van Schayck C P, Dompeling E, Rutten M P, Folgering H, van den Boom G, van Weel C
Department of General Practice, University of Nijmegen, The Netherlands.
Chest. 1995 May;107(5):1199-205. doi: 10.1378/chest.107.5.1199.
Relatively little is known about the influence of inhaled corticosteroids on general well-being (quality of life) in patients with asthma or COPD. In a 4-year prospective controlled study, we examined the influence of beclomethasone dipropionate (BDP), 400 micrograms, two times daily, on quality of life in 56 patients with asthma or COPD in comparison with the effects of BDP on symptoms and lung function. During the first 2 years, patients received only bronchodilator therapy with salbutamol or ipratropium bromide. During the third and fourth years, additional treatment with BDP was given. Fifty-six patients (28 with asthma, 28 with COPD) with an annual decline in the forced expiratory volume in 1 s (FEV1) of at least 80 mL/yr in combination with at least two exacerbations per year during bronchodilator therapy alone participated. Quality of life was assessed at the start and after 2 and 4 years by means of the Inventory of Subjective Health (ISH) and the Nottingham Health Profile (NHP). Although BDP significantly improved the course of lung function (FEV1)(p < 0.0001), it did not improve the ISH score or the six dimensions of the NHP neither in asthma nor in COPD. Beclomethasone dipropionate temporarily decreased respiratory symptoms during months 4 to 6 of BDP treatment in patients with asthma (p < 0.01) and during months 7 to 12 in patients with COPD (p < 0.05). A weak correlation was found both cross-sectionally and longitudinally between (change in) symptoms and quality of life on the one hand, and the (change in) FEV1 on the other. It was concluded that BDP did not improve the general well-being of patients with asthma or COPD as measured by these generic health instruments. However, BDP significantly improved the course of lung function and temporarily decreased the severity of symptoms. It seems probable that changes in quality of life would have been better detected by use of a disease-specific health instrument. Such an instrument was not available at the start of the study. Another possible explanation for these observations is that patients soon get used to different levels of lung function and learn to live with their disease. It is advised that disease-specific health instruments are used in future intervention studies and that quality of life is measured frequently during the early phase of the intervention, eg, once every month.
关于吸入性糖皮质激素对哮喘或慢性阻塞性肺疾病（COPD）患者总体健康状况（生活质量）的影响，人们了解相对较少。在一项为期4年的前瞻性对照研究中，我们研究了每日两次、每次400微克的二丙酸倍氯米松（BDP）对56例哮喘或COPD患者生活质量的影响，并将其与BDP对症状和肺功能的影响进行比较。在最初的2年里，患者仅接受沙丁胺醇或异丙托溴铵的支气管扩张剂治疗。在第3年和第4年，增加BDP治疗。56例患者（28例哮喘患者，28例COPD患者）参与研究，这些患者在仅接受支气管扩张剂治疗期间，1秒用力呼气容积（FEV1）每年至少下降80 mL，且每年至少有两次病情加重。在研究开始时以及2年和4年后，通过主观健康量表（ISH）和诺丁汉健康量表（NHP）评估生活质量。尽管BDP显著改善了肺功能（FEV1）的病程（p < 0.0001），但在哮喘患者和COPD患者中，它均未改善ISH评分或NHP的六个维度。在哮喘患者中，二丙酸倍氯米松在BDP治疗的第4至6个月暂时减轻了呼吸道症状（p < 0.01）；在COPD患者中，在第7至12个月减轻了呼吸道症状（p < 0.05）。一方面，症状（变化）与生活质量之间，另一方面，FEV1（变化）之间，在横断面和纵向研究中均发现存在弱相关性。研究得出结论，通过这些通用健康工具测量发现，BDP并未改善哮喘或COPD患者的总体健康状况。然而，BDP显著改善了肺功能病程，并暂时减轻了症状的严重程度。使用针对特定疾病的健康工具可能会更好地检测到生活质量的变化。在研究开始时没有这样的工具。对这些观察结果的另一种可能解释是，患者很快就适应了不同水平的肺功能，并学会了与疾病共存。建议在未来的干预研究中使用针对特定疾病的健康工具，并在干预的早期阶段频繁测量生活质量，例如每月测量一次。
