Traditional Chinese medicine compound preparation for treating non-small cell lung cancer

Abstract

This invention relates to the field of traditional Chinese medicine technology, specifically to a compound traditional Chinese medicine preparation for treating non-small cell lung cancer, made from the following herbs: Schisandra chinensis, Gecko, Sea Snail, Strychnos nux-vomica, Wisteria zedoaria, Centella asiatica, Paris polyphylla, Clerodendrum trichotomum, Pinus massoniana, Smilax china, Terminalia chebula, Dioscorea nipponica, and Vaccaria segetalis. The weight ratio of the herbs is: Schisandra chinensis 9g-15g, Gecko 3g-9g, Sea Snail 9g-15g, Strychnos nux-vomica 3g-9g, Wisteria zedoaria 1g, and Smilax china 1g. The ingredients are 0g-30g, Centella asiatica 15g-30g, Paris polyphylla 9g-15g, Clerodendrum trichotomum 9g-15g, Pinus massoniana 9g-15g, Smilax china 9g-15g, Terminalia chebula 6g-12g, Dioscorea nipponica 9g-15g, and Vaccaria segetalis 9g-15g. This invention can significantly improve patients' symptoms such as cough, phlegm, chest pain, and purplish tongue, alleviate pain, improve patients' quality of life, reduce toxicity and increase efficacy, reduce treatment costs, and prolong patients' lifespan.

Description

Technical Field

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

[0002] Non-small-cell lung cancer (NSCLC) is a common cancer that occurs in the lungs. Based on pathological tissue structure, it is divided into different types such as squamous cell carcinoma, adenocarcinoma, and large cell carcinoma. NSCLC accounts for about 80-85% of all lung cancers. At the time of diagnosis, 80% of these patients are already in the middle or late stages and have lost the opportunity for surgery. The overall 5-year survival rate for these patients is less than 5%, and only 20% can undergo surgical treatment. The postoperative recurrence and metastasis rate is still as high as 50%. Modern medical treatment mainly uses surgery, radiotherapy, chemotherapy, and targeted therapy. Although surgery and radiotherapy and chemotherapy have clear clinical efficacy, the adverse reactions they bring are still difficult for many patients to tolerate. Targeted drugs are expensive, which brings a heavy economic burden to most patients. Moreover, targeted drugs are only effective for some patients with gene mutations. Therefore, many patients seek treatment with traditional Chinese medicine. Summary of the Invention

[0003] The purpose of this invention is to address the shortcomings of existing technologies and provide a traditional Chinese medicine compound preparation for treating non-small cell lung cancer that can significantly improve symptoms such as cough, sputum production, chest pain, and purplish tongue, alleviate pain, improve patients' quality of life, reduce toxicity and enhance efficacy, reduce treatment costs, and prolong patients' lifespan.

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

[0005] A traditional Chinese medicine compound preparation for treating non-small cell lung cancer, characterized in that it is made from the following traditional Chinese medicines: Schisandra chinensis, Gecko, Sea snail, Strychnos nux-vomica, Wisteria zedoaria, Centella asiatica, Paris polyphylla, Clerodendrum trichotomum, Pinus massoniana, Smilax china, Terminalia chebula, Dioscorea nipponica, and Vaccaria segetalis.

[0006] The weight ratio of the Chinese herbs described in this invention is as follows: Schisandra chinensis 9g-15g, Gecko 3g-9g, Sea snail 9g-15g, Strychnos nux-vomica 3g-9g, Wisteria 10g-30g, Centella asiatica 15g-30g, Paris polyphylla 9g-15g, Clerodendrum trichotomum 9g-15g, Pinus massoniana 9g-15g, Smilax china 9g-15g, Terminalia chebula 6g-12g, Dioscorea nipponica 9g-15g, Vaccaria segetalis 9g-15g.

[0007] The weight ratio of the Chinese herbs described in this invention is as follows: Schisandra chinensis 9g, Gecko 3g, Sea snail 9g, Strychnos nux-vomica 3g, Wisteria 10g, Centella asiatica 15g, Paris polyphylla 9g, Clerodendrum trichotomum 9g, Pinus massoniana 9g, Smilax china 9g, Terminalia chebula 6g, Dioscorea nipponica 9g, Vaccaria segetalis 9g.

[0008] The traditional Chinese medicine compound preparations described in this invention can be decoctions, pills, powders, granules, or capsules.

[0009] A method for preparing a traditional Chinese medicine compound for treating non-small cell lung cancer, characterized by comprising the following steps:

[0010] Step 1: Weigh out the following ingredients separately: Schisandra chinensis 9g-15g, Gecko 3g-9g, Sea snail 9g-15g, Strychnos nux-vomica 3g-9g, Wisteria 10g-30g, Centella asiatica 15g-30g, Paris polyphylla 9g-15g, Clerodendrum trichotomum 9g-15g, Pinus thunbergii 9g-15g, Smilax china 9g-15g, Terminalia chebula 6g-12g, Dioscorea nipponica 9g-15g, and Vaccaria segetalis 9g-15g.

