重視中藥基礎(chǔ)藥理研究與臨床藥理研究緊密結(jié)合，并制定國際認(rèn)可的中藥臨床研究評價標(biāo)準(zhǔn)和規(guī)范

聶 克（中國藥理學(xué)會中藥與天然藥物藥理專業(yè)委員會委員，廣東藥科大學(xué)中藥學(xué)院教授，主要從事中藥藥理學(xué)研究。）

中藥藥理學(xué)包括中藥基礎(chǔ)藥理學(xué)（或稱為中藥實驗藥理學(xué)）和中藥臨床藥理學(xué)。目前比較重視中藥基礎(chǔ)藥理學(xué)研究，由于研究難度較大等原因，對于中藥臨床藥理學(xué)的研究相對薄弱。另外，很多中藥基礎(chǔ)藥理研究與中醫(yī)臨床嚴(yán)重脫節(jié)，很多中藥基礎(chǔ)藥理研究的結(jié)果不能有效指導(dǎo)臨床實踐。中醫(yī)藥的生命力在于臨床。中藥基礎(chǔ)藥理研究如何與臨床藥理研究緊密結(jié)合，從安全性、有效性等方面更加有效地指導(dǎo)中藥新藥和健康產(chǎn)品研發(fā)，是急需解決的問題?！綪harmacology 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.】

中藥藥理學(xué)是中藥創(chuàng)新藥物和保健產(chǎn)品研發(fā)的重要領(lǐng)域和工具，是中藥產(chǎn)品進(jìn)入國際市場的重要橋梁。中藥產(chǎn)品的研發(fā)上市過程必須采用國際通行標(biāo)準(zhǔn)對其安全性和有效性進(jìn)行評價，否則無法為西方主流市場所接受。中藥與天然藥物具有共性，但其應(yīng)用的理論體系不同。現(xiàn)行的歐美標(biāo)準(zhǔn)，不一定適用于中藥產(chǎn)品。我們應(yīng)主動作為，根據(jù)中藥的特點，從安全、有效、可控等方面制定歐美認(rèn)可的評價標(biāo)準(zhǔn)和規(guī)范。2017年6月，美國《內(nèi)科學(xué)年鑒》以簡體中文、繁體中文和英文3種文字同期發(fā)表了由中國、加拿大、英國學(xué)者組成的國際團(tuán)隊共同完成的《中醫(yī)復(fù)方臨床隨機對照試驗報告規(guī)范2017：CONSORT聲明的擴展、說明與詳述》，該國際標(biāo)準(zhǔn)的發(fā)表意義重大，不但有利于提高中藥復(fù)方隨機對照臨床試驗的報告質(zhì)量，有利于提升中醫(yī)藥臨床研究的國際認(rèn)可度，而且對于中藥新藥和健康產(chǎn)品的國際標(biāo)準(zhǔn)起了一個很好的示范作用。國家在《中醫(yī)藥“一帶一路”發(fā)展規(guī)劃（2016-2020年）》中要求，到2020年，頒布20項中醫(yī)藥國際標(biāo)準(zhǔn)，注冊100種中藥產(chǎn)品。在這20項中醫(yī)藥國際標(biāo)準(zhǔn)中，涉及中藥新藥和健康產(chǎn)品的有多少項？目前我們處于中醫(yī)藥發(fā)展的最好歷史時期，是機遇，更是巨大挑戰(zhàn)?！綪harmacology 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.】