Traditional Chinese medicine composition for treating gastric cancer

Abstract

The application belongs to the technical field of traditional Chinese medicine, and discloses a traditional Chinese medicine composition for treating gastric cancer. The application is aimed at treating gastric cancer in the late stage, gastric discomfort such as cancerous induration, stomach pain, eating obstruction and the like. The application takes softening and resolving nodules, strengthening the body and protecting the stomach as the core, and provides a traditional Chinese medicine composition. The traditional Chinese medicine composition is composed of prunella vulgaris, patrinia, fritillaria thunbergii miq, mentha, fructus aurantii immaturus, forsythia, coix lachryma-jobi semen, scrophulariaceae, radix biondii, fructus jujubae carbonisatus and zingiber officinale. The traditional Chinese medicine composition is compatible with science, that is, it can effectively inhibit tumors and avoid damage to the spleen and stomach caused by harsh drugs, significantly improve the tolerance of patients, restore the function of the stomach and intestines, stabilize the lesions of patients, improve the physical condition of patients, and realize the survival with tumors and high-quality survival.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition for treating gastric cancer. Background Technology

[0002] Cancer has a long-standing high incidence rate in clinical practice. Its pathogenesis is complex and highly dangerous; without timely intervention, it can directly endanger a patient's life. As the disease progresses, it also leads to a continuous decline in the patient's immune function and a deterioration in their quality of life, further complicating disease control. To improve the overall treatment outcomes for patients with advanced cancer, clinicians need to develop more effective treatment strategies.

[0003] Gastric cancer is currently the fifth most common cancer and the third leading cause of cancer death worldwide. Due to its insidious pathological progression, high invasiveness, and significant molecular and phenotypic heterogeneity, although a comprehensive treatment system has been established clinically, centered on surgical resection combined with chemotherapy, targeted therapy, and immunotherapy, challenges remain, including rising postoperative recurrence and metastasis rates, decreased chemotherapy sensitivity, and low response rates to immunotherapy. Traditional Chinese medicine (TCM) categorizes gastric cancer based on its clinical manifestations, classifying it under the categories of "stomach pain," "abdominal distension," "regurgitation," "esophageal obstruction," and "accumulation." TCM considers its pathogenesis to be rooted in spleen deficiency, with cancerous toxins as the superficial manifestation, and closely related to pathological products such as qi stagnation, phlegm-dampness, blood stasis, and heat toxins. Conventional TCM treatments mainly include oral administration of herbal decoctions and prepared Chinese medicines, as well as external therapies such as acupuncture and acupoint application. TCM plays an important auxiliary role in the treatment of gastric cancer; when combined with modern medical treatment, it can improve patients' quality of life, reduce the risk of metastasis and recurrence, and improve patient prognosis.

[0004] Currently, the main clinical treatment for gastric cancer is surgical resection combined with radiotherapy, chemotherapy, and targeted / immunotherapy. Traditional Chinese medicine (TCM) is mostly used as an adjunct. Existing TCM formulas related to gastric cancer generally fall into two categories: one focuses on clearing heat and detoxifying, promoting blood circulation and removing blood stasis, softening and dispersing masses, emphasizing eliminating pathogenic factors and fighting cancer; the other focuses on strengthening the spleen and replenishing qi, nourishing the stomach and promoting body fluids, emphasizing supporting the body's resistance and consolidating its foundation. Some formulas only focus on eliminating pathogenic factors while neglecting the underlying deficiency in gastric cancer patients, simply supporting the body's resistance without targeted tumor-suppressing and mass-dispersing effects.

[0005] Among the mainstream treatment methods in Western medicine, surgical resection and other surgical treatments are highly invasive, while radiotherapy, chemotherapy, and targeted immunotherapy have significant side effects and low tolerance in patients with advanced gastric cancer, making them prone to drug resistance. Existing traditional Chinese medicine formulas for gastric cancer that aim to expel pathogenic factors often contain potent anti-cancer herbs with bitter and cold properties. Long-term use can easily damage the spleen and stomach's vital energy, exacerbating symptoms such as loss of appetite, diarrhea, and fatigue in gastric cancer patients, leading to decreased patient compliance. On the other hand, formulas that simply strengthen the body lack direct effects in softening and inhibiting tumor growth, and have limited effects on shrinking gastric cancer lesions and softening cancerous nodules. Summary of the Invention

[0006] This invention addresses the gastric discomfort caused by cancerous nodules in advanced gastric cancer, including stomach pain and difficulty swallowing. It provides a traditional Chinese medicine composition with the core principles of softening and dispersing nodules, and strengthening the body's resistance to disease and protecting the stomach. This composition has the effects of dispersing nodules and detoxifying without harming the spleen and stomach, improving stomach discomfort, and reducing toxicity while enhancing efficacy. Based on this, the invention was completed.

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating gastric cancer, the traditional Chinese medicine composition comprising the following traditional Chinese medicines in parts by weight: 20-50 parts of Prunella vulgaris, 20-50 parts of Patrinia scabiosaefolia, 5-20 parts of Fritillaria thunbergii, 5-15 parts of Mentha haplocalyx, 5-20 parts of Citrus aurantium stir-fried with wheat bran, 5-15 parts of Forsythia suspensa, 20-50 parts of Coix lacryma-jobi stir-fried with wheat bran, 10-30 parts of Scrophularia ningpoensis, 5-20 parts of Ampelopsis japonica, 5-20 parts of Crataegus pinnatifida charcoal, and 1-15 parts of Zingiber officinale.

