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氯倍他索乳膏与卡泊三醇/倍他米松二丙酸酯泡沫剂治疗轻至中度斑块状银屑病疗效的非侵入性临床及微观评估:一项研究者发起的、IV期、单中心、开放、随机临床试验

Non-invasive clinical and microscopic evaluation of the response to treatment with clobetasol cream vs. calcipotriol/betamethasone dipropionate foam in mild to moderate plaque psoriasis: an investigator-initiated, phase IV, unicentric, open, randomized clinical trial.

作者信息

Yélamos O, Alejo B, Ertekin S S, Villa-Crespo L, Zamora-Barquero S, Martinez N, Domínguez M, Iglesias P, Herrero A, Malvehy J, Puig S

机构信息

Dermatology Department, Hospital Clínic, Institut d'Investigacions Biomediques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.

Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Spain.

出版信息

J Eur Acad Dermatol Venereol. 2021 Jan;35(1):143-149. doi: 10.1111/jdv.16559. Epub 2020 Jul 6.

DOI:10.1111/jdv.16559
PMID:32365242
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7818495/
Abstract

BACKGROUND

Treatment response for psoriasis is typically evaluated using clinical scores. However, patients can relapse after clinical clearance, suggesting persistent inflammation. Dermoscopy, reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) can non-invasively improve treatment response assessment.

OBJECTIVES

To compare the clinical and non-invasive microscopic features in a psoriatic target lesion treated with clobetasol cream or calcipotriol/betamethasone dipropionate foam (Cal/BD foam).

METHODS

Prospective, unicentric, open, randomized clinical trial comparing clinical data [total clinical score (TCS)] and microscopic data (dermoscopy, RCM and OCT) in psoriasis patients treated with clobetasol or Cal/BD foam.

RESULTS

We included 36 adult patients (22 men). At week 4, more patients treated with Cal/BD foam achieved TCS ≤1 than with clobetasol (63.2% vs. 18.8%, P = 0.016). Treatment satisfaction was higher with Cal/BD foam (P < 0.03). Microscopically, Cal/BD foam induced more reduction in epidermal thickness at week 4 (P < 0.049). Dilated horizontal blood vessels were more common with clobetasol than with Cal/BD foam at week 8 (69.2% vs. 31.2%, P = 0.159). If epidermal hyperplasia was noted at baseline, the response was poorer with clobetasol (P = 0.029).

LIMITATIONS

Small sample size, open study, imaging sampling bias.

CONCLUSION

Cal/BD foam is more effective than clobetasol, has better patient satisfaction and induces greater reduction in the hyperkeratosis/acanthosis, regardless of baseline epidermal hyperplasia.

摘要

背景

银屑病的治疗反应通常使用临床评分进行评估。然而,患者在临床症状清除后可能会复发,提示存在持续性炎症。皮肤镜检查、反射式共聚焦显微镜(RCM)和光学相干断层扫描(OCT)可无创地改善治疗反应评估。

目的

比较用丙酸氯倍他索乳膏或卡泊三醇/倍他米松二丙酸酯泡沫剂(Cal/BD泡沫剂)治疗的银屑病靶皮损的临床和无创显微镜特征。

方法

一项前瞻性、单中心、开放、随机临床试验,比较用丙酸氯倍他索或Cal/BD泡沫剂治疗的银屑病患者的临床数据[总临床评分(TCS)]和显微镜数据(皮肤镜检查、RCM和OCT)。

结果

我们纳入了36例成年患者(22例男性)。在第4周时,与使用丙酸氯倍他索相比,更多使用Cal/BD泡沫剂治疗的患者TCS≤1(63.2%对18.8%,P = 0.016)。Cal/BD泡沫剂的治疗满意度更高(P < 0.03)。在显微镜下,Cal/BD泡沫剂在第4周时使表皮厚度减少更多(P < 0.049)。在第8周时,扩张的水平血管在使用丙酸氯倍他索的患者中比在使用Cal/BD泡沫剂的患者中更常见(69.2%对31.2%,P = 0.159)。如果在基线时观察到表皮增生,则使用丙酸氯倍他索的反应较差(P = 0.029)。

局限性

样本量小、开放研究、成像采样偏差。

结论

Cal/BD泡沫剂比丙酸氯倍他索更有效,患者满意度更高,并且能更有效地减少角化过度/棘层肥厚,无论基线时表皮是否增生。

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