Multi-mode ultrasonic evaluation method for treating diabetic neuropathy by traditional Chinese medicine

Abstract

The invention provides a multi-mode ultrasonic evaluation method for treating diabetic neuropathy through traditional Chinese medicine. According to the method, traditional Chinese medicine differentiation and modern multi-mode neural ultrasound technologies are combined, and high-frequency ultrasound, shear wave elastography and micro blood flow imaging are included. By performing applicability evaluation and personalized traditional Chinese medicine treatment on the patient, the change of the neurological function can be monitored in real time, so that the treatment effect is accurately evaluated. According to the technology, an innovative mode is provided, traditional Chinese medicine and the advanced imaging technology are combined, the treatment scheme is optimized, the DPN treatment accuracy and effect are improved, and remarkable clinical application value is achieved.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical diagnosis, and in particular relates to a multimodal ultrasound evaluation method for treating diabetic neuropathy with traditional Chinese medicine. Background Art

[0002] Diabetic peripheral neuropathy (DPN) is a common complication caused by diabetes, which is mainly manifested by decreased sensation, pain and numbness, and has a significant impact on patients' daily life and quality of life. Currently, the diagnosis and evaluation of DPN mainly rely on electrophysiological tests and clinical symptom assessment, such as nerve conduction velocity tests. However, these methods have limitations: electrophysiological tests are complex and invasive, and are not sensitive enough to detect mild or early nerve damage.

[0003] Traditional Chinese medicine has shown potential advantages in the treatment of DPN due to its unique treatment methods and good patient adaptability. However, the evaluation of the effect of traditional Chinese medicine in the treatment of DPN usually relies on the subjective feelings of patients and the improvement of clinical symptoms. There is a lack of objective evaluation methods to accurately measure the changes before and after treatment, which limits the scientific verification and widespread acceptance of traditional Chinese medicine treatment methods.

[0004] In recent years, the development of multimodal nerve ultrasound technology has provided a new evaluation method, combining high-frequency ultrasound, shear wave elastography (SWE) and microblood flow imaging technology, which can provide detailed information about the structural and functional status of nerves non-invasively. This technology can monitor the changes in nerve morphology, blood flow and tissue elasticity in real time, providing the possibility for early diagnosis and evaluation of treatment effects. However, the systematic application of these technologies to the evaluation of the effect of traditional Chinese medicine treatment of DPN, especially the combination of quantitative and qualitative analysis, is still insufficient.

[0005] Therefore, it is necessary to develop a method combining multimodal neuroultrasound technology to objectively and quantitatively evaluate the efficacy of traditional Chinese medicine in the treatment of diabetic peripheral neuropathy, so as to make up for the shortcomings of existing technologies and improve the scientificity and verifiability of treatment methods. Summary of the invention

[0006] The purpose of the present invention is to provide a multimodal ultrasound evaluation method for treating diabetic neuropathy with traditional Chinese medicine, which is used to objectively and scientifically evaluate the efficacy of traditional Chinese medicine in treating diabetic peripheral neuropathy (DPN). This method solves the limitations of the prior art that relies on subjective symptom evaluation and electrophysiological testing, and uses high-frequency ultrasound, shear wave elastography (SWE) and microblood flow imaging technology to comprehensively evaluate the changes in nerve structure and function before and after treatment.

[0007] To achieve the above object, the present invention adopts the following method steps:

[0008] S1: Patient Suitability Assessment

[0009] S1.1 Confirmation of indications

[0010] Diagnostic criteria: Based on the diagnostic criteria for diabetic neuropathy in the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)", it is applicable to patients who meet the following conditions:

[0011] Nerve conduction velocity (NCV) testing shows abnormal nerve function;

[0012] Patients reported symptoms of paresthesia, including numbness, pain (tingling, burning), and cold pain.

[0013] Nerve conduction velocity test: Use electrophysiological instruments to measure the nerve conduction velocity of the median nerve, ulnar nerve, posterior tibial nerve and superficial peroneal nerve. During the test, electrodes are used to stimulate specific parts of the nerves and record the nerve conduction velocity (NCV). The calculation formula is NCV = d / t, where d is the distance of the nerve conduction path (unit: cm) and t is the nerve signal transmission time (unit: ms). If the NCV is less than 50m / s, it indicates nerve damage.

