Establishment Of Multiple Evidence Sets For Chinese Patent Medicine Varieties Derived From Classic Prescriptions

BackgroundThe clinical evaluation of traditional Chinese medicine has received increasing attention in recent years.It is an important path for traditional Chinese medicine to obtain marketing qualifications,realize its modern value,and then move towards international development.In 2018,the State Administration of Traditional Chinese Medicine issued the "Catalog of Ancient Classic Famous Prescriptions(First Batch)" and the "Administrative Regulations on Simplified Registration and Approval of Ancient Classic Famous Prescriptions and Chinese Medicine Compound Preparations",which provided a new foothold for this work.The relationship between the varieties of traditional Chinese medicines in classic prescriptions and their source prescriptions.In February 2021,the General Office of the State Council issued the "Policies and Measures on Accelerating the Development of Traditional Chinese Medicine Characteristics",emphasizing the need to optimize the management of Chinese medicine review and approval,and improve the management of classification and registration of Chinese medicines,and proposed "establishing Chinese medicine theory,human experience,and clinical trials.The "combined Chinese medicine registration review evidence system" provides a new paradigm for clinical evaluation of Chinese medicine.Select Chinese patent medicines derived from classic ancient prescriptions,comprehensively collect the relevant evidence-based medical research data in three aspects:Chinese medicine theory,human experience,and research evidence,systematically sort out the information basis of Chinese medicine evaluation in the new era,and construct a comprehensive coverage of the above three The multi-layered evidence collection has become a practical and feasible method to promote the clinical evaluation of Chinese medicine varieties.ObjectiveTake the Chinese patent medicine Tongsaimai Tablet and the Simiao Yongan Decoction and Gubu Decoction as its source prescriptions as examples,and explore the evidence system of Chinese medicine registration and review with reference to the theory of Chinese medicine,human experience,and the "three-in-one"clinical trial The question of "where does the variety come from,and where does it go".That is,based on the relationship between the varieties of traditional Chinese medicines and the ancient prescriptions from which they originate,analyze from the perspective of basic theory,and integrate human experience represented by medical records and research evidence based on relevant clinical trials and animal experiment system evaluation.The method of constructing a multivariate evidence set can then clarify the clinical positioning of Chinese medicine varieties and find out the potential advantageous application areas to be developed.Methods1 The theoretical analysisRefer to the concept of "three-in-one" to form the idea of constructing multiple evidence sets.And using theoretical analysis methods,collect and sort out relevant ancient books and modern research results of the ancient recipes of Tongsaimai Tablets,Simiao Yongan Decoction and Gu Bu Decoction,to form the theoretical basis of traditional Chinese medicine for multiple evidence collections.2.The literature surveyUsing literature retrieval methods,systematically search the databases of China Knowledge Network(CNKI),WanFang Data,VIP,PubMed,Embase,Web of science,The cochrane library,and include Tongsaimai Tablets and Simiao Yongan Decoction The original research on animal experiments and clinical trials related to Gubu Decoction.Quantitative analysis is used to describe the publication trends,document types,disease types,etc.of the included literature,and cluster analysis is used to draw disease evidence maps.Count and read and analyze the type of case report literature,compare and analyze the medical records related to Tongsaimai Tablets,Simiao Yongan Decoction,and Gubutang,and conduct clinical positioning of Tongsaimai Tablets based on the type of disease,thereby integrating Evidence from human experience.3 The systematic evaluationTo summarize the randomized controlled animal experiments of Tongsaimai Tablets,Simiao Yongan Decoction,and Gubu Decoction on the intervention of atherosclerosis model and the randomized controlled clinical trials for the treatment of atherosclerotic obliterans,using the methods of systematic review and Meta analysis,Judge the intervention effect of Tongsaimai Tablet on related indicators,so as to integrate research evidence.Results1 Through theoretical analysis,it is found that from the point of