Traditional Chinese medicine composition for treating esophageal cancer and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating esophageal cancer. The traditional Chinese medicine composition is prepared from, by weight, 180-210 g of prepared rehmannia roots, 120-150 g of radix clematidis, 100-120 g of rhizoma atractylodis macrocephalae, 120-150 g of fructus lycii, 120-150 g of semen cuscutae, 100-120 g of rhizoma alismatis, 100-120 g of rhizoma dioscoreae, 40-60 g of taxus chinensis, 100-120 g of codonopsis pilosula, 20-40 g of scorpions, 40-60 g of curcuma zedoary, 60-80 g of peach kernels, 120-150 g of salvia chinensis, 120-150 g of rabdosia rubescens, 90-120 g of Chinese dates, 100-120 g of camptotheca acuminate, 30-50 g of ground beetles, 60-80 g of pseudo-ginseng The composition has the effect of treating both symptoms and root causes in the aspect of treating esophageal cancer, can control tumors, improve the living quality of patients and prolong survival, and is small in side effect.

Description

Technical Field

[0001] The invention belongs to the technical field of medicines and relates to a traditional Chinese medicine composition for treating esophageal cancer and a preparation method thereof. Background Art

[0002] Esophageal cancer ranks sixth in mortality among all malignant tumors in the world, with an estimated 600,000 new cases each year. Esophageal cancer mainly includes two pathological types, esophageal adenocarcinoma and esophageal squamous cell carcinoma, which are highly malignant and have a very poor prognosis. Since the clinical symptoms of early esophageal cancer are hidden, about 80% of esophageal cancer patients are already in the advanced stage when diagnosed and lose the chance of radical cure. Therefore, chemotherapy drugs occupy an important position in the comprehensive treatment of esophageal cancer. The overall prognosis of esophageal cancer patients is poor, with a 5-year survival rate of less than 30%. Drug resistance and metastasis are the main reasons for treatment failure. Traditional Chinese medicine is also an important aspect of comprehensive clinical treatment.

[0003] Esophageal cancer belongs to the category of "dysphagia", "choking", and "regurgitation" in traditional Chinese medicine, and is also known as "diaphragm", "diaphragmatic choking", and "diaphragmatic obstruction". The earliest record of this disease name can be found in the "Inner Canon of Medicine". "Suwen·Yin Yang Bie Lun" says: "The knot of three yangs is called diaphragm", "food cannot be taken down, diaphragm choking is blocked, and eating will cause vomiting", "Su Ling Wei Yun" says "upper diaphragm is dysphagia, lower diaphragm is regurgitation". Regarding the cause of this disease, ancient doctors mostly blamed it on qi, phlegm, and blood stasis. "Lingshu·Ci Jie Zhen Xie" says: "People with weak evil...evil qi stays in them and does not turn back, and it develops into a tumor", "Yi Zong Must Read" says: "The accumulation is caused by insufficient righteous qi, and then evil qi stays in it", "Research on the Origin of Diseases" says: "The spleen and stomach are weak, and they don't want to eat. Food cannot be digested, and the disease is like regurgitation and dysphagia". It can be seen that ancient doctors believed that weak righteous qi can neither repel evil from the outside nor expel evil from the outside, resulting in evil qi staying and forming a tumor. "Suwen·Tongpingxushilun" says: "If the diaphragm is blocked and the upper and lower parts are blocked, it is a disease caused by sudden worry." "Zhubingyuanhoulun" says: "Worry and anger will cause qi stagnation, and qi stagnation will not flow freely, causing choking." "Yidengxuyan" says: "Stagnation of phlegm, accumulation of alcohol and food, accumulation of qi, gastric reflux and dysphagia." "Zhengzhiyaojue·pisai" says: "All kinds of stagnation and dysphagia are caused by phlegm being stimulated by qi and qi being blocked by phlegm. Phlegm and qi fight and cannot flow freely." "Jinkuiyi·dysphagia" says: "Diseases of dysphagia There are both deficiency and excess. For the excess, there may be phlegm or blood attached to the stomach, fighting with the qi, wrapped in the film, or vomited out again, the diaphragmatic qi is temporarily relieved, and then it returns to normal". "Su Ling Wei Yun" says: "The lung and stomach are reversed, the turbid qi is filled, and it is further blocked by phlegm and blood stasis, which are sticky and cannot go down. This is the origin of choking." It can be seen that choking is mostly caused by spleen and stomach qi deficiency, qi stagnation, abnormal rise and fall, and the body fluid cannot be normally distributed, gathering into phlegm, phlegm and qi blocking each other in the esophagus, forming accumulation and blood stasis, phlegm and blood stasis forming tumors, and qi and yin are dissipated over time.

[0004] In the existing technology, surgery, radiotherapy, chemotherapy, traditional Chinese medicine and the rapidly developing immunotherapy are the main treatments for ESCC. However, the overall clinical efficacy is not high, and with the increase of combined treatment methods, the adverse reactions related to treatment are becoming more and more obvious. At present, no drug with good efficacy, fast effect and few side effects has been found. Summary of the invention

[0005] The purpose of the present invention is to overcome the defects of the above-mentioned technology and provide a Chinese medicine composition for treating esophageal cancer with small side effects and treating both the symptoms and the root cause and its preparation method. The medicine can control tumors, improve the quality of life of patients, prolong survival time, and has low toxic and side effects, can significantly improve the control rate of esophageal cancer, and has good clinical efficacy.

[0006] The specific technical solution is:

[0007] A traditional Chinese medicine composition for treating esophageal cancer is prepared from the following raw materials in parts by weight: 180g-210g of Rehmannia root, 120g-150g of Clematidis root, 100g-120g of Atractylodes macrocephala, 120g-150g of Lycium barbarum, 120g-150g of Cuscuta seed, 100g-120g of Alismatis, 100g-120g of Dioscorea opposita, 40g-60g of Taxus chinensis, 100g-120g of Codonopsis pilosula, 20g-40g of Scorpio, 40g-60g of Curcuma, 60g-80g of Persica seed, 120g-150g of Ilex erythrorhizon, 120g-150g of Rabdosia rubescens, 90g-120g of jujube, 100g-120g of Camptotheca acuminata, 30g-50g of Eupolyphaga sinensis, 60g-80g of Panax notoginseng, and 60g-80g of Radix Glycyrrhizae Preparata.

