Balzano G, Battiloro R, Biraghi M, Stefanelli F, Fuschillo S, Gaudiosi C, De Angelis E
Division of Pneumology, Salvatore Maugeri Foundation, Rehabilitation Institute of Telese Terme, BN, Italy.
J Aerosol Med. 2000 Spring;13(1):25-33. doi: 10.1089/jam.2000.13.25.
The aim of this study was to compare the immediate and long-term bronchodilator effect as well as the patient acceptability of a 2-week, multidrug, inhalation treatment delivered by a metered dose inhaler (MDI) versus a jet nebulizer in a group of elderly patients with chronic obstructive pulmonary disease (COPD) or asthma and an at least partially reversible airflow obstruction. Twenty elderly outpatients (17 men; mean +/- SD age, 67 +/- 2 years; mean +/- SD baseline forced expiratory volume in 1 second [FEV1], 46.5 +/- 14% of predicted value) with COPD or asthma participated in the study, which was of an open, randomized, crossover design. After a 1-day baseline evaluation, including patient history, clinical examination, and spirometry, participants were randomly assigned to receive a multidrug inhalation treatment (a combination of salbutamol, ipratropium, and flunisolide) with either an MDI or a jet nebulizer. Two weeks later, they were shifted to treatment with the alternative system for a further 2 weeks. FEV1 was measured on the first and fourteenth days of each treatment period, on each occasion both before and 30 minutes after the morning inhalation. At the end of the study, patients were asked to express a personal preference for one of the two inhalation treatments with regard to effectiveness and acceptability by filling out a simple questionnaire. Both the MDI and jet nebulizer had a significant immediate bronchodilator effect on the first and fourteenth days of treatment, with no differences between treatments. No long-term bronchodilator effect was seen with either aerosol delivery system. Patient preferences were clearly in favor of the jet nebulizer with regard to effectiveness and in favor of the MDI with regard to acceptability. In conclusion, in elderly patients with COPD or asthma and partially reversible airflow obstruction, a maintenance multidrug bronchodilator/anti-inflammatory inhalation treatment produced a statistically significant and clinically relevant bronchodilator effect without substantial differences between the two delivery systems. Most patients considered the MDI to be more acceptable and the jet nebulizer to be more effective. These preferences should be taken into consideration when prescribing a maintenance aerosol inhalation treatment.
本研究的目的是比较在一组患有慢性阻塞性肺疾病（COPD）或哮喘且存在至少部分可逆性气流受限的老年患者中，使用定量吸入器（MDI）与喷射雾化器进行为期2周的多药吸入治疗的即时和长期支气管扩张作用以及患者的可接受性。20名患有COPD或哮喘的老年门诊患者（17名男性；平均±标准差年龄，67±2岁；平均±标准差基线第1秒用力呼气量[FEV1]，为预测值的46.5±14%）参与了本研究，该研究采用开放、随机、交叉设计。在进行包括患者病史、临床检查和肺功能测定的1天基线评估后，参与者被随机分配接受使用MDI或喷射雾化器的多药吸入治疗（沙丁胺醇、异丙托溴铵和氟尼缩松的联合用药）。两周后，他们改用另一种系统进行治疗，为期2周。在每个治疗期的第1天和第14天，在早晨吸入前和吸入后30分钟测量FEV1。在研究结束时，要求患者通过填写一份简单问卷，就有效性和可接受性对两种吸入治疗中的一种表达个人偏好。MDI和喷射雾化器在治疗的第1天和第14天都有显著的即时支气管扩张作用，两种治疗之间无差异。两种气雾剂给药系统均未观察到长期支气管扩张作用。在有效性方面，患者明显偏好喷射雾化器；在可接受性方面，患者明显偏好MDI。总之，在患有COPD或哮喘且存在部分可逆性气流受限的老年患者中，维持性多药支气管扩张剂/抗炎吸入治疗产生了具有统计学意义且临床相关的支气管扩张作用，两种给药系统之间无实质性差异。大多数患者认为MDI更可接受，喷射雾化器更有效。在开具维持性气雾剂吸入治疗处方时应考虑这些偏好。
