Traditional Chinese medicine compound preparations for treating liver cancer

Abstract

This invention relates to the field of traditional Chinese medicine technology, specifically to a compound traditional Chinese medicine preparation for treating liver cancer, made from the following herbs: cinnamon twig, schisandra fruit, inula flower, immature bitter orange, peony root, scutellaria root, rhubarb, turtle shell, physalis, and wisteria vine. The weight ratio of the above herbs is as follows: cinnamon twig 9g-15g, schisandra fruit 12g-18g, inula flower 9g-15g, immature bitter orange 9g-15g, peony root 12g-30g, scutellaria root 9g-15g, rhubarb 3g-9g, turtle shell 15g-45g, physalis vine 15g-30g, and wisteria vine 15g-30g. This invention can significantly improve symptoms such as hypochondriac pain, poor appetite, depression, abdominal distension, and bitter taste in the mouth, reduce the damage to the digestive system function caused by targeted therapy, improve the quality of life for patients, reduce toxicity and increase efficacy, lower treatment costs, and prolong patient life.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine compound preparation for treating liver cancer. Background Technology

[0002] Hepatocellular carcinoma (HCC) is one of the most common malignant tumors of the digestive system in my country. It progresses rapidly and seriously threatens human life and health. Because liver cancer is relatively insidious in its early stages, it is easily overlooked by patients, and by the time it is diagnosed, it is usually already in the middle or late stages, missing the best opportunity for treatment. Currently, modern medical treatment mainly uses surgery, radiotherapy, chemotherapy, and targeted therapy. However, for patients with advanced liver cancer, the surgical effect is not ideal, with a 5-year survival rate of less than 10%. Although surgery and radiotherapy / chemotherapy have clear clinical efficacy, the adverse reactions they bring are still difficult for many patients to tolerate. Targeted therapy has significant toxic side effects, causing great suffering for patients. Therefore, many patients seek treatment with traditional Chinese medicine. Summary of the Invention

[0003] The purpose of this invention is to address the shortcomings of existing technologies and provide a traditional Chinese medicine compound preparation for treating liver cancer that can significantly improve symptoms such as hypochondriac pain, poor appetite, depression, abdominal distension, and bitter taste in the mouth, reduce the damage to the digestive system function caused by targeted therapy, improve the quality of life of patients, reduce toxicity and increase efficacy, reduce treatment costs, and prolong the life of patients.

[0004] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0005] A traditional Chinese medicine compound preparation for treating liver cancer, characterized in that it is made from the following traditional Chinese medicines: cinnamon twig, schisandra fruit, inula flower, immature bitter orange, peony root, scutellaria root, rhubarb, turtle shell, phyllum, and wisteria vine.

[0006] The weight ratio of the Chinese herbs described in this invention is as follows: Cinnamon twig 9g-15g, Schisandra chinensis 12g-18g, Inula japonica 9g-15g, Citrus aurantium 9g-15g, Paeonia lactiflora 12g-30g, Scutellaria baicalensis 9g-15g, Rheum palmatum 3g-9g, Trionyx sinensis 15g-45g, Phyllanthus urinaria 15g-30g, and Wisteria rubra 15g-30g.

[0007] The weight of the Chinese herbs described in this invention is as follows: 9g of cinnamon twig, 12g of schisandra fruit, 9g of inula flower, 9g of immature bitter orange, 12g of peony root, 9g of scutellaria root, 3g of rhubarb, 15g of turtle shell, 15g of Phyllanthus urinaria, and 15g of wisteria vine.

[0008] A method for preparing a traditional Chinese medicine compound preparation for treating liver cancer, characterized by comprising the following steps:

[0009] Step 1: Weigh out 9g-15g of cinnamon twig, 12g-18g of schisandra fruit, 9g-15g of inula flower, 9g-15g of immature bitter orange, 12g-30g of peony root, 9g-15g of scutellaria root, 3g-9g of rhubarb, 15g-45g of turtle shell, 15g-30g of physalis, and 15g-30g of wisteria vine.

[0010] Step 2: Place the herbs in a pot, add an equal amount of cold water, and soak for 20-30 minutes; bring to a boil over high heat, then simmer over low heat for 30 minutes. Separate the decoction, add water to the dregs and boil a second time, then combine the decoctions to obtain the aqueous decoction.

