Traditional Chinese medicine preparation for treating advanced non-small cell lung cancer and preparation method thereof
Through a decoction containing a variety of traditional Chinese medicine ingredients, the cold and heat disorders and phlegm and turbidity of patients with advanced non-small cell lung cancer are decomposed and treated, which significantly improves the quality of life and extends the survival time, and solves the existing traditional Chinese medicine treatments The problem of low efficacy.
Patent Information
- Application Number
- CN202411494348.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-24
- Publication Date
- 2024-12-27
AI Technical Summary
The current traditional Chinese medicine has low efficacy in the treatment of advanced non-small cell lung cancer, and the quality of life and survival time have not been significantly improved.
A Chinese medicine preparation is adopted, including ephedra, saccharomycea, angelica, scutellaria baicalensis, cypress, cinnamon twig, dried ginger, gypsum, asparagus, white peony, poria cocos, atractylodes, roasted licorice, trichosanthes and scallion, and soaked Boil the decoction and prepare it, take it warm three times a day, and decompose the invisible evil qi of cold and heat and the invisible evil qi of phlegm and body, and combine it with the treatment method of using cold and warm and both attack and replenishment.
It significantly improves the quality of life of patients with advanced non-small cell lung cancer and extends survival time. It also has convenient dosage form, high safety, wide application range and low treatment cost.
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Abstract
Description
Technical Field
[0001] The invention belongs to the technical field of Chinese medicine compositions, and particularly relates to a Chinese medicine preparation for treating advanced non-small cell lung cancer and a preparation method thereof. Background Art
[0002] Primary lung cancer has become the leading cause of cancer death worldwide, of which non-small cell lung cancer accounts for about 80-85%. Studies have shown that about 57% of lung cancer patients have already developed distant metastasis when they are first diagnosed, making it difficult for them to benefit from early surgery. Although Western medicine has adopted comprehensive treatment methods such as radiotherapy, chemotherapy, biological targeting, immune checkpoint inhibitors and anti-angiogenesis, the survival time of patients has been extended, but the main means of modern medicine to treat lung cancer are aimed at killing cancer cells, which are often accompanied by cytotoxic reactions, short remission periods, and poor quality of life; the precision treatment that has emerged in recent years is strictly limited by biological characteristics, the beneficiary population is limited, and drug resistance is inevitable, which extends the survival time by about 2-5 years on average; most of the remaining advanced lung cancer patients can only receive palliative treatment, and the 1-year survival rate is less than 10%.
[0003] Traditional Chinese medicine has a long history of treating lung cancer. Especially in the past 50 years, many hospitals have carried out clinical research on the treatment of lung cancer with traditional Chinese medicine and the combination of traditional Chinese and Western medicine. Starting from a holistic perspective, they have combined the traditional Chinese medicine methods of differentiation of symptoms and disease, strengthening the body and eliminating pathogens with Western medicine methods such as surgery, radiotherapy and chemotherapy, and implemented comprehensive treatment to learn from each other's strengths and overcome each other's weaknesses. Great progress has been made in short-term efficacy, prolonging survival time and improving quality of life.
[0004] Advanced non-small cell lung cancer is difficult to treat, and there is an urgent need for breakthroughs in the understanding and treatment of etiology and pathogenesis. The Six-Channel Syndrome Differentiation is based on the rise and fall of yin and yang and the Qi transformation of the Six-Channel. It is not only used for exogenous cold-related diseases, but also reflects the development law of tumor diseases from the surface to the inside, from the real to the virtual, and from the yang to the yin. Therefore, it can be used for the syndrome differentiation and treatment of lung cancer. At the same time, due to the complex etiology and pathogenesis of lung cancer, which often involves endogenous evil qi and changes in the qi, blood, and body fluids of the internal organs, it is necessary to use the combination of the Six-Channel Syndrome Differentiation and the Qi, Blood, and Body Fluids Syndrome Differentiation of the Internal Organs to more comprehensively reflect the laws of the evolution of yin and yang, qi, and blood in each stage of lung cancer, so as to more accurately guide the treatment of each stage. However, there are still major differences in the Chinese medicine community regarding the treatment of advanced lung cancer. In terms of strengthening the body, some are mainly for replenishing qi and nourishing yin, while others are mainly for replenishing qi and supporting yang; in terms of expelling evil, some are mainly for clearing heat, some are mainly for dispelling cold, some are mainly for fighting cancer and attacking toxins, and some are mainly for removing phlegm and removing blood stasis; in terms of efficacy, reports vary from one source to another. Generally speaking, the median survival period of TCM treatment of advanced lung cancer is about 8.8 to 15.5 months, and the 5-year survival rate is 4 to 24.22%. The median survival period of TCM combined with Western medicine treatment is about 11 to 15 months, and the 5-year survival rate is about 20.71%. Overall, TCM treatment methods have still not been able to significantly improve the survival status of patients with advanced lung cancer. Summary of the invention
[0005] In view of the above-mentioned prior art, the present invention discloses a traditional Chinese medicine preparation for treating advanced non-small cell lung cancer, so as to solve the technical problem of low efficacy of existing traditional Chinese medicine treatment methods.
