Research method for regulating effect of liver-intestine axis mechanism on malnutrition in decompensated period of liver cirrhosis

Abstract

The invention discloses a method for researching the regulating effect of a traditional Chinese medicine radix astragali and blue medicated diet on dystrophy in a decompensated period of liver cirrhosis through a hepatointestinal axis mechanism, and the method comprises the following steps: S1, firstly preparing 120 patients meeting inclusion standards, and grouping the 120 patients into three groups, each group comprising 40 patients; s2, observing indexes of the groups; and S3, data statistical analysis. According to the invention, the clinical curative effect of the astragalus membranaceus and blue medicated diet on improving malnutrition in the decompensated period of liver cirrhosis is observed, and the astragalus membranaceus and blue medicated diet plays a role in regulating the liver-intestinal axis function by regulating liver immunity, regulating intestinal flora imbalance, relieving intestinal endotoxemia and the like; the traditional Chinese medicinal diet is provided as a treatment method for improving malnutrition of the patients with liver cirrhosis, has an obvious curative effect on improving the life quality of the patients in the decompensated stage of liver cirrhosis, is convenient in material taking, economical and practical, rich in nutrition, low in price and suitable for long-term administration of the patients in the decompensated stage of liver cirrhosis; and a new basis and a new method are provided for improving the life quality of decompensated groups with liver cirrhosis by popularizing medicinal material processing products, namely the astragalus membranaceus-blue medicated food.

Description

Technical Field

[0001] This invention relates to the field of liver cirrhosis research technology, specifically to a research method for studying the regulatory effect of the liver-gut axis mechanism on malnutrition in the decompensated stage of liver cirrhosis. Background Technology

[0002] Decompensated cirrhosis is a common and critical illness in clinical practice, with a low cure rate. Patients are repeatedly hospitalized annually due to complications such as refractory ascites, gastrointestinal bleeding, infection, hepatic encephalopathy, liver failure, and hepatorenal syndrome. The severity of the condition, its long course, and high costs cause significant suffering for patients and their families, resulting in poor quality of life and low survival rates. Quality of life has become a major indicator for evaluating patients with decompensated cirrhosis, encompassing physiological, psychological, social, familial, work, and emotional aspects. Malnutrition is a major factor affecting the quality of life of patients with decompensated cirrhosis and a significant pathogenic mechanism contributing to the high incidence of complications. Currently, clinical treatment for decompensated cirrhosis primarily focuses on internal medicine therapies such as etiological treatment, complication management, anti-fibrotic therapy, immune modulation, and gut microbiota regulation. However, the available medications are extremely expensive, and they are rarely used to treat malnutrition in cirrhosis patients. Summary of the Invention

[0003] Therefore, the purpose of this invention is to provide a research method for the regulatory effect of the hepato-gut axis mechanism on malnutrition in the decompensated stage of cirrhosis, to observe the clinical efficacy of Astragalus and Indigofera Root Diet in the decompensated stage of cirrhosis, to clarify that Astragalus and Indigofera Root Diet exerts its regulatory effect on hepato-gut axis function by regulating hepatic immunity, regulating intestinal flora imbalance, and reducing enterogenic endotoxemia, and to propose that traditional Chinese medicine diet as a treatment method to improve malnutrition in patients with cirrhosis and to significantly improve the quality of life in the decompensated stage of cirrhosis. Moreover, traditional Chinese medicine diet is convenient to obtain, economical, practical, nutritious, and inexpensive, making it suitable for long-term use by patients with decompensated cirrhosis. This invention provides new evidence and methods for promoting the processed medicinal product Astragalus and Indigofera Root Diet to improve the quality of life of the decompensated cirrhosis population.

[0004] To solve the above-mentioned technical problems, according to one aspect of the present invention, the present invention provides the following technical solution: a method for studying the regulatory effect of the hepato-gut axis mechanism on malnutrition in the decompensated stage of cirrhosis, comprising:

[0005] S1: First, prepare 120 patients who meet the inclusion criteria and divide them into three groups of 40 patients each. The groups are: observation group, control group 1, and control group 2.

