Jones Paul W, Gelhorn Heather, Wilson Hilary, Benson Victoria S, Karlsson Niklas, Menjoge Shailendra, Müllerova Hana, Rennard Stephen I, Tal-Singer Ruth, Merrill Debora, Tabberer Maggie
Institute of Infection and Immunity, St George's University of London, United Kingdom.
Evidera, Bethesda, Maryland.
Chronic Obstr Pulm Dis. 2017 Apr 1;4(2):150-158. doi: 10.15326/jcopdf.4.2.2017.0132.
: Randomized controlled trials (RCTs) often recruit patients from low and high socioeconomic status (SES) countries, but little is known about the effect of SES on clinical outcomes, particularly patient-centered measures of symptomatic benefit. : Combined individual chronic obstructive pulmonary disease (COPD) patient data from the placebo and long-acting bronchodilator arms of 17 RCTs (from the COPD Biomarkers Qualification Consortium database) were analyzed. Health status was measured using the St George's Respiratory Questionnaire (SGRQ) (minimum clinically important difference [MCID]: 4 units). Trials were grouped into short-term (≤12 months) and medium-term (>12 months to 48 months). A participant's country of residence was categorized into Low/Medium or High SES using World Health Organization criteria. : Data from 19765 individuals (6109 Low/Medium SES) were available. Patients in Low/Medium SES countries had more severe disease at baseline. Improvement in SGRQ score with placebo was ≈2 units greater in Low/Medium than in High SES countries; at its greatest, the improvement from baseline exceeded the MCID in Low/Medium countries. This difference was maintained for at least 1 year. Improvement with bronchodilator was also greater in Low/Medium versus High SES countries; overall there was no evidence that the treatment effect versus placebo was different between countries of different SES status. : Participants in Low/Medium SES countries experienced significantly larger treatment effects, irrespective of treatment group (placebo and bronchodilator). Despite this, COPD patients in Low/Medium SES countries experienced a health status gain from long-acting bronchodilator treatment that is similar to that seen in High SES countries.
随机对照试验(RCT)通常从社会经济地位(SES)低和高的国家招募患者,但对于SES对临床结局的影响,尤其是以患者为中心的症状改善指标,了解甚少。分析了17项随机对照试验(来自慢性阻塞性肺疾病生物标志物资格认证联盟数据库)中安慰剂组和长效支气管扩张剂组的慢性阻塞性肺疾病(COPD)患者个体合并数据。使用圣乔治呼吸问卷(SGRQ)测量健康状况(最小临床重要差异[MCID]:4分)。试验分为短期(≤12个月)和中期(>12个月至48个月)。根据世界卫生组织标准,将参与者的居住国分为低/中等或高SES。有19765名个体(6109名低/中等SES)的数据可用。低/中等SES国家的患者在基线时疾病更严重。低/中等SES国家安慰剂组SGRQ评分的改善比高SES国家大约多2分;在低/中等国家,从基线开始的最大改善超过了MCID。这种差异至少维持了1年。低/中等SES国家使用支气管扩张剂的改善也大于高SES国家;总体而言,没有证据表明不同SES状态国家之间与安慰剂相比的治疗效果存在差异。低/中等SES国家的参与者无论治疗组(安慰剂和支气管扩张剂)如何,都经历了明显更大的治疗效果。尽管如此,低/中等SES国家的COPD患者通过长效支气管扩张剂治疗获得的健康状况改善与高SES国家相似。