[0006] In order to achieve the above-mentioned purpose, the technical scheme adopted by the present invention is: to provide a traditional Chinese medicine preparation for treating advanced non-small cell lung cancer, which comprises the following raw materials: ephedra, cimicifuga, angelica, scutellaria, anemarrhena, polygonatum, cassia twig, dried ginger, gypsum, asparagus, white peony root, poria, atractylodes, roasted licorice, trichosanthes, allium macrostemon and pinellia.
[0007] Based on the above technical solution, the present invention can also be improved as follows.
[0008] Furthermore, this traditional Chinese medicine preparation includes the following raw materials in parts by mass: 10-20 parts of ephedra, 7-14 parts of cimicifuga, 7-14 parts of angelica, 2-7 parts of scutellaria, 2-7 parts of anemarrhena, 2-7 parts of polygonatum, 1-5 parts of cassia twig, 1-5 parts of dried ginger, 1-5 parts of gypsum, 1-5 parts of asparagus, 1-5 parts of white peony root, 1-5 parts of poria, 1-5 parts of atractylodes, 1-5 parts of roasted liquorice, 9-15 parts of trichosanthes, 7-13 parts of allium macrostemon and 9-15 parts of pinellia.
[0009] Further, this traditional Chinese medicine preparation includes the following raw materials in parts by mass: 13-17 parts of ephedra, 9-12 parts of cimicifuga, 9-12 parts of angelica, 3-6 parts of scutellaria, 3-6 parts of anemarrhena, 3-6 parts of polygonatum, 2-4 parts of cinnamon twig, 2-4 parts of dried ginger, 2-4 parts of gypsum, 2-4 parts of asparagus, 2-4 parts of white peony root, 2-4 parts of poria, 2-4 parts of atractylodes, 2-4 parts of roasted liquorice, 11-13 parts of trichosanthes, 8-11 parts of allium macrostemon and 11-13 parts of pinellia.
[0010] Furthermore, this Chinese medicine preparation includes the following raw materials in parts by mass: 15 parts of ephedra, 10 parts of cimicifuga, 10 parts of angelica, 5 parts of scutellaria, 5 parts of anemarrhena, 5 parts of polygonatum, 3 parts of cinnamon twig, 3 parts of dried ginger, 3 parts of gypsum, 3 parts of asparagus, 3 parts of white peony root, 3 parts of poria, 3 parts of atractylodes, 3 parts of roasted liquorice, 12 parts of trichosanthes, 9 parts of allium macrostemon and 12 parts of pinellia.
[0011] The present invention also discloses a method for preparing the above-mentioned Chinese medicine preparation, which comprises the following steps: S1: Put the raw materials in the formula into a container and soak them in cold water; S2: Boil the soaking liquid over high heat, then keep it over low heat for 25-30 minutes; S3: Filter while hot and collect the filtrate to obtain.
[0012] Furthermore, the soaking time in step S1 is 20 to 25 minutes.
[0013] Furthermore, the amount of cold water used in step S1 is such that it covers the Chinese herbal medicine pieces by 2 to 3 cm.
[0014] Usage and Dosage: Three times a day, about 150ml each time, taken warm after meals.
