Welch Michael J, Nelson Harold S, Shapiro Gail, Bensch George W, Sokol William N, Smith Joseph A, Parasuraman Bhash M
Allergy & Asthma Medical Group and Research Center, San Diego, California 92123, USA.
J Aerosol Med. 2004 Summer;17(2):129-39. doi: 10.1089/0894268041457174.
A multicenter, randomized, open-label, crossover study with two 4-week evaluation periods compared patient preference and ease of teaching correct inhaler technique for Pulmicort Turbuhaler versus pressurized metered-dose inhalers (pMDIs). Patients 18 to 65 years of age with stable, mild to moderate asthma, who required or were eligible for inhaled corticosteroid therapy, were randomized to treatment sequences consisting of 4-week evaluation periods with Pulmicort Turbuhaler (budesonide inhalation powder) two puffs (400 microg) bid and one of three inhaled corticosteroids via pMDI: Aerobid-M (flunisolide) four puffs (1 mg) bid, Flovent (fluticasone propionate) two puffs (440 microg) bid, or Vanceril Double Strength (beclomethasone dipropionate) five puffs (420 microg) bid. Patients indicated device preference at study end and completed the Patient Device Experience Assessment (PDEA) questionnaire after each evaluation period. Ease of teaching, time required to master use of the device, percentage of patients demonstrating mastery on the first attempt, and the number of attempts required to demonstrate mastery were assessed. Despite previous use of pMDIs by most patients, Pulmicort Turbuhaler was significantly preferred (p < 0.001) and required significantly less time to master than pMDIs (p < 0.001). Median times to device mastery were 3.67 min for Pulmicort Turbuhaler versus 5.33 min for pMDIs. Patients rated Pulmicort Turbuhaler significantly better than pMDIs on PDEA ease of use (p = 0.0005) and overall satisfaction (p < 0.0001) single-item scales and all four multi-item scales (pharyngeal symptoms, oral sensation, operational use, and inhaler attributes; p < 0.05). Overall, patients preferred Pulmicort Turbuhaler over pMDIs and required less time to be taught how to correctly use Turbuhaler trade mark.
一项多中心、随机、开放标签、交叉研究,设有两个为期4周的评估期,比较了患者对普米克都保与压力定量吸入器(pMDIs)的偏好以及教授正确吸入器技术的难易程度。年龄在18至65岁、患有稳定的轻度至中度哮喘且需要或符合吸入皮质类固醇治疗条件的患者,被随机分配到治疗序列中,每个序列包括一个为期4周的评估期,在此期间使用普米克都保(布地奈德吸入粉)每日两次、每次两吸(400微克),并通过pMDI使用三种吸入皮质类固醇之一:必可酮(氟尼缩松)每日两次、每次四吸(1毫克),辅舒酮(丙酸氟替卡松)每日两次、每次两吸(440微克),或二丙酸倍氯米松双强度(倍氯米松二丙酸酯)每日两次、每次五吸(420微克)。患者在研究结束时表明对设备的偏好,并在每个评估期后完成患者设备体验评估(PDEA)问卷。评估了教授的难易程度、掌握设备使用所需的时间、首次尝试即掌握的患者百分比以及掌握所需的尝试次数。尽管大多数患者以前使用过pMDIs,但普米克都保更受青睐(p < 0.001),且掌握使用所需的时间明显少于pMDIs(p < 0.001)。普米克都保掌握设备使用的中位时间为3.67分钟,而pMDIs为5.33分钟。在PDEA易用性(p = 0.0005)和总体满意度(p < 0.0001)单项量表以及所有四个多项目量表(咽部症状、口腔感觉、操作使用和吸入器属性;p < 0.05)方面,患者对普米克都保的评分明显高于pMDIs。总体而言,患者更喜欢普米克都保而非pMDIs,并且教授如何正确使用都保所需的时间更少。