中藥國際化的關(guān)鍵是用“現(xiàn)代醫(yī)學語言”確定臨床有效性

周文霞（中國藥理學會常務(wù)理事兼副秘書長，中藥與天然藥物藥理專業(yè)委員會副主任委員兼秘書長，北京藥理毒理研究所研究員，主要從事中藥復方物質(zhì)基礎(chǔ)和作用機理研究及抗衰老和益智藥藥理學研究。）

中藥國際化既是中藥產(chǎn)業(yè)面臨的重要任務(wù)，也是國家實施“走出去”戰(zhàn)略、推進“一帶一路”建設(shè)的重要組成部分。然而，由于中藥與西藥相比具有特殊性和復雜性，再加上其他一些客觀原因，中藥國際化進程并非一路坦途。據(jù)報道，到目前為止，我國已有數(shù)十種中藥產(chǎn)品向美國FDA提交了IND申請，其中許多開展了Ⅱ期或Ⅲ期臨床試驗，但到目前為止，均未取得實質(zhì)性突破。因此有學者認為，中西醫(yī)學的理論體系不同，中藥和西藥有著不同的標準，簡單地將西藥標準用于中藥是失敗的根源，而中藥要想走向世界，就必須建立世界上都認可的中藥標準，所謂得標準者得天下。這一觀點完全正確，但前提是，首先要證明標準的科學性，只有如此，才能夠得到世界的公認。而所有的標準都是以獲得臨床有效性為前提的，可以說中藥國際化的關(guān)鍵是用“現(xiàn)代醫(yī)學語言”確定臨床有效性。【The inter?nationalization of TCM is not only an important task facing the TCM industry,but also an impor?tant part of the country′s implementation of the"going out"strategy and promoting the building of"the Belt and Road".However,due to the particularity and complexity of TCM compared with western medicine,and for some other objec?tive reasons,the internationalization process of TCM is not always smooth.It is reported that dozens of TCM products have submitted the Investigational New Drug Application to the FDA so far,and a lot of them have carried out phaseⅡ orⅢ clinical trials,but no substantial break?through has been achieved.Therefore,some scholars believe that TCM and western medi?cine,which are two things in the world,have different theoretical systems and different stan?dards.The failure of internationalization of TCM stemmed from the use of western medicine stan?dards for TCM.And TCM can never become wel?come to the world unless it can establish the world′s approved standards of TCM,which is in?terpreted as"the one who wins the standards wins the world".This viewpoint is absolutely right.But only when the standards are proved scientific,can they win worldwide recognition.All stan?dards are based on the acquisition of clinical effi?cacy,so it could be said that the key to the inter?nationalization of TCM is to use"modern medi?cal language"to confirm the clinical efficacy.】

