Efficacy of Amorolfine in Onychomycosis Treatment: A Mixed-Effects Models and Multivariate Logistic Regression Analysis.

IF 4.1 2区医学 Q1 DERMATOLOGY Mycoses Pub Date : 2024-09-01 DOI:10.1111/myc.13801

Chichi Du, Mingming Ding, Lin Zhang, Guan Jiang

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Abstract

Background: Onychomycosis (OM) is a common nail infection treated with amorolfine hydrochloride nail lacquer in China. Monitoring drug concentrations and using dermoscopy to evaluate treatment efficacy may provide new insights.

Objective: The study aims to analyse amorolfine concentrations in nails with mild to moderate OM, assess treatment outcomes using dermoscopy and explore factors influencing drug concentrations and efficacy.

Methods: Patients with mild to moderate OM confirmed by fungal microscopy were enrolled. Amorolfine nail lacquer was applied twice weekly for 36 weeks. Monthly nail samples measured amorolfine concentrations using liquid chromatography. Dermoscopy was performed before and after treatment to evaluate responses. Mixed-effects models and logistic regression analysed factors affecting drug concentrations and outcomes.

Results: Ninety-seven nails were included. Amorolfine concentrations increased over time, with higher levels in females, fingernails, 2nd-5th digits and superficial white OM (p < 0.05). Age was a risk factor, while drug concentration and OM type were protective for clinical efficacy (p < 0.05). Peak concentration correlated with clinical (r = 0.487, p = 0.000) and mycological (r = 0.433, p = 0.000) responses. Dermoscopic features improved significantly in successful cases (p < 0.05).

Limitations: In the assessment of fungal efficacy, only fungal microscopy was used, and fungal cultures were not performed. The study was limited by a small sample size and the lack of a longer follow-up to assess relapse.

Conclusion: Amorolfine concentrations vary with patient and nail characteristics, influencing efficacy. Dermoscopy is valuable for monitoring OM treatment.

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阿莫罗芬治疗甲癣的疗效：混合效应模型和多元逻辑回归分析

背景：在中国，甲癣（OM）是使用盐酸阿莫罗芬甲霜治疗的一种常见甲沟炎。监测药物浓度和使用皮肤镜评估疗效可提供新的见解：本研究旨在分析轻度至中度OM患者指甲中的阿莫罗芬浓度，使用皮肤镜评估治疗效果，并探讨影响药物浓度和疗效的因素：入选患者均为经真菌显微镜检查确诊的轻度至中度甲沟炎患者。阿莫罗芬指甲油每周使用两次，持续36周。每月采集指甲样本，使用液相色谱法测量阿莫罗芬的浓度。在治疗前后进行皮肤镜检查以评估反应。混合效应模型和逻辑回归分析了影响药物浓度和结果的因素：结果：共纳入 97 枚指甲。随着时间的推移，阿莫罗芬的浓度会增加，女性、指甲、第 2-5 位手指和浅表白色 OM 中的浓度较高（p 限制）：在评估真菌疗效时，只使用了真菌显微镜，没有进行真菌培养。该研究的局限性在于样本量较小，且缺乏较长时间的随访以评估复发情况：结论：阿莫罗芬的浓度因患者和指甲特征而异，会影响疗效。结论：阿莫罗芬的浓度因患者和指甲特征而异，影响疗效，皮肤镜检查对监测 OM 治疗很有价值。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Mycoses 医学-皮肤病学

CiteScore

10.00

自引率

8.20%

发文量

143

审稿时长

6-12 weeks

期刊介绍： The journal Mycoses provides an international forum for original papers in English on the pathogenesis, diagnosis, therapy, prophylaxis, and epidemiology of fungal infectious diseases in humans as well as on the biology of pathogenic fungi. Medical mycology as part of medical microbiology is advancing rapidly. Effective therapeutic strategies are already available in chemotherapy and are being further developed. Their application requires reliable laboratory diagnostic techniques, which, in turn, result from mycological basic research. Opportunistic mycoses vary greatly in their clinical and pathological symptoms, because the underlying disease of a patient at risk decisively determines their symptomatology and progress. The journal Mycoses is therefore of interest to scientists in fundamental mycological research, mycological laboratory diagnosticians and clinicians interested in fungal infections.