Guyatt G H, Townsend M, Keller J, Singer J, Nogradi S
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Respir Med. 1989 Jul;83(4):293-7. doi: 10.1016/s0954-6111(89)80199-4.
The optimal method of assessing the effect of treatment on the day-to-day function of patients with chronic airflow limitation is not established. Therefore, we examined the performance of the Six Minute Walk test, a rating of dyspnea following the test and three different questionnaires measuring dyspnea in daily activities, in a controlled trial of inhaled salbutamol and oral theophylline in 24 patients with primarily fixed chronic airflow limitation. Clinically important and statistically significant effects of salbutamol and theophylline on dyspnea during day-to-day activities were detected by each measure, but the Chronic Respiratory Questionnaire (CRQ) appeared more powerful than either the Oxygen Cost Diagram or the Medical Research Council Dyspnea Questionnaire as modified by the Rand Corporation. Changes in the CRQ dyspnea score showed a higher correlation with changes in spirometry, walk test score, dyspnea following the walk test, and global ratings of dyspnea than did the other two measures. Results of the walk test demonstrated statistically significant salbutamol and theophylline effects, but suggested that no added benefit could be obtained with both drugs; the rating of dyspnea following the walk test, however, was consistent with an additive effect. We conclude that the CRQ is a responsive, valid measure of functional status for clinical trials in chronic lung disease, and that when the six minute walk is used as a measure of outcome, dyspnea following the walk test should be measured.
评估治疗对慢性气流受限患者日常功能影响的最佳方法尚未确定。因此，在一项针对24例主要为固定性慢性气流受限患者的吸入沙丁胺醇和口服茶碱的对照试验中，我们检测了六分钟步行试验的性能、试验后呼吸困难评分以及三种测量日常活动中呼吸困难的不同问卷。每种测量方法均检测到沙丁胺醇和茶碱对日常活动中呼吸困难具有临床重要且具有统计学意义的效果，但慢性呼吸问卷（CRQ）似乎比兰德公司修改后的氧耗图或医学研究委员会呼吸困难问卷更有效。与其他两种测量方法相比，CRQ呼吸困难评分的变化与肺功能测定、步行试验评分、步行试验后呼吸困难及呼吸困难总体评分的变化具有更高的相关性。步行试验结果显示沙丁胺醇和茶碱具有统计学意义的效果，但表明两种药物联合使用无法获得额外益处；然而，步行试验后呼吸困难评分与相加效应一致。我们得出结论，CRQ是慢性肺病临床试验中一种反应灵敏、有效的功能状态测量方法，并且当使用六分钟步行作为结局指标时，应测量步行试验后的呼吸困难。
