Mitchell D M, Gildeh P, Rehahn M, Dimond A H, Collins J V
Lancet. 1984 Jul 28;2(8396):193-6. doi: 10.1016/s0140-6736(84)90481-1.
A double-blind, randomised, placebo-controlled, crossover trial of prednisolone (40 mg daily for 14 days) was carried out in 43 patients with chronic airflow limitation (mean age 60 years, mean FEV1 1.02 litres, FEV1/FVC ratio 43.7%). Several subjective and objective variables for response were measured. Significant improvements occurred with prednisolone in most variables measured, but improvements also occurred with placebo in some variables. The improvements with prednisolone in general wellbeing, 12 min walk distance, peak expiratory flow, FEV1, and relaxed vital capacity were significantly greater than those with placebo. Clinical assessment and assessment of atopic status did not reveal any feature of major predictive value for steroid responsiveness. A proportion of patients with chronic airflow limitation do improve on oral corticosteroids and the continued use of such trials in clinical practice is justified, though a placebo period should be included, and several variables for response should be measured.
对43例慢性气流受限患者(平均年龄60岁,平均第一秒用力呼气容积1.02升,第一秒用力呼气容积/用力肺活量比值43.7%)进行了一项关于泼尼松龙(每日40毫克,共14天)的双盲、随机、安慰剂对照、交叉试验。测量了几个反映疗效的主观和客观变量。在大多数测量变量中,泼尼松龙治疗有显著改善,但在一些变量中安慰剂治疗也有改善。泼尼松龙在总体健康状况、12分钟步行距离、呼气峰值流速、第一秒用力呼气容积和静息肺活量方面的改善显著大于安慰剂。临床评估和特应性状态评估未发现对类固醇反应性有任何主要预测价值的特征。一部分慢性气流受限患者口服皮质类固醇后确实有所改善,在临床实践中继续进行此类试验是合理的,不过应包括一个安慰剂期,并测量几个反映疗效的变量。