Renkema T E, Schouten J P, Koëter G H, Postma D S
Department of Pulmonology, University of Groningen, The Netherlands.
Chest. 1996 May;109(5):1156-62. doi: 10.1378/chest.109.5.1156.
To determine the effectiveness of treatment with corticosteroids in patients with COPD.
In this study, we investigated the effect of a 2-year treatment with corticosteroids on clinical symptoms and the decline of lung function in 58 nonallergic patients with COPD. Subjects were treated in a double-blind, randomized, placebo-controlled, parallel way with inhaled budesonide (bud), 1,600 micrograms/d; inhaled budesonide, 1,600 micrograms/d, plus oral prednisolone, 5 micrograms/d (bud + pred); or placebo (plac). Clinical assessment (history, physical examination, and spirometry) was carried out every 2 months. The rate of decline in FEV1 was assessed by calculating individual regression co-efficients from linear regression of FEV1 on time for each subject.
Eleven patients dropped out. The number of withdrawals due to pulmonary problems was significantly higher in the plac group (n = 5 out of 18) than in the actively treated groups (n = 2 out of 40). Treatment with corticosteroids significantly reduced pulmonary symptoms. Median decline of FEV1 was 60 mL/yr in the plac group, 40 mL/yr in the bud + pred group, and 30 mL/yr in the bud group. Variation was large and differences were not statistically significant. No treatment effect was found on frequency or duration of exacerbations, possibly because of the high number of withdrawals due to pulmonary deterioration in the plac group. Treatment with a combination of inhaled plus oral corticosteroids was not more effective than inhaled corticosteroids alone. Morning plasma cortisol levels remained within the normal range in all three groups.
Our study shows beneficial effects of long-term daily treatment with inhaled corticosteroids in patients with COPD with regard to symptoms and drop out due to pulmonary problems. Lung function decline tends to decrease during treatment with inhaled corticosteroids. The observed effects are limited but warrant further studies on the effectiveness of corticosteroids in larger numbers of patients with COPD.
确定皮质类固醇对慢性阻塞性肺疾病（COPD）患者的治疗效果。
在本研究中，我们调查了皮质类固醇2年治疗对58例非过敏性COPD患者临床症状及肺功能下降的影响。受试者采用双盲、随机、安慰剂对照、平行方式接受治疗，分别为吸入布地奈德（bud），1600微克/天；吸入布地奈德，1600微克/天加口服泼尼松龙，5微克/天（bud + pred）；或安慰剂（plac）。每2个月进行一次临床评估（病史、体格检查和肺量计检查）。通过计算每个受试者FEV1随时间的线性回归的个体回归系数来评估FEV1的下降率。
11例患者退出研究。因肺部问题退出的人数在plac组（18例中有5例）显著高于积极治疗组（40例中有2例）。皮质类固醇治疗显著减轻了肺部症状。FEV1的中位下降量在plac组为每年60毫升，在bud + pred组为每年40毫升，在bud组为每年30毫升。差异较大且无统计学意义。未发现治疗对急性加重的频率或持续时间有影响，可能是因为plac组因肺部恶化而退出的人数较多。吸入加口服皮质类固醇联合治疗并不比单独吸入皮质类固醇更有效。三组患者早晨血浆皮质醇水平均保持在正常范围内。
我们的研究表明，对于COPD患者，长期每日吸入皮质类固醇治疗在症状及因肺部问题退出方面具有有益效果。吸入皮质类固醇治疗期间肺功能下降趋势趋于减缓。观察到的效果有限，但值得对更多COPD患者进行皮质类固醇有效性的进一步研究。
