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外用克林霉素+过氧化苯甲酰与阿达帕林治疗轻至中度寻常性面部痤疮的随机单盲对照研究

A randomized, single-blind comparison of topical clindamycin + benzoyl peroxide and adapalene in the treatment of mild to moderate facial acne vulgaris.

作者信息

Langner A, Chu A, Goulden V, Ambroziak M

机构信息

Department of Dermatology, il Koszykowa 82a, Warsaw Medical University and Zespol Naukowo Badawczy, Iwolang, Plac Karola I Jozefa 3, Iwonicz Zdroj, Poland.

出版信息

Br J Dermatol. 2008 Jan;158(1):122-9. doi: 10.1111/j.1365-2133.2007.08308.x. Epub 2007 Nov 28.

Abstract

BACKGROUND

Antibiotics are often combined with other agents to provide topical acne treatments that are effective against both inflammatory and noninflammatory lesions and minimize the development of antibiotic resistance. Retinoids and associated treatments also have anti-inflammatory activity and decrease microcomedo formation. To date, few direct comparisons of these different acne treatments have been conducted.

OBJECTIVES

To compare the clinical effectiveness of two treatments for facial acne: a ready-mixed once-daily gel containing clindamycin phosphate 10 mg mL(-1) + benzoyl peroxide 50 mg mL(-1) (CDP + BPO; Duac; Stiefel, High Wycombe, U.K.) and a once-daily gel containing adapalene 0.1% (ADA; Differin; Galderma, Watford, U.K.).

METHODS

In this assessor-blind, randomized study; 65 patients were treated with CDP + BPO once daily and 65 patients with ADA once daily. The treatment period was 12 weeks and lesion counts, acne grade and global improvement were assessed at weeks 1, 2, 4, 8 and 12.

RESULTS

CDP + BPO showed an earlier onset of action with a faster significant reduction in inflammatory and total lesion counts than ADA. A between-group comparison of the percentage change from baseline showed that CDP + BPO was statistically significantly superior to ADA from week 1 onwards both for inflammatory lesions (P < or = 0.001) and for total lesions (P < or = 0.004). While 76% of inflammatory lesions remained at week 2 for patients using ADA, in contrast, only 55% of inflammatory lesions remained at week 2 in the CDP + BPO group, resulting in a treatment effect of 1.38. Thus CDP + BPO removed 38% more inflammatory lesions than ADA at this timepoint. The trend in favour of CDP + BPO, although less marked, continued to the end of the study. CDP + BPO was better tolerated than ADA, with a greater proportion of ADA-treated patients experiencing treatment-related adverse events. Adjunctive topical or oral agents and their impact on acne were not studied in this trial. Due to product differences, this study could not be double blinded but was only single (assessor) blinded.

CONCLUSIONS

CDP + BPO and ADA are both effective treatments for acne, but CDP + BPO has a significantly earlier onset of action, is significantly more effective against inflamed and total lesions and is better tolerated, which should improve patient compliance.

摘要

背景

抗生素常与其他药物联合使用,以提供对炎性和非炎性皮损均有效的局部痤疮治疗方案,并尽量减少抗生素耐药性的产生。维甲酸类药物及相关治疗也具有抗炎活性,并可减少微粉刺的形成。迄今为止,很少有人对这些不同的痤疮治疗方法进行直接比较。

目的

比较两种面部痤疮治疗方法的临床疗效:一种是预混的每日一次凝胶,含10 mg/mL磷酸克林霉素+50 mg/mL过氧化苯甲酰(CDP+BPO;达芙文凝胶;施泰福公司,英国海威科姆),另一种是含0.1%阿达帕林的每日一次凝胶(ADA; Differin;高德美公司,英国沃特福德)。

方法

在这项评估者盲法的随机研究中,65例患者每日一次使用CDP+BPO治疗,65例患者每日一次使用ADA治疗。治疗期为12周,在第1、2、4、8和12周评估皮损计数、痤疮分级和整体改善情况。

结果

与ADA相比,CDP+BPO起效更早,炎性和总皮损计数显著更快降低。从基线变化百分比的组间比较显示,从第1周起,CDP+BPO在炎性皮损(P≤0.001)和总皮损(P≤0.004)方面在统计学上均显著优于ADA。使用ADA的患者在第2周时76%的炎性皮损仍然存在,相比之下,CDP+BPO组在第2周时只有55%的炎性皮损仍然存在,治疗效果为1.38。因此,在这个时间点,CDP+BPO比ADA多消除38%的炎性皮损。支持CDP+BPO的趋势虽然不太明显,但一直持续到研究结束。CDP+BPO的耐受性优于ADA,使用ADA治疗的患者中出现治疗相关不良事件的比例更高。本试验未研究辅助性局部或口服药物及其对痤疮的影响。由于产品差异,本研究无法进行双盲,而只是单(评估者)盲法。

结论

CDP+BPO和ADA都是治疗痤疮的有效方法,但CDP+BPO起效明显更早,对炎性和总皮损的疗效显著更高,耐受性更好,这应该会提高患者的依从性。

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