[0011] The above technical solutions can be implemented in the following ways:

[0012] A method for preparing a traditional Chinese medicine compound preparation for treating liver cancer, characterized by comprising the following steps:

[0013] Step 1: Weigh out 9g-15g of cinnamon twig, 12g-18g of schisandra fruit, 9g-15g of inula flower, 9g-15g of immature bitter orange, 12g-30g of peony root, 9g-15g of scutellaria root, 3g-9g of rhubarb, 15g-45g of turtle shell, 15g-30g of physalis, and 15g-30g of wisteria vine.

[0014] Step 2: After mixing all the above Chinese herbs evenly, grind them with a pulverizer, sieve them (60-100 mesh) to form a powder.

[0015] The above technical solutions can also be implemented in the following ways:

[0016] A method for preparing a traditional Chinese medicine compound preparation for treating liver cancer, characterized by comprising the following steps:

[0017] Step 1: Weigh out 9g-15g of cinnamon twig, 12g-18g of schisandra fruit, 9g-15g of inula flower, 9g-15g of immature bitter orange, 12g-30g of peony root, 9g-15g of scutellaria root, 3g-9g of rhubarb, 15g-45g of turtle shell, 15g-30g of physalis, and 15g-30g of wisteria vine.

[0018] Step 2: After mixing all the above Chinese herbs evenly, grind them in a pulverizer and sieve them with a mesh size of 60-100 to form a powder.

[0019] Step 3: Sterilize the powder obtained in Step 2 with moist heat, and encapsulate it, with each capsule containing 0.43 grams; or add honey to the powder obtained in Step 2 in a 1:1 ratio to make honey pills; or add purified water to the powder obtained in Step 2 to make water pills.

[0020] Dosage of capsules: Take 3 to 6 capsules orally, 3 times a day. Or as directed by your doctor.

[0021] Contraindications of this invention: Avoid smoking, alcohol, and spicy foods; not for use by pregnant women; use with caution in patients with liver or kidney dysfunction; contraindicated in patients with severe liver or kidney dysfunction or severe coagulation disorders; contraindicated in patients allergic to any of the ingredients of this product.

[0022] This invention, through the use of the aforementioned formulation, significantly improves patient symptoms, alleviates pain, and enhances quality of life; it can reduce toxicity and increase efficacy when used in combination with chemotherapy drugs; and it has unique advantages in prolonging survival. The pharmacological effects of the various traditional Chinese medicines in this invention are as follows:

[0023] Cinnamon twig is pungent, sweet, and warm in nature, and enters the heart, lung, and bladder meridians. The Shennong's Classic of Materia Medica refers to cinnamon twig as "Mu Gui" and lists it as a superior herb, stating that it "treats shortness of breath and cough, sore throat due to qi stagnation, vomiting and inhalation, benefits joints, and tonifies the middle jiao and benefits qi." Cinnamon twig has the effects of assisting yang and transforming qi, dispelling pathogens with its pungent properties, warming the meridians and promoting blood circulation, inducing sweating and relieving muscle tension, harmonizing the blood and relieving pain. It can also warm the spleen and stomach, promote blood circulation, and tonify primordial yang. It is particularly effective in relieving symptoms such as chest and rib pain caused by abdominal distension.

[0024] Peony root, bitter and slightly cold in nature, is described in the *Shennong Bencao Jing* as: "It treats abdominal pain caused by pathogenic factors, eliminates blood stasis, breaks up hard masses, treats hernia caused by cold and heat, relieves pain, promotes urination, and benefits qi." It has repeatedly demonstrated remarkable efficacy in treating abdominal pain caused by disharmony of qi and blood in the abdomen and muscle spasms. Peony root nourishes and regulates the liver, and when combined with cinnamon twig to nourish the liver and kidneys, restore primordial yang, and warm and unblock the meridians, it helps to clear and resolve portal vein cancer thrombi. Peony root has astringent and diuretic properties, strengthening the cell membrane's protective function against intracellular fluid and preventing its leakage. This has a good effect on ascites caused by liver cancer. Cinnamon twig warms yang and transforms qi, vaporizing and eliminating ascites that has seeped out of the tissues. The combination of these two herbs prevents intracellular fluid from dissipating outwards, and the fluid that has already seeped out of the cells (ascites) is vaporized and returned to the cells, thus achieving a better therapeutic effect on liver ascites.

