Traditional Chinese medicine curative effect evaluation method based on real world clinical data

Abstract

The invention provides a traditional Chinese medicine curative effect evaluation method based on real world clinical data, and the method comprises the steps: completing the curative effect evaluation of traditional Chinese medicine clinical cases through an evaluation model and an evaluation method, and the evaluation method comprises syndrome differentiation element clinical outcome grading measurement evaluation and traditional Chinese medicine symptom clinical comprehensive curative effect grading measurement evaluation. According to the method, a dynamic evolution trend vector calculation model is constructed, a traditional Chinese medicine clinical curative effect evaluation methodology system including traditional Chinese medicine dialectical element outcome and traditional Chinese medicine symptom comprehensive curative effect evaluation is created, and the traditional Chinese medicine clinical curative effect evaluation method is established by using technical means such as a scale method, standardized science, big data and knowledge engineering. The problems that traditional Chinese medicine syndromes are complex and diverse and quantitative evaluation is difficult are solved, an effective syndrome evaluation model is developed, disease changes of patients are accurately reflected, a traditional Chinese medicine curative effect evaluation system is perfected, effectiveness and safety of clinical decisions are verified, and scientificity and international recognition degree of traditional Chinese medicine clinical research are improved.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional medicine, and particularly to a method for evaluating the efficacy of traditional Chinese medicine based on real-world clinical data. Background Art

[0002] As an important part of traditional medicine, traditional Chinese medicine (TCM) has become increasingly prominent in modern society. With the continuous improvement of the country's attention to TCM, the modernization process of TCM has been accelerated. Syndrome differentiation and treatment, as the core method of TCM diagnosis and treatment, emphasizes individualized treatment. However, the evaluation of its efficacy has long restricted the development of TCM. How to apply advanced scientific and technological means to construct a clinical efficacy evaluation system that conforms to the self-development law of TCM has become a major scientific problem that urgently needs to be solved in the modernization of TCM.

[0003] The existing clinical efficacy evaluation system of TCM mainly relies on the traditional method of syndrome differentiation and treatment. By analyzing the specific symptoms, tongue and pulse conditions, and physical signs of patients, they are differentiated into different TCM syndromes, and then an individualized treatment plan is formulated. The efficacy evaluation is based on the symptom changes, improvement of physical signs, and subjective feelings of patients before and after treatment. This method highly depends on the experience and subjective judgment of clinicians and lacks systematic and standardized evaluation tools. With the development of efficacy evaluation methods, the academic community has proposed TCM syndrome scales to quantify the TCM syndrome differentiation process and make up for the deficiencies of traditional evaluation methods.

[0004] However, the clinical efficacy evaluation system of TCM is not yet perfect, lacking complete and effective theories and technical methods. Due to the uniqueness and complexity of TCM diagnosis and treatment, key technologies such as the standardization and grading quantification of evaluation elements, and the establishment of evaluation models are still being explored, making it difficult to comprehensively and objectively reflect the effects of TCM diagnosis and treatment. In addition, TCM syndromes are complex and diverse, coexisting with each other. Traditional evaluation methods are difficult to accurately quantify the symptom and syndrome changes of patients and cannot effectively guide clinical decisions. Against the background of the rapid development of big data, artificial intelligence technology, etc., the existing TCM efficacy evaluation methods have not fully utilized modern technologies and lack intelligent analysis capabilities, and are unable to process and analyze the massive clinical data of TCM in real time. Summary of the Invention

[0005] Aiming at the deficiencies of the existing technology, the purpose of the present invention is to provide a method for evaluating the efficacy of traditional Chinese medicine based on real-world clinical data to solve the problems raised in the above background art. The present invention uses technical means such as scale method, standardization science, big data, and knowledge engineering to solve the problems of complex and diverse TCM syndromes and difficult quantitative evaluation, develop an effective syndrome evaluation model, accurately reflect the changes in the patient's condition, improve the TCM efficacy evaluation system, and promote the inheritance and innovative development of TCM.

