Zhang M, Nishimura K, Ikeda A, Tsukino M, Koyama H, Izumi T
Department of Pulmonary Medicine, Kyoto University, Japan.
Nihon Kyobu Shikkan Gakkai Zasshi. 1995 Dec;33(12):1386-1391.
High doses of inhaled beclomethasone dipropionate (BDP) are effective in some patients with chronic obstructive pulmonary disease (COPD). However, dose-response data for this agent are limited. To determine whether patients receive maximum benefit from 1600 micrograms of BDP, we performed a randomized, double-blind, placebo-controlled, cross-over trial. Twenty-one patients with stable COPD [mean +/- SD: age, 69.1 +/- 6.8 yrs; FEV1, 0.86 +/- 0.28 L] were treated with both inhaled bronchodilators and 1600 micrograms of BDP daily for at least 3 months. Each patient received 30 mg of oral prednisolone or a placebo for 3 weeks. In addition to end-point spirometric assessments daily peak expiratory flow rate, symptom scores, and scores on a chronic respiratory disease questionnaire were recorded for the last week of each 3-week period. Oral prednisolone did not improve FEV1, FVC, symptoms or scores on the questionnaire. We conclude that 1600 micrograms of BDP in addition to inhaled bronchodilators produces maximal improvements in stable patients with COPD.
高剂量吸入丙酸倍氯米松（BDP）对一些慢性阻塞性肺疾病（COPD）患者有效。然而，该药物的剂量反应数据有限。为了确定患者是否能从1600微克BDP中获得最大益处，我们进行了一项随机、双盲、安慰剂对照的交叉试验。21例稳定期COPD患者[平均±标准差：年龄，69.1±6.8岁；第一秒用力呼气容积（FEV1），0.86±0.28升]接受吸入支气管扩张剂治疗，并每日使用1600微克BDP，至少持续3个月。每位患者接受30毫克口服泼尼松龙或安慰剂治疗3周。除了终点肺量计评估外，还记录了每个3周期间最后阶段的每日呼气峰值流速、症状评分以及慢性呼吸系统疾病问卷评分。口服泼尼松龙并未改善FEV1、用力肺活量（FVC）、症状或问卷评分。我们得出结论，对于稳定期COPD患者，除吸入支气管扩张剂外，1600微克BDP能产生最大程度的改善。