[0008] Furthermore, the traditional Chinese medicine composition comprises the following traditional Chinese medicines in parts by weight: 25-40 parts of Prunella vulgaris, 25-40 parts of Patrinia scabiosaefolia, 10-15 parts of Fritillaria thunbergii, 8-12 parts of Mentha haplocalyx, 6-18 parts of Citrus aurantium stir-fried with wheat bran, 8-12 parts of Forsythia suspensa, 25-35 parts of Coix lacryma-jobi stir-fried with wheat bran, 12-25 parts of Scrophularia ningpoensis, 10-18 parts of Ampelopsis japonica, 8-18 parts of Crataegus pinnatifida stir-fried with wheat bran, and 5-12 parts of Zingiber officinale.

[0009] Furthermore, the herbal composition comprises the following parts by weight of herbs: 30 parts of Prunella vulgaris, 30 parts of Patrinia scabiosaefolia, 15 parts of Fritillaria thunbergii, 10 parts of Mentha haplocalyx, 15 parts of Citrus aurantium stir-fried with wheat bran, 10 parts of Forsythia suspensa, 30 parts of Coix lacryma-jobi stir-fried with wheat bran, 16 parts of Scrophularia ningpoensis, 15 parts of Ampelopsis japonica, 15 parts of Crataegus pinnatifida stir-fried with wheat bran, and 6 parts of fresh ginger.

[0010] Secondly, the present invention provides an application of a traditional Chinese medicine composition in the preparation of a traditional Chinese medicine preparation for treating advanced gastric cancer. The traditional Chinese medicine composition consists of the following traditional Chinese medicines in parts by weight: 20-50 parts of Prunella vulgaris, 20-50 parts of Patrinia scabiosaefolia, 5-20 parts of Fritillaria thunbergii, 5-15 parts of Mentha haplocalyx, 5-20 parts of Citrus aurantium stir-fried with wheat bran, 5-15 parts of Forsythia suspensa, 20-50 parts of Coix lacryma-jobi stir-fried with wheat bran, 10-30 parts of Scrophularia ningpoensis, 5-20 parts of Ampelopsis japonica, 5-20 parts of Crataegus pinnatifida charcoal, and 1-15 parts of Zingiber officinale.

[0011] Furthermore, the traditional Chinese medicine preparation is selected from one of the following: ointment, oral liquid, decoction, granule, capsule or tablet.

[0012] Furthermore, the traditional Chinese medicine preparation contains pharmaceutically acceptable excipients.

[0013] Furthermore, the pharmaceutically acceptable excipients are pharmaceutical excipients that enhance the efficacy of the active pharmaceutical ingredient, reduce its toxicity, and / or alleviate its side effects.

[0014] Furthermore, the traditional Chinese medicine composition can be used in combination with conventional Western medicine treatments.

[0015] Furthermore, the conventional Western medicine treatments include, but are not limited to, palliative radiotherapy / chemotherapy, targeted therapy, immune checkpoint inhibitor therapy, and paracentesis.

[0016] The medicinal properties and effects of each Chinese medicinal herb in this invention are as follows: Prunella vulgaris: pungent, bitter, and cold. It enters the liver and gallbladder meridians. It clears liver heat, improves eyesight, and disperses nodules and reduces swelling. It is used for red, swollen, and painful eyes, nighttime eye pain, headache, dizziness, scrofula, goiter, mastitis, breast lumps, and breast distension and pain.

[0017] Fritillaria thunbergii: Bitter, cold. Enters the Lung and Heart meridians. Clears heat, resolves phlegm, stops cough, detoxifies, dissipates nodules, and reduces swelling. Used for wind-heat cough, phlegm-fire cough, lung abscess, mastitis, scrofula, and carbuncles.

[0018] Patrinia scabiosifolia: pungent, bitter, slightly cold. It enters the liver, stomach, and large intestine meridians. Used for clearing heat and detoxifying, reducing swelling and draining pus, removing blood stasis and relieving pain.

[0019] Peppermint: Pungent, cool. Enters the lung and liver meridians. Disperses wind-heat, clears the head and eyes, soothes the throat, promotes rash eruption, and regulates liver qi. Used for wind-heat colds, early stages of wind-heat syndrome, headache, red eyes, sore throat, mouth ulcers, urticaria, measles, and chest and rib distension.

[0020] Forsythia: Bitter, slightly cold. Enters the lung, heart, and small intestine meridians. Clears heat and detoxifies, reduces swelling and dissipates nodules, disperses wind-heat. Used for carbuncles, scrofula, mastitis, erysipelas, wind-heat common cold, initial stage of febrile disease, febrile disease entering the nutritive level, high fever with thirst, delirium with rashes, and painful urination due to heat.

[0021] Job's tears: sweet, bland, and cool in nature. It enters the spleen, stomach, and lung meridians. It promotes diuresis and eliminates dampness, strengthens the spleen and stops diarrhea, relieves numbness, drains pus, and detoxifies and dissipates nodules. It is used for edema, beriberi, difficulty urinating, spleen deficiency diarrhea, dampness-induced numbness and contractures, lung abscess, intestinal abscess, warts, and cancer.

[0022] Fructus Aurantii Immaturus: Bitter, pungent, sour, slightly cold. Enters the spleen and stomach meridians. Regulates qi, relieves chest tightness, promotes digestion, and eliminates bloating. Used for qi stagnation in the chest and hypochondrium, abdominal distension and pain, indigestion, phlegm retention, and organ prolapse.