[0014] Symptom evaluation: Detailed recording and evaluation of patient-reported neuropathy-related symptoms, such as the nature of pain (tingling, burning pain), frequency of attacks, and their impact on daily function. A detailed description of these symptoms helps assess the severity of DPN and the baseline status before treatment.

[0015] S1.2 Description of applicable patients

[0016] Age and gender: The age range of patients participating in the study was determined to be 30 to 75 years old. This age range was selected based on the prevalence and representativeness of diabetes and its complications in this population to ensure the wide applicability of the study results.

[0017] Symptom classification: Pay special attention to symptoms that reflect the cold-dampness arthralgia syndrome, such as whether the patient's limbs often feel cold and painful, reactions to cold environments (such as increased chills), heaviness or stiffness of the limbs, and whether the pain fluctuates with changes in cold and damp weather.

[0018] TCM diagnosis: It is performed by qualified TCM experts through traditional methods such as face-to-face consultation, inspection, auscultation and questioning to ensure the accurate classification of the patient's TCM syndrome type, which is crucial for the subsequent design of personalized TCM treatment plans.

[0019] S2: Traditional Chinese Medicine Treatment

[0020] S2.1 Treatment options

[0021] S2.1.1 Basic treatment

[0022] A. Provide diabetes health education to all patients so that they understand relevant treatment matters.

[0023] B. Through diet control, appropriate increase in exercise, and hypoglycemic drugs, the patient's blood sugar is kept stable and within the target range, with fasting blood sugar controlled at 4.4-7.8mmol / L and 2h postprandial blood sugar controlled at <13.9mmol / L;

[0024] C. For patients with other concurrent diseases, appropriate medications should be selected based on the patient's specific conditions to control blood pressure and blood lipids at normal levels.

[0025] D. Instruct the patient to take methylcobalamin tablets (National Medicine Approval Number: H20143107, Weicai (China) Pharmaceutical Co., Ltd.) 0.5 mg / time, 3 times / day, and epalrestat capsules (National Medicine Approval Number: H2004084, Yangtze River Pharmaceutical Group Nanjing Hailing Pharmaceutical Co., Ltd.) 50 mg / time, 3 times / day orally for 8 consecutive weeks.

[0026] E. Evaluate blood sugar stability using the formula:

[0027]

[0028] Among them, BG i For each blood sugar value, is the average blood glucose value, n is the number of measurements, and SD is used to evaluate blood glucose fluctuations.

[0029] S2.1.2 Traditional Chinese Medicine Treatment

[0030] On the basis of basic Western medicine treatment, the patient was given Jiawei Jimingsan Granules (the drug composition includes 12g of Perilla Leaf, 6g of Evodia rutaecarpa, 12g of Tangerine Peel, 15g of Areca Nut, 12g of Papaya, 6g of Ginger, 12g of Achyranthes Bidentata, 12g of Eucommia ulmoides, 15g of Discontinuous Tablets, 20g of Clematidis, 12g of Codonopsis pilosula, 12g of Atractylodes macrocephala, produced by the Pharmacy Department of Xiyuan Hospital, China Academy of Chinese Medical Sciences), 1 bag each time, taken orally, 3 times a day, for 8 consecutive weeks.

[0031] S2.2 Treatment implementation:

[0032] S2.2.1 Medication monitoring and adjustment

[0033] During treatment, the patient's response and progress need to be monitored regularly, with changes in symptoms recorded through online or in-person counseling sessions.

[0034] Evaluate treatment effectiveness every two weeks and adjust medication dosage or formulation based on patient feedback and treatment response.

[0035] Professional Chinese medicine practitioners are responsible for adjusting the prescription to ensure the scientificity and adaptability of the adjustment to maximize the treatment effect.

[0036] S2.2.2 Treatment records

[0037] Each time a medication or treatment regimen is adjusted, it should be recorded in detail in the patient's treatment log, including medication changes, dosage adjustments, and patient responses.

[0038] These records are crucial for evaluating long-term treatment effects and also provide data support for possible treatment optimization.

[0039] Step S3: Neurological assessment

[0040] S3.1 Multimodal ultrasound imaging setup

[0041] It uses a color Doppler ultrasound diagnostic instrument equipped with a 10-18MHz high-frequency linear array probe, built-in real-time two-dimensional shear wave elastic imaging (2D-SWE) and microblood flow (MicroV) software, suitable for complex nerve imaging and blood flow analysis.

