A traditional Chinese medicine composition for treating pulmonary nodules and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating lung nodules, which is prepared from the following components in parts by weight: orange pith 5-10 parts, Zhejiang fritillary bulb 10-30 parts, snakegourd seed 10-30 parts, raw oyster 10-30 parts, and forsythia 5-15 parts. The traditional Chinese medicine composition is cheap in raw material, simple in preparation and convenient in use. The traditional Chinese medicine composition is safe and non-toxic, and can be taken for a long time.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically, it relates to a traditional Chinese medicine composition for treating pulmonary nodules and its application. Background Technology

[0002] Pulmonary nodules (PN) are a common clinical finding, referring to round or irregular lesions in the lungs with a diameter of 3 cm or less (30 mm). On imaging, they appear as shadows with increased density, and can be single or multiple, with clear or indistinct borders. They are usually discovered incidentally during physical examinations or when treating other diseases. Most patients have no obvious symptoms, while those who do experience symptoms such as dyspnea, chest pain, cough, and hemoptysis.

[0003] Causes of pulmonary nodules:

[0004] 1. Basic Etiology (1) Malignant Lesions ① Primary Lung Cancer: mainly includes lung adenocarcinoma, lung squamous cell carcinoma, lung large cell carcinoma, and lung small cell carcinoma. ② Metastatic Malignant Tumors: such as head and neck malignant tumors, melanoma, colon cancer, etc. (2) Benign Lesions ① Benign Tumors: such as lung hamartoma, lung fibroma, and lung lipoma. ② Infections: infection with Mycobacterium tuberculosis, infection with lung fungi (such as Candida, Aspergillus, and Mucor). ③ Inflammatory Lesions: such as granulomatous disease and sarcoidosis. ④ Pulmonary Vascular Abnormalities: such as pulmonary arteriovenous malformations and pulmonary capillary dilatation. ⑤ Congenital Pulmonary Diseases: such as bronchial cysts and pulmonary sequestration.

[0005] 2. High-risk factors: (1) Smoking or a history of smoking. (2) Presence of fungal or bacterial infection of the lungs. (3) Previous history of malignant tumors or family history of lung cancer. (4) History of environmental or high-risk occupational exposure, such as frequent exposure to asbestos, beryllium, uranium, radon, etc. (5) Comorbid chronic obstructive pulmonary disease or diffuse pulmonary fibrosis.

[0006] Typical symptoms of pulmonary nodules:

[0007] 1. Cough: When pulmonary nodules involve pulmonary nerves, persistent and recurrent cough may occur. Pulmonary nodules caused by infection are often accompanied by purulent sputum.

[0008] 2. Chest pain: When tumors or tuberculous lesions involve the pleura or chest wall, chest pain may occur, which is aggravated by breathing and coughing.

[0009] 3. Difficulty breathing: If the nodules continue to enlarge and compress the large bronchi, symptoms such as chest tightness, shortness of breath, wheezing, and difficulty breathing may occur.

[0010] 4. Hemoptysis: When nodules involve pulmonary blood vessels, patients may experience hemoptysis.

[0011] 5. Systemic manifestations: For pulmonary nodules caused by malignant tumors or tuberculosis infection, nonspecific manifestations such as fatigue, low-grade fever, weight loss, and night sweats (sweating during sleep at night, which stops upon waking) may occur. If the tuberculous lesions progress and spread rapidly, high fever may occur.

[0012] Treatment of pulmonary nodules: The treating physician will provide an individualized treatment plan based on the cause of the pulmonary nodules. If the pulmonary nodule is diagnosed as benign or malignant, surgical removal may be considered. For those caused by Mycobacterium tuberculosis infection or fungal infection, anti-tuberculosis and antifungal treatments will be given respectively. If the pulmonary nodule cannot be definitively diagnosed but is deemed suitable for observation, the physician will develop an appropriate follow-up plan for the patient based on the probability of malignancy.