[0023] Scrophularia: Sweet, bitter, salty, slightly cold. Enters the lung, stomach, and kidney meridians. Clears heat and cools the blood, nourishes yin and reduces fire, detoxifies and dissipates nodules. Used for heat entering the blood level, febrile diseases causing rashes, febrile diseases damaging yin, red tongue with thirst, constipation due to fluid depletion, steaming bone cough, red eyes, sore throat, diphtheria, scrofula, carbuncles and boils.

[0024] Bai Lian: Bitter, slightly cold. Enters the Heart and Stomach meridians. Clears heat and detoxifies, reduces swelling and dissipates nodules, promotes wound healing and tissue regeneration. Used for carbuncles, boils, scrofula, burns, and scalds.

[0025] Hawthorn: Sour, sweet, slightly warm. It enters the spleen, stomach, and liver meridians. It aids digestion, strengthens the stomach, promotes qi circulation, disperses blood stasis, and reduces lipids. It is used for food stagnation due to excessive meat consumption, abdominal distension, diarrhea and abdominal pain, amenorrhea due to blood stasis, postpartum blood stasis, stabbing pain in the heart and abdomen, chest pain, hernia pain, and hyperlipidemia. Roasted hawthorn has enhanced digestive and stagnation-relieving effects. It is used for food stagnation due to excessive meat consumption and incomplete diarrhea.

[0026] Ginger: Pungent, slightly warm. It enters the lung, spleen, and stomach meridians. It relieves exterior syndromes and dispels cold, warms the middle jiao and stops vomiting, resolves phlegm and stops coughing, and detoxifies fish and crab poisoning. It is used for common cold due to wind-cold, vomiting due to stomach cold, cough with phlegm due to cold, and fish and crab poisoning.

[0027] The formulation and treatment principles of this invention For patients with advanced gastric cancer, especially those undergoing radiotherapy and chemotherapy, the clinical presentation often includes complex syndromes such as phlegm and blood stasis, qi and yin deficiency, and stomach disharmony. Using only tonifying formulas cannot effectively control tumor progression; using only pathogen-expelling formulas can easily damage the spleen and stomach, exacerbating adverse reactions such as poor appetite, nausea, and fatigue. Therefore, the herbal composition of this invention establishes the core treatment principles of softening and dispersing masses, detoxifying and inhibiting tumors, tonifying qi and nourishing yin, and harmonizing the stomach and suppressing adverse reactions, addressing both the root cause and the symptoms to achieve the goal of eliminating pathogens without harming the body's vital energy.

[0028] In this formula, Prunella vulgaris and Patrinia scabiosaefolia are the principal herbs: Prunella vulgaris disperses nodules and eliminates masses, clears the liver and detoxifies, while Patrinia scabiosaefolia clears heat and detoxifies, disperses blood stasis and relieves pain. The two herbs combined specifically target the hardened nodules of gastric cancer, inhibiting tumor proliferation and reducing invasion and metastasis, directly addressing the root cause. Fritillaria thunbergii, Scrophularia ningpoensis, Ampelopsis japonica, Forsythia suspensa, and Coix lacryma-jobi (stir-fried with wheat bran) are the assistant herbs: Fritillaria thunbergii, Scrophularia ningpoensis, Ampelopsis japonica, and Forsythia suspensa work together to enhance the detoxification, nodule-dispersing, mass-eliminating, and pain-relieving effects, assisting the principal herbs in softening the tumor. Coix lacryma-jobi (stir-fried with wheat bran) is sweet, bland, and mild, strengthening the spleen and replenishing qi, eliminating dampness and detoxifying, nourishing the spleen and stomach qi and yin, and repairing damaged spleen and stomach function. To support the body's vital energy and ward off pathogens, addressing the patient's underlying deficiency; bran-fried immature bitter orange peel, charred hawthorn, and fresh ginger serve as adjuvant herbs: bran-fried immature bitter orange peel regulates qi, relieves bloating and dissipates fullness, and unblocks the qi mechanism of the stomach and intestines; charred hawthorn promotes digestion, disperses blood stasis, and harmonizes the stomach, improving poor appetite and food stagnation; fresh ginger warms the middle jiao, harmonizes the stomach, relieves nausea and vomiting, moderates the properties of the cold herbs in the formula, alleviates the main digestive symptoms such as stomach pain, food obstruction, nausea, and vomiting, and restores the smooth flow of qi in the stomach and intestines; peppermint serves as the guiding herb: its light and ascending nature soothes the liver, promotes qi circulation, relieves stagnation, guides the herbs directly to the stomach and intestines, disperses stomach heat, and harmonizes the properties of all the herbs in the formula.

[0029] The formula is balanced in terms of cold and heat, and combines tonification and purgation. It disperses nodules and detoxifies without the harm of bitter and cold herbs to the spleen. It strengthens the spleen and protects the stomach without hindering the elimination of nodules and anti-cancer effects. It can improve the deficiency of both qi and yin and the mutual accumulation of phlegm and blood stasis in patients with advanced gastric cancer, enhance the body's own anti-cancer ability, and can also work synergistically with radiotherapy and chemotherapy to enhance efficacy and reduce toxicity.