[0006] To achieve the above object, the present invention is implemented by the following technical solutions: A traditional Chinese medicine efficacy evaluation method based on real-world clinical data, which includes completing the efficacy evaluation of traditional Chinese medicine clinical cases from two parts: an evaluation model and an evaluation method. The evaluation method includes a dialectical element clinical outcome grading measurement evaluation and a traditional Chinese medicine syndrome clinical comprehensive efficacy grading measurement evaluation. The evaluation model includes: evaluation dimensions, evaluation indicators, the correspondence between clinical efficacy evaluation and trend vector values and symbol values; The dialectical element clinical outcome grading measurement evaluation method includes: selecting the integral scale of traditional Chinese medicine specialty syndromes and their dialectical elements, observing the three-dimensional dynamic change values of each traditional Chinese medicine dialectical element of a certain syndrome, determining the observation period, calculating the three-dimensional evolution trend vector of each dialectical element of a certain syndrome, and evaluating the clinical outcome of each dialectical element of this syndrome; The traditional Chinese medicine syndrome clinical comprehensive efficacy grading measurement evaluation method includes: designing the grading quantization of the three-dimensional dynamic evolution state of traditional Chinese medicine syndromes, calculating the grading values of the three-dimensional evolution state of traditional Chinese medicine syndromes, determining the observation period, calculating the trend vector values of the three-dimensional dynamic evolution of traditional Chinese medicine syndromes, and grading and measuring the clinical comprehensive efficacy of traditional Chinese medicine syndromes.

[0007] Further, the evaluation dimensions include three aspects: degree, nature, and scope. And the evaluation dimensions are respectively divided into the degree, nature, and scope of each dialectical element, as well as the degree, nature, and scope of traditional Chinese medicine syndromes in the evaluation method. Each dimension is observed for measured values at different observation times during the entire diagnosis and treatment cycle.

[0008] Further, the evaluation indicators include: trend vector values and trend vector symbols. And the evaluation indicators have corresponding degree trend vectors, nature trend vector values, and scope trend vector values for different evaluation latitudes; and degree trend symbol values, nature trend symbol values, and scope trend symbol values.

[0009] Further, the efficacy evaluation results are divided into three categories: cured, improved, and not cured. The method for evaluating the clinical outcome of each dialectical element of this syndrome using the trend vector value and the trend vector symbol is as follows:

[0010] If the observed value of the indicator is less than the normal value, the trend vector value is greater than 0, and when the observed indicator returns to normal, it represents "cured"; the trend vector value is greater than 0, and when the observed indicator does not return to normal, it represents "improved"; the trend vector value is less than or equal to 0 represents "not cured";

[0011] If the observed value of the indicator is greater than the normal value, the trend vector value is less than 0, and when the observed indicator returns to normal, it represents "cured"; the trend vector value is less than 0, and when the observed indicator does not return to normal, it represents "improved"; the trend vector value is greater than or equal to 0 represents "not cured".

[0012] Furthermore, the method for evaluating the clinical prognosis of each syndrome differentiation element of this disease syndrome using the trend vector symbol is as follows: If the observed value of the index is less than the normal value, the trend symbol value is equal to 1, and the recovery of the observed index to normal represents "cured"; the trend symbol value is equal to 1, and the observed index not recovering to normal represents "improved"; the trend symbol value equal to -1 or 0 represents "not cured".

[0013] If the observed value of the index is greater than the normal value, the trend symbol value is equal to -1, and the recovery of the observed index to normal represents "cured"; the trend symbol value is equal to -1, and the observed index not recovering to normal represents "improved"; the trend symbol value equal to 1 or 0 represents "not cured".

[0014] Furthermore, in the process of selecting the integral scale of traditional Chinese medicine (TCM) specialty disease syndromes and their syndrome differentiation elements, for the TCM specialty disease syndromes for which clinical efficacy evaluation is carried out, the integral scales of each syndrome differentiation element of the TCM disease syndromes are selected as the measurement standard basis for observing the dynamic evolution of each syndrome differentiation element.

[0015] Furthermore, in the process of observing the three-dimensional dynamic change values of each TCM syndrome differentiation element of a certain disease syndrome, according to the actual situation of the clinical specialty disease syndrome, based on the standard of the integral scale of the syndrome differentiation elements of this specialty disease syndrome, for any evaluated object, it is described from three dimensions: degree, nature, and scope, and a hierarchical measurement method is used to obtain values, and a three-dimensional dynamic change broken line graph of the TCM syndrome differentiation elements is drawn.