[0008] Preferably, 200g of Rehmannia glutinosa, 130g of Clematidis, 110g of Atractylodes macrocephala, 130g of Lycium barbarum, 130g of Cuscuta australis, 110g of Alismatis, 110g of Dioscorea opposita, 50g of Taxus chinensis, 110g of Codonopsis pilosula, 30g of Scorpio, 50g of Curcuma zedoaria, 70g of Persica rapa, 130g of Lithospermum officinale, 130g of Rabdosia rubescens, 110g of Jujube, 110g of Camptotheca acuminata, 40g of Eupolyphaga sinensis, 70g of Panax notoginseng, and 70g of Radix Glycyrrhizae Preparata.

[0009] Preferably, 190g of Rehmannia glutinosa, 140g of Clematidis, 120g of Atractylodes macrocephala, 140g of Lycium barbarum, 140g of Cuscuta australis, 120g of Alismatis, 130g of Dioscorea opposita, 60g of Taxus chinensis, 120g of Codonopsis pilosula, 40g of Scorpio, 60g of Curcuma, 80g of Persica, 140g of Lithospermum officinale, 140g of Rabdosia rubescens, 120g of Jujube, 120g of Camptotheca acuminata, 50g of Eupolyphaga sinensis, 80g of Panax notoginseng, and 80g of Radix Glycyrrhizae Preparata.

[0010] Preferably, 180g of Rehmannia glutinosa, 120g of Clematidis, 100g of Atractylodes macrocephala, 120g of Lycium barbarum, 120g of Cuscuta australis, 110g of Alisma orientalis, 100g of Dioscorea opposita, 40g of Taxus chinensis, 100g of Codonopsis pilosula, 20g of Scorpio, 40g of Curcuma zedoaria, 60g of Persica rapa, 120g of Lithospermum officinale, 120g of Rabdosia rubescens, 90g of Jujube, 100g of Camptotheca acuminata, 30g of Eupolyphaga sinensis, 60g of Panax notoginseng, and 60g of Radix Glycyrrhizae preparata.

[0011] The present invention also relates to a method for preparing a Chinese medicine composition for treating esophageal cancer, which is characterized by:

[0012] Step 1: weigh each raw material drug according to the above weight, grind it into coarse powder, and sieve it;

[0013] Step 2: further crush the coarse powder of Eupolyphaga sinensis and Scorpio powder to obtain fine powder, and mix the fine powder to obtain mixed powder;

[0014] Step 3: ultrasonically extract the crude powders of other drugs respectively, obtain the drug solutions of each component after filtering, and mix the drug solutions of each component to obtain a mixed drug solution;

[0015] Step 4: Concentrate the medicinal solution obtained in step 3 under reduced pressure to obtain an extract;

[0016] Step 5: Mix the mixed powder obtained in step 2 and the extract obtained in step 4, stir evenly, and crush again after drying, and sieve to obtain a mixed powder;

[0017] Step 6: Add auxiliary materials to the powder obtained in step 5 to prepare granules.

[0018] Wherein, in step 3, 6-8 times the weight of water is added for ultrasonic extraction.

[0019] Wherein, the extraction conditions in step 3 are: extraction 2-3 times, each extraction time 30-60 minutes.

[0020] Among them, the functions of each medicinal flavor are as follows: Rehmannia root is sweet in taste, slightly warm in nature, and enters the liver and kidney meridians. It has the effects of invigorating qi and strengthening spleen, nourishing blood and nourishing yin, invigorating kidney and strengthening yang, replenishing essence and nourishing marrow, and clearing away heat and detoxification. Clematis root is pungent, salty, warm, and enters the bladder meridian; it is used to dispel rheumatism, dredge meridians, eliminate phlegm, and disperse bad habits. Atractylodes macrocephala is bitter, sweet, warm, non-toxic, and enters the spleen and stomach meridians. It has the effects of invigorating qi and strengthening spleen, drying dampness and promoting diuresis, and stopping sweating. Lycium barbarum is flat in nature and sweet in taste. It enters the liver, kidney, and lung meridians. It is used to nourish liver and kidney, improve essence and improve eyesight. Cuscuta chinensis is pungent and sweet in taste, flat in nature, and enters the liver, kidney, and spleen meridians. It has the functions of invigorating liver and kidney, consolidating essence and reducing urine. Alisma orientalis is sweet and light in taste, cold in nature, and enters the kidney meridian, which can invigorate kidney qi. Chinese yam is sweet and flat, and it enters the spleen, lung, and kidney meridians; it has the functions of strengthening the spleen, consolidating the kidney, and benefiting the essence; it can nourish the spleen and stomach, promote fluid and benefit the lungs, and nourish the kidney and astringe the essence. Taxus is bitter and pungent, slightly cold in nature, and pungent and dispersing, which can promote qi and blood, and has the functions of warming the kidney and dredging the meridians, promoting blood circulation and removing blood stasis, and promoting diuresis and reducing swelling. Codonopsis is sweet and flat in nature; it enters the spleen and lung meridians; it has the functions of strengthening the spleen and benefiting the lungs, nourishing blood and promoting fluid. Scorpion is pungent and flat; it enters the liver meridian; it has the functions of dredging the meridians and relieving pain, attacking toxins and dispersing knots. The functions of Xuejie are to disperse blood stasis and relieve pain, stop bleeding and promote muscle regeneration; Curcuma is pungent and bitter, warm in nature; it enters the liver and spleen meridians; the functions are: promoting qi, breaking blood, eliminating accumulation, and relieving pain. Peach kernel is bitter, sweet, and flat; it enters the heart, liver, and large intestine meridians; it has the functions of promoting blood circulation and removing blood stasis. Lithospermum officinale is bitter and pungent, and flat; it has the functions of clearing heat and detoxifying, promoting blood circulation and relieving pain, and removing blood stasis and promoting new growth. Rabdosia rubescens tastes bitter and sweet, and is slightly cold in nature. It enters the lung, stomach, and liver meridians. It has the functions of clearing away heat and detoxifying, promoting blood circulation and relieving pain. Jujube tastes sweet and is neutral. It enters the spleen and stomach meridians. It has the functions of nourishing the spleen and stomach, replenishing qi and promoting body fluid. Camptotheca acuminata tastes bitter and pungent, and is cold in nature. It enters the spleen, stomach, and liver meridians. It has the functions of clearing away heat and detoxifying, dispersing knots and eliminating symptoms. Eupolyphaga sinensis tastes salty and is cold in nature. It enters the liver meridian. It is good at wandering, has strong blood circulation ability, and is good at breaking blood and removing blood stasis. Panax notoginseng is sweet, slightly bitter, and warm. It enters the liver and stomach meridians. It has the functions of stopping bleeding, breaking blood and removing blood stasis, relieving inflammation and pain, and nourishing. Roasted Licorice root tastes sweet and is neutral in nature. It is used to nourish the spleen and replenish qi, clear away heat and detoxify, remove phlegm and relieve cough, relieve urgency and relieve pain, and harmonize various medicines.