[0025] Schisandra chinensis, with a sour, sweet, and warm nature, enters the lung, heart, and kidney meridians. It has astringent and consolidating effects, replenishes qi and generates fluids, and tonifies the kidneys and calms the mind. In this invention, the main function of Schisandra chinensis is to astringe and suppress rebellious qi, and to assist yin and nourish yang to protect the liver.

[0026] Inula japonica is bitter, pungent, and salty, and slightly warm. It enters the lung and stomach meridians. It lowers qi, promotes diuresis, resolves phlegm, and relieves nausea and vomiting. The Shennong's Classic of Materia Medica states: "Inula japonica is salty and warm. It mainly treats qi stagnation, fullness under the ribs, palpitations, eliminates water retention, removes cold qi between the five internal organs, tonifies the middle jiao, and lowers qi."

[0027] Scutellaria baicalensis, bitter and cold in nature, belongs to the lung, stomach, gallbladder, and large intestine meridians. Its effects include clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and preventing miscarriage. It is used for damp-warm syndrome, summer dampness, chest distress and nausea, damp-heat obstruction, diarrhea, dysentery, jaundice, cough due to lung heat, high fever and restlessness, vomiting blood and epistaxis due to blood heat, carbuncles and sores, and fetal restlessness. It is recorded in "Shennong Ben Cao Jing": "It is mainly used for various types of heat-induced jaundice, intestinal purulent disease, diarrhea, expelling water, removing blood stasis, (treating) malignant sores, carbuncle erosion, and fire ulcers." It is recorded in "Ri Hua Zi Ben Cao": "It can lower qi, mainly treat epidemic febrile diseases, furuncles, and drain pus. It is used to treat breast abscess and back carbuncle." The flavonoid components in Scutellaria baicalensis have extensive anti-tumor activities. Scutellaria baicalensis can protect against chemical liver injury, immune liver injury, alcoholic liver disease, non-alcoholic fatty liver disease, viral hepatitis, drug-induced liver injury, and ischemia-reperfusion liver injury.

[0028] Fructus Aurantii Immaturus, bitter, pungent, and sour in taste, slightly cold in nature, belongs to the spleen and stomach meridians, and has the effects of regulating qi and resolving accumulation, dissipating phlegm and dispersing stagnation. It is mainly used to treat symptoms such as internal retention of food stagnation, fullness and distending pain, constipation, and qi stagnation caused by phlegm retention.

[0029] Rheum palmatum, bitter and cold, enters the stomach, large intestine, and liver meridians. In "Yaoxing Lun", it is mentioned that Rheum palmatum: mainly treats cold and heat, aids digestion, purifies the five internal organs, regulates the menstrual cycle of women, promotes diuresis, breaks phlegm accumulation, treats cold and heat accumulations, retained food, promotes defecation in both the large and small intestines, applies to heat-toxic swelling, mainly treats infantile cold and heat and seasonal diseases, restlessness, and erodes pus, and breaks retained blood.

[0030] Carapax Trionycis, salty and flat in nature, enters the liver, spleen, and kidney meridians, and has the effects of nourishing yin and suppressing yang, softening hardness and dissipating masses, and removing steaming and fever. It is stated in "Ben Cao Xin Bian": "Carapax Trionycis is good at attacking masses without damaging qi, and it is suitable for those with stagnation and obstruction in both yin and yang, upper and lower parts."

[0031] Phyllanthus niruri, first recorded in "Sheng Cao Yao Xing Bei Yao" by He Jian in the Qing Dynasty, slightly bitter in taste, cool in nature, belongs to the liver, spleen, and kidney meridians, and has the effects of calming the liver and clearing heat, promoting diuresis and detoxifying, improving eyesight, and eliminating accumulation. It is used for the treatment of diseases such as dysentery, diarrhea, jaundice, edema, and snake bites. Research has found that Phyllanthus niruri has good pharmacological effects in anti-hepatitis B virus, protecting the liver, anti-tumor, and anti-thrombosis.

[0032] Wisteria tumor, a tumor growing on the stem of Wisteria sinensis, can be used as medicine and has the effects of relieving pain, detoxifying, and sterilizing.

