在健康志愿者和慢性阻塞性肺疾病（COPD）患者中通过干粉吸入器的吸气流量参数：装置阻力不会限制 COPD 中的使用。
Inspiratory Flow Parameters Through Dry Powder Inhalers in Healthy Volunteers and Patients with Chronic Obstructive Pulmonary Disease (COPD): Device Resistance Does Not Limit Use in COPD.
机构信息
Tartu University Hospital, Lung Clinic, Tartu, Estonia.
Medical Affairs, Orion Corporation, Espoo, Finland.
出版信息
Int J Chron Obstruct Pulmon Dis. 2021 Apr 30;16:1193-1201. doi: 10.2147/COPD.S298514. eCollection 2021.
INTRODUCTION
Achieving correct inhalation technique through an inhaler to ensure effective drug delivery is key to managing symptoms in patients with chronic obstructive pulmonary disease (COPD). However, many patients struggle to use their inhalers correctly, with the resultant reduction in therapeutic benefit. Consequently, appropriate inhaler choice is important to maximize clinical benefit. The primary objective of this study was to characterize inspiratory flow parameters across two Easyhaler inhalers and the HandiHaler inhaler in patients with COPD and healthy volunteers.
METHODS
In this randomized, open-label, crossover study, subjects (100 patients with COPD; 100 healthy volunteers) were trained to perform inhalations of placebo powder via two variants of Easyhaler and placebo capsules via the HandiHaler inhalers. Subjects then performed three placebo inhalations through each inhaler in a random sequence. Inspiratory flow parameters were assessed, including peak inspiratory flow (PIF), for each inhaler. A parallel sub-study was conducted in patients with COPD from the main study to assess correct use of the inhalers, patient's preference, ability to learn to use the inhalers, and the feasibility of the In-Check Dial device to measure PIF values.
RESULTS
Mean PIF rates and inspiratory volumes through the three inhalers were similar between patients with COPD and healthy volunteers, and all subjects achieved the 30 L/min PIF required for effective use of Easyhaler. Almost 70% of the 88 patients enrolled in the sub-study used the Easyhaler and HandiHaler inhalers without errors. The Easyhaler was preferred by 51% of patients, while 25% favored the HandiHaler. Teaching the use of both inhalers to almost 70% of patients was very easy. The In-Check Dial PIF values and those obtained via spirometry were strongly correlated (p<0.0001) for all three inhalers.
CONCLUSION
The respiratory performance of patients with COPD does not appear to be a limiting factor in the use of Easyhaler.
简介
通过吸入器实现正确的吸入技术以确保有效药物输送对于慢性阻塞性肺疾病（COPD）患者的症状管理至关重要。然而，许多患者难以正确使用吸入器，导致治疗效果降低。因此，选择合适的吸入器对于最大限度地提高临床获益非常重要。本研究的主要目的是描述 COPD 患者和健康志愿者使用两种 Easyhaler 吸入器和 HandiHaler 吸入器时的吸气流量参数。
方法
在这项随机、开放标签、交叉研究中，受试者（100 名 COPD 患者；100 名健康志愿者）接受培训，通过两种变体的 Easyhaler 吸入安慰剂粉末，并通过 HandiHaler 吸入器吸入安慰剂胶囊。然后，受试者以随机顺序通过每个吸入器进行三次安慰剂吸入。评估了每个吸入器的吸气流量参数，包括吸气峰流量（PIF）。从主要研究中对 COPD 患者进行了一项平行子研究，以评估吸入器的正确使用、患者的偏好、学习使用吸入器的能力以及 In-Check Dial 设备测量 PIF 值的可行性。
结果
COPD 患者和健康志愿者通过三种吸入器的平均 PIF 率和吸气量相似，所有受试者均达到了有效使用 Easyhaler 所需的 30 L/min PIF。在参加子研究的 88 名患者中，近 70%的患者无错误地使用了 Easyhaler 和 HandiHaler 吸入器。51%的患者更喜欢使用 Easyhaler，而 25%的患者更喜欢使用 HandiHaler。几乎 70%的患者非常容易学会使用这两种吸入器。In-Check Dial PIF 值与所有三种吸入器的肺活量计测量值高度相关（p<0.0001）。
结论
COPD 患者的呼吸功能似乎不是使用 Easyhaler 的限制因素。
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