中藥新藥創(chuàng)制與國(guó)際化發(fā)展過(guò)程中的實(shí)事求是

連曉媛（中國(guó)藥理學(xué)會(huì)中藥與天然藥物藥理專業(yè)委員會(huì)委員，浙江大學(xué)藥學(xué)院教授，主要從事神經(jīng)藥理學(xué)和中藥藥理學(xué)的基礎(chǔ)和應(yīng)用研究。

實(shí)事求是指從實(shí)際對(duì)象出發(fā)，探求事物的內(nèi)部聯(lián)系及其發(fā)展的規(guī)律性，認(rèn)識(shí)事物的本質(zhì)。通常指按照事物的實(shí)際情況辦事。中藥新藥創(chuàng)制與國(guó)際化過(guò)程是一個(gè)發(fā)明創(chuàng)造的過(guò)程，其目的是產(chǎn)生可惠及國(guó)內(nèi)外的研究成果。創(chuàng)新貫穿著中藥新藥創(chuàng)制與國(guó)際化發(fā)展的全過(guò)程。首先是專業(yè)技術(shù)層面的創(chuàng)新和創(chuàng)新成果的呈現(xiàn)，可以是新治療策略、新理論、新技術(shù)和新方法在中藥新藥創(chuàng)制過(guò)程中的應(yīng)用，也可以是中醫(yī)藥理論和其蘊(yùn)含的中國(guó)智慧與西方或現(xiàn)代醫(yī)學(xué)思維和最新研究成果在中藥新藥創(chuàng)制過(guò)程中的碰撞融合。從更大范圍來(lái)說(shuō)，中藥新藥創(chuàng)制是涉及到不同參與者和機(jī)構(gòu)之間（研發(fā)人員、課題或項(xiàng)目評(píng)審專家、科研結(jié)構(gòu)、政府和企業(yè)等）交互作用的網(wǎng)絡(luò)。在這個(gè)網(wǎng)絡(luò)中，任何一個(gè)節(jié)點(diǎn)都可能成為創(chuàng)新行為實(shí)現(xiàn)的特定空間，顯然相關(guān)節(jié)點(diǎn)的協(xié)調(diào)一致的創(chuàng)新行為將有力推動(dòng)中藥新藥創(chuàng)制過(guò)程中創(chuàng)新行為的實(shí)現(xiàn)。在此過(guò)程中將涉及到理念和思維的改變，如應(yīng)該認(rèn)識(shí)到創(chuàng)新就需要探索，探索就意味著風(fēng)險(xiǎn)，而高風(fēng)險(xiǎn)意味著高回報(bào)。因此，中藥新藥創(chuàng)制與其他發(fā)明創(chuàng)造一樣需要允許失敗的創(chuàng)新生態(tài)；創(chuàng)新還意味著與眾不同，這就需要適合百花齊放的學(xué)術(shù)生態(tài)；再比如對(duì)疾病的科學(xué)認(rèn)識(shí)是一個(gè)漸進(jìn)的過(guò)程，過(guò)去認(rèn)為對(duì)的不一定是真理，反之亦然。因此，無(wú)論是新藥創(chuàng)制研發(fā)者還是評(píng)審專家均需要不斷學(xué)習(xí)、不斷更新相關(guān)知識(shí)結(jié)構(gòu)，否則可能出現(xiàn)誤判現(xiàn)象?！綯o 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.】

對(duì)中藥新藥創(chuàng)制與國(guó)際化發(fā)展來(lái)說(shuō)，實(shí)事求是還可以是：針對(duì)西藥尚不能解決或解決不好的臨床問(wèn)題（如國(guó)際重大疾病包括神經(jīng)退行性疾病、代謝性疾病和惡性腫瘤），開(kāi)展創(chuàng)新中藥研發(fā)，發(fā)揮中醫(yī)藥的特色和優(yōu)勢(shì)。我們之所以期待中醫(yī)藥對(duì)防治重大疾病的特色和優(yōu)勢(shì)，是因?yàn)榭陀^上這些重大疾病無(wú)一不是涉及多因素及其相互作用導(dǎo)致的復(fù)雜疾病，疾病的發(fā)生和發(fā)展通常經(jīng)過(guò)了機(jī)體功能減弱或紊亂、功能丟失和器質(zhì)性病變的進(jìn)展過(guò)程。而以歐美為主體的新藥研發(fā)主要針對(duì)疾病主癥或疾病的某個(gè)側(cè)面因而遇到嚴(yán)重挑戰(zhàn)，中醫(yī)整體觀不僅體現(xiàn)在對(duì)疾病的系統(tǒng)認(rèn)識(shí)、更體現(xiàn)在通過(guò)遣方用藥對(duì)疾病進(jìn)行標(biāo)本兼治的系統(tǒng)治療?？梢?jiàn)，結(jié)合中醫(yī)整體觀和現(xiàn)代醫(yī)學(xué)最新研究成果，準(zhǔn)確認(rèn)識(shí)疾病的發(fā)生和發(fā)展規(guī)律，同時(shí)發(fā)揮好中藥多成分、多靶點(diǎn)的優(yōu)勢(shì)，努力使創(chuàng)新中藥可實(shí)施中醫(yī)“標(biāo)本兼治、綜合治療”的理念，就有可能在防治國(guó)際重大疾病中體現(xiàn)中醫(yī)藥特色和優(yōu)勢(shì)，以及中醫(yī)藥理論蘊(yùn)含的中國(guó)智慧?！綟or 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".】