Research and development of traditional Chinese medicine compound new drugs should pay special attention to the overall efficacy research
LV Guiyuan
Vice chairman of the pharmacology Committee of traditional Chinese medicine and natural medicine of the Chinese Pharmacological Society
. In recent decades, the world has invested a huge amount of research and development funds in the research and development of new drugs for these diseases. New targets, new theories and new technologies continue to make breakthroughs, but the therapeutic effect has not been significantly improved. The main reason may be that there are serious problems in the research ideas and methods.
First, it is basically impossible to cure modern chronic diseases according to individual targets.. Another example is hypertension, which is known to be related to hypertension400 There are many other factors. Drugs developed for individual targets often have poor efficacy.
Second, research on the efficacy of new traditional Chinese medicine drugs for the treatment of chronic diseases.At present, the international mainstream research on new drug creation is basically to take“A”Cells (human body CA50 . However, the results of in vitro cell-based research are often far from the treatment of these diseases. Early chemical drugs, especially anti pathogen drugs, have made great achievements that attract worldwide attention, but they are basically not drugs developed through target discovery, and the biological structure of pathogens such as Mycobacterium tuberculosis is not very different in different regions of the world, so the drugs invented are very effective in the world. However, nowadays, the etiology of chronic diseases is unclear, and there are still large differences among ethnic groups, and the correlation between the overall efficacy and disease treatment is recent, which should be paid full attention to.
Third, the overall efficacy study is the key to the non clinical research of new drugs of traditional Chinese medicine.The characteristics of traditional Chinese medicine are that its effective components are unknown and its target is unclear, but it is indeed effective. There are hundreds or thousands of compounds in one traditional Chinese medicine, and new compounds may be produced when the compound traditional Chinese medicine is extracted together. Such a complex compound group is difficult to fully understand, and the target of compound traditional Chinese medicine is even more difficult to understand; Moreover, using the component target to elaborate the efficacy will make the characteristic advantages of traditional Chinese medicine lost. In addition, clinical trials are also difficult to carry out comparative studies of efficacy intensity. Therefore, the overall efficacy index is very important for the development of reliable traditional Chinese medicine compound new drugs. It can reflect the efficacy of compound traditional Chinese medicine and is a particularly important index for non clinical research of new drugs.
Fourth, the overall efficacy research content.① Comparative efficacy study: for new drugs with clear indications or evaluation indicators, standardized comparative study of efficacy intensity should be carried out, such as comparative study of efficacy intensity of blood pressure reduction, lipid-lowering and blood tonic. . Special attention should be paid not to compare the intensity of different traditional Chinese medicines (samples) by the method of comparison between groups, but to carry out2 Comparative study on dose effect curves of different traditional Chinese medicine samples, that is, the same traditional Chinese medicine sample should be set at least≥ 3 For each dose group, dose-response curves should be made for different traditional Chinese medicine samples, and the dose-response curves should be compared to select the more effective traditional Chinese medicine samples. .② Relevant pharmacodynamic research: metabolic disease, hypertension and other diseases often exist at the same time. For example, the blood lipid, blood glucose and blood viscosity of hypertensive patients have at least two different degrees of increase, and the increase of these indicators is an important factor causing hypertension complications. In the research and development of antihypertensive compound new drugs, while observing the antihypertensive effect, we should also carry out the pharmacodynamic research of lipid-lowering, glucose lowering, blood viscosity lowering, etc., which is more conducive to explain the therapeutic value of compound new drugs.③ Syndrome selective pharmacodynamic study: new drugs of traditional Chinese medicine compound are generally suitable for diseases of a certain syndrome type, such as fenghan Ganmao granules suitable for colds caused by exogenous wind cold, Shuanghuanglian oral liquid suitable for colds caused by exogenous wind heat, etc. In carrying out the pharmacodynamic study of these new drugs, in addition to the pharmacodynamic study of the main indications, the pharmacodynamic study of the corresponding syndromes was also carried out with syndrome model animals to observe the effect on the corresponding syndromes.④ Other pharmacodynamic studies: many effects that are considered to be basically irrelevant have been found to be relevant, such as the impact on intestinal flora, which can reduce the symptoms of Alzheimer's disease, depression and fatty liver, etc; Improving immune function can treat oral ulcer and osteoporosis. .⑤ Pharmacodynamic mechanism research: the pharmacodynamic mechanism of traditional Chinese medicine can be studied from different levels and different model animals, such as from the overall, organ, tissue, cell and molecular levels, to comprehensively elaborate the pharmacodynamic mechanism, action characteristics and advantages compared with non traditional Chinese medicine.
It is of great significance to carry out systematic research on the mechanism of action of new Chinese medicine or existing Chinese patent medicine with definite clinical efficacy, to guide its rational use of drugs, to show its characteristics and advantages, and to be international. However, the significance of studying the mechanism of action of compound Chinese medicine extract or single Chinese medicine extract with uncertain efficacy is worth thinking deeply, or it may have little practical significance. .
Copyright notice: the article is fromChinese Journal of pharmacology and toxicology 2020, 34 (4).
