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卡泊三醇0.005%与二丙酸倍他米松0.064%固定复方泡沫治疗头皮斑块状银屑病的疗效:一项II期随机临床研究的附加分析

Efficacy of Fixed-combination Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Foam for Scalp Plaque Psoriasis: Additional Analysis of a Phase II, Randomized Clinical Study.

作者信息

Patel Dharm S, Veverka Karen A, Hansen Jes B, Yamauchi Paul S, Alonso-Llamazares Javier, Lebwohl Mark

机构信息

Drs. Patel and Veverka are with LEO Pharma in Madison, New Jersey.

Dr. Hansen is with LEO Pharma in Ballerup, Denmark.

出版信息

J Clin Aesthet Dermatol. 2020 May;13(5):12-18. Epub 2020 May 1.

PMID:32802249
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7380692/
Abstract

There are a variety of treatment options currently available for plaque psoriasis affecting the scalp, yet scalp psoriasis remains one of the most frustrating and difficult-to-manage forms of the disease. We investigated the efficacy of fixed-combination calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam for the treatment of scalp psoriasis. Additional (including ) analysis was conducted on data from a Phase II, randomized, double-blind, multicenter study of Cal/BD foam for the treatment of psoriasis vulgaris (NCT01536938). A total of 302 patients, ages 18 years or older, with psoriasis vulgaris of at least mild severity (scalp involvement of at least 10%) were included; 100, 101, and 101 patients were randomized to once-daily Cal/BD foam, Cal foam, or BD foam, respectively. Assessments included a severity score for lesion redness, scaliness, and plaque thickness, modified Psoriasis Area and Severity Index (mPASI) score, proportion of patients with reduction of 50 percent or greater in total sign score (TSS-50), and proportion of patients with at least a 75-percent reduction in mPASI score (mPASI-75). Patients achieved greater improvements in their scalp psoriasis with Cal/BD foam versus BD or Cal foam alone at Week 4 considering mPASI, mPASI-75, and TSS-50 outcomes. After four weeks of treatment, more patients receiving Cal/BD foam had a severity score for redness, scaliness, and thickness indicating "none" or "mild" versus BD foam or Cal foam alone. Improvements on the scalp appear to be consistent with those on the trunk and limbs. Scalp lesion severity improved considerably and rapidly with a four-week regimen of Cal/BD foam, suggesting that Cal/BD foam is an effective topical treatment option for scalp psoriasis.

摘要

目前有多种治疗方法可用于治疗头皮斑块状银屑病,但头皮银屑病仍然是该疾病中最令人沮丧且最难管理的形式之一。我们研究了固定复方卡泊三醇0.005%加二丙酸倍他米松0.064%(Cal/BD)泡沫剂治疗头皮银屑病的疗效。对一项关于Cal/BD泡沫剂治疗寻常型银屑病的II期随机双盲多中心研究(NCT01536938)的数据进行了额外(包括……)分析。总共纳入了302例年龄在18岁及以上、患有至少轻度严重程度寻常型银屑病(头皮受累至少10%)的患者;100例、101例和101例患者分别被随机分配至每日一次使用Cal/BD泡沫剂、卡泊三醇泡沫剂或二丙酸倍他米松泡沫剂组。评估包括皮损发红、脱屑和斑块厚度的严重程度评分、改良银屑病面积和严重程度指数(mPASI)评分、总体征评分降低50%或更多的患者比例(TSS - 50)以及mPASI评分降低至少75%的患者比例(mPASI - 75)。考虑到mPASI、mPASI - 75和TSS - 50结果,在第4周时,与单独使用BD或Cal泡沫剂相比,使用Cal/BD泡沫剂的患者头皮银屑病有更大改善。治疗四周后,与单独使用BD泡沫剂或Cal泡沫剂相比,更多接受Cal/BD泡沫剂治疗的患者发红、脱屑和厚度的严重程度评分为“无”或“轻度”。头皮上的改善似乎与躯干和四肢的改善一致。使用四周疗程的Cal/BD泡沫剂后,头皮皮损严重程度显著且迅速改善,表明Cal/BD泡沫剂是治疗头皮银屑病的一种有效的局部治疗选择。

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Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO-ABLE study.卡泊三醇倍他米松二丙酸酯气雾剂泡沫剂治疗寻常型银屑病的疗效优于凝胶剂:随机对照PSO-ABLE研究
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Fixed Combination Aerosol Foam Calcipotriene 0.005% (Cal) Plus Betamethasone Dipropionate 0.064% (BD) is More Efficacious than Cal or BD Aerosol Foam Alone for Psoriasis Vulgaris: A Randomized, Double-blind, Multicenter, Three-arm, Phase 2 Study.固定组合气雾剂泡沫,含0.005% 卡泊三醇(Cal)加0.064% 二丙酸倍他米松(BD)治疗寻常型银屑病比单独使用Cal或BD气雾剂泡沫更有效:一项随机、双盲、多中心、三臂、2期研究。
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Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris--a Randomized Phase III Study (PSO-FAST).卡泊三醇倍他米松二丙酸酯气雾剂泡沫治疗寻常型银屑病的疗效和安全性——一项随机III期研究(PSO-FAST)
J Drugs Dermatol. 2015 Dec;14(12):1468-77.
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Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris--A randomized phase II study.卡泊三醇倍他米松二丙酸酯气雾剂泡沫剂与软膏剂治疗寻常型银屑病疗效对比——一项随机II期研究
J Dermatolog Treat. 2016;27(2):120-7. doi: 10.3109/09546634.2015.1083935. Epub 2015 Oct 7.