[0021] The present invention is an in-hospital preparation of a traditional Chinese medicine hospital. It is based on the traditional Chinese medicine system, starts from the various pathogenesis of esophageal cancer, fully considers the different symptoms of esophageal cancer patients, treats them according to syndrome differentiation, takes into account many aspects, and selects 19 kinds of Chinese medicinal materials for compatibility. The above-mentioned medicines can be used together to achieve the effects of strengthening the spleen and kidney, promoting blood circulation and unblocking collaterals, and detoxifying and dispersing knots.

[0022] The Chinese medicine composition of the present invention uses Rehmannia root, Atractylodes macrocephala and Lycium barbarum as monarch drugs, which work together to strengthen the spleen and kidney, and nourish the spleen and stomach; Curcuma zedoaria, peach kernel, Lithospermum officinale, Rubescens rubescens, Panax notoginseng and Clematidis as ministerial drugs; Cuscuta australis, Chinese yam, Taxus chinensis, Codonopsis pilosula, jujube, Camptotheca acuminata, Eupolyphaga sinensis, Scorpio and Licorice as guiding drugs. The monarch, minister, guiding and guiding drugs work synergistically to build the effects of strengthening the spleen and kidney, promoting blood circulation and unblocking collaterals, and detoxifying and dispersing knots.

[0023] Beneficial effects:

[0024] Compared with the prior art, the beneficial effects of the present invention are as follows: the pharmaceutical composition of the present invention is a pure Chinese medicine preparation, with the principle of strengthening the spleen and kidney, and at the same time taking the treatment ideas of promoting blood circulation and unblocking collaterals, detoxifying and dispersing nodules. It is suitable for patients with spleen and stomach deficiency, blood stasis, and heat accumulation due to deficiency of body fluid. The formula is used for the treatment of esophageal cancer, with rapid onset, few side effects, and both symptomatic and root treatment; it can control tumor development, improve the quality of life of patients, and prolong survival.

[0025] The Chinese medicine composition of the present invention can significantly improve the clinical symptoms of patients, has lower toxic and side effects than other Chinese medicine preparations and chemotherapy treatments, can significantly improve the control rate of esophageal cancer, and has good clinical efficacy.

[0026] Compared with the modified Chinese medicine composition, the Chinese medicine composition of the present invention has significantly improved therapeutic effect, can alleviate the pain of patients, prolong life, improve the quality of life, and obtain unexpected therapeutic effect.

[0027] The preparation method of the Chinese medicine composition of the present invention is simple, and adopts the ultrasonic extraction method. Compared with the traditional water decoction extraction method, the extraction efficiency is significantly improved; the medicine composition is extracted by grouping, and the obtained Chinese medicine preparation has a better therapeutic effect. DETAILED DESCRIPTION

[0028] The technical solution of the present invention is further described in detail below in conjunction with specific embodiments.

[0029] Example 1

[0030] A traditional Chinese medicine composition for treating esophageal cancer comprises the following raw materials in parts by weight: 200g of Rehmannia root, 130g of Clematidis root, 110g of Atractylodes macrocephala, 130g of Lycium barbarum, 130g of Cuscuta seed, 110g of Alisma orientalis, 110g of Dioscorea opposita, 50g of Taxus chinensis, 110g of Codonopsis pilosula, 30g of Scorpio, 50g of Curcuma zedoaria, 70g of Persica seed, 130g of Lithospermum officinale, 130g of Rabdosia rubescens, 110g of jujube, 110g of Camptotheca acuminata, 40g of Eupolyphaga sinensis, 70g of Panax notoginseng, and 70g of Radix Glycyrrhizae preparata.

[0031] The dosage form of the traditional Chinese medicine composition for treating esophageal cancer is granules.

[0032] The preparation method of the above-mentioned Chinese medicine preparation is:

[0033] Step 1: weigh each raw material drug according to the above weight portion, grind into 60 mesh coarse powder, and sieve;

[0034] Step 2: further crush the coarse powder of Eupolyphaga sinensis and Scorpio scorpion powder to obtain 100 mesh fine powder, and mix the fine powder to obtain a mixed powder;

[0035] Step 3: ultrasonically extract the crude powders of other drugs respectively, filter them to obtain the medicinal solutions of each component, and mix the medicinal solutions of each component to obtain a mixed medicinal solution; the extraction conditions are: add 8 times the amount of water to the crude powder of each drug for ultrasonic extraction, extract twice, and extract for 30 minutes each time;

[0036] Step 4: Concentrate the medicinal solution obtained in step 3 under reduced pressure to obtain an extract;

[0037] Step 5: Mix the mixed powder obtained in step 2 and the extract obtained in step 4, stir evenly, and crush again after drying, and sieve to obtain a mixed powder;

[0038] Step 6: Add auxiliary materials to the powder obtained in step 5 to prepare granules.

[0039] Example 2

[0040] A traditional Chinese medicine composition for treating esophageal cancer comprises the following raw materials in parts by weight: 190g of Rehmannia root, 140g of Clematidis root, 120g of Atractylodes macrocephala, 140g of Lycium barbarum, 140g of Cuscuta seed, 120g of Alisma orientalis, 130g of Dioscorea opposita, 60g of Taxus chinensis, 120g of Codonopsis pilosula, 40g of Scorpio, 60g of Curcuma zedoaria, 80g of Persica seed, 140g of Lithospermum officinale, 140g of Rabdosia rubescens, 120g of jujube, 120g of Camptotheca acuminata, 50g of Eupolyphaga sinensis, 80g of Panax notoginseng and 80g of Radix Glycyrrhizae preparata.

[0041] The dosage form of the traditional Chinese medicine composition for treating esophageal cancer is granules.

