单病例随机对照试验的证据级别和报告规范.PDF

• 612 • CHINESE JOURNAL OF EVIDENCE-BASED MEDICINE, May 2017, Vol. 17, No.5   ·方法学· 单病例随机对照试验的证据级别和报告规范 1# 2# 3 4, 5 4, 5 2 1 李江 ，翟静波 ，商洪才，杨克虎 ，田金徽 ，陈静，代敏 1. 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 ） 2. 天津中医药大学（天津  300193 ） 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 ） 4. 兰州大学基础医学院循证医学中心（兰州  730000 ） 5. 兰州大学甘肃省循证医学与临床转化重点实验室（兰州  730000 ） 【摘要】   本文对比呈现了 CONSORT 工作组有关随机对照试验与单病例随机对照试验报告规范的条目，将 GRADE 证据质量评估理念与单病例随机对照试验原理结合探索，进一步发展单病例随机对照试验方法学，以期 将来在疾病的临床研究中广泛应用单病例随机对照试验方法。 【关键词】  单病例随机对照试验；证据级别；质量评估 Level of evidence and reporting standard in N-of-1 trial 1# 2# 3 4, 5 4, 5 2 1 LI Jiang , ZHAI Jingbo , SHANG Hongcai , YANG Kehu , TIAN Jinhui , CHEN Jing , DAI Min 1. Program Office for Cancer Screening in Urban China, National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, P.R.China 2. Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, 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 4. Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, 730000, P.R.China 5. Key Laboratory of Evidence-Based Medicine and Knowledge Translation of Gansu Province, Lanzhou University, Lanzhou, 730000, P.R.China Corresponding author: CHEN Jing, Email: cjshcsyc@126.com ; DAI Min, Email: daimin2002@ 【Abstract 】 The study appeared the comparison between CONSORT and CENT, and promoted the combination with GRADE and N-of-1 trial. Our objective is to further develop the method of N-of-1 trial