[0011] Step 2: Place the herbs in a pot, add an equal amount of cold water, and soak for 20-30 minutes; bring to a boil over high heat, then simmer over low heat for 30 minutes. Separate the decoction, add water to the dregs and boil a second time, then combine the decoctions to obtain the aqueous decoction.

[0012] The above technical solutions can be implemented in the following ways:

[0013] A method for preparing a traditional Chinese medicine compound for treating non-small cell lung cancer, characterized by comprising the following steps:

[0014] Step 1: Weigh out the following ingredients separately: Schisandra chinensis 9g-15g, Gecko 3g-9g, Sea snail 9g-15g, Strychnos nux-vomica 3g-9g, Wisteria 10g-30g, Centella asiatica 15g-30g, Paris polyphylla 9g-15g, Clerodendrum trichotomum 9g-15g, Pinus thunbergii 9g-15g, Smilax china 9g-15g, Terminalia chebula 6g-12g, Dioscorea nipponica 9g-15g, and Vaccaria segetalis 9g-15g.

[0015] Step 2: After mixing all the above Chinese herbs evenly, grind them with a pulverizer, sieve them (60-100 mesh) to form a powder.

[0016] The above technical solutions can also be implemented in the following ways:

[0017] A method for preparing a traditional Chinese medicine compound for treating non-small cell lung cancer, characterized by comprising the following steps:

[0018] Step 1: Weigh out the following ingredients separately: Schisandra chinensis 9g-15g, Gecko 3g-9g, Sea snail 9g-15g, Strychnos nux-vomica 3g-9g, Wisteria 10g-30g, Centella asiatica 15g-30g, Paris polyphylla 9g-15g, Clerodendrum trichotomum 9g-15g, Pinus thunbergii 9g-15g, Smilax china 9g-15g, Terminalia chebula 6g-12g, Dioscorea nipponica 9g-15g, and Vaccaria segetalis 9g-15g.

[0019] Step 2: After mixing all the above Chinese herbs evenly, grind them in a pulverizer and sieve them with a mesh size of 60-100 to form a powder.

[0020] Step 3: Sterilize the powder obtained in Step 2 with moist heat, and encapsulate it, with each capsule containing 0.43 grams; or add honey to the powder obtained in Step 2 in a 1:1 ratio to make honey pills; or add purified water to the powder obtained in Step 2 to make water pills.

[0021] The pharmacological effects of the various traditional Chinese medicines in this invention are as follows:

[0022] Schisandra chinensis, first recorded in the Shennong's Classic of Materia Medica, is sour and warm in nature. It enters the lung and kidney meridians and is good at astringing the lungs and nourishing the kidneys, promoting body fluids and stopping sweating, astringing essence and stopping diarrhea. Clinically, it is used to treat cough, wheezing, spermatorrhea, spontaneous sweating, thirst, insomnia and dreaminess.

[0023] Gecko is neutral in nature and salty in taste. It enters the lung and kidney meridians and can nourish the lungs and kidneys, regulate qi and relieve asthma, and invigorate yang and replenish essence. It also has the effects of regulating immunity, anti-tumor, relieving asthma, anti-inflammation and anti-aging.

[0024] Sea snails are sweet and pungent in taste, neutral in nature, and enter the spleen and lung meridians. They have the effects of invigorating qi and nourishing yin, detoxifying and reducing swelling, draining pus, and promoting lactation.

[0025] Strychnos nux-vomica is bitter and cold in nature, and has the effects of clearing the meridians, dispersing nodules, reducing swelling, and relieving pain. The Compendium of Materia Medica records that it "treats typhoid fever, sore throat, and eliminates lumps." The active ingredients of Strychnos nux-vomica, such as strychnine, strychnine N-oxide, and isosteminine, can inhibit the growth and proliferation of tumor cells through multiple mechanisms, and have inhibitory effects on various tumors.

[0026] Wisteria tubercles are growths that grow on the stems of wisteria. They can be used in medicine and have analgesic, detoxifying, and antibacterial effects.

[0027] Centella asiatica is cold in nature and bitter and pungent in taste. It enters the liver, spleen and kidney meridians and has the effects of clearing heat and dampness, detoxifying and reducing swelling. It is mainly used to treat damp-heat jaundice, heatstroke diarrhea, urinary stones and hematuria, carbuncles and boils, and injuries from falls.

[0028] Paris polyphylla, also known as Chonglou, has a bitter taste, is slightly cold in nature, and is slightly toxic. It has the effects of clearing heat and detoxifying, reducing swelling and relieving pain, cooling the liver and calming the nerves.

