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一项评估含外泌体植物提取物配方治疗男性脱发疗效的随机对照试验(RCT)初步研究

A Pilot Randomized Controlled Trial (RCT) Evaluating the Efficacy of an Exosome-Containing Plant Extract Formulation for Treating Male Alopecia.

作者信息

Amini Farahnaz, Teh Jing Ju, Tan Chung Keat, Tan Eugenie Sin Sing, Ng Edmond Siah Chye

机构信息

Faculty of Medicine (Neurology), University of British Columbia, Vancouver, BC V6T 1Z4, Canada.

School of Healthy Ageing, Aesthetics & Regenerative Medicine, Faculty of Medicine and Health Sciences, UCSI University, Kuala Lumpur 56000, Malaysia.

出版信息

Life (Basel). 2025 Mar 20;15(3):500. doi: 10.3390/life15030500.

DOI:10.3390/life15030500
PMID:40141845
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11943915/
Abstract

: Hair loss affects self-esteem, confidence, and psychological well-being. Exosomes, as molecular carriers of growth factors and active compounds, offer a promising treatment. This study evaluates the efficacy of an exosome formulation containing extracts from two known hair-regenerating plants, and (ECPE), for male pattern alopecia. : A randomized controlled trial included 20 male participants with Norwood grade 2-3 androgenetic alopecia who were randomly assigned into two groups, placebo (0.9% sodium chloride) and ECPE, administered bi-weekly across four sessions. Evaluations included hair density measurements, adverse effect tracking, and self-assessments. : Most participants (55%) were aged 18 to 35, with 75% reporting hair loss for over a year and 80% noting scalp thinning. The hair counts showed no significant change in the placebo group from baseline to week 16 (Wilcoxon signed-rank test: V = 13.5, = 0.163), while a significant increase was observed in the ECPE group (V = 0, = 0.002). Between-group analysis revealed a significant difference in the hair count changes (Wilcoxon rank-sum test: W = 86.5, = 0.006) with a large effect size (Cliff's Delta: & = 0.73, 95% CI: 0.41-0.89), with the ECPE group showing higher median hair growth (9.5, IQR = 16.88) compared to the placebo group (1.5, IQR = 3.00). A Bayesian ANCOVA, adjusted for covariates (the father's scalp hair condition, baseline hair count, and Norwood classification), showed no significant effect of these factors on the outcomes. : These findings suggest that ECPE significantly improves hair regrowth compared to the placebo, with no notable adverse effects.

摘要

脱发会影响自尊、自信和心理健康。外泌体作为生长因子和活性化合物的分子载体,提供了一种有前景的治疗方法。本研究评估了一种含有两种已知促进头发生长植物提取物的外泌体制剂(ECPE)对男性型脱发的疗效。

一项随机对照试验纳入了20名患有诺伍德2 - 3级雄激素性脱发的男性参与者,他们被随机分为两组,安慰剂组(0.9%氯化钠)和ECPE组,每两周给药一次,共四个疗程。评估包括头发密度测量、不良反应跟踪和自我评估。

大多数参与者(55%)年龄在18至35岁之间,75%的人报告脱发超过一年,80%的人注意到头皮变薄。头发计数显示,安慰剂组从基线到第16周没有显著变化(威尔科克森符号秩检验:V = 13.5,P = 0.163),而ECPE组观察到显著增加(V = 0,P = 0.002)。组间分析显示,头发计数变化存在显著差异(威尔科克森秩和检验:W = 86.5,P = 0.006),效应量较大(克利夫德尔塔:δ = 0.73,95%置信区间:0.41 - 0.89),与安慰剂组(中位数为1.5,四分位距 = 3.00)相比,ECPE组显示出更高的中位头发生长(9.5,四分位距 = 16.88)。一项针对协变量(父亲的头皮头发状况、基线头发计数和诺伍德分类)进行调整的贝叶斯协方差分析显示,这些因素对结果没有显著影响。

这些发现表明,与安慰剂相比,ECPE能显著改善头发生长,且无明显不良反应。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8fe2/11943915/2f5e202b1999/life-15-00500-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8fe2/11943915/f32f0a03cbe4/life-15-00500-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8fe2/11943915/acbf97161f85/life-15-00500-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8fe2/11943915/2f5e202b1999/life-15-00500-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8fe2/11943915/f32f0a03cbe4/life-15-00500-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8fe2/11943915/acbf97161f85/life-15-00500-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8fe2/11943915/2f5e202b1999/life-15-00500-g003.jpg

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本文引用的文献

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Exosomes derived from uMSCs promote hair regrowth in alopecia areata through accelerating human hair follicular keratinocyte proliferation and migration.人骨髓间充质干细胞来源的外泌体通过加速人毛囊角质形成细胞增殖和迁移促进斑秃毛发生长。
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脂肪来源干细胞条件培养基联合米诺地尔治疗男性雄激素性脱发的随机、双盲临床试验。
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