上市后中成药个性识别方法的探索

Technique of personality identification for Chinese patent medicine:a post-marketing exploration

针对当前中成药存在的同类品种多、适应症宽泛、个性不突出等问题,借鉴循证医学理念,运用"查证用证"和"创证用证"的方法,同时结合中医药理论,初步建立了中成药个性识别方法(TOPIC),包括文献检索、筛选分类、系统评价、组方分析、专家意见以及同类比较6步;并以3种常用的治疗冠心病的中成药(麝香保心丸、芪参益气滴丸、丹蒌片)为载体,举例说明该方法的实施过程。该方法首次从证据分类分级的角度,客观地分析评价中成药品种,将为初步确定上市后中成药品种的临床定位,明确品种的优势及特点,最终促进临床合法合理循证用药提供技术保证;随着该方法的不断完善,将对中成药的再评价和二次开发产生重要影响。

At present, some common problems on Chinese patent medicine （CPM） appear such as so many similar drug design and products, unclear indications and no individuality. Therefore, we initially developed a method, named the technique of personality identification for Chinese patent medicine （TOPIC）, based on methods and concept of evidence-based medicine （EBM） and theory of traditional Chinese medicine （TCM）. The whole process included six steps, that was literature search, screening and classification, systematic reviews, prescription analysis, summary of expert opinions and comparison in similar CPM, thereby recognizing the individuality. To show how this method was applied in detail, 3 common CPMs, for coronary heart disease （CHD）, Shexiangbaoxin pill, Qishenyiqi dropping pill and Danlou tablet, were selected as examples. From the view of the classification and grading of evidence, this method first gave a relatively objective analysis and evaluation for CPM. It will provide technology supporting for forming clinical orientation initially and recognizing the personality, thus promoting legitimate, rational and evidence-based medication of post-marketing CPM. Moreover, after further improvement in practice, it will play a significant role in revaluation and redevelopment of CPM.