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0.05%丙酸氯倍他索洗发水与0.005%卡泊三醇溶液:头皮银屑病患者疗效与安全性的随机对照研究

Clobetasol propionate shampoo 0.05% and calcipotriol solution 0.005%: a randomized comparison of efficacy and safety in subjects with scalp psoriasis.

作者信息

Reygagne P, Mrowietz U, Decroix J, de Waard-van der Spek F B, Acebes L Olmos, Figueiredo A, Caputo R, Poncet M, Arsonnaud S

机构信息

Centre Sabouraud, Paris, France.

出版信息

J Dermatolog Treat. 2005 Feb;16(1):31-6. doi: 10.1080/09546630410024853.

Abstract

BACKGROUND

Scalp involvement in psoriatic patients represents a common issue. Treatment of the hairy skin requires adequate pharmaceutical formulations; hence, a new specific shampoo formulation of clobetasol propionate 0.05% was developed by Galderma R&D, Inc.

METHODS

For this multicenter, randomized, investigator-masked, parallel group study, 151 subjects with moderate to severe scalp psoriasis were randomized to 4 weeks of treatment with clobetasol propionate shampoo or calcipotriol solution.

RESULTS

Clobetasol propionate demonstrated significantly superior efficacy to calcipotriol solution (total severity score: mean difference 0.51, 95% CI 0.05-0.97, p = 0.028; global severity score: mean difference 0.43, 95% CI 0.08-0.78, p = 0.016). Adverse events were more common in the calcipotriol group than in the clobetasol propionate shampoo group. Telangiectasia and skin atrophy did not differ significantly between treatments; however, a burning sensation was significantly more common in the calcipotriol solution group.

CONCLUSIONS

Short contact therapy of scalp psoriasis with this new shampoo formulation of clobetasol propionate was significantly more effective and better tolerated than calcipotriol solution for the treatment of scalp psoriasis.

摘要

背景

银屑病患者头皮受累是一个常见问题。治疗多毛皮肤需要合适的药物制剂;因此,高德美研发公司开发了一种新的0.05%丙酸氯倍他索专用洗发水配方。

方法

在这项多中心、随机、研究者设盲、平行组研究中,151例中度至重度头皮银屑病患者被随机分为两组,分别接受4周的丙酸氯倍他索洗发水或卡泊三醇溶液治疗。

结果

丙酸氯倍他索的疗效显著优于卡泊三醇溶液(总严重程度评分:平均差值0.51,95%可信区间0.05 - 0.97,p = 0.028;整体严重程度评分:平均差值0.43,95%可信区间0.08 - 0.78,p = 0.016)。卡泊三醇组的不良事件比丙酸氯倍他索洗发水组更常见。两种治疗方法在毛细血管扩张和皮肤萎缩方面无显著差异;然而,卡泊三醇溶液组的烧灼感明显更常见。

结论

对于头皮银屑病的治疗,使用这种新的丙酸氯倍他索洗发水配方进行短程接触疗法比卡泊三醇溶液更有效且耐受性更好。

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