Application of Peiyuan Gubenfang in reducing the toxicity of adjuvant chemotherapy after radical resection of non-small cell lung cancer

Abstract

This invention belongs to the field of traditional Chinese medicine technology, specifically relating to the application of a formula for nourishing vital energy and strengthening the body in reducing the toxicity of adjuvant chemotherapy after radical resection of non-small cell lung cancer. This invention discloses a formula for nourishing vital energy and strengthening the body, characterized in that it is composed of the following components by weight: 15-30 parts raw Astragalus membranaceus, 9-21 parts prepared Rehmannia glutinosa, 15-30 parts stir-fried Dioscorea opposita, 9-15 parts Atractylodes macrocephala, 9-15 parts Poria cocos, 15-30 parts raw Coix lacryma-jobi, 9-15 parts Ophiopogon japonicus, 9-15 parts Asparagus cochinchinensis, 15-30 parts Adenophora stricta, 9-15 parts Ligustrum lucidum, 9-15 parts Eclipta prostrata, 9-15 parts stir-fried germinated barley, 9-15 parts stir-fried malt, and 3-6 parts prepared Glycyrrhiza uralensis. This invention can restore vital energy, reverse postoperative weakness, build a foundation for chemotherapy tolerance to reduce toxic side effects, improve chemotherapy tolerance, reduce the risk of interruption to ensure efficacy, improve quality of life during chemotherapy, and help prolong postoperative survival.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and in particular relates to the application of Peiyuan Gubenfang in reducing the toxicity of adjuvant chemotherapy after radical resection of non-small cell lung cancer. Background Technology

[0002] For patients with stage IB-IIIA non-small cell lung cancer (NSCLC), radical surgical resection is the core treatment. However, the five-year survival rate after surgery is only about 50%, with a high risk of recurrence and metastasis. Postoperative adjuvant chemotherapy is crucial for prolonging survival. However, patients are already in a weakened state after surgery due to damage to their qi and blood and lingering pathogens. Chemotherapy drugs can further deplete their vital energy, causing serious toxic side effects such as bone marrow suppression, gastrointestinal reactions, and decreased immunity. This not only reduces their quality of life but also leads some patients to discontinue chemotherapy due to intolerance, affecting the treatment outcome.

[0003] Currently, clinical practice primarily treats the toxic side effects of chemotherapy with Western medicine, but this only addresses a single symptom and cannot comprehensively improve the patient's weakened condition after surgery. Furthermore, it may trigger new adverse reactions, failing to meet the need for toxicity reduction. In contrast, Traditional Chinese Medicine's "Nourishing the Origin and Strengthening the Foundation" formula, by tonifying the spleen and kidneys and replenishing qi and blood, can restore the body's vital energy. Related studies have confirmed that this formula can reduce toxic side effects and improve quality of life in advanced NSCLC combined with chemotherapy, providing a solution to the challenges of postoperative adjuvant chemotherapy. Summary of the Invention

[0004] This invention aims to address the problems of severe toxic side effects from chemotherapy after surgery for stage IB-IIIA NSCLC and the limited symptomatic relief provided by Western medicine. It proposes the application of Peiyuan Gubenfang (a traditional Chinese medicine formula) in reducing the toxicity of adjuvant chemotherapy after radical resection of non-small cell lung cancer. This formula aims to alleviate toxic side effects, restore the body's vital energy by tonifying the spleen and kidneys and nourishing qi and blood, and provide a feasible comprehensive postoperative treatment plan.

[0005] This invention provides a formula for nourishing the body's vital energy and strengthening its foundation, which is made from the following components in parts by weight: 15-30 parts of raw Astragalus membranaceus, 9-21 parts of prepared Rehmannia glutinosa, 15-30 parts of stir-fried Dioscorea opposita, 9-15 parts of Atractylodes macrocephala, 9-15 parts of Poria cocos, 15-30 parts of raw Coix lacryma-jobi, 9-15 parts of Ophiopogon japonicus, 9-15 parts of Asparagus cochinchinensis, 15-30 parts of Adenophora stricta, 9-15 parts of Ligustrum lucidum, 9-15 parts of Eclipta prostrata, 9-15 parts of stir-fried germinated barley, 9-15 parts of stir-fried malt, and 3-6 parts of prepared Glycyrrhiza uralensis.

[0006] Furthermore, the formula for nourishing the body and strengthening the foundation is made from the following components by weight: 30 parts raw Astragalus membranaceus, 20 parts prepared Rehmannia glutinosa, 30 parts stir-fried Dioscorea opposita, 15 parts Atractylodes macrocephala, 15 parts Poria cocos, 30 parts raw Coix lacryma-jobi, 15 parts Ophiopogon japonicus, 15 parts Asparagus cochinchinensis, 30 parts Adenophora stricta, 15 parts Ligustrum lucidum, 15 parts Eclipta prostrata, 15 parts stir-fried germinated barley, 15 parts stir-fried malt, and 6 parts prepared licorice root.