[0013] Drug treatment for pulmonary nodules:

[0014] 1. Anti-tuberculosis drugs are mainly used for pulmonary nodules caused by pulmonary tuberculosis. Commonly used drugs include isoniazid and rifampin, which can kill tuberculosis bacteria and control the disease.

[0015] 2. Commonly used antibiotics include ofloxacin, norfloxacin, moxifloxacin, and erythromycin. They are mainly used for patients with infection symptoms and can prevent secondary infections.

[0016] 3. Antifungal drugs are mainly used for patients with fungal infections. Commonly used drugs include itraconazole, fluconazole, and terbinafine hydrochloride. Related drugs include isoniazid, rifampin, ofloxacin, norfloxacin, moxifloxacin, erythromycin, itraconazole, fluconazole, and terbinafine hydrochloride.

[0017] Surgical treatment of pulmonary nodules:

[0018] 1. Surgical procedure

[0019] (1) Video-assisted thoracoscopic surgery (VATS): The surgeon makes a small incision in the patient's chest and inserts a tube with a camera and light source to perform the surgery. It features a wide field of vision, minimal trauma, less pain, and faster postoperative recovery. At the same time, it can remove more mediastinal lymph nodes and reduce the incidence of residual lymph nodes, making it the main surgical method at present.

[0020] (2) Thoracotomy: For lung nodules located deep in the lungs, thoracotomy may be necessary.

[0021] 2. Surgical resection scope: The surgeon will determine the extent of resection based on the size and nature of the nodule, including sublobar or lobectomy, wedge resection, segmentectomy or subsegmentectomy, and regional lymph node dissection. Other treatments: For high-probability malignant pulmonary nodules that cannot tolerate surgery, ablation therapy may be considered after PET evaluation.

[0022] Early-stage pulmonary nodules often present no specific symptoms and are frequently discovered during routine chest CT scans. Scientific management is crucial, focusing on differentiating between benign and malignant nodules, avoiding overly invasive examinations and treatments for benign nodules, intervening early in the detection of malignant nodules, maintaining or reducing the size of benign pulmonary nodules to some extent, and improving the patient's quality of life. Western medicine often treats pulmonary nodules that do not meet surgical criteria primarily through follow-up, with limited treatment options. Patients often do not receive effective treatment, leading to significant psychological stress and a vicious cycle. In such cases, Traditional Chinese Medicine (TCM) can fully leverage its advantages, offering multi-target, multi-pathway, and multi-faceted treatment for pulmonary nodules.

[0023] Traditional Chinese medicine (TCM) considers pulmonary nodules to be tangible pathogenic factors, primarily formed by the interaction of phlegm, blood stasis, and toxins. When nodules enlarge and develop into secondary infections, they exhibit certain syndrome characteristics, such as Qi stagnation and phlegm obstruction syndrome, cold phlegm stagnation syndrome, damp-heat phlegm stasis syndrome, and Yang deficiency with internal heat syndrome. TCM has rich experience in treating this disease, with diverse treatment methods and high efficacy. Modern TCM combines disease differentiation with syndrome differentiation, exploring many new treatment plans and prescriptions, demonstrating unique advantages in clinical practice. Summary of the Invention

[0024] The purpose of this invention is to provide a traditional Chinese medicine composition for treating pulmonary nodules.

[0025] Another object of the present invention is to provide the use of the traditional Chinese medicine composition in the preparation of a medicament for treating pulmonary nodules.

[0026] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0027] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating pulmonary nodules, which is made of the following components in parts by weight: 5-10 parts of tangerine peel, 10-30 parts of Fritillaria thunbergii, 10-30 parts of Trichosanthes kirilowii seed, 10-30 parts of raw oyster shell, and 5-15 parts of Forsythia suspensa.

[0028] The traditional Chinese medicine composition for treating pulmonary nodules is made from the following components in parts by weight: 8 parts of tangerine peel, 25 parts of Fritillaria thunbergii, 15 parts of Trichosanthes kirilowii seed, 15 parts of raw oyster shell, and 10 parts of Forsythia suspensa.

