Traditional Chinese medicine composition for treating pulmonary nodule as well as preparation and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating pulmonary nodules and a preparation and application thereof, and relates to the field of traditional Chinese medicines. The traditional Chinese medicine composition for treating pulmonary nodule comprises the following raw materials in parts by weight: 8-12 parts of radix bupleuri, 8-12 parts of cassia twig, 8-12 parts of ginseng, 8-12 parts of scutellaria baicalensis, 8-12 parts of pinellia ternate, 13-18 parts of radix paeoniae alba, 8-12 parts of liquorice, 8-12 parts of ginger, 8-12 parts of jujube, 8-12 parts of rhizoma sparganii, 13-18 parts of curcuma zedoary, 25-35 parts of spina gleditsiae, 17-23 parts of fritillaria, 25-35 parts of coix seed and 13-18 parts of stiff silkworm. In the formula, radix bupleuri and cassia twig are used as monarch drugs, radix scutellariae and radix paeoniae alba are used as ministerial drugs, spina gleditsiae, stiff silkworm and thunberg fritillary bulb eliminate phlegm and dissipate stagnation, and pinellia ternate is matched to enhance the phlegm eliminating capacity; rhizoma sparganii and curcuma zedoary can promote blood circulation to remove blood stasis; the ginseng, the Chinese date and the ginger are used for assisting, regulating the middle warmer, resolving dampness, strengthening the spleen and the stomach, enhancing the transportation and transformation functions, strengthening the spleen and the stomach, fixing and protecting the postnatal and reducing the generation of phlegm dampness from the source; the liquorice is used as a guide to harmonize the medicines; all the medicines have a synergistic effect, and the curative effect on pulmonary nodules is remarkable.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine compositions, and particularly to a traditional Chinese medicine composition for treating pulmonary nodules, its preparation and application. Background Technology

[0002] Pulmonary nodules refer to solid or subsolid shadows with a long diameter ≤3cm found on chest imaging. In recent years, with the continuous expansion of CT applications in clinical purposes and lung cancer screening, and the improvement of high-resolution cross-sectional imaging technology, the detection rate of pulmonary nodules has increased significantly. Studies have shown that the incidence of pulmonary nodules abroad is approximately 30%. Domestic epidemiological surveys reveal that the detection rate of pulmonary nodules in my country is 27%-45.8%. Traditional Chinese medicine believes that the etiology of this disease is divided into exogenous and endogenous factors, and the pathogenesis is considered to be deficiency of the root and excess of the branch. Among them, the deficiency of the root is mainly due to the deficiency of the lungs, spleen, and kidneys; the excess of the branch is often considered to be related to factors such as qi stagnation, phlegm dampness, blood stasis, latent toxins, and cancer toxins. The treatment principle of this disease is to strengthen the body's resistance and eliminate pathogenic factors, treating both the root and the branch. However, current research focuses on single pathological products or single organ dysfunction, and there is still a lack of a comprehensive diagnostic and treatment approach that can integrate multiple organs and multiple links. The "Suwen" states, "The five organs are interconnected, and their movement is orderly," indicating that the disease is not limited to a single organ and is related to the transmission of diseases to other organs. Therefore, treating pulmonary nodules without a holistic approach will significantly limit the accuracy of syndrome differentiation and treatment, as well as the improvement of treatment efficacy. We believe that the formation and development of pulmonary nodules is not simply an isolated local lesion in the lung, but rather a result of dysfunction in multiple systems, including liver dysfunction, lung qi stagnation, disharmony of ying and wei qi, and obstruction of the triple jiao.

[0003] Therefore, developing a highly targeted, effective, and safe traditional Chinese medicine composition is of great clinical significance and application value for effectively intervening in the progression of pulmonary nodules, reducing the risk of malignant transformation, and improving patients' quality of life. Summary of the Invention

[0004] In view of this, the present invention proposes a traditional Chinese medicine composition for treating pulmonary nodules, its preparation and application, which has strong targeting, significant efficacy and high safety.

