Cazzola M, Matera M G, Santangelo G, Vinciguerra A, Rossi F, D'Amato G
Division of Pneumology and Allergology, A. Cardarelli Hospital, Naples, Italy.
Respir Med. 1995 May;89(5):357-62. doi: 10.1016/0954-6111(95)90008-x.
When testing the response to beta 2-agonist drugs in severe chronic obstructive pulmonary disease (COPD), a dose-response assessment should be undertaken. This study compares the time course of inhaled salmeterol (25, 50 and 75 micrograms) and formoterol (12, 24 and 36 micrograms) at different doses in a group of 12 patients with partially reversible, but severe COPD (FEV1 of 12-32% of predicted values after beta 2-agonist drugs had been withheld for 24 h). All doses of salmeterol and formoterol induced a significant (P < 0.01) spirometric improvement over the 12-h monitoring period, when compared to the spirometric improvement after placebo, but while formoterol induced a dose-dependent increase of the FVC, FEV1 and FEF50, this was not the case for salmeterol. In fact, 75 micrograms salmeterol did not produce a further improvement of these parameters. Mean peak bronchodilation, expressed as the increase in FEV1 over baseline values, occurred 2 h after inhalation of the three doses of salmeterol, and 1 h after inhalation of the three doses of formoterol. A comparison of 50 micrograms salmeterol with 12 micrograms or 24 micrograms formoterol (clinically recommended doses), showed that improvement of FEV1 after salmeterol was statistically (P < 0.05) higher than that after the two doses of formoterol, although the mean peak bronchodilations were similar. This was because salmeterol has a longer duration of action than formoterol. These data demonstrate that salmeterol is equally effective as, but longer-acting than, formoterol at clinically recommended doses in patients suffering from COPD, with severe airway obstruction.(ABSTRACT TRUNCATED AT 250 WORDS)
在对重度慢性阻塞性肺疾病(COPD)患者进行β2受体激动剂药物反应测试时,应进行剂量反应评估。本研究比较了12例部分可逆但病情严重的COPD患者(在停用β2受体激动剂药物24小时后,FEV1为预测值的12% - 32%)吸入不同剂量沙美特罗(25、50和75微克)和福莫特罗(12、24和36微克)后的时间过程。与安慰剂后的肺量计改善情况相比,在12小时监测期内,所有剂量的沙美特罗和福莫特罗均引起了显著的(P < 0.01)肺量计改善,但福莫特罗引起FVC、FEV1和FEF50呈剂量依赖性增加,而沙美特罗并非如此。事实上,75微克沙美特罗并未使这些参数进一步改善。以FEV1相对于基线值的增加表示的平均峰值支气管扩张,在吸入三剂沙美特罗后2小时出现,在吸入三剂福莫特罗后1小时出现。将50微克沙美特罗与12微克或24微克福莫特罗(临床推荐剂量)进行比较,结果显示,沙美特罗后的FEV1改善在统计学上(P < 0.05)高于两剂福莫特罗后的改善,尽管平均峰值支气管扩张相似。这是因为沙美特罗的作用持续时间比福莫特罗长。这些数据表明,在患有COPD且气道严重阻塞的患者中,临床推荐剂量下,沙美特罗与福莫特罗疗效相当,但作用时间更长。(摘要截选至250字)