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中国临床药理学与治疗学 ›› 2004, Vol. 9 ›› Issue (9): 1077-1080.

• 设计·统计·方法 • 上一篇    

临床医生的个案研究设计

罗玫, 熊宁宁, 汪秀琴, 邹建东, 蒋萌, 刘芳, 符为民   

  1. 南京中医药大学附属医院临床药理科, 南京210029, 江苏
  • 收稿日期:2004-07-05 修回日期:2004-08-02 出版日期:2004-09-26 发布日期:2020-11-23
  • 通讯作者: 熊宁宁, 男, 教授, 主任医师, 博士生导师, 主要从事临床药理研究。Tel:025-86506055 E-mail:xiongnin @public1. ptt. js. cn
  • 作者简介:罗玫, 女, 博士研究生。E-mail:jsszyyjd@jlonline.com
  • 基金资助:
    科技部“ 临床试验关键技术及平台研究” 课题资助(№2002AA2Z341i )

Single case research designs for clinician

LUO Mei, XIONG Ning-Ning,WANG Xiu-Qin, ZOU Jian-Dong, JIANG Meng, LIU Fang, FU Wei-Min   

  1. Department of Clinical Pharmacology, Affiliated Hospital, Nanjing University of Traditional Chinese Medicine, Nanjing 210029, Jiangsu, China
  • Received:2004-07-05 Revised:2004-08-02 Online:2004-09-26 Published:2020-11-23

摘要: 个案研究设计适合于提出研究假说, 这种假说以后可以通过其他方法得到临床确认, 这也适用于先导性临床试验(pilot study ), 即在设计正式的临床试验之前, 对要研究的药物进行一个初步的评估。其设计类型包括简单的A-B 时序设计、经典的A-BA反转设计、替代治疗设计、多基线设计。该设计应用的前提是治疗在较短时间能表现出最大效应, 并且效应是短暂的, 一旦治疗停止, 则病情可逆, 如果不是这种情况, 则必须考虑成组设计。个案研究的方法一般依赖于“A” 阶段的稳定基线期。该研究方法不适宜对急性或易变的疾病状况进行研究, 而适用于对具有稳定病症表现的慢性或复发性疾病的研究。

关键词: 个案研究设计, 简单的A-B 时序设计, 经典的A-B-A 反转设计, 替代治疗设计, 多基线设计

Abstract: Single case research design is suitable for raising research hypothesis, and the clinical confirmation of this hypothesis can be gained by other methods afterwards. It is also suitable for the pilot study, which carries on a preliminary assessment to the medicine that will be studied before designing and planning the formal clinical study. The classification of single case research designs includes simplest single-case design, classical reversal design, alternating-treatment design, and multiple-baseline design. The premise of this design is that the treatment can display the most remarkable effect in a shorter time, and the effect is temporarily, once the treatment is stopped, the patient' s condition is reversed. Otherwise, the group design must be considered. Generally, the approach of single case research depends on the “A” stage of stable baseline phase. It means that this research approach is not suitable for carrying on research to the acute or inconstantly diseases, but suitable for carrying on research to the chronic or recurrent diseases which have stable manifestations.

Key words: single case research designs, simplest single-case design, classical reversal design, alternatingtreatment design, multiple-baseline design

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