蔣寧（中國藥理學(xué)會中藥與天然藥物藥理專業(yè)委員會委員兼副秘書長，北京藥理毒理研究所副研究員，主要從事神經(jīng)藥理學(xué)、中藥藥理學(xué)研究及中藥新 藥 研 發(fā) 。）

中醫(yī)藥在人類健康與保健中發(fā)揮著重大作用，中藥新藥以中醫(yī)藥體系中蘊(yùn)含的豐富臨床經(jīng)驗(yàn)為基礎(chǔ)，是新藥研發(fā)的重要領(lǐng)域，表現(xiàn)出巨大的應(yīng)用潛力和價值優(yōu)勢，受到全世界范圍內(nèi)的廣泛關(guān)注。未來中藥新藥研發(fā)應(yīng)以滿足臨床需求為目標(biāo)，以科學(xué)性、合規(guī)性為保障，主要關(guān)注以下幾點(diǎn)?！綯CM plays a significant role in human health and health care.Based on the rich clinical experi?ence contained in TCM system,new TCM drugs are an important field for research and development.It shows great potential and valuable advantages and has attracted worldwide attention.The future development of new drug research and develop?ment of TCM should meet the clinical needs as the goal,and be guaranteed by science and compliance.The main ideas are as follows.】

1 關(guān)注疾病譜變化，調(diào)整研發(fā)方向【Observe changes in disease spectrum，adjust direction of research and development】

隨著現(xiàn)代醫(yī)學(xué)的高速發(fā)展，疾病譜和醫(yī)學(xué)模式發(fā)生著很大的改變。我國社會經(jīng)濟(jì)和醫(yī)藥衛(wèi)生事業(yè)的快速發(fā)展，使得人民生活水平快速提升，生活方式、飲食結(jié)構(gòu)、生活環(huán)境等均發(fā)生了顯著變化，心腦血管疾病、神經(jīng)退行性疾病、惡性腫瘤、免疫性疾病、代謝性疾病等慢性復(fù)雜性疾病已經(jīng)取代傳染病、寄生蟲病等，成為當(dāng)前威脅人民健康、導(dǎo)致醫(yī)療費(fèi)過度增長的主要健康問題。這些治療領(lǐng)域也正是近年大量藥物快速發(fā)展的優(yōu)勢領(lǐng)域。中醫(yī)藥作為服務(wù)于中華民族數(shù)千年的醫(yī)療科學(xué)體系和現(xiàn)代基本醫(yī)療與衛(wèi)生保健體系的重要組成，也對其提出了嶄新的要求。根據(jù)疾病譜的變化，中藥新藥研發(fā)方向也要做出必要的調(diào)整?！網(wǎng)ith the rapid devel?opment of modern medicine,the spectra of diseases and medical mode have undergone great changes.The rapid development of social economy and medical and health services has led to the rapid improvement of people′s living standards,as well as changes in lifestyle,diet and the living environment.Cardiovascular and cerebrovascular diseases,neurodegenerative diseases,malignant tumors,immune diseases,metabolic disease and other chronic complex diseases have become the major health problems that currently threaten human health and cause excessive growth of medical expenses instead of infectious diseases and parasitic diseases.These areas are also the advantageous areas which a large number of drugs were developed rapidly in recent years.As an important component of the medical science system serving the Chinese nation for thousands of years and the modern basic medical and health care system,TCM also faces new require?ments.According to the changes in disease spectrum,the direction of new drug research and development of TCM should be adjusted accordingly.】

2 發(fā)揮中藥優(yōu)勢，明確臨床定位【Give full play to advantages of traditional Chinese medicine and define clinical positioning】