[0016] Furthermore, the three-dimensional dynamic evolution state grading and quantification of the TCM disease syndrome comprehensively consider the three-dimensional dynamic evolution state of the TCM disease syndrome from four aspects: the main symptoms, secondary symptoms, tongue manifestation, and pulse condition of the disease syndrome. The weighted summation method is used to multiply the observed values of the main symptoms, secondary symptoms, tongue manifestation, and pulse condition in terms of degree, scope, and nature by their respective weights as the comprehensive quantification values of the disease syndrome in terms of degree, scope, and nature.

[0017] Furthermore, it also includes calculating its state grading value according to the calculation method of the three-dimensional dynamic evolution state grading value of the TCM disease syndrome, and marking the evolution state values of the three evaluation dimensions of the TCM disease syndrome.

[0018] Furthermore, it includes calculating the three-dimensional dynamic evolution trend vector value of the TCM disease syndrome from three dimensions: degree, nature, and scope, and obtaining the three-dimensional dynamic evolution trend vector value of the TCM disease syndrome and the trend symbol based on this calculation process to evaluate the clinical comprehensive efficacy of the TCM disease syndrome.

[0019] The beneficial effects of the present invention:

[0020] 1. The traditional Chinese medicine (TCM) efficacy evaluation method based on real-world clinical data is carried out through a dynamic evolution trend vector calculation model, a graded measurement evaluation of the clinical prognosis of TCM syndrome differentiation elements, and a graded measurement evaluation of the comprehensive clinical efficacy of TCM syndromes and diseases. The construction of the dynamic evolution trend vector calculation model based on the syndrome differentiation element integral scale improves the objectivity and accuracy of efficacy evaluation.

[0021] 2. The TCM efficacy evaluation method based on real-world clinical data uses technical means such as the scale method, standardization science, big data, and knowledge engineering to solve the problems of complex and diverse TCM syndromes that are difficult to quantitatively evaluate, develop effective syndrome evaluation models, accurately reflect the changes in the patient's condition, improve the TCM efficacy evaluation system, verify the effectiveness and safety of clinical decisions, help improve the scientific nature and international recognition of TCM clinical research, and promote the inheritance and innovative development of TCM.

[0022] 3. The present invention constructs a "three-dimensional dynamic evolution trend evaluation method for multiple syndrome differentiation elements" as a method for refined quantitative evaluation of the efficacy of TCM clinical syndromes and diseases. The dynamic evolution trend is used as the basic quantitative model for evaluating the clinical efficacy of TCM syndromes and diseases, and the dynamic evolution trend vector calculation of TCM syndromes and their syndrome differentiation elements is carried out from three dimensions: degree, nature, and scope. The calculation results are used to accurately evaluate the prognosis of each syndrome differentiation element and the comprehensive efficacy of syndromes and diseases, and thus form a complete set of clinical efficacy evaluation methodology systems with TCM characteristics. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 is the dynamic evolution trend vector calculation model of the present invention;

[0024] Figure 2 is the flow chart of the graded measurement evaluation method for the clinical prognosis of TCM syndrome differentiation elements of the present invention;

[0025] Figure 3 is the flow chart of the graded measurement evaluation method for the comprehensive clinical efficacy of TCM syndromes and diseases of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0026] In order to make the technical means, creative features, achieved purposes, and functions of the present invention easy to understand, the present invention will be further described below in conjunction with specific embodiments.

[0027] Please refer to Figures 1 to 3 , the present invention provides the following technical solutions: A TCM efficacy evaluation method based on real-world clinical data. Constructing a "three-dimensional dynamic evolution trend evaluation method for multiple syndrome differentiation elements" as a method for refined quantitative evaluation of the efficacy of TCM clinical syndromes and diseases, this method mainly includes: selecting a dynamic evolution trend vector calculation model, a graded measurement evaluation of the clinical prognosis of TCM syndrome differentiation elements, and a graded measurement evaluation of the comprehensive clinical efficacy of TCM syndromes and diseases.

