中药国际化的一大难题，是很多中药的疗效缺乏客观的临床评价标准，因此国际医学界对中药的疗效争议较大。目前，越来越多的中药在选择循证医学验证其疗效。医学专家认为，引入国际通用的循证医学方法研究中药疗效，有助于促进中药临床研究的规范化、国际化。

The internationalization of traditional Chinese medicine (TCM) a big problem,The effect of traditional Chinese medicine is a lack of objective clinical evaluation standard,So the curative effect of traditional Chinese medicine for international medical dispute is bigger.At present,More and more Chinese medicine in the choice of evidence-based medicine to verify the curative effect.Medical experts have thought that a,Introduce the international general evidence-based medicine method to study traditional Chinese medicine efficacy,Help to promote the standardization of the traditional Chinese medicine clinical research/international.

　　最严格循证医学研究证明中药疗效 The most strict evidence-based medical research that traditional Chinese medicine efficacy

　　卫生部副部长、国家中医药管理局局长王国强在2012年全国中医药工作会议上表示，中医药能否切实发挥作用，真正赢得信任，关键在于临床疗效的不断提高，在于对维护和增进人们健康所作的贡献。与此同时，国际社会对中医药的态度发生了新的变化，许多国家正利用其资金、技术等方面的优势，积极开展中医药的研究和利用，使我国中医药的原创优势和资源优势受到威胁。

Vice minister of health/The state administration of traditional Chinese medicine WangGuoJiang director in 2012 national Chinese medicine work conference on Wednesday,Traditional Chinese medicine can be to play a role,Really win the trust,The key lies in the continuous improvement of the clinical curative effect,Is to maintain and enhance the contribution of the people's health.meanwhile,The international society for Chinese medicine attitude has undergone new changes,Many countries are using their money/The advantages of the technology,Actively carry out research and utilization of traditional Chinese medicine,Traditional Chinese medicine in the original advantage and resource advantage under threat.

　　中药具有悠久的历史，但很多中药在临床用药方面缺乏现代循证医学研究证据，严重阻碍中药走向国际市场。最近，由全国60余家三甲医院参与的“稳心颗粒循证临床试验”研究项目收官。项目主要负责人、中国科学院院士葛均波教授表示，这项历时两年半临床研究项目的完成，标志着我国中药药效机制研究取得重大成果，中药国际化推广取得突破性进展。

Traditional Chinese medicine has a long history,But a lot of traditional Chinese medicine in clinical medicine lack of modern evidence-based medical research evidence,Serious obstacles of traditional Chinese medicine to the international market.recently,By the national more than sixty in hospital"Metacentre grain evidence-based clinical test"The final project.The principal person in charge of the project/GeJunBo academician of the Chinese academy of sciences professor said,The last two and half years clinical research project complete,Marks the traditional Chinese medicine efficacy in mechanism research made great achievements,Traditional Chinese medicine international promotion breakthrough.

　　据介绍，稳心颗粒循证医学临床研究项目是我国目前中药循证临床研究项目中标准最严格的。稳心颗粒循证医学临床试验2010年3月启动，由中国科学院院士葛均波教授和中国医学科学院阜外心血管病医院主任医师华伟等为主要研究负责人。中国医学科学院阜外心血管病医院、解放军总医院、四川大学华西医院等60余家三甲医院参与。由卫生部心血管病防治中心生物统计室质量控制及数据统计，第三方独立专业组织管理监察。

According to introducing,Metacentre grain evidence-based clinical research project is at present in China, the traditional Chinese medicine evidence-based clinical research projects in the most stringent standards.Metacentre grain evidence-based medicine clinical trials in March 2010 start,By the China academy of sciences and Chinese academy of medical sciences professor GeJunBo fortune recourse international cardiovascular disease hospital chief physician HuaWei as the main research person in charge.Chinese academy of medical sciences fortune recourse international hospital cardiovascular disease/Liberation army general hospital/West China hospital of sichuan university, such as more than sixty in hospital.By the ministry of public health of cardiovascular disease control and prevention center biometric room quality control and data statistics,The third party independent professional organization management and supervision.

　　华伟说，稳心颗粒循证医学临床试验共收集到2400例病例，是目前中药循证医学临床试验中病例最多的，严格按照循证医学试验标准进行，同时符合美国F D A标准。这种与国际接轨的医学研究为我国中药临床研究起到了积极示范作用，对促进我国中药现代化、走向国际化意义重大。

HuaWei said,Metacentre grain evidence-based medicine clinical trials to collect a total of 2400 cases,Traditional Chinese medicine is the evidence-based medicine clinical trials of most cases,In strict accordance with the evidence-based medical test standards,At the same time in the U.S. F D A standard.This medical research with international standards for Chinese traditional Chinese medicine clinical research which has played a positive role model,To promote the modernization of traditional Chinese medicine/Internationalization is of great significance.

