A Chinese medicine composition for postoperative treatment of lung cancer and its application

Abstract

The invention discloses a Chinese medicine composition for postoperative treatment of lung cancer and its application. The Chinese medicine composition is prepared from the following raw materials: raw astragalus, cimicifuga, platycodon, rhizoma anemarrhenae, inula flower, madder, bombyx batryticatus, scutellaria baicalensis and oldenlandia diffusa. The Chinese medicine composition can be used to treat lung qi deficiency and residual toxicity postoperative lung cancer patients, promote rapid postoperative recovery of lung cancer patients (especially improve lung function), improve clinical symptoms of lung cancer patients, improve their quality of life, and prevent and treat postoperative recurrence and metastasis.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and more specifically, to a traditional Chinese medicine composition for postoperative treatment of lung cancer and its application. Background Art

[0002] With the increase in the detection rate of early lung cancer (malignant lung nodules), surgery has become the preferred treatment for early lung cancer, and the number of patients who have undergone lung cancer surgery has increased significantly, of which about 45% are resectable early and middle stages. More than 30% of patients with stage I lung cancer still die of recurrence or metastasis within 5 years after surgery. The 5-year survival rates of stage IIA, stage IIB, and stage IIIA patients are 60%, 53%, and 36%, respectively. The 5-year survival rate of non-small cell lung cancer (NSCLC) after surgery in my country is only 48.1%. The high recurrence and metastasis rate after surgery seriously affects the survival time of NSCLC patients. In addition, about 79.8% of lung cancer patients are prone to respiratory dysfunction such as cough, shortness of breath, fatigue, and sputum, which is most prominent in the first month after surgery. About 28.82% of patients will have respiratory dysfunction for more than 1 year, and it takes at least 1 year for the lung function of patients after surgery to return to the preoperative level. Studies have found that lung capacity and parenchymal damage are signs of decreased survival in lung cancer patients, and forced expiratory volume in 1 second (FEV1) < 80% is independently associated with poor overall survival (OS) in lung cancer patients, and patients with a shorter 6-minute walk test distance or a lower percentage of reference value have a poorer postoperative survival rate. Similarly, respiratory dysfunction after lung cancer surgery can easily cause negative emotions such as anxiety and depression in patients. Compared with patients without depression, the mortality rate of depressed patients increased by 17%, the median OS decreased by about 200 days, and the risk of death increased by 50% in patients with new depression and persistent depression. Therefore, postoperative respiratory dysfunction will reduce the quality of life of patients, induce negative emotions, delay postoperative recovery, and is an important factor in promoting tumor recurrence and metastasis and the risk of death.

[0003] Modern medicine has shortcomings in the management of postoperative symptoms of lung cancer and lacks effective treatment methods. For example, for persistent postoperative cough and pain, the treatment is mainly oral antitussives and analgesics, but they have certain toxic side effects and are prone to dependence, which is not conducive to postoperative recovery. Therefore, promoting rapid recovery after lung cancer surgery, reducing postoperative respiratory dysfunction, improving quality of life, preventing and treating postoperative recurrence and metastasis, and prolonging survival time are important topics and research focuses facing current clinical practice. Summary of the invention

[0004] One object of the present invention is to provide a Chinese medicine composition for postoperative treatment of lung cancer, which can be used to treat patients with lung qi deficiency and residual toxicity after surgery for lung cancer, promote rapid recovery after lung cancer surgery (especially improve lung function), improve clinical symptoms of lung cancer patients, improve their quality of life, and prevent and treat postoperative recurrence and metastasis.

[0005] The second object of the present invention is to provide a Chinese medicine preparation made using the above Chinese medicine composition.

[0006] The third object of the present invention is to provide applications of the above-mentioned Chinese medicine composition and Chinese medicine preparation.

[0007] In order to achieve the above object, the present invention adopts the following technical solutions:

[0008] In a first aspect, the present invention provides a traditional Chinese medicine composition for postoperative treatment of lung cancer, which is made from the following raw materials: raw astragalus, cimicifuga, platycodon, anemarrhena, inula, madder, bombyx batryticatus, smilax glabra and oldenlandia diffusa.

[0009] Furthermore, the traditional Chinese medicine composition is preferably made of the following raw medicines in parts by weight: 30-60 parts of raw astragalus, 6-9 parts of cimicifuga, 10-15 parts of platycodon, 10-15 parts of anemarrhena, 10-15 parts of inula, 10-15 parts of madder, 10-15 parts of bombyx batryticatus, 10-15 parts of smilax china and 10-30 parts of oldenlandia diffusa.