[0006] Among them, three groups of patients received routine internal medicine nursing care, including bed rest, liver-protecting drugs, antiviral drugs, anti-liver fibrosis drugs, diuretics, and human serum albumin. Routine nursing care included nursing education, advising patients to rest more and engage in light activities, guiding them to eat a diet high in protein, fiber, easily digestible, and low in sodium, urging them to quit smoking and drinking, providing psychological support, and managing skin hygiene.

[0007] The observation group was given 200ml of Astragalus and Blue Medicinal Diet as a nighttime snack, and control group 1 was given 200ml of high-carbohydrate nutritional porridge as a nighttime snack; control group 2 did not receive dietary intervention; all patients were observed for a total of 48 weeks, specifically including 2 weeks of hospitalization and 46 weeks of outpatient follow-up, of which 24 weeks were for nighttime snack intervention;

[0008] S2: Observe the indicators of the above groups, including: (1) Child-P score, TCM symptom score, RFH-GA score, QOL score, NAI index, LSMSA; (2) T cell subsets, endotoxin, Fibroscan, color Doppler ultrasound; (3) 48-week survival rate, readmission rate, and incidence of critical events.

[0009] S3: Statistical analysis of data; all quantitative data are expressed as mean ± standard deviation. The data were presented as follows: paired t-tests were used to compare each group with baseline; independent samples t-tests were used to compare the differences before and after treatment between groups; chi-square test was used to determine if the overall efficacy followed a normal distribution; P < 0.05 was considered statistically significant; the data were processed, verified, and then analyzed by computer.

[0010] As a preferred embodiment of the research method for the study of the regulatory effect of the liver-gut axis mechanism on malnutrition in the decompensated stage of liver cirrhosis as described in this invention, in step S1, the composition of the Astragalus and Gynostemma pentaphyllum medicinal diet specifically includes: 30g of raw Astragalus membranaceus, 30g of Lycium barbarum, 9g of Gynostemma pentaphyllum, 5g of lotus leaf, 15g of maltose, and 50g of millet.

[0011] As a preferred embodiment of the research method for the study of the regulatory effect of the hepato-gut axis mechanism on malnutrition in the decompensated stage of cirrhosis as described in this invention, the preparation method of Astragalus membranaceus medicinal diet is as follows:

[0012] ① Soaking: Place raw Astragalus membranaceus, Gynostemma pentaphyllum, lotus leaf, and wolfberry in a decoction bag and soak in 800mL of purified water for 20 minutes; ② Decoction: Pour the soaked herbs and water into a clay pot, bring to a boil over high heat, then simmer over low heat for 30 minutes; ③ Cooking: Remove the decoction bag, add millet, and simmer over low heat for 20 minutes, reducing to about 200mL; ④ Dissolving: Add maltose and stir until dissolved; Pack the prepared medicinal food into a bag and take it warm at night.

[0013] As a preferred embodiment of the research method for the study of the regulatory effect of the liver-gut axis mechanism on malnutrition in the decompensated stage of liver cirrhosis described in this invention, the specific preparation method of the high-carbohydrate nutritional porridge is as follows: 50g of millet, 15g of white sugar, and 800mL of purified water are put into a clay pot, brought to a boil over high heat, and then simmered over low heat for 20 minutes until about 200mL is simmered. The porridge is then packaged into a bag and taken warm at night.

[0014] As a preferred embodiment of the method for studying the regulatory effect of the hepato-gut axis mechanism on malnutrition in decompensated cirrhosis as described in this invention, the specific index parameters in step S2 are as follows:

[0015] The Child-P score for liver function, which includes five indicators—hepatic encephalopathy, ascites, albumin, bilirubin, and PT—was established before treatment and at 2, 24, and 48 weeks after treatment to assess the severity of cirrhosis. Based on the patient's score, liver function can be divided into three levels: A, B, and C.

[0016] Before treatment, and at 2, 24, and 48 weeks after treatment, T cell subsets (T3, T4, CD3, CD4), endotoxin, Fibroscan, and color Doppler ultrasound were measured.

[0017] RFH-GA scores were measured before treatment and at 24 and 48 weeks after treatment, including body mass index (BMI), upper arm circumference (MAC), triceps skinfold thickness (TSF), mid-arm muscle circumference (MAMC), and relative MAMC. The calculation formulas were: MAMC = MAC - (TSF × 0.314) and BMI = weight (W) / height (h)².