[0005] The technical solution of the present invention is implemented as follows: a traditional Chinese medicine composition for treating pulmonary nodules, comprising the following raw materials in parts by weight: Bupleurum chinense 8-12 parts, Cinnamomum cassia 8-12 parts, Ginseng 8-12 parts, Scutellaria baicalensis 8-12 parts, Pinellia ternata 8-12 parts, Paeonia lactiflora 13-18 parts, Glycyrrhiza uralensis 8-12 parts, Zingiber officinale 8-12 parts, Ziziphus jujuba 8-12 parts, Sparganium stoloniferum 8-12 parts, Curcuma zedoaria 13-18 parts, Gleditsia sinensis thorns 25-35 parts, Fritillaria cirrhosa 17-23 parts, Coix lacryma-jobi 25-35 parts, and Bombyx mori 13-18 parts. Preferably, the traditional Chinese medicine composition for treating pulmonary nodules comprises the following raw materials in parts by weight: 10 parts Bupleurum chinense, 10 parts Cinnamomum cassia, 10 parts Ginseng, 10-12 parts Scutellaria baicalensis, 10 parts Pinellia ternata, 15 parts Paeonia lactiflora, 10 parts Glycyrrhiza uralensis, 10 parts Zingiber officinale, 10 parts Ziziphus jujuba, 10 parts Sparganium stoloniferum, 15 parts Curcuma zedoaria, 30 parts Gleditsia sinensis thorns, 20 parts Fritillaria cirrhosa, 30 parts Coix lacryma-jobi, and 15 parts Bombyx mori.

[0006] Furthermore, the aforementioned traditional Chinese medicine composition for treating pulmonary nodules also contains dragon bone and oyster shell, including the following raw materials in parts by weight: Bupleurum chinense 8-12 parts, Cinnamomum cassia 8-12 parts, Ginseng 8-12 parts, Scutellaria baicalensis 8-12 parts, Pinellia ternata 8-12 parts, Paeonia lactiflora 13-18 parts, Glycyrrhiza uralensis 8-12 parts, Zingiber officinale 8-12 parts, Ziziphus jujuba 8-12 parts, Sparganium stoloniferum 8-12 parts, Curcuma zedoaria 13-18 parts, Gleditsia sinensis thorns 25-35 parts, Fritillaria cirrhosa 17-23 parts, Coix lacryma-jobi 25-35 parts, Bombyx mori 13-18 parts, Dragon bone 13-18 parts, and Oyster shell 13-18 parts. Preferably, the traditional Chinese medicine composition for treating pulmonary nodules also contains dragon bone and oyster shell, comprising the following raw materials in parts by weight: 10 parts Bupleurum, 10 parts Cinnamon Twig, 10 parts Ginseng, 10 parts Scutellaria, 10 parts Pinellia, 15 parts White Peony Root, 10 parts Licorice Root, 10 parts Fresh Ginger, 10 parts Jujube, 10 parts Sparganium Rhizome, 15 parts Curcuma Rhizome, 30 parts Gleditsia Sinensis Thorn, 20 parts Fritillaria, 30 parts Coix Seed, 15 parts Silkworm, 15 parts Dragon Bone, and 15 parts Oyster Shell.

[0007] Furthermore, the aforementioned traditional Chinese medicine composition for treating pulmonary nodules also contains Perilla stem, comprising the following raw materials in parts by weight: Bupleurum chinense 8-12 parts, Cinnamomum cassia 8-12 parts, Ginseng 8-12 parts, Scutellaria baicalensis 8-12 parts, Pinellia ternata 8-12 parts, Paeonia lactiflora 13-18 parts, Glycyrrhiza uralensis 8-12 parts, Zingiber officinale 8-12 parts, Ziziphus jujuba 8-12 parts, Sparganium stoloniferum 8-12 parts, Curcuma zedoaria 13-18 parts, Gleditsia sinensis thorns 25-35 parts, Fritillaria cirrhosa 17-23 parts, Coix lacryma-jobi 25-35 parts, Bombyx mori 13-18 parts, and Perilla stem 13-18 parts. Preferably, the traditional Chinese medicine composition for treating pulmonary nodules comprises the following raw materials in parts by weight: 10 parts Bupleurum chinense, 10 parts Cinnamomum cassia, 10 parts Ginseng, 10 parts Scutellaria baicalensis, 10 parts Pinellia ternata, 15 parts Paeonia lactiflora, 10 parts Glycyrrhiza uralensis, 10 parts Zingiber officinale, 10 parts Ziziphus jujuba, 10 parts Sparganium stoloniferum, 15 parts Curcuma zedoaria, 30 parts Gleditsia sinensis thorns, 20 parts Fritillaria cirrhosa, 30 parts Coix lacryma-jobi, 15 parts Bombyx mori, and 15 parts Perilla frutescens stem.