[0010] The inventors of the present invention believe that the treatment principle for patients after lung cancer surgery is to strengthen the body and eliminate toxins, and to use the method of tonifying the lungs and lifting the sunken to adjust the postoperative internal organs function and alleviate postoperative discomfort symptoms to promote rapid recovery. At the same time, detoxifying products are added as appropriate to prevent and treat postoperative recurrence and metastasis and prolong the patient's survival time.

[0011] In the present invention, raw Astragalus is sweet, slightly warm in nature, and enters the lung and spleen meridians. It has the ascending Qi of Shaoyang in spring, is good at replenishing Qi and raising Yang, and replenishing the Qi of the lungs and spleen. "Medical Records of Zhongzhong Canxi" says that "Astragalus is good at replenishing Qi and raising Qi. And its quality is light, and it contains oxygen, which has the same effect as the atmosphere in the chest", which can strengthen the body and eliminate evil, replenish Yang and eliminate Yin, make the body strong and the evil retreat, especially suitable for those with lung and spleen deficiency and sinking of lung Qi after lung cancer surgery, and is the main medicine of the whole prescription.

[0012] Zhimu tastes sweet and bitter, is cold in nature, enters the lung, stomach, and kidney meridians, and is good at clearing heat and purging fire, nourishing yin and moistening dryness. "Suwen·Yin Yang Ying Xiang Da Lun" says: "Strong fire weakens the qi, and strong fire consumes qi." Huangqi is slightly warm, and long-term use may cause the risk of consuming qi and damaging qi, so I use the cool and moist nature of Zhimu to help it, because it can eliminate the strong fire of eating qi and the qi will benefit from it. As stated in "Yi Xue Zhong Can Xi Lu": "When using Huangqi to nourish the qi of the spleen and lungs, in order to prevent the generation of pathogenic heat by replenishing qi, you can use Zhimu to nourish yin and purge heat, and use sweet and bitter together; if you use Huangqi to replenish qi and benefit yang, in case of heat that cannot be tolerated, you should always use Zhimu as a supplement."

[0013] Cimicifuga tastes pungent and slightly sweet, and is slightly cold in nature. It enters the lung, spleen, stomach, and large intestine meridians and is good at relieving rashes, clearing away heat and detoxifying, and raising Yang Qi. "Compendium of Materia Medica" says that it "leads the Yangming clear Qi upward. It is the most important medicine for guiding the spleen and stomach meridians for people with congenital deficiency, weak vital energy, overwork, hunger, and fullness, and internal injuries caused by raw and cold food." "Compendium of Materia Medica" also says, "Cimicifuga is a light medicine for raising Yang, detoxifying, pungent and slightly bitter, and is a medicine for guiding the meridians of the Yangming and Taiyin meridians of the foot... It can raise the Yang Qi below the most Yin Qi and lead the sweet and warm medicines upward." Therefore, I use Cimicifuga to raise Yang and raise Qi, as Zhang Xichun said, "Cimicifuga is a Yangming medicine that can lead the trapped Qi to rise from the right."

[0014] Inula flower tastes bitter, pungent and salty, is slightly warm in nature, and enters the lung, spleen, stomach, and large intestine meridians. It is good at descending qi, eliminating phlegm, promoting qi circulation, and stopping vomiting. "Compendium of Materia Medica" says that "Inula flower can eliminate phlegm, expel water, and promote qi downward. It is effective for the heart and lung qi, fullness under the hypochondrium, phlegm in the chest, belching due to abdominal distension, or retained fluid in the heart and spleen, and retained fluid in the bladder"; Rubia cordifolia tastes bitter, is cold in nature, and enters the liver meridian. "Compendium of Materia Medica" says that "Rubia cordifolia can promote blood circulation, promote circulation, and stop... It can promote blood circulation and qi, dredge meridians, and is the best way to treat blood stasis without damaging blood and qi." Rubia cordifolia is good at promoting blood circulation, removing blood stasis, stopping bleeding and dredging meridians. It is used together with Inula flower, which can eliminate phlegm and promote water circulation. They are the minister of the whole prescription, and together they can dredge the lung meridians, promote blood circulation, remove blood stasis, and stop cough and eliminate phlegm. It is especially suitable for those with postoperative lung qi sinking, qi and blood body fluid qi transformation disorders, and lung meridian stasis.