[0042] S3.2 Precise neuroimaging operations

[0043] A. Patient preparation: Instruct the patient to avoid long walking or other activities that may affect nerve measurement before the examination. Ensure that the patient remains relaxed during the examination to reduce the impact of muscle tension on the test results.

[0044] B. Environmental preparation: Adjust the indoor temperature to maintain at 20-25℃ to reduce the impact of temperature fluctuations on the elasticity of nerve and muscle tissues.

[0045] C. Inspection process:

[0046] Body position adjustment and probe placement: Before each examination, adjust the patient's body position according to the type of nerve to be examined to ensure correct exposure and comfort of the examination site. Apply sufficient coupling agent under the probe to isolate air interference, and place the probe gently to reduce compression and deformation of the nerve.

[0047] High-frequency ultrasound: Check the median nerve, ulnar nerve, posterior tibial nerve and superficial peroneal nerve one by one. Starting from specific anatomical landmarks, systematically scan and measure the transverse and long diameters of the nerves, and outline the morphological contour of the cross section of the lateral edge of the epineurium.

[0048] Micro blood flow mode: After high-frequency ultrasound examination, switch to MicroV mode to record the blood flow at specific observation points of each nerve, and use a semi-quantitative method to evaluate the ratio of blood flow to cross-sectional area.

[0049] 2D-SWE: In 2D-SWE mode, adjust the region of interest (ROI) and range settings to ensure that the motion stability and credibility index of the color elastogram are optimal and then freeze the image. The system automatically calculates and records the shear wave elastic velocity (SWV) and the corresponding Young's modulus value, and measures three times in a row to take the average value to improve the accuracy and repeatability of the measurement.

[0050] S3.3 Comprehensive comparative neurological assessment

[0051] This comprehensive evaluation method has not been reported in the existing literature. This study particularly emphasizes the simultaneous observation of multiple nerves in order to find the best and most sensitive nerves when conducting individual evaluations of traditional Chinese medicine treatment.

[0052] This comprehensive comparative observation not only improves the accuracy of diagnosis, but also provides a scientific basis for the optimization of traditional Chinese medicine treatment strategies.

[0053] S4: Data collection and analysis

[0054] S4.1 Data collection

[0055] A.Data Type:

[0056] Nerve cross-sectional area (CSA): Place the probe at anatomical landmarks such as the median nerve, ulnar nerve, posterior tibial nerve, and superficial peroneal nerve to measure the cross-sectional area (CSA) of the nerve and record the specific anatomical location. CSA = π × a × b / 4, where a and b are the long and short axis lengths of the nerve cross section, respectively, in millimeters (mm), and π is pi. Measure and record the cross-sectional area of ​​each nerve at a specific anatomical point in square millimeters (mm). 2 ), which helps assess structural changes in the nerve.

[0057] Nerve tissue elastic modulus: Shear wave elastography is used to measure the elastic modulus of the nerve tissue. The data unit is kilopascal (kPa), which can reflect the hardness of the nerve tissue and is closely related to the health status of the nerves.

[0058] Blood flow parameters: Micro-blood flow imaging technology is used to evaluate the blood flow around the nerves, including blood flow velocity and blood volume. The data is expressed as the proportion of blood flow in the nerve cross-section, providing semi-quantitative evaluation results.

[0059] B. Recording method:

[0060] Automatic data collection: Use the ultrasound device's built-in software to automatically detect and record the above parameters. The device converts this data into a digital format in real time for subsequent analysis.

[0061] Data Storage: All collected data will be automatically stored in the ultrasound device's memory and can be transferred to a dedicated medical database to ensure data security and confidentiality.

[0062] Data Export: Provides data export functionality, allowing data to be exported in commonly used formats (such as CSV or Excel) for detailed statistical analysis.

[0063] S4.2 Data analysis

[0064] Descriptive statistics: Basic statistics such as mean and standard deviation of nerve cross-sectional area, elastic modulus, and blood flow parameters were calculated to provide an overall overview of the data.

[0065] Comparative analysis: Paired comparisons of data before and after treatment were performed, and changes in neural parameters were analyzed using t-test or ANOVA to evaluate the effectiveness of treatment.

[0066] Trend analysis: Analyze the changing trends of data over time, using regression analysis or time series analysis methods to evaluate the persistence and changing patterns of treatment effects.

[0067] Data visualization: Use graphical tools (such as bar charts, line charts, and scatter plots) to intuitively display data analysis results and enhance the interpretability and presentation of results.