[0015] On the one hand, advanced lung cancer often has symptoms such as cough, expectoration, blood in sputum, even pus and blood, asthma, chest tightness and chest pain, which are mostly caused by long-term inhalation of tobacco or environmental turbidity, leading to lung failure, unfavorable descending, sputum turbidity, long-term depression and heat transformation, and phlegm heat obstructing the lungs; on the other hand, advanced lung cancer also often has symptoms such as abdominal distension, diarrhea, loss of appetite, fatigue, cold limbs and slow pulse, which are often caused by long-term consumption of spleen and stomach yang by turbid toxic evil qi, leading to endogenous cold evil, spleen deficiency and cold dampness. Its pathological characteristics are not only mixed with deficiency and excess, cold and heat, and pathological products such as endogenous phlegm turbidity, forming the cementation of cold and heat invisible evil qi and phlegm solid tangible evil qi. Therefore, cold and heat want to mix, phlegm knot chest and lung are the basic pathogenesis of advanced lung cancer, and the treatment strategy of the Chinese medicine preparation in the present invention is to decompose the cold and heat invisible evil qi and phlegm solid tangible evil qi, so that evil qi has nothing to attach to.
[0016] "Treatise on Febrile Diseases, Volume 5" says: "Jueyin is the extreme of yin when two yins meet. When yin reaches its extreme, yang is born..." Jueyin disease is characterized by stagnation of yang qi and mixed cold and heat because the two yins meet but yang qi has not recovered and yin and yang qi are not connected smoothly. From the perspective of six meridians differentiation, the pathogenesis of advanced lung cancer is that the invisible evil of cold and heat and the visible evil of phlegm are deeply trapped in Jueyin, the whole body yang qi cannot rise, and the chest yang is blocked; its clinical manifestations of mixed cold and heat are consistent with the main symptoms of Jueyin disease; it is at the end of the disease, which is also consistent with Jueyin disease being in the final stage of the six meridian disease transmission. Therefore, advanced lung cancer can be treated from the perspective of Jueyin disease mixed cold and heat syndrome, using the treatment methods of combining cold and heat, attacking and supplementing, and regulating yin and yang. However, from the perspective of viscera and meridians, lung cancer is located in the chest and lungs, which is related to the fact that the Jueyin liver meridian runs through the chest, is blocked by phlegm and turbid evil, and yin and yang qi are not connected smoothly, so it manifests as lung heat and spleen cold. Lung heat ascends along the Jueyin meridian (penetrating the diaphragm, injecting into the lungs and following the throat), burning the lung collaterals, so throat discomfort and spitting of blood and pus; spleen yang is weak and the middle earth sinks, so diarrhea and diarrhea continue and the pulse in the lower part is not strong; yang qi is blocked and yin and yang are not connected smoothly, so the limbs are cold and the inch pulse is deep and slow. Modern medicine has found that advanced lung cancer, especially central lung cancer, often causes hoarseness due to tumor invasion or metastatic lymph node compression of the recurrent laryngeal nerve, and often causes obstructive pneumonia due to tumor blocking the lobe or segmental bronchus, or hemoptysis or hemoptysis due to tumor erosion of the bronchial wall.
[0017] Under the guidance of the theory of monarch, minister, assistant and envoy of traditional Chinese medicine, this Chinese medicine preparation uses ephedra and cimicifuga as monarch drugs. Ephedra dispels cold, promotes lung function and relieves depression, while cimicifuga clears heat, detoxifies and relieves sore throat. Cinnamon twig and dried ginger help ephedra to open the body with pungent properties, while scutellaria and rhubarb help cimicifuga to descend with bitter properties, so that the evils of cold and heat are resolved separately. They are all minister drugs. Angelica, Polygonatum, Peony and Asparagus nourish the yin of the lungs and stomach, taking into account the characteristics of a long course of illness and severe loss of yin fluid. Atractylodes and Poria dry dampness and transform dampness, nourish yin without causing greasiness, and resolve phlegm without damaging yin. They are all adjuvant drugs. Licorice and gypsum are envoys. Licorice detoxifies and relieves sore throat, harmonizes all drugs, and gypsum has the effects of cooling, anti-inflammatory, relieving spasms and calming. All drugs work together to clear lung heat, warm spleen cold, moisten lung dryness and resolve spleen dampness. This formula is in line with the pathological characteristics of advanced lung cancer with mixed deficiency and excess, cold and heat caking and mixed dryness and dampness (phlegm).