[0015] White silkworm tastes sweet and bitter, is cold in nature, and enters the liver and stomach meridians. The "Zhenglei Bencao" says that it "treats irritability, rubella, erysipelas, malaria, cold and heat, and fever in children", and has the effects of clearing away heat and dampness, detoxifying and reducing swelling. Modern research has found that it has a certain anti-cancer effect on tumors such as lung cancer and cervical cancer; Bombyx batryticatus tastes salty and spicy, is neutral in nature, enters the liver, lung, and stomach meridians, and can calm wind and stop convulsions, dispel wind and relieve pain, and resolve phlegm and disperse knots. The "Shennong Bencao Jing" records that it "treats children's epilepsy, night crying, and removes three worms... Makes people look good". Traditional Chinese medicine believes that it has a mild and non-toxic nature and can remove human toxins, especially suitable for tumor patients. Modern research has also confirmed that it has anti-tumor effects; White flower snake tongue grass tastes slightly bitter and sweet, is cold in nature, enters the stomach, large intestine, and small intestine meridians, and can clear away heat and detoxify, remove dampness and relieve stranguria. The "Guangxi Chinese Medicine Records" says that it "treats children's malnutrition, snake bites, and cancer". Modern research has found that it can inhibit a variety of tumor cells. All three have anti-tumor effects, and their mutual compatibility can enhance the anti-tumor efficacy. When used in patients after lung cancer surgery, they can help inhibit tumors, prevent recurrence and metastasis, and they are collectively adjuvants.

[0016] Platycodon grandiflorum is pungent and bitter in taste, neutral in nature, enters the lung meridian, and is good at clearing the lung and removing phlegm, relieving throat and draining pus. Zhang Yuansu said that it "clears lung qi, relieves throat, and is white in color, so it is used as a guide for the lung meridian, and is used together with licorice as a vessel." Platycodon grandiflorum is a vessel among medicines. It is not only a guide for the lung meridian, but also a guiding medicine for the whole prescription, which can carry the power of other medicines to the diseased area in the chest.

[0017] The whole prescription is pungent in nature and bitter in nature, and uses both cold and warmth, and both attacking and tonifying. Raw Astragalus is the main medicine, Anemarrhena asphodeloides, Cimicifuga heracleifolia, Inula japonica, and Rubia cordifolia are ministerial medicines, Bletilla striata, Bombyx batryticatus, and Oldenlandia diffusa are adjuvant medicines, and Platycodon grandiflorum is the guiding medicine. The main, minister, guiding, and guiding medicine complement each other, and have the function of benefiting the lungs, lifting trapped qi and detoxifying. It is especially suitable for patients with lung qi deficiency and residual toxins after lung cancer surgery.

[0018] In addition, the Chinese medicine composition of the present invention takes into account the disease, syndrome and symptom from the perspective of the formula principle, and is intended to relieve the symptoms of fatigue, chest tightness, shortness of breath, spontaneous sweating, cough, sputum and the like for patients with lung qi deficiency and residual toxicity after lung cancer surgery, and is the core prescription for syndrome differentiation after lung cancer surgery. In clinical syndrome differentiation, it is beneficial to the effect of lung detoxification, relieves lung qi deficiency and residual toxicity in lung cancer patients, promotes rapid recovery after lung cancer surgery, improves patient symptoms, improves quality of life, prevents and treats postoperative recurrence and metastasis, and improves long-term survival.

[0019] The raw materials of the above-mentioned Chinese medicine composition of the present invention constitute the basic formula. When implemented, the above-mentioned Chinese medicine composition can be adjusted according to clinical symptoms to achieve the purpose of improving certain combined clinical symptoms after lung cancer surgery, further enhance the adaptability of the composition of the present invention, and improve the therapeutic effect. These adjustments made based on the basic formula of the present invention are also within the protection scope of this application.

[0020] In a second aspect, the present invention provides a traditional Chinese medicine preparation for postoperative treatment of lung cancer. The traditional Chinese medicine preparation is prepared using the above-mentioned traditional Chinese medicine composition as a raw material. Optionally, according to the actual preparation molding needs, pharmaceutically acceptable excipients may be added during the preparation.

[0021] The dosage form of the traditional Chinese medicine preparation includes decoction, tablet, granule, pill, powder, capsule or powder.

[0022] In a third aspect, the present invention provides the use of the above-mentioned Chinese medicine composition or Chinese medicine preparation for postoperative treatment of lung cancer in the preparation of any of the following drugs;

[0023] 1) Drugs for improving clinical symptoms of patients after lung cancer surgery, wherein the clinical symptoms include at least one of cough, expectoration, shortness of breath, dry mouth, fatigue, chills, shortness of breath, fatigue, loss of appetite, insomnia, and constipation;

[0024] 2) Drugs for improving the lung function status of patients after lung cancer surgery, wherein the lung function status includes at least one of forced vital capacity, forced expiratory volume in 1 second, and peak expiratory flow;

[0025] 3) Drugs for preventing and treating recurrence and metastasis of lung cancer patients after surgery.

[0026] In addition, unless otherwise specified, the raw materials of the Chinese medicine composition of the present invention can be obtained commercially, and any range recorded in the present invention, including the end values ​​and any numerical value between the end values, and any sub-range of the Chinese medicine composition composed of the end values ​​or any numerical value between the end values, can achieve the purpose of controlling gastric cancer.