[0029] Clerodendrum trichotomum is neutral in nature and has a bitter and pungent taste. It has the effects of dispelling wind and detoxifying, reducing swelling and relieving pain, and lowering blood pressure.

[0030] The evergreen pine, primarily the Masson pine (Pinus massoniana), belongs to the genus Pinus of the family Pinaceae and is used medicinally. Pine needles have a long history of medicinal use, first recorded in the *Compendium of Materia Medica*: "Finely chopped, it can be taken with water and flour as a drink, or pounded into powder and made into pills for consumption; it can relieve hunger and treat serious illnesses." Volatile oil compounds in pine needles are the most frequently reported type of compounds, representing the active ingredients responsible for their anti-aging, antibacterial, antiviral, analgesic, anti-inflammatory, and anti-tumor properties.

[0031] Green hibiscus is cold in nature and sweet in taste. It enters the heart, lung, and liver meridians and has the effects of clearing heat and moistening the lungs, strengthening the spleen and eliminating food stagnation, detoxifying and reducing swelling, dispersing blood stasis and reducing swelling, calming and relieving pain. It is mainly used to treat pulmonary tuberculosis with hemoptysis, cough due to lung heat, sore throat, scrofula, canker sores, carbuncles and boils, and traumatic injuries.

[0032] Terminalia chebula is bitter, sour, astringent, and neutral in nature. It enters the lung and large intestine meridians and has the effects of astringing the intestines to stop diarrhea, astringing the lungs to stop cough, reducing internal heat and relieving sore throat.

[0033] Dioscorea nipponica, scientifically known as Dioscorea nipponica, has a sweet and bitter taste, is warm in nature, and enters the liver, kidney, and lung meridians.

[0034] Wang Bu Liu Xing (Semen Vaccariae) is bitter and sweet in taste, neutral in nature, and non-toxic. It is primarily used to treat wounds, stop bleeding, relieve pain, remove thorns, dispel wind-dampness and internal cold, relieve irritability, treat nosebleeds, carbuncles, malignant sores, fistulas, and difficult childbirth in women. Long-term use is said to promote lightness of body, delay aging, and extend lifespan. Wang Bu Liu Xing contains a variety of chemical components, including volatile oils, flavonoid glycosides, cyclic peptides, and saponins, which possess pharmacological effects such as anti-tumor, antibacterial, anti-inflammatory, and antioxidant properties.

[0035] Because of the above-mentioned structure, this invention has the advantages of significantly improving patients' symptoms such as cough, sputum, chest pain, and purplish tongue, alleviating pain, improving patients' quality of life, reducing toxicity and increasing efficacy, low treatment cost, and prolonging patients' lifespan. Detailed Implementation

[0036] The specific embodiments of the present invention will be described in further detail below with reference to the accompanying drawings.

[0037] A traditional Chinese medicine compound preparation for treating non-small cell lung cancer, characterized in that it is made from the following traditional Chinese medicines: Schisandra chinensis, Gecko, Sea snail, Strychnos nux-vomica, Wisteria zedoaria, Centella asiatica, Paris polyphylla, Clerodendrum trichotomum, Pinus massoniana, Smilax china, Terminalia chebula, Dioscorea nipponica, and Vaccaria segetalis.

[0038] The weight ratio of the Chinese herbs described in this invention is as follows: Schisandra chinensis 9g-15g, Gecko 3g-9g, Sea snail 9g-15g, Strychnos nux-vomica 3g-9g, Wisteria 10g-30g, Centella asiatica 15g-30g, Paris polyphylla 9g-15g, Clerodendrum trichotomum 9g-15g, Pinus massoniana 9g-15g, Smilax china 9g-15g, Terminalia chebula 6g-12g, Dioscorea nipponica 9g-15g, Vaccaria segetalis 9g-15g.

[0039] The weight ratio of the Chinese herbs described in this invention is as follows: Schisandra chinensis 9g, Gecko 3g, Sea snail 9g, Strychnos nux-vomica 3g, Wisteria 10g, Centella asiatica 15g, Paris polyphylla 9g, Clerodendrum trichotomum 9g, Pinus massoniana 9g, Smilax china 9g, Terminalia chebula 6g, Dioscorea nipponica 9g, Vaccaria segetalis 9g.

[0040] The traditional Chinese medicine compound preparations described in this invention can be decoctions, pills, powders, granules, or capsules.

[0041] A method for preparing a traditional Chinese medicine compound for treating non-small cell lung cancer, characterized by comprising the following steps:

[0042] Step 1: Weigh out 9g of Schisandra chinensis, 3g of Gecko, 9g of Sea Snail, 3g of Strychnos nux-vomica, 10g of Wisteria zedoaria, 15g of Centella asiatica, 9g of Paris polyphylla, 9g of Clerodendrum trichotomum, 9g of Pinus massoniana, 9g of Smilax china, 6g of Terminalia chebula, 9g of Dioscorea nipponica, and 9g of Vaccaria segetalis.

