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一种含有氨基酸、铁、硒和海洋水解胶原蛋白的口服补充剂在脱发患者(雄激素性脱发、AGA 或 FAGA 或休止期脱发)中的疗效和耐受性。一项前瞻性、随机、3 个月、对照、评估者盲法研究。

Efficacy and tolerability of an oral supplement containing amino acids, iron, selenium, and marine hydrolyzed collagen in subjects with hair loss (androgenetic alopecia, AGA or FAGA or telogen effluvium). A prospective, randomized, 3-month, controlled, assessor-blinded study.

机构信息

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

出版信息

Skin Res Technol. 2023 Jun;29(6):e13381. doi: 10.1111/srt.13381.

DOI:10.1111/srt.13381
PMID:37357646
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10240182/
Abstract

BACKGROUND

Oral supplementation with some amino acids (like methionine, taurine, and cysteine) could be useful in subjects with hair loss conditions such as androgenic alopecia (AGA or FAGA) or telogen effluvium (TE). Hydrolysed collagen (HC) oral supplementation has demonstrated to have beneficial effects on nail and skin health and could improve hair growth. A food supplement in tablet formulation containing hydrolysed fish-origin collagen (300 mg/dose), taurine, cysteine, methionine, iron, and selenium has been recently available. To date no controlled data are available regarding the clinical efficacy of this product as adjuvant to hair loss specific treatments in these clinical conditions.

STUDY AIMS

To evaluate and compare the efficacy and tolerability of an oral supplementation based on HC and amino acids in subjects with hair loss due to AGA/FAGA or chronic TE in combination with drug treatments in comparison with drug treatments alone.

METHODS AND SUBJECTS

In a prospective, 12-week, randomized, assessor-blinded controlled trial 83 subjects (mean age 41 ± 16 years; 26 men and 57 women) were enrolled in the study. Fifty-nine subjects suffered from AGA/FAGA (Hamilton I-VA, Ludwig I-1, II-2) and 24 from chronic TE. Subjects were randomized to oral supplementation (1 tablet day) in combination with the specify drug treatment decided by the investigator according to the type of hair loss (AGA/FAGA or TE) (Group A; N = 48) or to specific drugs treatment only (Group B; N = 35). The main outcome of the trial was the clinical efficacy evaluation using a 7-point global assessment score (GAS) (from +3: Much Improved to -3 Much worsened; with score 0 representing no modification). The GAS score was evaluated using standardized photographs by an investigator unaware of the treatment groups at week 6 and at week 12. A secondary outcome was the evaluation of acceptability of the treatment regimen using a 10-point evaluation score.

RESULTS

Seventy-six participants (91.6%) completed the 12-week study period. The GAS score at week 6 was 0.5 ± 0.2 in group A and 0.0 ± 0.1 in Group B (p < 0.05; Mann-Whitney). At week 12 the GAS score in Group A was statistically significant higher in comparison with Group B (1.67 ± 0.16 and 0.66 ± 0.20, p < 0.001; Mann-Whitney test). A higher percentage of Group A subjects achieved a GAS score of ≥2 in comparison with group B (50% vs. 23%). The oral supplement was generally well tolerated.

CONCLUSION

An oral supplement containing hydrolysed fish-origin collagen, taurine, cysteine, methionine, iron, and selenium has demonstrated to improve the clinical efficacy of specific anti-hair loss treatments in subjects with AGA/FAGA or chronic TE.

摘要

背景

口服补充某些氨基酸(如蛋氨酸、牛磺酸和半胱氨酸)可能对雄激素性脱发(AGA 或 FAGA)或休止期脱发(TE)等脱发患者有用。口服水解胶原蛋白(HC)补充剂已被证明对指甲和皮肤健康有益,并能改善头发生长。最近有一种含有水解鱼源胶原蛋白(300mg/剂量)、牛磺酸、半胱氨酸、蛋氨酸、铁和硒的片剂配方的膳食补充剂。迄今为止,尚无关于该产品作为这些临床条件下脱发特定治疗辅助治疗的临床疗效的对照数据。

研究目的

评估和比较基于 HC 和氨基酸的口服补充剂在 AGA/FAGA 或慢性 TE 脱发患者中与单独药物治疗相比联合药物治疗的疗效和耐受性。

方法和受试者

在一项前瞻性、12 周、随机、评估者盲法对照试验中,83 名受试者(平均年龄 41±16 岁;26 名男性和 57 名女性)入组。59 名受试者患有 AGA/FAGA(汉密尔顿 I-VA、路德维希 I-1、II-2),24 名受试者患有慢性 TE。受试者被随机分为口服补充剂(每天 1 片)联合研究者根据脱发类型(AGA/FAGA 或 TE)决定的特定药物治疗(A 组;N=48)或仅特定药物治疗(B 组;N=35)。试验的主要结局是使用 7 分总体评估评分(GAS)(从+3:明显改善到-3:明显恶化;评分 0 表示无改善)评估临床疗效。GAS 评分在第 6 周和第 12 周由一名不了解治疗组的研究员使用标准化照片进行评估。次要结局是使用 10 分评估评分评估治疗方案的可接受性。

结果

76 名参与者(91.6%)完成了 12 周的研究。A 组第 6 周的 GAS 评分为 0.5±0.2,B 组为 0.0±0.1(p<0.05;Mann-Whitney)。第 12 周时,A 组的 GAS 评分明显高于 B 组(1.67±0.16 和 0.66±0.20,p<0.001;Mann-Whitney 检验)。与 B 组相比,A 组有更高比例的受试者获得了 GAS 评分≥2(50%对 23%)。口服补充剂通常具有良好的耐受性。

结论

含有水解鱼源胶原蛋白、牛磺酸、半胱氨酸、蛋氨酸、铁和硒的口服补充剂已被证明可提高 AGA/FAGA 或慢性 TE 患者特定抗脱发治疗的临床疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/725a/10240182/c5d4943b880f/SRT-29-e13381-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/725a/10240182/38d6910c7ce4/SRT-29-e13381-g003.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/725a/10240182/c5d4943b880f/SRT-29-e13381-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/725a/10240182/38d6910c7ce4/SRT-29-e13381-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/725a/10240182/68897c191006/SRT-29-e13381-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/725a/10240182/e2e83caa9be5/SRT-29-e13381-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/725a/10240182/3a3c70ea619f/SRT-29-e13381-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/725a/10240182/c5d4943b880f/SRT-29-e13381-g002.jpg

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