[0027] The beneficial effects of the present invention are as follows:

[0028] The Chinese medicine composition of the present invention has been verified by clinical trials. It is aimed at the core pathogenesis of "lung qi deficiency and residual toxins" after lung cancer surgery, and is intended to benefit the lungs, lift the deficient qi and eliminate toxins. It has certain advantages in promoting rapid recovery after lung cancer surgery, improving symptoms, improving quality of life, preventing and treating postoperative recurrence and metastasis, and has good drug safety. In addition, the Chinese medicine composition of the present invention is mainly based on syndrome differentiation. According to the syndromes manifested by the disease, the cause, pathogenesis, nature and location of the disease at the current stage are analyzed. On the basis of syndrome differentiation and treatment, the pharmacological research of modern Chinese medicine is combined, and the disease-symptom combination method is adopted, while taking into account symptomatic treatment, so as to achieve significant therapeutic effects and present the most rational treatment strategy. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 The dendrogram of cluster analysis of clinical symptom levels of patients before treatment is shown. DETAILED DESCRIPTION

[0030] In order to explain the present invention more clearly, the present invention is further described below in conjunction with preferred embodiments and statistical data. It should be understood by those skilled in the art that the content described below is illustrative rather than restrictive, and should not be used to limit the scope of protection of the present invention.

[0031] Example 1 A Chinese medicine composition for treating lung cancer

[0032] A traditional Chinese medicine composition for treating lung cancer comprises the following raw medicines: 30 parts of raw astragalus, 6 parts of cimicifuga, 10 parts of platycodon, 10 parts of anemarrhena, 10 parts of inula, 10 parts of madder, 10 parts of bombyx batryticatus, 10 parts of lycopodiella and 10 parts of oldenlandia diffusa.

[0033] Example 2 A Chinese medicine composition for treating lung cancer

[0034] A traditional Chinese medicine composition for treating lung cancer comprises the following raw medicines: 45 parts of raw astragalus, 6 parts of cimicifuga, 12 parts of platycodon, 12 parts of anemarrhena, 12 parts of inula, 12 parts of madder, 15 parts of bombyx batryticatus, 15 parts of lyracha and 15 parts of oldenlandia diffusa.

[0035] Example 3 A Chinese medicine composition for treating lung cancer

[0036] A traditional Chinese medicine composition for treating lung cancer comprises the following raw medicines: 60 parts of raw astragalus, 9 parts of cimicifuga, 15 parts of platycodon, 12 parts of anemarrhena, 15 parts of inula, 15 parts of madder, 15 parts of bombyx batryticatus, 15 parts of lycopodiella and 30 parts of oldenlandia diffusa.

[0037] Example 4 A Chinese medicine composition for treating lung cancer

[0038] A traditional Chinese medicine composition for treating lung cancer comprises the following raw medicines: 30 parts of raw astragalus, 6 parts of cimicifuga, 10 parts of platycodon, 10 parts of anemarrhena, 10 parts of inula, 10 parts of madder, 15 parts of bombyx batryticatus, 15 parts of smilax china, and 15 parts of oldenlandia diffusa.

[0039] Study 1: Intervention study on clinical symptoms, lung function and quality of life in patients after lung cancer surgery

[0040] 1. Research design: From November 2021 to April 2023, 59 patients with lung cancer who underwent surgery and received TCM treatment in the Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences were included. According to the UICC 2017 edition TNM stage IA-IIIA, there were 52 cases of adenocarcinoma (88.14%), 6 cases of squamous cell carcinoma (10.17%), and 1 case of large cell carcinoma (1.69%), including 23 males and 36 females, aged 34 to 71 years old. All patients had a clear clinical diagnosis, and the Chinese medicine composition of Example 1 of the present invention was used as the main formula to prepare a decoction. The treatment was evaluated for at least 4 weeks, and 30 patients were randomly selected for pulmonary function and Piper fatigue scale testing.

[0041] 2. Research standards: The clinical symptom scale for lung cancer and the EORTC-QLQ-C30 quality of life measurement scale were used to evaluate clinical efficacy and quality of life. Cluster analysis was performed on the clinical symptoms of patients before Chinese medicine intervention. The most common discomfort symptoms of patients after lung cancer surgery were observed. Thirty patients were randomly selected for lung function and Piper fatigue scale tests, and the results were compared and analyzed. Among them, the clinical symptom scale for lung cancer was formulated with reference to the "Guidelines for the Diagnosis and Treatment of Malignant Tumors in Traditional Chinese Medicine" - primary bronchial lung cancer, and the "Guiding Principles for New Chinese Medicines" - primary lung cancer symptom grading and quantitative table, and the items that best reflect the symptoms of patients after lung resection were screened out. This scale can objectively and comprehensively evaluate the complications and quality of life of patients after lung resection, mainly including 15 items such as cough, sputum, shortness of breath, chest tightness, chest pain, dry mouth and throat, fatigue, five upset fever, chills and cold limbs, spontaneous sweating, insomnia, loss of appetite, constipation, diarrhea, and frequent urination at night. Each item is divided into 4 levels according to the severity of the symptoms, and the values ​​are 1, 2, 3, and 4 points respectively. According to the scoring rules, the higher the patient's score, the more severe the symptoms or problems are and the worse the quality of life.

