Homnick D N, Anderson K, Marks J H
Michigan State University, Kalamazoo Center for Medical Studies, 49008, USA.
Chest. 1998 Oct;114(4):993-7. doi: 10.1378/chest.114.4.993.
A preliminary study comparing the efficacy and safety of the flutter device (Flutter) to standard, manual chest physiotherapy (CPT) in hospitalized cystic fibrosis (CF) patients undergoing an acute pulmonary exacerbation.
Open label, comparative trial with alternate assignment.
Community and childrens' hospital acute-care wards.
Twenty-two CF patients (ages 8 to 44 years) undergoing a total of 33 hospitalizations for acute pulmonary exacerbation.
Complete pulmonary function tests (PFTs) were done at baseline (admission), weekly, and upon discharge from the hospital. Clinical score (CS) was determined at the time of hospital admission and at discharge. Participants were assigned to receive supervised Flutter therapy or standard, manual CPT four times per day during the hospitalization. Patients were monitored for complications, including hemoptysis, hypoxemia, and pneumothorax.
The groups (CPT and Flutter) did not differ at baseline in demographics or Shwachman score, nor was length of hospitalization different. Significant improvements were noted from admission to discharge in CS and PFT results within each group. Mean percent change in CS and PFT results between CPT and Flutter groups showed no significant difference from hospital admission to discharge. Subsequent power analysis using the observed difference in percent change from admission to discharge for FEV1 indicated that to attain 80% power at alpha = 0.05, a sample of 219 subjects in each group would be necessary.
Comparative trials of airway clearance techniques with sufficient sample size are lacking. Although the Flutter appears to be a useful device for independent, cost-effective, and safe administration of CPT in this pilot study, a much larger clinical trial would be necessary to make definitive conclusions.
一项初步研究，比较颤振装置（Flutter）与标准手动胸部物理治疗（CPT）对因急性肺部加重而住院的囊性纤维化（CF）患者的疗效和安全性。
开放标签、交替分配的对照试验。
社区和儿童医院的急症病房。
22名CF患者（年龄8至44岁），共因急性肺部加重住院33次。
在基线（入院时）、每周以及出院时进行完整的肺功能测试（PFT）。在入院时和出院时确定临床评分（CS）。参与者被分配在住院期间每天接受4次有监督的颤振治疗或标准手动CPT。对患者进行并发症监测，包括咯血、低氧血症和气胸。
两组（CPT组和颤振组）在基线时的人口统计学特征或施瓦克曼评分无差异，住院时间也无差异。每组内从入院到出院CS和PFT结果均有显著改善。CPT组和颤振组之间CS和PFT结果的平均变化百分比从入院到出院无显著差异。随后使用观察到的FEV1从入院到出院变化百分比的差异进行的功效分析表明，要在α = 0.05时达到80%的功效，每组需要219名受试者的样本量。
缺乏足够样本量的气道清除技术对照试验。尽管在这项初步研究中，颤振装置似乎是一种用于独立、经济有效且安全地进行CPT的有用设备，但需要进行更大规模的临床试验才能得出明确结论。
