哮喘联盟

   摘要
   背景：Spiromax®是一种新型的干粉吸入剂，由布地奈德和福莫特罗（BF）成分组成。在哮喘和慢性阻塞性肺疾病（COPD）患者中，该设备旨在提供与Turbuhaler®等效剂量的药物，并增强用户使用的方便性。该项研究主要比较两个设备的吸入参数，并探讨强化培训的效果以鼓励更快的吸入。
   方法：这项随机、开放、交叉研究纳入儿童哮喘患者（n = 23）、青少年哮喘患者（n = 27）、成人哮喘患者（n = 50）、成人COPD患者（n = 50）和健康成人志愿者（n= 50）。通过患者信息手册（PIL）培训和用一个检查拨号设备强化培训后，分别记录每个设备的吸入情况。
   结果：PIL培训后，用Spiromax设备的吸气峰流量（PIF）、最大压力变化（ΔP）和吸入体积（Ⅳ）显著高于Turbuhaler设备（在所有患者分组中P值均至少<0.05）。强化培训后，与Turbuhaler设备相比，Spiromax设备除了COPD患者的ΔP，其他患者的PIF、ΔP和IV值均有数倍或显著升高并且依然加速升高。PIL培训后，使用Spiromax设备的有一名成人哮喘患者和一名COPD患者吸气峰流量<30升/分钟,而使用Turbuhaler设备的则有一名成人哮喘患者和五名COPD患者吸气峰流量<30升/分钟。所有患者的PIF值在强化培训后都至少达到30升/分钟。
   结论：两个吸入器具有相似的电阻，所以预计吸入流量和压力变化也将是相似的。PIL培训后，Spiromax较Turbuhaler可以得到更高的流量相关值，这提示Spiromax可能在实际使用中具有人为因素优势。强化培训后，设备间流量相关的差异仍然存在；这两个设备均实现了流量速率的增加，并且所有患者均达到递送足够药物所需的最小流量。强化培训可能是有用的，尤其对COPD患者。
 

（苏欣 审校）
 BMC Pulm Med. 2015 May 1;15(1):47. [Epub ahead of print]

 

Inhalation characteristics of asthma patients, COPD patients and healthy volunteers with the Spiromax® and Turbuhaler® devices: a randomised, cross-over study.

 Azouz W¹, Chetcuti P², Hosker H³, Saralaya D⁴, Chrystyn H⁵.
 

Abstract
BACKGROUND:Spiromax® is a novel dry-powder inhaler containing formulations of budesonide plus formoterol (BF). The device is intended to provide dose equivalence with enhanced user-friendliness compared to BF Turbuhaler® in asthma and chronic obstructive pulmonary disease (COPD). The present study was performed to compare inhalation parameters with empty versions of the two devices, and to investigate the effects of enhanced training designed to encourage faster inhalation.
METHODS:This randomised, open-label, cross-over study included children with asthma (n = 23), adolescents with asthma (n = 27), adults with asthma (n = 50), adults with COPD (n = 50) and healthy adult volunteers (n = 50). Inhalation manoeuvres were recorded with each device after training with the patient information leaflet (PIL) and after enhanced training using an In-Check Dial device.
RESULTS:After PIL training, peak inspiratory flow (PIF), maximum change in pressure (∆P) and the inhalation volume (IV) were significantly higher with Spiromax than with the Turbuhaler device (p values were at least <0.05 in all patient groups). After enhanced training, numerically or significantly higher values for PIF, ∆P, IV and acceleration remained with Spiromax versus Turbuhaler, except for ∆P in COPD patients. After PIL training, one adult asthma patient and one COPD patient inhaled <30 L/min through the Spiromax compared to one adult asthma patient and five COPD patients with the Turbuhaler. All patients achieved PIF values of at least 30 L/min after enhanced training.
CONCLUSIONS:The two inhalers have similar resistance so inhalation flows and pressure changes would be expected to be similar. The higher flow-related values noted for Spiromax versus Turbuhaler after PIL training suggest that Spiromax might have human factor advantages in real-world use. After enhanced training, the flow-related differences between devices persisted; increased flow rates were achieved with both devices, and all patients achieved the minimal flow required for adequate drug delivery. Enhanced training could be useful, especially in COPD patients.
 

BMC Pulm Med. 2015 May 1;15(1):47. [Epub ahead of print]