哮喘患儿的监测策略：一项随机对照试验。

Monitoring strategies in children with asthma: a randomised controlled trial.

机构信息

Department of Paediatrics, Division Paediatric Respiratory Medicine, Erasmus University Medical Centre-Sophia Children's Hospital, Rotterdam, the Netherlands.

Department of Paediatrics, Amphia Hospital, Breda, the Netherlands.

出版信息

Thorax. 2015 Jun;70(6):543-50. doi: 10.1136/thoraxjnl-2014-206161. Epub 2015 Mar 30.

DOI:10.1136/thoraxjnl-2014-206161

PMID:25825006

Abstract

BACKGROUND

Asthma guidelines recommend monitoring of asthma control. However, in a substantial proportion of children, asthma is poorly controlled and the best monitoring strategy is not known.

OBJECTIVES

We studied two monitoring strategies for their ability to improve asthma outcomes in comparison with standard care (SC): web-based monthly monitoring with the (Childhood) Asthma Control Test (ACT or C-ACT) and 4-monthly monitoring of FENO.

METHODS

In this randomised controlled, partly blinded, parallel group multicentre trial with a 1-year follow-up, children aged 4-18 with a doctor's diagnosis of asthma treated in seven hospitals were randomised to one of the three groups. In the web group, treatment was adapted according to ACT obtained via a website at 1-month intervals; in the FENO group according to ACT and FENO, and in the SC group according to the ACT at 4-monthly visits. The primary endpoint was the change from baseline in the proportion of symptom-free days (SFD).

RESULTS

Two-hundred and eighty children (mean age 10.4 years, 66% boys) were included; 268 completed the study. Mean changes from baseline in SFD were similar between the groups: -2.1% (web group, n=90), +8.9% (FENO group, n=91) versus 0.15% (SC, n=87), p=0.15 and p=0.78. Daily dose of inhaled corticosteroids (ICS) decreased more in the web-based group compared with both other groups (-200 μg/day, p<0.01), while ACT and SFD remained similar.

CONCLUSIONS

The change from baseline in SFD did not differ between monitoring strategies. With web-based ACT monitoring, ICS could be reduced substantially while control was maintained.

TRIAL REGISTRATION NUMBER

NTR 1995.

摘要

背景

哮喘指南建议监测哮喘控制情况。然而，在相当一部分儿童中，哮喘控制不佳，最佳监测策略尚不清楚。

目的

我们研究了两种监测策略在改善哮喘结局方面的能力，与标准护理（SC）相比：使用（儿童）哮喘控制测试（ACT 或 C-ACT）进行基于网络的每月监测，以及每 4 个月监测 FENO。

方法

在这项为期 1 年的随机对照、部分盲法、平行分组多中心试验中，对 7 家医院治疗的年龄在 4-18 岁、经医生诊断为哮喘的儿童进行随机分组，分为三组。在网络组中，根据通过网站在 1 个月间隔获得的 ACT 来调整治疗；在 FENO 组中，根据 ACT 和 FENO 进行调整，在 SC 组中，根据 ACT 在 4 个月的就诊时进行调整。主要终点是从基线开始，无症状天数（SFD）比例的变化。

结果

共纳入 280 名儿童（平均年龄 10.4 岁，66%为男性）；268 名完成了研究。各组间从基线开始的 SFD 变化相似：-2.1%（网络组，n=90），+8.9%（FENO 组，n=91）与 0.15%（SC 组，n=87）相比，p=0.15 和 p=0.78。与其他两组相比，基于网络的 ACT 监测组中吸入性皮质类固醇（ICS）的日剂量降低更多（-200μg/天，p<0.01），而 ACT 和 SFD 保持相似。