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系统性文献回顾:局部治疗银屑病的长期疗效数据。

Systematic literature review of long-term efficacy data for topical psoriasis treatments.

机构信息

RJW & partners, Filleigh, UK.

Svangren Life Science Consulting, Barseback, Sweden.

出版信息

J Dermatolog Treat. 2022 Jun;33(4):2118-2128. doi: 10.1080/09546634.2021.1925211. Epub 2021 Jun 1.

DOI:10.1080/09546634.2021.1925211
PMID:33945378
Abstract

OBJECTIVE

To identify long-term efficacy evidence that supports use of topical therapies as regular maintenance therapy in the prevention of psoriasis relapse.

METHODS

A systematic literature review identified clinical trials and observational studies that reported efficacy outcomes for topical psoriasis therapies with treatment durations of at least 12 weeks. For therapies with long-term data, the approved treatment schedules in product labels were reviewed.

RESULTS

Forty-six studies with at least 12-week efficacy outcomes were identified. Eight randomized controlled trials and six observational studies or single-arm open-label studies reported efficacy data for >12-week treatment periods. Most studies used treatment regimens that reflect current standard of care of repeated treatment of relapses. The PSO-LONG study is the only identified randomized controlled trial to have compared regular proactive maintenance use of a topical treatment (calcipotriol/betamethasone foam) with reactive management in response to psoriasis relapses.

CONCLUSIONS

Limited high-quality long-term efficacy data are available for topical psoriasis therapies. While some product labels mention clinical experience of up to 12 months, they do not provide specific recommendations on the optimal long-term regimen. Calcipotriol/betamethasone foam is the only treatment for which the approved label allows either reactive treatment of relapse or regular (twice weekly) maintenance use.

摘要

目的

确定支持将局部治疗作为预防银屑病复发的常规维持治疗的长期疗效证据。

方法

系统文献回顾确定了报告至少 12 周治疗时间的局部银屑病治疗疗效结果的临床试验和观察性研究。对于具有长期数据的治疗方法,审查了产品标签中批准的治疗方案。

结果

确定了 46 项具有至少 12 周疗效结果的研究。8 项随机对照试验和 6 项观察性研究或单臂开放标签研究报告了 >12 周治疗期间的疗效数据。大多数研究使用的治疗方案反映了目前针对复发进行重复治疗的标准护理。PSO-LONG 研究是唯一确定的比较局部治疗(卡泊三醇/倍他米松泡沫剂)常规主动维持治疗与银屑病复发时被动治疗的随机对照试验。

结论

局部银屑病治疗的高质量长期疗效数据有限。虽然一些产品标签提到了长达 12 个月的临床经验,但它们并未就最佳长期方案提供具体建议。卡泊三醇/倍他米松泡沫剂是唯一一种允许针对复发进行被动治疗或每周两次进行常规(维持)治疗的治疗方法。

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2
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