　　据卫生部心血管病中心医学研究统计中心李卫教授介绍，统计分析显示，稳心颗粒对于房性早搏的治疗有效率为83.6%，对室性早搏疗效达到83%，能有效改善心悸、胸闷、失眠、乏力等临床症状，且无明显不良反应，安全性好。

According to the ministry of health of cardiovascular disease center medical research center LiWei statistics professor is introduced,Statistical analysis showed that,Metacentre grain for room sex premature beat treatment effective rate was 83.6%,Effect of ventricular premature beat up to 83%,Can effectively improve the palpitation/Bosom frowsty/insomnia/The lack of clinical symptoms,And no obvious adverse reaction,safety.

　　中国工程院院士、心血管病学专家高润霖说，稳心颗粒循证医学临床研究成果的意义不仅在于为稳心颗粒治疗早搏提供了高水平的循证医学证据，也为如何评价中药疗效积累了宝贵经验，为中药开展大规模随机对照研究提供了很好的范例。

Chinese academy of engineering/Cardiovascular epidemiology GaoRunLin experts said,Metacentre grain evidence-based clinical research significance is not only for metacentric granule in treating premature beat provides a high level of evidence-based medical evidence,Also for how to evaluate curative effect of traditional Chinese medicine has accumulated valuable experience,Traditional Chinese medicine for large-scale randomized study provides a good example.

　　借力循证医学让中药获得国际认可 Borrows the evidence-based medicine of traditional Chinese medicine to obtain international recognition

　　稳心颗粒是我国第一个专门治疗心律失常的创新现代中药，它的诞生，打破了临床抗心律失常仅有西药的局面。1991年，稳心颗粒被列为国家“八五”科技攻关课题，1992年荣获中国中医科学院科技进步奖。多年来，稳心颗粒还多次荣获国家中医药管理局科技进步奖，先后列入基本医疗保险药品目录、全国中医医院急诊药品要目、中国高新技术产品目录、国家中药保护品种。2010年，稳心颗粒被列入《中华人民共和国药典(2010版)》，是迄今为止我国药典中唯一一个治疗心律失常的中成药。

Metacentre grain is China's first special treatment of arrhythmia innovation of modern Chinese medicine,It was born,To break the clinical anti-arrhythmic only western medicine situation.In 1991,,Metacentre grain were classified as a national"eighth"Science and technology research projects,In 1992 won the Chinese traditional Chinese medicine academy of sciences progress prize in science and technology.For many years,Metacentre grain has repeatedly won the state administration of traditional Chinese medicine progress prize in science and technology,Has been included in the basic medical insurance drug catalogue/The doctor of traditional Chinese medicine hospital emergency medicine particular/China's high technology and new technology product catalog/National protected variety of traditional Chinese medicines.In 2010,,Metacentre grain are on[Pharmacopoeia of the People's Republic of China(2010 edition)],Is so far the only one in China pharmacopoeia of the traditional Chinese medicine treatment of arrhythmia.

　　李卫说，我国很多中药的疗效指标都不是客观的，这正是国内患者感觉“很有效”的中药不能得到国际医学界认可的重要原因之一。近年来，随着健康观念的变化和医学模式的调整，以及医学目的的转变，中医药整体思维辨证论治和治未病预防保健的理论与方法的优势进一步凸显，国际社会和当代的生命科学也越来越重视和关注中医药，都对中医药服务提出了更高的要求和更广泛的需求。

LiWei said,Many Chinese traditional Chinese medicine efficacy variable is not objective,This is the domestic patients feel"Very effective"Traditional Chinese medicine can't get the international medical community recognized one of the important reasons.In recent years,Along with the changes in the concept of health and medical model of adjustment,And the change of medical purpose,Traditional Chinese medicine syndrome differentiation and treatment of holistic thinking and preventive treatment of disease prevention health care the advantage of the theory and method of further highlight,The international community and contemporary life science is also more and more attention and focus on traditional Chinese medicine,Traditional Chinese medicine service to put forward the higher request and the broader needs.

　　葛均波院士认为，中药要真正走向现代化，走出国门，需要把中医辨证施治的理论结合到临床试验里去。不能所有人都是一样的剂量，这样会影响对疗效的判断。中西医的指导思想是完全不一样的，而循证医学就是在是根据西方医学模式做中药的临床研究。

GeJunBo academicians think,Traditional Chinese medicine to really modernization,Go abroad,Need to take the doctor of traditional Chinese medicine syndrome differentiation theory by combining the clinical trials to.Not all people are the same dose,This will affect the judgment of the curative effect.The guiding ideology of traditional Chinese and western medicine is completely different,And evidence-based medicine is the western medicine is based on the mode of traditional Chinese medicine do clinical research.

