证候是中医理论的核心内容，也是中医认识生命活动的科学理论和方法。在中药新药研发中，证候疗效评价一直是具有中医特色的热门研究领域。本文从证候研究重要性、证候确立依据和构成、证候诊断标准、证候计量方法、证候疗效评价方法及关键点五个方面加以阐述，认为在注意吸收国际上药物评价的新观念、新方法的同时，更要重视能反映中医诊疗优势和特色的评价方法和指标。

在中成药二次开发的研究进程中，方法学的建立至关重要，试验设计的方法研究成为药物配比优化方案中的要素。围绕方剂的关键科学问题，我们建立了适用于效应明确中药小复方配比优选的试验设计方法,即基线等比增减设计法。

Background: Traditional Chinese medicine (TCM), especially herbal medicine, has been widely used in China and now is also being incresingly used in other countries for the treatment of cardiovascular diseases. Although many studies have demonstrated that certain Chinese herbal products are effective and safe for the treatment of cardiovascular diseases, most of these lack sufficient quality. Therefore, large randomized clinical trials and further scientific research to determine ist safety, effectiveness are necessary QiShen YiQi Dripping Pills (QSYQDP) is a herbal preparation clinically used in the treatment and prevention of coronary artery disease. Preliminary observations have shown its safety and effectiveness. Methods/Design: This randomized, controlled trial will recruit 3600 patients with a history of myocardial infarction. Patients will be randomized into two groups by a Centr-Randomized System. One group receivcs QSYQDP, the other group receive aspirin. This trial protocol will describe eligibility criteria, detailed information on the treatment definition, blinding, endpoints, statistical methods, sample size ditermination, data management, legal aspects, and the current status of the trial. Discussion: This trial is one of the first randomized, controlled clinical trial to evaluate the results of this study should help to difine the role of TCM in modern medical care, as well as to provide the management strategy for CAD patients in China and other countries. (J Geriatr Cardiol 2006; 3 (2): 116-9.)