[0030] Beneficial effects The formulation of this invention is based on softening and dispersing nodules, clearing heat and detoxifying, combined with Chinese herbs that strengthen the spleen and stomach and invigorate qi and protect the stomach. It takes into account the pathogenesis of gastric cancer patients with "deficiency of the root and excess of the branch", that is, it can effectively inhibit tumors and soften cancerous nodules, while avoiding damage to the spleen and stomach by bitter, cold and strong drugs, and significantly improve the patient's tolerance. The formulation of this invention significantly improves symptoms such as stomach pain and food obstruction, shortens gastric emptying time, and restores the gastrointestinal function. The formulation of this invention inhibits the proliferation and metastasis of cancer cells, and can stabilize lesions and prolong the survival of patients with advanced disease. The formulation of this invention reduces gastrointestinal reactions caused by radiotherapy and chemotherapy, lowers the incidence of bone marrow suppression, reduces liver and kidney damage, reduces the expression level of tumor markers, improves the patient's physical condition, and achieves "living with tumor and high-quality survival". Detailed Implementation

[0031] The specific embodiments of the present invention will be further described below. It should be noted that these descriptions are for the purpose of aiding understanding the present invention, but do not constitute a limitation thereof. Furthermore, the technical features involved in the embodiments described below can be combined with each other as long as they do not conflict with each other.

[0032] Unless otherwise specified, the experimental methods used in the following embodiments are conventional methods, and the experimental materials used in the following embodiments are all available through conventional commercial channels.

[0033] Example 1: Preparation of the traditional Chinese medicine preparation of the present invention The herbal composition consists of: 30g of Prunella vulgaris, 30g of Patrinia scabiosaefolia, 15g of Fritillaria thunbergii, 10g of Mentha haplocalyx, 15g of Citrus aurantium stir-fried with wheat bran, 10g of Forsythia suspensa, 30g of Coix lacryma-jobi stir-fried with wheat bran, 16g of Scrophularia ningpoensis, 15g of Ampelopsis japonica, 15g of Crataegus pinnatifida stir-fried with wheat bran, and 6g of fresh ginger.

[0034] Preparation process: The first step is to weigh the Chinese herbs according to the above ingredients and proportions, remove impurities, wash them, drain the water, and set them aside. The second step is to mix the Chinese herbs processed in the first step and soak them in water at a ratio of 1:10 for 30 minutes. The third step is to boil the raw material mixture soaking solution obtained in the second step over high heat, then simmer over low heat for 30 minutes, and repeat the simmering process several times. The fourth step is to combine the decoctions from several decoctions and concentrate them under reduced pressure until the amount of raw medicinal material is 1g / mL. The resulting decoction is the decoction of this invention.

[0035] Example 2: Clinical evaluation of the traditional Chinese medicine composition of the present invention 1. Case 1.1 Case Source and Grouping We selected 150 gastric cancer patients who visited the Department of Oncology and Hematology at the Ningxia Hui Autonomous Region Traditional Chinese Medicine Hospital (Institute of Traditional Chinese Medicine).

[0036] 1.2 Research Methods and Grouping A randomized, controlled, double-blind clinical study was conducted, selecting patients with early, mid, and late-stage gastric cancer undergoing palliative treatment and radiotherapy / chemotherapy. They were randomly divided into the formulation group of this invention, the combination therapy group (formula of this invention + palliative chemotherapy), and the control group (palliative chemotherapy). The clinical efficacy, safety, quality of life, and side effects of radiotherapy / chemotherapy were observed. The treatment course was 12 weeks, and the follow-up period was 6 months.

[0037] 2. Diagnostic criteria According to "Traditional Chinese Medicine Oncology", the syndrome is diagnosed as phlegm and blood stasis, qi and yin deficiency, and stomach disharmony.

[0038] Main symptoms: Stomach mass, stabbing / bloating pain, difficulty eating, fatigue, dry mouth and throat; Secondary symptoms: poor appetite, hot flashes, belching, and abnormal bowel movements; Tongue and pulse: The tongue is red or pale red, with a thin yellow or white greasy coating, and the pulse is thready and wiry or thready and hesitant.

[0039] 3. Inclusion and exclusion criteria: 3.1 Inclusion criteria: 1. Meets the diagnostic criteria; 2. Age 18-75 years old; 3. KPS score ≥ 60 points; 4. Expected survival time ≥ 3 months; 5. Willing to participate and sign the informed consent form, and able to cooperate in completing the treatment course and follow-up.

[0040] 3.2 Exclusion Criteria 1. Pathological examination confirmed it to be a highly malignant type such as gastric signet ring cell carcinoma or undifferentiated carcinoma; 2. Comorbid severe heart, liver, kidney, and hematopoietic system diseases; 3. Pregnant or breastfeeding women; 4. Individuals allergic to any of the drug components used in this study; 5. Individuals with mental illness who are unable to cooperate with treatment.

[0041] 3.3 Criteria for shedding and rejection (1) Case exclusion and dropout: (2) Cases that do not meet the inclusion criteria after inclusion must be excluded; (3) Dropout cases include those with poor compliance, those who experience serious adverse events and are therefore unsuitable to continue the trial, and those who withdraw on their own. (4) Management of dropout cases: When a subject drops out, the researcher should take active measures to complete a final test if possible in order to analyze the efficacy and safety of the test. For all dropout cases, the trial conclusion form and the reason for the dropout should be filled in the case report form.

[0042] 4. Drug intervention 4.1 Control Group SOX chemotherapy regimen was used: Oxaliplatin injection (Sichuan Huiyu Pharmaceutical, National Drug Approval Number H20213060, 50 mg / vial) 130 mg / m² 2On day 1, intravenous infusion of tegafur capsules (Qilu Pharmaceutical, National Drug Approval Number H20100150, specification 20 mg) 40 mg / m² 2 For oral administration, twice daily for 1-14 days. Treatment cycle is 3 weeks, with 14 consecutive days of administration followed by a 7-day break. Efficacy is evaluated after 4 treatment cycles.

