Study On The Connotation And Construction Of The Clinical Individual Curative Effect Evaluation System In TCM

This study aims to establish a personalized clinical efficacy evaluation system that is practical and effective and widely applicable,so as to reflect the characteristics of traditional Chinese medicine,and to change the current situation that TCM,though adept at individualized syndrome differentiation,still lacks corresponding objective evaluation methods and measurement indicators.As a result,the evaluation index is fixed,and TCM often use western medicine standards instead.This thesis builds a therapeutic evaluation framework based on personalized measurement of overall health status,which is in line with the thinking patterns of TCM.It provides a scientific basis for exploring and perfecting the clinical diagnosis and treatment system of TCM as well as giving full play to the advantages of TCM syndrome differentiation and treatment.This thesis is divided into five parts.By using documents and researches of ancient and modern doctors on the efficacy evaluation,excavating the advantages and disadvantages and individualized components of ancient and modern Chinese medicine curative effect evaluation,analyzing the individualized curative effect evaluation connotation,it establishes a preliminary construction of curative effect evaluation system based on the clinical investigation.The details are as follows:1.From the literature,it is concluded that the evaluation of the efficacy of ancient physicians on diseases has individualized characteristics,and the emphasis is placed on the physiological and pathological characteristics of different groups of people,differences in physical fitness,personal habits,urgency of diseases,course of diseases,syndromes,and tendency of diseases.It is believed that the ancient literature on the evaluation of therapeutic effects was detailed,covering a wide range and highlighting the individualized components.Yet some medical process records mainly focused on the empirical medical model and were relatively vague,with the evaluation based on the improvementindividual patients' symptoms,and lacks a unified and generally accepted evaluation criteria for the diseases.2.With reference to modern literature researches,this thesis also aims to comment on the current common methods for evaluation of TCM clinical efficacy:a.following the traditional TCM clinical efficacy evaluation methods,using the increase,decrease,disappearance or change of symptoms as a criterion;b.on the basis of evidence-based medicine biological index method,using some biological and physical and chemical indicators to evaluate the efficacy of TCM;c.the establishment of therapeutic evaluation system of syndromes,the evaluation system of western medicine evaluation system plus TCM syndromes(quantitative,semi-quantitative,primary and secondary);d.comprehensive evaluation methods:a collection of multiple evaluation indicators to a comprehensive evaluation of the overall system value;e.subjective measurement methods on the quality of life,the scale evaluation methods,the efficacy evaluation based on real-world and other methods.It is convincing that in modern clinical studies,mechanical laboratory indicators and the improvements of clinical symptoms are often used to evaluate the clinical efficacy.In terms of disease prognosis,there is a lack of relatively objective end-point indicators for long-term and dynamic follow-up,it does not reflect the individuality of Chinese medicine.3.According to the above combing and research on theory and literature,it is believed that TCM therapy is an intervention to the functional status of the individual's complexity system.The change in the overall health status of the human body is the core of clinical curative effect evaluation.Individualized scientific measurement that varies from person to person,disease-specific and evidence-based,is a manifestation of the personalized connotation of TCM clinical efficacy evaluation,thus it enriches the research on the connotation of TCM efficacy evaluation.4.Following the overall thinking of TCM and the rules of syndrome differentiation and treatment,the differences in diagnostic parameters and curative effect evaluation parameters are clearly defined on the basis of previous studies on the characterization parameters of human health,and a hierarchical classification principle reflecting the personalized TCM clinical curative effect evaluation parameters is formulated.A framework for the clinical evaluation of TCM is established with the goal of "measurement of overall health status",reflecting the individualized components,evaluating the efficacy of the disease,evaluating the syndromes of TCM,with the organic integration of the patient report outcome(PRO)and the clinical report outcome(CRO).5.Taking the chronic disease of hypertension as an example,this thesis preliminarilyverifies the curative evaluation mode constructed according to the principles of grading and classification.This study is based on the collection scope of the clinical curative effect evaluation parameters of TCM,the collection index,and the clearness of the collection screening in the early stage of the research group.It uses a combination of literature research and the consultation of authoritative experts and the team's core working group to discuss the curative effect.It evaluates the literature collation research,excavates the advantages and disadvantages and individualized components of ancient and modern Chinese medicine curative effect evaluation,analyzes and explores the connotation of personalized curative effect evaluation,and preliminarily constructs a 2X-4Y system that embodies individualized curative effect evaluation system.Taking hypertension as an example,the preliminary evaluation and explanation of the efficacy evaluation system is conducted.In summary,this thesis studies the treatment of ancient and modern physicians on efficacy evaluation methods and literature,and compares the advantages and disadvantages of the individualized curative effect evaluation of ancient and modern Chinese medicine;it provides an in-depth analysis of the connotation of personalized curative effect evaluation.It has fundamentally clarified the connotations of the individualized clinical efficacy evaluation of TCM based on the differences among individuals,diseases and syndromes,and the connotation of the individualized evaluation of TCM clinical efficacy before and after treatment.It is proposed that the individualized measurement of overall health status before and after treatment is the core of TCM clinical efficacy evaluation.and establishes a preliminary construction of curative effect based on literature research and expert consultation.This thesis also puts forward the principles of parameter classification,and sets the preliminary establishment of a method of individualized clinical efficacy evaluation of TCM,namely the construction of 2X-4Y which embodies the individual characteristics of syndrome differentiation and treatment clinical efficacy evaluation method system(with the combination of general evaluation parameters and specialist assessment parameters,it lays equal stress on biological outcomes and changes of the syndromes patient report outcome and doctors report the outcome)and at last it takes hypertension as an example to verify the efficacy of the evaluation system that it has constructed.