[0018] Nutritional assessment index (NAI) before treatment, at 24 weeks and 48 weeks after treatment; NAI = 2.64 MAMC + 0.60 PA + 3.76 RBP + 0.017 PPD - 53.80; In the formula, AMC (arm muscle circumference) is the upper arm muscle circumference (cm), PA (prealbumin) is serum prealbumin (mg / dL), RBP (retinol-binding protein) is serum retinol-binding protein (mg / dL), and PPD (purified protein derivative test) is a delayed hypersensitivity skin reaction test using purified protein derivatives, with induration diameter <5mm as 1, >5mm as 2, and no reaction as 0;

[0019] Before treatment, and at 24 and 48 weeks after treatment, the cross-sectional area of ​​lumbar skeletal muscle (LSMSA) was measured by CT scan, with the muscle area at the level of the third lumbar vertebra (L3) selected for measurement.

[0020] TCM symptom scores before treatment, 24 weeks after treatment, and 48 weeks after treatment were based on the consensus of TCM diagnosis and treatment guidelines.

[0021] Quality of life (QOL) scores were assessed before treatment and at 24 and 48 weeks post-treatment using a questionnaire based on the European Organization for Research and Treatment of Cancer's core quality of life scale (QOL). The scale covered physical, psychological, and social aspects, including family roles, mental state, and appetite factors. Each factor was scored from 1 to 5, with higher scores indicating better quality of life. The survey was conducted by a designated person who explained the completion method to the patients in detail, without any hints, ensuring that the patients completed the questionnaire voluntarily and truthfully.

[0022] As a preferred embodiment of the research method for the study of the regulatory effect of the liver-gut axis mechanism on malnutrition in the decompensated stage of cirrhosis, the research method for the regulatory effect of the liver-gut axis mechanism on malnutrition in the decompensated stage of cirrhosis also includes adverse event observation, specifically including: recording the time of occurrence of adverse reactions, vital signs, clinical manifestations, laboratory tests, and treatment plans, and conducting tests once before and once after treatment.

[0023] As a preferred embodiment of the research method for studying the regulatory effect of the hepato-gut axis mechanism on malnutrition in decompensated cirrhosis as described in this invention, the research method for studying the regulatory effect of the hepato-gut axis mechanism on malnutrition in decompensated cirrhosis also includes the management of adverse events. The specific management methods are as follows: For general adverse reactions, such as when the patient's vital signs are stable and there is only nausea, vomiting or other mild discomfort and allergic reactions are ruled out, the dosage of the drug is reduced or the drug is discontinued, and the patient is dynamically observed. If the symptoms are relieved and disappear, the drug is continued. If the symptoms persist, the drug is discontinued and the patient is excluded from the study. For allergic reactions, such as rash, itching, chest tightness, fever, etc., if the vital signs are stable, the drug is temporarily discontinued and the patient is dynamically observed. If necessary, oral or intramuscular anti-allergic drugs are administered. For critical conditions, such as anaphylactic shock, dyspnea, etc., if the vital signs are unstable, the drug is discontinued, vital signs are monitored, and the patient is sent to the emergency room and relevant departments for emergency treatment.

[0024] As a preferred embodiment of the research method for studying the regulatory effect of the hepato-gut axis mechanism on malnutrition in decompensated cirrhosis as described in this invention, the research method also includes a data management plan, specifically as follows: Researchers complete the Clinical Record Form (CRF) while treating subjects, ensuring that data records are timely, complete, accurate, and truthful. Any corrections to the CRF can only be made by drawing lines and annotating the revised data, with the researcher signing and dated. The original records must not be erased or covered. The subjects' original laboratory reports must be pasted into the original medical records. After each subject's observation course ends, the researcher should promptly complete the relevant content on the CRF, and review and sign it for confirmation.

[0025] As a preferred embodiment of the research method for the study of the regulatory effect of the hepato-gut axis mechanism on malnutrition in the decompensated stage of cirrhosis described in this invention, in step S1, the criteria for determining the standard patient are: age between 18 and 70 years old, gender not limited, presence of portal hypertension and related complications of decreased liver function, such as ascites and hepatic encephalopathy; and the cause of the disease is hepatitis B.