[0043] Step 2: Place the herbs in a pot, add an equal amount of cold water, and soak for 20-30 minutes; bring to a boil over high heat, then simmer over low heat for 30 minutes. Separate the decoction, add water to the dregs and boil a second time, then combine the decoctions to obtain the aqueous decoction.

[0044] A method for preparing a traditional Chinese medicine compound for treating non-small cell lung cancer, characterized by comprising the following steps:

[0045] Step 1: Weigh out 9g of Schisandra chinensis, 3g of Gecko, 9g of Sea Snail, 3g of Strychnos nux-vomica, 10g of Wisteria zedoaria, 15g of Centella asiatica, 9g of Paris polyphylla, 9g of Clerodendrum trichotomum, 9g of Pinus massoniana, 9g of Smilax china, 6g of Terminalia chebula, 9g of Dioscorea nipponica, and 9g of Vaccaria segetalis.

[0046] Step 2: After mixing all the above Chinese herbs evenly, grind them with a pulverizer, sieve them (60-100 mesh) to form a powder.

[0047] A method for preparing a traditional Chinese medicine compound for treating non-small cell lung cancer, characterized by comprising the following steps:

[0048] Step 1: Weigh out 9g of Schisandra chinensis, 3g of Gecko, 9g of Sea Snail, 3g of Strychnos nux-vomica, 10g of Wisteria zedoaria, 15g of Centella asiatica, 9g of Paris polyphylla, 9g of Clerodendrum trichotomum, 9g of Pinus massoniana, 9g of Smilax china, 6g of Terminalia chebula, 9g of Dioscorea nipponica, and 9g of Vaccaria segetalis.

[0049] Step 2: After mixing all the above Chinese herbs evenly, grind them in a pulverizer and sieve them with a mesh size of 60-100 to form a powder.

[0050] Step 3: Sterilize the powder obtained in Step 2 with moist heat, and encapsulate it, with each capsule containing 0.43 grams; or add honey to the powder obtained in Step 2 in a 1:1 ratio to make honey pills; or add purified water to the powder obtained in Step 2 to make water pills.

[0051] Dosage instructions:

[0052] The decoction should be taken twice a day, once in the morning and once in the evening.

[0053] The capsules are to be taken orally, 3 to 6 capsules at a time, 3 times a day, or as directed by a physician.

[0054] Contraindications of this invention: Avoid smoking, alcohol, and spicy foods; not for use by pregnant women; use with caution in patients with liver or kidney dysfunction; contraindicated in patients with severe liver or kidney dysfunction or severe coagulation disorders; contraindicated in patients allergic to any of the ingredients of this product.

[0055] This invention, by using the above-mentioned preparation, significantly improves patients' symptoms such as cough, sputum, chest pain, and purplish tongue, alleviates pain, improves patients' quality of life, reduces toxicity and increases efficacy, has low treatment costs, and prolongs patients' lifespan.

[0056] Clinical trials

[0057] 1. Clinical Data

[0058] 1.1 Research Subjects

[0059] The study cases in this clinical trial were patients with stage IIIB to IV non-small cell lung cancer with phlegm-blood stasis syndrome who visited Yantai Traditional Chinese Medicine Hospital between June 2020 and June 2022.

[0060] 1.2 Inclusion Criteria

[0061] 1.2.1 Western Medicine Diagnostic Criteria:

[0062] The WHO Remedial Clinical Trial and Evaluation Criteria in Solid Tumors (RECIST) classifies the condition as stable. B or Patients with stage I NSCLC, a KPS score ≥60, an expected survival of more than 3 months, basically normal liver and kidney function and electrocardiogram, and no brain metastasis.

[0063] 1.2.2 Diagnostic criteria for syndromes in Traditional Chinese Medicine:

[0064] Based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" issued by the State Food and Drug Administration in 2002, and combined with many years of clinical experience in the oncology department, the following diagnostic criteria for the syndrome of phlegm-blood stasis in traditional Chinese medicine were formulated:

[0065] Phlegm-blood stasis syndrome:

[0066] Main symptoms: (1) paroxysmal cough; (2) white and sticky sputum or yellow and sticky sputum; (3) chest tightness and shortness of breath; (4) chest pain, like a needle or a thorn.

[0067] Secondary symptoms: (1) chest and rib distension; (2) fever; (3) shortness of breath; (4) bitter taste in the mouth;

[0068] Tongue and pulse: The tongue is purplish or dark red, or has ecchymosis, with a white or yellow greasy coating, and the pulse is wiry and slippery or slippery and rapid.

