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一种新型草药溶液治疗雄激素性脱发的疗效和安全性及其与 5%米诺地尔的比较:一项双盲、随机对照试验研究。

Efficacy and safety of a novel herbal solution for the treatment of androgenetic alopecia and comparison with 5% minoxidil: A double-blind, randomized controlled trial study.

机构信息

Faculty of Pharmacy, Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.

Faculty of Medicine, Department of Dermatology, Tabriz University of Medical Sciences, Tabriz, Iran.

出版信息

Dermatol Ther. 2020 Nov;33(6):e14467. doi: 10.1111/dth.14467. Epub 2020 Nov 5.

Abstract

FDA-approved drugs for the most common type of hair loss, androgenetic alopecia (AGA), present many side effects and disadvantages. However, herbal compounds are characterized by patient compliance, fewer side effects, and several mechanisms of action. The present study set to evaluate the effectiveness and safety of the topical herbal solution and to compare it with 5% minoxidil in men with AGA. A randomized, double-blind controlled trial was conducted from 28 November 2018 to 2 September 2019, in Sina Hospital, Tabriz, Iran. 24 healthy males (mean [SD] age 33.04 [5.81]) with mild to moderate AGA were selected from 44 volunteer participants. Participants were randomly assigned (1:1) into two groups. They received 1 ml of topical solutions at morning and evening intervals for 9 months. Primary outcomes consisted of measured hair diameters at baseline and repeated at weeks 12, 24, and 36. Furthermore, hair density was measured at baseline and week 36. The MTS + THS group was significantly superior to the MTS group after 36 weeks of therapy in the hair diameter improvement. At week 36, the mean hair diameter of the MTS + THS group significantly increased compared to the MTS group (P = .001). Hair density increased in both groups; however, only in the MTS + THS group, it was significant (P < .05). The findings established that the topical herbal solution has significant influence on patients with AGA and improvement of their quality of life. This solution can be considered a significant step towards the prevention and treatment of AGA. clinicaltrials.gov Identifier: NCT03753113.

摘要

美国食品药品监督管理局批准的用于治疗最常见的脱发类型——雄激素性脱发(AGA)的药物存在许多副作用和缺点。然而,草药化合物的特点是患者顺应性好、副作用少,且具有多种作用机制。本研究旨在评估局部草药溶液的有效性和安全性,并将其与 5%米诺地尔在男性 AGA 中的疗效进行比较。一项随机、双盲对照试验于 2018 年 11 月 28 日至 2019 年 9 月 2 日在伊朗大不里士的 Sina 医院进行。从 44 名志愿者中选择了 24 名健康男性(平均[标准差]年龄 33.04[5.81]),他们患有轻度至中度 AGA。参与者随机分为两组(1:1),每天早晚各接受 1 毫升局部溶液治疗,共 9 个月。主要结局包括基线和重复测量的 12、24 和 36 周时的毛发直径。此外,在基线和 36 周时测量了毛发密度。治疗 36 周后,MTS+THS 组在改善毛发直径方面明显优于 MTS 组。在第 36 周时,MTS+THS 组的平均毛发直径明显高于 MTS 组(P=0.001)。两组的毛发密度均增加,但只有 MTS+THS 组的增加有统计学意义(P<0.05)。这些发现表明,局部草药溶液对 AGA 患者有显著影响,并改善了他们的生活质量。这种溶液可以被认为是预防和治疗 AGA 的重要一步。临床试验注册编号:NCT03753113。

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