[0018] In addition, modern research shows that: Ephedra has antitussive, antiasthmatic, diuretic, antibacterial, antioxidant, anticoagulant and antiviral effects. The water-soluble components of Ephedra have strong anti-tumor effects and have significant effects in the treatment of lung cancer; Cimicifuga has multiple physiological activities such as antiviral, anti-tumor and anti-inflammatory; Angelica has anti-inflammatory, hematopoietic, antioxidant and immune regulation functions, and its volatile oil can effectively inhibit the growth of lung adenocarcinoma cells; Scutellaria has antibacterial, antiviral, anti-inflammatory and anti-allergic effects, and baicalin can inhibit human lung adenocarcinoma LTEP-A2 cell line in vitro, inhibit lung cancer proliferation and invasion; Anemarrhena has anti-blood. Its water extract, steroidal saponins, sapogenins and mangiferin have anti-tumor activity; Polygonatum odoratum has anti-inflammatory, antibacterial, antioxidant, hypoglycemic, immune regulation and anti-tumor effects. Its high isoflavones and polysaccharide components can promote cancer cell apoptosis and inhibit cancer cell proliferation; Gypsum mainly has antipyretic, anti-inflammatory, antispasmodic and sedative effects; Poria cocos polysaccharides and triterpenoids extracted from Poria cocos have multiple pharmacological effects such as improving immunity, anti-inflammatory and anti-tumor; Cassia twig has antiviral, antibacterial, hypoglycemic, antipyretic, anti-inflammatory, anti-allergic, anticoagulant, anti-tumor, Cinnamaldehyde has direct cytotoxic effect on human tumor cells, and can effectively improve the thymus and spleen index of tumor-bearing mice and improve immune function; Atractylodes macrocephala can inhibit tumor cell proliferation, invasion and metastasis, induce tumor cell apoptosis, and has anti-inflammatory, free radical scavenging, antioxidant, immunomodulatory, anti-platelet activation and aggregation, thrombosis prevention and treatment and antibacterial effects; Licorice active ingredients have anti-tumor, anti-inflammatory, antibacterial, liver-protecting, hypoglycemic and estrogen-like effects; Dry ginger chemical components have antipyretic, analgesic, anti-inflammatory, antioxidant, anti-hypoxic, anti-tumor and growth promoting effects. It has pharmacological activities such as strong immunity; Peony has an inhibitory effect on many tumors, and this anti-proliferation and anti-cancer activity is related to the presence of polyphenol compounds; Trichosanthes has many pharmacological activities such as improving myocardial ischemia, anti-thrombosis, antioxidant and immunomodulatory, and has good anti-tumor activity; Allium macrostemon has antihypertensive and diuretic, anti-cancer and anti-atherosclerotic effects. Allium macrostemon volatile oil and Allium macrostemon polysaccharide can inhibit platelet aggregation, improve the state of blood stasis and hypoxia, and are beneficial to improving the tumor hypoxic microenvironment and thus inhibiting the growth of tumor cells; Pinellia has pharmacological activities such as anti-tumor, antibacterial and anti-inflammatory, and can be used to treat a variety of thoracic and abdominal cancers.
[0019] The beneficial effects of the present invention are: 1. The Chinese medicine preparation of the present invention can decompose the invisible evil qi of cold and heat and the visible evil qi of phlegm, so that the evil qi has no place to attach. In addition, it can release the depressed yang, clear the lungs and warm the spleen, and penetrate the inner meridian of Jueyin. It is suitable for the pathogenesis of advanced lung cancer with mixed invisible evil qi of cold and heat and visible evil qi of phlegm, deep sinking into Jueyin, inability of whole body yang qi to rise, and depression of chest yang. It has a significant therapeutic effect on patients with advanced non-small cell lung cancer and helps to improve the quality of life and prolong the survival time of patients with advanced lung cancer.
[0020] 2. The dosage form of the Chinese medicine preparation of the present invention is a decoction, which has the advantages of being easy to take, having obvious efficacy, being highly safe, having a wide range of applications and having low treatment costs. DETAILED DESCRIPTION
[0021] The specific implementation modes of the present invention are described in detail below with reference to the embodiments.
[0022] Example 1 A traditional Chinese medicine preparation for treating stable stage of chronic obstructive pulmonary disease, comprising the following raw materials in parts by mass: 15 parts of ephedra, 10 parts of cimicifuga, 10 parts of angelica, 5 parts of scutellaria, 5 parts of anemarrhena, 5 parts of polygonatum, 3 parts of cassia twig, 3 parts of dried ginger, 3 parts of gypsum, 3 parts of asparagus, 3 parts of white peony root, 3 parts of poria, 3 parts of atractylodes, 3 parts of roasted liquorice, 12 parts of trichosanthes, 9 parts of allium macrostemon and 12 parts of pinellia.
