Zhang Hao, Ou Hongqi, Zhao Panli, Luo Xi, Zhang Ping, Huang Hua
Department of Pharmacy, Chengdu Seventh People's Hospital (Affiliated Cancer Hospital of Chengdu Medical College), Chengdu, China.
Front Neurol. 2025 Jun 13;16:1616851. doi: 10.3389/fneur.2025.1616851. eCollection 2025.
Postmarketing pharmacovigilance data have raised concerns regarding the potential cognitive effects associated with finasteride administration. However, existing epidemiological evidence remains inconclusive, with studies reporting both positive and null associations between finasteride exposure and memory dysfunction. This highlights the need for further comprehensive clinical investigations.
This investigation employed a comprehensive, multi-source analytical approach to evaluate the potential correlation between finasteride administration and self-reported memory dysfunction, aiming to establish an evidence-based framework for clinical safety evaluation and therapeutic risk-benefit analysis.
This study incorporated two principal data repositories: the National Health and Nutrition Examination Survey (NHANES, 2001-2018) and the Food and Drug Administration Adverse Event Reporting System (FAERS, 2004-2018). A comprehensive analytical framework was implemented, incorporating descriptive statistics, multivariable logistic regression modeling, and receiver operating characteristic (ROC) curve analysis to examine potential associations between finasteride exposure and cognitive performance metrics.
Multivariable logistic regression analysis of the NHANES dataset, adjusted for demographic variables and lifestyle factors, revealed a significant positive correlation between finasteride exposure and memory impairment risk (adjusted OR = 6.15, 95% CI: 1.62-23.4, = 0.008). Concurrent analysis of the FAERS database identified 6,624 finasteride-related adverse reports, with cognitive dysfunction ( = 526) comprising a notable proportion of documented complications.
Convergent evidence from both epidemiological studies and pharmacovigilance surveillance suggests a potential association between finasteride administration and cognitive dysfunction, particularly in memory-related domains. These findings underscore the need for comprehensive risk communication strategies regarding potential neurocognitive adverse effects during clinical consultations and for establishing routine cognitive monitoring protocols for patients undergoing prolonged finasteride therapy.
上市后药物警戒数据引发了人们对非那雄胺给药相关潜在认知影响的担忧。然而，现有的流行病学证据仍无定论，一些研究报告了非那雄胺暴露与记忆功能障碍之间的正相关和无关联。这凸显了进一步进行全面临床研究的必要性。
本研究采用全面的多源分析方法，评估非那雄胺给药与自我报告的记忆功能障碍之间的潜在相关性，旨在建立一个基于证据的临床安全性评估和治疗风险效益分析框架。
本研究纳入了两个主要数据存储库：国家健康与营养检查调查（NHANES，2001 - 2018年）和美国食品药品监督管理局不良事件报告系统（FAERS，2004 - 2018年）。实施了一个全面的分析框架，包括描述性统计、多变量逻辑回归建模和受试者工作特征（ROC）曲线分析，以检查非那雄胺暴露与认知表现指标之间的潜在关联。
对NHANES数据集进行多变量逻辑回归分析，并对人口统计学变量和生活方式因素进行调整后，发现非那雄胺暴露与记忆损害风险之间存在显著正相关（调整后的OR = 6.15，95% CI：1.62 - 23.4，P = 0.008）。对FAERS数据库的同期分析确定了6624份与非那雄胺相关的不良报告，其中认知功能障碍（n = 526）占记录并发症的相当比例。
流行病学研究和药物警戒监测的一致证据表明，非那雄胺给药与认知功能障碍之间存在潜在关联，特别是在与记忆相关的领域。这些发现强调了在临床咨询期间就潜在的神经认知不良反应制定全面风险沟通策略的必要性，以及为接受长期非那雄胺治疗的患者建立常规认知监测方案的必要性。
