Kemp J P, Cook D A, Incaudo G A, Corren J, Kalberg C, Emmett A, Cox F M, Rickard K
Allergy & Asthma Medical Group and Research Center, APC, San Diego, Calif. 92123, USA.
J Allergy Clin Immunol. 1998 Feb;101(2 Pt 1):188-95. doi: 10.1016/s0091-6749(98)70383-5.
Traditional clinical outcomes have demonstrated that salmeterol improves pulmonary function and reduces asthma symptoms. However, they do not evaluate how patients perceive the effect of therapeutic intervention on day-to-day functioning and well-being.
We sought to evaluate the impact of salmeterol on disease-specific quality of life with the Asthma Quality-of-Life Questionnaire, as well as the efficacy and safety of salmeterol in patients with stable asthma who were symptomatic despite daily use of inhaled corticosteroids.
This was a randomized, double-blind, placebo-controlled, parallel-group study of 506 patients. Patients were treated with 42 microg salmeterol or placebo twice daily for 12 weeks delivered through a metered dose inhaler.
Mean change from baseline in asthma quality-of-life scores was significantly greater (p < or = 0.006) after 12 weeks of treatment with salmeterol compared with placebo ("as-needed" albuterol) in global scores (1.08 vs 0.61) and individual domains (activity limitations, 0.91 vs 0.54; asthma symptoms, 1.28 vs 0.71; emotional function, 1.17 vs 0.65; and environmental exposure, 0.84 vs 0.47). Patients treated with salmeterol experienced significantly greater improvements from baseline to week 12 compared with placebo in FEV1 (0.42 L vs 0.15 L, p < 0.001), morning peak expiratory flow (47 L/min vs 14 L/min, p < 0.001), evening peak expiratory flow (29 L/min vs 11 L/min, p < 0.001), and asthma symptom scores (daytime scores reduced by 0.55 vs 0.30, p < 0.001). Patients treated with salmeterol used significantly less supplemental albuterol (reduced by 3 puffs/day vs 1 puff/day, p < 0.001).
Salmeterol provided significantly greater improvement in quality-of-life outcomes in patients whose asthma symptoms are not well controlled with inhaled corticosteroids. These results demonstrate that the benefits of salmeterol are not limited to conventional clinical measures of efficacy.
传统的临床结果表明，沙美特罗可改善肺功能并减轻哮喘症状。然而，这些结果并未评估患者如何看待治疗干预对日常功能和健康状况的影响。
我们试图通过哮喘生活质量问卷评估沙美特罗对特定疾病生活质量的影响，以及沙美特罗对尽管每日使用吸入性糖皮质激素仍有症状的稳定期哮喘患者的疗效和安全性。
这是一项对506例患者进行的随机、双盲、安慰剂对照、平行组研究。患者通过定量吸入器，每日两次接受42微克沙美特罗或安慰剂治疗，为期12周。
与安慰剂（按需使用沙丁胺醇）相比，沙美特罗治疗12周后，哮喘生活质量评分较基线的平均变化在总体评分（1.08对0.61）和各个领域（活动受限，0.91对0.54；哮喘症状，1.28对0.71；情绪功能，1.17对0.65；环境暴露，0.84对0.47）方面均显著更大（p≤0.006）。与安慰剂相比，接受沙美特罗治疗的患者从基线到第12周在第1秒用力呼气容积（0.42升对0.15升，p<0.001）、晨起呼气峰流速（47升/分钟对14升/分钟，p<0.001）、夜间呼气峰流速（29升/分钟对11升/分钟，p<0.001）以及哮喘症状评分（日间评分降低0.55对0.30，p<0.001）方面有显著更大的改善。接受沙美特罗治疗的患者使用的补充沙丁胺醇显著更少（减少3喷/天对1喷/天，p<0.001）。
对于哮喘症状未被吸入性糖皮质激素良好控制的患者，沙美特罗在生活质量结果方面提供了显著更大的改善。这些结果表明，沙美特罗的益处不仅限于传统的临床疗效指标。
