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一种新型膳食补充剂对雄激素性脱发药物治疗疗效的影响:一项针对225名受试者的真实生活、多中心、随机、评估者盲法试验。

Impact of a Novel Dietary Supplement on Efficacy of Pharmacological Treatments for Androgenic Alopecia: A Real-Life, Multicenter, Randomized, Assessor-Blinded Trial on 225 Subjects.

作者信息

Milani Massimo, Alfano Stefano

机构信息

Medical Department, Cantabria Labs Difa Cooper, Milano, Italy.

出版信息

J Cosmet Dermatol. 2025 Sep;24(9):e70388. doi: 10.1111/jocd.70388.

Abstract

BACKGROUND

Minoxidil and finasteride are currently the only FDA-approved pharmacological treatments for androgenic alopecia (AGA) and female androgenic alopecia (FAGA). However, substantial improvement is observed in no more than 20% of patients in the medium term. To enhance clinical responses, nonpharmacological dietary supplementation is often utilized.

AIMS

This study evaluated the efficacy of a novel dietary supplement, AGA-P, which contains Serenoa repens extract, Cucurbita pepo extract, L-Cystine, and Vitamin C, in a multicenter, randomized, assessor-blinded, real-life trial alongside pharmacological treatments. The objective was to determine whether dietary supplementation could improve the clinical efficacy of minoxidil and finasteride.

PATIENTS AND METHODS

A total of 225 subjects with AGA or FAGA (165 men, mean age 40 ± 14 years, range 18-74) were enrolled after obtaining informed consent. Inclusion criteria included male subjects over 18 years and postmenopausal women with mild to moderate AGA/FAGA, eligible for dietary and/or pharmacological treatment. Of these participants, 106 (24 women and 82 men) were assigned to receive pharmacological treatment plus dietary supplementation (one capsule daily; Group A), while 119 (36 women and 83 men) received drug treatment only (Group B). The pharmacological treatments consisted of topical minoxidil and oral finasteride in most cases. Treatment duration was 6 months.

RESULTS

The results indicated that oral supplementation significantly increased the clinical efficacy of pharmacological treatments for mild-to-severe AGA/FAGA compared to drug treatment alone (great improvement: Group A 36.5% vs. Group B 25%; p = 0.04).

CONCLUSION

Oral supplementation of AGA-P significantly increases the clinical efficacy of pharmacological treatments for mild-to-severe AGA/FAGA (Study Registration: ISRCTN-19671217).

摘要

背景

米诺地尔和非那雄胺是目前美国食品药品监督管理局(FDA)批准的仅有的用于治疗雄激素性脱发(AGA)和女性雄激素性脱发(FAGA)的药物治疗方法。然而,在中期,不超过20%的患者有显著改善。为了提高临床疗效,常采用非药物饮食补充。

目的

本研究在一项多中心、随机、评估者盲法的实际生活试验中,评估了一种新型饮食补充剂AGA-P(含有锯叶棕提取物、西葫芦提取物、L-胱氨酸和维生素C)与药物治疗联合使用的疗效。目的是确定饮食补充是否能提高米诺地尔和非那雄胺的临床疗效。

患者和方法

在获得知情同意后,共招募了225名AGA或FAGA患者(165名男性,平均年龄40±14岁,范围18-74岁)。纳入标准包括18岁以上男性受试者和患有轻度至中度AGA/FAGA的绝经后女性,适合饮食和/或药物治疗。在这些参与者中,106名(24名女性和82名男性)被分配接受药物治疗加饮食补充(每日一粒胶囊;A组),而119名(36名女性和83名男性)仅接受药物治疗(B组)。在大多数情况下,药物治疗包括外用米诺地尔和口服非那雄胺。治疗持续时间为6个月。

结果

结果表明,与单独药物治疗相比,口服补充剂显著提高了对轻度至重度AGA/FAGA的药物治疗的临床疗效(显著改善:A组36.5% vs. B组25%;p = 0.04)。

结论

口服AGA-P显著提高了对轻度至重度AGA/FAGA的药物治疗的临床疗效(研究注册号:ISRCTN-19671217)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea27/12376952/72ed1f76d69d/JOCD-24-e70388-g002.jpg

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