[0007] In a second aspect, the present invention provides a pharmaceutical preparation made from the Peiyuan Gubenfang formula according to any one of claims 1 to 2.

[0008] Furthermore, the pharmaceutical preparation also includes pharmaceutically acceptable excipients.

[0009] Furthermore, the pharmaceutical formulation includes a variety of acceptable dosage forms.

[0010] Furthermore, the dosage form of the pharmaceutical preparation is any one of capsules, granules, tablets, powders, ointments, powders, pills, or liquids.

[0011] Furthermore, the aforementioned Peiyuan Gubenfang formula is used in the preparation of adjuvant chemotherapy drugs to reduce toxicity after radical resection of non-small cell lung cancer.

[0012] It should be noted that the pharmacological effects of some of the medicinal materials in the formulation of this invention are as follows:

[0013] Raw Astragalus: The dried root of *Astragalus membranaceus* (Fisch.) Bge. var. *mongholicus* (Bge.) Hsiao or *Astragalus membranaceus* (Fisch.) Bge. (Fabaceae). Processing: Take the above-mentioned dried roots, clean and moisten them thoroughly, then cut them into thick slices and dry them again. Properties and Channels Entered: Sweet, slightly warm. Enters the Lung and Spleen channels. Functions and Indications: Tonifies Qi and raises Yang, consolidates the exterior and stops sweating, promotes diuresis and reduces swelling, generates fluids and nourishes blood, promotes circulation and relieves pain, promotes pus drainage and detoxification, and promotes tissue regeneration and wound healing. Used for Qi deficiency and fatigue, poor appetite and loose stools, Qi sinking, chronic diarrhea and rectal prolapse, hematochezia and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to Qi deficiency, internal heat and thirst, blood deficiency and chlorosis, hemiplegia, numbness and pain, carbuncles and boils that are difficult to heal, and chronic ulcers that do not heal.

[0014] Prepared Rehmannia Root: The tuberous root of Rehmannia glutinosa, a plant in the Scrophulariaceae family, processed by steaming and drying. Properties and Channels Entered: Sweet, slightly warm. Enters the Liver and Kidney channels. Functions and Indications: Nourishes blood and Yin, replenishes essence and marrow. Used for blood deficiency and chlorosis, palpitations, irregular menstruation, metrorrhagia, liver and kidney Yin deficiency, soreness and weakness of the lower back and knees, bone steaming fever, night sweats, seminal emission, internal heat and thirst, dizziness, tinnitus, and premature graying of hair.

[0015] Stir-fried Yam with Wheat Bran: This product is the dried rhizome of *Dioscorea opposita* Thunb., a plant in the Dioscoreaceae family. Processing Method: Take slices of hairy or smooth yam and stir-fry them according to the wheat bran stir-frying method (General Rule 0213) until yellow. Properties and Channels Entered: Sweet, neutral. Enters the spleen, lung, and kidney channels. Functions and Indications: Tonifies the spleen and stomach, promotes fluid production and benefits the lungs, tonifies the kidneys and astringes essence. Used for spleen deficiency with poor appetite, chronic diarrhea, lung deficiency with cough and wheezing, kidney deficiency with seminal emission, leukorrhea, frequent urination, and thirst due to deficiency heat. Stir-fried yam with wheat bran tonifies the spleen and stomach. Used for spleen deficiency with poor appetite, loose stools, and excessive leukorrhea.

[0016] Atractylodes macrocephala: The dried rhizome of Atractylodes macrocephala Koidz., a plant in the Asteraceae family. Properties and Channels Entered: Bitter, sweet, warm. Enters the Spleen and Stomach channels. Functions and Indications: Strengthens the spleen and replenishes Qi, dries dampness and promotes diuresis, stops sweating, and calms the fetus. Used for spleen deficiency with poor appetite, abdominal distension and diarrhea, phlegm retention with dizziness and palpitations, edema, spontaneous sweating, and threatened abortion.

[0017] Poria cocos: The dried sclerotium of the fungus Poria cocos (Schw.) Wolf. (family Polyporaceae). Properties and Channels Entered: Sweet, bland, neutral. Enters the Heart, Lung, Spleen, and Kidney channels. Functions and Indications: Promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. Used for edema with scanty urine, phlegm retention with dizziness and palpitations, spleen deficiency with poor appetite, loose stools and diarrhea, restlessness, palpitations, and insomnia.

[0018] Raw Job's tears: This product is the dried, mature seed kernel of *Coix lacryma-jobi* L. var. *mayuen* (Roman.) Stapf, a plant of the Poaceae family. Properties and Channels Entered: Sweet, bland, cool. Enters the Spleen, Stomach, and Lung channels. Functions and Indications: Promotes diuresis and eliminates dampness, strengthens the spleen and stops diarrhea, relieves numbness, drains pus, detoxifies and dissipates nodules. Used for edema, beriberi, dysuria, spleen deficiency diarrhea, dampness-induced arthralgia, lung abscess, intestinal abscess, warts, and cancer.