[0069] If two main symptoms or one main symptom plus two secondary symptoms are met, combined with tongue and pulse diagnosis, a diagnosis of phlegm-blood stasis syndrome can be made.

[0070] 1.3 Inclusion Criteria

[0071] (1) All patients were diagnosed by cytological or histopathological examination. B or (1) Patients with stage NSCLC who are diagnosed with phlegm-blood stasis syndrome according to traditional Chinese medicine; (2) Can be followed up and observed; (3) Voluntarily participate in this study and sign an informed consent form.

[0072] 1.4 Exclusion Criteria

[0073] (1) Those suffering from mental disorders or mental illnesses; (2) Those with right brain metastases and whose condition is not under control; (3) Those who cannot take oral medications; (4) Those with severe infectious diseases; (5) Those with severe heart, liver, kidney, or other functional abnormalities; (6) Those who are allergic to drugs.

[0074] 2. Research Content and Methods

[0075] This study observed 300 patients with stage IIIB to IV non-small cell lung cancer who were hospitalized and eligible for follow-up treatment in the Department of Oncology at Yantai Traditional Chinese Medicine Hospital from June 2020 to June 2022. Patients were randomly divided into a treatment group (n=150) and a control group (n=150). There were no statistically significant differences between the two groups in terms of gender, age, pathological type, clinical stage, and KPS score. The observation period was from before the start of chemotherapy to one week after the end of chemotherapy. Efficacy was evaluated every two cycles.

[0076] 2.1 Treatment Plan

[0077] Control group: Paclitaxel (albumin-bound) 100 mg / m² for injection 2 Cisplatin 25 mg / m² was administered intravenously on days 1, 8, and 15. 2 The regimen is administered via intravenous infusion on days 2, 3, and 4, for a total of 4 cycles. Before chemotherapy, antiemetics such as granisetron or tropisetron are routinely given to stop vomiting. When using cisplatin, routine hydration and diuresis are performed, along with routine symptomatic and supportive treatment.

[0078] Treatment group: The chemotherapy regimen was the same as that of the control group. In addition to the treatment regimen of the control group, the traditional Chinese medicine preparation of this invention was taken, 5 pills each time, 3 times a day, for one month as one course of treatment. The efficacy was evaluated every 2 cycles.

[0079] 2.2 Observation Indicators

[0080] 2.2.1 Changes in tumor lesions before and after treatment: Imaging examinations were performed before and after treatment to assess changes in tumor lesions, referring to the RECIST 1.1 criteria for solid tumor assessment.

[0081] (1) Complete remission (CR): All lesions completely disappear and are maintained for at least 4 weeks.

[0082] (2) Partial remission (PR): For lesions with measurable diameters, the sum of the products of the maximum diameters of each lesion (take the maximum diameter of the lesion and the diameter perpendicular to it, multiply the lengths of the two to obtain the product of the maximum perpendicular diameter, and then add the products of the maximum perpendicular diameters of each lesion) is reduced by more than 50% and maintained for at least 4 weeks; for lesions with measurable diameters, the sum of the maximum diameters of each lesion is reduced by more than 50% and maintained for at least 4 weeks.

[0083] (3) No change (NC) lesions with measurable diameters in both diameters, where the sum of the products of the maximum vertical diameters of each lesion has decreased by less than 50% or increased by no more than 25%, and have been maintained for at least 4 weeks, and can only be evaluated as NC after at least two cycles of treatment (6 weeks).

[0084] (4) Progressive disease (PD): If one or more lesions increase in size by more than 25%, or new lesions appear, or new pleural or peritoneal effusions appear, and cancer cells are found in cytology, it should be determined as PD.

[0085] Clinical efficacy: Efficacy rate = (Number of PR cases / Total number of cases) × 100%;

[0086] Lesion stabilization rate = (PR + NC) cases / total number of cases × 100%.

[0087] 2.2.2 Clinical symptoms: The TCM symptoms were evaluated using five indicators: cough, sputum production, chest pain, shortness of breath, and purplish tongue. According to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" (Ministry of Health of the People's Republic of China, Guiding Principles for Clinical Research of New Traditional Chinese Medicines, Vol. 3, 1997, 3-36), common symptoms were divided into four levels: 0 points for no symptoms, 1 point for mild symptoms, 2 points for moderate symptoms, and 3 points for severe symptoms. The scores were measured and recorded once before and after treatment, and the changes in the scores before and after treatment were observed to evaluate the efficacy.

[0088] (1) Significant effect: The clinical symptom score after treatment decreased by more than 70% compared with that before treatment;

[0089] (2) Effective: The score decreased by more than 30% and less than 70% after treatment;

[0090] (3) Stable: No change in score after treatment;

[0091] (4) Ineffective: The score actually increased after treatment;

[0092] Effectiveness rate = (Number of cases with significant effect + Number of cases with effective effect) / Total number of cases × 100%.

