Rutten-van Mölken M P, Custers F, van Doorslaer E K, Jansen C C, Heurman L, Maesen F P, Smeets J J, Bommer A M, Raaijmakers J A
Dept of Health Economics, University of Limburg, Maastricht, The Netherlands.
Eur Respir J. 1995 Jun;8(6):888-98.
Quality of life measures are increasingly used as important efficacy endpoints in studies of drugs for asthma. The purpose of this study was to assess both the sensitivity to change and the construct validity of four different quality of life instruments in patients with asthma. In a double-blind, parallel group study, 120 moderate asthma patients, aged between 18-70 yrs, received either inhaled salmeterol 50 micrograms b.i.d. or inhaled salbutamol 400 micrograms b.i.d. In addition to respiratory outcomes, quality of life was measured at a 6 weeks follow-up using: 1) Asthma Quality of Life Questionnaire (AQLQ); 2) Living With Asthma Questionnaire (LWAQ); 3) Sickness Impact Profile (SIP); 4) Rating Scale (RS); and Standard Gamble (SG) utilities. Salmeterol led to significant improvements over salbutamol on virtually all clinical outcomes. Although all the quality of life instruments showed the same trend in favour of salmeterol, only the AQLQ and RS utilities showed significantly greater improvement on salmeterol than on salbutamol. Except for the AQLQ, the correlation between change in lung function and change in quality of life was generally low. Whereas, the AQLQ correlated well with the patient's overall assessment of efficacy (r = 0.64), the LWAQ, SIP and utilities failed to show such a correlation. The AQLQ showed the best correlation with symptom scores. The cross-sectional correlation between the AQLQ and the LWAQ was 0.73, whereas the longitudinal correlation was only 0.29. The SG generally showed poor correlation with other measures, including the RS. In conclusion, patients given salmeterol showed a greater improvement in quality of life compared to patients given salbutamol. Of the disease-specific questionnaires the Asthma Quality of Life Questionnaire was found to be more responsive to change than the Living With Asthma Questionnaire and showed greater validity. Of the generic instruments, the rating scale utilities were most responsive. The Standard Gamble showed poor correlation with other measures.
生活质量测量越来越多地被用作哮喘药物研究中的重要疗效终点。本研究的目的是评估四种不同生活质量工具在哮喘患者中的变化敏感性和结构效度。在一项双盲、平行组研究中，120名年龄在18至70岁之间的中度哮喘患者，分别接受每日两次吸入50微克沙美特罗或每日两次吸入400微克沙丁胺醇治疗。除了呼吸指标外，在6周随访时使用以下工具测量生活质量：1）哮喘生活质量问卷（AQLQ）；2）哮喘患者生活问卷（LWAQ）；3）疾病影响量表（SIP）；4）评分量表（RS）和标准博弈（SG）效用。在几乎所有临床指标上，沙美特罗比沙丁胺醇带来了更显著的改善。虽然所有生活质量工具都显示出有利于沙美特罗的相同趋势，但只有AQLQ和RS效用显示沙美特罗比沙丁胺醇有显著更大的改善。除AQLQ外，肺功能变化与生活质量变化之间的相关性通常较低。然而，AQLQ与患者对疗效的总体评估相关性良好（r = 0.64），而LWAQ、SIP和效用未能显示出这种相关性。AQLQ与症状评分的相关性最好。AQLQ与LWAQ的横断面相关性为0.73，而纵向相关性仅为0.29。SG通常与其他测量方法的相关性较差，包括RS。总之，与接受沙丁胺醇治疗的患者相比，接受沙美特罗治疗的患者生活质量改善更大。在特定疾病问卷中，发现哮喘生活质量问卷比哮喘患者生活问卷对变化更敏感，且效度更高。在通用工具中，评分量表效用反应最为灵敏。标准博弈与其他测量方法的相关性较差。
