合症（CTS）是一种常见的压迫性神经病变，具有多个已充分记录的机械和系统性风险因素。然而，药物在CTS的发展中的作用仍然未被充分研究。本研究旨在使用来自美国食品药品监督管理局不良事件报告系统（FAERS）的数据，识别与CTS报告不成比例相关的药物。

方法: 采用回顾性的药物流行病学分析，使用OpenVigil 2.1评估从2003年10月至2024年9月期间FAERS数据库中收录的CTS不良事件（AE）报告。仅包括被确定为至少10份AE报告中的主要怀疑药物。采用包括报告比值比（RORs）在内的不一致性分析，来评估CTS与特定药物之间的关联。使用贝叶斯置信传播神经网络算法验证阳性信号，并将ROR≥10且具有显著贝叶斯置信区间（IC025 > 0）的药物视为强烈相关于CTS。

结果: 在研究期间报告的12,929,504例不良事件中，有6,837例（0.05%）涉及CTS。女性患者占CTS病例的69.5%，平均年龄为57.0±14.9岁。发现10种药物在CTS报告中有显著过量报道，包括依杜硫酸酶 (ROR=51.2, 95% CI=39.0-67.2)，加卢硫酸酶 (ROR=26.8, 95% CI=17.2-41.7)，拉洛尼达酶 (ROR=20.9, 95% CI=14.4-30.3)，特斯莫林 (ROR=20.7, 95% CI=13.7-31.3)，阿那曲唑 (ROR=20.6, 95% CI=17.0-24.9)，阿仑膦酸钠 (ROR=17.1, 95% CI=14.5-20.1)，γ-羟基丁酸盐（GHB） (ROR=16.3, 95% CI=9.6-27.6)，罗非昔布 (ROR=16.1, 95% CI=14.3-18.2)，阿仑膦酸钠 (ROR=12.9, 95% CI=11.0-15.2)，和塔法米迪 (ROR=12.0, 95% CI=9.2-15.7)。

结论: 在FAERS数据库中，几种药物与CTS的不成比例关联包括酶替代疗法（ERTs），芳香化酶抑制剂，双膦酸盐，生长激素（GH）释放因子类似物，GHB，罗非昔布和塔法米迪。这些发现强调了对高风险人群新发或恶化的CTS进行密切监控的迫切需要，并应仔细审查患者的药物使用历史。

关键词: 腕管综合症；药物；FAERS；神经病变；药物流行病学。