[0043] 4.2 Combined Treatment Group In addition to the control group, the patient was treated with the decoction prepared in Example 1 of this invention. One dose consisted of one sachet (300 mL / sachet), taken warm twice a day after breakfast and dinner. The decoction was started one week after chemotherapy began and continued for two weeks. The efficacy was evaluated after four cycles of treatment.

[0044] 4.3 Formulation of the present invention The decoction prepared in Example 1 was administered in doses of 300 mL per packet, divided into two administrations: one packet after breakfast and one packet after dinner, taken warm for two consecutive weeks. The efficacy was evaluated after four treatment cycles.

[0045] 5. Common adverse reactions and their management Gastrointestinal reactions are common adverse effects during chemotherapy for gastric cancer, with nausea, vomiting, and loss of appetite being the most frequent manifestations. These reactions are mainly related to the stimulation of the gastrointestinal mucosa and central nervous system by chemotherapy drugs. Clinical management includes administering antiemetics such as serotonin receptor antagonists, along with enhanced nutritional support.

[0046] 6. Statistical Analysis and Content ① SPSS 27.0 statistical analysis software was used.

[0047] ② Count data: expressed as frequency (n) and percentage (%), with χ² used for comparisons between groups. 2 For ordinal data, the Mann-Whitney U test was used.

[0048] ③ Quantitative data: First, the Shapiro-Wilk normality test was performed. Data conforming to a normal distribution were expressed as mean ± standard deviation (Mean ± SD). Independent samples t-tests and paired t-tests were used for comparisons between and within groups before and after treatment, respectively. Data not conforming to a normal distribution were expressed as median and interquartile range (M / P). 25 P 75 The results indicate that the Mann-Whitney U test and the Wilcoxon signed-rank test were used to compare the pre- and post-treatment outcomes between and within groups, respectively.

[0049] ④ All tests were two-tailed tests, with α=0.05 as the significance level. P<0.05 was considered statistically significant, and P>0.05 was considered not statistically significant.

[0050] 7. Detection indicators and their results 7.1 Imaging Indicators Recent tumor efficacy refers to the clinical judgment made on the recent changes in the tumor after a certain period of treatment, based on imaging examinations or solid tumor efficacy evaluation criteria. It is mainly used to reflect the control effect of the treatment plan on tumor growth and progression in the short term.

[0051] Efficacy was evaluated according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. The total longest diameter of the tumor was measured by CT scan, and changes in tumor size were categorized into four levels: complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).

[0052] Calculate the objective response rate (ORR) and disease control rate (DCR): ORR = (Number of CR cases + Number of PR cases) / Total number of cases evaluated × 100%; DCR = (Number of CR cases + Number of PR cases + Number of SD cases) / Total number of cases evaluated × 100%.

[0053] Table 1 Evaluation of treatment efficacy for solid tumors

[0054] After 12 weeks of treatment, tumor control in the three groups was assessed according to RECIST 1.1 criteria. Evaluation of solid tumor response (CR, PR, SD, and PD) was performed as ordinal categorical data using the Kruskal-Wallis rank-sum test; ORR and DCR were evaluated using the chi-square test.

[0055] Table 2 Evaluation of Treatment Efficacy in Solid Tumor Treatment

[0056] As shown in Table 2, after 12 weeks of treatment, compared with the control group, the tumor lesions of patients in both the preparation group and the combined treatment group of the present invention disappeared, and the objective response rate and disease control rate were improved. This indicates that the traditional Chinese medicine composition of the present invention can control tumor growth and progression, and has a synergistic effect when used in combination with conventional Western medicine treatment.

[0057] 7.2 Laboratory testing indicators (a) CEA, CA19-9 and CA72-4 testing The expression levels of carcinoembryonic antigen (CEA), carbohydrate antigen (CA19-9), and carbohydrate antigen (CA72-4) before and after treatment were measured using chemiluminescent immunoassay. The combined use of these three markers effectively compensates for the limitations of single-indicator detection due to insufficient sensitivity or specificity, thereby improving the diagnostic value for gastric cancer. The three tumor markers were detected simultaneously using the same batch, instrument, and method to ensure data comparability between groups.

[0058] Fasting venous blood was collected from patients one day before treatment and after four treatment cycles. Serum was collected after centrifugation, and the expression levels of carcinoembryonic antigen (CEA), carbohydrate antigen (CA19-9), and carbohydrate antigen (CA72-4) in the patient's serum were detected by chemiluminescent immunoassay (CLIA).

[0059] Among them, CEA is a core tumor marker for gastric cancer, reflecting tumor burden, treatment response, and risk of recurrence and metastasis; CA19-9 is a sensitive indicator for gastrointestinal tumors, assessing gastric cancer invasion, metastasis, and inflammation-related tumor progression; CA72-4 is more specific for gastric tumors than CA19-9, and is often combined with CEA and CA19-9 to improve the accuracy of diagnosis and efficacy assessment.

[0060] Table 3 Evaluation Table of Tumor Marker Level Changes

[0061] Note: #P<0.05 compared with the control group As shown in Table 3, compared with the control group, the levels of tumor markers in the combined treatment group and the preparation group of the present invention were significantly reduced after 12 weeks of treatment (P<0.05), indicating that the traditional Chinese medicine composition of the present invention has good anti-tumor activity and disease control effect.

[0062] (II) Complete blood count White blood cell (WBC), hemoglobin (Hb), and platelet (PLT) counts; After 12 weeks of treatment, fasting venous blood was collected from the patients, and the levels of WBC, Hb, and PLT were measured using a blood cell analyzer.