[0008] Furthermore, the fritillaria is Zhejiang fritillaria; the pinellia is processed pinellia; and the white peony is stir-fried white peony.

[0009] A traditional Chinese medicine preparation for treating pulmonary nodules, prepared from any one of the traditional Chinese medicine compositions described in this invention.

[0010] A traditional Chinese medicine decoction for treating pulmonary nodules, prepared from any one of the traditional Chinese medicine compositions described in this invention.

[0011] The traditional Chinese medicine composition described in any one of the present invention is used in the preparation of a treatment for pulmonary nodules.

[0012] Furthermore, the traditional Chinese medicine composition is used in the preparation of pulmonary nodules for the treatment of phlegm-blood stasis syndrome according to traditional Chinese medicine diagnosis.

[0013] Compared with the prior art, the beneficial effects of the present invention are: In this formula, Bupleurum and Cinnamon Twig are the chief herbs: Bupleurum soothes the Shaoyang meridian and promotes the upward and outward flow of Qi; Cinnamon Twig releases exterior pathogens and helps the lung Qi to ascend and spread. Together, they can relieve stagnation in the upper Jiao and restore its function of distributing body fluids. Scutellaria and White Peony are the assistant herbs: Scutellaria clears and drains Shaoyang stagnant fire, directly counteracting "wood fire." Bupleurum combined with Scutellaria not only soothes the liver and relieves stagnation, but also promotes the flow of Shaoyang Qi, effectively relieving stagnant liver Qi, preventing excessive upward movement, and avoiding further damage to lung metal. Peony harmonizes Yin and nourishes Ying Qi, and astringes lung Qi; Cinnamon Twig combined with White Peony, one dispersing and the other astringing, harmonizes Ying and Wei Qi, restoring the normal dispersing function of the lungs. When the lung Qi's dispersing function is normal, its descending function is also improved, helping to clear phlegm and turbidity in the lungs and aiding in "lung descending." Peony root nourishes Yin and regulates the blood, and when combined with Scutellaria baicalensis, it can prevent excessive heat-clearing from damaging Yin fluids; Gleditsia sinensis thorns, Bombyx batryticatus, and Fritillaria cirrhosa: eliminate phlegm and dissipate nodules, and when combined with Pinellia ternata, enhance the phlegm-eliminating power; Sparganium stoloniferum and Curcuma zedoaria invigorate blood and remove blood stasis, while Coix lacryma-jobi strengthens the spleen and eliminates pus; taking the "symbolic" thinking of traditional Chinese medicine, Gleditsia sinensis thorns serve as the vanguard for eliminating phlegm and dissipating nodules, paving the way for subsequent nodule-breaking drugs, and adding the insect-derived Bombyx batryticatus, which not only resolves stubborn phlegm but also has the effect of purging, the two drugs are combined to target the pathogenesis of phlegm and blood stasis, and then Coix lacryma-jobi strengthens the spleen and eliminates phlegm, expelling the existing phlegm nodules; Sparganium stoloniferum and Curcuma zedoaria, which invigorate blood and promote Qi circulation, are added to clear stagnation; Ginseng, jujube, and ginger are used as adjuvants: to regulate the middle Jiao and eliminate dampness, tonify the spleen and stomach, enhance the function of transportation and transformation, tonify the spleen and stomach, and protect the acquired constitution, reducing the generation of phlegm and dampness from the source; Prepared licorice root is used as an adjuvant to harmonize the effects of other herbs and reduce the toxicity of Pinellia ternata; the synergistic effect of these herbs enhances the efficacy of the treatment of pulmonary nodules, demonstrating significant therapeutic effects.