[0042] The EORTC-QLQ-C30 quality of life scale has 30 items. The 29th and 30th items are divided into 7 levels, with 1-7 points from "poor" to "very good" respectively; the other items are divided into 4 levels, with 1, 2, 3, and 4 points from "none", "little", "more" to "very much". These 30 items are divided into nine areas, including five functional areas (physical function, role function, emotional function, cognitive function, and social function); three symptom areas (fatigue, nausea and vomiting, and pain), one overall quality of life area, and six single measurement items (each as a area), including shortness of breath, insomnia, loss of appetite, constipation, diarrhea, and financial difficulties, which can be collectively referred to as fifteen dimensions. The scoring method of this scale is: the scores of the items included in each area are added and divided by the number of items included to obtain the rough score of the area, and then the rough score is converted into a standardized score with a value between 0 and 100. According to the scoring rules, higher scores in the functional domain and overall quality of life domain indicate better functional status and quality of life, while higher scores in the symptom domain indicate more symptoms or problems and worse quality of life.

[0043] Pulmonary function tests mainly include FVC (forced vital capacity), FEV1 (forced expiratory volume in 1 second), FEV1%FVC (1 second rate), VC MAX (maximum vital capacity), MEF 75 (75% expiratory flow rate), MEF 50 (50% expiratory flow rate), MEF 25 (25% expiratory flow rate), MMEF (maximum mid-expiratory flow), PEF (peak expiratory flow) and other indicators.

[0044] The Piper Fatigue Scale mainly evaluates the patient's fatigue based on factors such as the patient's physical condition and behavior. The specific value range of each score is 0-10 points. The scores of each item are added together to get the final score. The higher the score, the more severe the patient's fatigue.

[0045] 3. Research results:

[0046] Cluster analysis of common clinical symptoms of patients before TCM treatment (see Figure 1), according to clinical observation and the distribution characteristics of symptoms after clustering, the postoperative symptoms of lung cancer can be divided into 5 categories. The first category is spontaneous sweating, constipation, and diarrhea. The second category is frequent urination at night. The third category is cough, insomnia, fever in the five hearts, and loss of appetite. The fourth category is fatigue, shortness of breath, dry mouth and tongue, chest tightness, chills and cold limbs, and chest pain. The fifth category is sputum. The results show that the most common symptoms after lung cancer surgery include fatigue, shortness of breath, dry mouth and tongue, chest tightness, chills and cold limbs, and chest pain, followed by cough, insomnia, fever in the five hearts, and loss of appetite, followed by sputum, frequent urination at night, spontaneous sweating, constipation, and diarrhea. The results of the lung cancer clinical symptom scale EORTC-QLQ-C30 score, lung function test, and Piper fatigue scale score (see Tables 1-4) after treatment showed that the Chinese medicine composition was used as the main prescription. After treatment, the patients showed significant improvements in FVC (forced vital capacity), FEV1 (forced expiratory volume in 1 second), PEF (peak expiratory flow), cough, sputum, shortness of breath, dry mouth, fatigue, chills and cold limbs, loss of appetite, insomnia, physical function, role function, overall health status, shortness of breath, fatigue, and constipation before and after treatment (P<0.05), all of which were statistically significant. Compared with previous studies, the present invention can not only improve typical symptoms after lung cancer surgery such as cough, shortness of breath, and fatigue, but also has significant efficacy in improving postoperative fatigue, shortness of breath, chills and cold limbs, dry mouth, loss of appetite, insomnia, and constipation, indicating that the Chinese medicine composition can effectively improve common symptoms after lung cancer surgery, improve the quality of life of patients, improve the lung function of patients, and promote rapid recovery after surgery.

