Azouz Wahida, Chetcuti Philip, Hosker Harold S R, Saralaya Dinesh, Stephenson John, Chrystyn Henry
1 Department of Pharmacy, School of Applied Sciences, University of Huddersfield , Huddersfield, HD1 3DH, United Kingdom .
J Aerosol Med Pulm Drug Deliv. 2015 Feb;28(1):35-42. doi: 10.1089/jamp.2013.1119. Epub 2014 May 9.
BACKGROUND: The characteristics of each inhalation maneuver when patients use dry powder inhalers (DPIs) are important, because they control the quality of the emitted dose. METHODS: We have measured the inhalation profiles of asthmatic children [CHILD; n=16, mean forced expiratory volume in 1 sec (FEV1) 79% predicted], asthmatic adults (ADULT; n=53, mean predicted FEV1 72%), and chronic obstructive pulmonary disease (COPD; n=29, mean predicted FEV1 42%) patients when they inhaled through an Aerolizer, Diskus, Turbuhaler, and Easyhaler using their "real-life" DPI inhalation technique. These are low-, medium-, medium/high-, and high-resistance DPIs, respectively. The inhalation flow against time was recorded to provide the peak inhalation flow (PIF; in L/min), the maximum pressure change (ΔP; in kPa), acceleration rates (ACCEL; in kPa/sec), time to maximum inhalation, the length of each inhalation (in sec), and the inhalation volume (IV; in liters) of each inhalation maneuver. RESULTS: PIF, ΔP, and ACCEL values were consistent with the order of the inhaler's resistance. For each device, the inhalation characteristics were in the order ADULT>COPD>CHILD for PIF, ΔP, and ACCEL (p<0.001). The results showed a large variability in inhalation characteristics and demonstrate the advantages of ΔP and ACCEL rather than PIFs. Overall inhaled volumes were low, and only one patient achieved an IV >4 L and ΔP >4 kPa. CONCLUSION: The large variability of these inhalation characteristics and their range highlights that if inhalation profiles were used with compendial in vitro dose emission measurements, then the results would provide useful information about the dose patients inhale during routine use. The inhalation characteristics highlight that adults with asthma have greater inspiratory capacity than patients with COPD, whereas children with asthma have the lowest. The significance of the inhaled volume to empty doses from each device requires investigation.
背景:患者使用干粉吸入器(DPI)时每次吸入动作的特征很重要,因为它们控制着喷出剂量的质量。 方法:我们测量了哮喘儿童[儿童组;n = 16,1秒用力呼气容积(FEV1)平均为预测值的79%]、哮喘成人(成人组;n = 53,FEV1平均预测值为72%)和慢性阻塞性肺疾病(COPD;n = 29,FEV1平均预测值为42%)患者使用其“实际生活中”的DPI吸入技术通过Aerolizer、Diskus、Turbuhaler和Easyhaler吸入时的吸入曲线。这些分别是低阻力、中阻力、中/高阻力和高阻力的DPI。记录吸气流量随时间的变化,以提供每次吸入动作的峰值吸气流量(PIF;单位为L/min)、最大压力变化(ΔP;单位为kPa)、加速度(ACCEL;单位为kPa/秒)、达到最大吸气的时间、每次吸入的时长(单位为秒)以及吸入容积(IV;单位为升)。 结果:PIF、ΔP和ACCEL值与吸入器阻力顺序一致。对于每种装置,PIF、ΔP和ACCEL的吸入特征顺序为成人组>COPD组>儿童组(p<0.001)。结果显示吸入特征存在很大变异性,并证明了ΔP和ACCEL而非PIF的优势。总体吸入容积较低,只有一名患者的IV>4 L且ΔP>4 kPa。 结论:这些吸入特征的巨大变异性及其范围突出表明,如果将吸入曲线与药典规定的体外剂量喷出测量相结合,那么结果将提供有关患者在常规使用期间吸入剂量的有用信息。吸入特征突出表明,哮喘成人的吸气能力大于COPD患者,而哮喘儿童的吸气能力最低。每种装置吸入容积对排空剂量的意义需要进行研究。
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