Beeh K M, Wiewrodt R, Salem A E, Buhl R
Schwerpunkt Pneumologie, III. Medizinische Klinik und Poliklinik, Klinikum der Johannes Gutenberg-Universität, Mainz.
Pneumologie. 2000 Jun;54(6):225-31. doi: 10.1055/s-2000-8992.
Salmeterol is a long-acting inhaled beta 2-agonist with a bronchodilating effect lasting over 10 to 12 hours.
A prospective, open, multi-centre study was performed to evaluate the efficacy and safety of inhaled salmeterol (50 micrograms BID) over a mean treatment period of 29 months (range: 4-1145 days) in 634 patients (54% male, age 45 +/- 15 years) with mild to moderate asthma or chronic obstructive pulmonary disease (COPD). Peak expiratory flow rates, rescue use of short acting beta 2-agonists and safety were study objectives. Patients were critically monitored for a possible loss of bronchodilator efficacy of salmeterol during long-term treatment.
During the first month of salmeterol therapy, morning peak flow improved from 384 +/- 104 l/min to 413 +/- 112 l/min (p < 0.001), and use of rescue salbutamol was significantly reduced (21 +/- 21 to 8 +/- 14 puffs/week during daytime and 9 +/- 12 to 4.5 +/- 9 puffs/week during nighttime, p < 0.001 both comparisons). Peak flow improvement and reduction of short-acting beta 2-agonist use was maintained during the whole study period. Frequent adverse events were exacerbations of the underlying airway disease (24%) and infections (12%), while typical pharmacological side-effects like tremor or tachycardia where reported in less than 1% of all patients.
These results confirm the persistent efficacy and favourable safety profile of salmeterol during long-term therapy over more than two years. No clinical signs of a decreasing bronchodilator potency indicating tachyphylaxis were observed. Salmeterol treatment provides a therapeutic option to further improve the management and care of patients with moderate obstructive airway diseases.
沙美特罗是一种长效吸入型β2受体激动剂，其支气管扩张作用可持续10至12小时以上。
开展了一项前瞻性、开放性、多中心研究，以评估634例（男性占54%，年龄45±15岁）轻度至中度哮喘或慢性阻塞性肺疾病（COPD）患者在平均29个月（范围：4 - 1145天）的治疗期内吸入沙美特罗（50微克，每日两次）的疗效和安全性。研究目标包括峰值呼气流速、短效β2受体激动剂的急救使用情况及安全性。对患者进行密切监测，以观察长期治疗期间沙美特罗的支气管扩张疗效是否可能丧失。
在沙美特罗治疗的第一个月，早晨峰值流速从384±104升/分钟提高到413±112升/分钟（p<0.001），急救沙丁胺醇的使用显著减少（白天从每周21±21喷减少到8±14喷，夜间从每周9±12喷减少到4.5±9喷，两项比较p均<0.001）。在整个研究期间，峰值流速的改善和短效β2受体激动剂使用的减少得以维持。常见不良事件为基础气道疾病加重（24%）和感染（12%），而震颤或心动过速等典型的药理学副作用在所有患者中的报告发生率不到1%。
这些结果证实了沙美特罗在两年多的长期治疗中持续的疗效和良好的安全性。未观察到表明快速减敏的支气管扩张效力降低的临床迹象。沙美特罗治疗为进一步改善中度阻塞性气道疾病患者的管理和护理提供了一种治疗选择。