[0047] Table 1 Comparison of lung cancer clinical symptom scale scores before and after treatment

[0048]

[0049]

[0050] * indicates P < 0.01 compared with before treatment; Δ indicates P < 0.05 compared with before treatment

[0051] Table 2 Comparison of EORTC-QLQ-C30 scores before and after treatment

[0052]

[0053] * indicates P < 0.01 compared with before treatment; Δ indicates P < 0.05 compared with before treatment

[0054] Table 3 Comparison of pulmonary function test results before and after treatment

[0055]

[0056]

[0057] * indicates P < 0.01 compared with before treatment; Δ indicates P < 0.05 compared with before treatment

[0058] Table 4 Comparison of Piper Fatigue Scale scores before and after treatment

[0059]

[0060] * indicates P < 0.01 compared with before treatment; Δ indicates P < 0.05 compared with before treatment

[0061] Study 2: Typical cases and efficacy:

[0062] Case 1: Acute phase after lung cancer surgery, promoting rapid recovery of lung function

[0063] The patient, a 48-year-old female, underwent lung cancer resection on February 28, 2023. Postoperative pathology showed moderately differentiated adenocarcinoma in the right lower lobe of the lung, which was papillary (80%), alveolar (10%), and mural (10%). The maximum diameter of the tumor was 2.2 cm, and it did not involve the visceral pleura (PL0) and lobar and segmental bronchi. No clear vascular tumor thrombus and nerve invasion were found. No cancer was found at the bronchial resection margin. No significant lesions were found in the surrounding lungs. No metastatic cancer was found in the lymph nodes (0 / 12). pTNM: pT1cN0M0.

[0064] The first visit was on March 8, 2023. The patient complained of fatigue, tiredness, shortness of breath, no cough or sputum, chills, dry mouth, back pain, good appetite, shallow sleep, easy to wake up, able to fall asleep again after waking up, 1-2 bowel movements / day, formed, regular urination, dark tongue, slightly yellow and greasy fur, and fine pulse. Pulmonary function test showed: FVC 3.16 liters, FEV1 2.49 liters, FVC / FEV1 79%, MMEF 2.31L / sec, MEF 750.94L / sec, MEF 50 3.02L / sec, MEF 25 4.99L / sec, PEF 5.75L / sec, VC max 3.16 liters. Western medicine diagnosis: lung cancer; Chinese medicine diagnosis: lung cancer, lung qi deficiency, residual toxins not completely eliminated. Chinese medicine treatment: benefit the lungs, lift the deficiency and detoxify. Prescription: 45g of raw Astragalus, 6g of Cimicifuga, 12g of Platycodon grandiflorum, 12g of Anemarrhena asphodeloides, 12g of Inula flower, 12g of Rubia cordifolia, 15g of Bombyx batryticatus, 15g of Bletilla striata, 15g of Hedyotis diffusa. 28 doses of decoction, one dose per day, divided into morning and evening after meals. The patient continued to take the original prescription for 2 months.

[0065] Follow-up on June 18, 2023: The patient complained of fatigue, tiredness, reduced chills, occasional shortness of breath, slight spontaneous sweating, aggravated after exercise, irritating dry cough, dry throat, foreign body sensation in the throat, bitter mouth, bad taste in the mouth, good appetite, improved sleep, regular bowel movements, easy anxiety, pale red tongue, thin white fur, and slippery pulse. Re-examination of pulmonary function showed: FVC 3.68 liters, FEV1 2.75 liters, FVC / FEV1 75%, MMEF 2.08L / sec, MEF 75 0.91L / sec, MEF 50 2.63L / sec, MEF 25 8L / sec, PEF 8.52L / sec, VC max 3.68 liters, which was significantly improved compared with the previous results. Continue to take 28 doses of decoction, one dose per day, divided into morning and evening after meals. After that, the patient was followed up in the outpatient clinic, and all postoperative discomfort symptoms were eliminated, and the quality of life was significantly improved.

[0066] Case 2: After lung cancer surgery, promote postoperative recovery and improve postoperative symptoms

[0067] The patient, a 34-year-old female, underwent right lower lobectomy on April 2, 2022. Postoperative pathology showed: alveolar invasive adenocarcinoma (peripheral type, diameter 0.9 cm); airway spread (+); no invasion of local visceral pleura; no involvement of lung stump; no cancer metastasis in regional lymph nodes (group 2 0 / 1, group 4 0 / 1, group 7 0 / 2, group 9 0 / 1, group 10 0 / 1, group 11 0 / 1, group 12 0 / 1). pTNM stage: T1N0M0. Immunohistochemistry: TTF-1 (-), Napsin A (+), P40 (-), ALK (D5F3) (-), ALK (D5F3) N (-), CK5 / 6 (-), PD-L1 (22C3) (TPS < 1%).

[0068] The first visit was on April 27, 2022. The patient complained of cough, shortness of breath, chest tightness, chest pain, fatigue, easy fatigue, cold hands and feet, like hot drinks, anxiety, irritability, upset, poor sleep, difficulty falling asleep, early awakening, one bowel movement a day, formed, and regular urination. The tongue is dark red, the fur is thin and white, and the pulse is weak. Western medicine diagnosis: lung cancer; Chinese medicine diagnosis: lung cancer, lung qi deficiency, and residual toxins are not completely confirmed. Chinese medicine treatment: benefit the lungs, lift the sinking and detoxify. Prescription: 30g of raw astragalus, 6g of shengma, 10g of platycodon, 10g of anemarrhena, 10g of xuanfu flower, 10g of madder, 15g of white silkworm, 15g of white gentian, and 15g of white flower snake tongue grass. 28 doses of decoction, one dose per day, divided into morning and evening after meals.

