重视中药基础药理研究与临床药理研究紧密结合，并制定国际认可的中药临床研究评价标准和规范

聂 克（中国药理学会中药与天然药物药理专业委员会委员，广东药科大学中药学院教授，主要从事中药药理学研究。）

中药药理学包括中药基础药理学（或称为中药实验药理学）和中药临床药理学。目前比较重视中药基础药理学研究，由于研究难度较大等原因，对于中药临床药理学的研究相对薄弱。另外，很多中药基础药理研究与中医临床严重脱节，很多中药基础药理研究的结果不能有效指导临床实践。中医药的生命力在于临床。中药基础药理研究如何与临床药理研究紧密结合，从安全性、有效性等方面更加有效地指导中药新药和健康产品研发，是急需解决的问题。【Pharmacology of TCM consists of basic pharmacology(or experimental pharmacology)and clinical pharmacology of TCM.At present,more attention has been paid to the basic phar⁃macological research,but little attention has been paid to clinical research of TCM due to the difficulty of clinical research.Beyond that,many of the basic pharmacological researches of TCM are disconnected with clinical practice,correspond⁃ingly,these basic research results cannot effec⁃tively guide clinical prescription.The vitality of TCM relies on its confirmed clinical efficacy.It is urgent to solve the problem of how to integrate the basic pharmacological research with clinical pharmacological research of TCM so as to guide the research and development of new drugs and health products more effectively from aspects of safety and effectiveness.】

中药药理学是中药创新药物和保健产品研发的重要领域和工具，是中药产品进入国际市场的重要桥梁。中药产品的研发上市过程必须采用国际通行标准对其安全性和有效性进行评价，否则无法为西方主流市场所接受。中药与天然药物具有共性，但其应用的理论体系不同。现行的欧美标准，不一定适用于中药产品。我们应主动作为，根据中药的特点，从安全、有效、可控等方面制定欧美认可的评价标准和规范。2017年6月，美国《内科学年鉴》以简体中文、繁体中文和英文3种文字同期发表了由中国、加拿大、英国学者组成的国际团队共同完成的《中医复方临床随机对照试验报告规范2017：CONSORT声明的扩展、说明与详述》，该国际标准的发表意义重大，不但有利于提高中药复方随机对照临床试验的报告质量，有利于提升中医药临床研究的国际认可度，而且对于中药新药和健康产品的国际标准起了一个很好的示范作用。国家在《中医药“一带一路”发展规划（2016-2020年）》中要求，到2020年，颁布20项中医药国际标准，注册100种中药产品。在这20项中医药国际标准中，涉及中药新药和健康产品的有多少项？目前我们处于中医药发展的最好历史时期，是机遇，更是巨大挑战。【Pharmacology of TCM is a key component and important tool of the research and development of innovative drugs and health products of TCM,and is also an important bridge for TCM products to enter the international markets.The safety and effectiveness of TCM products must be eval⁃uated by universal standards,otherwise they will not be accepted by the mainstream markets in western countries.TCM and natural medicine share some common properties,but the guiding principles and theory systems for their application are utterly different.The current European and American standards are not necessarily applicable to TCM products.We should take the initiative to establish a series of Euramerican recognized standards and regulations in terms of safety,effectiveness and controllability for the evaluation of TCM according to its own characteristics.In June 2017,a paper entitledCONSORT Exten⁃sionforChineseHerbalMedicineFormulas 2017:Recommendations,Explanation,and Elab⁃orationwas published inAnnals of Internal Medi⁃cinein Simplified Chinese,Traditional Chinese and English languiges,which was jointly completed by an international team of TCM clinical experts,methodologists,epidemiologists and editors from China,Canada and UK.TheCONSORTExten⁃sion forChinese Herbal Medicine Formulas 2017is of great significance,which can not only help to improve the quality of randomized controlled trials of TCM,but also enhance the international recognition of clinical research in TCM.Moreover,it sets a good example for establishing international standards for new drugs and health products of TCM.According to the requirement of"The Belt and Road Initiatives for the Planning Project of Chinese Medicine(2016-2020)",twenty interna⁃tional standards for TCM will be promulgated and one hundred types of TCM products will be registered by the year 2020.We wonder how many standards of new drugs and health prod⁃ucts will be involved in the above 20 international standards.At present,we are in the best historical era for the development of TCM,which is more of a huge challenge than an opportunity.】