对严重哮喘患者进行的基于互联网的口服皮质激素递减治疗：实用性随机对照试验
2011/06/17
摘要
背景：对于强的松依赖的哮喘患者，口服激素的剂量应该根据疗效进行调整，以使最小的剂量达到最佳控制，来减少长期激素治疗的副作用。然而，目前口服皮质激素剂量递减的最佳方案尚不清楚。
目的：研究基于互联网的管理工具（包括家庭监测症状、肺功能和呼出气一氧化氮分数FENO）是否有助于口服皮质激素的递减，是否该工具在不影响哮喘控制或哮喘相关生命质量的前提下减少皮质激素用量。
方法：在一项为期6个月的随机前瞻性多中心研究中，来自6个肺科门诊的95名泼尼松依赖性哮喘患者入选，采用2种皮质激素递减方案：传统方案治疗(n=43)及新的基于互联网的监测系统（网络方案）(n=52)。主要结果为强的松累积节省用量哮喘控制和哮喘相关生命质量。次要结果为第一秒用力呼气体积（FEV1）、哮喘恶化、住院和患者对递减方案的满意度。
结果：强的松累积节省剂量中位数为网络组205 mg (25-75th百分位间距为-221～777)，传统组0 mg (-497～282) (p=0.02)。与基线状态相比，泼尼松剂量的变化值在网络组和传统组分别为-4.79 mg/天和+1.59 mg/天(p<0.001)。两组间的哮喘控制、哮喘相关生命质量、FEV1、哮喘恶化和住院及患者对治疗措施的满意度无显著差异。
结论：对于严重哮喘患者，基于互联网的管理工具（包括家庭监测症状、肺功能和FENO）在不影响哮喘控制或哮喘相关生命质量的前提下，在减少总糖皮质激素用量上与传统治疗相比具有优势。该研究的临床试验注册信息见http://www.trialregister.nl (荷兰临床试验注册号1146).
（林江涛 审校）
Thorax. 2011 Apr 7. [Epub ahead of print]
Internet-based tapering of oral corticosteroids in severe asthma: a pragmatic randomised controlled trial.
Hashimoto S, Brinke AT, Roldaan AC, van Veen IH, Möller GM, Sont JK, Weersink EJ, van der Zee JS, Braunstahl GJ, Zwinderman AH, Sterk PJ, Bel EH.
Department of Respiratory Medicine, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
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 (FEV(1)), 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 -4.79mg/day and +1.59mg/day, respectively (p<0.001). Asthma control, asthma-related quality of life, FEV(1), 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).
Thorax. 2011 Apr 7. [Epub ahead of print]
背景：对于强的松依赖的哮喘患者，口服激素的剂量应该根据疗效进行调整，以使最小的剂量达到最佳控制，来减少长期激素治疗的副作用。然而，目前口服皮质激素剂量递减的最佳方案尚不清楚。
目的：研究基于互联网的管理工具（包括家庭监测症状、肺功能和呼出气一氧化氮分数FENO）是否有助于口服皮质激素的递减，是否该工具在不影响哮喘控制或哮喘相关生命质量的前提下减少皮质激素用量。
方法：在一项为期6个月的随机前瞻性多中心研究中，来自6个肺科门诊的95名泼尼松依赖性哮喘患者入选，采用2种皮质激素递减方案：传统方案治疗(n=43)及新的基于互联网的监测系统（网络方案）(n=52)。主要结果为强的松累积节省用量哮喘控制和哮喘相关生命质量。次要结果为第一秒用力呼气体积（FEV1）、哮喘恶化、住院和患者对递减方案的满意度。
结果：强的松累积节省剂量中位数为网络组205 mg (25-75th百分位间距为-221～777)，传统组0 mg (-497～282) (p=0.02)。与基线状态相比，泼尼松剂量的变化值在网络组和传统组分别为-4.79 mg/天和+1.59 mg/天(p<0.001)。两组间的哮喘控制、哮喘相关生命质量、FEV1、哮喘恶化和住院及患者对治疗措施的满意度无显著差异。
结论：对于严重哮喘患者，基于互联网的管理工具（包括家庭监测症状、肺功能和FENO）在不影响哮喘控制或哮喘相关生命质量的前提下，在减少总糖皮质激素用量上与传统治疗相比具有优势。该研究的临床试验注册信息见http://www.trialregister.nl (荷兰临床试验注册号1146).
（林江涛 审校）
Thorax. 2011 Apr 7. [Epub ahead of print]
Internet-based tapering of oral corticosteroids in severe asthma: a pragmatic randomised controlled trial.
Hashimoto S, Brinke AT, Roldaan AC, van Veen IH, Möller GM, Sont JK, Weersink EJ, van der Zee JS, Braunstahl GJ, Zwinderman AH, Sterk PJ, Bel EH.
Department of Respiratory Medicine, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
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 (FEV(1)), 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 -4.79mg/day and +1.59mg/day, respectively (p<0.001). Asthma control, asthma-related quality of life, FEV(1), 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).
Thorax. 2011 Apr 7. [Epub ahead of print]
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