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比卡鲁胺25毫克联合米诺地尔1毫克与米诺地尔1毫克治疗女性型脱发的随机双盲临床试验。

Bicalutamide 25 mg combined with minoxidil 1 mg versus minoxidil 1 mg for female pattern hair loss: A randomized double-blind clinical trial.

作者信息

Libório Ricardo da Silva, Motta Adriana Viana da, Miot Hélio Amante, Müller Ramos Paulo

机构信息

Departamento de Dermatologia, FMB-UNESP, Botucatu, SP, Brazil.

Hospital do Servidor Público Municipal de São Paulo, São Paulo, Brazil.

出版信息

JAAD Int. 2025 Jan 10;19:48-55. doi: 10.1016/j.jdin.2024.12.002. eCollection 2025 Apr.

DOI:10.1016/j.jdin.2024.12.002
PMID:40034971
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11875198/
Abstract

BACKGROUND

Antiandrogenic drugs are often used to treat female pattern hair loss (FPHL) despite limited evidence supporting their use. There is growing interest in bicalutamide for this purpose, but its efficacy in treating FPHL has not been evaluated in clinical trials.

OBJECTIVES

To assess the efficacy of 25 mg/d bicalutamide combined with 1 mg/d minoxidil compared to 1 mg/d minoxidil monotherapy over 24 weeks for FPHL treatment.

METHODS

A randomized, controlled, double-blind clinical trial enrolled 74 participants into 2 groups: bicalutamide 25 mg/d plus minoxidil 1 mg/d or placebo plus minoxidil 1 mg/d for 24 weeks. The primary outcome was the change in total hair density in the target area.

RESULT

Sixty-four (86.5%) participants completed the study (32 per group). There was a mean increase of 18.1 hairs/cm in the bicalutamide-minoxidil group and 21.5 hairs/cm in the minoxidil group ( = .86). According to the global consensus analysis of clinical photographs, there was no difference in clinical improvement between the groups ( = .78).

LIMITATIONS

Single-center study and short follow-up period (24 weeks).

CONCLUSION

Bicalutamide 25 mg/d combined with minoxidil 1 mg/d did not provide additional improvement in FPHL treatment compared to minoxidil alone after 24 weeks.

摘要

背景

尽管支持使用抗雄激素药物治疗女性型脱发(FPHL)的证据有限,但此类药物仍常被用于该疾病的治疗。比卡鲁胺用于此目的的关注度日益增加,但其治疗FPHL的疗效尚未在临床试验中得到评估。

目的

评估每日25毫克比卡鲁胺联合每日1毫克米诺地尔与每日1毫克米诺地尔单药治疗相比,在24周内治疗FPHL的疗效。

方法

一项随机、对照、双盲临床试验将74名参与者分为两组:每日25毫克比卡鲁胺加每日1毫克米诺地尔组或安慰剂加每日1毫克米诺地尔组,为期24周。主要结局指标为目标区域总毛发密度的变化。

结果

64名(86.5%)参与者完成了研究(每组32名)。比卡鲁胺 - 米诺地尔组平均每平方厘米毛发增加18.1根,米诺地尔组平均每平方厘米毛发增加21.5根(P = 0.86)。根据临床照片的全球共识分析,两组间临床改善情况无差异(P = 0.78)。

局限性

单中心研究且随访期短(24周)。

结论

24周后,每日25毫克比卡鲁胺联合每日1毫克米诺地尔与单用米诺地尔相比,在治疗FPHL方面未提供额外改善。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac87/11875198/643c186cb298/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac87/11875198/c87290340024/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac87/11875198/3cad2e0688b3/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac87/11875198/643c186cb298/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac87/11875198/c87290340024/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac87/11875198/3cad2e0688b3/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac87/11875198/643c186cb298/gr3.jpg

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本文引用的文献

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Australas J Dermatol. 2024 Aug;65(5):437-443. doi: 10.1111/ajd.14306. Epub 2024 May 19.
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Bicalutamide and the new perspectives for female pattern hair loss treatment: What dermatologists should know.比卡鲁胺与女性型脱发治疗的新视角:皮肤科医生应该知道的。
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Bicalutamide improves minoxidil-induced hypertrichosis in female pattern hair loss: A retrospective review of 35 patients.比卡鲁胺改善女性型脱发中米诺地尔引起的多毛症:35例患者的回顾性研究
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