[0093] 2.2.3 Changes in quality of life before and after treatment: The changes in patients' Karnofsky Performance Status (KPS) scores before and after treatment were observed and compared, using the Karnofsky scoring system: 100 points: Normal, no symptoms or signs; 90 points: Able to perform normal activities, with mild symptoms and signs; 80 points: Barely able to perform normal activities, with some symptoms or signs; 70 points: Able to live independently, but unable to maintain a normal life and work; 60 points: Able to live mostly independently, but occasionally needs assistance; 50 points: Often needs care; 40 points: Unable to live independently, requiring special care and assistance; 30 points: Severely unable to live independently; 20 points: Seriously ill, requiring hospitalization and active supportive treatment; 10 points: Critically ill, nearing death; 0 points: Death. Higher scores indicate better health and greater tolerance for the side effects of treatment, making complete treatment more likely. Lower scores indicate poorer health; scores below 60 points may preclude the implementation of many effective anti-tumor treatments.

[0094] (1) Increase: KPS score increased by ≥10 points compared with before treatment;

[0095] (2) Stable: The increase or decrease in KPS score after treatment is less than 10 points;

[0096] (3) Decrease: KPS score decreased by ≥10 points compared with before treatment.

[0097] 2.2.4 Adverse reactions: Observe and compare common adverse reactions of chemotherapy (bone marrow suppression, nausea and vomiting, fatigue, numbness in the hands and feet) that occur in patients during treatment. According to the CTCAE v5.0 system for evaluating adverse reactions of tumor chemotherapy drugs, the above adverse events are classified into five levels: 1, 2, 3, 4, and 5.

[0098] CTCAE provides specific clinical descriptions of the severity (grade 1-5) of each adverse event based on the following fundamental criteria:

[0099] Grade 1: Mild: Asymptomatic or mild: Only clinically or diagnostically observed, no surgery required.

[0100] Grade 2: Moderate: Requires minor, local or non-invasive treatment; age-appropriate limitations in instrumental activities of daily living.

[0101] Level 3: Serious or of significant medical importance but not immediately life-threatening; requires hospitalization or prolongs hospitalization; disabling: limited ability to perform daily living activities.

[0102] Level 4: Life-threatening: Requires emergency treatment.

[0103] Level 5: Deaths related to AE.

[0104] 2.3 Statistical Methods

[0105] Statistical analysis of the obtained data was performed using SPSS 26.0 software. t-tests were used for continuous data, chi-square tests for categorical data, and rank-sum tests for ordinal data. All statistical analyses employed two-tailed hypothesis testing.

[0106] The significance level for the hypothesis test is set at α = 0.05, meaning that P < 0.05 is considered to indicate a statistically significant difference.

[0107] 3. Results

[0108] 3.1 Changes in lesions before and after treatment: Table 1 shows the changes in lesions before and after treatment in the treatment group and the control group. Before treatment, there was no statistically significant difference in the lesion condition between the treatment group and the control group (P>0.05). As can be seen from the data in Table 1, after treatment, the effective rate of treatment in the treatment group (12%) was higher than that in the control group (10%), and the lesion stabilization rate (69.3%) was higher than that in the control group (63.3%). This indicates that the traditional Chinese medicine preparation of the present invention has a certain effect in treating and stabilizing lesions. Although the statistical results show that there is no statistically significant difference in the effective rate and lesion stabilization rate between the treatment group and the control group after treatment (P>0.05), this also indirectly shows that the traditional Chinese medicine preparation of the present invention has non-inferiority in stabilizing lesions.

[0109] Table 1 Comparison of lesion changes before and after treatment

[0110]

[0111] 3.2 Changes in clinical symptoms and physical condition in the two groups: Table 2 shows the data on changes in clinical symptoms before and after treatment in the treatment group and the control group.

[0112] Before treatment, the symptom scores of the treatment group and the control group were (7.35±2.12) and (7.28±2.15) respectively, with no significant difference (P>0.05). After treatment, the treatment group showed significant improvement in the five main symptoms of cough, sputum production, chest pain, shortness of breath, and purplish tongue compared with the control group, with significant differences (P<0.05). The improvement in sputum production was more significant, indicating that this compound preparation can significantly improve the main clinical symptoms of patients with mid-to-late stage lung cancer.

[0113] Table 2 Symptom improvement after treatment

[0114]

[0115] 3.3 Changes in quality of life before and after treatment: Table 3 shows the KPS scores of the treatment group and the control group before and after treatment.