[0033] Due to the adoption of the above structure, the present invention has the advantages of significantly improving symptoms such as hypochondriac pain, anorexia, emotional depression, abdominal distension, and bitter taste in the mouth of patients, reducing the damage of targeted therapy to the digestive system function, improving the quality of life of patients, reducing toxicity and enhancing efficacy, low treatment cost, and prolonging the lifespan of patients. Detailed Embodiment

[0034] The following will further describe the detailed embodiment of the present invention in conjunction with the accompanying drawings.

[0035] A traditional Chinese medicine compound preparation for treating liver cancer, characterized in that it is made from the following traditional Chinese medicines: cinnamon twig, schisandra fruit, inula flower, immature bitter orange, peony root, scutellaria root, rhubarb, turtle shell, phyllum, and wisteria vine.

[0036] The weight ratio of the Chinese herbs described in this invention is as follows: 9g of cinnamon twig, 12g of schisandra fruit, 9g of inula flower, 9g of immature bitter orange, 12g of peony root, 9g of scutellaria root, 3g of rhubarb, 15g of turtle shell, 15g of Phyllanthus urinaria, and 15g of wisteria vine.

[0037] A method for preparing a traditional Chinese medicine compound preparation for treating liver cancer, characterized by comprising the following steps:

[0038] Step 1: Weigh out 9g of cinnamon twig, 12g of schisandra fruit, 9g of inula flower, 9g of immature bitter orange, 12g of peony root, 9g of scutellaria root, 3g of rhubarb, 15g of turtle shell, 15g of physalis, and 15g of wisteria vine.

[0039] Step 2: After mixing all the above Chinese herbs evenly, grind them in a pulverizer and sieve them with a mesh size of 60-100 to form a powder.

[0040] Step 3: Sterilize the powder obtained in Step 2 with moist heat, and fill it into capsules, with each capsule containing 0.43 grams.

[0041] Dosage: Take 3 to 6 capsules orally, 3 times a day. Or as directed by your doctor.

[0042] Contraindications of this invention: Avoid smoking, alcohol, and spicy foods; not for use by pregnant women; use with caution in patients with liver or kidney dysfunction; contraindicated in patients with severe liver or kidney dysfunction or severe coagulation disorders; contraindicated in patients allergic to any of the ingredients of this product.

[0043] This invention, through the use of the above-mentioned formulation, significantly improves patient symptoms, alleviates pain, and enhances patients' quality of life; when used in combination with chemotherapy drugs, it can reduce toxicity and enhance efficacy; and it has unique advantages in prolonging survival. Dosage: Oral administration, 3 to 6 tablets each time, 3 times a day, or as directed by a physician.

[0044] Contraindications of this invention: Avoid smoking, alcohol, and spicy foods; not for use by pregnant women; contraindicated in patients with severe liver or kidney dysfunction or severe coagulation disorders; contraindicated in patients allergic to any of the ingredients of this product.

[0045] Because of the above-mentioned formulation, this invention can significantly improve symptoms such as hypochondriac pain, poor appetite, depression, abdominal distension, and bitter taste in patients, reduce the damage of targeted therapy to the digestive system, improve patients' quality of life, reduce toxicity and increase efficacy, reduce treatment costs, and prolong patients' lifespan.

[0046] Clinical trials

[0047] 1. Clinical Data

[0048] 1.1 Research Subjects

[0049] The study cases in this clinical trial were patients with stage BCLCC or CNLC IIIa-IV liver cancer with liver stagnation and spleen deficiency syndrome who visited Yantai Traditional Chinese Medicine Hospital between June 2019 and June 2022.

[0050] 1.2 Inclusion Criteria

[0051] 1.2.1 Western Medicine Diagnostic Criteria:

[0052] All patients were diagnosed by imaging or histopathological examination, and were BCLC stage C or CNLC stage IIIa-IV liver cancer patients with a KPS score ≥60, an expected survival of more than 2 months, a Child-Pugh classification of 5-10, and basically normal renal function and electrocardiogram.

[0053] 1.2.2 Traditional Chinese Medicine (TCM) syndrome differentiation criteria:

[0054] Traditional Chinese Medicine (TCM) syndrome differentiation criteria: Based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs" (issued by the State Food and Drug Administration in 2002) and combined with years of clinical experience in oncology, the TCM syndrome differentiation criteria for Liver Qi Stagnation and Spleen Deficiency were formulated.

