中药国际化的关键是用“现代医学语言”确定临床有效性

周文霞（中国药理学会常务理事兼副秘书长，中药与天然药物药理专业委员会副主任委员兼秘书长，北京药理毒理研究所研究员，主要从事中药复方物质基础和作用机理研究及抗衰老和益智药药理学研究。）

中药国际化既是中药产业面临的重要任务，也是国家实施“走出去”战略、推进“一带一路”建设的重要组成部分。然而，由于中药与西药相比具有特殊性和复杂性，再加上其他一些客观原因，中药国际化进程并非一路坦途。据报道，到目前为止，我国已有数十种中药产品向美国FDA提交了IND申请，其中许多开展了Ⅱ期或Ⅲ期临床试验，但到目前为止，均未取得实质性突破。因此有学者认为，中西医学的理论体系不同，中药和西药有着不同的标准，简单地将西药标准用于中药是失败的根源，而中药要想走向世界，就必须建立世界上都认可的中药标准，所谓得标准者得天下。这一观点完全正确，但前提是，首先要证明标准的科学性，只有如此，才能够得到世界的公认。而所有的标准都是以获得临床有效性为前提的，可以说中药国际化的关键是用“现代医学语言”确定临床有效性。【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.】

只要是药物，不论是中药还是西药，都是为了防病或治病，其终极目的都是为了获得临床疗效。因此，在所谓“安全、有效、质量可控”这一药物评价的基本原则中，有效性是第一位的，而安全性和质量可控性都是为有效性这一目标服务的。目前，中药存在的普遍问题是显示临床有效性的证据缺乏系统性、规范性和科学性，即使临床应用范围很广、销量很大的中药品种，即使是使用历史悠久的中药经典方剂，也难以拿出令人信服的能证明临床有效性的证据。从而导致不少国人都不相信中药的有效性，更别说西方人了，这应该是阻碍中药国际化的最根本的障碍。实施中药现代化研究20年来，国家投入确实已经很多了，但中药品种的上市后评价或经典方剂的临床研究或疗效验证的工作开展不够，尤其是对那些“传说”有效、但没有证据证明是否“真的”有效的中药基本缺乏科学、规范的验证性研究工作，因为这些工作与中药新药开发不直接相关，是需要花大量经费但又不会带来什么经济效益的事，所以没人做，这就造成了大量基础或动物水平的有关中药的研究工作缺乏临床有效性的支撑，为进一步国际化临床试验带来了有效性上的风险。个人认为，促进中药国际化进程应该先立足国内，练好内功，由国家资助（企业不可能投资开展这类工作）、选择一些“传说”或“看起来”有效的中药品种，尤其是经典方剂，采用“病”“证”结合思路（主要目的是获得中医和现代医学理论体系下的2套对应的数据）开展系统的、科学的临床有效性验证，即既可获得用“中医语言”描述的有效性，又可获得用“现代医学语言”描述的有效性，这样相当于为中医药理论体系下的有效性描述提供了现代医学翻译，既可以减少国际化研究时在有效性方面的盲目性，又可以为国际化研究提供有针对性的现代医学指标。当然，这类研究的结果直接发表在国际高水平学术期刊上本身就是非常重要的中药国际化途径，不但可成为中药走出国门的重要科学依据，同时也是宣传中医药文化的重要途径。当然，上面所说的研究主要说的是针对以疗效验证为目的的中药研究，并不完全适用于以新药开发为目的的研究。【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.】