[0023] The Chinese medicine preparation in this embodiment is prepared by the following steps: S1: Put the raw materials in the formula into a container and soak them in cold water for 20 minutes. The amount of cold water is enough to cover the Chinese herbal medicine pieces by 3 cm; S2: Boil the soaking liquid over high heat, then keep it over low heat for 30 minutes; S3: Filter while hot and collect the filtrate to obtain.
[0024] Example 2 A traditional Chinese medicine preparation for treating stable stage of chronic obstructive pulmonary disease, comprising the following raw materials in parts by mass: 10 parts of ephedra, 7 parts of cimicifuga, 7 parts of angelica, 7 parts of scutellaria, 2 parts of anemarrhena, 7 parts of polygonatum, 1 part of cassia twig, 5 parts of dried ginger, 5 parts of gypsum, 5 parts of asparagus, 1 part of white peony root, 5 parts of poria, 1 part of atractylodes, 1 part of roasted liquorice, 9 parts of trichosanthes, 7 parts of allium macrostemon and 9 parts of pinellia.
[0025] The Chinese medicine preparation in this embodiment is prepared by the following steps: S1: Put the raw materials in the formula into a container and soak them in cold water for 25 minutes. The amount of cold water is enough to cover the Chinese herbal medicine pieces by 2 cm; S2: Boil the soaking liquid over high heat, then keep it over low heat for 30 minutes; S3: Filter while hot and collect the filtrate to obtain.
[0026] Example 3 A traditional Chinese medicine preparation for treating stable stage of chronic obstructive pulmonary disease, comprising the following raw materials in parts by mass: 20 parts of ephedra, 14 parts of cimicifuga, 14 parts of angelica, 2 parts of scutellaria, 7 parts of anemarrhena, 2 parts of polygonatum, 5 parts of cassia twig, 1 part of dried ginger, 1 part of gypsum, 1 part of asparagus, 5 parts of white peony root, 1 part of poria, 5 parts of atractylodes, 5 parts of roasted liquorice, 15 parts of trichosanthes, 13 parts of allium macrostemon and 15 parts of pinellia.
[0027] The Chinese medicine preparation in this embodiment is prepared by the following steps: S1: Put the raw materials in the formula into a container and soak them in cold water for 22 minutes. The amount of cold water is enough to cover the Chinese herbal medicine pieces by 2.5 cm; S2: Boil the soaking liquid over high heat, then keep it over low heat for 25 minutes; S3: Filter while hot and collect the filtrate to obtain.
[0028] Example 4 A traditional Chinese medicine preparation for treating stable stage of chronic obstructive pulmonary disease, comprising the following raw materials in parts by mass: 13 parts of ephedra, 12 parts of cimicifuga, 9 parts of angelica, 3 parts of scutellaria, 3 parts of anemarrhena, 3 parts of polygonatum, 4 parts of cassia twig, 2 parts of dried ginger, 4 parts of gypsum, 4 parts of asparagus, 2 parts of white peony root, 2 parts of poria, 4 parts of atractylodes, 2 parts of roasted liquorice, 11 parts of trichosanthes, 8 parts of allium macrostemon and 13 parts of pinellia.
[0029] The Chinese medicine preparation in this embodiment is prepared by the following steps: S1: Put the raw materials in the formula into a container and soak them in cold water for 25 minutes. The amount of cold water is enough to cover the Chinese herbal medicine pieces by 3 cm; S2: Boil the soaking liquid over high heat, then keep it over low heat for 27 minutes; S3: Filter while hot and collect the filtrate to obtain.
[0030] Example 5 A traditional Chinese medicine preparation for treating stable stage of chronic obstructive pulmonary disease, comprising the following raw materials in parts by mass: 17 parts of ephedra, 9 parts of cimicifuga, 12 parts of angelica, 6 parts of scutellaria, 6 parts of anemarrhena, 6 parts of polygonatum, 2 parts of cassia twig, 4 parts of dried ginger, 2 parts of gypsum, 2 parts of asparagus, 4 parts of white peony root, 4 parts of poria, 2 parts of atractylodes, 4 parts of roasted liquorice, 13 parts of trichosanthes, 11 parts of allium macrostemon and 11 parts of pinellia.