[0063] Among them, WBC is used to monitor chemotherapy-induced bone marrow toxicity to guide treatment and monitor disease progression; Hb is used to assess patients' physical tolerance and guide blood transfusion and blood replenishment interventions; and PLT is used to predict bleeding risk.

[0064] Table 4. Blood Routine Test Results

[0065] As shown in Table 4, the preparation group of the present invention did not undergo palliative chemotherapy intervention and did not experience bone marrow suppression. Moreover, the overall blood routine indicators were stable. Both the combined treatment group and the control group underwent palliative chemotherapy and experienced bone marrow suppression. The incidence of bone marrow suppression in the combined treatment group was lower than that in the control group, indicating that the traditional Chinese medicine composition of the present invention has a good effect of reducing toxicity and enhancing efficacy.

[0066] (III) Liver and kidney function tests Liver function tests: alanine aminotransferase (ALT) and aspartate aminotransferase (AST); Kidney function: creatinine (Cr) and blood urea nitrogen (BUN).

[0067] After 12 weeks of treatment, fasting venous blood was collected from patients, and serum was obtained by centrifugation. ALT, AST, Cr and BUN were simultaneously detected by biochemical rate colorimetric method.

[0068] Among them, liver function indicators are used to monitor liver damage caused by drugs and tumors; kidney function indicators are used to assess nephrotoxicity caused by chemotherapy and drugs.

[0069] Table 5 Liver and Kidney Function Evaluation Table

[0070] As shown in Table 5, compared with the control group, the abnormal rates of liver and kidney function indicators in the preparation group and the combined treatment group of the present invention were both lower, indicating that the traditional Chinese medicine composition of the present invention is mild in nature, has no liver and kidney toxicity, and can reduce the damage to liver and kidney function caused by palliative chemotherapy, and has good safety for long-term use.

[0071] 7.3 Symptom Indicators Cancer pain, postoperative pain, chronic pain, and various types of physical pain are assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10 points, with higher scores indicating more severe pain.

[0072] 1. Scoring method: Draw a 10cm straight line, with 0 points on the left (no pain) and 10 points on the right (severe and unbearable pain). The patient marks the location of the pain and reads the value.

[0073] 2. Pain grading standards: ①0 points: Completely painless; ② 1-3 points: Mild pain, tolerable, does not affect sleep and daily activities; ③ 4-6 points: Moderate pain, affecting sleep and activity, requiring medication; ④ 7-10 points: Severe, unbearable pain, inability to sleep, and limited mobility.

[0074] 3. Criteria for evaluating therapeutic efficacy: Table 6. Criteria for Evaluating Therapeutic Effect

[0075] Overall effective rate = (Number of cured cases + Number of cases with significant improvement + Number of cases with improvement) / Total number of cases × 100% Table 7 Comparison of VAS scores before and after treatment

[0076] Note: #P<0.05 compared with the control group; there was no statistically significant difference in VAS pain scores among the three groups before treatment (P>0.05), indicating that the pain levels of the components were balanced and comparable, which met the design requirements of a randomized controlled trial.

[0077] Table 8 VAS Score Evaluation Table

[0078] As shown in Tables 7 and 8, compared with the control group, the VAS scores of both the combined treatment group and the preparation group of the present invention were significantly lower after 12 weeks of treatment (P<0.05); the average pain relief rate and the total effective rate were effectively improved, indicating that the traditional Chinese medicine composition of the present invention can effectively relieve cancer pain.

[0079] 7.4 Quality of Life Assessment The Karnofsky Performance Status (KPS) score is used to assess the physical condition and chemotherapy / treatment tolerance of patients with cancer, chronic diseases, and severe illnesses. The maximum score is 100 points, and the higher the score, the better the condition.

[0080] Table 9 KPS Scoring Table

[0081] Table 10 KPS Therapy Evaluation Criteria

[0082] Clinical Reference 1. >80 points: Physical strength is acceptable, and the patient can tolerate active treatments such as radiotherapy, chemotherapy, and targeted therapy; 2. 50-70 points: Physical condition is poor, only suitable for conservative and mild treatment; <50 points: Severe weakness, mainly treated with palliative and symptomatic supportive care.

[0083] Table 11 Comparison of KPS Changes

[0084] As shown in Table 11, compared with the control group, the total effective rate of KPS in the combined treatment group and the preparation group of the present invention was increased, and the number of effective patients and stable patients was greater than that in the control group, indicating that the traditional Chinese medicine composition of the present invention can effectively improve the physical condition and treatment tolerance of patients.

[0085] 7.5 Traditional Chinese Medicine Syndrome Scoring The TCM syndrome score can objectively evaluate the degree of improvement of TCM syndromes in patients by TCM treatment. A decrease in the score after treatment indicates the relief of clinical symptoms.

[0086] Table 12 Traditional Chinese Medicine Syndrome Scoring Table

[0087] Table 13 Evaluation Criteria for the Therapeutic Effect of Traditional Chinese Medicine Syndromes

[0088] The TCM syndrome scores before and after treatment were evaluated based on symptoms such as stomach pain, fatigue, dry mouth and throat, shortness of breath, and constipation.

[0089] Table 14 Evaluation Table of Traditional Chinese Medicine Syndrome Scores

[0090] Note: #P<0.05 compared with the control group Table 15 Evaluation Table of Therapeutic Effects of Traditional Chinese Medicine Syndromes

[0091] As shown in Tables 14 and 15, the combined treatment group and the preparation group of the present invention were significantly better than the control group in improving symptoms such as stomach pain, fatigue, dry mouth and throat, shortness of breath, and constipation (P<0.05), and the total effective rate was also higher. This indicates that the traditional Chinese medicine composition of the present invention can effectively relieve clinical symptoms such as stomach pain, fatigue, dry mouth and throat, shortness of breath, and constipation.