[0116] Before treatment, there was no significant difference in KPS scores between the treatment group and the control group (P>0.05). After treatment, in the treatment group, 109 patients showed effective KPS scores and 30 patients showed stable scores; in the control group, 73 patients showed effective KPS scores and 58 patients showed stable scores. The number of patients with elevated KPS scores in the treatment group was significantly higher than that in the control group, and the differences between the two groups were statistically significant (P<0.05). This indicates that the traditional Chinese medicine preparation of this invention improves the clinical symptoms of "phlegm and blood stasis" through the methods of resolving phlegm, removing blood stasis, detoxifying, and dispersing nodules, thereby improving the quality of life of patients.

[0117] Table 3 Comparison of changes in KPS scores before and after treatment.

[0118]

[0119] 3.4 Adverse reactions: Table 4 shows the comparative data of adverse reactions after chemotherapy in the experimental group and the control group. The treatment group showed significant improvement in nausea and vomiting, leukopenia, and peripheral neuropathy compared with the control group, with statistically significant differences (P<0.05). This indicates that the important compound preparation of the present invention can greatly reduce the symptoms of nausea and vomiting, leukopenia, and peripheral neuropathy caused by chemotherapy, and improve the comfort of patients.

[0120] Table 4 Comparison of adverse reactions after chemotherapy in the two groups

[0121]

[0122] In conclusion, this traditional Chinese medicine compound preparation combined with chemotherapy (paclitaxel (albumin-bound) 100mg / m2 intravenously on days 1, 8, and 15, and cisplatin 25mg / m2 intravenously on days 2, 3, and 4) for the treatment of "phlegm-stasis-toxin" type non-small cell lung cancer showed superior results compared to the control group treated with chemotherapy alone in terms of improving major symptoms and increasing KPS scores, demonstrating the unique advantages of this preparation in enhancing efficacy and reducing toxicity in the treatment of non-small cell lung cancer.

[0123] 4. Typical Cases

[0124] Typical case:

[0125] 1. Mr. Tang, male, 62 years old, from Yantai City, visited the clinic on July 1, 2021. The patient had been diagnosed with multiple metastases of lung adenocarcinoma for 6 months and had undergone 3 cycles of chemotherapy. At the time of consultation, he presented with cough, stabbing pain in the right chest, which worsened with coughing, poor appetite, constipation, dark red tongue with white and greasy coating, and wiry and slippery pulse. He was diagnosed with "lung cancer" and the syndrome was diagnosed as phlegm and blood stasis. The treatment should focus on resolving phlegm, removing blood stasis, detoxifying and dispersing nodules. He was given chemotherapy combined with this compound preparation orally, 5 pills each time, three times a day. After 2 months of taking the medicine, the patient's cough, phlegm, and stabbing pain in the chest and ribs were reduced. After 6 cycles of chemotherapy, he continued to take this compound preparation orally for maintenance treatment. The patient's condition remained stable during a 1-year follow-up.

[0126] 2. Patient Xue, male, 68 years old, from Yantai City, presented on December 6, 2020, with a history of squamous cell carcinoma of the right lung for six months. His current symptoms included cough, chest tightness and shortness of breath, chest pain, expectoration of white, sticky sputum with occasional blood in the sputum, a KPS score of 70, poor appetite, and constipation. His tongue was dark red with a white, greasy coating, and his pulse was wiry and slippery. He was diagnosed with lung cancer, with the syndrome being phlegm and blood stasis. The treatment principle was to resolve phlegm, remove blood stasis, detoxify, and dissipate nodules. This compound preparation was prescribed orally, 5 pills each time, three times a day. After two months of treatment, the patient's cough and sputum production decreased, and the blood in the sputum disappeared. The chest pain also lessened. He discontinued the medication after one year of treatment. During a six-month follow-up, his condition remained stable, and his KPS score was 80.

[0127] 3. Mr. Jiang, male, 61 years old, from Yantai City, visited the hospital on August 23, 2021. He had been diagnosed with multiple metastases of lung adenocarcinoma for 6 months. At the time of consultation, he presented with lower abdominal pain, difficulty urinating, headache, fatigue, cough with white sticky sputum, occasional chest pain, poor appetite, difficulty defecating, dark purple tongue with white greasy coating, and slippery and rapid pulse. He was diagnosed with "lung cancer" and the syndrome was diagnosed as phlegm and blood stasis. The treatment should be to resolve phlegm, remove blood stasis, detoxify and dissipate nodules. He was given chemotherapy combined with this compound preparation orally, 5 pills each time, three times a day. After taking the medicine for 2 months, the patient's cough and sputum were reduced. He continued to take this compound preparation for 6 months. The patient's condition remained stable and his quality of life was good.