[0014] Furthermore, this invention adds dragon bone and oyster shell to the above-mentioned traditional Chinese medicine formula to further enhance its effects of calming the mind, softening hardened masses, and dispersing nodules. The addition of perilla stem regulates qi and resolves phlegm, working synergistically with jujube in the formula to further enhance the spleen and stomach's digestive function. Detailed Implementation

[0015] Unless otherwise specified, the experimental methods used in the embodiments of this invention are conventional methods; Unless otherwise specified, all materials and reagents used in the embodiments of this invention are commercially available.

[0016] Example 1 A traditional Chinese medicine composition for treating pulmonary nodules comprises the following ingredients by weight: Bupleurum chinense 10g, Cinnamomum cassia twig 10g, Ginseng 10g, Scutellaria baicalensis 10g, Pinellia ternata 10g, Paeonia lactiflora (fried) 15g, Glycyrrhiza uralensis 10g, Zingiber officinale 10g, Ziziphus jujuba 10g, Sparganium stoloniferum 10g, Curcuma zedoaria 15g, Gleditsia sinensis thorns 30g, Fritillaria thunbergii 20g, Coix lacryma-jobi 30g, and Bombyx mori 15g. The ingredients are decocted in water to prepare a soup.

[0017] Example 2 A traditional Chinese medicine composition for treating pulmonary nodules comprises the following ingredients by weight: Bupleurum chinense 8g, Cinnamomum cassia 12g, Ginseng 8g, Scutellaria baicalensis 12g, Pinellia ternata 8g, Paeonia lactiflora (fried) 13g, Glycyrrhiza uralensis 8g, Zingiber officinale 12g, Ziziphus jujuba 8g, Sparganium stoloniferum 12g, Curcuma zedoaria 18g, Gleditsia sinensis thorns 25g, Fritillaria thunbergii 23g, Coix lacryma-jobi 35g, and Bombyx mori 13g. The herbs are decocted in water to prepare a soup.

[0018] Example 3 A traditional Chinese medicine composition for treating pulmonary nodules comprises the following ingredients by weight: Bupleurum chinense 12g, Cinnamomum cassia 8g, Ginseng 12g, Scutellaria baicalensis 8g, Pinellia ternata 12g, Paeonia lactiflora (fried) 17g, Glycyrrhiza uralensis 12g, Zingiber officinale 8g, Ziziphus jujuba 12g, Sparganium stoloniferum 8g, Curcuma zedoaria 13g, Gleditsia sinensis thorns 33g, Fritillaria thunbergii 17g, Coix lacryma-jobi 25g, and Bombyx mori 18g. The herbs are decocted in water to prepare a soup.

[0019] Comparative Example 1 A traditional Chinese medicine composition for treating pulmonary nodules, the main difference from Example 1 is that the thorns of Gleditsia sinensis are replaced with an equal weight of Trichosanthes kirilowii. The functions and indications of Trichosanthes kirilowii are: clearing heat and resolving phlegm, relieving chest congestion and dispersing nodules, and moistening dryness and promoting bowel movement.

[0020] Specifically, a traditional Chinese medicine composition for treating pulmonary nodules comprises the following ingredients by weight: Bupleurum chinense 10g, Cinnamomum cassia 10g, Ginseng 10g, Scutellaria baicalensis 10g, Pinellia ternata 10g, Paeonia lactiflora (fried) 15g, Glycyrrhiza uralensis 10g, Zingiber officinale 10g, Ziziphus jujuba 10g, Sparganium stoloniferum 10g, Curcuma zedoaria 15g, Trichosanthes kirilowii 30g, Fritillaria thunbergii 20g, Coix lacryma-jobi 30g, and Bombyx mori 15g. The herbs are decocted in water to prepare a soup.

