单个病例随机对照试验的设计与应用

Design and Application of Single Case Randomized Controlled Trial

随机对照试验根据分配单位的不同 ,可以是单个病例 (随机分配治疗 )、多个病例 (随机分组 ) ,也可以是群组如家庭、班级、社区。中医药擅长治疗慢性病 ,其辨证论治的特点要求研究方法的多样化。单个病例随机对照试验以其便于观察 ,减少个体差异 ,研究费用低廉 ,适用于慢性病的对症治疗研究。其特点是对两种治疗方案用随机的方法进行多次交叉的随访观察 ,评价治疗的效果。本文介绍了该设计的原理、方法、步骤。

The principle, method, procedure, indicated subject and feasibility of application of single case randomized controlled trial (SCRCT) were reviewed in the article. In randomized controlled trials (RCT), the allocation unit can be a single case (random therapy), multiple cases (random allocation) or group such as family, class or community. Traditional Chinese medicine is good at treatment of chronic disease, Syndrome differentiation, the traits of TCM, requires multiple research methods. SCRCT is suitable for symptomatic treatment of chronic disease due to its convenience in observation, reduce individual divergence and low research cost. SCRCT is characterized by using randomized method to carry out multiple crossover follow-up, to assess the efficacy of treatment for two therapeutic schemes.