[0031] The Chinese medicine preparation in this embodiment is prepared by the following steps: S1: Put the raw materials in the formula into a container and soak them in cold water for 20 minutes. The amount of cold water is enough to cover the Chinese herbal medicine pieces by 2 cm; S2: Boil the soaking liquid over high heat, then keep it over low heat for 25 minutes; S3: Filter while hot and collect the filtrate to obtain.
[0032] Comparative Example 1 A traditional Chinese medicine preparation for treating stable stage of chronic obstructive pulmonary disease, comprising the following raw materials in parts by mass: 10 parts of Cimicifuga, 10 parts of Angelica sinensis, 5 parts of Scutellaria baicalensis, 5 parts of Anemarrhena asphodeloides, 5 parts of Polygonatum odoratum, 3 parts of Cassia twig, 3 parts of dried ginger, 3 parts of Gypsum, 3 parts of Asparagus cochinchinensis, 3 parts of White Peony Root, 3 parts of Poria, 3 parts of Atractylodes macrocephala, 3 parts of Radix Glycyrrhizae Preparata, 12 parts of Trichosanthes, 9 parts of Allium macrostemon and 12 parts of Pinellia ternata.
[0033] The Chinese medicine preparation in this comparative example is prepared by the following steps: S1: Put the raw materials in the formula into a container and soak them in cold water for 20 minutes. The amount of cold water is enough to cover the Chinese herbal medicine pieces by 3 cm; S2: Boil the soaking liquid over high heat, then keep it over low heat for 30 minutes; S3: Filter while hot and collect the filtrate to obtain.
[0034] Clinical research trials 1. Case selection 1. Diagnostic criteria According to the diagnostic criteria for primary bronchogenic lung cancer in the "Chinese Primary Lung Cancer Diagnosis and Treatment Guidelines 2021 Edition"; the clinical staging adopts the TNM international staging of non-small cell lung cancer (UICC, 2015, 8th edition); TCM syndrome standards: the TCM syndrome standards for lung cancer in the "Traditional Chinese Medicine Diagnosis and Treatment Plan for Lung Cancer" (2021 edition) of the State Administration of Traditional Chinese Medicine are adopted.
[0035] 1.2. Case inclusion criteria: ① Stage III / IV non-small cell lung cancer that is not suitable for surgery as confirmed by pathological or cytological examination; ② Progression or recurrence after standard comprehensive anticancer treatment recommended by the 2019 version of the Guidelines for the Diagnosis and Treatment of Lung Cancer by the Chinese Society of Clinical Oncology (CSCO) (including first-line and second-line chemotherapy, radiotherapy, biological targeted and immune checkpoint inhibitor therapy recommended based on pathological classification, genetic testing and physical condition), or intolerance to adverse reactions of standard anticancer treatment; ③ Laboratory examinations meet the following criteria: WBC ≥3.0×10 9 / L, neutrophil ≥1.5×10 9 / L, platelet ≥60×10 9 / L, red blood cells ≥ 2×10 12 / L, hemoglobin ≥80g / L, total bilirubin ≤1.5 times the upper limit of normal, alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤3.0 times the upper limit of normal; ④ Age between 18 and 80 years old; ⑤ Karnofsky score greater than 40 points, expected survival period greater than 3 months; ⑥ There are measurable lesions; ⑦ Signed informed consent; 1.3. Case Exclusion Criteria: ① The patient's condition is stable after receiving standard first-line and second-line chemotherapy; ② The patient is positive for EGFR sensitive mutation or ALK fusion gene and is stable after receiving such drugs; ③ The patient's condition is stable after receiving immune checkpoint inhibitors; ④ Pregnant or lactating women or those preparing for pregnancy in the near future; ⑤ Patients with severe diseases such as liver, kidney, and hematopoietic system, or severe complications, infection, bleeding tendency, etc. that make them unable to tolerate the drugs used in this study; ⑥ Patients with severe mental illness, suspected or confirmed history of alcohol or drug abuse; ⑦ Allergic to the drugs used in this study or any of their ingredients; ⑧ Participated in other drug clinical trials in the past 3 months.
