Jones P W, Bosh T K
Division of Physiological Medicine, St. George's Hospital Medical School, London, United Kingdom.
Am J Respir Crit Care Med. 1997 Apr;155(4):1283-9. doi: 10.1164/ajrccm.155.4.9105068.
Changes in health-related quality of life (HRQoL) were evaluated in patients with chronic obstructive pulmonary disease (COPD) following treatment with placebo, salmeterol 50 microg twice a day or 100 microg twice a day by metered-dose inhaler. Patients completed the disease-specific St. George's Respiratory Questionnaire (SGRQ) and the Medical Outcomes Study Short Form 36 (SF-36) at baseline and after 16 wk of treatment. Data from 283 patients (95 patients in the placebo group and 94 in each salmeterol group) were available for HRQoL analysis. Apart from a small difference in ages, all treatment groups were well matched at baseline in terms of forced expiratory volume in one second (FEV1) and HRQoL scores. Compared with placebo, salmeterol 50 microg twice a day was associated with significant improvements in SGRQ "Total" and "Impacts" scores which exceeded the threshold for a clinically significant change. This was not seen with salmeterol 100 microg twice a day. Changes in SGRQ and SF-36 scores correlated. They also showed a weak but significant relationship with FEV1. This study has shown that a modest change in lung function may be associated with clinically significant gain in health and well-being in COPD patients.
通过定量吸入器，对慢性阻塞性肺疾病（COPD）患者分别给予安慰剂、每日两次50微克沙美特罗或每日两次100微克沙美特罗治疗后，评估其健康相关生活质量（HRQoL）的变化。患者在基线期和治疗16周后完成特定疾病的圣乔治呼吸问卷（SGRQ）和医学结局研究简明健康调查问卷（SF-36）。共有283例患者（安慰剂组95例，沙美特罗各剂量组各94例）的数据可用于HRQoL分析。除年龄存在细微差异外，所有治疗组在基线期的一秒用力呼气容积（FEV1）和HRQoL评分方面均匹配良好。与安慰剂相比，每日两次50微克沙美特罗可使SGRQ“总分”和“影响”评分显著改善，且超过临床显著变化的阈值。每日两次100微克沙美特罗则未出现这种情况。SGRQ和SF-36评分的变化具有相关性。它们与FEV1也呈现出微弱但显著的关系。该研究表明，肺功能的适度变化可能与COPD患者健康和幸福感的临床显著改善相关。