[0068] The present invention is beneficial in that:

[0069] 1. Improve the accuracy of diagnosis and treatment

[0070] This invention provides a non-invasive and accurate method to evaluate the effect of TCM treatment of diabetic peripheral neuropathy (DPN) by using multimodal neuro-ultrasound technology, combining high-frequency ultrasound, micro-blood flow imaging and two-dimensional shear wave elastic imaging. This comprehensive imaging technology enables doctors to observe the structural changes, blood flow status and tissue elasticity of nerves in detail, thereby improving the accuracy of diagnosis and optimizing treatment plans.

[0071] 2. Enhance individualized treatment plans

[0072] The present invention enables the treatment plan to be adjusted according to the individual's specific symptoms and constitution through detailed TCM syndrome differentiation and Western medicine diagnosis of the patient. The personalized formula of TCM combined with basic Western medicine treatment not only takes into account the patient's physiological state, but also involves overall health management, such as lifestyle adjustment and chronic disease management, thus providing a more comprehensive treatment method.

[0073] 3. Continuous monitoring and real-time feedback

[0074] Through regular multimodal neuro-ultrasound examinations, the present invention allows for continuous monitoring of nerve conditions during treatment. This monitoring provides doctors with real-time feedback, allowing them to adjust treatment plans in a timely manner to respond to the patient's changing conditions, improving the responsiveness and effectiveness of treatment.

[0075] 4. Facilitate clinical decision making and research

[0076] The data collection and analysis method of the present invention provides a large amount of quantitative data for research, such as nerve cross-sectional area, elastic modulus and blood flow, which are crucial for evaluating disease progression and treatment effects. These detailed quantitative parameters can be used for further clinical research and promote the application and scientific verification of traditional Chinese medicine in the field of modern medicine.

[0077] 5. Improve treatment safety and patient comfort

[0078] Since non-invasive ultrasound imaging technology is used, the present invention avoids the risks and discomfort of traditional invasive diagnostic methods, providing patients with a safe and comfortable diagnosis and treatment experience. This method reduces patients' resistance to treatment and helps improve patients' compliance with treatment plans. BRIEF DESCRIPTION OF THE DRAWINGS

[0079] Figure 1 A flow chart of the steps of the present invention is shown; DETAILED DESCRIPTION

[0080] Combination Figure 1 The present invention provides a multimodal ultrasound evaluation method for treating diabetic neuropathy with traditional Chinese medicine.

[0081] Specifically, the scheme includes the following steps:

[0082] Method steps:

[0083] S1: Patient Suitability Assessment

[0084] S1.1 Confirmation of indications

[0085] Diagnostic criteria: Based on the diagnostic criteria for diabetic neuropathy in the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)", it is applicable to patients who meet the following conditions:

[0086] Nerve conduction velocity (NCV) testing shows abnormal nerve function;

[0087] Patients reported symptoms of paresthesia, including numbness, pain (tingling, burning), and cold pain.

[0088] Nerve conduction velocity test: Use electrophysiological instruments to measure the nerve conduction velocity of the median nerve, ulnar nerve, posterior tibial nerve and superficial peroneal nerve. During the test, electrodes are used to stimulate specific parts of the nerves and record the nerve conduction velocity (NCV). The calculation formula is NCV = d / t, where d is the distance of the nerve conduction path (unit: cm) and t is the nerve signal transmission time (unit: ms). If the NCV is less than 50m / s, it indicates nerve damage.

[0089] Symptom evaluation: Detailed recording and evaluation of patient-reported neuropathy-related symptoms, such as the nature of pain (tingling, burning pain), frequency of attacks, and their impact on daily function. A detailed description of these symptoms helps assess the severity of DPN and the baseline status before treatment.

[0090] S1.2 Description of applicable patients

[0091] Age and gender: The age range of patients participating in the study was determined to be 30 to 75 years old. This age range was selected based on the prevalence and representativeness of diabetes and its complications in this population to ensure the wide applicability of the study results.

[0092] Symptom classification: Pay special attention to symptoms that reflect the cold-dampness arthralgia syndrome, such as whether the patient's limbs often feel cold and painful, reactions to cold environments (such as increased chills), heaviness or stiffness of the limbs, and whether the pain fluctuates with changes in cold and damp weather.

[0093] TCM diagnosis: It is performed by qualified TCM experts through traditional methods such as face-to-face consultation, inspection, auscultation and questioning to ensure the accurate classification of the patient's TCM syndrome type, which is crucial for the subsequent design of personalized TCM treatment plans.

