2007年4月5日记者:Jane Qiu中国宣布了一项雄心勃勃的计划,试图让古老的中医药采用现代标准。中国政府称它将拓展基础和临床研究,并改进中药出口的检测和开发。但是批评者们质疑该研究是否会符合要获得国际认可所必需的科学标准。
虽然中国以前也投资中医药,但是该15年计划的方向有所改变,并将获得多得多的资金。该项目受到16个部委的支持,由科技部、卫生部和中医药管理局领头。
科技部分管卫生与生物技术的负责人邹建强说,中国政府拨款10亿元(1亿3千万美元)用于中医药研究和开发,在未来的五年总预算至少是以前7亿4千万元总资金的5到6倍。
在这个多数人口未能享受公共医疗并负担不起去医院看病的国家,用于与中医药有关的公共医疗的资金也增加了10倍,达到85亿元。“中医药自古就在为中国人民服务,现在在医疗中仍然起到重要的作用,特别是在那些人们没有机会用到或负担不起西医治疗的地区,”中医药管理局副局长于文明说。
这项措施是在遍及全国的有关中医药的激烈讨论之后产生的。去年,湖南长沙中南大学的一名学者张功耀在《医学与哲学》杂志上发表了一篇题为《告别中医中药》的文章,引发了一场全国性的辩论。张功耀争辩说,中医是伪科学,不应该是国家医疗体系和研究的一部分。
争论的各方都在焦急地等待政府的立场,结果它坚定地支持把中医当成科学来宣扬。中国极度渴望中药在海外能够获得管理部门的批准,并希望在2020年让中医药全球化。在过去的十年,中药的世界市场翻了一番,其中欧洲和美国是最大的进口国。但是来自中国的中药糟糕的安全记录导致其出口量持续下降,部分市场份额被日本、韩国等邻国占据。
因此中国的计划制定了提高标准的策略,包括对中药的安全性和有效性开展临床研究,促进国际合作,改进制造技术并对医药管理系统采用国际规范。
中国政府在方法方面的改变引发了更大的争议。要从中药开发出经科学检验的药物,以前的做法是注重从中药中分离出活性成分,一一进行筛选。这个做法获得了少数的新成果,例如用于治疗疟疾的青蒿素和减充血剂麻黄碱,但是获得批准的药物并未大量涌现。新的计划致力于开发出更有传统特色和原理的方法来检验中医药。这要求采用整体论的方法对待疾病的治疗,不是用一种药治疗一种特定的疾病,而是使用植物提取物的复杂混合。每一种混合物都是个体化的,针对某个病人的症状和特性。
中医药的从业者和研究人员还在等着看政府是否会真的给钱,但是他们一般来说都欢迎这个计划。“这是一个重大的进步,”上海中医药大学副校长刘平说。
不过,有些人不愿附和。北京中国医学科学院一位要求匿名的教授认为,在经过数千年的实践和发展之后,中医已经近乎完善,让中医现代化只不过是歪曲了其实质。
美国培养的生物化学学者、现在在主持打击中国伪科学和科研不端行为的“新语丝”的网站的方是民也对这个计划不以为然,但是是出于相反的原因。他支持对中草药进行科学研究,但是认为对检验中医理论的强调是错误的。“中医的基本概念,例如阴阳、五行和经络理论,是对人体模糊的描述,近乎臆测,”
他说,“政府已经花费了大量的资金试图证明中医理论的物质基础,但是一无所获。”
上海药物研究所药物国家新药筛选中心主任王明伟同意这个观点:“要真正让中医药现代化,我们必须首先去掉这些理论的神秘性。”
有些批评者也担心该计划没有设定足够严格的科学标准。虽然临床研究被列为首要任务之一,但是该计划并没有具体说明是否应该采用随机、对照、双盲(研究人员和病人都不知道谁获得药物谁获得安慰剂)的临床试验。而且,并没有要求中医药研究人员要在国际认可的刊物上发表论文。“过去有关中医药的研究多数质量都很差,而且只发表在没有经过同行评议的中国医学期刊上,”王明伟评论说,“如果政府对此没有清楚的立场,那么这种情况不太可能会发生改变。”
另一个大家关心的问题是政府没有具体说明它将如何管理科研资金的分配。
有些批评者觉得,现在的资源只是被某些受优待的大学和研究所分享,他们争辩说,如果想要获得真正的进展,就应该对此进行改革,确保中医药的资金是择优分配的。否则的话,如上海交通大学药学院副院长贾伟所言,该措施将会只是“雷声大,雨滴小”。
邹建强说,政府注意到了围绕中医药的争论和问题,而该计划已经过广泛的商议,就是为了解决这些问题的。中医药管理局科技司副司长钢强指出该计划概括了中医药发展的总原则和长远方向,而不涉及细节,并说将来将会发布策略具体地说明如何实施这些框架。
中国政府在起草这些计划时是否会考虑批评者的担心,人们拭目以待,但是许多人表达了谨慎的乐观。“现在发展中医药势头正好,”贾伟说,“但愿不会错失良机。”
NewsNature 446, 590-591 (5 April 2007) | doi:10.1038/446590a; Publishedonline 4 April 2007
China plans to modernize traditional medicine
Jane Qiu, Beijing
Abstract
Government initiative aims to meet scientific standards.
China has announced an ambitious attempt to bring the ancient practiceof traditional Chinese medicine (TCM) into line with modern standards.The government says it will expand basic and clinical research, andimprove the testing and developing of TCM remedies for export. Butcritics question whether the research will meet the scientificstandards necessary for international recognition.