[0042] The preparation method of the above-mentioned Chinese medicine preparation is:

[0043] Step 1: weigh each raw material drug according to the above weight portion, grind into 60 mesh coarse powder, and sieve;

[0044] Step 2: further crush the coarse powder of Eupolyphaga sinensis and Scorpio scorpion powder to obtain 100 mesh fine powder, and mix the fine powder to obtain a mixed powder;

[0045] Step 3: ultrasonically extract the crude powders of other drugs respectively, filter them to obtain the medicinal solutions of each component, and mix the medicinal solutions of each component to obtain a mixed medicinal solution; the extraction conditions are: add 8 times the amount of water to the crude powder of each drug for ultrasonic extraction, extract twice, and extract for 30 minutes each time;

[0046] Step 4: Concentrate the medicinal solution obtained in step 3 under reduced pressure to obtain an extract;

[0047] Step 5: Mix the mixed powder obtained in step 2 and the extract obtained in step 4, stir evenly, and crush again after drying, and sieve to obtain a mixed powder;

[0048] Step 6: Add auxiliary materials to the powder obtained in step 5 to prepare granules.

[0049] Example 3

[0050] A traditional Chinese medicine composition for treating esophageal cancer comprises the following raw materials in parts by weight: 180g of Rehmannia root, 120g of Clematidis root, 100g of Atractylodes macrocephala, 120g of Lycium barbarum, 120g of Cuscuta seed, 110g of Alisma orientalis, 100g of Dioscorea opposita, 40g of Taxus chinensis, 100g of Codonopsis pilosula, 20g of Scorpio, 40g of Curcuma zedoaria, 60g of Persica seed, 120g of Lithospermum officinale, 120g of Rabdosia rubescens, 90g of jujube, 100g of Camptotheca acuminata, 30g of Eupolyphaga sinensis, 60g of Panax notoginseng, and 60g of Radix Glycyrrhizae preparata.

[0051] The dosage form of the traditional Chinese medicine composition for treating esophageal cancer is granules.

[0052] The preparation method of the above-mentioned Chinese medicine preparation is:

[0053] Step 1: weigh each raw material drug according to the above weight portion, grind into 60 mesh coarse powder, and sieve;

[0054] Step 2: further crush the coarse powder of Eupolyphaga sinensis and Scorpio scorpion powder to obtain 100 mesh fine powder, and mix the fine powder to obtain a mixed powder;

[0055] Step 3: ultrasonically extract the crude powders of other drugs respectively, filter them to obtain the medicinal solutions of each component, and mix the medicinal solutions of each component to obtain a mixed medicinal solution; the extraction conditions are: add 8 times the amount of water to the crude powder of each drug for ultrasonic extraction, extract twice, and extract for 30 minutes each time;

[0056] Step 4: Concentrate the medicinal solution obtained in step 3 under reduced pressure to obtain an extract;

[0057] Step 5: Mix the mixed powder obtained in step 2 and the extract obtained in step 4, stir evenly, and crush again after drying, and sieve to obtain a mixed powder;

[0058] Step 6: Add auxiliary materials to the powder obtained in step 5 to prepare granules.

[0059] Example 4 (Control Group 1 Prescription Preparation)

[0060] 120g of Codonopsis pilosula, 40g of whole scorpion, 80g of peach kernel, 140g of Lithospermum officinale, 140g of Rubescens herb, 120g of jujube, 120g of Camptotheca acuminata, 50g of Eupolyphaga sinensis, and 80g of roasted liquorice.

[0061] The preparation method is the same as that of Example 1-3.

[0062] Example 5 (Control Group 2 Prescription Preparation)

[0063] 120g of Codonopsis pilosula, 40g of whole scorpion, 80g of peach kernel, 140g of Lithospermum officinale, 140g of Rubescens herb, 120g of jujube, 120g of Camptotheca acuminata, 50g of Eupolyphaga sinensis, 80g of roasted Licorice root, 120g of Inula japonica, 100g of Daheshi, 90g of ginger, 20 centipedes, and 120g of Pinellia ternata.

[0064] The preparation method is the same as that of Example 1-3.

[0065] Clinical Research

[0066] 1. Case characteristics

[0067] 1.1 Case source

[0068] The cases come from Henan Cancer Hospital. Patients with pathological diagnosis of stage III-IV esophageal squamous cell carcinoma who visited Henan Cancer Hospital from December 2022 to August 2024 were selected and divided into the experimental group and the control group according to the proportion. A total of 600 cases were collected, each with 120 people in a group, and a total of five groups, including 360 cases in the treatment group and 240 cases in the control group.

[0069] 1.2 Case selection

[0070] 1.2.1 Diagnostic criteria

[0071] (1) Western medicine diagnostic criteria

[0072] Based on the 2020 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines and the 2018 American Joint Committee on Cancer (AJCC) Cancer Staging Eighth Edition staging standards, patients were diagnosed with esophageal squamous cell carcinoma based on clinical manifestations, imaging examinations (such as CT or MRI) and pathological examinations, and the clinical stage was III-IV.

[0073] (2) TCM diagnostic criteria

[0074] According to the four diagnostic methods of traditional Chinese medicine, with reference to the "TCM Diagnosis and Treatment Program for Esophageal Cancer (2018)" of the State Administration of Traditional Chinese Medicine and the new century national higher traditional Chinese medicine school planning textbook "Chinese Medicine Internal Medicine" (2021 edition), the diagnosis is made by two physicians at the level of deputy chief physician or above. The diagnostic criteria are common knowledge in the field and are not elaborated in the instructions.

[0075] 1.2.2 Inclusion criteria

[0076] (1) Patients diagnosed with stage III-IV esophageal squamous cell carcinoma by imaging and pathology;

[0077] (2) no previous chemotherapy or more than 6 months since neoadjuvant chemoradiotherapy;

[0078] (3) Age 18–75 years old;

[0079] (4) expected survival period ≥ 3 months;

[0080] (5) PS score of 0 to 2;

[0081] (6) having measurable lesions that meet iRECIST 1.1 criteria;

[0082] (7) Have signed the informed consent form and are willing and able to carry out the trial plan.

