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离子交换软水器治疗儿童湿疹的多中心随机对照试验:软水湿疹试验(SWET)方案(国际标准随机对照试验编号:71423189)

A multicentre randomized controlled trial of ion-exchange water softeners for the treatment of eczema in children: protocol for the Softened Water Eczema Trial (SWET) (ISRCTN: 71423189).

作者信息

Thomas K S, Sach T H

机构信息

Centre of Evidence Based Dermatology, University of Nottingham, King's Meadow Campus, UK.

出版信息

Br J Dermatol. 2008 Sep;159(3):561-6. doi: 10.1111/j.1365-2133.2008.08704.x. Epub 2008 Jul 4.

DOI:10.1111/j.1365-2133.2008.08704.x
PMID:18616772
Abstract

BACKGROUND

There is epidemiological evidence linking increased water hardness with increased eczema prevalence. A number of plausible mechanisms can be forwarded to suggest why hard water could exacerbate eczema. The most likely explanation is increased soap usage in hard water areas, the deposits of which can cause skin irritation in individuals with eczema.

OBJECTIVES

To assess the cost and cost-effectiveness of ion-exchange water softeners for the treatment of eczema in children.

PATIENTS/METHODS: Three hundred and ten children aged 6 months to 16 years, with moderate to severe eczema. The children must live in hard water areas (>or= 200 mg L(-1) of calcium carbonate) and have a home that is suitable for the installation of a water softener. This is a single-blind, parallel-group, randomized controlled trial of 12 weeks duration followed by a 4-week cross-over period. RESULTS/ANALYSIS PLAN:

PRIMARY OUTCOME

difference in the mean change in disease severity (Six Area, Six Sign Atopic Dermatitis score) at 12 weeks compared with baseline.

SECONDARY OUTCOMES

(i) proportion of time spent moving during the night; (ii) self-reported global changes in eczema severity; (iii) amount of topical treatment used; (iv) Patient Oriented Eczema Measure; (v) number of totally controlled and well controlled weeks; (vi) impact on health-related quality of life for the child (EQ-5D) and the family (Dermatitis Family Impact questionnaire); and (vii) cost-effectiveness. It is planned that recruitment will be completed by the end of 2008 and results will be available towards the end of 2009.

摘要

背景

有流行病学证据表明水硬度增加与湿疹患病率上升有关。可以提出一些合理的机制来解释硬水为何会加重湿疹。最可能的解释是硬水地区肥皂使用量增加,其沉积物会导致湿疹患者皮肤受到刺激。

目的

评估离子交换软水器治疗儿童湿疹的成本及成本效益。

患者/方法:310名年龄在6个月至16岁之间、患有中度至重度湿疹的儿童。这些儿童必须生活在硬水地区(碳酸钙含量≥200毫克/升),且家中适合安装软水器。这是一项为期12周的单盲、平行组随机对照试验,随后有4周的交叉期。结果/分析计划:

主要结局

与基线相比,12周时疾病严重程度的平均变化(六区域、六体征特应性皮炎评分)差异。

次要结局

(i)夜间活动时间比例;(ii)自我报告的湿疹严重程度总体变化;(iii)外用治疗使用量;(iv)患者导向性湿疹测量;(v)完全控制和良好控制的周数;(vi)对儿童健康相关生活质量(EQ - 5D)和家庭(皮炎家庭影响问卷)的影响;以及(vii)成本效益。计划于2008年底完成招募,2009年底得出结果。

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PLoS Med. 2011 Feb 15;8(2):e1000395. doi: 10.1371/journal.pmed.1000395.