单病例随机对照试验的设计和实施要点.PDFVIP

• 364 • CHINESE JOURNAL OF EVIDENCE-BASED MEDICINE, Mar. 2017, Vol. 17, No.3   ·方法学· 单病例随机对照试验的设计和实施要点 1 1 1 2 3 王辉 ，翟静波，陈静，李江，商洪才 1. 天津中医药大学（天津  300193 ） 2. 国家癌症中心/ 中国医学科学院北京协和医学院肿瘤医院城市癌症早诊早治项目办公室（北京  100021 ） 3. 北京中医药大学东直门医院中医内科学教育部重点实验室和北京市重点实验室（北京  100700 ） 【摘要】   单病例随机对照试验设计提供了一种方法来对单个患者的治疗进行最佳决策，本文简要介绍单病 例随机对照设计的适用对象、实施过程以及临床实际应用，探讨单病例随机对照试验的设计和实施要点。 【关键词】  单病例随机对照；设计；实施；应用 The design and implementation of N-of-1 trials 1 1 1 2 3 WANG Hui , ZHAI Jingbo , CHEN Jing , LI jiang , SHANG Hongcai 1. Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, P.R.China 2. National Cancer Center/Program Office for Cancer Screening in Urban, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, P.R.China 3. Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China Corresponding author: CHEN Jing, Email: cjshcsyc@126.com; SHANG Hongcai, Email: shanghongcai@ 【Abstract 】 N-of-1 trial design offers a methodologically sound approach to determining optimum treatment for an individual patient and solves some limitations of randomized controlled trials. This design could offer an efficient method of reaching a personal treatment regime tailored to suit individual needs and preferences. The paper introduces practical application, objects and the implementation process of N-of-1 trial, to explore its design points and implementation. 【Key words 】 N-of-1 trial; Design; Implementation; Application 随机对照临床试验（randomized clinical trials ， 为对照、双盲、随机、多次交叉的试验。通过观察 RCT ）的设计要求以群体为研究对象，个体之间具 患者对干预措施的反应，来评价某种药物与安慰剂