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将熟知的活性成分重新配方应用于寻常性银屑病的局部治疗,可以改善患者的临床疗效。

Reformulations of well-known active ingredients in the topical treatment of psoriasis vulgaris can improve clinical outcomes for patients.

机构信息

Department of Dermatology and Venereology, Aarhus University Hospital, Aarhus, Denmark.

Department of Dermatology, Hospital Universitario de la Princesa, Madrid, Spain.

出版信息

J Eur Acad Dermatol Venereol. 2017 Aug;31(8):1271-1284. doi: 10.1111/jdv.14277. Epub 2017 May 22.

Abstract

Although the majority of patients with psoriasis vulgaris are treated exclusively with topical therapies, research to develop more effective topical therapies that are associated with higher patient satisfaction has lagged behind the development of systemic agents. The aim of this literature review was to determine whether there is documented evidence that applying an innovative approach to improving the formulation of active ingredients commonly used in the topical treatment of psoriasis can have a positive effect on clinical outcomes and patient-reported outcomes (PROs). The Embase and PubMed databases were searched for articles published between 2001 and 2016 that made direct head-to-head comparisons of different formulations of an active pharmaceutical ingredient (API), focusing on clinical outcomes and PROs. In total, 22 publications on APIs or API combinations met the eligibility criteria (19 head-to-head clinical trials, one pooled analysis, one health-economic modelling study and one systematic review). Significant clinical benefit associated with the use of a reformulated API over an older formulation was reported in three trials of clobetasol propionate, one trial of calcipotriol, three trials of betamethasone and five trials/pooled analyses of calcipotriol/calcipotriene + betamethasone dipropionate (Cal/BD) formulations. Significantly improved PROs associated with the use of a reformulated API over an older formulation were reported in three trials of clobetasol propionate, one trial of betamethasone valerate and two trials of Cal/BD formulations. These results demonstrate that the innovative reformulation of APIs used in the treatment of psoriasis can produce therapies that attain significantly improved clinical outcomes and PROs. This suggests that improvement in topical therapy for psoriasis need not only to be achieved by the identification of new targets and the development of new APIs, but that improvement in the vehicle used to deliver existing APIs has the potential to result in significant clinical and patient benefits.

摘要

虽然大多数寻常型银屑病患者仅接受局部治疗,但与提高患者满意度相关的更有效的局部治疗方法的研究进展落后于系统药物的发展。本文献综述旨在确定是否有文献证据表明,采用创新方法改进常用于银屑病局部治疗的活性成分的制剂,可以对临床结局和患者报告结局(PRO)产生积极影响。在 2001 年至 2016 年间,我们在 Embase 和 PubMed 数据库中搜索了直接比较不同活性药物成分(API)制剂的文章,重点关注临床结局和 PRO。共有 22 篇关于 API 或 API 联合制剂的文章符合入选标准(19 项头对头临床试验、1 项汇总分析、1 项健康经济学模型研究和 1 项系统评价)。在 3 项丙酸氯倍他索、1 项卡泊三醇、3 项倍他米松和 5 项卡泊三醇/卡泊三烯+倍他米松二丙酸酯(Cal/BD)制剂的临床试验中,报告了使用改良 API 相对于旧制剂具有显著临床获益。在 3 项丙酸氯倍他索、1 项倍他米松戊酸酯和 2 项 Cal/BD 制剂的临床试验中,报告了使用改良 API 相对于旧制剂具有显著改善的 PRO。这些结果表明,银屑病治疗中 API 的创新性改良配方可以产生显著改善的临床结局和 PRO。这表明,改善银屑病的局部治疗方法不仅需要通过确定新靶点和开发新 API 来实现,而且改善用于输送现有 API 的载体也有可能带来显著的临床和患者获益。

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