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生活质量作为治疗终点:高血压治疗试验分析

Quality of life as a therapeutic end-point. An analysis of therapeutic trials in hypertension.

作者信息

Hollenberg N K, Testa M, Williams G H

机构信息

Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

出版信息

Drug Saf. 1991 Mar-Apr;6(2):83-93. doi: 10.2165/00002018-199106020-00001.

DOI:10.2165/00002018-199106020-00001
PMID:2043286
Abstract

The term 'quality of life' is finding increasing use in the popular press and the medical community. In both areas, its use often lacks precision: a comprehensive and universal definition probably does not exist. Indeed, the precise elements contributing probably vary from person to person and from time to time. There is broad agreement that 5 major areas always need assessment, including physical and emotional state, performance of social roles, intellectual function and general feelings of well-being or life satisfaction. A wide range of instruments has been employed in a large number of studies on the effects of antihypertensive agents on quality of life in the patient with hypertension. Hypertension represents a special problem in which the patient is thought to be free of related symptoms, and treatment designed to improve natural history brings with it the burden of adverse reactions. Although some insights have been gained on the relative influence of various therapeutic regimens on the quality of life of treated patients, in many of the studies too little consideration has been given to the use of instruments that have been validated in the patient population to be studied, to the power of the study and its design, to the contribution of confounding variables such as age and gender, and to evidence that short term trials (measured in weeks) can miss important changes that occur over months in a process where treatment is life-long. For these reasons, we believe, the literature on the subject is burdened by many reports that describe no difference among treatment regimens where important differences might exist. On the positive side, important advances have been made in our understanding of the elements that contribute to quality of life and in approaches to its assessment.

摘要

“生活质量”一词在大众媒体和医学界的使用越来越广泛。在这两个领域,其使用往往缺乏精确性:可能不存在一个全面且通用的定义。事实上,构成生活质量的具体要素可能因人而异,也会随时间变化。人们普遍认为,始终需要评估5个主要方面,包括身体和情绪状态、社会角色表现、智力功能以及总体的幸福感或生活满意度。大量关于抗高血压药物对高血压患者生活质量影响的研究使用了各种各样的评估工具。高血压是一个特殊问题,患者被认为没有相关症状,而旨在改善疾病自然病程的治疗却带来了不良反应的负担。尽管对于各种治疗方案对接受治疗患者生活质量的相对影响已经有了一些认识,但在许多研究中,对于在待研究患者群体中经过验证的评估工具的使用、研究的效力及其设计、年龄和性别等混杂变量的影响,以及短期试验(以周为单位衡量)可能会忽略在终身治疗过程中数月内发生的重要变化等问题,考虑得太少。基于这些原因,我们认为,关于该主题的文献中有许多报告描述不同治疗方案之间没有差异,但实际上可能存在重要差异,这使得该文献负担沉重。从积极的方面来看,我们在对影响生活质量的因素及其评估方法的理解上已经取得了重要进展。

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