[0128] Traditional Chinese medicine (TCM) believes that the pathogenesis of lung cancer involves deficiency of the spleen, lung, and kidney, allowing external pathogens to invade, leading to phlegm, dampness, and blood stasis obstructing the meridians, eventually forming accumulations. Deficiency of the lung, spleen, and kidney is the root cause, while phlegm accumulation, blood stasis, and obstruction of the meridians are the manifestations of cancerous toxins. The mutual binding of phlegm, blood stasis, and toxins is a crucial pathogenesis of lung cancer, closely related to the three organs. Qi stagnation, phlegm accumulation, blood stasis, and toxin accumulation are inseparable and mutually influential in the development and progression of lung cancer. Treatment focuses on resolving phlegm, removing blood stasis, detoxifying, and dispersing nodules, improving the internal environment for the smooth flow of Qi, blood, and body fluids, and eliminating pathogenic factors without... Extensive clinical practice has shown that treating phlegm, blood stasis, and toxins simultaneously, and the rational combination of traditional Chinese medicines for resolving phlegm, removing blood stasis, detoxifying, and dispersing nodules, can achieve the goal of eliminating phlegm, removing blood stasis, and resolving toxins. This can stabilize or shrink lesions to the greatest extent, alleviate the condition, reduce symptoms, and prolong survival. Therefore, the treatment principle of resolving phlegm, removing blood stasis, detoxifying, and dispersing nodules is established and applied throughout the treatment of lung cancer. Based on this mechanism, this invention uses Schisandra chinensis, Gecko, Sea Snail, Strychnos nux-vomica, Wisteria zedoaria, Centella asiatica, Paris polyphylla, Clerodendrum trichotomum, and Pinus massoniana. This invention comprises thirteen herbs, including *Clematis armandii*, *Terminalia chebula*, *Dioscorea nipponica*, and *Vaccaria segetalis*. The combination of these herbs, with their rational formulation, enhances the efficacy of the medicine, emphasizing both strengthening the body's resistance and eliminating pathogenic factors. The treatment primarily focuses on resolving phlegm, removing blood stasis, detoxifying, and dispersing nodules, improving the internal environment for the smooth flow of qi, blood, and body fluids. It eliminates pathogenic factors without harming the body's vital energy. Clinical trials have also demonstrated that treating phlegm, blood stasis, and toxins simultaneously, and the rational combination of herbs for resolving phlegm, removing blood stasis, detoxifying, and dispersing nodules, can achieve the goal of eliminating phlegm, removing blood stasis, and dispersing toxins, maximizing the stabilization or reduction of lesions, alleviating the condition, reducing symptoms, and prolonging survival. This invention is particularly suitable for patients with mid-to-late stage lung cancer. These patients have a low surgical treatment rate, a high rate of postoperative recurrence and metastasis, and surgery can cause various adverse reactions, increasing patient suffering. Furthermore, targeted drugs are not only expensive but also only effective for some patients with gene mutations. The herbal preparation of this invention can greatly alleviate patients' suffering and improve their quality of life. Compared to surgery and targeted drugs, it is lower in cost, safer, has no toxic side effects, and has a definite curative effect, making it worthy of clinical promotion.

[0129] Because of the above-mentioned structure, this invention has the advantages of significantly improving patients' symptoms such as cough, sputum, chest pain, and purplish tongue, alleviating pain, improving patients' quality of life, reducing toxicity and increasing efficacy, low treatment cost, and prolonging patients' lifespan.

Claims

1. A traditional Chinese medicine compound preparation for treating non-small cell lung cancer, characterized in that: Made from the following Chinese medicinal herbs: Schisandra chinensis, Gecko, Sea Snail, Strychnos nux-vomica, Wisteria zedoaria, Centella asiatica, Paris polyphylla, Clerodendrum trichotomum, Pinus massoniana, Smilax china, Terminalia chebula, Dioscorea nipponica, and Vaccaria segetalis. The weight ratio of the herbs is as follows: Schisandra chinensis 9g-15g, Gecko 3g-9g, Sea Snail 9g-15g, Strychnos nux-vomica 3g-9g, Wisteria zedoaria 10g-30g, Centella asiatica 15g-30g, Paris polyphylla 9g-15g, Clerodendrum trichotomum 9g-15g, Pinus massoniana 9g-15g, Smilax china 9g-15g, Terminalia chebula 6g-12g, Dioscorea nipponica 9g-15g, and Vaccaria segetalis 9g-15g.

2. The traditional Chinese medicine compound preparation for treating non-small cell lung cancer according to claim 1, characterized in that: The weight ratio of the Chinese herbs is as follows: Schisandra chinensis 9g, Gecko 3g, Sea snail 9g, Strychnos nux-vomica 3g, Wisteria 10g, Centella asiatica 15g, Paris polyphylla 9g, Clerodendrum trichotomum 9g, Pinus massoniana 9g, Smilax china 9g, Terminalia chebula 6g, Dioscorea nipponica 9g, Vaccaria segetalis 9g.

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