[0021] Comparative Example 2 A traditional Chinese medicine composition for treating pulmonary nodules, the main difference from Example 1 is that Fritillaria thunbergii is replaced with an equal weight of dandelion. The main functions and indications of dandelion are: clearing heat and detoxifying, reducing swelling and dissipating nodules, and promoting diuresis and relieving strangury.

[0022] Specifically, a traditional Chinese medicine composition for treating pulmonary nodules comprises the following ingredients by weight: Bupleurum chinense 10g, Cinnamomum cassia twig 10g, Ginseng 10g, Scutellaria baicalensis 10g, Pinellia ternata 10g, Paeonia lactiflora (fried) 15g, Glycyrrhiza uralensis 10g, Zingiber officinale 10g, Ziziphus jujuba 10g, Sparganium stoloniferum 10g, Curcuma zedoaria 15g, Gleditsia sinensis thorns 30g, Taraxacum mongolicum 20g, Coix lacryma-jobi 30g, and Bombyx mori 15g. The herbs are decocted in water to prepare a soup.

[0023] Comparative Example 3 A traditional Chinese medicine composition for treating pulmonary nodules, the main difference from Example 1 is that the silkworm pupae are replaced with an equal weight of Prunella vulgaris. The main functions and indications of Prunella vulgaris are: clearing heat, improving eyesight, dispersing nodules, and reducing swelling.

[0024] Specifically, a traditional Chinese medicine composition for treating pulmonary nodules comprises the following ingredients by weight: Bupleurum chinense 10g, Cinnamomum cassia twig 10g, Ginseng 10g, Scutellaria baicalensis 10g, Pinellia ternata 10g, Paeonia lactiflora (fried) 15g, Glycyrrhiza uralensis 10g, Zingiber officinale 10g, Ziziphus jujuba 10g, Sparganium stoloniferum 10g, Curcuma zedoaria 15g, Gleditsia sinensis thorns 30g, Fritillaria thunbergii 20g, Coix lacryma-jobi 30g, and Prunella vulgaris 15g. The herbs are decocted in water to prepare a soup.

[0025] Clinical research example 1. Research Subjects Inclusion criteria: This study selected patients with pulmonary nodules admitted to the outpatient department of the Traditional Chinese Medicine (TCM) department of the hospital as the research subjects, who were randomly divided into study group 1-2 and control group 1-3, with 36 patients in each group. Referring to the diagnostic criteria for pulmonary nodules in the "Chinese Expert Consensus on the Diagnosis and Treatment of Pulmonary Nodules," pulmonary nodules, as seen on imaging examinations, are defined as shadows ≤3cm in size in the lungs, with some localized increases in density. TCM diagnostic criteria: Currently, there is no unified TCM diagnostic standard for pulmonary nodules. In this study, patients diagnosed with pulmonary nodules through imaging examinations, while excluding those with pulmonary heat disease or pulmonary tuberculosis, were all included in the category of pulmonary accumulation.

[0026] 2. Inclusion criteria (1) The lung nodules with a maximum diameter of less than 3 cm are found and meet the diagnostic criteria for lung nodules; (2) Based on the primary symptoms, secondary symptoms and tongue and pulse characteristics, the TCM syndrome differentiation is phlegm and blood stasis. (3) Patients have high compliance, are willing to participate in this study, and are willing to receive traditional Chinese medicine treatment. 3. Exclusion Criteria (1) Individuals with combined heart, liver, kidney, or other functional abnormalities; (2) Other diseases that need to be differentiated from pulmonary nodules, such as pulmonary tuberculosis and lung abscess; (3) Acute infections, immune system diseases, malignant tumors, etc.; (4) Patients who need long-term use of high-dose hormones or immunosuppressants; (5) Those with blisters, boils, or broken skin on the local area, or those with a tendency to form keloids; (6) Pregnant or breastfeeding women; (7) Allergy to any of the drugs involved in this study; (8) Participate in other clinical research projects concurrently.

[0027] 4. How to use According to the traditional Chinese medicine formula in the example or comparative example, one dose is taken daily, decocted in 400mL of water, and taken warm in the morning and evening. One month constitutes one course of treatment, and a total of three courses of treatment are required.