只要是藥物，不論是中藥還是西藥，都是為了防病或治病，其終極目的都是為了獲得臨床療效。因此，在所謂“安全、有效、質(zhì)量可控”這一藥物評價的基本原則中，有效性是第一位的，而安全性和質(zhì)量可控性都是為有效性這一目標服務(wù)的。目前，中藥存在的普遍問題是顯示臨床有效性的證據(jù)缺乏系統(tǒng)性、規(guī)范性和科學性，即使臨床應(yīng)用范圍很廣、銷量很大的中藥品種，即使是使用歷史悠久的中藥經(jīng)典方劑，也難以拿出令人信服的能證明臨床有效性的證據(jù)。從而導致不少國人都不相信中藥的有效性，更別說西方人了，這應(yīng)該是阻礙中藥國際化的最根本的障礙。實施中藥現(xiàn)代化研究20年來，國家投入確實已經(jīng)很多了，但中藥品種的上市后評價或經(jīng)典方劑的臨床研究或療效驗證的工作開展不夠，尤其是對那些“傳說”有效、但沒有證據(jù)證明是否“真的”有效的中藥基本缺乏科學、規(guī)范的驗證性研究工作，因為這些工作與中藥新藥開發(fā)不直接相關(guān)，是需要花大量經(jīng)費但又不會帶來什么經(jīng)濟效益的事，所以沒人做，這就造成了大量基礎(chǔ)或動物水平的有關(guān)中藥的研究工作缺乏臨床有效性的支撐，為進一步國際化臨床試驗帶來了有效性上的風險。個人認為，促進中藥國際化進程應(yīng)該先立足國內(nèi)，練好內(nèi)功，由國家資助（企業(yè)不可能投資開展這類工作）、選擇一些“傳說”或“看起來”有效的中藥品種，尤其是經(jīng)典方劑，采用“病”“證”結(jié)合思路（主要目的是獲得中醫(yī)和現(xiàn)代醫(yī)學理論體系下的2套對應(yīng)的數(shù)據(jù)）開展系統(tǒng)的、科學的臨床有效性驗證，即既可獲得用“中醫(yī)語言”描述的有效性，又可獲得用“現(xiàn)代醫(yī)學語言”描述的有效性，這樣相當于為中醫(yī)藥理論體系下的有效性描述提供了現(xiàn)代醫(yī)學翻譯，既可以減少國際化研究時在有效性方面的盲目性，又可以為國際化研究提供有針對性的現(xiàn)代醫(yī)學指標。當然，這類研究的結(jié)果直接發(fā)表在國際高水平學術(shù)期刊上本身就是非常重要的中藥國際化途徑，不但可成為中藥走出國門的重要科學依據(jù)，同時也是宣傳中醫(yī)藥文化的重要途徑。當然，上面所說的研究主要說的是針對以療效驗證為目的的中藥研究，并不完全適用于以新藥開發(fā)為目的的研究。【Any medicine,be it TCM or western medicine,is for treating disease,and its ultimate aim is to deliver clinical effect.Hence,among the basic principles of drug evaluation,which are known as"safety,validity and quality controllability",validity is the first priority,while safety and quality controllability are all serving it.At present,the general problem facing TCM is the lack of systematic,normative and scientific evidence to indicate the clinical efficacy.Whether the varieties of TCM have a wide range of clinical applications and large sales or the TCM prescriptions with a long history,it is hard to present enough convincing evidence to prove the clinical validity.As a result,many Chinese do not believe in the efficacy of TCM,let alone westerners.And it should be the most fundamental obstacle to the internation?alization of TCM.Over the past 20 years since the start of modernization of TCM,there has been a lot of funding from the state.However,post-market evaluation of the approved TCM or clinical researches or efficacy verifications of classical TCM prescriptions are not enough,especially those"allegedly"effective but with no evidence they are"really"effective TCM,for lack of scientific,normative and confirmatory research.This has led to a large number of basic or animal level researches on TCM that lack clinical validity support and are at the risk of invalidity for further internationalization of clinical trials.Personally,the process of promoting the interna?tionalization of TCM should be firstly based on domestic efforts,such as improving the internal ability and being financed by the state(enterprises are unlikely to invest in this kind of work)and choose some"allegedly"or"seemingly"effective varieties of TCM,especially classic prescriptions,using a philosophy in combination of"disease"and"syndrome"(the main purpose is to obtain two sets of corresponding data under the medi?cal theory system of TCM)to carry out systematic and scientific clinical efficacy verification.That is,it can obtain the validity of the description in both"Chinese medical language"and"modern medical language".This is equivalent to providing modern medical translation for the validity description under the theoretical system of TCM,which can not only reduce the blindness in confirming the validity of international research,but also provide modern medicalindicators forinternationalresearch.Certainly,the results of such research are directly published in the international high level academic journals,which is of utmost importance for inter?nationalizing TCM.It can not only be regarded as an important scientific basis for TCM to go abroad,but also an important way to popularize the culture of TCM.Of course,the above-mentioned research mainly refers to the study of TCM for the purpose of efficacy verification and is not entirely applicable to the research aimed at the development of new drugs.】