Spencer S, Calverley P M, Sherwood Burge P, Jones P W
Department of Physiological Medicine, St George's Hospital Medical School, London, United Kingdom.
Am J Respir Crit Care Med. 2001 Jan;163(1):122-8. doi: 10.1164/ajrccm.163.1.2005009.
This study examined health status decline in patients with chronic obstructive pulmonary disease (COPD). Data are from the Inhaled Steroids in Obstructive Lung Disease (ISOLDE) trial. After an 8-wk run-in, 751 patients (566 male), mean age 64 yr, were randomized to receive fluticasone propionate (FP) 500 microg twice daily (376 patients) or placebo (375 patients). Mean baseline postbronchodilator FEV1 was 50 +/- 15% predicted. Patients completed the St George's Respiratory Questionnaire (SGRQ) and the Short-Form 36 (SF-36) at baseline and every 6 mo for 3 yr. FEV1 and smoking status were assessed at baseline and at 3-mo intervals. A total of 387 (212 FP) patients completed the trial. All SGRQ components (p = 0.03 to 0.004) and Physical Function, Mental Health, Energy/ Vitality, and Physical Role Limitation scales of the SF-36 (p = 0.05 to 0.005) deteriorated faster in the placebo group. FEV1 and SGRQ scores correlated at baseline values (r = -0.25, p < 0.0001), as did change in FEV1 and change in SGRQ (Delta r = -0.24, p < 0.0001). At baseline values smokers had worse SGRQ Total, Symptoms, and Impacts scores than ex-smokers. This difference was maintained throughout the study. Smoking status did not influence the rate of decline in health status. The SGRQ Total scores of FP-treated patients took 59% longer than placebo to deteriorate by a clinically significant amount. We conclude that health status decline in moderate to severe COPD can be reduced by high-dose fluticasone.
本研究调查了慢性阻塞性肺疾病（COPD）患者的健康状况下降情况。数据来自阻塞性肺病吸入性类固醇（ISOLDE）试验。经过8周的导入期后，751例患者（566例男性），平均年龄64岁，被随机分为两组，分别接受每日两次500微克丙酸氟替卡松（FP）治疗（376例患者）或安慰剂治疗（375例患者）。支气管扩张剂使用后平均基线第1秒用力呼气容积（FEV1）为预测值的50±15%。患者在基线时以及之后3年中每6个月完成一次圣乔治呼吸问卷（SGRQ）和简明健康调查问卷（SF-36）。在基线时以及每隔3个月评估FEV1和吸烟状况。共有387例（212例接受FP治疗）患者完成了试验。安慰剂组中，SGRQ的所有组成部分（p = 0.03至0.004）以及SF-36的身体功能、心理健康、精力/活力和身体角色限制量表（p = 0.05至0.005）恶化得更快。FEV1与SGRQ评分在基线值时具有相关性（r = -0.25，p < 0.0001），FEV1的变化与SGRQ的变化也具有相关性（Δr = -0.24，p < 0.0001）。在基线值时，吸烟者的SGRQ总分、症状评分和影响评分比戒烟者更差。这种差异在整个研究过程中一直存在。吸烟状况不影响健康状况下降的速率。接受FP治疗的患者SGRQ总分恶化到具有临床意义的程度所需的时间比安慰剂组长59%。我们得出结论，高剂量氟替卡松可减缓中重度COPD患者的健康状况下降。