[0028] Study groups 1-2 and control groups 1-3 corresponded to the traditional Chinese medicine formulas of Examples 1-2 and Comparative Examples 1-3, respectively. Among them, research group 1: Example 1; research group 2: Example 2; Comparison Group 1: Comparison Example 1; Comparison Group 2: Comparison Example 2; Comparison Group 3: Comparison Example 3.

[0029] 4. Criteria for Evaluating Therapeutic Effect The efficacy of traditional Chinese medicine in treating solitary pulmonary nodules was graded based on changes in cross-sectional area, diameter, and malignant signs before and after treatment. Liver and kidney function were monitored before and after treatment.

[0030] (1) Cured: The nodules disappeared and the cross-sectional area decreased by 100%.

[0031] (2) Significant effect: nodules decrease in size, cross-sectional area decreases by ≥50%, cross-sectional area decreases by <100%.

[0032] (3) Effective: Nodules are reduced, cross-sectional area is reduced by <50%, and diameter is reduced by >1 mm.

[0033] (4) Stable: No significant changes in nodules, no change in cross-sectional area, or diameter increase or decrease of ≤1 mm.

[0034] (5) Progression: Nodules enlarge, cross-sectional area increases, diameter increases by more than 1 mm, or malignant signs increase.

[0035] Total effective = cured + significantly effective + effective.

[0036] 5. Treatment Results Table 1. Efficacy of each group in treating pulmonary nodules

[0037] The results showed that Examples 1-2 had better therapeutic effects on pulmonary nodules, with a total effective rate of 94.4%~97.2%. Comparative Examples 1-3, however, had poorer therapeutic effects, with a total effective rate of 72.2%~77.8%. The addition of Gleditsia sinensis thorns, Fritillaria thunbergii, and Bombyx mori to the present invention synergistically enhanced the therapeutic effect on pulmonary nodules. Furthermore, liver and kidney function tests were normal after the completion of the treatment course in each group.

[0038] Example 4 The main difference from Example 1 is the addition of keel and oyster.

[0039] A traditional Chinese medicine composition for treating pulmonary nodules comprises the following ingredients by weight: Bupleurum chinense 10g, Cinnamomum cassia twig 10g, Ginseng 10g, Scutellaria baicalensis 10g, Pinellia ternata 10g, Paeonia lactiflora (fried) 15g, Glycyrrhiza uralensis 10g, Zingiber officinale 10g, Ziziphus jujuba 10g, Sparganium stoloniferum 10g, Curcuma zedoaria 15g, Gleditsia sinensis thorns 30g, Fritillaria thunbergii 20g, Coix lacryma-jobi 30g, Bombyx mori 15g, Os draconis 15g, and Ostrea gigas 15g. The ingredients are decocted in water to prepare a soup.

[0040] Typical clinical application case 1: General information: Female, 69 years old, BMI 24.0 kg / m² 2 No history of smoking. 10-year history of diabetes (no medication, fasting blood glucose 6.9 mmol / L), 6 years post-thyroidectomy for thyroid cancer (regularly taking levothyroxine sodium tablets, thyroid indicators within normal range), and a history of irritability. Chief complaint and present illness: In October 2024, a physical examination revealed multiple pulmonary nodules and linear opacities in both lungs, accompanied by chest and rib pain (VAS score 5), spontaneous sweating upon exposure to wind, dry mouth and bitter taste, difficulty falling asleep at night, waking up at 4 AM and unable to fall back asleep, good appetite, and normal bowel movements. Western medicine recommended a follow-up chest CT scan in 3 months. The patient sought treatment from Traditional Chinese Medicine due to concerns about nodule progression. Physical examination: Dark tongue with a yellow, greasy coating, and a wiry, thready pulse. Auxiliary examinations: Chest CT: Multiple pulmonary nodules in both lungs (ground-glass opacity in the right lung, nodule size 6mm*5mm; multiple solid nodules in the right middle lobe, nodule length range approximately 4mm*4mm, the largest nodule being 4mm*4mm; single calcified nodule in the left upper lobe, nodule size 4mm*3mm), and linear opacities in both lungs. Liver and kidney function (ALT, AST, Cr) were normal.

