Boothman-Burrell D, Delany S G, Flannery E M, Hancox R J, Taylor D R
Department of Medicine, University of Otago, Dunedin.
N Z Med J. 1997 Oct 10;110(1053):370-3.
The aims of this investigation were to evaluate the efficacy of regular inhaled beclomethasone in the control of symptoms and lung function with non-asthmatic smoking related obstructive pulmonary disease and to evaluate the relationship between clinical responses to a short course of oral prednisone and longer term outcomes using inhaled steroid.
The study was a randomised, double blind, placebo controlled, crossover investigation in 18 patients. The active treatment was inhaled beclomethasone 1000 micrograms given twice daily for three months by metered dose inhaler. At the end of each treatment period, patients received oral prednisone 30 mg/day for ten days. The two treatment phases were separated by a one month washout interval. Peak flow rates, symptom scores and "rescue" bronchodilator use were recorded twice daily. Lung function (FEV1, FVC and lung volumes) and bronchial hyperresponsiveness (PC20 methacholine) were measured at monthly visits. The number of exacerbations requiring intervention therapy were also recorded.
There were no consistent benefits attributable to beclomethasone. Lung function was not significantly better as a result of active treatment. Sputum production improved but other symptom scores were similar during active and placebo therapy. Three patients exhibited an increase in FEV1 of 15% or more during active treatment but did not do so when oral prednisone was administered immediately after the period of placebo treatment. A further three patients showed an improvement in FEV1 of 15% or more with oral prednisone but failed to improve during treatment with inhaled beclomethasone. The predictive value of the "trial of steroid" was 0% and 81.3% for positive and negative outcomes respectively.
Our results indicate that in non-asthmatic chronic obstructive pulmonary disease inhaled corticosteroid fails to achieve significant improvements in either lung function or symptoms. The response to a "trial of steroid" using oral prednisone is not clinically helpful in selecting the small number of patients who may subsequently benefit from this form of therapy.
本研究旨在评估常规吸入倍氯米松对非哮喘性吸烟相关阻塞性肺疾病症状及肺功能的控制效果，并评估短期口服泼尼松的临床反应与长期吸入类固醇治疗效果之间的关系。
本研究为一项针对18名患者的随机、双盲、安慰剂对照、交叉试验。活性治疗为使用定量吸入器，每日两次吸入1000微克倍氯米松，持续三个月。在每个治疗阶段结束时，患者接受为期十天的每日30毫克口服泼尼松治疗。两个治疗阶段之间有一个月的洗脱期。每日记录两次峰值流速、症状评分及“急救”支气管扩张剂的使用情况。每月就诊时测量肺功能（第一秒用力呼气容积、用力肺活量及肺容积）及支气管高反应性（乙酰甲胆碱激发试验的PC20）。记录需要干预治疗的急性加重次数。
未发现倍氯米松有持续的益处。活性治疗后肺功能并无显著改善。痰液分泌有所改善，但活性治疗与安慰剂治疗期间其他症状评分相似。三名患者在活性治疗期间第一秒用力呼气容积增加了15%或更多，但在安慰剂治疗期后立即给予口服泼尼松时未出现此情况。另外三名患者口服泼尼松后第一秒用力呼气容积改善了15%或更多，但吸入倍氯米松治疗期间未改善。“类固醇试验”对阳性和阴性结果的预测价值分别为0%和81.3%。
我们的结果表明，在非哮喘性慢性阻塞性肺疾病中，吸入皮质类固醇未能使肺功能或症状得到显著改善。使用口服泼尼松进行“类固醇试验”的反应在临床上无助于筛选出少数可能随后从这种治疗形式中获益的患者。
