抽象的
BackgroundRecent randomised clinical trials in bronchiectasis have failed to reach their primary end-points, suggesting a need to reassess how we measure treatment response. Exacerbations, quality of life (QoL) and lung function are the most common end-points evaluated in bronchiectasis clinical trials. We aimed to determine the relationship between responses in terms of reduced exacerbations, improved symptoms and lung function in bronchiectasis.
方法We evaluated treatment response in three randomised clinical trials that evaluated mucoactive therapy (inhaled mannitol), an oral anti-inflammatory/antibiotic (azithromycin) and an inhaled antibiotic (aztreonam). Treatment response was defined by an absence of exacerbations during follow-up, an improvement of QoL above the minimum clinically important difference and an improvement in forced expiratory volume in 1 s (FEV1)距基线≥100毫升。
结果Cumulatively the three trials included 984 patients. Changes in FEV1, QoL and exacerbations were heterogeneous in all trials analysed. Improvements in QoL were not correlated to changes in FEV1in the azithromycin and aztreonam trials (r= −0.17, p=0.1 and r=0.04, p=0.4, respectively) and weakly correlated in the mannitol trial (r=0.22, p<0.0001). An important placebo effect was observed in all trials, especially regarding improvements in QoL. Clinical meaningful lung function improvements were rare across all trials evaluated, suggesting that FEV1is not a responsive measure in bronchiectasis.
Conclusions肺功能,症状和加剧频率的改善在支气管扩张中分离。FEV1响应良好,与其他关键结果指标的相关性不佳。临床参数对治疗反应的预测很难预测,这表明需要开发生物标志物以识别响应者。
抽象的
对治疗的反应在支气管扩张中是异质的,对不同结果的反应之间没有关系,没有反应的临床预测指标https://bit.ly/3lN6NwL
脚注
作者贡献:所有作者都参与了数据设计,数据分析和数据解释。所有作者都参与了提交之前的书面和修订手稿。
这项研究已注册PROSPEROwith identifier number CRD42018106167.
Conflict of interest: O. Sibila has nothing to disclose.
Conflict of interest: E. Laserna has nothing to disclose.
利益冲突:A。Shoemark没有什么可披露的。
利益冲突:L。Perea无话可说。
利益冲突:D。Bilton无话可说。
利益冲突:M.L。克里顿(Crichton)在提交的工作之外报告了阿斯利康(Astrazeneca)的个人费用。
Conflict of interest: A. De Soyza reports grants, travel support to attend international congresses and lecture fees from AstraZeneca, Bayer, Chiesi, Grifols, GlaxoSmithKline, Insmed, Pfizer, Novartis, Medimmune and Zambon, outside the submitted work.
利益冲突:W.G. Boersma没有什么可披露的。
利益冲突:J。Altenburg没有什么可披露的。
利益冲突:J.D. Chalmers报告了Glaxosmithkline,Grifols,Boehringer Ingelheim和Insmed的赠款和个人费用,Astrazeneca和Bayer Healthcare的赠款,Aradigm,Pfizer,Pfizer和Napp的个人费用,在提交的工作之外。
支持声明:这项研究是由欧洲呼吸社会通过EMBARC2财团资助的。188bet官网地址Embarc2得到了Project Partners Astrazeneca,Chiesi,Grifols,Insmed,Janssen,Novartis和Zambon的支持。J.D. Chalmers得到了GSK/英国肺部呼吸研究主席的支持。本文的资金信息已存入Crossref Funder Registry.
- 已收到June 20, 2019.
- Accepted2021年9月15日。
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