哮喘联盟

   摘要
   背景：在西欧国家大约10%～20%的儿童患有过敏性皮炎(AD)，并常作为过敏综合征的一部分。完整的过敏综合征还包括过敏性哮喘、过敏性鼻炎和食物过敏。过敏性皮炎和哮喘的治疗方法包括使用糖皮质激素进行间断抗炎治疗、健康教育和自主管理训练。然而，部分亚组患者会持续存在过敏症状。一些观察性研究表明高海拔治疗后过敏性皮炎或哮喘儿童和成人的临床症状得到明显改善，但是仍缺乏与海平面治疗的疗效比较证据。
   方法：本研究是对过敏综合征中中重度AD儿童进行的一项实用性随机对照试验。本研究中患者纳入标准为：诊断为过敏综合征中的中重度AD，年龄8～18岁之间，荷兰语流利，在家可以上网，能使用乌特勒支数字湿疹中心的数字患者系统(DECU)，愿意且能够在达沃斯进行为期6周的治疗。所有数据都来自Wilhelmina儿童医院和DECU。患者被随机分为两组。一组在瑞士达沃斯的荷兰哮喘中心进行为期6周的多学科住院治疗。第二组在荷兰乌特勒支的Wilhelmina儿童医院进行6周的多学科门诊治疗。该实验并未设计为单盲实验。该试验包括三个组成部分：社会心理、临床和平移参数。主要结局是应对瘙痒、生活质量和疾病活动。次要结局包括哮喘控制、药物使用、父母的生活质量、儿童的社会和心理健康，平移参数。
   讨论：该研究结果将为高海拔治疗vs海平面治疗中重度AD儿童提供疗效比较证据。
   试验注册：随机对照试验ISRCTN88136485
 

（刘国梁 审校）
Trials. 2014 Mar 26;15(1):94. [Epub ahead of print]

 

Comparing high altitude treatment with current best care in Dutch children with moderate to severe atopic dermatitis (and asthma): study protocol for a pragmatic randomized controlled trial (DAVOS trial).
 

Fieten KB, Zijlstra WT, van Os-Medendorp H, Meijer Y, Venema MU, Rijssenbeek-Nouwens L, L Hoir MP, Bruijnzeel-Koomen CA, Pasmans SG.
 

ABSTRACT
BACKGROUND: About 10 to 20% of children in West European countries have atopic dermatitis (AD), often as part of the atopic syndrome. The full atopic syndrome also consists of allergic asthma, allergic rhinitis and food allergy. Treatment approaches for atopic dermatitis and asthma include intermittent anti-inflammatory therapy with corticosteroids, health education and self-management training. However, symptoms persist in a subgroup of patients. Several observational studies have shown significant improvement in clinical symptoms in children and adults with atopic dermatitis or asthma after treatment at high altitude, but evidence on the efficacy when compared to treatment at sea level is still lacking.
METHODS: This study is a pragmatic randomized controlled trial for children with moderate to severe AD within the atopic syndrome. Patients are eligible for enrolment in the study if they are: diagnosed with moderate to severe AD within the atopic syndrome, aged between 8 and 18 years, fluent in the Dutch language, have internet access at home, able to use the digital patient system Digital Eczema Center Utrecht (DECU), willing and able to stay in Davos for a six week treatment period. All data are collected at the Wilhelmina Children's Hospital and DECU. Patients are randomized over two groups. The first group receives multidisciplinary inpatient treatment during six weeks at the Dutch Asthma Center in Davos, Switzerland. The second group receives multidisciplinary treatment during six weeks at the outpatient clinic of the Wilhelmina Children's Hospital, Utrecht, the Netherlands. The trial is not conducted as a blind trial. The trial is designed with three components: psychosocial, clinical and translational. Primary outcomes are coping with itch, quality of life and disease activity. Secondary outcomes include asthma control, medication use, parental quality of life, social and emotional wellbeing of the child and translational parameters.
DISCUSSION: The results of this trial will provide evidence for the efficacy of high altitude treatment compared to treatment at sea level for children with moderate to severe AD.
TRIAL REGISTRATION: Current Controlled Trials ISRCTN88136485.
 

Trials. 2014 Mar 26;15(1):94. [Epub ahead of print]