[0026] As a preferred embodiment of the method for studying the regulatory effect of the hepato-gut axis mechanism on malnutrition in the decompensated stage of cirrhosis as described in this invention, the exclusion criteria for patients are as follows: those with malignant tumors of other organs; acute exacerbation of cardiovascular and cerebrovascular diseases; renal failure; pregnant or lactating women; patients with mental illness; acute or subacute liver failure; active gastrointestinal bleeding; intestinal obstruction; DIC; HIV infection; diabetes; and patients with cirrhosis caused by other etiologies.

[0027] The criteria for excluding and dropping out cases are as follows:

[0028] Those who cannot follow the treatment protocol; those who cannot accept regular follow-up, resulting in missing data and affecting the assessment of efficacy and safety; those who are lost to follow-up during the observation process; those who take drugs or foods that affect the assessment of results during the study period, such as alcohol; those who experience serious adverse events or complications that make them unsuitable to continue the study and withdraw voluntarily.

[0029] Compared with the prior art, the advantages of the present invention are as follows:

[0030] This study observed the clinical efficacy of Astragalus and Indigo Dietary Therapy in the decompensated stage of liver cirrhosis. It clarified that Astragalus and Indigo Dietary Therapy regulates liver-gut axis function by modulating liver immunity, controlling intestinal flora imbalance, and alleviating enterogenic endotoxemia. The study proposes that traditional Chinese medicine dietary therapy is an effective treatment for improving malnutrition in patients with liver cirrhosis and significantly improving the quality of life in the decompensated stage of liver cirrhosis. Furthermore, traditional Chinese medicine dietary therapy is convenient to obtain, economical, nutritious, and inexpensive, making it suitable for long-term use by patients with decompensated liver cirrhosis. This provides new evidence and methods for promoting Astragalus and Indigo Dietary Therapy, a processed medicinal product, to improve the quality of life of this group. Attached Figure Description

[0031] To more clearly illustrate the technical solutions of the embodiments of the present invention, the present invention will be described in detail below with reference to the accompanying drawings and detailed embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort. Wherein:

[0032] Figure 1 This is a technical roadmap for the present invention. Detailed Implementation

[0033] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0034] Many specific details are set forth in the following description in order to provide a full understanding of the invention. However, the invention may also be practiced in other ways different from those described herein, and those skilled in the art can make similar extensions without departing from the spirit of the invention. Therefore, the invention is not limited to the specific embodiments disclosed below.

[0035] Secondly, the present invention will be described in detail with reference to the schematic diagrams. When describing the embodiments of the present invention, for ease of explanation, the cross-sectional views illustrating the device structure will be partially enlarged, not according to the usual scale. Furthermore, the schematic diagrams are merely examples and should not limit the scope of protection of the present invention. In addition, actual fabrication should include the three-dimensional spatial dimensions of length, width, and depth.

[0036] To make the objectives, technical solutions, and advantages of the present invention clearer, the embodiments of the present invention will be described in further detail below with reference to the accompanying drawings.

[0037] This invention provides a research method for studying the regulatory effect of the hepato-gut axis mechanism on malnutrition in the decompensated stage of cirrhosis. It observes the clinical efficacy of Astragalus and Indigofera Root Diet in the decompensated stage of cirrhosis, clarifying that Astragalus and Indigofera Root Diet regulates hepato-gut axis function by modulating hepatic immunity, controlling intestinal flora imbalance, and alleviating enterogenic endotoxemia. It proposes that traditional Chinese medicine dietary therapy is a treatment method for improving malnutrition in patients with cirrhosis and has significant efficacy in improving the quality of life in the decompensated stage of cirrhosis. Furthermore, traditional Chinese medicine dietary therapy is convenient to obtain, economical, nutritious, and inexpensive, making it suitable for long-term use by patients with decompensated cirrhosis. This provides new evidence and methods for promoting the processed medicinal product Astragalus and Indigofera Root Diet to improve the quality of life of the decompensated cirrhosis population.

[0038] Figure 1 The diagram shown is an overall structural schematic of one embodiment of the method for studying the regulatory effect of the hepato-gut axis mechanism of the present invention on malnutrition in the decompensated stage of liver cirrhosis. Please refer to [link / reference]. Figure 1 The main steps of this implementation method include: S1: First, prepare 120 patients who meet the inclusion criteria, and divide the 120 patients into three groups of 40 patients each. The groups are observation group, control group 1 and control group 2 respectively.

