对照单受试者试验。
The controlled single subject trial.
作者信息
Johannessen T, Petersen H, Kristensen P, Fosstvedt D
机构信息
Department of Community Medicine and General Practice, University of Trondheim, Norway.
出版信息
Scand J Prim Health Care. 1991 Mar;9(1):17-21. doi: 10.3109/02813439109026576.
Randomized controlled trials in single subjects ('N of 1 RCT') are double-blind, multi crossover trials in which the effects of two or more treatments are compared within one individual. The aim is to provide a controlled assessment of the efficacy of a new drug in a specific patient. Suitable diseases for single subject trials are particularly those which significantly impair the quality of life and in which there are uncertain treatment effects. Appropriate drugs should have a prompt action, a minimum of carry-over effect, and no side-effects. The trial design is determined by the length, number, and order of successive treatment periods, the outcome measures, and the statistical requirements. Each of these elements may be altered and tailored to the clinical entity and drug(s) applied, thus, providing a large potential for design options.
单受试者随机对照试验（“N-of-1随机对照试验”）是双盲、多交叉试验，在个体内比较两种或更多治疗的效果。目的是对特定患者中新药的疗效进行对照评估。适合单受试者试验的疾病尤其包括那些严重损害生活质量且治疗效果不确定的疾病。合适的药物应起效迅速、残留效应最小且无副作用。试验设计由连续治疗期的长度、数量和顺序、结局指标以及统计要求决定。这些要素中的每一个都可以根据所应用的临床实体和药物进行改变和调整，因此，提供了很大的设计选择潜力。
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