[0092] 7.6 Gastric emptying function and routine blood tests Functional gastric emptying disorder is relatively common after gastric cancer surgery, which has a negative impact on the patient's recovery. Gastric emptying function testing is used to assess and shorten the duration of functional gastric emptying disorder and to understand the patient's nutritional status.

[0093] Gastric emptying function testing is used as an objective indicator of drug efficacy.

[0094] Detection method: 13 C-Octaic Acid Breath Test Test reagents and instruments Reagents: 13 C-Octaic acid reagent (Cambridge Isotope Laboratories, USA, batch number: CLM-447-1), standard test meal (consisting of 75g white bread, 50g peanut butter, 1 egg, and 200ml sterile water, with a total energy of approximately 450kcal and a fat content of <10g to avoid high-fat diets affecting gastric emptying); instrument: 13C-infrared spectroscopy breath analyzer (model: IRIS 200, Wagner GmbH, Germany), disposable breath collection bag, high-precision electronic balance.

[0095] Standardized operating procedures Patient preparation: Fasting and abstaining from water for more than 8 hours before the test, and discontinuing medications that affect gastric motility (such as prokinetic drugs, anticholinergic drugs, and opioid analgesics) for at least 48 hours. Remain in a resting state for 30 minutes before the test and avoid strenuous activity. Baseline expiratory breath sample collection: With the patient fasting, exhale at a constant rate into the expiratory breath collection bag to collect a baseline blank expiratory breath sample, which is then sealed and stored. Test meal and reagent administration: The patient finishes the standard test meal at a steady pace within 5 minutes, and simultaneously takes a solution containing 100mg of reagent. 13 Take 200ml of sterile warm water with C-caprylic acid. Avoid drinking water, eating, or strenuous activity after taking the medicine. Dynamic breath sample collection: After taking the reagent, breath samples were collected at 15, 30, 45, 60, 90, 120 and 180 min respectively, with each collection lasting ≥30s to ensure stable sample concentration; Instrument detection and data calculation: Place all exhaled breath samples into 13 C. Infrared spectroscopy breath analyzer to detect expiratory gases at various time points. 13 CO2 / 12 The isotopic abundance ratio of CO2 was used to calculate key indicators such as gastric emptying half-emptying time (T1 / 2) and the incidence of delayed gastric emptying using the instrument's software.

[0096] Criteria for assessing gastric emptying function Table 16 Criteria for Assessing Gastric Emptying Function

[0097] Table 17 Evaluation Table for Gastric Emptying Function Test

[0098] Note: #P<0.05 compared with the control group As shown in Table 17, after 12 weeks of treatment, compared with the control group, the preparation group and the combined treatment group of the present invention can effectively shorten the gastric emptying and half-emptying time, indicating that the traditional Chinese medicine composition of the present invention can effectively shorten the gastric emptying and half-emptying time and improve the body's nutritional level.

[0099] 7.7 Follow-up Indicators Overall survival rate: (Number of surviving cases during follow-up / Total number of cases in this group) × 100%; Lesion stability rate: (CR+PR+SD) number of cases / total number of cases in this group × 100%, determined according to RECIST 1.1 criteria for solid tumor evaluation; Recurrence rate: Number of cases experiencing recurrent symptoms of epigastric pain and food obstruction during the follow-up period / Total number of cases in this group × 100%; KPS quality of life maintenance rate: (Number of cases with effective KPS + Number of cases with stable KPS) / Total number of cases in this group × 100%; Repeat chemotherapy completion rate: Number of cases that completed all planned chemotherapy cycles according to standard / Total number of cases in the chemotherapy group × 100%, only for the control group and combination therapy group receiving palliative chemotherapy.

[0100] Table 18 Results of 6-month follow-up

[0101] Note: #P<0.05 compared with the control group As shown in Table 18, at the 6-month follow-up, compared with the control group, the combined treatment group could improve the completion rate of chemotherapy. Both the preparation group and the combined treatment group of the present invention could significantly improve the survival rate and quality of life (P<0.05), significantly reduce the recurrence rate (P<0.05), and improve the patient's self-help ability, indicating that the traditional Chinese medicine composition of the present invention has a good effect of reducing toxicity and enhancing efficacy.

[0102] 8. Conclusion This invention's traditional Chinese medicine composition has definite effects in softening and flattening tumors, significantly reducing / stabilizing gastric cancer lesions and softening cancerous nodules; it can quickly relieve core symptoms such as pain, obstruction, and epigastric fullness, and improve gastric function; it significantly improves KPS scores and quality of life, prolongs survival, and reduces the risk of progression. Combined with conventional Western medicine treatments, it can enhance efficacy and reduce toxicity, and improve tolerance to radiotherapy and chemotherapy. Furthermore, its medicinal properties are mild and its safety is high, making it suitable for palliative care and combined use with radiotherapy and chemotherapy in advanced gastric cancer.

[0103] Example 3: Typical Clinical Cases The patient is a 62-year-old male.

[0104] In March 2025, the patient was diagnosed with stage IV gastric adenocarcinoma with peritoneal lymph node metastasis, making surgery impossible.

[0105] Main symptoms: hard, swollen mass in the stomach, sharp pain upon palpation, difficulty swallowing, poor appetite, fatigue, and emaciation.

[0106] KPS score: 60; VAS pain score: 6; CEA: 86.4 ng / mL.

