中医药随机_双盲_安慰剂对照临床试验的质量控制探讨_谢志军.pdf

( ) • 1479 • CJTCMP , June 2012, Vol . 27, No. 6 Discussion on quality control of randomized, double-blind and placebo controlled clinical trial of Chinese medicine XIE Zhi-jun, WEN Cheng-ping, FAN Yong-sheng ( TCM Clinical Basis Institute of Zhejiang University of Chinese Medicine, Hangzhou 310053, China ) Abstract: The randomized, double-blind and placebo controlled trial is recognized as the gold standard of intervening trial, and the most desirable approach to evaluate the effect of medicine and security. Optimum design and strict management are important for the quality of clinical trials. In Chinese medicine clinical trials we have explored the implementation of the double- blind and placebo, the management of Chinese medicine and the improvement of treatment compliance of patients to strictly control the quality of Chinese medicine clinical trial and to provide the reliable proof of evidence based medicine. Key words:Chinese medicine clinical trial; Randomized, double-blind and placebo controlled; Quality control Fund assistance:National Key Technology RD Program during the ‘Eleventh Five-Year’ Plan Period (No.2006BAI04A10, No. 2007BAI20B06) TCM Industry Science Research Special Program(No.200707016)