[0028] Based on the fact that the dynamic evolution trend is mathematically represented by the slope vector of the broken line connected by the observed values at each time point of the "index" (the object to be evaluated) within the observation period, that is, the so-called "dynamic evolution trend vector calculation model", so the present invention takes it as the basic measurement model for the clinical efficacy evaluation of traditional Chinese medicine syndromes and diseases, and calculates the dynamic evolution trend vectors of traditional Chinese medicine syndromes and their syndrome differentiation elements from three dimensions of degree, nature and scope, and uses the calculation results to accurately evaluate the outcome of each syndrome differentiation element and the comprehensive efficacy of syndromes and diseases, forming a complete clinical efficacy evaluation methodology system with the characteristics of traditional Chinese medicine.

[0029] In the method provided by the present invention, the clinical efficacy evaluation of traditional Chinese medicine cases is achieved from two aspects of the evaluation model and the evaluation method. Among them, the evaluation method is further divided into the graded measurement evaluation of the clinical outcome of syndrome differentiation elements and the graded measurement evaluation of the clinical comprehensive efficacy of traditional Chinese medicine syndromes and diseases. The specific content is as follows:

[0030] 1. Efficacy evaluation model

[0031] 1.1. Evaluation dimensions.

[0032] There are three evaluation dimensions: degree, nature and scope. In the following evaluation method, they are respectively divided into the degree, nature and scope of each syndrome differentiation element, and the degree, nature and scope of traditional Chinese medicine syndromes and diseases. Each dimension is observed according to different observation times during the entire diagnosis and treatment cycle, and the observation times are represented by T1, T2,...; V c1 , V c2 ,... represent the observed values of the "degree" dimension at different time points; V x1 , V x2 ,... represent the observed values of the "nature" dimension at different time points; V f1 , V f2 ,... represent the observed values of the "scope" dimension at different time points.

[0033] 1.2. Evaluation indicators.

[0034] There are two evaluation indicators: the trend vector value k ij and the trend vector symbol I ij . Corresponding to different evaluation latitudes, there are corresponding degree trend vector values k cij , nature trend vector values k xij and scope trend vector values k fij , as well as degree trend symbol values I cij , nature trend symbol values I xij and scope trend symbol values I fij . The calculation formulas are as follows

[0035] Degree trend vector value

[0036] Nature trend vector value

[0037] Range trend vector value

[0038] The calculation formula for the trend symbol is as follows:

[0039] Degree trend symbol

[0040] Nature trend symbol

[0041] Range trend symbol

[0042] 1.3. The correspondence between the clinical efficacy evaluation and the trend vector value and symbol value.

[0043] According to the "Diagnostic and Therapeutic Criteria for Traditional Chinese Medical Syndromes and Diseases", the efficacy evaluation results are divided into three categories: cured, improved, and not cured. The method for evaluating the clinical prognosis of each syndrome differentiation element of this disease syndrome using the trend vector value and the trend vector symbol is as follows:

[0044] (1) The method for evaluating the clinical prognosis of each syndrome differentiation element of this disease syndrome using the trend vector value is as follows:

[0045] If the observed value of the indicator is less than the normal value, the trend vector value is greater than 0, and when the observed indicator returns to normal, it represents "cured"; the trend vector value is greater than 0, and when the observed indicator does not return to normal, it represents "improved"; the trend vector value is less than or equal to 0 represents "not cured".

[0046] If the observed value of the indicator is greater than the normal value, the trend vector value is less than 0, and when the observed indicator returns to normal, it represents "cured"; the trend vector value is less than 0, and when the observed indicator does not return to normal, it represents "improved"; the trend vector value is greater than or equal to 0 represents "not cured".

[0047] (2) The method for evaluating the clinical prognosis of each syndrome differentiation element of this disease syndrome using the trend vector symbol is as follows:

[0048] If the observed value of the indicator is less than the normal value, the trend symbol value is equal to 1, and when the observed indicator returns to normal, it represents "cured"; the trend symbol value is equal to 1, and when the observed indicator does not return to normal, it represents "improved"; the trend symbol value is equal to -1 or 0 represents "not cured".

[0049] If the observed value of the indicator is greater than the normal value, the trend symbol value is equal to -1, and when the observed indicator returns to normal, it represents "cured"; the trend symbol value is equal to -1, and when the observed indicator does not return to normal, it represents "improved"; the trend symbol value is equal to 1 or 0 represents "not cured".

