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基于互联网的严重哮喘口服皮质类固醇减量方案:一项实用随机对照试验。

Internet-based tapering of oral corticosteroids in severe asthma: a pragmatic randomised controlled trial.

机构信息

Department of Respiratory Medicine, Academic Medical Centre, University of Amsterdam, F5-260, Meibergdreef 9, Amsterdam 1105 AZ, The Netherlands.

出版信息

Thorax. 2011 Jun;66(6):514-20. doi: 10.1136/thx.2010.153411. Epub 2011 Apr 7.

DOI:10.1136/thx.2010.153411
PMID:21474498
Abstract

BACKGROUND

In patients with prednisone-dependent asthma the dose of oral corticosteroids should be adjusted to the lowest possible level to reduce long-term adverse effects. However, the optimal strategy for tapering oral corticosteroids is unknown.

OBJECTIVE

To investigate whether an internet-based management tool including home monitoring of symptoms, lung function and fraction of exhaled nitric oxide (FE(NO)) facilitates tapering of oral corticosteroids and leads to reduction of corticosteroid consumption without worsening asthma control or asthma-related quality of life.

METHODS

In a 6-month pragmatic randomised prospective multicentre study, 95 adults with prednisone-dependent asthma from six pulmonary outpatient clinics were allocated to two tapering strategies: according to conventional treatment (n=43) or guided by a novel internet-based monitoring system (internet strategy) (n=52). Primary outcomes were cumulative sparing of prednisone, asthma control and asthma-related quality of life. Secondary outcomes were forced expiratory volume in 1 s (FEV1), exacerbations, hospitalisations and patient's satisfaction with the tapering strategy.

RESULTS

Median cumulative sparing of prednisone was 205 (25-75th percentile -221 to 777) mg in the internet strategy group compared with 0 (-497 to 282) mg in the conventional treatment group (p = 0.02). Changes in prednisone dose (mixed effect regression model) from baseline were -4.79 mg/day and +1.59 mg/day, respectively (p < 0.001). Asthma control, asthma-related quality of life, FEV1, exacerbations, hospitalisations and satisfaction with the strategy were not different between groups.

CONCLUSIONS

An internet-based management tool including home monitoring of symptoms, lung function and FE(NO) in severe asthma is superior to conventional treatment in reducing total corticosteroid consumption without compromising asthma control or asthma-related quality of life. Clinical trial registration number Clinical trial registered with http://www.trialregister.nl (Netherlands Trial Register number 1146).

摘要

背景

在依赖泼尼松治疗的哮喘患者中,应将口服皮质类固醇的剂量调整至最低水平,以减少长期不良反应。然而,皮质类固醇逐渐减量的最佳策略尚不清楚。

目的

研究基于互联网的管理工具(包括症状、肺功能和呼出气一氧化氮分数的家庭监测)是否有助于皮质类固醇逐渐减量,并减少皮质类固醇的使用量,同时不影响哮喘控制或哮喘相关生活质量。

方法

在一项为期 6 个月的实用随机前瞻性多中心研究中,来自 6 个肺门诊的 95 例依赖泼尼松的哮喘成人患者被分配至两种逐渐减量策略:根据常规治疗(n=43)或新型基于互联网的监测系统(互联网策略)(n=52)进行治疗。主要结局是累积泼尼松节省量、哮喘控制和哮喘相关生活质量。次要结局是 1 秒用力呼气容积(FEV1)、加重、住院和患者对逐渐减量策略的满意度。

结果

互联网策略组的累积泼尼松节省量中位数为 205(25-75 分位值为-221 至 777)mg,而常规治疗组为 0(-497 至 282)mg(p=0.02)。从基线开始,泼尼松剂量的变化(混合效应回归模型)分别为-4.79 mg/天和+1.59 mg/天(p<0.001)。两组间哮喘控制、哮喘相关生活质量、FEV1、加重、住院和对策略的满意度无差异。

结论

在严重哮喘中,包括症状、肺功能和呼出气一氧化氮分数家庭监测的基于互联网的管理工具在不影响哮喘控制或哮喘相关生活质量的情况下,降低了总皮质类固醇的使用量。临床试验注册号 临床研究注册于 http://www.trialregister.nl(荷兰临床试验注册中心注册号 1146)。

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