Strauss W E, Fortin T, Hartigan P, Folland E D, Parisi A F
Department of Veterans Affairs Medical Center, West Roxbury, MA 02132, USA.
Circulation. 1995 Oct 1;92(7):1710-9. doi: 10.1161/01.cir.92.7.1710.
Evaluations of therapy for the treatment of angina have traditionally consisted of a combination of objective measures, such as exercise tolerance, and subjective markers, such as angina attack rate. Recently, the need to assess "how patients feel"--their quality of life (QOL)--has been regarded with increasing importance. Standard instruments are available to assess QOL and its change after therapeutic intervention. Although QOL instruments have been used to assess the efficacy of percutaneous transluminal coronary angioplasty (PTCA), they have not been used previously to compare the impact of PTCA with that of medical therapy in patients with angina pectoris. We report on the changes in self-assessed QOL among patients randomly assigned to treatment by PTCA or medical therapy and relate these measurements to changes in exercise performance and coronary angiograms.
Patients with stable angina, a positive exercise tolerance test, and at least 70% stenosis (index lesion) in the proximal two thirds of one major coronary artery were randomly assigned to receive PTCA or medical therapy. Six months after randomization, each patient underwent repeat exercise testing and coronary angiography. Before randomization and at the 6-month visit, patients completed a self-administered QOL questionnaire that measured physical functioning and psychological well-being. We compared the changes in QOL with changes between the baseline and 6-month exercise tests, stratified by terciles (decrease in duration, 0- to 2-minute increase, and > 2-minute improvement). We also stratified patients by whether there was more or less than 2 SD change (18.8%) in diameter stenosis of the index lesion (initial minus follow-up angiogram), and we related these to changes in QOL measures. One hundred eighty-two patients with one-vessel disease completed baseline and 6-month questionnaires. At baseline, there were no differences in any QOL measurements between treatment groups. At the 6-month follow-up visit, there was greater improvement in both physical functioning and psychological well-being scores for patients receiving PTCA (+7.36 +/- 15.6, PTCA; +1.98 +/- 14.7, medical therapy; P < .02). Improvement in QOL variables was noted only in patients demonstrating an increase in exercise performance. Also, patients assigned to either treatment whose angiograms demonstrated more than 18.8% improvement in index lesion percent stenosis experienced a significant increase in their QOL scores.
This was the first study of the relative changes in QOL measures assessed with the use of previously validated and standardized instruments in patients randomly assigned to treatment with PTCA or medical therapy. Patients assigned to PTCA demonstrated a significantly greater improvement in both physical and psychological measures. This improvement was noted in patients whose exercise performance improved and whose angiograms demonstrated an improvement in lesion severity.
传统上，对心绞痛治疗效果的评估包括客观指标（如运动耐量）和主观指标（如心绞痛发作率）的综合评估。最近，评估“患者感受如何”——即他们的生活质量（QOL）——的需求受到了越来越多的重视。有标准工具可用于评估生活质量及其在治疗干预后的变化。尽管生活质量工具已用于评估经皮腔内冠状动脉成形术（PTCA）的疗效，但此前尚未用于比较PTCA与药物治疗对心绞痛患者的影响。我们报告了随机分配接受PTCA或药物治疗的患者自我评估生活质量的变化，并将这些测量结果与运动表现和冠状动脉造影的变化相关联。
稳定性心绞痛、运动耐量试验阳性且一条主要冠状动脉近端三分之二处至少有70%狭窄（索引病变）的患者被随机分配接受PTCA或药物治疗。随机分组6个月后，每位患者接受重复运动测试和冠状动脉造影。在随机分组前和6个月随访时，患者完成一份自我管理的生活质量问卷，该问卷测量身体功能和心理健康。我们将生活质量的变化与基线和6个月运动测试之间的变化进行比较，按三分位数分层（持续时间减少、增加0至2分钟、改善超过2分钟）。我们还根据索引病变直径狭窄（初始减去随访血管造影）是否有超过或少于2个标准差的变化（18.8%）对患者进行分层，并将这些与生活质量测量的变化相关联。182例单支血管病变患者完成了基线和6个月的问卷。在基线时，治疗组之间的任何生活质量测量均无差异。在6个月随访时，接受PTCA治疗的患者在身体功能和心理健康评分方面的改善更大（PTCA组为+7.36±15.6；药物治疗组为+1.98±14.7；P<0.02）。仅在运动表现增加的患者中观察到生活质量变量的改善。此外，血管造影显示索引病变狭窄百分比改善超过18.8%的接受任何一种治疗的患者，其生活质量评分显著增加。
这是第一项使用先前验证和标准化的工具评估随机分配接受PTCA或药物治疗的患者生活质量测量相对变化的研究。接受PTCA治疗的患者在身体和心理测量方面的改善明显更大。在运动表现改善且血管造影显示病变严重程度改善的患者中观察到了这种改善。