[0050] 2. The quantitative evaluation method for the clinical prognosis grading of syndrome differentiation elements is as follows:

[0051] 2.1. Selection of TCM special disease syndromes and their syndrome differentiation element integral scales.

[0052] Select TCM special disease syndromes that need to be evaluated for clinical efficacy, and select the integral scales of each syndrome differentiation element of TCM disease syndromes as the measurement standard basis for observing the dynamic evolution of each syndrome differentiation element.

[0053] 2.2. Observe the three-dimensional dynamic change values of each TCM syndrome differentiation element of a certain disease syndrome.

[0054] According to the actual situation of clinical special disease syndromes, based on the standard of the syndrome differentiation element integral scale of this special disease syndrome, for any evaluated object ("index"), it is described from three dimensions: degree, nature and scope, and the graded measurement method is used to obtain values. A three-dimensional dynamic change broken line chart of TCM syndrome differentiation elements can be drawn.

[0055] 2.3. Determine the observation period.

[0056] The evaluation time period (T i -T j ) is set according to the requirements and needs of the researcher to evaluate the prognosis of syndrome differentiation elements. The span of the evaluation time interval can be any positive integer greater than or equal to 1. For example, if the selected span is 1, the evaluation time periods are T2 - T1, T3 - T2, T4 - T3...; if the selected span interval is 2, the evaluation time periods are T3 - T1, T5 - T3, T7 - T5...

[0057] 2.4. Calculate the three-dimensional evolution trend vectors of each syndrome differentiation element of a certain disease syndrome.

[0058] The three-dimensional evolution trend vector of the syndrome differentiation element includes two aspects: the trend vector value and the trend symbol. The calculation formula of the trend vector can be seen in step 1.2: the degree trend vector value, the nature trend vector value, and the scope trend vector value. The trend symbol value refers to the degree trend symbol, the nature trend symbol, and the scope trend symbol described in step 1.2.

[0059] 2.5. Evaluate the clinical prognosis of each syndrome differentiation element of this disease syndrome.

[0060] Evaluate the clinical prognosis of each syndrome differentiation element of this disease syndrome based on the trend vector value range trend symbol calculated in step 2.4. The evaluation method can be seen in step 1.3: the part of "the corresponding relationship between clinical efficacy evaluation and trend vector value and symbol value".

[0061] 3. The graded measurement evaluation method for the clinical comprehensive efficacy of TCM disease syndromes is as follows:

[0062] 3.1. Design the graded quantification of the three-dimensional dynamic evolution state of TCM disease syndromes.

[0063] This embodiment comprehensively considers the three-dimensional dynamic evolution state of traditional Chinese medicine syndromes from four aspects: the main symptoms, secondary symptoms, tongue manifestations, and pulse conditions of the disease syndrome. The weighted summation method is used to multiply the observed values of the main symptoms, secondary symptoms, tongue manifestations, and pulse conditions in terms of degree, scope, and nature by their respective weights as the comprehensive quantitative values of the disease syndrome in terms of degree, scope, and nature. Let w1, w2, w3, and w4 represent the weights of the main syndrome, secondary syndrome, tongue manifestation, and pulse condition. The weights can be allocated according to the actual situation, but the following requirements need to be met: w1, w2, w3, and w4 are all greater than 0; w1 + w2 + w3 + w4 = 1; w1 > w2 > w3 or w4. The recommended weight allocation method is: w1 = 60%, w2 = 30%, w3 = 5%, w4 = 5%.

[0064] 3.2. Calculate the graded value of the three-dimensional evolution state of traditional Chinese medicine syndromes.

[0065] Calculate its state graded value according to the calculation method of the graded value of the three-dimensional dynamic evolution state of traditional Chinese medicine syndromes. Use V zc , V zx , V zf to identify the evolution state values of the three evaluation dimensions of traditional Chinese medicine syndromes. The observed values of all syndrome differentiation elements of the disease syndrome at each time point from T1 - T n are calculated by "weighted summation" respectively according to the three dimensions, and its calculation formula is:

[0066]

[0067] Among them: V zcj , V zxj , V zfj represent the calculated values of the degree, nature, and scope of the syndrome at the observation time T j . i represents the serial number of the syndrome differentiation element. respectively represent the observed values of the degree, nature, and scope of the i-th syndrome differentiation element at the observation time point T j . w i represents the weight of the i-th syndrome differentiation element.

