针对当前名优中药二次开发过程中普遍存在的临床定位不清的弊端，剖析了导致中药品种临床定位不清的订单原因，阐明了临床定位在名优中药品种二次开发中的必要性。基于循证医学的理念，提出了中成药上市后再评价临床定位的确定原则，方法和步骤，为名优中成药二次开发的顺利实施奠定了理论基础和方法保证。

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.)

目的：针对方剂配伍研究中最优剂量配比的分析和预测，对丹参、三七7种不同剂量组合治疗实验性急性心肌缺血犬的数据进行处理，从而建立了一种适用于方剂最优剂量配比分析的综合评价方法。方法：采用多目标优化、模糊综合评判方法。结果：明确了丹参、三七不同配比的总体药效及其趋势，发现丹参、三七10:6、10:3 组对病变的改善程度与消心痛对照组接近，是实验所选各比例的最优。结论：此方法适用于中成药二次开发中方剂最优剂量配比分析的综合评价。