[0036] 1.4. Included cases: All 180 cases of advanced non-small cell lung cancer were inpatients and outpatients from Sichuan Second Hospital of Traditional Chinese Medicine from 2020 to 2023, including 87 males and 93 females, aged between 40 and 78 years old, with an average age of 55 years.
[0037] 2. Treatment Methods Grouping method: 180 cases were randomly divided into 5 groups, 4 of which were treatment groups and 1 was a control group, with 36 people in each group. There were no statistically significant differences in gender, age, symptom classification and grouping, and number of hospitalizations in the previous year among each group.
[0038] (1) Control group: The control group was treated according to the NCCN (2015 edition) guidelines for palliative treatment of tumors: psychological counseling and support were given to patients; cancer pain was assessed according to the step-by-step analgesia method, and first-level pain was treated with meloxicam tablets 7.5 mg, once a day; second-level pain was treated with tramadol hydrochloride sustained-release capsules 0.15 g, twice a day; third-level pain was treated with morphine titration; anorexia and cachexia were treated with megestrol acetate dispersible tablets 160 mg, twice a day; dyspnea was treated with oxygen inhalation, anti-infection, expectoration, and tracheal dilation according to different causes; dry cough was treated with compound codeine phosphate 10 mL, 3 times a day; anxiety and insomnia were treated with estazolam 1 mg, once a night. One course of treatment was 21 days of continuous treatment, and the second course was continued after 7 days of rest, for a total of 4 courses.
[0039] (2) Treatment group: The treatment was the same as that of the control group; the patients in the treatment group were treated with the decoction prepared in Example 1, Example 2, Example 3 and Comparative Example 1, respectively, orally, one dose per day, three times a day, for 21 consecutive days as one course of treatment, and then continued the second course of treatment after a 7-day rest, for a total of 4 courses of treatment.
[0040] 3. Efficacy evaluation 1.1 Short-term efficacy: According to the RECIST1.1 standard, the efficacy was evaluated according to the changes in target lesions and was divided into complete remission (CR): all target lesions disappeared, partial remission (PR): the diameter of the target lesion decreased by ≥30%, stable (SD): the target lesion changed between -30% and +20%, and progressive (SD): the diameter of the target lesion increased by ≥20% or new lesions were generated.
[0041] Objective response rate (ORR) = CR + PR, disease control rate (DCR) = CR + PR + SD.
[0042] 1.2. Evaluation of TCM syndromes: refer to the "Guidelines for Clinical Research of New Chinese Medicines" (2002 edition) and "Guidelines for the Treatment of Primary Bronchogenic Lung Cancer with New Chinese Medicines" combined with the provisions of Ma Huang Sheng Ma Decoction in Treatise on Febrile Diseases to grade and evaluate the efficacy of advanced lung cancer-related symptoms: cough, sputum, shortness of breath, chest pain, spitting blood and pus, laryngopharyngeal discomfort, cold hands and feet, diarrhea, fatigue, fever, poor appetite, dry mouth, and slow pulse; Evaluation indicators: divided into 4 levels based on clinical observation: no symptoms: 0 points, mild: 2 points, moderate: 3 points, severe: 4 points.
[0043] Evaluation method: Comparison of total symptom scores before and after treatment; markedly effective: symptoms disappear, or symptom scores decrease ≥2 / 3; effective: symptoms are alleviated, scores decrease ≥1 / 3, ≤2 / 3; ineffective: symptoms are not alleviated or are alleviated <1 / 3.
[0044] 1.3. Evaluation of laboratory indicators: systemic immune inflammatory index (SII) = absolute platelet value × absolute neutrophil value / absolute lymphocyte value; advanced lung cancer inflammatory index (ALI) = body mass index × albumin / NLR (NLR = absolute neutrophil value / absolute lymphocyte value); serum C-reactive protein / serum albumin (CRP / ALB).
[0045] IV. Experimental Results Table 1 Results of short-term efficacy evaluation
[0046] As can be seen from Table 1, the patients in treatment groups 1 to 3 took the Chinese medicine preparation in the embodiment of the present invention orally for combined treatment while receiving palliative treatment, and their objective remission rate and disease control rate were significantly higher than those in the control group and treatment group 4.
[0047] Table 2 Results of TCM syndrome evaluation
[0048] As shown in Table 2, after treatment, the symptom scores of the patients in the control group were reduced by 7 points, the symptom scores of the patients in the treatment group 4 were reduced by 8 points, and the symptom scores of the patients in the treatment groups 1 to 3 were reduced by 20 points, 17 points, and 15 points, respectively. According to the evaluation method, it can be seen that the treatment methods of the patients in the treatment groups 1 to 3 met the standards for marked or effective results.