[0055] Liver Qi Stagnation and Spleen Deficiency Syndrome:

[0056] Main symptoms: (1) distending pain in the hypochondrium; (2) chest tightness and discomfort; (3) frequent sighing; (4) emotional depression; (5) irritability; (6) poor appetite and reduced food intake; (7) pale red tongue; (8) white and slightly greasy tongue coating; (9) wiry pulse.

[0057] Secondary symptoms: (1) abdominal distension and belching; (2) occasional nausea and vomiting; (3) diarrhea; (4) palpable mass under the ribs; (5) white or yellow greasy tongue coating; (6) thready or slippery pulse;

[0058] A diagnosis of liver stagnation and spleen deficiency can be made if two main symptoms are present, or one main symptom plus two secondary symptoms are present.

[0059] 1.3 Inclusion Criteria

[0060] (1) All patients were diagnosed by imaging or histopathological examination and were HCC patients of stage C of BCLC or stage IIIa-IV of CNLC, and were diagnosed by traditional Chinese medicine as having liver stagnation and spleen deficiency syndrome; (2) They could be followed up and observed; (3) They voluntarily participated in this study and signed an informed consent form.

[0061] 1.4 Exclusion Criteria

[0062] (1) Those with mental disorders or mental illnesses; (2) Those with a Child-Pugh score ≥11; (3) Those who cannot take oral medications; (4) Those with severe infectious diseases; (5) Those with severe heart, brain, kidney, or other functional abnormalities; (6) Those who are allergic to medications.

[0063] 2. Research Content and Methods

[0064] This study observed 180 patients with BCLC stage C and CNLC stage IIIa-IV hepatocellular carcinoma who were hospitalized and eligible for follow-up treatment in the Department of Oncology of Yantai Traditional Chinese Medicine Hospital from June 2019 to June 2022. They were randomly divided into a treatment group and a control group, with 90 patients in each group. There were no statistically significant differences between the two groups in terms of gender, age, Child-Pugh classification, clinical stage, and KPS score. The observation period was before the start of treatment and after the discontinuation of Western medicine. The efficacy was evaluated every 6 weeks, and routine symptomatic and supportive therapy was provided.

[0065] 2.1 Treatment Plan

[0066] Control group: Lenvatinib mesylate capsules 8mg orally once a day for 8 weeks. The observation period was before the start of treatment and after the end of treatment. The efficacy was evaluated every 6 weeks, and routine symptomatic and supportive treatment was provided.

[0067] Treatment group: In addition to the treatment given to the control group, patients took the herbal preparation of this invention, 5 pills each time, 3 times a day, for one month as one course of treatment, which can be taken continuously. The efficacy was evaluated every 6 weeks.

[0068] 2.2 Observation Indicators

[0069] 2.2.1 Changes in tumor lesions before and after treatment: Imaging examinations were performed before and after treatment to assess changes in tumor lesions, referring to the RECIST 1.1 criteria for solid tumor assessment.

[0070] (1) Complete remission (CR): All lesions completely disappear and are maintained for at least 4 weeks.

[0071] (2) Partial remission (PR): For lesions with measurable diameters, the sum of the products of the maximum diameters of each lesion (take the maximum diameter of the lesion and the diameter perpendicular to it, multiply the lengths of the two to obtain the product of the maximum perpendicular diameter, and then add the products of the maximum perpendicular diameters of each lesion) is reduced by more than 50% and maintained for at least 4 weeks; for lesions with measurable diameters, the sum of the maximum diameters of each lesion is reduced by more than 50% and maintained for at least 4 weeks.

[0072] (3) No change (NC) lesions with measurable diameters in both diameters, where the sum of the products of the maximum vertical diameters of each lesion has decreased by less than 50% or increased by no more than 25%, and have been maintained for at least 4 weeks, and can only be evaluated as NC after at least two cycles of treatment (6 weeks).

[0073] (4) Progressive disease (PD): If one or more lesions increase in size by more than 25%, or new lesions appear, or new pleural or peritoneal effusions appear, and cancer cells are found in cytology, it should be determined as PD.

[0074] Clinical efficacy: Efficacy rate = (Number of PR cases / Total number of cases) × 100%;

[0075] Lesion stabilization rate = (PR + NC) cases / total number of cases × 100%.

