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除氟西汀外的选择性5-羟色胺再摄取抑制剂(SSRI)所致性功能障碍女性患者药物假期的安全性和有效性:一项开放标签随机临床试验

Safety and Efficacy of Drug Holidays for Women with Sexual Dysfunction Induced by Selective Serotonin Reuptake Inhibitors (SSRIs) Other than Fluoxetine: An Open-Label Randomized Clinical Trial.

作者信息

Lalegani Elham, Eissazade Negin, Shalbafan Mohammadreza, Salehian Razieh, Shariat Seyed Vahid, Askari Sanaz, Orsolini Laura, Soraya Shiva

机构信息

Mental Health Research Center, Psychosocial Health Research Institute (PHRI), Department of Psychiatry, School of Medicine, Iran University of Medical Sciences, Tehran 14496-14535, Iran.

Student Research Committee, School of Medicine, Iran University of Medical Sciences, Tehran 14496-14535, Iran.

出版信息

Brain Sci. 2023 Sep 30;13(10):1397. doi: 10.3390/brainsci13101397.

Abstract

Selective serotonin reuptake inhibitors (SSRIs) are the cornerstone of psychopharmacology. However, they cause side effects such as sexual dysfunction, leading to the discontinuation of treatment. We aimed to investigate the efficacy and safety of drug holidays for women experiencing sexual dysfunction Induced by SSRIs other than fluoxetine. This study was an 8-week randomized, open-label, controlled trial including married women aged between 18 and 50 years who had experienced sexual dysfunction while undergoing treatment with SSRIs. The intervention group implemented drug holidays by not taking medications on Thursdays and Fridays, while the control group continued regular medication use. The female sexual function index (FSFI) and the 28-question general health questionnaire (GHQ-28) were administered to assess sexual function and mental health, respectively. A total of 50 participants completed the trial. The drug holidays' group showed significant improvements in arousal ( < 0.001), desire ( = 0.001), orgasm ( < 0.001), satisfaction ( < 0.001), lubrication ( = 0.021), and overall sexual health ( < 0.001). The between-group difference of pain was significant ( < 0.001), despite no significant within-group change. Mental health improved in both groups, despite no significant between-group difference. No major adverse effects were reported. Drug holidays did not introduce immediate safety concerns or significant adverse effects during the timeframe of eight weeks, suggesting that it may be a safe and effective strategy for managing SSRI-induced sexual dysfunction in women, alongside improving mental health. Further research is needed to reach a definitive conclusion.

摘要

选择性5-羟色胺再摄取抑制剂(SSRIs)是精神药理学的基石。然而,它们会引起性功能障碍等副作用,导致治疗中断。我们旨在研究药物假期对由除氟西汀以外的SSRIs引起性功能障碍的女性的疗效和安全性。本研究是一项为期8周的随机、开放标签、对照试验,纳入年龄在18至50岁之间、在接受SSRIs治疗期间出现性功能障碍的已婚女性。干预组通过在周四和周五不服药来实施药物假期,而对照组继续常规用药。分别采用女性性功能指数(FSFI)和28题一般健康问卷(GHQ - 28)来评估性功能和心理健康。共有50名参与者完成了试验。药物假期组在性唤起(<0.001)、性欲(=0.001)、性高潮(<0.001)、满意度(<0.001)、润滑(=0.021)和总体性健康(<0.001)方面有显著改善。尽管组内疼痛无显著变化,但组间疼痛差异显著(<0.001)。两组的心理健康均有所改善,尽管组间差异不显著。未报告重大不良反应。在8周的时间范围内,药物假期未引发即时安全问题或显著不良反应,这表明它可能是一种安全有效的策略,可用于管理女性SSRIs引起的性功能障碍,同时改善心理健康。需要进一步研究以得出明确结论。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c376/10605929/0ea90d06b01b/brainsci-13-01397-g001.jpg

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