实证医学与中医药研究和开发

Evidence─Based Medicine and Research and Development of Traditional Chinese Medicine

临床疗效是衡量一切防治措施价值的最高准则，也是决定一个医疗卫生体系效益的最基本因素。实证医学的核心就是任何有关疾病防治的整体策略和具体措施的制定都应基于现有最严谨的关于其临床疗效的科学证据之一。使用无效甚至有害的防治措施在伦理上是不能接受的，更是对人类宝贵医疗资源的浪费。因此，中医药研究和开发应从临床疗效的验证开始。机理的研究、有效成份的探索和剂型的改进是重要的，但应以证实临床有效为前提。本文从 ４个方面进行了论证： １、一个防治措施若没有防治作用，就没有其相关的作用机理可被发现，也没有其相关的有效成份可被探索，更没有改进剂型的必要。２、中医药临床疗效评价，为从中医药中开发新药提供一个经济的、快捷的途径。因为它节省了用于无临床疗效的药物的临床前研究所需要的大量资源。同时也大大缩短了一个新药从开发到临床使用的时间。３、中医药临床疗效评价具有巨大的经济效益。临床上无效的防治措施被淘汰，而有效的被进一步推广。从而一个医疗体系会因减少使用无效的防治措施而提高效益。４、对中医药临床疗效的评价也是对其理论体系在实践上的检验。

Among many other factors, effectiveness is the primary determinant of the efficiency of a health care system. Evidence -- based medicine is a new paradigm of medical practice that urges any clinical decision making be based on the current best evidence about the effectiveness. It would be a waste of our limited resources if many of the interventions we provide in health care are clinically ineffective. History, faith, popularity, enthusiasm and anecdotes are not the same as scientific evidence for clinical effectiveness. Scientifically, the randomized controlled clinical trial is the most rigorous method for eval uation of medid interventions, particularly when the therapy has only an effect of moderate magnitude. Lack of randomized evidence in traditional Chinese medicine has largely limited its further development and utilization. For the following reasons, organized efforts should be made to systematically evaluate, review and disseminate this kind of evidence on the effectiveness of therapies in traditional Chinese medicine. First, clinical effectiveness is what matters most in any medical interventions. Investigation of working mechanisms and adverse effects, search for active substances, and improvement of delivery method and formulation are undoubtedly important, but should commence after the clinical effectiveness is demonstrated. If a therapy does not work clinically, neither will there be any relevant active substances to be identified, nor any relevant mechanisms to be discovered, nor any necessity to improve the way a medicine is delivered or to study whether it causes any adverse effects or not. Furthermore, lack of knowledge on the working mechanism will not prevent the use of clinically effective therapies. Many powerful medical therapies were accepted and widely used before their mechanisms were understood, such as penicillin and smallpox vaccination, whereas therapies that lack a demonstration of clinical effectiveness will be eventually discarded whether we understand their mechanisms or not. Blood letting is a good example in case. Second, demonstration of clinical effectiveness first is the fast and cost -- effective way of identifying effective therapies from traditional Chinese medicine as it will avoid doing those unnecessary preclinical studies of inetfective therapies and tremendously save human resources. Third, randomized controlled trials that have either positive of negative results will have practical values and thus not waste resources. If a therapy proves effective, further promotion of its use will benefit many more people. On the other hand, if a therapy is found to be ineffective, stopping using it will save resources. Fourth, the value of medical theories lies in their capability of successfully guiding medical practice and generating effective therapies. Thus, demonstration of clinical effectiveness will also be the best empirical test of the validity of the theories of traditional Chinese medicine.