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美国食品药品监督管理局关于非那雄胺与自杀意念的警告:泌尿科医生应了解什么?

US Food and Drug Administration Warning Regarding Finasteride and Suicidal Ideation: What Should Urologists Know?

作者信息

Al Saffar Haidar, Xu Jennifer, O'Brien Jonathan S, Kelly Brian D, Murphy Declan G, Lawrentschuk Nathan

机构信息

Department of Genitourinary Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, Australia.

Urology Department, St. Vincent's Hospital, Fitzroy, Australia.

出版信息

Eur Urol Open Sci. 2023 Apr 29;52:4-6. doi: 10.1016/j.euros.2023.04.009. eCollection 2023 Jun.

DOI:10.1016/j.euros.2023.04.009
PMID:37182121
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10172713/
Abstract

UNLABELLED

Finasteride competitively inhibits 5α-reductase (5-AR) isoenzymes, which blocks dihydrotestosterone (DHT) production, thereby reducing DHT. Finasteride is used in the management of benign prostatic hyperplasia (BPH) and androgenic alopecia. Amid patient reports of suicidal ideation (SI), the Post Finasteride Syndrome advocacy group has petitioned for either a stop to selling of the drug or advertisement of stronger warnings. The US Food and Drug Administration recently added SI to the adverse effects listed for finasteride. Here we provide a brief but comprehensive review of the literature on the psychological side effects of 5-AR inhibitors (5-ARIs) to provide an opinion to help in guiding treating urologists. Most of the current evidence, obtained from the literature on dermatology, suggests that 5-ARI users experience a higher rate of depressive symptoms. However, given the lack of comprehensive randomised studies, the causal link between finasteride and SI remains unclear. Urologists prescribing 5-ARIs should be aware of the recent addition of suicide and SI risk to the list of side effects. A mental health screen should be performed and appropriate resources provided to patients commencing treatment. Furthermore, a review should be arranged with the general practitioner to assess new-onset mental health or SI symptoms.

PATIENT SUMMARY

We provide recommendations for urologists who prescribe finasteride for the treatment of benign prostate enlargement. Urologists should be aware of the recent addition of suicidal ideation to the list of side effects for this drug. Finasteride prescription should be continued; however, we recommend a detailed medical history to screen for prior mental health and personality disorders, with discontinuation of the medication in patients with new onset of depression or suicidal symptoms. Close liaison with the patient's general practitioner is vital for management of depressive or suicidal symptoms.

摘要

未标注

非那雄胺竞争性抑制5α-还原酶(5-AR)同工酶,从而阻断二氢睾酮(DHT)的生成,进而降低DHT水平。非那雄胺用于治疗良性前列腺增生(BPH)和雄激素性脱发。在有患者报告出现自杀意念(SI)后,非那雄胺综合征倡导组织已请求停止该药物的销售或发布更强的警告。美国食品药品监督管理局最近将SI添加到非那雄胺的不良反应列表中。在此,我们对5-AR抑制剂(5-ARIs)心理副作用的文献进行简要而全面的综述,以提供意见帮助指导泌尿外科医生的治疗。目前的大多数证据来自皮肤科文献,表明使用5-ARI的患者出现抑郁症状的几率更高。然而,鉴于缺乏全面的随机研究,非那雄胺与SI之间的因果关系仍不明确。开具5-ARIs的泌尿外科医生应意识到自杀和SI风险最近已被添加到副作用列表中。应进行心理健康筛查,并为开始治疗的患者提供适当的资源。此外,应安排与全科医生会诊,以评估新发的心理健康或SI症状。

患者总结

我们为开具非那雄胺治疗良性前列腺增生的泌尿外科医生提供建议。泌尿外科医生应意识到最近该药物的副作用列表中增加了自杀意念。应继续开具非那雄胺处方;然而,我们建议详细询问病史以筛查既往心理健康和人格障碍情况,对于出现新发抑郁或自杀症状的患者应停药。与患者的全科医生密切联络对于管理抑郁或自杀症状至关重要。

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本文引用的文献

1
Risk of Depression Associated With Finasteride Treatment.与非那雄胺治疗相关的抑郁风险。
J Clin Psychopharmacol. 2021;41(3):304-309. doi: 10.1097/JCP.0000000000001379.
2
Investigation of Suicidality and Psychological Adverse Events in Patients Treated With Finasteride.非那雄胺治疗患者的自杀意念和心理不良事件研究。
JAMA Dermatol. 2021 Jan 1;157(1):35-42. doi: 10.1001/jamadermatol.2020.3385.
3
Finasteride and Suicide: A Postmarketing Case Series.非那雄胺与自杀:上市后病例系列。
Dermatology. 2020;236(6):540-545. doi: 10.1159/000505151. Epub 2020 Jan 14.
4
Association of Suicidality and Depression With 5α-Reductase Inhibitors.自杀倾向及抑郁与5α-还原酶抑制剂的关联
JAMA Intern Med. 2017 May 1;177(5):683-691. doi: 10.1001/jamainternmed.2017.0089.
5
Persistent Sexual Dysfunction and Suicidal Ideation in Young Men Treated with Low-Dose Finasteride: A Pharmacovigilance Study.低剂量非那雄胺治疗的年轻男性中持续性性功能障碍和自杀意念:一项药物警戒研究。
Pharmacotherapy. 2015 Jul;35(7):687-95. doi: 10.1002/phar.1612. Epub 2015 Jul 1.
6
Finasteride reduces the risk of incident clinical benign prostatic hyperplasia.非那雄胺可降低临床良性前列腺增生的发病风险。
Eur Urol. 2012 Aug;62(2):234-41. doi: 10.1016/j.eururo.2012.03.007. Epub 2012 Mar 14.
7
A new look at the 5alpha-reductase inhibitor finasteride.对5α-还原酶抑制剂非那雄胺的新审视。
CNS Drug Rev. 2006 Spring;12(1):53-76. doi: 10.1111/j.1527-3458.2006.00053.x.
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