Jones K P
Department of Primary Medical Care, University of Southampton, UK.
Thorax. 1994 Oct;49(10):971-5. doi: 10.1136/thx.49.10.971.
Clinical studies of inhaled salmeterol xinafoate have been conducted mainly in moderately to severely affected asthmatic subjects in hospital settings. This study was conducted to investigate the effectiveness of this drug in patients with milder asthma in primary care.
A multicentre, double blind, randomised, parallel group comparison of salmeterol xinafoate in a dose of 50 micrograms twice daily with placebo, both administered from a four-place dry powder inhaler (Diskhaler), was performed over six weeks in United Kingdom general practices.
A total of 427 asthmatic patients aged 18 years or older were randomised to receive salmeterol or placebo in a 2:1 ratio. Of the total randomised population, 247 patients were previously on short acting bronchodilators alone whilst 180 patients were concurrently receiving up to 400 micrograms inhaled corticosteroid. Mean morning peak expiratory flow rose more in the salmeterol group than in the placebo group (treatment difference 17 l/min, 95% confidence interval 9 to 26 l/min) but there was a smaller, non-significant difference in mean evening peak expiratory flow. Improvements occurred in the salmeterol-treated group compared with placebo for wheeze, shortness of breath, undisturbed nights, and relief medication use, irrespective of concomitant inhaled corticosteroid use. In addition, improvement in activity restriction was seen in the salmeterol group compared with placebo in the subgroup receiving only bronchodilator.
Salmeterol is effective and well tolerated in the short term in mildly asthmatic adult patients irrespective of concomitant use of inhaled corticosteroid therapy.
吸入用昔萘酸沙美特罗的临床研究主要在医院环境中针对中度至重度哮喘患者开展。本研究旨在调查该药物在基层医疗中对轻度哮喘患者的有效性。
在英国的普通诊所中，进行了一项多中心、双盲、随机、平行组对照试验，将每日两次剂量为50微克的昔萘酸沙美特罗与安慰剂通过四剂量干粉吸入器（Diskhaler）给药，为期六周。
共有427名18岁及以上的哮喘患者被随机分组，以2:1的比例接受沙美特罗或安慰剂治疗。在所有随机分组的人群中，247名患者此前仅使用短效支气管扩张剂，而180名患者同时接受高达400微克的吸入性糖皮质激素治疗。沙美特罗组的平均晨起呼气峰值流速比安慰剂组升高得更多（治疗差异为17升/分钟，95%置信区间为9至26升/分钟），但平均夜间呼气峰值流速的差异较小且无统计学意义。与安慰剂相比，无论是否同时使用吸入性糖皮质激素，沙美特罗治疗组在喘息、气短、夜间安稳睡眠和缓解药物使用方面均有改善。此外，在仅接受支气管扩张剂治疗的亚组中，与安慰剂相比，沙美特罗组在活动受限方面也有改善。
无论是否同时使用吸入性糖皮质激素治疗，沙美特罗在轻度哮喘成年患者中短期内有效且耐受性良好。
