The research and development of traditional Chinese medicine from a clinical perspective

The 2018-05-07 health

At present, the state attaches great importance to drug research and development, which not only speeds up the approval of new drugs, but also stimulates relevant departments and personnel from the system and policy. In recent years, there are many clinical problems in the research and development of TCM drugs, which affect the enthusiasm of enterprises, colleges and researchers. Based on the work experience of personal clinical research, some problems and countermeasures are discussed.

The theoretical guidance of TCM should be emphasized.

The research and development of traditional Chinese medicine must be carried out under the guidance of TCM theory, but the practical situation is to ignore or ignore the guiding role of TCM theory. For example, a new drug for treating chronic pelvic inflammatory disease is basically a product of the use of heat and detoxification. Animal experiments also prove that the prescription has anti-inflammatory and analgesic effects, which is a false one. Chronic pelvic inflammatory disease is in the lower jiao, mostly cloudy with the accumulation of evil, the cure should be warm medicine, should use bitter cold products? This kind of new drug is often observed in the clinical research stage, because of the gastrointestinal reaction caused by the bitter cold and the stomach, which can not be successful. To reflect seriously on the guiding ideology of the group, in fact, is to focus on the "inflammation", according to the modern pharmacological research ideas, and completely out of the theory of TCM.

In the case of a traditional Chinese medicine for chronic headache, the prescription is mainly used to relieve pain, and animal experiments have proved that the prescription has analgesic effect. This kind of traditional Chinese medicine is not good in clinical research stage, why? Traditional Chinese medicine thinks "the head is the meeting of all the Yang", chronic headache person often has Yang deficiency of evidence, should take wen Yang's pain as the main, the product of zangqi gas analgesic, reflect the efficacy of Chinese medicine to treat both symptoms and root. What is the difference between a lot of analgesic and analgesic drugs if it's just a separate gas pain? How to embody the advantages of Chinese traditional medicine? So in the initial stages of research and development of new drug of TCM, should pay attention to the guidance of TCM theory, strengthen the pharmaceutical researchers, clinicians, and the basic theory of TCM expert discussion, because only make a point clear can obtain good effect.

Starting from clinical needs.

The research and development of new Chinese medicine should be based on the clinical needs, and in the field of TCM treatment. Unfortunately, there are too many other factors to be considered, such as market, sales channel, and prescription reputation, etc., which lead to the deviation of the project. For example, in the treatment of cold, acute pharyngitis and other Chinese medicine, the market is already a lot, but the new enterprise is still quite a lot, prescription, the main treatment, the efficacy basically is similar, "new" where? How does this breed of innovation manifest? It's really the designer of the clinical research program.

With coronary heart disease angina as an example, there are many famous products in the market, but the new drugs for treating angina pectoris of coronary heart disease are still quite a few, and often are aimed at blood stasis syndrome. In fact, the applicant should think seriously, the coronary heart disease besides angina pectoris, now what demand is clinical? For example, there are many patients with coronary heart disease complicated with anxiety and depression, and there is no ideal treatment. Traditional Chinese medicine believes that "the heart is the main blood vessel", "the heart god", such situation should be the advantage of TCM treatment, can be the basis of the establishment. At the same time, we should know more about the clinical needs of traditional Chinese medicine, and clearly define the advantages and positioning of clinical varieties, so as to achieve the target and not develop for r&d.

Make solid foundation research.

The research and development of new drugs in traditional Chinese medicine is focused on the outbreak of clinical research stage, which is worthy of reflection. Looking back at animal studies, some of them are not clear, such as a new drug for treating hyperlipidemia. The animal experiment is not clear whether to lower cholesterol or triglyceride. If it's lowering cholesterol, it's not clear what the pathway might be, and it's hard to support clinical research. Some effects, such as a new drug for treating chronic bronchitis, animal experiments found to have anti-inflammatory, antiviral, cough, phlegm, and many other effects, euphemistically called "target", but no goals.

Animals don't talk, but when it comes to clinical trials, it's not good. This kind of problem, whether traditional Chinese medicine compound new drug or modern Chinese traditional Chinese medicine exists, the reaction is the basic research is not solid, the innovation support is not enough. Some doctors think the prescription is effective according to the theory of traditional Chinese medicine. Why should we emphasize animal experiment? Must know that traditional Chinese medicine is water decoction, and proprietary Chinese medicine is the modern equipment to extract production, traditional Chinese medicine theory is that effective prescription, through modern process is not effective, so must carry out experiments on animals, provide evidence to support the development of new drug of TCM.

Optimize clinical design.

Clinical localization is an old problem of traditional Chinese medicine, but it has always existed, which has a lot to do with the design of clinical research scheme. At present, the medical progress is very rapid, the disease spectrum and the diagnosis and treatment mode have changed greatly. If the clinical location is still not accurate, the results of the study are often difficult to evaluate and cannot provide the basis for the approval of the listing. For example, for a new drug for chronic heart failure, what is the selection of people? Is the left ventricular ejection fraction low or left ventricular ejection fraction reserved? Is the main outcome measure improving cardiac function or controlling ventricular rate? Is it improving clinical symptoms or decreasing the incidence of major cardiovascular events? Is the improvement of quality of life or physical and chemical indicators such as BNP? These goals are not clear, inaccurate positioning, and all kinds of problems occur during the implementation stage of clinical research. The patients in the group and the basic therapeutic drugs are various, and the efficacy evaluation is not available. Therefore, in the research and development of traditional Chinese medicine new drugs, it is necessary to emphasize the clinical precision positioning and to design the clinical plan.

We will strengthen innovation in research and development mode.

At present, the research and development model of traditional Chinese medicine is solidified, and many clinical research programs are similar, which can be applied to each other, which can be called "eight shares". Although the clinical trial management standard (GCP) has normative requirements for clinical research protocols, the specific research plan should emphasize innovation and targeted design. The clinical research model of Chinese medicine new drugs can be the "cure disease" and "combination of syndrome" and "syndrome". For example, some diseases do not need to distinguish the syndrome is acceptable, there was a treatment of hyperlipidemia traditional Chinese medicine for the syndrome differentiation, the design of the design of a phlegm. The key is to be able to reduce cholesterol or triglyceride to be able to come down, there is no need to differentiate, to put an end to the "false dialectics" and "false identification" in clinical research.

Safety indicators should also be targeted and personalized design, rather than follow the guiding principles, such as some simple dermatological drugs, is it necessary to check the routine of stool? Does a few drops of eyedrops need to check electrocardiogram? Look up these indicators based on what is clear, what the purpose is to be clear, do not search for. Clinical design and technical reviewers should be encouraged to be bold and innovative, only to be innovative and energetic.