[0029] The traditional Chinese medicine composition for treating pulmonary nodules is made from the following components in parts by weight: 10 parts of tangerine peel, 30 parts of fritillaria thunbergii, 30 parts of trichosanthes kirilowii seed, 20 parts of raw oyster shell, and 9 parts of forsythia.

[0030] The traditional Chinese medicine composition for treating pulmonary nodules is made from the following components in parts by weight: 6 parts of tangerine peel, 20 parts of fritillaria thunbergii, 10 parts of trichosanthes kirilowii seed, 10 parts of raw oyster shell, and 7 parts of forsythia.

[0031] The traditional Chinese medicine composition for treating pulmonary nodules is made from the following components in parts by weight: 7 parts of tangerine peel, 10 parts of fritillaria thunbergii, 20 parts of trichosanthes kirilowii seed, 15 parts of raw oyster shell, and 8 parts of forsythia.

[0032] The traditional Chinese medicine composition for treating pulmonary nodules is made from the following components in parts by weight: 9 parts of tangerine peel, 15 parts of Fritillaria thunbergii, 15 parts of Trichosanthes kirilowii seed, 30 parts of raw oyster shell, and 12 parts of Forsythia suspensa.

[0033] In a second aspect, the present invention provides the use of the traditional Chinese medicine composition in the preparation of a medicament for treating pulmonary nodules.

[0034] In a third aspect, the present invention provides a traditional Chinese medicine preparation, which is prepared from the above-mentioned traditional Chinese medicine composition.

[0035] The dosage forms of the traditional Chinese medicine preparations are selected from decoctions, tablets, mixtures, oral liquids, granules, pills, capsules, umbilical patches, and suppositories.

[0036] This invention uses tangerine peel and fritillaria thunbergii as the principal herbs to achieve the effects of "regulating qi and relieving stagnation, resolving phlegm and dissipating nodules". Trichosanthes kirilowii seed is used as the assistant herb to help clear the lungs and resolve phlegm. Oyster shell is used to subdue yang and nourish yin, and to descend evil spirits in the chest. Forsythia suspensa is used as the guiding herb to direct the medicine to the affected area. Together, they clear the lungs, resolve phlegm, reduce swelling and dissipate nodules. The invention emphasizes regulating qi, resolving phlegm, and dissipating nodules to achieve the effect of "eliminating evil and supporting the body's resistance, and promoting the smooth flow of yin and yang".

[0037] The properties, meridian tropism, and indications of the traditional Chinese medicine raw materials of this invention are as follows:

[0038] This invention addresses the problem of obstructed Qi flow in the upper Jiao (upper burner), resulting in phlegm and Qi stagnation that transforms into heat. The treatment principle is to regulate Qi flow, clear the channels and disperse stagnation, and clear and moisten the lungs.

[0039] Orange pith, neutral in nature, sweet and bitter in taste, enters the lung and spleen meridians. Orange pith is mild and gentle in medicinal properties, with the functions of clearing the meridians and resolving phlegm, regulating qi and strengthening the spleen, breaking up accumulations and eliminating stagnation, especially effective in clearing the meridians and eliminating phlegm; Fritillaria thunbergii is bitter and cold, entering the lung and heart meridians. It has the effects of clearing heat and resolving phlegm, lowering qi and stopping cough, dispersing nodules and reducing swelling, and is particularly good at clearing heat from both the exterior and interior of the lungs and dispersing phlegm. The *Compendium of Materia Medica Supplement* states that orange pith clears stagnant qi in the meridians, relieves pulse distension, expels phlegm accumulated under the skin and membranes, and invigorates blood circulation. The *Compendium of Materia Medica Supplement* also records that Fritillaria thunbergii can detoxify and resolve phlegm, and open up lung qi, suitable for those with phlegm due to wind-heat in the lungs. These two are the main ingredients in the composition of this invention, working together to clear the meridians, disperse phlegm, and clear the exterior and interior.