[0039] The criteria for identifying standard patients are: age between 18 and 70 years old, gender not limited, presence of portal hypertension and related complications of impaired liver function, such as ascites and hepatic encephalopathy; and etiology of hepatitis B.

[0040] The exclusion criteria for patients are: malignant tumors of other organs; acute exacerbation of cardiovascular and cerebrovascular diseases; renal failure; pregnant or lactating women; patients with mental illness; acute or subacute liver failure; active gastrointestinal bleeding; intestinal obstruction; DIC; HIV infection; diabetes; and patients with cirrhosis due to other causes.

[0041] Among them, three groups of patients received routine internal medicine nursing care, including bed rest, liver-protecting drugs, antiviral drugs, anti-liver fibrosis drugs, diuretics, and human serum albumin. Routine nursing care included nursing education, advising patients to rest more and engage in light activities, guiding them to eat a diet high in protein, fiber, easily digestible, and low in sodium, urging them to quit smoking and drinking, providing psychological support, and managing skin hygiene.

[0042] The observation group was given 200ml of Astragalus and Blue Medicinal Diet as a nighttime snack, and control group 1 was given 200ml of high-carbohydrate nutritional porridge as a nighttime snack; control group 2 did not receive dietary intervention; all patients were observed for a total of 48 weeks, specifically including 2 weeks of hospitalization and 46 weeks of outpatient follow-up, of which 24 weeks were for nighttime snack intervention;

[0043] The specific ingredients of the Astragalus and Gynostemma pentaphyllum medicinal diet include: 30g raw Astragalus membranaceus, 30g wolfberry, 9g Gynostemma pentaphyllum, 5g lotus leaf, 15g maltose, and 50g millet. The preparation method is as follows: ① Soaking: Place the raw Astragalus membranaceus, Gynostemma pentaphyllum, lotus leaf, and wolfberry in a decoction bag and soak in 800mL of purified water for 20 minutes; ② Decoction: Pour the soaked herbs and water into a clay pot, bring to a boil over high heat, then simmer over low heat for 30 minutes; ③ Cooking: Remove the decoction bag, add the millet, and simmer over low heat for 20 minutes, reducing to approximately 200mL; ④ Melting: Add the maltose and stir until dissolved; Pack the prepared medicinal diet into a bag and take warm at night.

[0044] The specific preparation method for high-carbohydrate nutritious porridge is as follows: Put 50g of millet, 15g of white sugar, and 800mL of purified water into a clay pot, bring to a boil over high heat, then simmer over low heat for 20 minutes until about 200mL remains. Pack the porridge into a bag and consume it warm at night.

[0045] S2: Observe the indicators of the above groups, including: (1) the Child-P score of liver function before treatment, 2 weeks after treatment, 24 weeks after treatment, and 48 weeks after treatment. The liver cirrhosis severity assessment method is established by five indicators including hepatic encephalopathy, ascites, albumin, bilirubin and PT. According to the patient's score, liver function can be divided into three levels: A, B and C.

[0046] (2) T cell subsets (T3, T4, CD3, CD4), endotoxin, Fibroscan, color Doppler ultrasound, etc. before treatment, 2 weeks after treatment, 24 weeks after treatment, and 48 weeks after treatment.

[0047] (3) RFH-GA scores before treatment and at 24 and 48 weeks after treatment, including body mass index (BMI), upper arm circumference (MAC), triceps skinfold thickness (TSF), mid-arm muscle circumference (MAMC), and relative MAMC; calculation formulas: MAMC = MAC - (TSF × 0.314), BMI = weight (W) / height (h). 2 .

[0048] (4) Nutritional assessment index (NAI) before treatment, at 24 weeks after treatment, and at 48 weeks after treatment; NAI = 2.64 MAMC + 0.60 PA + 3.76 RBP + 0.017 PPD - 53.80. In the formula, AMC (arm muscle circumference) is the upper arm muscle circumference (cm), PA (prealbumin) is serum prealbumin (mg / dL), RBP (retinol-binding protein) is serum retinol-binding protein (mg / dL), and PPD (purified protein derivative test) is a delayed hypersensitivity skin reaction test using purified protein derivatives. Induration diameter <5mm is 1, >5mm is 2, and no reaction is 0.