[0076] 2.2.2 Clinical symptoms: The TCM symptoms were evaluated using five indicators: hypochondriac pain, poor appetite, depression, abdominal distension, and bitter taste in the mouth. Common symptoms were divided into four levels according to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" (Ministry of Health of the People's Republic of China, Guiding Principles for Clinical Research of New Traditional Chinese Medicines, Vol. 3, 1997.3-36): no symptoms = 0 points, mild = 1 point, moderate = 2 points, and severe = 3 points. The scores were measured and recorded once before and after treatment, and the changes in the scores before and after treatment were observed to evaluate the efficacy.

[0077] (1) Significant effect: The clinical symptom score after treatment decreased by more than 70% compared with that before treatment;

[0078] (2) Effective: The score decreased by more than 30% and less than 70% after treatment;

[0079] (3) Stable: No change in score after treatment;

[0080] (4) Ineffective: The score actually increased after treatment;

[0081] Effectiveness rate = (Number of cases with significant effect + Number of cases with effective effect) / Total number of cases × 100%.

[0082] 2.2.3 Changes in quality of life before and after treatment: The changes in patients' Karnofsky Performance Status (KPS) scores before and after treatment were observed and compared, using the Karnofsky scoring system: 100 points: Normal, no symptoms or signs; 90 points: Able to perform normal activities, with mild symptoms and signs; 80 points: Barely able to perform normal activities, with some symptoms or signs; 70 points: Able to live independently, but unable to maintain a normal life and work; 60 points: Able to live mostly independently, but occasionally needs assistance; 50 points: Often needs care; 40 points: Unable to live independently, requiring special care and assistance; 30 points: Severely unable to live independently; 20 points: Seriously ill, requiring hospitalization and active supportive treatment; 10 points: Critically ill, nearing death; 0 points: Death. Higher scores indicate better health and greater tolerance for the side effects of treatment, making complete treatment more likely. Lower scores indicate poorer health; scores below 60 points may preclude the implementation of many effective anti-tumor treatments.

[0083] (1) Increase: KPS score increased by ≥10 points compared with before treatment;

[0084] (2) Stable: The increase or decrease in KPS score after treatment is less than 10 points;

[0085] (3) Decrease: KPS score decreased by ≥10 points compared with before treatment.

[0086] 2.2.4 Adverse reactions: Common adverse reactions (hypertension, fatigue, diarrhea, decreased appetite, abdominal pain) that occurred in patients during treatment were observed and compared. The adverse events were classified into five levels (1, 2, 3, 4, and 5) according to the CTCAE v5.0 system for evaluating adverse reactions of chemotherapy drugs.

[0087] CTCAE provides specific clinical descriptions of the severity (grade 1-5) of each adverse event based on the following fundamental criteria:

[0088] Grade 1: Mild: Asymptomatic or mild: Only clinically or diagnostically observed, no surgery required.

[0089] Grade 2: Moderate: Requires minor, local or non-invasive treatment; age-appropriate limitations in instrumental activities of daily living.

[0090] Level 3: Serious or of significant medical importance but not immediately life-threatening; requires hospitalization or prolongs hospitalization; disabling: limited ability to perform daily living activities.

[0091] Level 4: Life-threatening: Requires emergency treatment.

[0092] Level 5: Deaths related to AE.

[0093] 2.3 Statistical Methods

[0094] Statistical analysis of the obtained data was performed using SPSS 26.0 software. t-tests were used for continuous data, chi-square tests for categorical data, and rank-sum tests for ordinal data. All statistical analyses employed two-tailed hypothesis testing.

[0095] The significance level for the hypothesis test is set at α = 0.05, meaning that P < 0.05 is considered to indicate a statistically significant difference.

[0096] 3. Results

[0097] 3.1 Changes in lesions before and after treatment:

[0098] Table 1 shows the changes in lesions before and after treatment in the treatment group and the control group. Before treatment, there was no statistically significant difference in the lesion condition between the treatment group and the control group (P>0.05). As can be seen from the data in Table 1, after treatment, the effective rate of the treatment group (21.1%) was higher than that of the control group (17.8%), and the lesion stabilization rate of the treatment group (71.1%) was higher than that of the control group (62.2%). This indicates that the traditional Chinese medicine preparation of the present invention has a certain effect in treating and stabilizing lesions. Although the statistical results show that there is no statistically significant difference in the effective rate and lesion stabilization rate between the treatment group and the control group after treatment (P>0.05), this also indirectly shows that the traditional Chinese medicine preparation of the present invention has non-inferiority in stabilizing lesions.