[0094] S2: Traditional Chinese Medicine Treatment

[0095] S2.1 Treatment options

[0096] S2.1.1 Basic treatment

[0097] A. Provide diabetes health education to all patients so that they understand relevant treatment matters.

[0098] B. Through diet control, appropriate increase in exercise, and hypoglycemic drugs, the patient's blood sugar is kept stable and within the target range, with fasting blood sugar controlled at 4.4-7.8mmol / L and 2h postprandial blood sugar controlled at <13.9mmol / L;

[0099] C. For patients with other concurrent diseases, appropriate medications should be selected based on the patient's specific conditions to control blood pressure and blood lipids at normal levels.

[0100] D. Instruct the patient to take methylcobalamin tablets (National Medicine Approval Number: H20143107, Weicai (China) Pharmaceutical Co., Ltd.) 0.5 mg / time, 3 times / day, and epalrestat capsules (National Medicine Approval Number: H2004084, Yangtze River Pharmaceutical Group Nanjing Hailing Pharmaceutical Co., Ltd.) 50 mg / time, 3 times / day orally for 8 consecutive weeks.

[0101] E. Evaluate blood sugar stability using the formula:

[0102]

[0103] Among them, BG i For each blood sugar value, is the average blood glucose value, n is the number of measurements, and SD is used to evaluate blood glucose fluctuations.

[0104] S2.1.2 Traditional Chinese Medicine Treatment

[0105] On the basis of basic Western medicine treatment, the patient was given Jiawei Jimingsan Granules (the drug composition includes 12g of Perilla Leaf, 6g of Evodia rutaecarpa, 12g of Tangerine Peel, 15g of Areca Nut, 12g of Papaya, 6g of Ginger, 12g of Achyranthes Bidentata, 12g of Eucommia ulmoides, 15g of Discontinuous Tablets, 20g of Clematidis, 12g of Codonopsis pilosula, 12g of Atractylodes macrocephala, produced by the Pharmacy Department of Xiyuan Hospital, China Academy of Chinese Medical Sciences), 1 bag each time, taken orally, 3 times a day, for 8 consecutive weeks.

[0106] S2.2 Treatment implementation:

[0107] S2.2.1 Medication monitoring and adjustment

[0108] During treatment, the patient's response and progress need to be monitored regularly, with changes in symptoms recorded through online or in-person counseling sessions.

[0109] Evaluate treatment effectiveness every two weeks and adjust medication dosage or formulation based on patient feedback and treatment response.

[0110] Professional Chinese medicine practitioners are responsible for adjusting the prescription to ensure the scientificity and adaptability of the adjustment to maximize the treatment effect.

[0111] S2.2.2 Treatment records

[0112] Each time a medication or treatment regimen is adjusted, it should be recorded in detail in the patient's treatment log, including medication changes, dosage adjustments, and patient responses.

[0113] These records are crucial for evaluating long-term treatment effects and also provide data support for possible treatment optimization.

[0114] Step S3: Neurological assessment

[0115] S3.1 Multimodal ultrasound imaging setup

[0116] It uses a color Doppler ultrasound diagnostic instrument equipped with a 10-18MHz high-frequency linear array probe, built-in real-time two-dimensional shear wave elastic imaging (2D-SWE) and microblood flow (MicroV) software, suitable for complex nerve imaging and blood flow analysis.

[0117] S3.2 Precise neuroimaging operations

[0118] A. Patient preparation: Instruct the patient to avoid long walking or other activities that may affect nerve measurement before the examination. Ensure that the patient remains relaxed during the examination to reduce the impact of muscle tension on the test results.

[0119] B. Environmental preparation: Adjust the indoor temperature to maintain at 20-25℃ to reduce the impact of temperature fluctuations on the elasticity of nerve and muscle tissues.

[0120] C. Inspection process:

[0121] Body position adjustment and probe placement: Before each examination, adjust the patient's body position according to the type of nerve to be examined to ensure correct exposure and comfort of the examination site. Apply sufficient coupling agent under the probe to isolate air interference, and place the probe gently to reduce compression and deformation of the nerve.

[0122] High-frequency ultrasound: Check the median nerve, ulnar nerve, posterior tibial nerve and superficial peroneal nerve one by one. Starting from specific anatomical landmarks, systematically scan and measure the transverse and long diameters of the nerves, and outline the morphological contour of the cross section of the lateral edge of the epineurium.