[0019] Ophiopogon japonicus: The dried tuberous root of Ophiopogon japonicus, a plant in the Liliaceae family. Properties and Channels Entered: Sweet, slightly bitter, slightly cold. Enters the Heart, Lung, and Stomach channels. Functions and Indications: Nourishes Yin and generates fluids, moistens the lungs and clears the heart. Used for dry cough due to lung dryness, consumptive cough due to Yin deficiency, sore throat, thirst due to fluid depletion, internal heat and thirst, irritability and insomnia, and constipation due to intestinal dryness.

[0020] Asparagus: This product is the dried tuberous root of Asparagus cochinchinensis (Lour.) Merr., a plant of the Liliaceae family. Properties and Channels Entered: Sweet, bitter, cold. Enters the Lung and Kidney channels. Functions and Indications: Nourishes Yin and moistens dryness, clears the lungs and generates fluids. Used for dry cough due to lung dryness, persistent cough with sticky phlegm, soreness and pain in the lower back and knees, steaming bone fever, internal heat and thirst, heat-related illnesses causing fluid depletion, dry throat and mouth, and constipation due to intestinal dryness.

[0021] North American ginseng: This product is the dried root of *Glehnia littoralis* Fr. Schmidt ex Miq., a plant belonging to the Apiaceae family. Properties and Channels Entered: Sweet, slightly bitter, slightly cold. Enters the Lung and Stomach channels. Functions and Indications: Nourishes Yin and clears the lungs, benefits the stomach and generates fluids. Used for dry cough due to lung heat, consumptive cough with hemoptysis, stomach Yin deficiency, fluid depletion due to febrile diseases, dry throat and thirst.

[0022] Privet Fruit: This product is the dried, ripe fruit of *Ligustrum lucidum* Ait., a plant in the Oleaceae family. Properties and Channels Entered: Sweet, bitter, cool. Enters the Liver and Kidney channels. Functions and Indications: Nourishes the Liver and Kidneys, improves eyesight and darkens hair. Used for Liver and Kidney Yin deficiency, dizziness and tinnitus, soreness and weakness of the lower back and knees, premature graying of hair, blurred vision, internal heat and thirst, and steaming bone fever.

[0023] Eclipta prostrata L. (also known as Mo Han Lian): This product is the dried aerial part of the plant Eclipta prostrata L. (family Asteraceae). Properties and Channels Entered: Sweet, sour, cold. Enters the Kidney and Liver channels. Functions and Indications: Nourishes the Liver and Kidneys, cools the blood and stops bleeding. Used for Liver and Kidney Yin deficiency, loose teeth, premature graying of hair, dizziness and tinnitus, soreness and weakness of the lower back and knees, yin deficiency and blood heat causing hematemesis, epistaxis, hematuria, bloody dysentery, metrorrhagia, and traumatic bleeding.

[0024] Fried Germinated Rice: This product is a processed product made from the germinated and dried mature fruit of the grass *Setaria italica* (L.) Beauv. Take clean germinated rice and stir-fry it according to the stir-frying method (General Rule 0213) until it turns deep yellow. Properties and Channels Entered: Sweet, warm. Enters the spleen and stomach channels. Functions and Indications: Promotes digestion and harmonizes the stomach, strengthens the spleen and improves appetite. Used for indigestion, abdominal distension, halitosis, spleen and stomach weakness, and poor appetite. Germinated rice is more effective in promoting digestion and is used for poor appetite. Roasted germinated rice is good at resolving stagnation and is used for indigestion.

[0025] Roasted malt: This product is a processed product made from the mature fruit of barley (Hordeum vulgare L.), a plant of the Poaceae family, after germination and drying. Take clean malt, stir-fry according to the stir-frying method (General Rule 0213) until brownish-yellow, cool, and sift to remove ash. Properties and Channels Entered: Sweet, neutral. Enters the Spleen and Stomach channels. Functions and Indications: Promotes digestion and relieves bloating, strengthens the spleen and stomach, reduces lactation and relieves abdominal distension. Used for indigestion, abdominal distension and pain, spleen deficiency with poor appetite, milk stasis, breast distension and pain, weaning, liver stagnation with hypochondriac pain, and liver and stomach qi pain. Raw malt strengthens the spleen and stomach, soothes the liver and promotes qi circulation. Used for spleen deficiency with poor appetite and milk stasis. Roasted malt promotes digestion and relieves bloating. Used for indigestion and weaning. Charred malt promotes digestion and resolves stagnation. Used for indigestion and abdominal distension and pain.

[0026] Prepared licorice root: This product is a processed form of licorice root. Properties and channels: Sweet, neutral. Channels entered: Heart, Lung, Spleen, Stomach. Functions and indications: Tonifies the spleen and stomach, replenishes qi and restores pulse. Used for spleen and stomach weakness, fatigue, palpitations, and irregular pulse.