[0040] Trichosanthes kirilowii Maxim. seeds are sweet and bitter in taste and cold in nature. Since they grow in the Shen month, Geng metal, You month, and contain Xu month, corresponding to the lung, stomach, and large intestine meridians, they have the effects of clearing heat and removing phlegm, widening the chest and dissipating binds, moistening dryness and lubricating the intestines. They can treat heat in the lungs, promote qi flow in the middle jiao, and unblock the intestines, thus regulating the qi mechanism of the whole body; Oyster is salty and slightly cold, entering the liver and kidney meridians, causing the qi of the human body to converge and descend. Its effects are astringing yin, softening hardness and dissipating binds, and can treat scrofula. Oyster is good at combining dispersing and resolving phlegm. "Complete Works of Jingyue": Trichosanthes kirilowii Maxim. seeds have a thick smell and taste, and their nature is descending and moistening. They can reduce excessive heat phlegm, open stagnant binds and qi blockages, relieve thirst, relieve distension and asthma, moisten the lungs and stop coughing. "Explanation of Medicinal Properties in Treatise on Febrile Diseases" states: "For all phlegm and blood stasis masses, goiters, scrofula, etc., they can be resolved when treated with it." It can be seen that the combination of the two drugs has a more specific effect.

[0041] Forsythia suspensa (Thunb.) Vahl is an adjuvant drug. It is cool and bitter in nature, light and floating upward, can treat various heat syndromes in the upper jiao, especially can detoxify and dissipate carbuncles and resolve binds, so it is an essential drug for treating sores. It not only guides the drug into the lung meridian and makes the drug power reach the affected area directly, but also combines with other drugs to jointly perform the functions of clearing the lung and resolving phlegm, reducing swelling and dissipating binds. Looking at the whole formula, Forsythia suspensa (Thunb.) Vahl and Fritillaria thunbergii Miq. have the power of promoting qi flow and dredging. Combining with the descending nature of Trichosanthes kirilowii Maxim. seeds and raw oyster, it regulates the qi mechanism of the human body. When the qi is smooth, the phlegm will be eliminated. Raw oyster and Retinervus Luffae Fructus are specific drugs that enter the zang-fu organs and meridians. When used together, they equally emphasize "promoting qi, resolving phlegm, and dissipating binds", treating both the symptoms and the root causes, so as to achieve the effect of "eliminating pathogenic factors and strengthening healthy qi, promoting the smooth flow of yin and yang".

[0042] Due to adopting the above technical solution, the present invention has the following advantages and beneficial effects:

[0043] The raw materials used in the traditional Chinese medicine composition of the present invention are inexpensive, easy to prepare, and convenient to use. The traditional Chinese medicine composition of the present invention is safe and non-toxic and can be taken for a long time. Specific Embodiments <000009​​​​​​​​​​​​​​​​​​Mix and grind 10g of tangerine peel, 30g of fritillaria thunbergii, 30g of trichosanthes kirilowii seed, 20g of raw oyster shell, and 9g of forsythia into a fine powder; extract with water under reflux three times (1000ml, 1 hour; 1000ml, 1 hour; 1000ml, 1 hour), combine the extracts, and concentrate to obtain an extract; add appropriate pharmaceutical excipients (white sugar, honey, benzopropionic acid or ethylparaben, etc.) to make pills, mixtures, oral liquids or syrups.

[0051] Example 3

[0052] A traditional Chinese medicine composition for treating pulmonary nodules:

[0053] Mix 6g of tangerine peel, 20g of fritillaria thunbergii, 10g of trichosanthes kirilowii seed, 10g of raw oyster shell, and 7g of forsythia; extract three times by reflux with water (1000ml, 1 hour; 1000ml, 1 hour; 1000ml, 1 hour), combine the extracts, concentrate to obtain an extract, dry and pulverize the extract to make granules.