[0083] 1.2.3 Exclusion criteria

[0084] (1) Patients with other types of tumors;

[0085] (2) Patients with severe liver and kidney dysfunction;

[0086] (3) Patients with known allergy or severe adverse reactions to paclitaxel, platinum drugs, or tislelizumab;

[0087] (4) Patients who are currently participating in or have participated in other clinical trials within the previous 4 weeks;

[0088] (5) Pregnant or breastfeeding women;

[0089] (6) Patients with active autoimmune diseases or a history of autoimmune diseases that may relapse;

[0090] (7) Patients with other serious physical or mental illnesses that may increase the risk of the trial or interfere with the trial results

[0091] 1.2.4 Termination criteria

[0092] (1) Those who stop taking the drug or add other esophageal cancer-related drugs without permission;

[0093] (2) Severe complications or comorbidities occur and the trial should not be continued;

[0094] (3) Severe adverse events occur and the trial should not be continued;

[0095] (4) Poor compliance, which affects the judgment of test results;

[0096] (5) Those who voluntarily withdraw from the trial;

[0097] (6) Those who were mistakenly included in the group due to violation of the inclusion and exclusion criteria;

[0098] (7) Subjects were lost to follow-up.

[0099] 1.2.5 Shedding Standard

[0100] Incomplete treatment was recorded as dropout.

[0101] 1.3 Case follow-up

[0102] Patients with no disease progression at the end of the trial were followed up monthly until their disease progressed or they died.

[0103] 2 Test methods

[0104] 2.1 Experimental design

[0105] Patients with stage III-IV esophageal squamous cell carcinoma (ESCC) who were hospitalized in the Department of Integrated Traditional Chinese and Western Medicine of the Provincial Cancer Hospital were screened and randomly divided into groups after being judged by the researchers to meet the inclusion criteria. The patients were randomly divided into groups according to the proportion of the experimental design, and the experimental group was given the Chinese medicine composition of the present invention, and the control group was given the Chinese medicine composition of other formulas.

[0106] 2.2 Treatment options

[0107] 2.2.1 Medicines

[0108] (1) The Chinese medicine composition of the present invention: a Chinese medicine preparation prepared according to the preparation method described in Examples 1-3, preparation specification: 15 g / bag;

[0109] (2) The Chinese medicine preparation prepared in Example 4 has a preparation specification of 15 g / bag.

[0110] (3) The Chinese medicine preparation prepared in Example 5 has a preparation specification of 15 g / bag.

[0111] 2.2.2 Method of use

[0112] Test group 1: the Chinese medicine composition of the present invention, prepared according to the preparation method described in Example 1, using method: 3 times a day, 1 bag each time, taken continuously;

[0113] Experimental group 2: the Chinese medicine composition of the present invention, prepared according to the preparation method described in Example 2, using method: 3 times a day, 1 bag each time, taken continuously;

[0114] Experimental group 3: the Chinese medicine composition of the present invention, prepared according to the preparation method described in Example 3, the method of use: 3 times a day, 1 bag each time, taken continuously;

[0115] Control group 1: a Chinese medicine preparation prepared according to the preparation method described in Example 4; usage: 3 times a day, 1 bag each time, taken continuously;

[0116] Control group 2: a Chinese medicine preparation prepared according to the preparation method described in Example 5; usage: 3 times a day, 1 bag each time, take continuously.

[0117] One cycle is 21 days, and the drug is used until 6 cycles or disease progression or intolerable toxicity.

[0118] 2.2.3 Combined medication

[0119] During the trial, patients are prohibited from using any traditional Chinese medicine (including Chinese patent medicine and external treatment methods) with anti-tumor ingredients and Western medicine other than the prescribed treatment plan.

[0120] 2.3 Observation indicators

[0121] 2.3.1 Clinical efficacy indicators

[0122] Main indicators: ORR DCR

[0123] Secondary indicators:

[0124] (1) Progression-free survival (mPFS): the time from the start of drug administration to tumor progression or death due to any cause.

[0125] (2) TCM syndrome efficacy: Patients were evaluated before treatment and at the end point of the trial.

[0126] (3) Adverse reactions: Observe the incidence and severity of adverse reactions before and after each cycle of medication. During clinical observation, the actual situation shall prevail and the inspection data shall be adjusted dynamically.

[0127] 2.3.2 Safety indicators Objective response rate

[0128] (1) Respiration, pulse, heart rate, and blood pressure are checked once every cycle and evaluated every 2 cycles.

[0129] (2) Routine blood tests (WBC, RBC, Hb, PLT), liver function tests (ALT, AST, LDH, etc.), renal function tests (Cr, etc.), electrocardiograms, and coagulation function tests were performed once every cycle and evaluated every 2 cycles.

[0130] 2.4 Evaluation Criteria

[0131] 2.4.1 Objective efficacy evaluation criteria

[0132] Based on iRECIST 1.1 criteria, imaging examinations were used to evaluate changes in tumor volume and efficacy after medication, with evaluations conducted every 2 cycles and at the trial endpoint.

[0133] ORR (objective response rate) = (CR + PR) (CR + PR + SD + PD) * 100%

[0134] DCR (disease control rate) = (CR + PR + SD) (CR + PR + SD + PD) * 100%

[0135] 2.4.2 Evaluation of symptom improvement

[0136] Refer to the "Guidelines for Clinical Research of New Chinese Medicines" formulated and issued by the Ministry of Health to determine the efficacy of the symptoms of this disease. Record once before and after treatment in the clinical observation form. TCM symptoms are divided into 4 levels based on clinical observation: asymptomatic, mild, moderate, and severe. The main symptoms are scored 0, 2, 4, and 6 points respectively, and the secondary symptoms are scored 0, 1, 2, and 3 points respectively. The statistical change in the total score is divided into four levels, as follows:

[0137] (1) Clinical recovery: All or almost all clinical symptoms disappear, and the total symptom score decreases by ≥95%.

[0138] (2) Significantly effective: The main symptoms basically disappeared, and the total symptom score decreased by ≥70%.

[0139] (3) Effective: The main symptoms improved and the total symptom score decreased by ≥30%.

[0140] (4) Ineffective: The total symptom score decreased by less than 30%, or even increased. The total clinical efficacy was calculated as cured + markedly effective + effective.

[0141] 2.4.3 Quality of life evaluation

[0142] The Karnofsky score method was used. According to the KPS scoring standard, after treatment, an increase of ≥10 points in the KPS score was recorded as improvement, a decrease of ≥10 points was recorded as progression, and an increase or decrease of less than 10 points was recorded as stability. The total clinical efficacy was calculated as improvement + stability.