[0123] Micro blood flow mode: After high-frequency ultrasound examination, switch to MicroV mode to record the blood flow at specific observation points of each nerve, and use a semi-quantitative method to evaluate the ratio of blood flow to cross-sectional area.

[0124] 2D-SWE: In 2D-SWE mode, adjust the region of interest (ROI) and range settings to ensure that the motion stability and credibility index of the color elastogram are optimal and then freeze the image. The system automatically calculates and records the shear wave elastic velocity (SWV) and the corresponding Young's modulus value, and measures three times in a row to take the average value to improve the accuracy and repeatability of the measurement.

[0125] S3.3 Comprehensive comparative neurological assessment

[0126] This comprehensive evaluation method has not been reported in the existing literature. This study particularly emphasizes the simultaneous observation of multiple nerves in order to find the best and most sensitive nerves when conducting individual evaluations of traditional Chinese medicine treatment.

[0127] This comprehensive comparative observation not only improves the accuracy of diagnosis, but also provides a scientific basis for the optimization of traditional Chinese medicine treatment strategies.

[0128] S4: Data collection and analysis

[0129] S4.1 Data collection

[0130] A.Data Type:

[0131] Nerve cross-sectional area (CSA): Place the probe at anatomical landmarks such as the median nerve, ulnar nerve, posterior tibial nerve, and superficial peroneal nerve to measure the cross-sectional area (CSA) of the nerve and record the specific anatomical location. CSA = π × a × b / 4, where a and b are the long and short axis lengths of the nerve cross section, respectively, in millimeters (mm), and π is pi. Measure and record the cross-sectional area of ​​each nerve at a specific anatomical point in square millimeters (mm). 2 ), which helps assess structural changes in the nerve.

[0132] Nerve tissue elastic modulus: Shear wave elastography is used to measure the elastic modulus of the nerve tissue. The data unit is kilopascal (kPa), which can reflect the hardness of the nerve tissue and is closely related to the health status of the nerves.

[0133] Blood flow parameters: Micro-blood flow imaging technology is used to evaluate the blood flow around the nerves, including blood flow velocity and blood volume. The data is expressed as the proportion of blood flow in the nerve cross-section, providing semi-quantitative evaluation results.

[0134] B. Recording method:

[0135] Automatic data collection: Use the ultrasound device's built-in software to automatically detect and record the above parameters. The device converts this data into a digital format in real time for subsequent analysis.

[0136] Data Storage: All collected data will be automatically stored in the ultrasound device's memory and can be transferred to a dedicated medical database to ensure data security and confidentiality.

[0137] Data Export: Provides data export functionality, allowing data to be exported in commonly used formats (such as CSV or Excel) for detailed statistical analysis.

[0138] S4.2 Data analysis

[0139] Descriptive statistics: Basic statistics such as mean and standard deviation of nerve cross-sectional area, elastic modulus, and blood flow parameters were calculated to provide an overall overview of the data.

[0140] Comparative analysis: Paired comparisons of data before and after treatment were performed, and changes in neural parameters were analyzed using t-test or ANOVA to evaluate the effectiveness of treatment.

[0141] Trend analysis: Analyze the changing trends of data over time, using regression analysis or time series analysis methods to evaluate the persistence and changing patterns of treatment effects.

[0142] Data visualization: Use graphical tools (such as bar charts, line charts, and scatter plots) to intuitively display data analysis results and enhance the interpretability and presentation of results.

[0143] The following is a specific example, which shows how to use the method proposed in the present invention to evaluate the effect of traditional Chinese medicine in treating diabetic peripheral neuropathy.

[0144] Example 1: Application of multimodal neurosonography

[0145] 1. Patient Information

[0146] Age and gender: 65 years old female

[0147] Medical background: Diagnosed with type 2 diabetes, he recently developed symptoms of DPN, mainly manifested as numbness, tingling, and intermittent pain in his feet.

[0148] 2. Treatment process

[0149] A. Basic treatment

[0150] Educate patients about diabetes management, emphasizing the importance of proper diet and regular exercise.

[0151] B. Drug treatment

[0152] Metformin and repaglinide are used daily to control blood sugar.

[0153] ACE inhibitors and statins are taken at the same time to prevent and treat hypertension and adjust blood lipids.

