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首页> 外文期刊>The New England journal of medicine >Long-term treatment with inhaled budesonide in persons with mild chronic obstructive pulmonary disease who continue smoking. European Respiratory Society Study on Chronic Obstructive Pulmonary Disease (see comments)
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Long-term treatment with inhaled budesonide in persons with mild chronic obstructive pulmonary disease who continue smoking. European Respiratory Society Study on Chronic Obstructive Pulmonary Disease (see comments)

机译：在继续吸烟的轻度慢性阻塞性肺疾病患者中长期吸入布地奈德治疗。欧洲呼吸学会对慢性阻塞性肺疾病的研究（见评论）

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BACKGROUND: Although patients with chronic obstructive pulmonary disease (COPD) should stop smoking, some do not. In a double-blind, placebo-controlled study, we evaluated the effect of the inhaled glucocorticoid budesonide in patients with mild COPD who continued smoking. After a six-month run-in period, we randomly assigned 1277 subjects (mean age, 52 years; mean forced expiratory volume in one second [FEV1], 77 percent of the predicted value; 73 percent men) to twice-daily treatment with 400 microg of budesonide or placebo, inhaled from a dry-powder inhaler, for three years. RESULTS: Of the 1277 subjects, 912 (71 percent) completed the study. Among these subjects, the median decline in the FEV1 after the use of a bronchodilator over the three-year period was 140 ml in the budesonide group and 180 ml in the placebo group (P=0.05), or 4.3 percent and 5.3 percent of the predicted value, respectively. During the first six months of the study, the FEV1 improved at the rate of 17 ml per year in the budesonide group, as compared with a decline of 81 ml per year in the placebo group (P<0.001). From nine months to the end of treatment, the FEV1 declined at similar rates in the two groups (P=0.39). Ten percent of the subjects in the budesonide group and 4 percent of those in the placebo group had skin bruising (P<0.001). Newly diagnosed hypertension, bone fractures, postcapsular cataracts, myopathy, and diabetes occurred in less than 5 percent of the subjects, and the diagnoses were equally distributed between the groups. CONCLUSIONS: In patients with mild COPD who continue smoking, the use of inhaled budesonide is associated with a small one-time improvement in lung function but does not appreciably affect the long-term progressive decline.
机译：背景：尽管患有慢性阻塞性肺疾病（COPD）的患者应停止吸烟，但有些人则不应吸烟。在一项双盲，安慰剂对照研究中，我们评估了吸入糖皮质激素布地奈德对持续吸烟的轻度COPD患者的影响。经过六个月的磨合期后，我们随机分配了1277名受试者（平均年龄52岁;平均一秒钟的平均呼气量[FEV1]，占预测值的77％;男性73％）接受每天两次的治疗从干粉吸入器中吸入400微克布地奈德或安慰剂，持续三年。结果：在1277名受试者中，有912名（71％）完成了研究。在这些受试者中，三年内使用支气管扩张剂后，FEV1的中位数下降为布地奈德组为140 ml，安慰剂组为180 ml（P = 0.05），分别是对照组的4.3％和5.3％。预测值。在研究的前六个月中，布地奈德组的FEV1每年以17 ml的速度改善，而安慰剂组的FEV1则以每年81 ml的速度减少（P <0.001）。从9个月到治疗结束，两组的FEV1下降速度相似（P = 0.39）。布地奈德组中有10％的受试者和安慰剂组中有4％的受试者有皮肤瘀伤（P <0.001）。新诊断的高血压，骨折，囊后性白内障，肌病和糖尿病发生在不到5％的受试者中，并且诊断在各组之间平均分布。结论：在继续吸烟的轻度COPD患者中，吸入布地奈德的使用可使肺功能短暂改善一次，但不会对长期进行性下降产生明显影响。

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