Cleland John G F, Charlesworth Andrew, Lubsen Jacobus, Swedberg Karl, Remme Willem J, Erhardt Leif, Di Lenarda Andrea, Komajda Michel, Metra Marco, Torp-Pedersen Christian, Poole-Wilson Philip A
Department of Cardiology, University of Hull, Kingston-upon-Hull, United Kingdom.
J Am Coll Cardiol. 2006 Apr 18;47(8):1603-11. doi: 10.1016/j.jacc.2005.11.069. Epub 2006 Mar 29.
This study was designed to investigate the loss of well-being, in terms of life-years, overall and in patients randomized to metoprolol versus carvedilol in the Carvedilol Or Metoprolol European Trial (COMET).
The ultimate objectives of treating patients with heart failure are to relieve suffering and prolong life. Although the effect of treatment on mortality is usually described in trials, the effects on patient well-being throughout the trials' courses are rarely reported.
A total of 3,029 patients randomized in the COMET study were included in the analysis. "Patient journey" was calculated by adjusting days alive and out of hospital over four years using a five-point score completed by the patient every four months, adjusted according to the need for intensification of diuretic therapy. Scores ranged from 0% (dead or hospitalized) to 100% (feeling very well).
Over 48 months, 17% of all days were lost through death, 1% through hospitalization, 23% through impaired well-being, and 2% through the need for intensified therapy. Compared with metoprolol, carvedilol was associated with fewer days lost to death, with no increase in days lost due to impaired well-being or days in hospital. The "patient journey" score improved from a mean of 54.8% (SD 26.0) to 57.4% (SD 26.3%) (p < 0.0068).
Despite treatment with beta-blockers, heart failure remains associated with a marked reduction in well-being and survival. Loss of quality-adjusted life-years through death and poor well-being seemed of similar magnitude over four years, and both were much larger than the loss that could be attributed to hospitalization.
本研究旨在依据生命年数,全面调查在卡维地洛或美托洛尔欧洲试验(COMET)中随机分配至美托洛尔组与卡维地洛组患者的幸福感丧失情况。
治疗心力衰竭患者的最终目标是减轻痛苦并延长生命。尽管试验中通常会描述治疗对死亡率的影响,但很少报告整个试验过程中对患者幸福感的影响。
COMET研究中随机分组的3029例患者纳入分析。“患者历程”通过以下方式计算:使用患者每四个月完成的五分制评分对四年内的存活天数和出院天数进行调整,并根据利尿剂治疗强化需求进行校正。评分范围从0%(死亡或住院)至100%(感觉非常良好)。
在48个月期间,所有天数中有17%因死亡而损失,1%因住院而损失,23%因幸福感受损而损失,2%因需要强化治疗而损失。与美托洛尔相比,卡维地洛导致因死亡而损失的天数更少,因幸福感受损或住院而损失的天数未增加。“患者历程”评分从平均54.8%(标准差26.0)提高至57.4%(标准差26.3%)(p<0.0068)。
尽管使用了β受体阻滞剂进行治疗,但心力衰竭仍与幸福感和生存率的显著降低相关。在四年期间,因死亡和幸福感差导致的质量调整生命年损失似乎幅度相近,且两者均远大于可归因于住院的损失。