DETERMINING OPTIMAL THERAPY - RANDOMIZED TRIALS IN INDIVIDUAL PATIENTS
DETERMINING OPTIMAL THERAPY - RANDOMIZED TRIALS IN INDIVIDUAL PATIENTS
复制标题
DOI：
10.1056/nejm198604033141406
复制
发表时间：
1986-04-03
影响因子：
158.5
通讯作者：
PUGSLEY, S
中科院分区：
文献类型：
--
作者：
GUYATT, G;SACKETT, D;PUGSLEY, S
虽然在常规临床实践中对单个患者的治疗被比作一个实验，但这种方法很容易受到偏倚的影响，因此我们要求对疗效进行多患者、双盲、随机对照试验。不幸的是，对于许多临床疾病，没有或不能进行这样的试验;为了解决这个问题，我们开始使用双盲随机试验，其中一名患者接受一系列成对的治疗，每对包括一种活性药物和一种安慰剂或替代治疗，其顺序由随机分配确定。使用适当的治疗目标（体征、症状或实验室检查）作为疗效的衡量标准，并继续进行试验，直到疗效被确定或被证明无效。我们描述了这样一个试验，这导致了一个显着有益的修改治疗患者部分可逆的气流限制。我们已经建立了一个临床服务，促进了该方法在我们社区的广泛使用。（N Engl J Med 1986; 314：889-92.）
Although the treatment of an individual patient in routine clinical practice has been likened to an experiment, the method is so susceptible to bias that we have come to demand multi-patient, double-blind, randomized controlled trials on matters of efficacy. Unfortunately, such trials have not or cannot be carried out for many clinical disorders; even when they have been executed their results may be difficult to extrapolate to individual patients.To resolve this problem, we have begun to use double-blind randomized trials in which a single patient under-goes a series of pairs of treatments, consisting of one active and one placebo or alternative treatment per pair, with the order determined by random allocation. Appropriate treatment targets (signs, symptoms, or laboratory tests) are used as the measure of efficacy, and the trial is continued until efficacy is established or disproved. We describe such a trial, which resulted in a dramatically beneficial modification of treatment in a patient with partially reversible airflow limitation. We have established a clinical service that facilitates the widespread use of the method in our community. (N Engl J Med 1986; 314:889–92.)