[0143] 3. Recording and handling of adverse reactions

[0144] 3.1 Definition

[0145] (1) Adverse events: refers to all adverse medical events that occur after the subjects receive the trial drug, which may manifest as symptoms (such as nausea, vomiting, fatigue, etc.), signs (such as rash, fever, etc.), diseases or abnormal laboratory tests, but they do not necessarily have a causal relationship with the trial drug.

[0146] (2) Serious adverse event: refers to an adverse medical event that occurs after the subject receives the investigational drug, resulting in death, life-threatening or functional loss, or the subject requiring hospitalization or prolonged hospitalization.

[0147] (3) Adverse drug reaction: refers to any harmful or unexpected reaction to the human body that may be related to the investigational drug and occurs during a clinical trial.

[0148] 3.2 Processing

[0149] The first principle is to ensure the safety of the subjects. Immediate measures should be taken when adverse events are discovered; the name, dosage, time of occurrence, duration, severity, etc. of the medication should be recorded; it should be determined whether the event is related to the medication of the present invention and recorded; unrelieved adverse events should be followed up until they are relieved.

[0150] 4. Statistical Analysis

[0151] The statistical analysis software of the present invention is SPSS26.0, and the quantitative data are The count data are expressed as frequency and percentage. For quantitative indicators such as age, if normality and homogeneity of variance are met, the t test is used. If neither of them is met, the Wilcoxon rank sum test is used. For qualitative data, the χ2 test is generally used. The independent sample rank sum test is used between the groups for graded data, and the paired sample rank sum test is used for comparison before and after treatment. The above statistical results are considered statistically significant when P < 0.05 or P < 0.01 or P < 0.001.

[0152] 5. Ethical principles

[0153] The protocol of the present invention complies with the relevant provisions of the Declaration of Helsinki, ensuring that all subjects voluntarily participate in the trial, fully understand and agree to the content of the trial, and have been informed of possible adverse reactions and results. This trial protocol has been submitted to the Ethics Committee for approval.

[0154] 6. Informed Consent

[0155] Based on the principles of full disclosure, full understanding, and voluntary participation, all subjects signed informed consent.

[0156] Test results

[0157] The present invention included 600 cases meeting the criteria, including 360 cases in the experimental group and 240 cases in the control group.

[0158] The average age of the test group in the present invention was 65.02±7.79, and the average age of the control group was 64.73±7.313. The data of each group were analyzed and compared by t test, P>0.05, and there was no statistically significant difference.

[0159] The present invention included 402 males, including 261 in the experimental group and 141 in the control group; and 198 females, including 99 in the experimental group and 99 in the control group.

[0160] 1. Comparison of clinical efficacy indicators

[0161] 1.1 Comparison of recent objective tumor efficacy (see Table 1 for specific data).

[0162] Table 1 Comparison of objective efficacy indicators among groups

[0163]

[0164]

[0165] Conclusion: According to Table 1, the data are as follows:

[0166] CR (complete remission) column: All patients in the five groups of the present invention did not achieve CR (complete remission), that is, the number of cases in the experimental groups 1-3 and the control groups 1-2 was 0.

[0167] PR (partial remission) column: In the present invention, there are 92 PR patients in the test groups 1-3, and the average value of the three groups is about 31 cases; there are 19 patients in the control groups 1-2, and the average value of the two groups is about 10 cases.

[0168] SD (stable disease) column: In the present invention, there are 74 SD patients in the test groups 1-3, and the average value of the three groups is about 25 cases; there are 35 cases in the control groups 1-2; the average value of the two groups is about 18 cases.

[0169] PD (ineffective) column: There are 194 PD patients in the test groups 1-3 of the present invention, and the average value of the three groups is about 64 cases; there are 186 patients in the control group 1-2, and the average value of the two groups is 93 cases.

[0170] ORR (objective response rate): The average ORR of the experimental groups 1-3 in the present invention was 25.57%; the average ORR of the control groups 1-2 was 7.95%. Statistical analysis of the mean values ​​of the two groups showed that the mean response rate of the experimental group was significantly higher than that of the control group (P < 0.05).

[0171] DCR (Disease Control Rate) Column: The average DCR of the experimental groups 1-3 in the present invention is 48%; the average DCR of the control groups 1-2 is 22.5%. The inventors conducted a statistical analysis on the mean values ​​of the above two groups, showing that the mean disease control rate of the experimental group was significantly higher than that of the control group (P < 0.05).

[0172] The inventors further compared the ORR and DCR data of each group in Table 1 for statistical analysis, and obtained the P value as follows:

[0173] ORR (Chi-square test)

[0174] #Experimental group 2 vs. experimental group 1: P = 0.032

[0175] #Experimental group 2 vs. experimental group 3: P = 0.014

[0176] #Experimental group 1 VS control group 1: P = 0.002

[0177] #Experimental group 1 VS control group 2: P = 0.012

[0178] #Experimental group 3 VS control group 1: P = 0.004

[0179] #Experimental group 3 VS control group 2: P = 0.028

[0180] DCR (Chi-square test)

[0181] #Experimental group 2 vs. experimental group 1: P = 0.028

[0182] #Experimental group 2 vs. experimental group 3: P = 0.003

[0183] #Experimental group 1 VS control group 1: P < 0.001

[0184] #Experimental group 1 VS control group 2: P = 0.002

[0185] #Experimental group 3 VS control group 1: P = 0.019

[0186] #Experimental group 3 VS control group 2: P = 0.001

[0187] Note: For the comparison of DCR among the above groups, #P<0.05 indicates significant difference.

[0188] Conclusion: The above statistical analysis results show that:

[0189] The therapeutic effect of the experimental group 1 relative to the control group 1, and the therapeutic effect of the experimental group 1 relative to the control group 2, both showed significant differences. In other words, it can be clearly seen that the therapeutic effect of the experimental group 1 is significantly better than the therapeutic effects of the two Chinese medicine formulas in the control group.

[0190] The therapeutic effect of the experimental group 3 relative to the control group 1, and the therapeutic effect of the experimental group 3 relative to the control group 2, both showed significant differences. In other words, it can be clearly seen that the therapeutic effect of the experimental group 3 is significantly better than the therapeutic effects of the two Chinese medicine formulas in the control group.

[0191] There are significant differences in the therapeutic effects of test group 2 relative to test group 1 and test group 2 relative to test group 3. It can be seen that the therapeutic effect of the formula ratio of test group 2 is better than that of test groups 1 and 3.

