中药新药创制与国际化发展过程中的实事求是

连晓媛（中国药理学会中药与天然药物药理专业委员会委员，浙江大学药学院教授，主要从事神经药理学和中药药理学的基础和应用研究。

实事求是指从实际对象出发，探求事物的内部联系及其发展的规律性，认识事物的本质。通常指按照事物的实际情况办事。中药新药创制与国际化过程是一个发明创造的过程，其目的是产生可惠及国内外的研究成果。创新贯穿着中药新药创制与国际化发展的全过程。首先是专业技术层面的创新和创新成果的呈现，可以是新治疗策略、新理论、新技术和新方法在中药新药创制过程中的应用，也可以是中医药理论和其蕴含的中国智慧与西方或现代医学思维和最新研究成果在中药新药创制过程中的碰撞融合。从更大范围来说，中药新药创制是涉及到不同参与者和机构之间（研发人员、课题或项目评审专家、科研结构、政府和企业等）交互作用的网络。在这个网络中，任何一个节点都可能成为创新行为实现的特定空间，显然相关节点的协调一致的创新行为将有力推动中药新药创制过程中创新行为的实现。在此过程中将涉及到理念和思维的改变，如应该认识到创新就需要探索，探索就意味着风险，而高风险意味着高回报。因此，中药新药创制与其他发明创造一样需要允许失败的创新生态；创新还意味着与众不同，这就需要适合百花齐放的学术生态；再比如对疾病的科学认识是一个渐进的过程，过去认为对的不一定是真理，反之亦然。因此，无论是新药创制研发者还是评审专家均需要不断学习、不断更新相关知识结构，否则可能出现误判现象。【To seek truth from facts means starting from the actual object,exploring the internal relationships of things and the regu⁃larity of their developments,and recognizing the nature.It usually refers to things that are done in accordance with the actual situation.The process of creation and internationalization of new drugs of TCM is an inventive process for the purpose of producing research results that are of benefit bothathomeandabroad.Innovation runs through the whole process.The first is the inno⁃vation at the professional and technical level and the presentation of innovative achievements.It can be the application of new treatment strate⁃gies,theories,technologies and methods in the process of creating new Chinese medicine.It can also be the collision and integration of TCM theory within its wisdom in China and the western ormodern medicalthinking with the latest research results in the creation of TCM.More generally,the creation of new drugs for TCM is a network that involves the interactions between different participants and institutions(research and development personnel,review experts of research programs,scientific institutions,govern⁃ments and enterprises,and so on).In this network,any link may become a specific spot for innova⁃tion.It is clear that the coordinated innovation of related links will effectively promote the innova⁃tion of new drug discovery in TCM.In this process,it will involve changes in concepts and thinking.For example,it should be recognized that innova⁃tion requires exploration which means risk,and high risk means high returns.Therefore,like other inventions and innovations,the creation of new drugs of TCM calls for an innovation ecology that allows for failure.Innovation also means being different from others,which requires an academic ecology suitable for boom in each field.Another one is that the scientific understanding of disease is a step by step process.What used to be true is not necessarily the truth,and vice versa.Therefore,both new drug developers and reviewers need to learn constantly and keep updating rele⁃vant knowledge structures,otherwise misjudg⁃ments may occur.】

对中药新药创制与国际化发展来说，实事求是还可以是：针对西药尚不能解决或解决不好的临床问题（如国际重大疾病包括神经退行性疾病、代谢性疾病和恶性肿瘤），开展创新中药研发，发挥中医药的特色和优势。我们之所以期待中医药对防治重大疾病的特色和优势，是因为客观上这些重大疾病无一不是涉及多因素及其相互作用导致的复杂疾病，疾病的发生和发展通常经过了机体功能减弱或紊乱、功能丢失和器质性病变的进展过程。而以欧美为主体的新药研发主要针对疾病主症或疾病的某个侧面因而遇到严重挑战，中医整体观不仅体现在对疾病的系统认识、更体现在通过遣方用药对疾病进行标本兼治的系统治疗。可见，结合中医整体观和现代医学最新研究成果，准确认识疾病的发生和发展规律，同时发挥好中药多成分、多靶点的优势，努力使创新中药可实施中医“标本兼治、综合治疗”的理念，就有可能在防治国际重大疾病中体现中医药特色和优势，以及中医药理论蕴含的中国智慧。【For the creation and globalization of new Chinese medicine,seeking truth from facts also means carrying out innovative research and development of TCM and bringing into play the characteristics and advantages of TCM for those clinical problems that western medicine cannot solve or solve poorly(such as major international diseases including neurodegenerative diseases,metabolic diseases and malignant tumors).The reason why we expect TCM to prevent and control major diseases is that these major diseases are all complicated diseases objectively caused by multiple factors and interactions.The occurrence and development of diseases usually go through the decline or disorder in the body′s functions,the progression of the loss of function and organic disease.The research and development of new drugs in western countries that mainly targets the main complaintor some aspects of disease,however,have come under severe chal⁃lenges.The overall concept of TCM is not only reflected in the systematic understanding of the disease,but also manifested in treating the disease by the prescription using a system therapy of treating both principal and secondary aspects of the disease.Obviously,it is possible to reflect the characteristics and advantages of TCM in the prevention and treatment of major international diseases,as well as the Chinese wisdom contained in the theory when it is combined with the overall view of TCM and the latest research result of modern medicine,gets accurate understanding of the occurrence and development of disease,plays the role of good multi-components and multi-target advantages of TCM,and strives to make innovative TCM under the concept of"treating both the symptoms and the comprehen⁃sive treatment".】