充分利用中医药独特优势研发中药新药

蒋宁（中国药理学会中药与天然药物药理专业委员会委员兼副秘书长，北京药理毒理研究所副研究员，主要从事神经药理学、中药药理学研究及中药新 药 研 发 。）

中医药在人类健康与保健中发挥着重大作用，中药新药以中医药体系中蕴含的丰富临床经验为基础，是新药研发的重要领域，表现出巨大的应用潜力和价值优势，受到全世界范围内的广泛关注。未来中药新药研发应以满足临床需求为目标，以科学性、合规性为保障，主要关注以下几点。【TCM 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 关注疾病谱变化，调整研发方向【Observe changes in disease spectrum，adjust direction of research and development】

随着现代医学的高速发展，疾病谱和医学模式发生着很大的改变。我国社会经济和医药卫生事业的快速发展，使得人民生活水平快速提升，生活方式、饮食结构、生活环境等均发生了显著变化，心脑血管疾病、神经退行性疾病、恶性肿瘤、免疫性疾病、代谢性疾病等慢性复杂性疾病已经取代传染病、寄生虫病等，成为当前威胁人民健康、导致医疗费过度增长的主要健康问题。这些治疗领域也正是近年大量药物快速发展的优势领域。中医药作为服务于中华民族数千年的医疗科学体系和现代基本医疗与卫生保健体系的重要组成，也对其提出了崭新的要求。根据疾病谱的变化，中药新药研发方向也要做出必要的调整。【With 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 发挥中药优势，明确临床定位【Give full play to advantages of traditional Chinese medicine and define clinical positioning】

中药擅长整体系统调节，长于疑难、复杂疾病的治疗，中药新药研发或品种二次开发可根据疾病谱的变化，瞄准重大疾病的不同病理环节和不同发展阶段，选择中药治疗的优势病种，将中医药整体治疗观念的宏观性与现代临床治疗用药的微观性相结合，按照疾病不同分型、不同发展阶段、不同转归精准设计用药方案。如糖尿病的防治已经成为中国乃至全球医学界的重大和疑难课题，开发糖尿病相关中药时，如果单纯关注血糖指标，在口服降糖药既便宜又有效的当下，此类中药将毫无优势可言。然而，对糖尿病患者而言，单纯的降糖治疗是不够的，防治糖尿病多种并发症，如糖尿病视网膜病变、糖尿病肾病、糖尿病周围神经病变等的发生、发展才是关键。而中药对糖尿病的并发症具有良好的疗效和患者顺应性，能够满足单一靶点的西药无法治疗的临床需求。中药新药如果临床定位在针对糖尿病一种或几种并发症的综合防治，更能体现出中药的优势和临床价值。【TCM 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 注重疾病预防和个体化精准医疗【Focus on disease prevention and individualized preci⁃sion medicine】

世界卫生组织在《迎接21世纪的挑战》报告中指出“21世纪的医学，不应继续以疾病为主要研究对象，而应以人类健康作为医学研究的主要方向。”我国国务院颁布的《国家中长期科学技术发展规划纲要（2006－2020）》中也明确指出，疾病防治要重心前移，重点研究开发重大疾病的早期预警和诊断、疾病危险因素早期干预等关键技术。这与中医药“治未病”的基本理念高度一致，充分体现了中医药“天人合一”“整体观”“辨证论治”“治未病”等核心思想的前瞻性与正确性。中医“治未病”思想与全球医学目标从疾病向健康的转变不谋而合，也符合我国“从以疾病为主导而走向以健康为主导”的卫生战略，体现了中医药在“治未病”中所具有的魅力和优势。作为中药研发工作者，应借助“中医药发展上升为国家战略”的热潮，努力发掘新机遇，促进创新中药开发和中药大品种开发，服务于健康中国的建设。【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.】