摘要 证候类中药的研究是近几年中药创新研究的热点，但评价证候类中药的临床疗效是目前研究的难点。通过文献研究和专家咨询对证候命名达成共识是首要解决的问题；制作合理、公认的证候诊断量表和证候疗效评价量表是研究客观化的前提；构建中医证候临床研究核心指标集是减少不同研究异质性的方式。采用基于注册登记研究的随机对照试验方法进行以证统病研究和病证结合研究，可以进行证候类中药主治优势病种的筛选及治疗特定证候最佳中药的筛选；采用随机对照试验方法可以严格验证方-证-病-效的关系；采用单病例随机对照试验方法对个体进行方证相应研究，及证候类中药新药和辨证论治比较研究，以探寻证候类中药的合理性及中医辨证论治的意义。最后，结合循证目标成就量表法、模糊综合评价法的优点，构建以个体化评价为基础，证候疗效评价为主的综合疗效评价方法。

    关键词 证候类中药；临床研究；疗效评价；方法学

    Abstract New TCM drugs used for certain syndromes are spotlights in the research of Traditional Chinese Medicine (TCM) in recent years. But it is difficult to evaluate the clinical efficacy of these drugs. Developing standardized and unified syndrome names based on literature reviews and expert consultation is important. Then it is necessary to develop acknowledged syndrome diagnosis scales and syndrome evaluation scales to ensure clinical trials objective. It is a decent method to decrease heterogeneity if a core outcome set is developed for syndrome evaluation. Randomized registry trials can be used in screening applicable diseases for New TCM drugs used for certain syndromes ......