证候类中药新药临床试验四诊信息采集规范探讨

摘要

探讨证候类中药新药临床试验四诊信息采集的现状，总结其存在的问题，并提出规范证候类中药新药四诊信息采集的对策。对病例报告中四诊信息含义、采集的方法及程序进行规范化，对试验中心中研究人员进行系统的培训及评估，保证客观及科学的疗效评价。%To investigate the syndrome type of traditional Chinese medicine new drug clinical trials in the present situation of the four diagnostic information collection, summarized the existing problems, and put forward the standard class four of new drug of TCM syndrome diagnosis information acquisition countermeasures. On the case report in the four diagnostic information meaning, the collection of methods and procedures standardization, researchers in the test center system of training and assessment, guarantee the curative effect of objective and scientific evaluation.