[0027] Compared with the prior art, the beneficial effects of the present invention are:

[0028] 1. Improve postoperative weakness and strengthen the foundation for chemotherapy resistance.

[0029] Addressing the core issue of "dual damage to Qi and blood, and weakness of vital energy" in patients after radical resection of non-small cell lung cancer, the Peiyuan Guben formula relies on the traditional Chinese medicine mechanisms of tonifying the spleen and kidneys, and nourishing Qi and blood. It can directly repair the body's damaged vital energy, fundamentally reversing postoperative weakness. Unlike Western medicine, which only targets a single toxic side effect, this formula can build a physical foundation for patients to tolerate chemotherapy, significantly reducing the probability and severity of chemotherapy-related side effects such as bone marrow suppression and gastrointestinal reactions.

[0030] 2. Improve chemotherapy tolerance and reduce the risk of discontinuation to ensure efficacy.

[0031] Chemotherapy-induced side effects such as decreased immunity, persistent fatigue, nausea, and vomiting are the main reasons why patients discontinue treatment. The Peiyuan Gubenfang formula, by regulating bodily functions, can effectively alleviate these symptoms, significantly improving patients' tolerance to chemotherapy and helping them strictly adhere to the treatment plan to complete the full course. This effect ensures the control of tumor recurrence and metastasis by chemotherapy, indirectly supporting the prolongation of postoperative survival.

[0032] 3. Balancing "toxicity reduction" and "quality improvement" to reduce additional burdens related to treatment.

[0033] This formula not only specifically reduces the toxic side effects of chemotherapy, but also holistically regulates the patient's bodily functions, improving key life indicators such as mental state, appetite, and sleep quality during chemotherapy, thus comprehensively enhancing the patient's quality of life. Furthermore, compared to the commonly used symptomatic treatment regimens with multiple Western medicines, this traditional Chinese medicine formula avoids new adverse reactions that may arise from combining multiple drugs, reducing the additional physical burden of treatment on the patient. Detailed Implementation

[0034] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0035] I. Preparation Examples

[0036] Example 1

[0037] A formula for nourishing the body's vital energy and strengthening its foundation, made by weight of the following components: 30 g of raw Astragalus membranaceus, 20 g of prepared Rehmannia glutinosa, 30 g of stir-fried Dioscorea opposita, 15 g of Atractylodes macrocephala, 15 g of Poria cocos, 30 g of raw Coix lacryma-jobi, 15 g of Ophiopogon japonicus, 15 g of Asparagus cochinchinensis, 30 g of Adenophora stricta, 15 g of Ligustrum lucidum, 15 g of Eclipta prostrata, 15 g of stir-fried germinated barley, 15 g of stir-fried malt, and 6 g of prepared Glycyrrhiza uralensis.

[0038] Example 2

[0039] A formula for nourishing the body's vital energy and strengthening its foundation, made by weight of the following components: 15 g of raw Astragalus membranaceus, 9 g of prepared Rehmannia glutinosa, 15 g of stir-fried Dioscorea opposita, 9 g of Atractylodes macrocephala, 9 g of Poria cocos, 15 g of raw Coix lacryma-jobi, 9 g of Ophiopogon japonicus, 9 g of Asparagus cochinchinensis, 15 g of Adenophora stricta, 9 g of Ligustrum lucidum, 9 g of Eclipta prostrata, 9 g of stir-fried germinated barley, 9 g of stir-fried malt, and 3 g of prepared Glycyrrhiza uralensis.

[0040] Example 3

[0041] A formula for nourishing the body's vital energy and strengthening its foundation, made by weight of the following components: 30 g of raw Astragalus membranaceus, 21 g of prepared Rehmannia glutinosa, 30 g of stir-fried Dioscorea opposita, 15 g of Atractylodes macrocephala, 15 g of Poria cocos, 30 g of raw Coix lacryma-jobi, 15 g of Ophiopogon japonicus, 15 g of Asparagus cochinchinensis, 30 g of Adenophora stricta, 15 g of Ligustrum lucidum, 15 g of Eclipta prostrata, 15 g of stir-fried germinated barley, 15 g of stir-fried malt, and 6 g of prepared Glycyrrhiza uralensis.

[0042] Example 4

[0043] A formula for nourishing the body's vital energy and strengthening its foundation, made by weight of the following components: 22 g of raw Astragalus membranaceus, 14 g of prepared Rehmannia glutinosa, 22 g of stir-fried Dioscorea opposita, 12 g of Atractylodes macrocephala, 12 g of Poria cocos, 22 g of raw Coix lacryma-jobi, 12 g of Ophiopogon japonicus, 12 g of Asparagus cochinchinensis, 22 g of Adenophora stricta, 12 g of Ligustrum lucidum, 12 g of Eclipta prostrata, 12 g of stir-fried germinated barley, 12 g of stir-fried malt, and 4 g of prepared Glycyrrhiza uralensis.