[0192] Through the above analysis, it can be seen that from the data of the two indicators of ORR and DCR, on the one hand, the therapeutic effects of the experimental groups 1-3 (the Chinese medicine composition of the present invention) are significantly better than the therapeutic effects of the control groups 1-2 (other Chinese medicine compositions).

[0193] At the same time, for test groups 1-3, the proportions of the three groups of Chinese medicine compositions are different, and it can be seen that the therapeutic effect of test group 2 is better than that of test groups 1 and 3. It can be seen that the therapeutic effect of test group 2 is the best, and its disease control rate reaches 60%.

[0194] 1.2 Comparison of progression-free survival (see Table 2 for specific data)

[0195] Table 2 Comparison of mPFS between the two groups

[0196] Group Experimental Group 1 Experimental Group 2 Experimental Group 3 Control group 1 Control group 2 mPFS(m) 5±2.2 5.8±2.3 5.1±2.7 4.4±2.0 4±2.2

[0197] mPFS (t test)

[0198] #Experimental group 2 vs. experimental group 1: P = 0.006

[0199] #Experimental group 2 vs. experimental group 3: P = 0.031

[0200] #Experimental group 1 VS control group 1: P = 0.027

[0201] #Experimental group 1 VS control group 2: P < 0.001

[0202] #Experimental group 3 VS control group 1: P = 0.022

[0203] #Experimental group 3 VS control group 2: P < 0.001

[0204] Note: After t-test, #P<0.05, the difference is statistically significant.

[0205] Conclusion: The above statistical analysis results show that:

[0206] The mPFS of the experimental group 1 relative to the control group 1, and the mPFS of the experimental group 1 relative to the control group 2, both showed significant differences. In other words, it can be clearly seen that the mPFS and progression-free survival of the experimental group 1 were significantly longer than the mPFS of the two Chinese medicine formulas in the control group.

[0207] The mPFS of the experimental group 3 relative to the control group 1, and the mPFS of the experimental group 3 relative to the control group 2, both showed significant differences. In other words, it can be clearly seen that the mPFS and progression-free survival of the experimental group 3 were significantly longer than the mPFS of the two Chinese medicine formulas in the control group.

[0208] There were significant differences in mPFS between experimental group 2 and experimental group 1, and between experimental group 2 and experimental group 3. It can be seen that the mPFS of the formula ratio of experimental group 2 was better than that of experimental group 1 and experimental group 3.

[0209] The above analysis shows that, judging from the data of the mPFS index, on the one hand, the mPFS of the experimental groups 1-3 (the Chinese medicine compositions of the present invention) are significantly better than the mPFS of the control groups 1-2 (other Chinese medicine compositions).

[0210] At the same time, for test groups 1-3, the ratios of the three groups of Chinese medicine compositions are different, and it can be seen that the mPFS of test group 2 is also better than that of test groups 1 and 3. It can be seen that the mPFS of test group 2 is the best.

[0211] 1.3 Comparison of TCM syndrome scores

[0212] The total scores of TCM syndromes in each group of patients were compared: before treatment, the total scores of TCM syndromes in each group of patients were compared. After rank sum test, P>0.05, the difference was not statistically significant, indicating that the groups were comparable; before and after treatment, the groups were compared. After rank sum test, P<0.001 in the experimental group showed a significant difference; after rank sum test, P<0.001 in the control group showed a significant difference; after treatment, the two groups were compared. After rank sum test, P<0.01, the difference was statistically significant. See Table 3 for details.

[0213] Table 3 Comparison of total score of TCM syndrome before and after treatment

[0214] Group Number of cases Before treatment After treatment Experimental Group 1 120 10.9±4.8 7.8±4.2 Experimental Group 2 120 10.5±4.3 7.1±4.6 Experimental Group 3 120 10.3±4.4 7.5±4.1 Control group 1 120 10.8±4.3 8.3±4.1 Control group 2 120 10.6±4.2 8.2±4.2

[0215] Note: After rank sum test analysis, within-group comparison, P < 0.001; between-group comparison, ## P<0.01, the difference was statistically significant.

[0216] ##Experimental group 2 vs. experimental group 1: P = 0.002

[0217] ##Experimental group 2 vs. experimental group 3: P < 0.001

[0218] ##Experimental group 1 VS control group 1: P < 0.001

[0219] ##Experimental group 1 VS control group 2: P < 0.001

[0220] ##Experimental group 3 VS control group 1: P = 0.008

[0221] ##Experimental group 3 VS control group 2: P < 0.001

[0222] Conclusion: The above statistical analysis results show that:

[0223] The syndrome scores of the experimental group 1 relative to the control group 1, and the syndrome scores of the experimental group 1 relative to the control group 2, all showed significant differences. In other words, it can be clearly seen that the syndrome scores of the experimental group 1 are significantly lower than the syndrome scores of the two Chinese medicine formulas in the control group.

[0224] The syndrome scores of the experimental group 3 relative to the control group 1, and the syndrome scores of the experimental group 3 relative to the control group 2, all showed significant differences. In other words, it can be clearly seen that the syndrome score values ​​of the experimental group 3 are significantly lower than the syndrome scores of the two Chinese medicine formulas in the control group.

[0225] There were significant differences in mPFS between trial group 2 and trial group 1, and between trial group 2 and trial group 3. It can be seen that the syndrome score of the prescription ratio of trial group 2 was lower than that of trial group 1 and trial group 3.

[0226] Through the above analysis, it can be seen that from the data of the syndrome score index, on the one hand, the syndrome scores of the experimental groups 1-3 (the Chinese medicine composition of the present invention) are significantly lower than the syndrome scores of the control groups 1-2 (other Chinese medicine compositions), reflecting that the experimental groups have fewer side effects and other symptoms than the control groups, and the treatment effect is better.

[0227] At the same time, for test groups 1-3, the ratios of the three groups of Chinese medicine compositions are different, and it can be seen that the syndrome score value of test group 2 is also lower than that of test groups 1 and 3. It can be seen that the syndrome score value of test group 2 is the lowest, reflecting the least symptoms and the best treatment effect.

[0228] 2. Security comparison

[0229] 2.1 Comparison of blood system safety

[0230] The safety of blood system in each group of patients after treatment was compared: 27 cases of adverse blood system reactions occurred in the experimental group, and 333 cases had no clear adverse blood system reactions; 62 cases of adverse blood system reactions occurred in the control group, and 178 cases had no clear adverse blood system reactions. See Table 4 for details.