[0099] Table 1 Comparison of lesion changes before and after treatment

[0100]

[0101] 3.2 Changes in clinical symptoms and physical condition in the two groups:

[0102] Table 2 shows the changes in clinical symptoms before and after treatment in the treatment group and the control group.

[0103] Before treatment, the symptom scores of the treatment group and the control group were (7.41±2.12) and (7.25±2.08) respectively, with no significant difference (P>0.05). After treatment, the treatment group showed significant improvement in the five main symptoms of hypochondriac pain, poor appetite, depression, abdominal distension, and bitter taste in the mouth compared with the control group, with significant differences (P<0.05). This indicates that the compound preparation can significantly improve the main clinical symptoms of patients with advanced liver cancer.

[0104] Table 2 Symptom improvement after treatment

[0105]

[0106] 3.3 Changes in quality of life before and after treatment:

[0107] Table 3 shows the KPS score data before and after treatment in the treatment group and the control group.

[0108] Before treatment, there was no statistically significant difference in KPS scores between the treatment group and the control group (P>0.05). After treatment, in the treatment group, 75 patients showed effective KPS scores and 14 patients showed stable scores; in the control group, 43 patients showed effective KPS scores and 38 patients showed stable scores. The number of patients with elevated KPS scores in the treatment group was significantly higher than that in the control group, and the differences between the two groups were statistically significant (P<0.05). This indicates that "the pathogenic factors are eliminated and the body's resistance recovers." By using methods to soothe the liver and relieve stagnation, and to detoxify and disperse nodules, the clinical symptoms of liver cancer with "liver stagnation and spleen deficiency" syndrome were improved, and the patients' quality of life was correspondingly improved.

[0109] Table 3 Comparison of changes in KPS scores before and after treatment.

[0110]

[0111] 3.4 Toxic and adverse reactions:

[0112] Table 3 shows the comparative data of adverse reactions during the treatment and control groups. The treatment group showed significant differences in fatigue, diarrhea, and decreased appetite compared with the control group (P<0.05), indicating that the traditional Chinese medicine preparation of the present invention can significantly reduce the damage to the digestive system function caused by targeted therapy, improve fatigue caused by targeted drugs, and reduce gastrointestinal adverse reactions.

[0113] Table 4 Comparison of adverse reactions after chemotherapy in the two groups

[0114]

[0115] In summary, the combination of the traditional Chinese medicine preparation of this invention with lenvatinib targeted therapy is superior to the control group treated with targeted therapy alone in terms of improving main symptoms, increasing KPS scores, and reducing toxic side effects in the treatment of advanced liver cancer of the "liver stagnation and spleen deficiency" type. This demonstrates the unique advantages of the traditional Chinese medicine preparation of this invention in enhancing efficacy and reducing toxicity in the treatment of liver cancer.

[0116] 4. Typical Cases

[0117] Typical case:

[0118] 1. Mr. Chen, male, 52 years old, from Yantai City, visited the hospital on July 4, 2020. The patient had been diagnosed with liver cancer 8 months prior, relapsed 4 months prior to surgery, and underwent TACE intervention 1 month prior to consultation. At the time of consultation, he presented with chest tightness, shortness of breath, significant fatigue, occasional chest and rib pain, poor appetite, loose stools, depression, dry mouth, and bitter taste. His tongue was dark red with a white, greasy coating, and his pulse was wiry and slippery. He was diagnosed with "liver cancer" and diagnosed with liver stagnation and spleen deficiency. The treatment principle was to soothe the liver, strengthen the spleen, detoxify, and dissipate nodules. He was prescribed lenvatinib 8mg orally in combination with the traditional Chinese medicine preparation of this invention, 5 tablets each time, three times a day. After one month of treatment, the patient's chest tightness, shortness of breath, fatigue, dry mouth, and bitter taste were relieved. He continued to take lenvatinib orally in combination with the traditional Chinese medicine preparation of this invention for up to six months without any significant adverse reactions, and the targeted drug was well tolerated.