中藥擅長整體系統(tǒng)調(diào)節(jié)，長于疑難、復(fù)雜疾病的治療，中藥新藥研發(fā)或品種二次開發(fā)可根據(jù)疾病譜的變化，瞄準(zhǔn)重大疾病的不同病理環(huán)節(jié)和不同發(fā)展階段，選擇中藥治療的優(yōu)勢病種，將中醫(yī)藥整體治療觀念的宏觀性與現(xiàn)代臨床治療用藥的微觀性相結(jié)合，按照疾病不同分型、不同發(fā)展階段、不同轉(zhuǎn)歸精準(zhǔn)設(shè)計(jì)用藥方案。如糖尿病的防治已經(jīng)成為中國乃至全球醫(yī)學(xué)界的重大和疑難課題，開發(fā)糖尿病相關(guān)中藥時，如果單純關(guān)注血糖指標(biāo)，在口服降糖藥既便宜又有效的當(dāng)下，此類中藥將毫無優(yōu)勢可言。然而，對糖尿病患者而言，單純的降糖治療是不夠的，防治糖尿病多種并發(fā)癥，如糖尿病視網(wǎng)膜病變、糖尿病腎病、糖尿病周圍神經(jīng)病變等的發(fā)生、發(fā)展才是關(guān)鍵。而中藥對糖尿病的并發(fā)癥具有良好的療效和患者順應(yīng)性，能夠滿足單一靶點(diǎn)的西藥無法治療的臨床需求。中藥新藥如果臨床定位在針對糖尿病一種或幾種并發(fā)癥的綜合防治，更能體現(xiàn)出中藥的優(yōu)勢和臨床價值?！綯CM excels in the overall system regulation and effective for diffi?cult and complex diseases.With the changes of disease spectrum,R&D of new drugs of TCM or the second R&D should target different pathological stages and evolution stages of major disease and combine the macroscopic nature of the overall concept of TCM treatment and the microscopic nature of modern clinical treatment to design medical regimens precisely aiming at different types,stages and outcomes of diseases.Taking diabetes for example,the prevention and treat?ment of this disease has become a major and difficult issue in the fields of Chinese and global medicine.When developing TCM for treating diabetes,focusing on blood glucose alone can lead to no advantage of such TCM at all,espe?cially when oral hypoglycemic agents are both cheap and effective now.However,for patients with diabetes,hypoglycemic treatment alone is not enough.The key is prevention and treatment of the occurrence and development of various complications of diabetes,such as diabetic reti?nopathy,diabetic nephropathy,and diabetic peripheral neuropathy.With good effects on the complications of diabetes and good compliance,TCM can meet the clinical requirement that the single target western medicine is not capable of.If the clinical positioning of TCM aims at the comprehensive prevention and treatment of one or several complications of diabetes,it will better embody the advantages and clinical value of TCM.】

3 注重疾病預(yù)防和個體化精準(zhǔn)醫(yī)療【Focus on disease prevention and individualized preci?sion medicine】

世界衛(wèi)生組織在《迎接21世紀(jì)的挑戰(zhàn)》報告中指出“21世紀(jì)的醫(yī)學(xué)，不應(yīng)繼續(xù)以疾病為主要研究對象，而應(yīng)以人類健康作為醫(yī)學(xué)研究的主要方向?！蔽覈鴩鴦?wù)院頒布的《國家中長期科學(xué)技術(shù)發(fā)展規(guī)劃綱要（2006－2020）》中也明確指出，疾病防治要重心前移，重點(diǎn)研究開發(fā)重大疾病的早期預(yù)警和診斷、疾病危險因素早期干預(yù)等關(guān)鍵技術(shù)。這與中醫(yī)藥“治未病”的基本理念高度一致，充分體現(xiàn)了中醫(yī)藥“天人合一”“整體觀”“辨證論治”“治未病”等核心思想的前瞻性與正確性。中醫(yī)“治未病”思想與全球醫(yī)學(xué)目標(biāo)從疾病向健康的轉(zhuǎn)變不謀而合，也符合我國“從以疾病為主導(dǎo)而走向以健康為主導(dǎo)”的衛(wèi)生戰(zhàn)略，體現(xiàn)了中醫(yī)藥在“治未病”中所具有的魅力和優(yōu)勢。作為中藥研發(fā)工作者，應(yīng)借助“中醫(yī)藥發(fā)展上升為國家戰(zhàn)略”的熱潮，努力發(fā)掘新機(jī)遇，促進(jìn)創(chuàng)新中藥開發(fā)和中藥大品種開發(fā)，服務(wù)于健康中國的建設(shè)。【In the report"Meeting the Challenges of the 21stCentury",WHO pointed out that"the main areas of medical research in the 21stCentury are not diseases,but human health"."Plan on National Medium-and Long-term Development of Science and Technology(2006-2020)",issued by China′s State Council,also clearly points out that the main emphasis of major diseases should shift to the prevention and treatment and focus on research and development of key technolo?gies of early warning and diagnosis of major diseases and early intervention of disease risk factors.This is highly consistent with the basic concept of"preventive treatment"in TCM and fully reflects the prospectiveness and correctness of the core concepts of"holism of human beings and universe","holistic view","treatment based on syndrome differentiation"and "preventive treatment".The idea of"preventive treatment of disease"agrees with the global medical objec?tive,which has shifted the core from disease to health,and is also in line with the health strategy of our country"shifting from disease-oriented to health-oriented strategy",which shows the charm and advantages of"preventive treatment".In the boom of"TCM development as a national strategy",TCM researchers should try to explore new opportunities and promote the R&D of innovative TCM and major TCM varieties for serving the construction of healthy China.】