　　他认为，“稳心颗粒”循证医学更重要的是为中成药如何走出一条通过临床、科研结合，而且运用现代高科技来评价中成药疗效的道路。这样既能够得到中医药界同仁们的认可，也能得到西药界人们的认同，能够得到国际的认同。

He thinks,"Metacentre grain"Evidence-based medicine is more important for traditional Chinese medicine how to go out a through the clinical/Research combined with,And the use of modern technology to evaluate the curative effect of traditional Chinese medicine road.Such already can get colleagues in the industry recognition,Also can get the western medicine boundary people's identity,To get international recognition.

　　医药专家认为，这种探索所取得的成果，以及它形成的路径、方法，远远比稳心颗粒这一个药重要得多。以后我们很多的中成药可以学习借鉴稳心颗粒以及其他一些中成药在循证医学方面的成功经验，使更多的中成药既能得到国内更多的认可，也能得到国际上更多认可。

Medical experts say,The exploration achievements made,And it formed path/methods,Than metacentre grain this medicine is much more important.Later we a lot of traditional Chinese medicine can study and use for reference metacentre grain and other traditional Chinese medicine in the evidence-based medicine successful experience,More traditional Chinese medicine can get more domestic recognition,Also can get more international recognition.

　　运用现代科学理论技术发展壮大中医药 The use of modern science and technology development theory of traditional Chinese medicine

　　据稳心颗粒的研发、生产企业步长制药集团董事长赵涛介绍，稳心颗粒2001年上市，今年的销售收入可达20多亿元，目前全国90%以上的正规医院都有销售。他说，稳心颗粒循证临床试验投入3000多万元，步长制药集团在稳心颗粒销售规模逐年扩大的前提下，还愿意冒着巨大的风险，投入这么大的资金搞循证临床试验，就是为了适应国际社会和当代生命科学对中医药的新需求，探索一条中药现代化、市场国际化的有效路径。

According to the development of metacentric particles/Production enterprise step pharmaceutical group chairman of the board of directors ZhaoTao is introduced,Metacentre grain listed in 2001,This year's sales income can reach and more than one hundred million yuan,At present the national more than 90% of the normal hospital have sales.He said,Metacentre grain evidence-based clinical trials invested more than 3000 yuan,Step length pharmaceutical group in metacentre grain sales scale under the premise of increasing,Is willing to take a great risk,In such a big money make evidence-based clinical test,Is in order to adapt to the international society and the modern life science and traditional Chinese medicine to the new demand,Explore a modernization of traditional Chinese medicine/Internationalization of market effective path.

　　赵涛说，此前稳心颗粒已出口菲律宾、越南、泰国等东南亚国家，俄罗斯也有销售，但总量都不大。循证临床试验完成后，企业将进一步加快成果推广，拓展国际市场，在全球范围内体现中医药的价值和优势。

ZhaoTao said,Previously metacentre grain have exported the Philippines/Vietnam/Thailand and other southeast Asian countries,Russia also have sales,But not the total of all.Evidence-based clinical test after completion,Enterprise will further accelerate the speed of achievement promotion,To develop international market,In the worldwide Chinese medicine value and advantage.

　　医药专家认为，中药要进一步走向现代化、国际化，必须努力推动建立符合中医药实践特点和科研方法的科学体系，丰富和发展生命科学的认识论和方法论。当前，新药研发的资源越来越少，以化学药物为主导的新药研发周期长、投资大、风险高，化学创新药物越来越困难。这种形势给中药创新并走向国际化，提供了难得的发展机遇。

Medical experts say,Traditional Chinese medicine to further toward modernization/international,Must strive to promote the establishment conforms to the Chinese medicine practice characteristics and research methods of scientific system,Rich and the development of life science epistemology and methodology.The current,New medicine r&d resources less and less,With chemical drugs for leading new drug research and development cycle is long/Investment big/High risk,Chemical innovation drugs more and more difficult.The situation of traditional Chinese medicine to innovation and internationalization,Provides a rare opportunity for development.

　　葛均波说，中成药现代临床研究在20世纪80年代以来，积极运用现代生物医药知识与方法，取得了较为显著的成绩。但从总体上看，目前的研究工作仍处于探索阶段，缺乏重大原始创新性的成果和思路，这也是不可否认的现实。展望未来，中成药临床研究还需从思路和方法上予以认真思考并大胆探索。（宗焕平　李亚红）

GeJunBo said,Traditional Chinese medicine modern clinical research in the 1980 s,Active use of modern biological medicine knowledge and method,Achieved remarkable results.However, from the overall perspective,The present research work is still in the stage of exploration,The lack of significant original innovative achievements and ideas,It is also undeniable reality.Looking to the future,Traditional Chinese medicine clinical research also need to be careful thought and method on thinking and bold exploration.(ZongHuanPing LiYaGong)