使用倍氯米松治疗的哮喘患者手持式与临床肺功能测定之间的关系
2019/05/10
摘要
介绍：患者家中使用手持式肺功能测量计使得纵向收集每日肺功能数据成为可能同时解决临床上肺功能测定的限制问题（测量之间间隔时间长，结果可能受到测试点指导及给定就诊期间哮喘状态的影响）。
目标：确定临床试验期间临床和手持式肺功能仪测量值之间的关系。
方法：对年龄≥12岁的持续哮喘患者进行为期6周的二丙酸倍氯米松与安慰剂的3期回顾性相关性分析研究。在研究期间，在第2周，第4周和第6周通过临床肺功能仪评估FEV1，每日通过手持式肺功能仪记录FEV1。
结果：在家中和临床中测量的FEV1值之间存在高度相关性（总体相关系数= 0.8393，R = 0.81921、BAI320μg/天,0.85927、BAI640μg/天,0.85369、BDP320μg/天及0.83734、安慰剂治疗组），散点图显示所有治疗组呈上升趋势。几乎所有患者的家中测量的FEV1值都临床FEV1值相近，同时异常值极少。
结论：临床和手持式肺量计测定相对于安慰剂组显示出明显的治疗效果，表明家庭中肺功能测定可用于帮助患者监测其哮喘严重程度。每日进行FEV1测量提供比门诊就诊更全面的数据，并且可能引领临床试验设计新方法。
Relationship between handheld and clinic-based spirometry measurements in asthma patients receiving beclomethasone.
Kerwin EM, Hickey L, Small CJ.
Abstract
INTRODUCTION:Handheld spirometers for home use by patients allow longitudinal spirometry data to be collected daily and may overcome some of the limitations of in-clinic spirometry (long intervals between measurements, results can be affected by site-based coaching and patient's asthma status during a given visit).
OBJECTIVES:To determine the relationship between spirometry values measured by clinic-based and handheld spirometers during a clinical trial.
METHODS:A post hoc correlation analysis of data from a 6-week phase 3 study of beclomethasone dipropionate (BDP; delivered by breath-actuated inhaler: BAI) versus placebo in patients aged ≥12 years with persistent asthma. During the study, forced expiratory volume in 1 s (FEV1) was assessed by both office-based spirometry at Weeks 2, 4 and 6, and daily by handheld spirometer as a secondary study endpoint.
RESULTS:There was a high correlation between FEV1 values measured at home and in-clinic (overall correlation coefficient = 0.8393, R = 0.81921, 0.85927, 0.85369 and 0.83734 for BAI 320 μg/day, BAI 640 μg/day, BDP metered dose inhaler 320 μg/day and placebo treatment groups, respectively), with the scatterplot showing an upward trend for all treatment groups. Nearly all patients achieved home FEV1 values close to clinic FEV1 values, with very few outliers.
CONCLUSIONS:Clinic-based and handheld spirometry demonstrated comparable treatment effects relative to placebo, suggesting that home spirometry could be used to help patients monitor their asthma severity. Daily measurement of FEV1 provides more comprehensive data than can be achieved through clinic visits, and may lead to a new approach to clinical trial design.
介绍：患者家中使用手持式肺功能测量计使得纵向收集每日肺功能数据成为可能同时解决临床上肺功能测定的限制问题（测量之间间隔时间长，结果可能受到测试点指导及给定就诊期间哮喘状态的影响）。
目标：确定临床试验期间临床和手持式肺功能仪测量值之间的关系。
方法：对年龄≥12岁的持续哮喘患者进行为期6周的二丙酸倍氯米松与安慰剂的3期回顾性相关性分析研究。在研究期间，在第2周，第4周和第6周通过临床肺功能仪评估FEV1，每日通过手持式肺功能仪记录FEV1。
结果：在家中和临床中测量的FEV1值之间存在高度相关性（总体相关系数= 0.8393，R = 0.81921、BAI320μg/天,0.85927、BAI640μg/天,0.85369、BDP320μg/天及0.83734、安慰剂治疗组），散点图显示所有治疗组呈上升趋势。几乎所有患者的家中测量的FEV1值都临床FEV1值相近，同时异常值极少。
结论：临床和手持式肺量计测定相对于安慰剂组显示出明显的治疗效果，表明家庭中肺功能测定可用于帮助患者监测其哮喘严重程度。每日进行FEV1测量提供比门诊就诊更全面的数据，并且可能引领临床试验设计新方法。
（中日友好医院呼吸与危重症医学科 张鑫 摘译 林江涛 审校）
（Respir Med. 2019 May;151:35-42. doi: 10.1016/j.rmed.2019.03.010. Epub 2019 Mar 20.）
（Respir Med. 2019 May;151:35-42. doi: 10.1016/j.rmed.2019.03.010. Epub 2019 Mar 20.）
Relationship between handheld and clinic-based spirometry measurements in asthma patients receiving beclomethasone.
Kerwin EM, Hickey L, Small CJ.
Abstract
INTRODUCTION:Handheld spirometers for home use by patients allow longitudinal spirometry data to be collected daily and may overcome some of the limitations of in-clinic spirometry (long intervals between measurements, results can be affected by site-based coaching and patient's asthma status during a given visit).
OBJECTIVES:To determine the relationship between spirometry values measured by clinic-based and handheld spirometers during a clinical trial.
METHODS:A post hoc correlation analysis of data from a 6-week phase 3 study of beclomethasone dipropionate (BDP; delivered by breath-actuated inhaler: BAI) versus placebo in patients aged ≥12 years with persistent asthma. During the study, forced expiratory volume in 1 s (FEV1) was assessed by both office-based spirometry at Weeks 2, 4 and 6, and daily by handheld spirometer as a secondary study endpoint.
RESULTS:There was a high correlation between FEV1 values measured at home and in-clinic (overall correlation coefficient = 0.8393, R = 0.81921, 0.85927, 0.85369 and 0.83734 for BAI 320 μg/day, BAI 640 μg/day, BDP metered dose inhaler 320 μg/day and placebo treatment groups, respectively), with the scatterplot showing an upward trend for all treatment groups. Nearly all patients achieved home FEV1 values close to clinic FEV1 values, with very few outliers.
CONCLUSIONS:Clinic-based and handheld spirometry demonstrated comparable treatment effects relative to placebo, suggesting that home spirometry could be used to help patients monitor their asthma severity. Daily measurement of FEV1 provides more comprehensive data than can be achieved through clinic visits, and may lead to a new approach to clinical trial design.
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小气道功能障碍可能是早期哮喘的预测指标：来自高分辨率CT的研究发现
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