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多中心研究:含0.1%阿达帕林和2.5%过氧化苯甲酰的固定剂量复方凝胶(Epiduo®)治疗巴西人群寻常痤疮的有效性和安全性评估

Multicenter study for efficacy and safety evaluation of a fixeddose combination gel with adapalen 0.1% and benzoyl peroxide 2.5% (Epiduo® for the treatment of acne vulgaris in Brazilian population.

作者信息

Sittart José Alexandre de Souza, Costa Adilson da, Mulinari-Brenner Fabiane, Follador Ivonise, Azulay-Abulafia Luna, Castro Lia Cândida Miranda de

机构信息

Hospital do Servidor Público Estadual de São Paulo, São Paulo, SP, Brazil.

Pontifícia Universidade Católica de Campinas, Campinas, SP, Brazil.

出版信息

An Bras Dermatol. 2015 Dec;90(6 Suppl 1):1-16. doi: 10.1590/abd1806-4841.20153969.

DOI:10.1590/abd1806-4841.20153969
PMID:27168522
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4840853/
Abstract

BACKGROUND

The current options for the treatment of acne vulgaris present many mechanisms of action. For several times, dermatologists try topical agents combinations, looking for better results.

OBJECTIVES

To evaluate the efficacy, tolerability and safety of a topical, fixed-dose combination of adapalene 0.1% and benzoyl peroxide 2.5% gel for the treatment of acne vulgaris in the Brazilian population.

METHODS

This is a multicenter, open-label and interventionist study. Patients applied 1.0 g of the fixed-dose combination of adapalene 0.1% and benzoyl peroxide 2.5% gel on the face, once daily at bedtime, during 12 weeks. Lesions were counted in all of the appointments, and the degree of acne severity, overall improvement, tolerability and safety were evaluated in each visit.

RESULTS

From 79 recruited patients, 73 concluded the study. There was significant, fast and progressive reduction of non-inflammatory, inflammatory and total number of lesions. At the end of the study, 75.3% of patients had a reduction of >50% in non-inflammatory lesions, 69.9% in inflammatory lesions and 78.1% in total number of lesions. Of the 73 patients, 71.2% had good to excellent response and 87.6% had satisfactory to good response. In the first week of treatment, erythema, burning, scaling and dryness of the skin were frequent complaints, but, from second week on, these signals and symptoms have reduced.

CONCLUSION

The fixed-dose combination of adapalene 0.1% and benzoyl peroxide 2.5% gel is effective, safe, well tolerated and apparently improves patient compliance with the treatment.

摘要

背景

寻常痤疮目前的治疗选择有多种作用机制。皮肤科医生多次尝试局部用药联合方案,以期获得更好疗效。

目的

评估含0.1%阿达帕林和2.5%过氧化苯甲酰的局部固定剂量复方凝胶治疗巴西人群寻常痤疮的疗效、耐受性和安全性。

方法

这是一项多中心、开放标签的干预性研究。患者于睡前每日一次在面部涂抹1.0 g含0.1%阿达帕林和2.5%过氧化苯甲酰的固定剂量复方凝胶,持续12周。在每次就诊时对皮损进行计数,并评估痤疮严重程度、总体改善情况、耐受性和安全性。

结果

79名招募患者中,73名完成研究。非炎性、炎性和皮损总数均有显著、快速且持续的减少。研究结束时,75.3%的患者非炎性皮损减少>50%,炎性皮损减少69.9%,皮损总数减少78.1%。73名患者中,71.2%有良好至极佳反应,87.6%有满意至良好反应。治疗第一周,皮肤红斑、烧灼感、脱屑和干燥是常见主诉,但从第二周起,这些体征和症状有所减轻。

结论

含0.1%阿达帕林和2.5%过氧化苯甲酰的固定剂量复方凝胶有效、安全、耐受性良好,且明显提高了患者的治疗依从性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/4d037c83876b/abd-90-06-s1-0001-g11.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/88782979499b/abd-90-06-s1-0001-g01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/a467a94d0c70/abd-90-06-s1-0001-g02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/7e00021fd949/abd-90-06-s1-0001-g03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/1587cd8885e9/abd-90-06-s1-0001-g04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/285f29ed9213/abd-90-06-s1-0001-g05.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/a21d3f53cdc6/abd-90-06-s1-0001-g06.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/233f9e255970/abd-90-06-s1-0001-g07.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/45c89ca19247/abd-90-06-s1-0001-g08.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/df4cf2ff94d7/abd-90-06-s1-0001-g09.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/3925e03b0c50/abd-90-06-s1-0001-g10.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/4d037c83876b/abd-90-06-s1-0001-g11.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/88782979499b/abd-90-06-s1-0001-g01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/a467a94d0c70/abd-90-06-s1-0001-g02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/7e00021fd949/abd-90-06-s1-0001-g03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/1587cd8885e9/abd-90-06-s1-0001-g04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/285f29ed9213/abd-90-06-s1-0001-g05.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/a21d3f53cdc6/abd-90-06-s1-0001-g06.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/233f9e255970/abd-90-06-s1-0001-g07.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/45c89ca19247/abd-90-06-s1-0001-g08.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/df4cf2ff94d7/abd-90-06-s1-0001-g09.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/3925e03b0c50/abd-90-06-s1-0001-g10.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8303/4840853/4d037c83876b/abd-90-06-s1-0001-g11.jpg

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Fixed-Combination Gels of Adapalene and Benzoyl Peroxide Provide Optimal Percutaneous Absorption Compared to Monad Formulations of These Compounds: Results from Two In Vitro Studies.与这些化合物的单一制剂相比,阿达帕林和过氧化苯甲酰的固定组合凝胶具有最佳的经皮吸收:两项体外研究的结果。
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