基于病证结合的中医经典名方上市后评价要点

Key points of post-marketing evaluation of classic traditional Chinese medicine prescriptions based on combination of disease and syndrome

经典名方、院内制剂、名老中医经验方是新药研发创新的主要源头,中药多成分、多靶点的治疗特点是优势,但同时适应症宽泛、临床定位不清、缺乏循证证据支持是影响中医药疗效发挥、制约推广应用的关键问题。如何突破瓶颈,精准临床定位,突显中医经典名方的作用优势,完成从临床实践、临床研究到临床证据的转化,是现在研究的热点,也是难点。病证结合的临床研究模式,能够充分体现中医经典名方的古代医案证据、人用历史经验以及辨证论治特点,突出中医药优势;同时,在现代疾病分类体系及研究模式下,有利于建立规范的临床证据报告及评价体系,有利于临床研究的证据整合,避免信息的过度衰减。该文结合团队前期工作基础,认为基于病证结合的中医经典名方上市后评价,应突出以下要点:(1)以证为载体,连接经典名方与临床疾病,宏观聚焦临床定位;(2)证候可视化、标准化与药效分子基础相结合,微观聚焦临床精准定位;(3)创新疗效评价方法,体现辨证论治疗效特点;(4)"随机对照循证研究"与"真实世界循证评价"相结合,聚焦临床优势,充分循证证据;(5)充分利用临床注册研究,重视安全性。该文围绕以上要点作一评述。

Classic prescriptions, hospital preparations and famous traditional Chinese medicine(TCM) experience prescriptions are the main sources of new drug development and innovation. The multi-components and multi-targets treatment characteristics of TCM are advantages, but at the same time, broad indications, unclear clinical positioning and lack of evidence-based evidence support are the key problems affecting the play of TCM efficacy and restricting its promotion and application. The hot in recent research was to how to break through the bottleneck, precise clinical positioning, highlight the advantages of the classic TCM prescriptions, and complete the transformation from clinical practice, clinical research to clinical evidence, but at the same time, it is also the difficulty. The clinical research model of the combination of disease and syndrome can fully reflect the ancient medical case evidence of classic TCM prescriptions, the historical experience of human used and the characteristics of syndrome differentiation and treatment, and highlight the advantages of Chinese medicine. At the same time, under the modern disease classification system and research mode, is conducive to established the standardized clinical evidence report and evaluation system, is conducive to promote the integration of clinical research evidence, and avoids excessive attenuation of information. Based on the previous work of our team, the intention of this study was to make a comment about the key points of the post-marketing evaluation of the classic TCM prescriptions under the combination of disease and syndrome and includes key points:(1)With the syndrome as the carrier, connected with the classical prescription and clinical diseases, focused on the clinical positioning on macroscopically.(2)The combination of syndrome visualization, standardization and pharmacological molecular basis, focus on clinical precise positioning in microscopic.(3)Innovating therapeutic effect evaluation methods, reflecting the curative effect characteristics based on syndrome differentiation.(4)The combination of "randomized controlled evidence-based studies" and "real world evidence-based evaluation", focusing on clinical advantages, fully evidence-based evidence.(5)Make full use of clinical registration studies and pay attention to safety.