[0054] Example 4

[0055] Mix 7g of tangerine peel, 10g of fritillaria thunbergii, 20g of trichosanthes kirilowii seed, 15g of raw oyster shell, and 8g of forsythia suspensa; extract three times by reflux with water (1000ml, 1 hour; 1000ml, 1 hour; 1000ml, 1 hour), combine the extracts, concentrate to obtain an extract, dry and pulverize the extract into granules, add pharmaceutical excipients, and compress into tablets or capsules.

[0056] Example 5

[0057] Mix 9g of tangerine peel, 15g of Zhejiang fritillary bulb, 15g of trichosanthes seed, 30g of raw oyster shell, and 12g of forsythia; extract three times by reflux with water (1000ml, 1 hour; 1000ml, 1 hour; 1000ml, 1 hour), combine the extracts, and concentrate them into a decoction.

[0058] Example 6

[0059] 1. Case selection and grouping

[0060] (1) Case selection: Refer to the Chinese Expert Consensus on the Diagnosis and Treatment of Pulmonary Nodules (2018 Edition) and the Chinese Guidelines for Classification, Diagnosis and Treatment of Pulmonary Nodules (2016 Edition) drafted by the Chinese Expert Group for Early Diagnosis and Treatment of Lung Cancer in 2016.

[0061] ① Quantity: A single lesion is considered isolated, while two or more lesions are defined as multiple.

[0062] ②Density: Based on density and degree of mixing, nodules are classified into three categories: solid nodules, pure ground-glass nodules, and partially solid nodules.

[0063] ③ Risk level: Solid nodules were classified according to the Mayo Cognitive Probability Prediction Formula and lung cancer risk factors as <5% (low risk), 5%–65% (intermediate risk), and >65% (high risk); Partially solid nodules were classified with an 8mm cutoff as >8mm (high risk) and <8mm (intermediate risk); Pure ground-glass nodules were classified with a 5mm cutoff as >5mm (intermediate risk) and <5mm (low risk). Multiple nodules were classified according to the nodule with the highest risk level.

[0064] (2) Case grouping: The patients were randomly divided into a treatment group and a control group according to a random table.

[0065] ① Treatment group (taken the preparation prepared in Example 5 of this invention + follow-up): 105 cases.

[0066] ② Control group (follow-up only): 105 cases.

[0067] There were no significant differences between the two groups of patients in terms of age, sex, disease duration, and disease severity (P>0.05), making them comparable.

[0068] 2. Observation and Treatment Methods

[0069] ① Observation method: Observe the morphology of lung nodules on CT scans before and after treatment in the two groups.

[0070] ② Treatment method: The treatment group took 150ml twice a day, once in the morning and once in the evening, for a course of treatment of 3 months.

[0071] 3. Efficacy criteria: Refer to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines".

[0072] (1) Clinical cure: pulmonary nodules disappeared;

[0073] (2) Significant effect: Lung nodules reduced by more than 60%;

[0074] (3) Effective: Lung nodules decreased by 30% to 59%;

[0075] (4) Ineffective: The pulmonary nodules show no change or turn into high-risk nodules;

[0076] Total effectiveness is the sum of cure, significant effect, and effectiveness.

[0077] 4. Treatment Results and Analysis

[0078] ① The treatment group consisted of 105 patients, and the results are shown in Table 1:

[0079] Table 1

[0080]

[0081] Of the 30 clinically cured cases, 12 showed significant improvement, 32 showed improvement, and 31 showed no improvement, with a total effective rate of 70.50%.

[0082] ② The control group consisted of 105 patients, and the results are shown in Table 2:

[0083] Table 2

[0084]

[0085] Six cases were clinically cured, seven cases showed significant improvement, 15 cases showed improvement, and 77 cases showed no improvement, with a total effective rate of 26.67%.

[0086] Compared with the control group, the total effective rate of the treatment group was significantly higher, and the difference was statistically significant (P<0.05).