[0044] II. Clinical Trial Cases

[0045] 1. Research Methods

[0046] 1.1. Research Subjects

[0047] Study participants: 120 patients with stage IB-IIIA NSCLC who underwent radical surgery at the Department of Integrated Traditional Chinese and Western Medicine, Tongji University Affiliated Pulmonary Hospital, between July 1, 2016 and June 30, 2019, were selected. All cases had a clear pathological diagnosis, and all patients started adjuvant chemotherapy within 6 weeks after surgery.

[0048] 1.1.1. Diagnostic and Staging Criteria

[0049] (1) Western medicine diagnostic criteria: Patients diagnosed with NSCLC (non-small cell lung cancer) by pathology are classified according to pathological classification criteria (mainly squamous cell carcinoma, adenocarcinoma, alveolar cell carcinoma, mucinous adenocarcinoma, mixed adenosquamous carcinoma, etc.); the staging criteria for primary lung cancer refer to the 7th edition of the American Society of Cancer TNM staging system.

[0050] (2) Inclusion criteria: ① Patients with stage IB-IIIA NSCLC confirmed by surgical pathology, who underwent radical surgery and standardized lymph node dissection, and whose general condition was good after surgery; ② Age 23-75 years, gender not limited; ③ General condition score (ECOG score) ≤2 points; ④ Blood routine, liver and kidney function and electrocardiogram examination were normal, and the expected survival was greater than or equal to 6 months; ⑤ Signed informed consent form.

[0051] (3) Exclusion criteria: ① Patients with serious primary diseases of the heart, brain, kidneys and hematopoietic system, or mental illness; ② Pregnant or lactating women; ③ Patients with critical illness and poor compliance.

[0052] 1.2. Research Content

[0053] 1.2.1. Research Methods

[0054] Using the principle of random grouping and parallel control, 120 patients were randomly divided into a postoperative adjuvant chemotherapy group and a combination chemotherapy group with Peiyuan Gubenfang formula, with 60 patients in each group.

[0055] 1.2.2. Group Design

[0056] (1) Control group:

[0057] The specific regimen selection, administration method, and cycle management are as follows:

[0058] ① Docetaxel and / or cisplatin / carboplatin (T / TP / TC): Docetaxel injection, 20 mg (1.5 ml / vial), 75 mg / m 2 ; Cisplatin 25 mg / m 2 Or carboplatin 300 mg / m 2 All were administered via intravenous infusion on day 1. Patients were given 10 mg of dexamethasone orally the night before chemotherapy and twice a day on the day of administration. The dexamethasone was then administered via intravenous infusion on day 1 of each treatment cycle, with each infusion lasting 60 minutes. One cycle consisted of 21 days.

[0059] ② Pemetrexed and / or cisplatin / carboplatin (A / AP / AC): Pemetrexed injection, 100 mg / vial. Patients should begin taking folic acid 4 mg once daily 5 days before chemotherapy, and receive an intramuscular injection of vitamin B12 1 mg one day before chemotherapy. Dexamethasone tablets 10 mg orally should be administered the evening before chemotherapy and twice daily on the day of administration. Pemetrexed is administered at a dose of 500 mg / m². 2 The dose is infused over 30 minutes, cisplatin 25 mg / m². 2 Or carboplatin 300 mg / m 2 All were administered via intravenous infusion on day 1 of treatment, with 21 days constituting one cycle.

[0060] ③ Gemcitabine and / or cisplatin / carboplatin (G / GP / GC): Patients receive gemcitabine 1000 mg / m² on days 1 and 8 of chemotherapy. 2 Intravenous infusion of cisplatin 25 mg / m² 2 Or carboplatin 300 mg / m 2 Administer intravenously on days 1-3, with one cycle lasting 21 days;

[0061] The efficacy of the above chemotherapy regimens shall be evaluated every 2 cycles; at least 4 cycles shall be completed.

[0062] (2) Experimental group:

[0063] The treatment combined with postoperative adjuvant chemotherapy using the Peiyuan Gubenfang formula employs a combined intervention model of "postoperative adjuvant chemotherapy regimen + Peiyuan Gubenfang decoction." Specific medication regimens and cycle management are as follows:

[0064] The basic chemotherapy regimen was the same as that of the control group; the Peiyuan Gubenfang decoction used the Peiyuan Gubenfang formula of Example 1 as the base formula. In clinical application, the drug dosage was adjusted according to the principle of "treatment based on syndrome differentiation" and the specific symptoms of the patient.

[0065] Medication administration and course of treatment: One dose of Chinese medicine is taken daily, decocted in water, 150 ml each time, once in the morning and once in the evening; the medicine is administered on the first day of each treatment cycle, and is taken continuously for 21 days as one cycle; the efficacy is evaluated every 2 cycles, and at least 4 cycles must be completed.

[0066] 1.2.3. Follow-up

[0067] Both groups of patients were followed up after treatment, initially every 3 months, then every 6 months, then annually. Follow-up included chest X-ray or chest CT scan, bone scan, brain CT or MRI, blood tumor markers, and relevant immune indicators. The follow-up rate was ≥90%. If metastasis occurred, the site of metastasis, treatment, and disease progression were recorded.