[0107] Treatment: Administer the decoction of this invention (30g of Prunella vulgaris, 30g of Patrinia scabiosaefolia, 15g of Fritillaria thunbergii, 10g of Mentha haplocalyx, 15g of stir-fried Citrus aurantium, 10g of Forsythia suspensa, 30g of stir-fried Coix lacryma-jobi, 16g of Scrophularia ningpoensis, 15g of Ampelopsis japonica, 15g of charred Crataegus pinnatifida, and 6g of fresh ginger), one dose per bag, three times a day, for a course of 12 weeks.

[0108] After 12 weeks of treatment: the tumor was stable (SD), CEA decreased to 36.8 ng / mL; VAS score was 2; the obstruction of eating disappeared, and a normal semi-liquid diet was possible; KPS score increased to 75.

[0109] Follow-up for 6 months: The lesions were stable, with no new metastases, the patients had good physical strength, lived normal lives, had a good overall survival rate, and had no obvious adverse reactions.

Claims

1. A traditional Chinese medicine composition for treating gastric cancer, characterized in that, The traditional Chinese medicine composition consists of the following traditional Chinese medicines in parts by weight: 20-50 parts of Prunella vulgaris, 20-50 parts of Patrinia scabiosaefolia, 5-20 parts of Fritillaria thunbergii, 5-15 parts of Mentha haplocalyx, 5-20 parts of Citrus aurantium stir-fried with wheat bran, 5-15 parts of Forsythia suspensa, 20-50 parts of Coix lacryma-jobi stir-fried with wheat bran, 10-30 parts of Scrophularia ningpoensis, 5-20 parts of Ampelopsis japonica, 5-20 parts of Crataegus pinnatifida charcoal, and 1-15 parts of fresh ginger.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The traditional Chinese medicine composition consists of the following traditional Chinese medicines in parts by weight: 25-40 parts of Prunella vulgaris, 25-40 parts of Patrinia scabiosaefolia, 10-15 parts of Fritillaria thunbergii, 8-12 parts of Mentha haplocalyx, 6-18 parts of Citrus aurantium stir-fried with wheat bran, 8-12 parts of Forsythia suspensa, 25-35 parts of Coix lacryma-jobi stir-fried with wheat bran, 12-25 parts of Scrophularia ningpoensis, 10-18 parts of Ampelopsis japonica, 8-18 parts of Crataegus pinnatifida stir-fried with charred ginger, and 5-12 parts of fresh ginger.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following traditional Chinese medicines in parts by weight: 30 parts of Prunella vulgaris, 30 parts of Patrinia scabiosaefolia, 15 parts of Fritillaria thunbergii, 10 parts of Mentha haplocalyx, 15 parts of Citrus aurantium stir-fried with wheat bran, 10 parts of Forsythia suspensa, 30 parts of Coix lacryma-jobi stir-fried with wheat bran, 16 parts of Scrophularia ningpoensis, 15 parts of Ampelopsis japonica, 15 parts of Crataegus pinnatifida charcoal, and 6 parts of fresh ginger.

4. The application of a traditional Chinese medicine composition in the preparation of a drug for treating advanced gastric cancer, characterized in that, The traditional Chinese medicine composition consists of the following traditional Chinese medicines in parts by weight: 20-50 parts of Prunella vulgaris, 20-50 parts of Patrinia scabiosaefolia, 5-20 parts of Fritillaria thunbergii, 5-15 parts of Mentha haplocalyx, 5-20 parts of Citrus aurantium stir-fried with wheat bran, 5-15 parts of Forsythia suspensa, 20-50 parts of Coix lacryma-jobi stir-fried with wheat bran, 10-30 parts of Scrophularia ningpoensis, 5-20 parts of Ampelopsis japonica, 5-20 parts of Crataegus pinnatifida charcoal, and 1-15 parts of fresh ginger.

5. The application of the traditional Chinese medicine composition as described in claim 4 in the preparation of a medicament for treating advanced gastric cancer, characterized in that, The traditional Chinese medicine composition is formulated into a traditional Chinese medicine preparation; the traditional Chinese medicine preparation is selected from one of the following: ointment, oral liquid, decoction, granules, capsules or tablets; the traditional Chinese medicine preparation may contain pharmaceutically acceptable excipients; the pharmaceutically acceptable excipients are pharmaceutical excipients that enhance the efficacy, reduce toxicity and / or alleviate the side effects of the main drug.

6. The use of the traditional Chinese medicine composition as described in claim 4 in the preparation of a medicament for treating advanced gastric cancer, characterized in that, Late-stage gastric cancer refers to a condition where cancer cells have spread throughout the body, are no longer responsive to curative treatments, are accompanied by various uncomfortable symptoms, and are in a stage of continuous deterioration, prolonged course, and depletion of vital energy. Clinically, deficiency of both qi and yin, and internal accumulation of heat and toxins are more common. The criteria for determining late-stage gastric cancer are: tumor invasion of the serosal layer of the gastric wall, accompanied by extensive regional lymph node metastasis and distant organ metastasis such as liver, abdominal cavity, lung, and bone, or postoperative recurrence with distant metastasis, no indication for radical surgery, and conventional anti-tumor treatment cannot eradicate the lesions.

7. The application of the traditional Chinese medicine composition as described in claim 4 in the preparation of a medicament for treating advanced gastric cancer, characterized in that, The traditional Chinese medicine composition can be used in combination with conventional Western medicine treatments; the conventional Western medicine treatments include, but are not limited to, palliative radiotherapy / chemotherapy, targeted therapy, immune checkpoint inhibitor therapy, and paracentesis.

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