[0069] Follow-up on May 25, 2022: The patient reported that after taking the above prescription, fatigue, chest tightness, and shortness of breath were significantly relieved, appetite was good, poor sleep and difficulty falling asleep were relieved, tongue was dark red, thin white fur, and pulse was weak. If the prescription is effective, continue 28 doses, 1 dose / day, decocted in water, warm in the morning and evening. Since then, the patient has been followed up in the outpatient clinic, and the above prescription has been used for treatment so far, and the postoperative discomfort symptoms have been eliminated.

[0070] Case 3: After lung cancer surgery, simple TCM treatment based on syndrome differentiation improved the quality of life and prevented postoperative recurrence and metastasis

[0071] The patient, a 71-year-old female, underwent left upper lobectomy on September 27, 2021. Postoperative pathology showed: invasive adenocarcinoma, mainly alveolar type, size 1.3×0.8cm; no clear intravascular cancer thrombus; no invasion of the visceral pleura; no cancer invasion of the lung stump; no cancer metastasis in the lymph nodes (groups 5, 6, 7, 10, and 11). pTNM stage: T1N0M0. Immunohistochemistry: TTF-1(+), NapsinA(+), P40(-), CK5 / 6(-), Ki-67(20%+), ALK(D5F3)(-), CK(+).

[0072] The first visit was on December 29, 2021. The patient complained of fatigue, shortness of breath, easy fatigue, fear of cold, palpitations and dizziness, dry mouth at night, hoarseness, general appetite, poor sleep, difficulty falling asleep, one bowel movement a day, formed, and regular urination. The tongue was pale red, the fur was yellow and greasy, and the pulse was thin. Western medicine diagnosis: lung cancer; Chinese medicine diagnosis: lung cancer, lung qi deficiency, and residual toxins are not completely confirmed. Chinese medicine treatment: benefit the lungs, lift the deficiency and detoxify. Prescription: 60g of raw astragalus, 9g of shengma, 15g of platycodon, 12g of anemarrhena, 15g of inula flower, 15g of madder, 15g of white silkworm, 15g of white gentian, and 30g of white flower oldenlandia. 28 doses of decoction, one dose a day, divided into morning and evening after meals.

[0073] Follow-up on January 26, 2022: The patient reported that after taking the above prescription, his physical strength increased, fatigue and shortness of breath improved, he had a hoarse throat, dry mouth at night, good appetite, poor sleep, and difficulty falling asleep. The tongue was pale red, the coating was thin and yellow, and the pulse was weak. Continue 28 doses, 1 dose / day, decocted in water, warm in the morning and evening. Since then, the patient has been followed up in the outpatient clinic. With the above prescription plus or minus treatment, the postoperative discomfort symptoms have been eliminated, the quality of life has been significantly improved, and there has been no metastasis or recurrence.

[0074] Case 4: After lung cancer surgery, simple TCM treatment based on syndrome differentiation prevented postoperative recurrence and metastasis and prolonged survival time

[0075] The patient, a 68-year-old male, underwent VATS radical resection of lung cancer in the right upper lobe on January 11, 2016. Postoperative pathology showed: moderately poorly differentiated invasive adenocarcinoma in the right upper lobe; microscopic tumor size was about 1.3×1.0×0.5cm; chronic inflammation of the bronchial stump; chronic inflammation of lymphoid tissue in group 2 (0 / 4), group 3 (0 / 3), group 4 (0 / 3), group 7 (0 / 2), group 9 (0 / 1), and group 11 (0 / 5). pTNM stage: T1aN0M0. Immunohistochemistry: CK7(+), TTF-1(+), NapsinA(+), CK5 / 6(-), P63(-), P40(-), CD(-), Syn(-).

[0076] The first visit was on March 9, 2016. The patient complained of shortness of breath, cough, dry cough without sputum, dizziness, rotation, oral ulcer, good appetite and sleep, irritable temper, normal bowel movements, dark purple tongue, white greasy coating, and stringy and smooth pulse. Western medicine diagnosis: lung cancer; Chinese medicine diagnosis: lung cancer, lung qi deficiency, residual toxins not completely eliminated. Chinese medicine treatment: nourish the lungs, lift the deficiency and eliminate toxins. Prescription: 30g of raw astragalus, 6g of cimicifugae, 10g of platycodon, 10g of anemarrhena, 10g of inula flower, 10g of madder, 15g of white bombyx batryticatus, 15g of white gentian, 15g of white flower hedyotis diffusa. 28 doses of decoction, one dose per day, divided into morning and evening after meals.