[0049] Table 3 Laboratory index evaluation results
[0050] As can be seen from Table 3, after the patient took the Chinese medicine preparation in the embodiment of the present invention in combination with palliative treatment, the changes in the immune inflammation index indicated that the treatment was effective, the disease was being alleviated or controlled, and the patient had a better prognosis and a longer survival period.
[0051] In summary, it is shown that the Chinese medicine preparation of the present invention has a significant effect in improving the quality of life of patients with non-small cell lung cancer and controlling the disease.
[0052] Although the specific implementation of the present invention is described in detail in conjunction with the embodiments, it should not be understood as limiting the scope of protection of this patent. Within the scope described in the claims, various modifications and variations that can be made by those skilled in the art without creative work still fall within the scope of protection of this patent.
Claims
1. A Chinese medicine preparation for treating advanced non-small cell lung cancer, characterized in that: Ingredients include: Ephedra, Cimicifuga, Angelica, Scutellaria, Anemarrhena, Polygonatum, Cassia twig, Dried ginger, Gypsum, Asparagus, White Peony Root, Poria, Atractylodes, Roasted Licorice, Trichosanthes, Allium macrostemon and Pinellia.
2. The Chinese medicine preparation for treating advanced non-small cell lung cancer according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 10-20 parts of ephedra, 7-14 parts of cimicifuga, 7-14 parts of angelica, 2-7 parts of scutellaria, 2-7 parts of anemarrhena, 2-7 parts of polygonatum, 1-5 parts of cassia twig, 1-5 parts of dried ginger, 1-5 parts of gypsum, 1-5 parts of asparagus, 1-5 parts of white peony root, 1-5 parts of poria, 1-5 parts of atractylodes, 1-5 parts of roasted liquorice, 9-15 parts of trichosanthes, 7-13 parts of allium macrostemon and 9-15 parts of pinellia.
3. The Chinese medicine preparation for treating advanced non-small cell lung cancer according to claim 2, characterized in that: The invention comprises the following raw materials in parts by weight: 13-17 parts of ephedra, 9-12 parts of cimicifuga, 9-12 parts of angelica, 3-6 parts of scutellaria, 3-6 parts of anemarrhena, 3-6 parts of polygonatum, 2-4 parts of cassia twig, 2-4 parts of dried ginger, 2-4 parts of gypsum, 2-4 parts of asparagus, 2-4 parts of white peony root, 2-4 parts of poria, 2-4 parts of atractylodes, 2-4 parts of roasted liquorice, 11-13 parts of trichosanthes, 8-11 parts of allium macrostemon and 11-13 parts of pinellia.
4. The Chinese medicine preparation for treating advanced non-small cell lung cancer according to claim 3, characterized in that: The invention comprises the following raw materials in parts by weight: 15 parts of ephedra, 10 parts of cimicifuga, 10 parts of angelica, 5 parts of scutellaria, 5 parts of anemarrhena, 5 parts of polygonatum, 3 parts of cinnamon twig, 3 parts of dried ginger, 3 parts of gypsum, 3 parts of asparagus, 3 parts of white peony root, 3 parts of poria, 3 parts of atractylodes, 3 parts of roasted liquorice, 12 parts of trichosanthes, 9 parts of allium macrostemon and 12 parts of pinellia.
5. The Chinese medicine preparation for treating advanced non-small cell lung cancer according to any one of claims 1 to 4, characterized in that: The dosage form of the Chinese medicine preparation is a decoction.
6. The method for preparing the Chinese medicine preparation for treating advanced non-small cell lung cancer according to any one of claims 1 to 5, characterized in that: The following steps are involved: S1: Put the raw materials in the formula into a container and soak them in cold water; S2: Boil the soaking liquid over high heat, then keep it over low heat for 25-30 minutes; S3: Filter while hot and collect the filtrate to obtain.
7. The preparation method according to claim 6, characterized in that: The soaking time in step S1 is 20 to 25 minutes.
8. The preparation method according to claim 6, characterized in that: In step S1, the amount of cold water used is such that it covers the Chinese herbal medicine pieces by 2-3 cm.