[0049] (5) The cross-sectional area of ​​lumbar skeletal muscle (LSMSA) was measured by CT scan at the level of the third lumbar vertebra (L3).

[0050] (6) TCM symptom scores before treatment, 24 weeks after treatment, and 48 weeks after treatment, referencing the consensus on TCM diagnosis and treatment guidelines.

[0051] (7) Quality of life (QOL) scores were assessed before treatment and at 24 and 48 weeks after treatment using a questionnaire survey. The questionnaire was based on the European Organization for Research and Treatment of Cancer's Quality of Life Core Scale (Version 3 Chinese version). The scale covered physiological, psychological, and social aspects, including factors such as family roles, mental state, and appetite. Each factor was scored from 1 to 5, with higher scores indicating better quality of life. The survey was conducted by a designated person who explained the filling method to the patient in detail without any hints, ensuring that the patient filled it out voluntarily and truthfully.

[0052] (8) Statistical analysis of patients’ 48-week survival rate, readmission rate, and incidence of critical events.

[0053] S3: Statistical analysis of data; all quantitative data are expressed as mean ± standard deviation. The data were presented as follows: paired t-tests were used to compare each group with baseline; independent samples t-tests were used to compare the differences before and after treatment between groups; chi-square test was used to determine if the overall efficacy followed a normal distribution; p < 0.05 was considered statistically significant; the data were processed, verified, and then analyzed by computer.

[0054] In the cases analyzed above, those who could not be treated according to the protocol; those who could not accept regular follow-up, resulting in missing data and affecting the assessment of efficacy and safety; those who were lost to follow-up during the observation process; those who took drugs or foods that affected the assessment of results during the study period, such as alcohol; those who experienced serious adverse events or complications that made them unsuitable to continue the study; and those who withdrew voluntarily should be excluded.

[0055] Furthermore, research methods on the role of the gut-liver axis mechanism in regulating malnutrition in decompensated cirrhosis also include the observation and management of adverse events, as detailed below:

[0056] Record the time of adverse reaction occurrence, vital signs, clinical manifestations, laboratory tests, and treatment plan. Perform tests before and after treatment. For general adverse reactions, if the patient's vital signs are stable and only nausea, vomiting, or other mild discomfort is present, and allergic reactions are ruled out, reduce the drug dosage or temporarily discontinue use, and monitor dynamically. If symptoms subside and disappear, continue use; if symptoms persist, discontinue use and remove from the study. For allergic reactions, such as rash, itching, chest tightness, and fever, if vital signs are stable, temporarily discontinue use and monitor dynamically. If necessary, administer oral or intramuscular anti-allergy medication. For critical conditions, such as anaphylactic shock and respiratory distress, if vital signs are unstable, discontinue use, monitor vital signs, and transport the patient to the emergency room and relevant departments for resuscitation and treatment.

[0057] Researchers must complete the Clinical Response Report (CRF) while treating the subjects, ensuring that the data is recorded in a timely, complete, accurate, and truthful manner. Any corrections to the CRF must be made by drawing lines and annotating the revised data in the margins. The researcher must sign and date the correction. The original records must not be erased or covered. The subjects' original laboratory reports must be pasted into the original medical records. After each subject's observation period ends, the researcher should promptly complete the relevant information on the CRF and review and sign it for confirmation.

[0058] Although the present invention has been described above with reference to embodiments, various modifications can be made and components can be replaced with equivalents without departing from the scope of the invention. In particular, as long as there is no structural conflict, the features in the disclosed embodiments can be combined with each other in any manner. The lack of an exhaustive description of these combinations in this specification is merely for the sake of brevity and resource conservation. Therefore, the present invention is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.

