基于临床价值的经典名方类中成药上市后评价的思考  

Thoughts on post-marketing evaluation of classical Chinese patent medicines based on clinical value

作　　者：宋卓 王志飞[2] 吴煜[1] 谢雁鸣[2] 杨宇飞[1] 许云[1] SONG Zhuo;WANG Zhi-fei;WU Yu;XIE Yan-ming;YANG Yu-fei;XU Yun(Xiyuan Hospital,Chinese Academy of Chinese Medical Sciences,Beijing 100091,China;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]中国中医科学院西苑医院,北京100091 [2]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中国中药杂志》2021年第8期1988-1993,共6页China Journal of Chinese Materia Medica

基　　金：国家重点研发计划“中医药现代化研究”重点专项(2018YFC1707400,2018YFC1707406)。

摘　　要：经典名方类中成药是依据古代经典方剂的配伍及应用经验研制而成的现代制剂,其丰富的人用历史和可靠的临床疗效蕴含着中医药独特的理论精华和珍贵价值。随着循证医学的发展和医药政策的日益完善,基于临床价值的经典名方上市后评价显得尤为迫切。该文就经典名方上市后中成药临床价值评价存在的相关问题进行阐述,认为简化的评审标准导致经典名方类中成药临床价值评价证据的不足,进而造成中成药品种好坏难评、企业研发动力不足、产品科技含量低、国际化发展欠佳等不利的发展环境;并基于此背景指出临床价值评价是经典名方类中成药上市后评价的核心,应基于文献考证和最新实践反映的方向,坚持病证结合的研究模式和以证统病的用药特点,选择合适的试验类型开展包含临床疗效、卫生经济效益和安全性评价为主要内容的研究,以细化适应症、规范临床定位。临床价值评价为经典名方类中成药明确临床价值,获得继续上市的条件和规范临床应用提供依据,是其上市后综合研究的基础和主要内容,为优化经典名方类中成药的证据和质量服务,以传承中医药最核心的复方价值理念。Classical Chinese patent medicines(CPMs) are a kind of modern preparation developed from the experience of compatibility and application about ancient prescriptions. Its rich history of human use and reliable clinical efficacy imply the unique theoretical essence and precious value of traditional Chinese medicine(TCM). With the development of evidence-based medicine and the improvement of medical policy, it is particularly urgent to evaluate the clinical values of post-marketing classical CPMs. In this paper, some problems on the clinical value evaluation of CPMs would be described, and it is considered that the simplified evaluation procedures can lead to the lack of evidence for evaluating clinical value of CPMs, causing the difficulty in evaluating the quality of CPM, lack of R&D motivation of enterprises, low content of science and technology, and poor international development. Based on this background, it points out that the clinical value evaluation is the core of the post-marketing evaluation of the classical CPMs, and the eva-luation should be based on the direction of literature research and the latest practice. We should adhere to the research mode of combination disease with syndrome, and select the appropriate type of trials, with clinical efficacy, health economic benefits and safety eva-luation as the main content of the studies, in order to refine the indications and standardize the clinical positioning. Clinical value eva-luation is the basis and main content of post-marketing comprehensive researches on classic and famous CPMs to clarify their clinical value, obtain the conditions for continued marketingand standardize their clinical application, so as to optimize the evidence and quality service of classic and famous CPMs and inherit the core value concept of Chinese medicine.

关 键 词：经典名方 上市后评价 临床价值 研究特点 复方中成药 

分 类 号：R288[医药卫生—中药学]