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四种β2 - 拟交感神经支气管扩张气雾剂疗效的交叉研究

Cross-over study of the efficacy of four beta 2-sympathomimetic bronchodilator aerosols.

作者信息

Madsen B W, Tandon M K, Paterson J W

出版信息

Br J Clin Pharmacol. 1979 Jul;8(1):75-82. doi: 10.1111/j.1365-2125.1979.tb05912.x.

Abstract

1 Bronchodilator efficacy of four beta 2-sympathomimetic aerosols, fenoterol, orciprenaline, salbutamol and terbutaline has been compared in nine patients with chronic stable reversible airways obstruction using a double-blind placebo controlled cross-over design. Two puffs of each agent were given on two separate occasions to each of the patients and the forced expiratory volume in one second (FEV1) and the vital capacity (VC) were measured before and 30, 90, 150 and 210 min after administration. 2 Multivariate analysis of the data at 30 min showed FEV1 and VC in these patients to be so highly correlated that they could be considered as a single variable. 3 When absolute change in VC at 30 min was used as the response criterion, efficacy of the four drugs was significantly better than placebo (P < 0.01). It was not possible to rank all four drugs in order of effectiveness; fenoterol and salbutamol were significantly better than terbutaline and orciprenaline (P < 0.01) but this was complicated by a significant interaction effect between drugs and patients (P < 0.01). 4 Similar results were obtained when absolute and relative changes in FEV1 and VC and area under the curve were used as response variables. 5 The study demonstrates that important individual differences in patient response may be concealed if only average drug effects are considered.

摘要
  1. 采用双盲安慰剂对照交叉设计,比较了四种β2-拟交感神经气雾剂(非诺特罗、奥西那林、沙丁胺醇和特布他林)对9例慢性稳定可逆性气道阻塞患者的支气管扩张疗效。在两个不同的时间点,分别给每位患者使用两种药物各两喷,并在给药前以及给药后30、90、150和210分钟测量一秒用力呼气量(FEV1)和肺活量(VC)。2. 对30分钟时的数据进行多变量分析表明,这些患者的FEV1和VC高度相关,可视为一个单一变量。3. 以30分钟时VC的绝对变化作为反应标准时,四种药物的疗效均显著优于安慰剂(P<0.01)。无法将这四种药物按疗效排序;非诺特罗和沙丁胺醇显著优于特布他林和奥西那林(P<0.01),但药物与患者之间存在显著的交互作用(P<0.01),使情况变得复杂。4. 以FEV1和VC的绝对及相对变化以及曲线下面积作为反应变量时,得到了相似的结果。5. 该研究表明,如果仅考虑药物的平均效应,可能会掩盖患者反应中重要的个体差异。

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