[0041] Treatment and Monitoring: Following the herbal formula in Example 4, one dose was taken daily, decocted in 400mL of water, and taken warm in the morning and evening. One course of treatment lasted one month, with a total of three courses and a total duration of three months. Monitoring Indicators: ① Symptom Assessment: At the end of each course, VAS scores were used to record the improvement of symptoms such as chest and rib pain, spontaneous sweating, and bitter taste in the mouth; ② Imaging Assessment: A chest CT scan was performed after the course of treatment; ③ Safety Assessment: Liver and kidney function were re-examined after the course of treatment.

[0042] Treatment results: After one course of treatment, the bitter taste in the mouth was significantly improved, spontaneous sweating was reduced, and the VAS score for chest and rib pain dropped to 1 point; after two courses of treatment, the bitter taste in the mouth disappeared, difficulty falling asleep was relieved, and anxiety was reduced; after three courses of treatment, the symptoms completely disappeared, a follow-up chest CT scan showed that the lung nodules had disappeared, and a follow-up liver and kidney function test showed normal results.

[0043] Example 5 The main difference from Example 1 is the addition of perilla stem.

[0044] A traditional Chinese medicine composition for treating pulmonary nodules comprises the following ingredients by weight: Bupleurum chinense 10g, Cinnamomum cassia twig 10g, Ginseng 10g, Scutellaria baicalensis 10g, Pinellia ternata 10g, Paeonia lactiflora (fried) 15g, Glycyrrhiza uralensis 10g, Zingiber officinale 10g, Ziziphus jujuba 10g, Sparganium stoloniferum 10g, Curcuma zedoaria 15g, Gleditsia sinensis thorns 30g, Fritillaria thunbergii 20g, Coix lacryma-jobi 30g, Bombyx mori 15g, and Perilla frutescens stem 15g. The herbs are decocted in water to prepare a soup.

[0045] Typical clinical application case 2: General information: Female, 59 years old, retired worker, BMI 23.5 kg / m² 2 The father passed away from stomach cancer, and the mother from nasopharyngeal carcinoma. The patient usually stays home to care for her grandchildren and experiences emotional instability. Chief complaint and present illness: In August 2024, a chest CT scan was performed due to phlegm in the throat. The scan revealed a nodule in the right lung accompanied by cough, which worsened upon exposure to cold air. Other symptoms included dull chest and rib pain (VAS score 3), bitter taste in the mouth, bad breath, normal appetite, loose stools, and poor sleep. Physical examination: Dark tongue with a thick, greasy coating, and a wiry, slippery pulse. Auxiliary examinations: Chest CT: Ground-glass nodule in the anterior segment of the right upper lobe; scattered micronodules in the subpleural region of both lungs (ground-glass nodule shadow in the anterior segment of the right upper lobe, approximately 6mm*5mm in size; solid subpleural nodule shadow in the posterior segment of the right lower lobe, approximately 5mm*3mm in size; pure ground-glass nodule in the middle lobe). Blood routine and liver and kidney function tests were normal.

[0046] Treatment and Monitoring: Following the herbal formula in Example 5, one dose was taken daily, decocted in 400mL of water, and taken warm in the morning and evening. One course of treatment lasted one month, with a total of three courses and a total duration of three months. Monitoring Indicators: ① Symptom Assessment: At the end of each course, VAS scores were used to record the improvement of symptoms such as chest and rib pain, spontaneous sweating, and bitter taste in the mouth; ② Imaging Assessment: A chest CT scan was performed after the course of treatment; ③ Safety Assessment: Liver and kidney function were re-examined after the course of treatment.

[0047] Treatment results: After one course of treatment, the cough and loose stools were relieved, and the poor appetite improved (food intake returned to normal); after two courses of treatment, the dull pain in the chest and ribs and fatigue disappeared; after three courses of treatment, the symptoms completely disappeared, a follow-up chest CT scan showed that the lung nodules had disappeared, and a follow-up liver and kidney function test showed normal results.

