Institute of Primary Medical Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Eur J Intern Med. 2013 Jun;24(4):333-8. doi: 10.1016/j.ejim.2013.01.003. Epub 2013 Feb 1.
Little is known about parameters that lead to improvement in QoL in individual patients. We analysed the data of the Cardiac Insufficiency Bisoprolol Study in Elderly (CIBIS-ELD) in order to answer the question of how and to what extent change in health-related QoL during up-titration with bisoprolol vs. carvedilol is influenced by clinical and psychosocial factors in elderly patients with heart failure.
This is a QoL analysis of CIBIS-ELD, an investigator-initiated multi-center randomised phase III trial in elderly patients (65 years or older) with moderate to severe heart failure. Clinical parameters such as New York Heart Association functional class, heart rate, left ventricular ejection fraction (LVEF), 6-min walk distance, as well as the physical and psychosocial component scores on the short-form QoL health survey (SF36) and depression were recorded at baseline and at the final study visit.
Full baseline and follow-up QoL data were available for 589 patients (292 in the bisoprolol and 297 in the carvedilol group). Mean physical and psychosocial QoL improved significantly during treatment. In regression analyses, changes in both SF36 component scores from baseline to follow-up were mainly predicted by baseline QoL and depression as well as change in depression over time. Changes in cardiac severity markers were significantly weaker predictors.
Mean QoL increased during up-titration of bisoprolol and carvedilol. Both baseline depression and improvement in depression over time are associated with greater improvement in QoL more strongly than changes in cardiac severity measures.
对于导致个体患者生活质量改善的参数知之甚少。我们分析了心力衰竭老年患者比索洛尔和卡维地洛（CIBIS-ELD）研究的数据，以回答在比索洛尔与卡维地洛尔滴定过程中，健康相关生活质量变化的方式和程度如何受到老年心力衰竭患者临床和社会心理因素的影响。
这是 CIBIS-ELD 的一项生活质量分析，这是一项由研究者发起的多中心随机 III 期临床试验，纳入了 65 岁或以上的中度至重度心力衰竭老年患者。记录了临床参数，如纽约心脏协会功能分级、心率、左心室射血分数（LVEF）、6 分钟步行距离，以及短式健康调查（SF36）的身体和社会心理成分评分以及抑郁情况，在基线和最终研究访视时记录。
589 例患者（比索洛尔组 292 例，卡维地洛尔组 297 例）有完整的基线和随访生活质量数据。治疗期间，SF36 各成分评分和心理健康评分均显著改善。在回归分析中，SF36 各成分评分从基线到随访的变化主要由基线生活质量和抑郁以及随时间变化的抑郁改善来预测。心脏严重程度标志物的变化是较弱的预测因素。
比索洛尔和卡维地洛尔滴定过程中，平均生活质量均有所提高。与心脏严重程度测量的变化相比，基线抑郁和随时间改善的抑郁与生活质量的更大改善密切相关。
