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温控层流(TLA)设备治疗儿童严重特应性皮炎:开放标签、概念验证研究。

Temperature-controlled laminar airflow (TLA) device in the treatment of children with severe atopic eczema: Open-label, proof-of-concept study.

机构信息

Section of Paediatrics, Department of Medicine, Imperial College, London, UK.

Department of Paediatric Allergy, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK.

出版信息

Clin Exp Allergy. 2018 May;48(5):594-603. doi: 10.1111/cea.13105. Epub 2018 Mar 13.

DOI:10.1111/cea.13105
PMID:29383776
Abstract

BACKGROUND

Children with severe, persistent atopic eczema (AE) have limited treatment options, often requiring systemic immunosuppression.

OBJECTIVE

To evaluate the effect of the temperature-controlled laminar airflow (TLA) treatment in children/adolescents with severe AE.

METHODS

We recruited 15 children aged 2-16 years with long-standing, severe AE and sensitization to ≥1 perennial inhalant allergen. Run-in period of 6-10 weeks (3 visits) was followed by 12-month treatment with overnight TLA (Airsonett , Sweden). The primary outcome was eczema severity (SCORAD-Index and Investigator Global Assessment-IGA). Secondary outcomes included child/family dermatology quality of life and family impact questionnaires (CDQLI, FDQLI, DFI), patient-oriented eczema measure (POEM), medication requirements and healthcare contacts. The study is registered as ISRCTN65865773.

RESULTS

There was a significant reduction in AE severity ascertained by SCORAD and IGA during the 12-month intervention period (P < .001). SCORAD was reduced from a median of 34.9 [interquartile range 28.75-45.15] at Baseline to 17.2 [12.95-32.3] at the final visit, and IGA improved significantly from 4 [3-4] to 2 [1-3]. We observed a significant improvement in FDQLI (16.0 [12.25-19.0] to 12 [8-18], P = .023) and DFI (P = .011), but not CDQLI or POEM. Compared to 6-month period prior to enrolment, there was a significant reduction at six months after the start of the intervention in potent topical corticosteroids (P = .033). The exploratory cluster analysis revealed two strongly divergent patterns of response, with 9 patients classified as responders, and 6 as non-responders.

CONCLUSION AND CLINICAL RELEVANCE

Addition of TLA device to standard pharmacological treatment may be an effective add-on to the management of difficult-to-control AE.

摘要

背景

患有严重、持续性特应性皮炎(AE)的儿童选择有限,通常需要全身免疫抑制治疗。

目的

评估温度控制层流(TLA)治疗对患有严重 AE 的儿童/青少年的疗效。

方法

我们招募了 15 名年龄在 2-16 岁之间、患有长期严重 AE 且对≥1 种常年吸入性过敏原过敏的儿童。在进行为期 6-10 周(3 次就诊)的导入期后,他们接受了为期 12 个月的夜间 TLA(Airsonett,瑞典)治疗。主要结局是湿疹严重程度(SCORAD 指数和研究者整体评估-IGA)。次要结局包括儿童/家庭皮肤病生活质量和家庭影响问卷(CDQLI、FDQLI、DFI)、患者导向的湿疹测量(POEM)、药物需求和医疗保健接触。该研究在 ISRCTN65865773 注册。

结果

在 12 个月的干预期间,AE 严重程度通过 SCORAD 和 IGA 显著降低(P < 0.001)。SCORAD 从基线时的中位数 34.9(四分位距 28.75-45.15)降至最后一次就诊时的 17.2(12.95-32.3),IGA 从 4(3-4)显著改善至 2(1-3)。我们观察到 FDQLI(16.0 [12.25-19.0] 至 12 [8-18],P = 0.023)和 DFI(P = 0.011)显著改善,但 CDQLI 和 POEM 没有。与入组前 6 个月相比,在干预开始后 6 个月时,强效外用皮质类固醇的用量显著减少(P = 0.033)。探索性聚类分析显示出两种强烈的反应模式,9 名患者被归类为应答者,6 名患者为无应答者。

结论和临床相关性

在标准药物治疗的基础上增加 TLA 设备可能是治疗难以控制的 AE 的有效辅助手段。

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