[0077] Follow-up on April 19, 2016: The patient reported that after taking the above prescription, his physical strength was still good, his cough was relieved, he did not cough up sputum, his shortness of breath was relieved, his limbs were not warm, his appetite was good, his sleep was good, and his bowel movements were normal. The tongue was fat, slightly dark purple, the tongue coating was thin, and the pulse was weak. Continue 28 doses, 1 dose / day, decocted in water, warm in the morning and evening. Since then, the patient has been reviewed regularly, followed up in the outpatient clinic, and has taken Chinese medicine regularly until now. No subsequent radiotherapy or chemotherapy has been performed. On August 8, 2022, the tumor markers were normal. On February 6, 2023, the chest CT showed dilatation of the right bronchi, chronic inflammation of the lingular segment of the left upper lobe, and micronodules in the posterior segment of the apex of the left upper lobe, which was roughly the same as before. It has been 7 years since the operation, and there has been no metastasis or recurrence.

[0078] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not limitations on the implementation methods of the present invention. For ordinary technicians in the relevant field, other different forms of changes or modifications can be made based on the above description. It is impossible to list all the implementation methods here. All obvious changes or modifications derived from the technical solution of the present invention are still within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for postoperative treatment of lung cancer, characterized in that: The invention is prepared from the following raw materials in parts by weight: 30-60 parts of raw astragalus, 6-9 parts of cimicifuga, 10-15 parts of platycodon, 10-15 parts of rhizoma anemarrhenae, 10-15 parts of inula flower, 10-15 parts of madder, 10-15 parts of bombyx batryticatus, 10-15 parts of smilax glabra and 10-30 parts of oldenlandia diffusa.

2. The Chinese medicine composition according to claim 1, characterized in that: The drug is prepared from the following raw materials in parts by weight: 30 parts of raw astragalus, 6 parts of cimicifuga, 10 parts of platycodon, 10 parts of anemarrhena, 10 parts of inula, 10 parts of madder, 10 parts of bombyx batryticatus, 10 parts of smilax glabra and 10 parts of oldenlandia diffusa.

3. The Chinese medicine composition according to claim 1, characterized in that The drug is prepared from the following raw materials in parts by weight: 45 parts of raw astragalus, 6 parts of cimicifuga, 12 parts of platycodon, 12 parts of anemarrhena, 12 parts of inula, 12 parts of madder, 15 parts of bombyx batryticatus, 15 parts of smilax glabra and 15 parts of oldenlandia diffusa.

4. The Chinese medicine composition according to claim 1, characterized in that: The drug is prepared from the following raw materials in parts by weight: 60 parts of raw astragalus, 9 parts of cimicifuga, 15 parts of platycodon, 12 parts of anemarrhena, 15 parts of inula, 15 parts of madder, 15 parts of bombyx batryticatus, 15 parts of lycopodiella and 30 parts of oldenlandia diffusa.

5. The Chinese medicine composition according to claim 1, characterized in that: The drug is prepared from the following raw materials in parts by weight: 30 parts of raw astragalus, 6 parts of cimicifuga, 10 parts of platycodon, 10 parts of anemarrhena, 10 parts of inula, 10 parts of madder, 15 parts of bombyx batryticatus, 15 parts of smilax glabra, and 15 parts of oldenlandia diffusa.

6. A Chinese medicine preparation for postoperative treatment of lung cancer, characterized in that: The raw materials of the Chinese medicine preparation include the Chinese medicine composition described in any one of claims 1-5.

7. The Chinese medicine preparation according to claim 6, characterized in that: The raw materials of the traditional Chinese medicine preparation also include pharmaceutically acceptable excipients.

8. The Chinese medicine preparation according to claim 6 or 7, characterized in that: The dosage form of the traditional Chinese medicine preparation includes decoction, tablet, granule, pill, powder, capsule or powder.

9. Use of the Chinese medicine composition according to any one of claims 1 to 5 or the Chinese medicine preparation according to any one of claims 6 to 8 in the preparation of the following drugs; 1) Drugs for improving clinical symptoms of patients after lung cancer surgery, wherein the clinical symptoms include at least one of cough, expectoration, shortness of breath, dry mouth, fatigue, chills, shortness of breath, fatigue, loss of appetite, insomnia, and constipation; 2) a drug for improving the lung function status of patients after lung cancer surgery, wherein the lung function status includes at least one of forced vital capacity, forced expiratory volume in 1 second, and peak expiratory flow; and 3) Drugs for preventing and treating recurrence and metastasis of lung cancer patients after surgery.

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