view of medicinal taste and prescription,Simiao Yongan Decoction has strong heat-clearing and detoxifying power,and can nourish yin and nourish blood.The symptoms are targeted.Gubu Decoction is slightly weaker in clearing heat and detoxifying,and has stronger power in replenishing qi and nourishing yin.It is suitable for the symptoms of heat toxin attack,qi and yin injury,and blood stasis.However,Tongsaimai Tablet has the advantages of the two prescriptions,but the effect is more gentle,and it is more suitable for the recovery period of diseases with blood stasis blocking the collaterals and insufficient Qi and Yin as the main symptoms.2 Over the years,the number of studies on Simiao Yongan Decoction and Tongsaimai Tablets has been relatively large,and the overall trend is increasing.Gu Bu Decoction has received less attention,and the number of related original clinical studies and animal studies that are more closely related to the clinic is relatively small,with an average of less than one article per year.Through measurement and cluster analysis,it is found that the treatment range of Simiao Yongan Decoction and Gubu Decoction not only originated from the main diseases in ancient books,but also combined with modern clinical practice and expanded to a considerable extent.Most of the unique disease types and models in the research related to Simiao Yongan Decoction belong to the category of TCM heat syndrome,while the unique disease types and models in the related research of Tongsaimai Tablets mostly belong to the category of TCM deficiency syndrome.3 According to statistics,the number of reported cases of Simiao Yong'an Decoction and Gu Bu Decoction is basically consistent with the indication of the disease "out gangrene" contained in the original source.Under the guidance of the syndrome differentiation concept of treating different diseases with the same treatment,clinical physicians have greatly broadened the scope of clinical application of Simiao Yongan Decoction.At present,only through case report analysis,it is temporarily unable to carry out specific clinical positioning of Tongsaimai tablets,which is different from its instructions.4 Existing evidence shows that the intervention of Simiao Yongan Decoction in the atherosclerosis model can reduce the aortic plaque area and the ratio of aortic plaque to lumen area;reduce the levels of total cholesterol,triglycerides,and low-density lipoprotein cholesterol;and Reduce the levels of tumor necrosis factor-?,monocyte chemotactic factor-1,and C-reactive protein.Tongsaimai tablets intervention in atherosclerosis model can effectively reduce atherosclerosis index and circulating endothelial cell count.Simiao Yongan Decoction can increase the ankle-brachial index and reduce the viscosity of whole blood and plasma in the treatment of atherosclerotic obliterans.The cure rate and total effective rate of Tongsaimai Tablets on atherosclerosis obliterans were significantly higher than those of the control group.Conclusions1 From the point of view of basic theory,the clinical positioning of Tongsaimai Tablets in terms of syndromes is deficiency of Qi and Yin,blood stasis obstructing the collaterals,and disease types in the recovery period of gangrene and cerebral infarction,and the potential of head ulcers as Tongsaimai Tablets The main diseases are to be further clarified in future research.2 From the perspective of human experience,although the current case report alone cannot provide a clear clinical positioning of Tongsaimai Tablets,Simiao Yongan Decoction and Gubu Decoction-related case reports are more concentrated in diseases such as Tuogangrene and Heart Disease.Cerebrovascular diseases,even autoimmune diseases,infectious diseases,etc.,should be regarded as the potential clinical orientation of Tongsaimai Tablets.3 From the perspective of research evidence,Tongsaimai Tablets have good effects on blood lipid indexes and CEC counts,and are highly effective in the treatment of atherosclerosis obliterans.The role of indicators such as ankle-brachial index is the direction that future research can choose.4 This topic takes Tongsaimai tablets as an example,systematically combs the basic theories,human experience and research evidence related to the varieties of modern Chinese patent medicines and their source ancient prescriptions,draws on the concept of the "three-in-one"Chinese medicine registration review evidence system,and constructs three The multi-layered evidence collection explores the question of "where do Chinese medicines come from and where to go",and provides methodological examples for the clinical positioning and evaluation of Chinese medicines.