[關(guān)鍵詞]
[摘要]
國家大力推進(jìn)中藥現(xiàn)代化所取得的重要成就已為中藥學(xué)人所共識(shí),然而臨床醫(yī)生和廣大老百姓對(duì)中藥現(xiàn)代化成果的感受仍較為滯后。重視臨床、結(jié)合臨床,大力開展中藥轉(zhuǎn)化醫(yī)學(xué)研究,是推動(dòng)中藥現(xiàn)代化走進(jìn)臨床的重要出路和舉措。中藥轉(zhuǎn)化醫(yī)學(xué)研究路徑可概括為:源于臨床-證于實(shí)驗(yàn)-回歸臨床的循環(huán)往復(fù)過程;其研究內(nèi)容可概括為:面向臨床的中藥標(biāo)準(zhǔn)化研究和源于臨床的創(chuàng)新中藥研制。面向臨床的中藥標(biāo)準(zhǔn)化研究的核心是以臨床需求為導(dǎo)向,建立以功效為基礎(chǔ)的中藥品質(zhì)與性效評(píng)價(jià)方法和標(biāo)準(zhǔn),推動(dòng)中藥“品-質(zhì)-性-效-用”一體化,使中藥標(biāo)準(zhǔn)在臨床上能讓醫(yī)生看得懂、用得上;源于臨床的創(chuàng)新中藥研制,包括基于臨床經(jīng)驗(yàn)和循證醫(yī)學(xué)證據(jù)的特色復(fù)方中藥研制、基于臨床標(biāo)本和組學(xué)方法的現(xiàn)代組分中藥研制,加快中藥新藥研究與開發(fā)進(jìn)程,為中醫(yī)臨床提供“源于傳統(tǒng)、優(yōu)于傳統(tǒng)”的安全高效藥物。建議國家有關(guān)主管部門從科研立項(xiàng)、人才培養(yǎng)、新藥審評(píng)及配套的相關(guān)政策法規(guī)和組織機(jī)構(gòu)等方面,支持中醫(yī)藥轉(zhuǎn)化醫(yī)學(xué)研究工作。
[Key word]
[Abstract]
The vigorous advance on modernization of Chinese materia medica (CMM) has achieved great successes, which is the consensus of scholars. However, the physicians and populace have few awareness of the CMM modernization achievements. It is in great need to promote the modernization of CMM into clinic by translational medicine. The research pathway of CMM translational medicine could be summarized as a repeated cycle of bedside to bench to bedside. And, its main research might include two missions, one is the clinic-oriented standardization of CMM and the other is the clinic-derived discovery of CMM new drugs. The clinic-oriented standardization of CMM is focusing on the development of the effect-based evaluating methods and standards on CMM quality and drug property and promoting CMM integration of “species-quality-property-effect-usage”, which aims at making doctors be able to comprehend and emply the CMM standards. The clinic-derived discovery of CMM new drugs diverges into two pathways: one is the development of traditional compound formula drugs based on the physicians’ experiences and evidence-based medicine; the other is the innovation of modern multi-component CMM drugs based on the clinical specimens and -omic techniques. The clinic-derived drug discovery provides an efficient approach to develop novel CMM drugs with superior efficacy and safety to traditional ones. Thus, it is reasonable to suggest that the related administrations of state should strongly support the translational research of CMM by granting scientific research projects, training specialists of translational medicine, and reforming the regularities of new drug evaluation and relative policies.
[中圖分類號(hào)]
[基金項(xiàng)目]
國家杰出青年科學(xué)基金項(xiàng)目(30625042);國家“重大新藥創(chuàng)制”科技重大專項(xiàng)課題(2009ZX09502-022)