[0068] 1.3. Observation Indicators

[0069] Toxic reactions are classified into grades 0 to IV according to the WHO toxicity classification standards for anticancer drugs.

[0070] Quality of life was assessed using the Karnofsky Performance Status Scale, with a score range of 0 to 100. An increase of ≥10 points before and after treatment was considered improvement, a decrease of ≥10 points was considered decline, and a change within 10 points was considered stable.

[0071] 1.4. Statistical Methods

[0072] Statistical analysis was performed using SAS 9.4 statistical software. All statistical tests used in the results analysis employed two-tailed hypothesis testing, with a significance level of α=0.05. A p-value less than or equal to 0.05 was considered statistically significant.

[0073] 2. Research Results

[0074] 2.1. General Data Collection

[0075] From July 1, 2016 to June 30, 2019, a total of 120 NSCLC patients at stages IB-IIIA after radical surgery were included in the Department of Integrated Traditional Chinese and Western Medicine of Shanghai Pulmonary Hospital. According to the random data table, they were divided into a control group and a treatment group, with 60 cases in each group. Among them, the patients in the treatment group completed 4 cycles of adjuvant chemotherapy after surgery and took Peiyuan Guben Decoction for a long time during chemotherapy and follow-up. After routine 4 cycles of adjuvant chemotherapy, the patients in the control group did not receive traditional Chinese medicine treatment. There were no significant differences in the baseline data of the two groups of patients, including gender, age, smoking, pathology, stage, degree of differentiation, gene mutation status, and radiotherapy (see Table 1, P>0.05).

[0076] Table 1 General Information Table

[0077]

[0078] 2.2. Baseline Data Analysis

[0079] 2.2.1. Gender

[0080] As shown in Table 2: There were more male patients than female patients, about twice as many as female patients, which was in line with the higher incidence of male in non-small cell lung cancer. There was no significant difference in the gender comparison between the two groups of patients (P<0.05).

[0081] Table 2 Comparison of Gender between Two Groups of Patients

[0082]

[0083] 2.2.2. Age

[0084] As shown in Table 3: The proportion of patients over 55 years old was significantly higher than that of other age groups, suggesting that middle-aged patients may be the majority among early non-small cell lung cancer patients. There was no significant difference in the age groups between the two groups of patients (P<0.05).

[0085] Table 3 Comparison of Age between Two Groups of Patients

[0086]

[0087] 2.2.3. Smoking Status

[0088] The composition ratio of smoking history is shown in Table 4: Among non-small lung cancer patients, more than half have a smoking history, which is in line with smoking being one of the important risk factors for lung cancer. There was no significant difference in the composition ratio of smoking history between the two groups of patients (P<0.05).

[0089] Table 4 Comparison of smoking status between the two groups of patients

[0090]

[0091] 2.2.4. Pathological Types

[0092] As shown in Table 5, among the various pathological subtypes of non-small lung cancer, adenocarcinoma accounted for the largest proportion of patients, followed by squamous cell carcinoma, while adenosquamous carcinoma and carcinoid carcinoma accounted for a minority of patients, consistent with the possibility that adenocarcinoma is the most common type of lung cancer. There was no statistically significant difference in the composition of pathological types between the two groups of patients (P < 0.05).

[0093] Table 5 Comparison of pathological types between the two groups of patients

[0094]

[0095] 2.2.5. Degree of Differentiation

[0096] The degree of differentiation in lung cancer directly affects recurrence and metastasis. Adenocarcinoma pathological types include invasive, papillary, micropapillary, solid, and mucinous carcinomas, among which papillary and micropapillary carcinomas have the highest malignancy and are associated with recurrence. Squamous cell carcinoma pathological types include keratinizing and non-keratinizing types. Malignancy is categorized as high, intermediate, and low. There was no statistically significant difference in differentiation degree between the two groups of patients (Table 6, P < 0.05).

[0097] Table 6 Comparison of tumor differentiation degree between the two groups of patients

[0098]

[0099] 2.2.6. TNM staging

[0100] As shown in Table 7, stage IA patients were the most numerous among postoperative patients, followed by stage IIIA patients, while stage II patients were relatively few, which is consistent with the current incidence of early-stage lung cancer. There was no statistically significant difference in TNM stage between the two groups (P < 0.05).

[0101] Table 7 Comparison of TNM stages between the two groups of patients

[0102]

[0103] 2.2.7. Gene Mutation Status

[0104] The proportion of gene mutations in non-small cell lung cancer is approximately 30%. This study included 120 patients, of whom 41 had gene mutations, consistent with the proportion of non-small cell lung cancer patients with gene mutations. There was no statistically significant difference in mutation rates between the two groups (Table 8, P < 0.05).