[0068] 3.3. Determine the observation period.

[0069] The method here is the same as the content in step 2.3: "Determine the observation period".

[0070] 3.4. Calculate the three-dimensional dynamic evolution trend vector value of traditional Chinese medicine syndromes.

[0071] Calculate the three-dimensional dynamic evolution trend vector value of traditional Chinese medicine syndromes from the three dimensions of degree, nature, and scope. The calculation formula is as follows:

[0072] Degree trend vector value

[0073] Nature trend vector value

[0074] Range trend vector value

[0075] The calculation formula of the trend symbol is as follows:

[0076] Degree trend symbol

[0077] Nature trend symbol

[0078] Range trend symbol

[0079] 3.5. Evaluate the clinical comprehensive efficacy of traditional Chinese medicine syndromes by grading measurement.

[0080] According to the content in step 3.4: "Calculate the three-dimensional dynamic evolution trend vector value of traditional Chinese medicine syndromes", calculate the three-dimensional dynamic evolution trend vector value of traditional Chinese medicine syndromes and the trend symbol to evaluate the clinical comprehensive efficacy of traditional Chinese medicine syndromes. The evaluation method refers to step 1.3: "The corresponding relationship between clinical efficacy evaluation and trend vector value and symbol value".

[0081] The above shows and describes the basic principles, main features and advantages of the present invention. For those skilled in the art, it is obvious that the present invention is not limited to the details of the above exemplary embodiments, and without departing from the spirit or basic features of the present invention, the present invention can be implemented in other specific forms.

[0082] In addition, it should be understood that although this specification is described according to the embodiments, not every embodiment only contains an independent technical solution. This narrative way of the specification is only for clarity. Those skilled in the art should regard the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A traditional Chinese medicine efficacy evaluation method based on real-world clinical data, characterized in that: The evaluation of the curative effect of traditional Chinese medicine clinical cases is completed from two parts: the evaluation model and the evaluation method. The evaluation method includes the graded measurement evaluation of the clinical prognosis of syndrome differentiation elements and the graded measurement evaluation of the comprehensive clinical curative effect of traditional Chinese medicine syndromes and diseases. The evaluation model includes: evaluation dimensions, evaluation indicators, the corresponding relationship between clinical curative effect evaluation and trend vector values and sign values; The graded measurement evaluation method of the clinical prognosis of syndrome differentiation elements includes: selecting the integral scale of traditional Chinese medicine special syndromes and diseases and their syndrome differentiation elements, observing the three-dimensional dynamic change values of each traditional Chinese medicine syndrome differentiation element of a certain syndrome or disease, determining the observation period, calculating the three-dimensional evolution trend vector of each syndrome differentiation element of a certain syndrome or disease, and evaluating the clinical prognosis of each syndrome differentiation element of this syndrome or disease; The graded measurement evaluation method of the comprehensive clinical curative effect of traditional Chinese medicine syndromes and diseases includes: designing the graded quantification of the three-dimensional dynamic evolution state of traditional Chinese medicine syndromes and diseases, calculating the graded values of the three-dimensional evolution state of traditional Chinese medicine syndromes and diseases, determining the observation period, calculating the trend vector values of the three-dimensional dynamic evolution of traditional Chinese medicine syndromes and diseases, and grading and measuring the evaluation of the comprehensive clinical curative effect of traditional Chinese medicine syndromes and diseases.

2. The traditional Chinese medicine efficacy evaluation method based on real-world clinical data according to claim 1, wherein The evaluation dimensions include three aspects: degree, nature, and scope. And in the evaluation method, the evaluation dimensions are respectively divided into the degree, nature, and scope of each syndrome differentiation element, as well as the degree, nature, and scope of traditional Chinese medicine syndromes and diseases. Each dimension is observed and measured according to different observation times during the entire diagnosis and treatment cycle.

3. The traditional Chinese medicine efficacy evaluation method based on real-world clinical data according to claim 1, wherein, The evaluation indicators include: trend vector values and trend vector signs. And the evaluation indicators have corresponding degree trend vectors, nature trend vector values, and scope trend vector values for different evaluation latitudes; and degree trend sign values, nature trend sign values, and scope trend sign values.