Claims

1. A method for studying the regulatory effect of the liver-gut axis mechanism on malnutrition in decompensated cirrhosis, characterized by: include: S1: First, prepare 120 patients who meet the inclusion criteria and divide them into three groups of 40 patients each. The groups are: observation group, control group 1, and control group 2. Among them, three groups of patients received routine internal medicine nursing care, including bed rest, liver-protecting drugs, antiviral drugs, anti-liver fibrosis drugs, diuretics, and human serum albumin. Routine nursing care included nursing education, advising patients to rest more and engage in light activities, guiding them to eat a diet high in protein, fiber, easily digestible, and low in sodium, urging them to quit smoking and drinking, providing psychological support, and managing skin hygiene. The observation group was given 200ml of Astragalus and Blue Medicinal Diet as a nighttime snack, and control group 1 was given 200ml of high-carbohydrate nutritional porridge as a nighttime snack; control group 2 did not receive dietary intervention; all patients were observed for a total of 48 weeks, specifically including 2 weeks of hospitalization and 46 weeks of outpatient follow-up, of which 24 weeks were for nighttime snack intervention; S2: Observe the indicators of the above groups, including: (1) Child-P score, TCM symptom score, RFH-GA score, QOL score, NAI index, LSMSA; (2) T cell subsets, endotoxin, Fibroscan, color Doppler ultrasound; (3) 48-week survival rate, readmission rate, and incidence of critical events. S3: Statistical analysis of data; all quantitative data are expressed as mean ± standard deviation. The data were presented as follows: paired t-tests were used to compare each group with baseline; independent samples t-tests were used to compare the differences before and after treatment between groups; chi-square test was used to determine if the overall efficacy followed a normal distribution; P < 0.05 was considered statistically significant; the data were processed, verified, and then analyzed by computer.

2. The method for studying the regulatory effect of the liver-gut axis mechanism on malnutrition in decompensated cirrhosis according to claim 1, characterized in that, In step S1, the specific composition of the Astragalus and Gynostemma pentaphyllum medicinal diet includes: 30g of raw Astragalus membranaceus, 30g of wolfberry, 9g of Gynostemma pentaphyllum, 5g of lotus leaf, 15g of maltose, and 50g of millet.

3. The method for studying the regulatory effect of the liver-gut axis mechanism on malnutrition in decompensated cirrhosis according to claim 2, characterized in that, The preparation method of Astragalus and Indigo medicinal diet is as follows: ① Soaking: Place raw Astragalus membranaceus, Gynostemma pentaphyllum, lotus leaf, and wolfberry in a decoction bag and soak in 800mL of purified water for 20 minutes; ② Decoction: Pour the soaked herbs and water into a clay pot, bring to a boil over high heat, then simmer over low heat for 30 minutes; ③ Cooking: Remove the decoction bag, add millet, and simmer over low heat for 20 minutes, reducing to about 200mL; ④ Dissolving: Add maltose and stir until dissolved; Pack the prepared medicinal food into a bag and take it warm at night.

4. The method for studying the regulatory effect of the liver-gut axis mechanism on malnutrition in decompensated cirrhosis according to claim 3, characterized in that, The specific preparation method for high-carbohydrate nutritious porridge is as follows: Put 50g of millet, 15g of white sugar, and 800mL of purified water into a clay pot, bring to a boil over high heat, then simmer over low heat for 20 minutes until about 200mL remains. Pack the porridge into a bag and consume it warm overnight.

5. The method for studying the regulatory effect of the liver-gut axis mechanism on malnutrition in decompensated cirrhosis according to claim 4, characterized in that, In step S2, the specific index parameters are as follows: The Child-P score for liver function, which includes five indicators—hepatic encephalopathy, ascites, albumin, bilirubin, and PT—was established before treatment and at 2, 24, and 48 weeks after treatment to assess the severity of cirrhosis. Based on the patient's score, liver function can be divided into three levels: A, B, and C. T cell subsets, T3, T4, CD3, CD4, endotoxin, Fibroscan, and color Doppler ultrasound were measured before treatment and at 2, 24, and 48 weeks after treatment. RFH-GA scores were measured before treatment and at 24 and 48 weeks after treatment, including body mass index (BMI), upper arm circumference, triceps skinfold thickness, upper arm muscle circumference, and relative MAMC. The calculation formulas were: MAMC = MAC - (TSF × 0.314) and BMI = weight (W) / height (h). 2 ; Nutritional assessment index (NAI) before treatment, at 24 weeks and 48 weeks after treatment; NAI = 2.64MAMC + 0.60PA + 3.76RBP + 0.017PPD - 53.80; In the formula, AMC is upper arm muscle circumference (cm), PA is serum prealbumin (mg / dL), RBP is serum retinol-binding protein (mg / dL), and PPD is a delayed-type hypersensitivity skin reaction test using purified protein derivatives, with induration diameter <5mm as 1, >5mm as 2, and no reaction as 0; The cross-sectional area of ​​lumbar skeletal muscles was measured by CT scans before treatment and at 24 and 48 weeks after treatment, with the muscle area at the level of the third lumbar vertebra selected for measurement. TCM symptom scores before treatment, 24 weeks after treatment, and 48 weeks after treatment were based on the consensus of TCM diagnosis and treatment guidelines. Quality of life (QOL) scores were assessed before treatment and at 24 and 48 weeks after treatment using a questionnaire based on the European Organization for Research and Treatment of Cancer's core quality of life scale. The scale covered physiological, psychological, and social aspects, including family roles, mental state, and appetite factors. Each factor was scored from 1 to 5, with higher scores indicating better quality of life. The survey was conducted by a designated person who explained the completion method to the patients in detail, without any hints, ensuring that the patients completed the questionnaire voluntarily and truthfully.