[0105] Table 8 Comparison of gene mutations between the two groups of patients

[0106]

[0107] 2.2.8. Postoperative radiotherapy

[0108] Patients with positive lymph node dissection after non-small cell lung cancer surgery require adjuvant chemotherapy combined with radiotherapy, as the decision to receive radiotherapy directly affects the prognosis. In this study, the proportion of patients receiving postoperative radiotherapy was low, which may have some impact on subsequent outcomes, necessitating further stratified statistical analysis. There was no statistically significant difference in current radiotherapy status between the two groups (Table 9, P < 0.05).

[0109] Table 9 Postoperative radiotherapy in the two groups of patients

[0110]

[0111] 2.3. Comparison of toxic reactions

[0112] 2.3.1. Bone marrow suppression

[0113] As shown in Table 10, patients were physically weak after surgery and bone marrow suppression was common during the adjuvant chemotherapy period, mainly grade I bone marrow suppression. The incidence of grade I bone marrow suppression in the control group was 63.3%, which was significantly different from that in the treatment group (36.7%) (P<0.05).

[0114] Table 10 Bone marrow suppression after chemotherapy in the two groups of patients

[0115]

[0116] 2.3.2. Liver dysfunction

[0117] Chemotherapy easily leads to liver dysfunction, mainly grade I damage, which can be improved with the administration of hepatoprotective drugs. The severity is related to whether the patient has underlying liver disease. In the control group, there were 12 cases of grade I liver damage and 5 cases of grade II liver damage; in the treatment group, there were 11 cases of grade I liver damage and 3 cases of grade II liver damage. There was no statistically significant difference between the two groups (Table 11, P > 0.05).

[0118] Table 11 Comparison of liver function impairment between the two groups of patients

[0119]

[0120] 2.3.3. Renal insufficiency

[0121] Platinum-based chemotherapy regimens are prone to causing renal insufficiency, mainly grade I impairment, which can be improved with drug treatment. The condition is related to the patient's age, creatinine clearance rate, hypertension, diabetes, acute and chronic kidney disease, and other underlying diseases. Three patients in the control group and three patients in the treatment group developed renal insufficiency, and there was no statistically significant difference between the two groups (Table 12, P>0.05).

[0122] Table 12. Incidence of renal function impairment in the two groups of patients.

[0123]

[0124] 2.3.4. Nausea and vomiting

[0125] The most common gastrointestinal side effects of chemotherapy are nausea and vomiting, especially in patients using cisplatin-containing regimens, where nausea and vomiting are often severe and grade II toxicity is common.

[0126] The results of this study showed that in the control group, 11 patients experienced grade I nausea, 34 patients experienced grade II nausea, and 2 patients experienced grade III nausea, with an incidence rate of 78.3%; in the treatment group, 17 patients experienced grade I nausea, 2 patients experienced grade II nausea, and 0 patients experienced grade III nausea, with an incidence rate of 31.7%. The difference between the two groups was statistically significant (Tables 18 and 19, P < 0.05). In the control group, 12 patients experienced grade I vomiting, 28 patients experienced grade II vomiting, and 2 patients experienced grade III vomiting, with an incidence rate of 70%; in the treatment group, 5 patients experienced grade I vomiting, 2 patients experienced grade II vomiting, and 0 patients experienced grade III vomiting, with an incidence rate of 11.7%. The difference between the two groups was statistically significant (Tables 13 and 14, P < 0.05).

[0127] Table 13 Comparison of nausea-related adverse events between the two groups of patients

[0128]

[0129] Table 14 Comparison of adverse events of vomiting between the two groups of patients

[0130]

[0131] 2.3.5. Constipation

[0132] Chemotherapy can easily cause intestinal mucosal edema and slowed peristalsis, often leading to constipation, mainly manifested as dry stools and abdominal distension. This usually occurs within two weeks after chemotherapy and can resolve spontaneously; severe cases require drug intervention. The incidence of constipation in the control group was 33.3%, which was statistically significantly different from the 8.3% in the treatment group (Table 15, P < 0.05), indicating that traditional Chinese medicine can alleviate chemotherapy-induced constipation.

[0133] Table 15 Comparison of constipation-related adverse events between the two groups of patients

[0134]

[0135] 2.3.6. Hair Loss

[0136] As shown in the following table: In the control group, 16 patients had grade II hair loss and 5 had grade I; in the treatment group, 13 patients had grade II hair loss and 6 had grade I. There was no significant difference between the two groups (Table 16, P > 0.05), which was consistent with the actual situation. Hair loss was related to chemotherapy drugs.

[0137] Table 16 Comparison of Hair Loss in Two Groups of Patients

[0138]

[0139] 2.4. Quality of Life Comparison

[0140] The two groups of patients were scored using the Karnofsky scoring standard before and after treatment. The results are shown in Table 17: In the treatment group, 20 cases were stable, 3 cases improved, and 37 cases declined, with an effective rate of 5%; in the treatment group, 21 cases were stable, 15 cases improved, and 24 cases declined, with an effective rate of 25%. There was a significant difference between the two groups, especially in improving the quality of life of patients after adjuvant chemotherapy. The group treated with the formula for strengthening primordial qi and consolidating the root was significantly superior to the simple chemotherapy group (P < 0.05).

