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儿童银屑病的非标签治疗:临床经验

Off-Label Treatments for Pediatric Psoriasis: Lessons for the Clinic.

作者信息

Haulrig Morten B, Zachariae Claus, Skov Lone

机构信息

Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, DK-2900, Denmark.

Copenhagen Research Group for Inflammatory Skin (CORGIS), Hellerup, Denmark.

出版信息

Psoriasis (Auckl). 2021 Feb 11;11:1-20. doi: 10.2147/PTT.S268462. eCollection 2021.

Abstract

Psoriasis is a chronic inflammatory skin disease that affects up to 1.2% of children and adolescents. The treatment options for childhood psoriasis are often based on the same principles as in adults. However, most data on safety and efficacy derive from adult studies, and only a few of the frequently used treatments have achieved approval for use in children. The aim of this study was to review the current literature on off-label treatments for psoriasis in children and adolescents. We searched PubMed and identified 50 studies on off-label treatments. Of these, 23 studies were clinical trials (four randomized). There are only a small number of available studies on off-label treatments for children and adolescents with psoriasis, and many of these are retrospective reviews with few participants. Despite the current lack of studies, we still recommend the use of unapproved treatments since we have clinical experience with treatments such as topical corticosteroids, vitamin D analogs, and methotrexate that have shown promising effects. Regular clinical trials are needed to investigate the safety and efficacy of unapproved treatments. Due to The Pediatric Investigation Plans issued by The European Union, new drugs developed by pharmaceutical companies are required to undergo clinical trials in a pediatric population to get their application for marketing authorization processed. This will hopefully lead to much more data on the efficacy and safety of the new treatments, including treatments for children and adolescents with psoriasis.

摘要

银屑病是一种慢性炎症性皮肤病,影响着多达1.2%的儿童和青少年。儿童银屑病的治疗方案通常基于与成人相同的原则。然而,大多数关于安全性和有效性的数据来自成人研究,并且只有少数常用治疗方法已获批用于儿童。本研究的目的是回顾当前关于儿童和青少年银屑病非标签治疗的文献。我们检索了PubMed并确定了50项关于非标签治疗的研究。其中,23项研究为临床试验(4项随机试验)。关于儿童和青少年银屑病非标签治疗的现有研究数量很少,其中许多是回顾性综述,参与者较少。尽管目前缺乏研究,但我们仍推荐使用未经批准的治疗方法,因为我们在局部皮质类固醇、维生素D类似物和甲氨蝶呤等治疗方面有临床经验,这些治疗已显示出有前景的效果。需要进行常规临床试验来研究未经批准治疗方法的安全性和有效性。由于欧盟发布的《儿科研究计划》,制药公司开发的新药需要在儿科人群中进行临床试验,以便其上市许可申请得到处理。这有望带来更多关于新治疗方法有效性和安全性的数据,包括针对儿童和青少年银屑病的治疗方法。

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