Although China has invested in TCM before, the 15-year plan involves achange of direction and will receive significantly more money. Theproject is backed by 16 Chinese ministries, spearheaded by theMinistry of Science and Technology (MOST), the Ministry of Health andthe State Administration of Traditional Chinese Medicine (SATCM).
Zou Jian-qiang, director of MOST's health and biotechnology division,says the government has earmarked 1 billion yuan (US$130 million) forTCM research and development, with the total budget over the next fiveyears increasing to at least 5–6 times as much as the previous totalof 740 million yuan.
In a country where most of the population is not covered by the publichealthcare system and cannot afford to go to hospital, there is also atenfold increase in money for the TCM-related part of the publichealthcare system to 8.5 billion yuan. "Chinese medicine, which hasserved the Chinese people since antiquity, still has an important rolein today's healthcare, especially in areas where people do not haveaccess to, or could not afford, treatments based on Western medicine,"says Yu Wen-ming, deputy director of SATCM.
The initiative comes after heated discussions on TCM throughout China.Last year, Zhang Gong-yao, a scholar at the Central South Universityin Changsha, Hunan, sparked a national debate when he published anarticle titled "Farewell to Traditional Chinese Medicine" in theChinese journal Medicine and Philosophy (27, 14–17; 2006). Zhangargued that TCM is a pseudoscience and should not be part of publichealthcare and research.
All sides of the argument have been keenly awaiting the government'sstance, and it has come down firmly in favour of promoting TCM as ascience. China is desperate to earn regulatory approval for TCMremedies abroad, and hopes to globalize TCM by 2020. The world marketfor Chinese herbal medicine has doubled over the past decade, withEurope and the United States being the biggest importers. But thepatchy safety record of TCM from China has led to a steady decline inits exports, and it has lost market share to neighbouring nations suchas Japan and South Korea.
So China's plan specifies strategies to boost standards, includingconducting clinical research on the safety and efficacy of TCM remedies,encouraging international collaboration, improving manufacturingtechniques and bringing the drug regulatory system into line withinternational guidelines.
More controversial is the government's shift in approach. Previousattempts to develop scientifically tested drugs from TCM have focusedon isolating active ingredients from the remedies and screening themone at a time. This has led to a handful of new treatments, such asartemisinin for treating malaria and the decongestant ephedrine, butthere has been no goldrush of approved drugs. The new plan aims todevelop methodologies to test TCM's more traditional features andprinciples. The practice takes a holistic approach to disease treatment,so rather than using one drug to treat a particular disease, complex combinations of plant extracts are used. Each mixture is personalizedto the symptoms and characteristics of the patient.
TCM practitioners and researchers are still waiting to see whether thegovernment will actually come up with the money, but they havegenerally welcomed the plan. "It's a significant step forward," saysLiu Ping, vice-president of Shanghai University of Traditional ChineseMedicine. Some, however, are reluctant to jump on the bandwagon. Aprofessor at the China Academy of Chinese Medical Sciences in Beijing,who asked not be named, reckons that after thousands of years ofpractice and development, TCM is already close to perfect and thatmodernization will simply distort its essence.
Shi-min Fang, a US-trained biochemist who now runs a website called'New Threads' that fights pseudoscience and research misconduct inChina, is also unimpressed by the plan, but for opposite reasons. Heis in favour of scientific research into Chinese herbal remedies, butthinks the emphasis on testing the theories of TCM is misplaced. "Thebasic concepts of Chinese medicine, such as yin and yang, wu xing (thefive elements) and the qi (meridian) theory, are inaccurate descriptions of the human body that verge on imaginative," he says."The government has already spent a lot of money trying to prove theirmechanistic basis, but this hasn't gone anywhere."
Wang Ming-wei, director of the National Centre for Drug Screening atthe Shanghai Institute of Materia Medica, agrees: "To truly modernizeChinese medicine, we must first demystify these theories."
Some critics also worry that the plan doesn't set strict enoughscientific standards. Although clinical research is listed as apriority, the plan doesn't specify whether there should be randomized,controlled trials in which neither practitioners nor patients know whois receiving active remedy and who is getting a placebo. And there isno requirement for TCM researchers to publish in internationallyrecognized journals. "Most research on TCM in the past is of poorquality, and is published only in Chinese medical journals withoutproper peer-review processes," remarks Wang. "Without a clear positionfrom the government, it is unlikely that the situation will change."
Another concern is that the government does not specify how it willcontrol the way in which research funding is allocated. Some criticsfeel that resources are currently being circulated only among certainfavoured universities and institutes, and argue that reform to ensurethat TCM grants are based on merit is necessary if any real progressis to be achieved. Otherwise, as Jia Wei, associate dean of thepharmacy school at Shanghai Jiaotong University, puts it, theinitiative will be just "loud thunder, small raindrops".
Zou says that the government is aware of the controversy and problemssurrounding TCM, and that the plan, on which it has consulted widely,is set to resolve these issues. Su Gang-qiang, deputy director-generalof SATCM's science and technology department, points out that the planoutlines overall principles and long-term directions for thedevelopment of TCM, rather than going into details, and says thatfurther strategies will be published to specify exactly how theschemes will be carried out.
Whether the government will take critics' concerns into account whiledrafting these plans remains to be seen, but many are cautiouslyoptimistic. "The wind is now right for the development of TCM," saysJia. "Let's hope this will not be a missed opportunity."
评论 (0)