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外用西替利嗪治疗女性型脱发的疗效:一项随机对照非劣效性试验。

Therapeutic effects of topical cetirizine in the treatment of female pattern hair loss: a randomized controlled noninferiority trial.

作者信息

Alavi Seyed Mohammad Kazem, Layegh Pouran, Vahabi-Amlashi Sadegh, Sabeti Vahideh, Forouzanfar Mehdi, Darchini-Maragheh Emadodin

机构信息

Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.

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

出版信息

Expert Rev Clin Pharmacol. 2023 Jul-Dec;16(10):1009-1015. doi: 10.1080/17512433.2023.2243813. Epub 2023 Aug 8.

DOI:10.1080/17512433.2023.2243813
PMID:37552615
Abstract

BACKGROUND

Female pattern hair loss (FPHL) is the most prevalent form of hair loss in women. It was aimed to evaluate the therapeutic effects of topical cetirizine 1%, versus topical minoxidil 2% in patients with FPHL.

RESEARCH DESIGN AND METHODS

Through a triple-blind randomized clinical trial, 60 women with FPHL were randomly divided into two groups of treatment with topical cetirizine 1% or topical minoxidil 2%. The endpoint was changing in hair loss severity as well as terminal hair density and diameter, according to trichoscopic evaluation. Intention-to-treat analysis was also performed for those who accomplished 3 months of treatment.

RESULTS

Both groups showed improvement in hair diameter and density after 6 months; however, the outcome was significant only in the minoxidil group. According to per-protocol analysis, minoxidil was significantly superior to cetirizine in hair density, but not in hair diameter. According to the hair loss severity scales, FPHL was significantly improved in both the cetirizine and minoxidil groups after 6 months of therapy. The dropout rate due to adverse effects was 10.0% and 6.6% in the cetirizine and minoxidil groups, respectively.

CONCLUSION

Although inferior to topical minoxidil, topical cetirizine can provide favorable therapeutic effects for FPHL, specifically when patient incompatibility with Minoxidil is observed.

TRIAL REGISTRATION

The study is registered in the Iranian Registry of Clinical Trials (IRCT) with the registration code IRCT20200521047536N1.

摘要

背景

女性型脱发(FPHL)是女性中最常见的脱发形式。旨在评估1%西替利嗪局部用药与2%米诺地尔局部用药对FPHL患者的治疗效果。

研究设计与方法

通过一项三盲随机临床试验,将60名FPHL女性随机分为两组,分别用1%西替利嗪局部用药或2%米诺地尔局部用药治疗。根据毛囊镜评估,终点指标为脱发严重程度以及终毛密度和直径的变化。对完成3个月治疗的患者也进行了意向性分析。

结果

6个月后两组的头发直径和密度均有改善;然而,仅米诺地尔组的结果具有统计学意义。根据符合方案分析,米诺地尔在头发密度方面显著优于西替利嗪,但在头发直径方面并非如此。根据脱发严重程度量表,治疗6个月后,西替利嗪组和米诺地尔组的FPHL均有显著改善。西替利嗪组和米诺地尔组因不良反应导致的脱落率分别为10.0%和6.6%。

结论

虽然局部用西替利嗪不如局部用米诺地尔,但它可为FPHL提供良好的治疗效果,特别是在观察到患者对米诺地尔不耐受时。

试验注册

该研究已在伊朗临床试验注册中心(IRCT)注册,注册号为IRCT20200521047536N1。

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