[0141] Table 17 Improvement of Quality of Life in Two Groups of Patients before and after Treatment

[0142]

[0143] 3. Research Conclusions

[0144] The results of this study showed that the combined chemotherapy regimen with the formula for strengthening primordial qi and consolidating the root in patients after lung cancer surgery had significant clinical benefits, which were specifically reflected in the following two aspects: First, it could significantly reduce the occurrence of chemotherapy toxic and side reactions, especially showing significant advantages in improving common adverse reactions such as myelosuppression, nausea, vomiting, and constipation (P < 0.05); however, there was no significant difference in liver function, kidney function damage, and hair loss compared with the simple chemotherapy group (P > 0.05). Second, it could effectively improve the quality of life of patients. The proportion of patients with significantly improved quality of life after lung cancer surgery in the combined treatment group (25%) was significantly better than that in the simple chemotherapy group (5%), and the difference was statistically significant (P < 0.05).

[0145] From a pharmacological mechanism perspective, this invention has a clear effect of nourishing the body's vital energy and strengthening its foundation: Astragalus membranaceus, Atractylodes macrocephala, Poria cocos, and Coix lacryma-jobi can invigorate the spleen and replenish qi, nourishing the acquired constitution; Rehmannia glutinosa, Dioscorea opposita, Ligustrum lucidum, and Eclipta prostrata can nourish kidney yin, nourishing the innate constitution; Ophiopogon japonicus, Asparagus cochinchinensis, and Adenophora stricta can nourish yin and moisten the lungs, nourishing the body's vital energy; malted barley and roasted licorice harmonize the various herbs, and the entire formula works synergistically to nourish the lungs, spleen, and kidneys. Post-operative lung cancer patients often experience weakened constitution, lung and spleen qi deficiency, and the need to tolerate the toxic side effects of chemotherapy. In such cases, administering this formula as an adjunct treatment can support the body's vital energy, thereby reducing the toxic side effects of chemotherapy and improving quality of life.

[0146] In summary, this invention can effectively reduce the toxic side effects of chemotherapy in lung cancer patients after surgery and improve their quality of life. It has positive clinical application value and is worthy of clinical promotion.

[0147] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from the spirit or essential characteristics of the invention. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, it is intended that all variations falling within the meaning and scope of equivalents of the claims be included within the present invention.

Claims

1. A formula for nourishing the body's vital energy and strengthening its foundation, characterized in that, The formula for nourishing the body and strengthening the foundation is made from the following components by weight: 15-30 parts raw Astragalus membranaceus, 9-21 parts prepared Rehmannia glutinosa, 15-30 parts stir-fried Dioscorea opposita, 9-15 parts Atractylodes macrocephala, 9-15 parts Poria cocos, 15-30 parts raw Coix lacryma-jobi, 9-15 parts Ophiopogon japonicus, 9-15 parts Asparagus cochinchinensis, 15-30 parts Adenophora stricta, 9-15 parts Ligustrum lucidum, 9-15 parts Eclipta prostrata, 9-15 parts stir-fried germinated barley, 9-15 parts stir-fried malt, and 3-6 parts prepared Glycyrrhiza uralensis.

2. The formula for nourishing the body and strengthening the foundation according to claim 1, characterized in that, The formula for nourishing the body and strengthening the foundation is made from the following components by weight: 30 parts raw Astragalus membranaceus, 20 parts prepared Rehmannia glutinosa, 30 parts stir-fried Dioscorea opposita, 15 parts Atractylodes macrocephala, 15 parts Poria cocos, 30 parts raw Coix lacryma-jobi, 15 parts Ophiopogon japonicus, 15 parts Asparagus cochinchinensis, 30 parts Adenophora stricta, 15 parts Ligustrum lucidum, 15 parts Eclipta prostrata, 15 parts stir-fried germinated barley, 15 parts stir-fried malt, and 6 parts prepared Glycyrrhiza uralensis.

3. A pharmaceutical preparation made from the Vitality-Nourishing and Strengthening Formula as described in any one of claims 1 to 2.

4. The pharmaceutical preparation according to claim 3, characterized in that, The pharmaceutical preparation also includes pharmaceutically acceptable excipients.

5. The pharmaceutical preparation according to claim 3, characterized in that, The pharmaceutical preparations include a variety of acceptable dosage forms.

6. The pharmaceutical preparation according to claim 4, characterized in that, The dosage form of the pharmaceutical preparation is any one of capsules, granules, tablets, powders, ointments, powders, pills, or liquids.

7. The application of the Peiyuan Gubenfang formula according to any one of claims 1 to 2 in the preparation of adjuvant chemotherapy drugs to reduce toxicity after radical resection of non-small cell lung cancer.

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