[0087] Example 7

[0088] Patient Huang, male, 41 years old, first visited on May 25, 2021. On January 19, 2021, the patient underwent a physical examination at a local hospital, during which a chest CT scan showed a nodule in the posterior basal segment of the right lower lobe, approximately 6 mm in diameter, with clear borders. Carcinoembryonic antigen and other relevant tumor markers were normal, and no related treatment was initiated. Since the nodule was discovered, the patient has experienced insomnia and significant anxiety.

[0089] The patient presented with the following symptoms: difficulty sleeping, dry mouth, poor appetite, dry stools, normal urination, red tongue with a thin yellow coating, dark red lips and face, red eyes, and a deep, thready pulse.

[0090] Western medicine diagnosis: Insomnia, pulmonary nodules. Traditional Chinese medicine diagnosis: Sleeplessness (Yin deficiency with excessive fire syndrome).

[0091] Prescription: Fritillaria thunbergii 15g, Citrus reticulata peel 9g, Trichosanthes kirilowii seed 15g, Prunus persica kernel 15g, raw oyster shell 15g; Forsythia suspensa 12g, Adenophora stricta 15g, Ophiopogon japonicus 15g, Ziziphus jujuba seed 15g, Poria cocos 15g, pearl powder 30g, stir-fried chicken gizzard lining 12g, prepared licorice root 9g. Total 28 doses, 1 dose / day, 150ml each time, decocted in water and taken orally.

[0092] Second visit: On June 23, 2021, the patient reported that his sleep was gradually improving, he had no dry mouth, and his bowel movements were normal. However, he experienced slight acid reflux after meals. The prescription was modified by removing Poria cocos and pearl powder, and adding 30g of calcined oyster shell. He continued to take the prescription for 2 months.

[0093] Third visit: On August 18, 2021, the patient reported that all symptoms had healed. The prescription was modified by removing calcined oyster shell, jujube seed, north ginseng, and ophiopogon japonicus. The patient was instructed to continue taking the prescription for 3 months and then have a follow-up chest CT scan. On November 15, 2021, the patient followed up by phone and reported that a follow-up chest CT scan at the local hospital on November 11 showed no obvious abnormalities in both lungs.

[0094] Note: The patient is usually introverted and prone to sighing. Recently, a lung nodule was discovered, causing him great anxiety, leading to stagnation of Qi, obstruction of fluids, phlegm production, blood stasis, and the mutual binding of phlegm and blood stasis. Yin fluid deficiency resulted in insufficient nourishment and internal heat. Based on the tongue and pulse diagnosis, the basic pathogenesis is considered to be: phlegm and blood stasis, Yin deficiency with exuberant fire. The treatment principle should be to regulate Qi, resolve phlegm, relieve stagnation, nourish Yin, and calm the mind. The herbal composition of this invention is used as a basis for clinical application with modifications. In the formula, Fritillaria thunbergii and Citrus reticulata peel regulate Qi, relieve stagnation, resolve phlegm, and dissipate nodules; Adenophora stricta and Ophiopogon japonicus nourish Yin, moisten the lungs, benefit the stomach, and generate fluids; Ziziphus jujuba var. spinosa, Poria cocos, and pearl powder calm the mind and spirit; Prunus persica and Trichosanthes kirilowii seeds moisten the intestines, promote bowel movements, remove blood stasis, and dissipate nodules; Ostrea gigas further dissipates nodules and eliminates masses, while Forsythia suspensa guides the medicine to the affected area. The entire formula works synergistically to eliminate masses, dissipate nodules, and harmonize Yin and Yang. The patient's symptoms had lessened during the second visit, but slight acid reflux remained after meals. Therefore, Poria cocos and pearl powder were removed, and 30g of calcined oyster shell was added to suppress acid reflux and enhance the effects of phlegm removal, softening, and dispersing nodules. During the third visit, all symptoms had resolved. However, the pulmonary nodules were caused by pulmonary nodules and the condition was protracted, making frequent follow-up examinations inappropriate. Therefore, the patient continued to take the herbal composition of this invention for three months to observe the therapeutic effect. Subsequent examination revealed that the pulmonary nodules had disappeared.

