Proposal for a new clinical end point to evaluate the efficacy of drugs and devices in the treatment of chronic heart failure
Proposal for a new clinical end point to evaluate the efficacy of drugs and devices in the treatment of chronic heart failure
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DOI：
10.1054/jcaf.2001.25652
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发表时间：
2001-06-01
影响因子：
6
通讯作者：
Packer, M
中科院分区：
文献类型：
--
作者：
Packer, M
旨在评估药物和器械对慢性心力衰竭症状和临床状态影响的临床试验经常产生相互矛盾、不确定或误导性的结果。这些困难可以解释为这样一个事实，即以前的研究依赖于具有固有局限性的疗效测量，并且使用忽略临床恶化发作的统计方法进行分析。认识到这些缺陷导致了一种新的临床综合评分的发展，该评分结合了纽约心脏协会分级和整体评估的变化以及主要临床事件发生提供的信息。在早期的试验中，使用这个评分可以正确地区分积极治疗和安慰剂，从而避免一些误导性的结论。新的临床综合评分已被前瞻性地纳入评估内皮素拮抗剂、细胞因子拮抗剂、抗利尿激素拮抗剂和心脏再同步化治疗慢性心力衰竭疗效的研究设计中。在迄今为止已完成的试验中，临床综合评分比传统方法在辨别是否存在真正的治疗效果方面更为敏感。
Clinical trials designed to evaluate the effect of drugs and devices on the symptoms and clinical status in chronic heart failure have frequently produced conflicting, inconclusive, or misleading results. These difficulties can be explained by the fact that previous studies have relied on efficacy measures that have inherent limitations and have been analyzed using statistical approaches that ignored episodes of clinical deterioration. Recognition of these pitfalls has led to the development of a new clinical composite score, which combines changes in the New York Heart Association class and the global assessment together with the information provided from the occurrence of major clinical events. Use of this score would have correctly distinguished active therapy from placebo in earlier trials and thus would have avoided some of their misleading conclusions. The new clinical composite score has been prospectively incorporated into the design of studies evaluating the efficacy of endothelin antagonists, cytokine antagonists, vasopressin antagonists, and cardiac resynchronization in the treatment of chronic heart failure. In the trials that have been completed to date, the clinical composite score has been more sensitive than conventional approaches in discerning the presence or absence of a true treatment effect.