6. The method for studying the regulatory effect of the hepato-gut axis mechanism on malnutrition in decompensated cirrhosis according to claim 5, characterized in that: The research methodology for studying the role of the hepatobiliary axis mechanism in regulating malnutrition in decompensated cirrhosis also includes adverse event observation, specifically including: recording the time of adverse reaction occurrence, vital signs, clinical manifestations, laboratory tests, and treatment plans, with one examination before and one after treatment.

7. The method for studying the regulatory effect of the hepato-gut axis mechanism on malnutrition in decompensated cirrhosis according to claim 6, characterized in that: The research methodology for studying the role of the gut-liver axis mechanism in regulating malnutrition in decompensated cirrhosis also includes the management of adverse events. Specific management methods are as follows: For general adverse reactions, such as stable vital signs and only nausea, vomiting, or other mild discomfort, excluding allergic reactions, reduce the drug dosage or temporarily discontinue use, and monitor dynamically. If symptoms subside and disappear, continue use; if symptoms persist, discontinue use and be excluded from the study. For allergic reactions, such as rash, itching, chest tightness, and fever, if vital signs are stable, temporarily discontinue use and monitor dynamically. If necessary, administer oral or intramuscular anti-allergic drugs. For critical conditions, such as anaphylactic shock and dyspnea, if vital signs are unstable, discontinue use, monitor vital signs, and transfer the patient to the emergency room and relevant departments for resuscitation and treatment.

8. The method for studying the regulatory effect of the liver-gut axis mechanism on malnutrition in decompensated cirrhosis according to claim 7, characterized in that: The research methodology for studying the role of the gut-liver axis mechanism in regulating malnutrition in decompensated cirrhosis also includes a data management plan, as follows: Researchers complete the Clinical Response Report (CRF) while treating subjects, ensuring that data records are timely, complete, accurate, and truthful. Any corrections to the CRF must be made by drawing lines and annotating the revised data, with the researcher signing and dated. Original records must not be erased or covered. All original laboratory reports of subjects must be pasted into the original medical records. After each subject's observation period ends, the researcher should promptly complete the relevant information on the CRF, and review and sign it for confirmation.

9. The method for studying the regulatory effect of the liver-gut axis mechanism on malnutrition in decompensated cirrhosis according to claim 8, characterized in that: In step S1, the criteria for determining a standard patient are: age between 18 and 70 years old, gender not limited, presence of portal hypertension and related complications of decreased liver function, such as ascites and hepatic encephalopathy; and cause of illness being hepatitis B.

10. The method for studying the regulatory effect of the hepato-gut axis mechanism on malnutrition in decompensated cirrhosis according to claim 9, characterized in that: The exclusion criteria for patients are: malignant tumors of other organs; acute exacerbation of cardiovascular and cerebrovascular diseases; renal failure; pregnant or lactating women; patients with mental illness; acute or subacute liver failure; active gastrointestinal bleeding; intestinal obstruction; DIC; HIV infection; diabetes; and patients with cirrhosis due to other causes. The criteria for excluding and dropping out cases are as follows: Those who cannot follow the treatment protocol; those who cannot accept regular follow-up, resulting in missing data and affecting the assessment of efficacy and safety; those who are lost to follow-up during the observation process; those who take drugs or foods that affect the assessment of results during the study period, such as alcohol; those who experience serious adverse events or complications that make them unsuitable to continue the study and withdraw voluntarily.

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