[0095] Example 8

[0096] Patient Zhang, male, 61 years old, first visit on April 13, 2021. The patient had been experiencing a cough for over a month due to cold exposure. On April 9, 2021, he went to a local hospital for treatment. A chest CT scan showed multiple nodules in the upper lobe of the left lung, with clear borders, the largest being approximately 8mm. Tumor markers were normal. No related treatment has been initiated yet. Current symptoms include: cough, sputum production, fatigue, shortness of breath, loose stools, normal urination, pale and swollen tongue with teeth marks on the edges, thin white coating, dark lips and pale complexion, and a thready pulse.

[0097] Western medicine diagnosis: Cough, pulmonary nodules. Traditional Chinese medicine diagnosis: Cough (lung and spleen qi deficiency syndrome).

[0098] Prescription: Fritillaria thunbergii 15g, Citrus reticulata peel 9g, Trichosanthes kirilowii seed 15g, Prunus persica kernel 15g, raw oyster shell 15g; Forsythia suspensa 12g; Astragalus membranaceus 15g; raw Atractylodes macrocephala 15g; Pseudostellaria heterophylla 30g; Houttuynia cordata 30g; Tussilago farfara 15g; Aucklandia lappa 9g; stir-fried chicken gizzard lining 12g; prepared licorice root 9g. Total 28 doses, 1 dose / day, 150ml each time, decocted in water and taken orally.

[0099] Second visit: Follow-up visit on May 11, 2021. Cough and phlegm have subsided, fatigue and shortness of breath have decreased, and bowel movements are normal. The above prescription was modified by removing Houttuynia cordata, Tussilago farfara, and Aucklandia lappa. Continue taking the prescription for 2 months.

[0100] Third visit: Follow-up visit on July 6, 2021. The patient reported that all symptoms had been cured. The prescription was modified by removing Astragalus membranaceus, Atractylodes macrocephala, and Codonopsis pilosula. The patient was instructed to continue taking the prescription for three months and then have a follow-up chest CT scan.

[0101] Fourth consultation: Follow-up visit on October 28, 2021. A follow-up chest CT scan on October 27, 2021, showed a small nodule in the left upper lung, about 3mm, which had shrunk compared to the scan taken on April 9, 2021. The patient had no other discomfort and was instructed to stop taking Chinese medicine, follow up with the doctor, and have a chest CT scan every six months.

[0102] Note: The patient presented with a cough lasting over a month, exhibiting symptoms including expectoration, fatigue, shortness of breath, and loose stools. Combined with a pale, swollen tongue with teeth marks on the edges, a thin white coating, and a thready pulse, the diagnosis was lung and spleen qi deficiency. Furthermore, insufficient qi in the internal organs led to weak qi propulsion, impaired blood circulation, and blood stasis. Spleen deficiency resulted in inadequate digestion and transformation, leading to the generation of phlegm and dampness. The pathogenesis of this disease is: lung and spleen qi deficiency, phlegm stagnation, and blood stasis. The treatment principle is to tonify qi, resolve phlegm, stop cough, and resolve blood stasis. The herbal composition of this invention was modified accordingly. The formula includes Codonopsis pilosula, Astragalus membranaceus, and Atractylodes macrocephala to tonify qi, strengthen the spleen, generate fluids, and moisten the lungs; Aucklandia lappa warms the middle jiao, harmonizes the stomach, astringes the intestines, and stops diarrhea; Houttuynia cordata, Tussilago farfara, and Glycyrrhiza uralensis are added to enhance the cough-suppressing and phlegm-resolving effects, with Glycyrrhiza uralensis further harmonizing the effects of the other herbs. At the second visit, the patient's cough and phlegm had subsided, but slight fatigue and shortness of breath remained. Therefore, Houttuynia cordata, Tussilago farfara, and Aucklandia lappa were removed, and the herbal composition of this invention was continued for two months. The patient was asymptomatic after the third visit. After continuing to take the herbal composition of this invention for 3 months, a follow-up chest CT scan showed that the nodule had shrunk to 3mm. The clinical prescription consists of only a dozen or so ingredients, but although the prescription seems simple, it is actually comprehensive. The medicine reduces symptoms as soon as it is taken, and although the medicine is simple, the efficacy is very high.