[0154] C. Chinese medicine treatment

[0155] Prescription description: According to TCM syndrome differentiation and treatment, the prescription is modified Jimingsan granules, containing perilla leaves, evodia rutaecarpa, tangerine peel, betel nut, etc.

[0156] Dosage: Take one bag three times a day with warm water for 8 consecutive weeks.

[0157] 3. Neurological Function Assessment

[0158] A. Equipment Configuration

[0159] The Esaote Mylab8 color Doppler ultrasound diagnostic instrument was used, equipped with a high-frequency probe and built-in real-time two-dimensional shear wave elastography (2D-SWE) and microblood flow (MicroV) software.

[0160] B. Check time

[0161] Neurological function was evaluated before treatment (baseline), and 1, 2, and 3 months after treatment.

[0162] C. Check steps and parameters

[0163] Patient preparation: Ensure that the patient is well rested before the examination and avoid activities that may interfere with the neurological assessment.

[0164] Environmental settings: The room temperature is controlled at 20-25℃ to provide a comfortable inspection environment.

[0165] Inspection process:

[0166] Median nerve: The patient lies supine with the palm facing up, and the scan is performed continuously from 4 cm above the medial condyle of the humerus to the entrance of the carpal tunnel.

[0167] Ulnar nerve: With the patient sitting and the arm extended and abducted, begin testing at the tip of the medial epicondyle of the humerus.

[0168] Posterior tibial nerve and superficial peroneal nerve: The patient lies flat, the lower limbs are exposed, and the scan begins at the corresponding anatomical landmarks.

[0169] 4. Data Analysis

[0170] Data types: including nerve cross-sectional area (CSA), nerve tissue elastic modulus, blood flow parameters, etc.

[0171] Analytical methods:

[0172] Descriptive statistics were used to analyze changes in neurological function, and time series analysis was used to assess the sustainability and significance of treatment effects.

[0173] The present invention relates to a method combining traditional Chinese medicine theory and modern medical technology for evaluating and treating diabetic peripheral neuropathy (DPN). The core of the present invention is to use multimodal neural ultrasound technology, including high-frequency ultrasound, shear wave elastography and microblood flow imaging, to comprehensively evaluate and monitor the effect of traditional Chinese medicine in treating DPN. In addition, the present invention adopts a personalized traditional Chinese medicine treatment plan, adjusts the combination of Chinese medicines according to the specific symptoms of the patient, and achieves the maximum effect of treatment. The scope of protection of the present invention includes but is not limited to the entire process of diagnosing, treating and evaluating the effects of DPN patients using the above-mentioned techniques and methods. Through this method, the present invention not only improves the effect of treating DPN, but also provides a scientific basis and technical support for the modernization and internationalization of traditional Chinese medicine.

Claims

1. A multimodal ultrasound evaluation method for treating diabetic neuropathy with traditional Chinese medicine, the method comprising the following steps: S1. Conduct a suitability assessment on the patient, including using the diagnostic criteria for diabetic peripheral neuropathy and TCM syndrome differentiation to determine whether the patient is eligible for treatment; S2. Implement a comprehensive treatment plan that includes traditional Chinese medicine formulas and basic Western medicine treatments; S3. Perform regular neurological assessment using multimodal neuro-ultrasound technology; S4. Collect and analyze nerve function data, including nerve cross-sectional area, nerve tissue elastic modulus, and blood flow parameters.

2. The method according to claim 1, wherein the traditional Chinese medicine formula is modified Jimingsan granules, including syndrome differentiation and treatment based on the category of "wet foot ulcer", adopting the treatment principle of "warming yang and removing dampness, dispersing cold and unblocking meridians", and personalized adjustment of the drug combination according to the patient's specific clinical symptoms.

3. The method according to claim 1 or 2, wherein the multimodal neural ultrasound technology includes the use of high-frequency ultrasound, shear wave elastic imaging and microblood flow imaging technology to observe and record nerve damage and repair.

4. A method according to any preceding claim, wherein regular assessment of neurological function comprises assessment before treatment, one month, two months and three months after treatment.

5. A method according to any preceding claim, wherein data analysis comprises using statistical software to perform descriptive statistics, comparative analysis and trend analysis to assess the effectiveness and long-term impact of treatment.

6. A method according to any preceding claim, wherein a comparative comprehensive observation is performed on the four main nerves of both upper and lower limbs of the same patient at the same time, and the obtained data is used to perform an individualized assessment of the effect of traditional Chinese medicine treatment.

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