[0119] 2. Patient Wu, male, 61 years old, from Yantai City, presented with symptoms of "late-stage liver cancer diagnosed one month ago." His current symptoms included: weight loss, abdominal distension, diarrhea, cough with white, sticky sputum, poor appetite, itchy skin rash, and fatigue. His Karnofsky Performance Status (KPS) score was 70. Physical examination revealed hepatomegaly, positive shifting dullness, palmar erythema, spider angiomas, a red tongue with a thin coating, and a wiry, slippery pulse. He was diagnosed with "liver cancer," with the syndrome being liver stagnation and spleen deficiency. Treatment should focus on soothing the liver, strengthening the spleen, detoxifying, and resolving stagnation. He was prescribed this invention's traditional Chinese medicine preparation, 5 pills each time, three times a day, combined with lenvatinib 8mg targeted therapy. After one month of treatment, the patient's abdominal pain and diarrhea symptoms significantly improved, and fatigue lessened. After two months of oral administration, the patient's symptoms stabilized, and his KPS score reached 80.

[0120] Traditional Chinese medicine (TCM) believes that the occurrence of liver cancer is related to emotional distress, stagnation of liver qi, liver qi invading the spleen, impaired spleen function, phlegm-dampness and blood stasis, or damage from hepatitis toxins, resulting in stagnation of qi and blood, and obstruction of damp-heat and toxic stasis. Combining the physiological and pathological characteristics of the liver, it is believed that the liver is "yin in substance but yang in function," and that "the liver's substance is often insufficient while its function is often excessive." Therefore, the treatment of liver cancer should follow this natural course, addressing both the root cause and the symptoms. It emphasizes clearing damp-heat from the liver and gallbladder while simultaneously nourishing yin and softening the liver, while also focusing on protecting the body's vital energy. Treatment should be based on syndrome differentiation and comprehensive consideration to improve the body's immune function and disease-fighting ability, thus promoting yin-yang balance.

[0121] Based on this mechanism, this invention uses cinnamon twig, schisandra fruit, inula flower, immature bitter orange, peony root, scutellaria root, rhubarb, turtle shell, physalis, and wisteria. The combination of these herbs in this invention is rationally formulated, enhancing their efficacy. The treatment primarily focuses on soothing the liver and relieving stagnation, detoxifying and dispersing nodules, improving the internal environment for smooth flow of qi, blood, and body fluids, eliminating pathogens without harming the body's vital energy. Clinical data also indicate that the herbal preparation of this invention has a clear anti-tumor and liver-protective effect. Rational application can achieve the goals of liver protection, anti-tumor, and detoxification, maximizing the stabilization or reduction of lesions, alleviating the condition, reducing symptoms, prolonging survival, and improving the patient's quality of life. Compared to surgery, it is lower in cost, safer, and has no toxic side effects. Combined with targeted therapy, this herbal preparation can significantly reduce the damage to the digestive system caused by targeted therapy, improve fatigue caused by targeted drugs, and reduce gastrointestinal toxicity. It is suitable for patients with mid-to-late stage liver cancer, with definite efficacy and safe use, and is worthy of clinical promotion.

[0122] Because of the above-mentioned structure, this invention has the advantages of significantly improving patients' symptoms such as hypochondriac pain, poor appetite, depression, abdominal distension, and bitter taste in the mouth; reducing the damage of targeted therapy to the digestive system function; improving patients' quality of life; reducing toxicity and increasing efficacy; low treatment cost; and prolonging patients' lifespan.

Claims

1. A traditional Chinese medicine compound preparation for treating liver cancer, characterized in that: Made from the following Chinese medicinal herbs: Cinnamon Twig, Schisandra Fruit, Inula Flower, Immature Bitter Orange, Peony Root, Scutellaria Root, Rhubarb, Turtle Shell, Phyllanthus Rhizome, and Wisteria Wood Ear Mushroom. The weight ratio of the herbs is as follows: Cinnamon Twig 9g-15g, Schisandra Fruit 12g-18g, Inula Flower 9g-15g, Immature Bitter Orange 9g-15g, Peony Root 12g-30g, Scutellaria Root 9g-15g, Rhubarb 3g-9g, Turtle Shell 15g-45g, Phyllanthus Rhizome 15g-30g, and Wisteria Wood Ear Mushroom 15g-30g.

2. The traditional Chinese medicine compound preparation for treating liver cancer according to claim 1, characterized in that: The weights of the Chinese herbs are as follows: 9g of cinnamon twig, 12g of schisandra fruit, 9g of inula flower, 9g of immature bitter orange, 12g of peony root, 9g of scutellaria root, 3g of rhubarb, 15g of turtle shell, 15g of euphorbia root, and 15g of wisteria vine.

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