[0231] Table 4 Comparison of blood system safety

[0232]

[0233] Note: P<0.05, the difference is statistically significant.

[0234] The occurrence of adverse blood system reactions in patients after treatment was compared. The average number of cases of adverse blood system reactions in the trial group was 9, and the average number of cases of adverse blood system reactions in the control group was 31. It can be seen that the number of cases in the trial group was significantly less than that in the control group. After statistical analysis, P < 0.05, and the difference was statistically significant.

[0235] It can be seen that the Chinese medicine composition of the present invention has high safety, small side effects, can relieve the pain of patients, prolong life, and improve the quality of life; combined with chemotherapy drugs, it can also reduce the toxic and side effects of radiotherapy and chemotherapy. And the Chinese medicine composition of the present invention has fewer adverse reactions than the control group of drugs, and is safer.

[0236] in conclusion:

[0237] The Chinese medicine composition of the present invention can significantly improve the clinical symptoms of patients, has lower toxic and side effects than other Chinese medicine preparations and chemotherapy treatments, can significantly improve the control rate of esophageal cancer, and has good clinical efficacy.

[0238] Compared with the modified Chinese medicine composition, the Chinese medicine composition of the present invention has significantly improved therapeutic effect, can control tumors, improve the quality of life of patients, prolong survival, and has small side effects.

[0239] The preparation method of the Chinese medicine composition of the present invention is simple, and adopts the ultrasonic extraction method. Compared with the traditional water decoction extraction method, the extraction efficiency is significantly improved; the medicine composition is extracted by grouping, and the obtained Chinese medicine preparation has a better therapeutic effect.

[0240] The above is only a preferred specific implementation manner of the present invention, and the protection scope of the present invention is not limited thereto. Any simple change or equivalent replacement of the technical solution that can be obviously obtained by any technician familiar with the technical field within the technical scope disclosed in the present invention falls within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating esophageal cancer, characterized in that: The invention is prepared from the following raw materials in parts by weight: 180g-210g of Rehmannia root, 120g-150g of Clematidis root, 100g-120g of Atractylodes macrocephala, 120g-150g of Lycium barbarum, 120g-150g of Cuscuta seed, 100g-120g of Alisma orientalis, 100g-120g of Dioscorea opposita, 40g-60g of Taxus chinensis, 100g-120g of Codonopsis pilosula, 20g-40g of Scorpio, 40g-60g of Curcuma zedoaria, 60g-80g of Persica seed, 120g-150g of Lithospermum officinale, 120g-150g of Rabdosia rubescens, 90g-120g of Jujube, 100g-120g of Camptotheca acuminata, 30g-50g of Eupolyphaga sinensis, 60g-80g of Panax notoginseng and 60g-80g of Radix Glycyrrhizae Preparata.

2. The Chinese medicine composition for treating esophageal cancer according to claim 1, characterized in that: The product is prepared from the following raw materials in parts by weight: 200g of Rehmannia root, 130g of Clematidis root, 110g of Atractylodes macrocephala, 130g of Lycium barbarum, 130g of Cuscuta seed, 110g of Alisma orientalis, 110g of Dioscorea opposita, 50g of Taxus chinensis, 110g of Codonopsis pilosula, 30g of Scorpio, 50g of Curcuma zedoaria, 70g of Persica seed, 130g of Lithospermum officinale, 130g of Rabdosia rubescens, 110g of Jujube, 110g of Camptotheca acuminata, 40g of Eupolyphaga sinensis, 70g of Panax notoginseng, and 70g of Radix Glycyrrhizae Preparata.

3. The Chinese medicine composition for treating esophageal cancer according to claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 190g of Rehmannia root, 140g of Clematidis root, 120g of Atractylodes macrocephala, 140g of Lycium barbarum, 140g of Cuscuta seed, 120g of Alisma orientalis, 130g of Dioscorea opposita, 60g of Taxus chinensis, 120g of Codonopsis pilosula, 40g of Scorpio, 60g of Curcuma zedoaria, 80g of Persica seed, 140g of Lithospermum officinale, 140g of Rabdosia rubescens, 120g of Jujube, 120g of Camptotheca acuminata, 50g of Eupolyphaga sinensis, 80g of Panax notoginseng and 80g of Radix Glycyrrhizae preparata.

4. The Chinese medicine composition for treating esophageal cancer according to claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 180g of Rehmannia root, 120g of Clematidis root, 100g of Atractylodes macrocephala, 120g of Lycium barbarum, 120g of Cuscuta seed, 110g of Alisma orientalis, 100g of Dioscorea opposita, 40g of Taxus chinensis, 100g of Codonopsis pilosula, 20g of Scorpio, 40g of Curcuma zedoaria, 60g of Persica seed, 120g of Lithospermum officinale, 120g of Rabdosia rubescens, 90g of jujube, 100g of Camptotheca acuminata, 30g of Eupolyphaga sinensis, 60g of Panax notoginseng and 60g of Radix Glycyrrhizae preparata.

5. A method for preparing the Chinese medicine composition for treating esophageal cancer according to any one of claims 1 to 4, characterized in that: Step 1: weigh each raw material drug according to the weight portion of claims 1-4, grind into coarse powder, and sieve; Step 2: further crush the coarse powder of Eupolyphaga sinensis and Scorpio powder to obtain fine powder, and mix the fine powder to obtain mixed powder; Step 3: ultrasonically extract the crude powders of other drugs respectively, obtain the drug solutions of each component after filtering, and mix the drug solutions of each component to obtain a mixed drug solution; Step 4: Concentrate the medicinal solution obtained in step 3 under reduced pressure to obtain an extract; Step 5: Mix the mixed powder obtained in step 2 and the extract obtained in step 4, stir evenly, and crush again after drying, and sieve to obtain a mixed powder; Step 6: Add auxiliary materials to the powder obtained in step 5 to prepare granules.

6. A method for preparing the Chinese medicine composition for treating esophageal cancer according to any one of claims 1 to 4, characterized in that: In the step 3, 8 times the weight of water is added for ultrasonic extraction.

7. A method for preparing the Chinese medicine composition for treating esophageal cancer according to any one of claims 1 to 4, characterized in that: In step 3, extraction is performed twice, each time for 30 minutes.

8. Use of the Chinese medicine composition according to any one of claims 1 to 4 in preparing a medicine for treating esophageal cancer.

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