4. The traditional Chinese medicine efficacy evaluation method based on real-world clinical data according to claim 3, wherein: The curative effect evaluation results are divided into three categories: cured, improved, and not cured. The method for evaluating the clinical prognosis of each syndrome differentiation element of this syndrome or disease using trend vector values and trend vector signs is as follows: If the observed value of the indicator is less than the normal value, the trend vector value is greater than 0, and when the observed indicator returns to normal, it represents "cured"; The trend vector value is greater than 0, and when the observed indicator does not return to normal, it represents "improved"; The trend vector value is less than or equal to 0 represents "not cured"; If the observed value of the indicator is greater than the normal value, the trend vector value is less than 0, and when the observed indicator returns to normal, it represents "cured"; The trend vector value is less than 0, and when the observed indicator does not return to normal, it represents "improved"; The trend vector value is greater than or equal to 0 represents "not cured".

5. A traditional Chinese medicine efficacy evaluation method based on real-world clinical data according to claim 4, characterized in that: The method for evaluating the clinical prognosis of each syndrome differentiation element of this syndrome or disease using trend vector signs is as follows: If the observed value of the indicator is less than the normal value, the trend sign value is equal to 1, and when the observed indicator returns to normal, it represents "cured"; The trend sign value is equal to 1, and when the observed indicator does not return to normal, it represents "improved"; The trend sign value is equal to -1 or 0 represents "not cured"; If the observed value of the indicator is greater than the normal value, the trend sign value is equal to -1, and when the observed indicator returns to normal, it represents "cured"; The trend sign value is equal to -1, and when the observed indicator does not return to normal, it represents "improved"; The trend sign value is equal to 1 or 0 represents "not cured".

6. The traditional Chinese medicine efficacy evaluation method based on real-world clinical data according to claim 1, wherein: In the process of selecting the integrated scale for traditional Chinese medicine (TCM) special diseases and syndromes and their syndrome differentiation elements, for the TCM special diseases and syndromes evaluated clinically, select the integrated scale for each syndrome differentiation element of the TCM disease and syndrome as the measurement standard basis for observing the dynamic evolution of each syndrome differentiation element.

7. A traditional Chinese medicine efficacy evaluation method based on real-world clinical data according to claim 6, characterized in that: In the process of observing the three-dimensional dynamic change values of each TCM syndrome differentiation element of a certain disease and syndrome, according to the actual situation of the clinical special disease and syndrome, based on the standard of the integrated scale for the syndrome differentiation elements of this special disease and syndrome, for any evaluated object, describe it from three dimensions: degree, nature and scope, and adopt a grading measurement method to obtain values, and draw a broken line graph of the three-dimensional dynamic change of the TCM syndrome differentiation element.

8. The traditional Chinese medicine efficacy evaluation method based on real-world clinical data according to claim 1, characterized in that: The three-dimensional dynamic evolution state grading and quantification of the TCM disease and syndrome comprehensively consider the three-dimensional dynamic evolution state of the TCM disease and syndrome from four aspects: the main symptoms, secondary symptoms, tongue manifestation, and pulse condition of the disease and syndrome. The weighted summation method is used to multiply the observed values of the main symptoms, secondary symptoms, tongue manifestation, and pulse condition in terms of degree, scope, and nature by their respective weights as the comprehensive quantification values of the disease and syndrome in terms of degree, scope, and nature.

9. The traditional Chinese medicine efficacy evaluation method based on real-world clinical data according to claim 1, wherein: It also includes calculating the state grading value according to the calculation method of the three-dimensional dynamic evolution state grading value of the TCM disease and syndrome, and marking the evolution state values of the three evaluation dimensions of the TCM disease and syndrome.

10. A traditional Chinese medicine efficacy evaluation method based on real-world clinical data according to claim 1, characterized in that: It includes calculating the vector value of the dynamic evolution trend of the TCM disease and syndrome from three dimensions: degree, nature, and scope, and obtaining the three-dimensional dynamic evolution trend vector value and trend symbol of the TCM disease and syndrome based on this calculation process to evaluate the clinical comprehensive efficacy of the TCM disease and syndrome.

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