Pierce R J, McDonald C F, Landau L I, Le Souef P N, Armstrong J G, Mitchell C A, Francis P W, Martin A J, Musk A W, Antic R
Repatriation General Hospital, Heidelberg, Vic.
Med J Aust. 1992 Jun 1;156(11):771-4. doi: 10.5694/j.1326-5377.1992.tb121559.x.
To compare the clinical effectiveness and patient acceptance of a large spacer device (Nebuhaler) for delivery of metered dose aerosol (MDI) terbutaline with nebulised wet aerosol terbutaline.
Randomised open crossover study over two sequential four week treatment periods, following a two week run-in.
Multi-centre including five adult thoracic units and three paediatric centres throughout Australia.
Thirty-eight adults and 23 children with clinical asthma and reversible airflow obstruction (increase in forced expiratory volume in one second [FEV1] of greater than or equal to 15% in response to inhaled bronchodilator) entered the study proper. Six adults and one child withdrew.
Terbutaline was administered four times daily via Nebuhaler/MDI or nebuliser. Clinical assessment with spirometry and peak flow readings was made after run-in and at the end of each treatment period. Patients recorded on diary cards daily peak expiratory flow rates and symptom scores and comparisons of these results for each treatment period were made. At the completion of the study patients answered a treatment preference questionnaire.
No differences were found between the two treatment periods in diary card peak flow recordings and symptom score data, and in clinical assessment of spirometry and peak expiratory flow rates. There were also no differences between spirometry and peak flow values recorded at the clinic at randomisation and at the end of each treatment period, suggesting stable basal airflow obstruction over the period of the study. Thirty-two per cent of adults and 52% of children preferred the Nebuhaler/MDI combination, mainly because of convenience of use. Treatment preference was not related to any measured index of lung function.
MDI terbutaline delivered via Nebuhaler provides clinical benefit similar to that of wet aerosol terbutaline in the long-term domiciliary management of patients with stable airflow obstruction.
比较大容积储雾罐装置（百瑞雾化器）用于递送定量气雾剂（MDI）特布他林与雾化湿化特布他林的临床疗效及患者接受度。
在为期两周的导入期后，进行两个连续四周治疗期的随机开放交叉研究。
多中心研究，包括澳大利亚的五个成人胸科单元和三个儿科中心。
38名成人和23名患有临床哮喘及可逆性气流受限（吸入支气管扩张剂后一秒用力呼气容积[FEV1]增加大于或等于15%）的儿童进入本研究。6名成人和1名儿童退出。
通过百瑞雾化器/MDI或雾化器每日给予特布他林4次。在导入期后及每个治疗期结束时，通过肺功能测定和呼气峰值流速读数进行临床评估。患者在日记卡上记录每日呼气峰值流速和症状评分，并对每个治疗期的这些结果进行比较。研究结束时，患者回答一份治疗偏好问卷。
在日记卡呼气峰值流速记录和症状评分数据以及肺功能测定和呼气峰值流速的临床评估方面，两个治疗期之间未发现差异。随机分组时及每个治疗期结束时在诊所记录的肺功能测定和呼气峰值流速值之间也无差异，表明在研究期间基础气流受限情况稳定。32%的成人和52%的儿童更喜欢百瑞雾化器/MDI组合，主要是因为使用方便。治疗偏好与任何测量的肺功能指标均无关。
通过百瑞雾化器递送的MDI特布他林在稳定气流受限患者的长期家庭管理中提供了与雾化湿化特布他林相似的临床益处。
