van Schayck C P, van den Broek P J, den Otter J J, van Herwaarden C L, Molema J, van Weel C
Department of General Practice/Family Practice, University of Nijmegen, The Netherlands.
JAMA. 1995 Jul 12;274(2):161-4. doi: 10.1001/jama.274.2.161.
To determine whether inhaled corticosteroids can be discontinued in the stable phase of asthma or chronic obstructive pulmonary disease (COPD) or if this therapy should be continued.
Nonrandomized open uncontrolled 5-year trial.
Prospective study in general practice.
Forty-eight patients with steroid-dependent asthma or COPD who had shown a decline in forced expiratory volume in 1 second (FEV1) of at least 80 mL per year and at least one exacerbation per year during the first 2 years of bronchodilator treatment. Subjects were treated additionally with inhaled steroids for another 2 years and were finally given the option to stop using steroids. Sixteen patients were willing to stop using beclomethasone and were studied for another year. No recruitment bias took place in this consecutive sample in the fifth year of follow-up. Two of 16 patients developed carcinomas and dropped out.
Two years of bronchodilator treatment alone (400 micrograms of salbutamol or 40 micrograms of ipratropium bromide four times daily), followed by 2 years of additional inhaled corticosteroid treatment (400 micrograms of beclomethasone two times daily), and finally 1 year of bronchodilator treatment alone.
Decline in lung function (FEV1), change in bronchial hyperresponsiveness, indicated by a provocative concentration of histamine causing a 20% fall in FEV1 (PC20), morning peak expiratory flow rate (PEFR), diurnal PEFR, week-to-week variation of PEFR, bronchial symptoms, and exacerbations.
The course of FEV1 during the year in which beclomethasone was discontinued was not significantly different when compared with the 2-year period of beclomethasone treatment. Neither did the course of PC20, morning PEFR, diurnal PEFR, symptom score, and exacerbation rate change. Only the week-to-week variation of the PEFR increased after discontinuing steroids.
Discontinuing inhaled steroids is possible in some patients with asthma or COPD after 2 years of regular treatment. This might indicate that for certain groups of patients with mild asthma or COPD, periodic treatment schedules with inhaled steroids is the treatment policy for the future.
确定在哮喘或慢性阻塞性肺疾病(COPD)稳定期是否可以停用吸入性糖皮质激素,或者该治疗是否应继续。
非随机开放非对照5年试验。
全科医学前瞻性研究。
48例依赖糖皮质激素的哮喘或COPD患者,在支气管扩张剂治疗的前2年中,其1秒用力呼气量(FEV1)每年下降至少80 mL,且每年至少有一次病情加重。受试者额外接受吸入性糖皮质激素治疗2年,最后可选择停用糖皮质激素。16例患者愿意停用倍氯米松,并接受了为期一年的研究。在随访的第五年,这个连续样本中没有发生招募偏倚。16例患者中有2例患癌并退出研究。
单独使用支气管扩张剂治疗2年(沙丁胺醇400微克或异丙托溴铵40微克,每日4次),随后额外使用吸入性糖皮质激素治疗2年(倍氯米松400微克,每日2次),最后单独使用支气管扩张剂治疗1年。
肺功能下降(FEV1)、支气管高反应性变化,以组胺激发浓度使FEV1下降20%(PC20)表示、晨起呼气峰值流速(PEFR)、日间PEFR、PEFR的周间变化、支气管症状和病情加重情况。
停用倍氯米松的这一年中FEV1的变化过程与使用倍氯米松治疗的2年期间相比无显著差异。PC20、晨起PEFR、日间PEFR、症状评分和病情加重率的变化过程也均无差异。仅停用糖皮质激素后PEFR的周间变化增加。
经过2年的规律治疗后,部分哮喘或COPD患者可以停用吸入性糖皮质激素。这可能表明,对于某些轻度哮喘或COPD患者群体,吸入性糖皮质激素的定期治疗方案是未来的治疗策略。