上市后中成药个性特点辨识方法的探索.docVIP

  上市后中成药个性特点辨识方法的探索# 张莉1,3，张俊华1,3，郑文科1,2,3，王保和2,4，商洪才1,2,3** （1. 天津中医药大学循证医学中心，天津 300193； 5 10 15 20 25 2. 天津中医药临床评价研究所，天津 300193； 3. 天津中医药大学中医药研究院，天津 300193； 4. 天津中医药大学第二附属医院，天津 300150） 摘要：针对中成药存在的同类品种多、个性不突出、适应症宽泛等问题，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，探索建立了中成药个 性特点辨识方法，为初步确定上市中成药品种的临床定位，明确产品的优势特点，促进临 床合理用药提供了技术保证；通过进一步实践，不断完善该方法，对中成药的再评价和二 次开发具有重要意义。 关键词：中成药；个性特点辨识；循证医学 中图分类号：R2 Individuality identification of post-marketing Chinese Patent Medicine: an exploratory method ZHANG Li1,3, ZHANG Junhua1,3, ZHENG Wenke1,2,3, WANG Baohe2,4, SHANG Hongcai1,2,3 (1. Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 300193; 2. Tianjin Institute of Clinical Evaluation, Tianjin 300193; 3. Institute of TCM, Tianjin University of Traditional Chinese Medicine, Tianjin 300193; 4. Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300150) Abstract: At present, some common problems on Chinese Patent Medicine (CPM) appear such as so many similar drug design and products, no individuality and unclear indications. Therefore, we developed a method for Individuality identification of CPMs, based on methods and concept of 30 35 40 Evidence-based Medicine (EBM) and theory of Traditional Chinese medicine (TCM). It can form more clearly clinical orientation and identify the superiority of post-marketing CPMs. This method will provide technology supporting for more clearly clinical orientation, recognizing the individuality and rationally clinical use of post-marketing CPMs. Moreover, after the following improvement in practice, it will be of great importance in revaluation and Research and Development of CPMs. Key words: Chinese Patent Medicine; Individuality identification; Evidence-based Medicine 0 引言 中成药充分发挥了中医“药有个性之特长，方有合群之妙用”的特色优势，通过多环节、 多靶点发挥整合调节的特点，不仅丰富了中医临床治疗学内容，也为临床疾病治疗提供了更多 选择。在防治心脑血管疾病、恶性肿瘤等慢性病中发挥了独特的不可替代的作用，临床上使用 中成药日益增多。与此同时，其自身问题也逐渐显露。 基金项目：创新药物研究开发技术平台建设-心脑血管疾病中药新药临床评价技术平台及规范研究 （2012Z