Nielsen L P, Pedersen B, Faurschou P, Madsen F, Wilcke J T, Dahl R
Department of Respiratory Diseases, Aarhus University Hospital, Copenhagen, Denmark.
Respir Med. 1999 Dec;93(12):863-8. doi: 10.1016/s0954-6111(99)90051-3.
Previous results have demonstrated addition of long-acting beta2-adrenergic agonists to be beneficial in asthma patients already receiving inhaled corticosteroid. The purpose of this study was to determine, qualitatively as well as quantitatively, the steroid-sparing properties of salmeterol in stable asthma patients receiving maintenance inhaled corticosteroids (800-1600 microg day(-1)). In these patients, the daily dose of beclomethasone dipropionate was reduced by 200 microg each week until asthma deteriorated, with the minimal acceptable dose (MAD) being defined as the dose one step above deterioration (sensitivity period). Following this, patients received three times the MAD for 2 weeks. Patients were randomized to receive either salmeterol 50 microg twice daily or placebo and the MAD was again determined (treatment period). Forced expiratory volume in 1 sec (FEV1) was measured each week. Morning and evening peak expiratory flow (PEF), symptom score and use of bronchodilator were recorded each day. Fifteen patients received salmeterol and 19 placebo. The MAD was significantly lower in the salmeterol group compared with placebo during the treatment period (P<0.01). A 50% reduction of the MAD was achieved by more patients treated with salmeterol than placebo (P = 0.001). Salmeterol caused a significantly greater reduction in daytime symptom score and use of as-needed beta2-agoinist therapy between sensitivity and treatment periods compared with placebo (P<0.05 for both). The results demonstrate, that the addition of salmeterol to corticosteroid treatment offers a clinically relevant potential for reduction of inhaled corticosteroid dose in steroid sensitive asthmatics.
既往研究结果表明，对于已经接受吸入性糖皮质激素治疗的哮喘患者，加用长效β2肾上腺素能激动剂是有益的。本研究的目的是定性和定量地确定沙美特罗对接受维持性吸入糖皮质激素（800 - 1600微克/天）治疗的稳定期哮喘患者的糖皮质激素节省作用。在这些患者中，丙酸倍氯米松的每日剂量每周减少200微克，直至哮喘恶化，将最小可接受剂量（MAD）定义为高于恶化剂量一级的剂量（敏感期）。在此之后，患者接受三倍MAD剂量治疗2周。患者被随机分为两组，分别接受每日两次50微克沙美特罗或安慰剂治疗，然后再次确定MAD（治疗期）。每周测量1秒用力呼气容积（FEV1）。每天记录早晚呼气峰值流速（PEF）、症状评分和支气管扩张剂使用情况。15例患者接受沙美特罗治疗，19例接受安慰剂治疗。在治疗期，沙美特罗组的MAD显著低于安慰剂组（P<0.01）。与安慰剂相比，更多接受沙美特罗治疗的患者MAD降低了50%（P = 0.001）。与安慰剂相比，沙美特罗在敏感期和治疗期之间使日间症状评分和按需使用β2激动剂治疗的减少更为显著（两者均P<0.05）。结果表明，在糖皮质激素治疗中加用沙美特罗，对于激素敏感型哮喘患者减少吸入性糖皮质激素剂量具有临床相关的潜在作用。
