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抗抑郁药与性功能障碍:一项关于美国食品药品监督管理局不良事件报告系统的药物警戒-药效学研究

The antidepressants and sexual dysfunction: a pharmacovigilance-pharmacodynamic study of the FDA adverse event reporting system.

作者信息

Cheng Yu, Chen Youjun, Zhao Xue, Mou Fan, Tan Yingting, Wang Wanying, Qian Ruiyi, Xu Qingqing, Yu Shunying

机构信息

Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

出版信息

Expert Opin Drug Saf. 2024 Dec 23:1-11. doi: 10.1080/14740338.2024.2443956.

DOI:10.1080/14740338.2024.2443956
PMID:39693256
Abstract

BACKGROUND

Sexual dysfunction (SD) is a commonly occurring yet often underestimated adverse event associated with the use of antidepressants. This study aimed to analyze the reporting of SD associated with the use of antidepressants in comparison with one another, and to explore potential receptor mechanisms based on the real-world data from the Food and Drug Administration Adverse Event Reporting System (FAERS).

METHODS

Disproportionality analysis was conducted based on FAERS reports (2004 Q1 to 2024 Q2) using reporting odds ratios (ROR) and information components (IC) methods. Spearman correlation analysis was performed to explore the relationship between ROR and the related receptor-binding properties.

RESULTS

In total, 233 significant signals involving 9767 cases were included. The analysis confirmed that the selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors exhibited significant signals, consistent with previous research. Additionally, unexpected signals were detected for vortioxetine (ROR = 13.60), suggesting a potential risk despite its low reported incidence rates of SD. Spearman correlation analysis revealed potential effects for the binding affinities of serotonin transporter, 5-HT1B, and 5-HT2A receptors on reduced sexual desire.

CONCLUSIONS

The present investigation has detected new and unexpected signals of antidepressant-related SDs. Further research is needed to validate and clarify the observed associations.

摘要

背景

性功能障碍(SD)是使用抗抑郁药时常见但常被低估的不良事件。本研究旨在分析与使用抗抑郁药相关的性功能障碍报告之间的相互比较,并基于美国食品药品监督管理局不良事件报告系统(FAERS)的真实世界数据探索潜在的受体机制。

方法

基于FAERS报告(2004年第一季度至2024年第二季度),使用报告比值比(ROR)和信息成分(IC)方法进行不成比例分析。进行Spearman相关性分析以探索ROR与相关受体结合特性之间的关系。

结果

总共纳入了涉及9767例病例的233个显著信号。分析证实,选择性5-羟色胺再摄取抑制剂和5-羟色胺-去甲肾上腺素再摄取抑制剂显示出显著信号,与先前的研究一致。此外,检测到伏硫西汀存在意外信号(ROR = 13.60),表明尽管其性功能障碍报告发病率较低,但仍存在潜在风险。Spearman相关性分析揭示了5-羟色胺转运体、5-HT1B和5-HT2A受体的结合亲和力对性欲降低的潜在影响。

结论

本研究检测到了与抗抑郁药相关的性功能障碍的新的和意外的信号。需要进一步研究来验证和阐明观察到的关联。

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