[0103] Example 9

[0104] Patient Lü, female, 54 years old, Han nationality. On May 18, 2021, she underwent a chest CT scan at another hospital: a small solid nodule (thin slice, 1m30, 4mm) in the upper lobe of the left lung, followed up; a few fibrotic proliferative lesions in the medial segment of the middle lobe of the right lung. Tumor markers were normal. She visited the outpatient clinic on June 5, 2021. Current examination revealed: occasional fatigue, no obvious cough, sputum, chest tightness, shortness of breath or other discomfort, normal appetite, good sleep, normal bowel movements, pale red tongue with thin white coating, and deep and thready pulse.

[0105] Prescription: 9g of tangerine peel, 15g of fritillaria thunbergii, 15g of trichosanthes kirilowii seed, 30g of raw oyster shell, and 12g of forsythia. Decoct the above herbs, take 150ml orally twice a day, morning and evening.

[0106] A follow-up chest CT scan at another hospital on December 3, 2021, showed no obvious abnormalities.

[0107] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-described technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes, and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating lung nodules, characterized in that, The traditional Chinese medicine composition for treating pulmonary nodule is prepared from the following components in parts by weight: orange peel 5-10 parts, Zhejiang fritillary bulb 10-30 parts, gualouzi 10-30 parts, raw oyster 10-30 parts, and forsythia 5-15 parts.

2. The traditional Chinese medicine composition for treating pulmonary nodule according to claim 1, characterized in that, The traditional Chinese medicine composition for treating pulmonary nodule is prepared from the following components in parts by weight: orange peel 8 parts, Zhejiang fritillary bulb 25 parts, gualouzi 15 parts, raw oyster 15 parts, and forsythia 10 parts.

3. The traditional Chinese medicine composition for treating pulmonary nodule according to claim 1, characterized in that, The traditional Chinese medicine composition for treating pulmonary nodule is prepared from the following components in parts by weight: orange peel 10 parts, Zhejiang fritillary bulb 30 parts, gualouzi 30 parts, raw oyster 20 parts, and forsythia 9 parts.

4. The traditional Chinese medicine composition for treating pulmonary nodule according to claim 1, characterized in that, The traditional Chinese medicine composition for treating pulmonary nodule is prepared from the following components in parts by weight: orange peel 6 parts, Zhejiang fritillary bulb 20 parts, gualouzi 10 parts, raw oyster 10 parts, and forsythia 7 parts.

5. The traditional Chinese medicine composition for treating pulmonary nodule according to claim 1, characterized in that, The traditional Chinese medicine composition for treating pulmonary nodule is prepared from the following components in parts by weight: orange peel 7 parts, Zhejiang fritillary bulb 10 parts, gualouzi 20 parts, raw oyster 15 parts, and forsythia 8 parts.

6. The traditional Chinese medicine composition for treating pulmonary nodule according to claim 1, characterized in that, The traditional Chinese medicine composition for treating pulmonary nodule is prepared from the following components in parts by weight: orange peel 9 parts, Zhejiang fritillary bulb 15 parts, gualouzi 15 parts, raw oyster 30 parts, and forsythia 12 parts.

7. Use of the traditional Chinese medicine composition of any one of claims 1 to 6 in the preparation of a medicament for treating pulmonary nodule.

8. A traditional Chinese medicine preparation prepared from the traditional Chinese medicine composition of any one of claims 1 to 6.

9. The traditional Chinese medicine preparation according to claim 8, characterized in that, The dosage form of the traditional Chinese medicine preparation is selected from water decoction, tablet, mixture, granule, pill, capsule, umbilical patch, and suppository.

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