[0048] Example 6 The main difference from Example 1 is that the amount of Scutellaria baicalensis added is 12g.

[0049] A traditional Chinese medicine composition for treating pulmonary nodules comprises the following ingredients by weight: Bupleurum chinense 10g, Cinnamomum cassia 10g, Ginseng 10g, Scutellaria baicalensis 12g, Pinellia ternata 10g, Paeonia lactiflora (fried) 15g, Glycyrrhiza uralensis 10g, Zingiber officinale 10g, Ziziphus jujuba 10g, Sparganium stoloniferum 10g, Curcuma zedoaria 15g, Gleditsia sinensis thorns 30g, Fritillaria thunbergii 20g, Coix lacryma-jobi 30g, and Bombyx mori 15g. The herbs are decocted in water to prepare a soup.

[0050] Typical clinical application case 3: General Information: Female, 48 years old, employee, BMI 23 kg / m², no smoking history, denies family history of cancer. Previously healthy, entered perimenopause in the past year, experiencing irregular menstruation (cycle 60-90 days), frequent hot flashes, sweating, irritability, and mood swings. Chief Complaint and Present Illness: Multiple nodules in the right lung were discovered during a routine physical examination in October 2024, accompanied by chest and rib distension, which worsened with emotional distress, cough with little sputum, significant night sweats, tinnitus, bitter taste in the mouth, dry throat, good appetite, restful sleep, normal bowel movements, and yellow, foul-smelling urine. Physical Examination: Dark red tongue with a yellow, greasy coating, wiry and rapid pulse. Auxiliary Examinations: Chest CT: Multiple nodules in the right lung (3mm*3mm in the anterior segment of the right upper lobe, and a single calcified nodule measuring 4mm*3mm in the lateral segment of the right middle lobe); linear lesions in the right middle lobe and left lower lobe. Liver and kidney function were normal.

[0051] Treatment and Monitoring: Following the herbal formula in Example 6, one dose was taken daily, decocted in 400mL of water, and taken warm in the morning and evening. One course of treatment lasted one month, with a total of three courses and a total duration of three months. Monitoring Indicators: ① Symptom Assessment: At the end of each course, VAS scores were used to record the improvement of symptoms such as chest and rib pain, spontaneous sweating, and bitter taste in the mouth; ② Imaging Assessment: A chest CT scan was performed after the course of treatment; ③ Safety Assessment: Liver and kidney function were re-examined after the course of treatment.

[0052] Treatment results: After one course of treatment, hot flashes and night sweats were reduced and bitter taste in the mouth was relieved; after two courses of treatment, chest and rib distension and tightness disappeared; after three courses of treatment, perimenopausal mood and irritability were significantly improved and menstrual cycles became more regular; a follow-up chest CT scan showed that the lung nodules had disappeared and liver and kidney function were normal.

[0053] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating pulmonary nodules, characterized in that, The ingredients include the following parts by weight: Bupleurum chinense 8-12 parts, Cinnamomum cassia 8-12 parts, Ginseng 8-12 parts, Scutellaria baicalensis 8-12 parts, Pinellia ternata 8-12 parts, Paeonia lactiflora 13-18 parts, Glycyrrhiza uralensis 8-12 parts, Zingiber officinale 8-12 parts, Ziziphus jujuba 8-12 parts, Sparganium stoloniferum 8-12 parts, Curcuma zedoaria 13-18 parts, Gleditsia sinensis thorns 25-35 parts, Fritillaria cirrhosa 17-23 parts, Coix lacryma-jobi 25-35 parts, and Bombyx mori 13-18 parts.

2. The traditional Chinese medicine composition for treating pulmonary nodules according to claim 1, characterized in that, The ingredients include the following parts by weight: Bupleurum chinense 10 parts, Cinnamomum cassia 10 parts, Ginseng 10 parts, Scutellaria baicalensis 10-12 parts, Pinellia ternata 10 parts, Paeonia lactiflora 15 parts, Glycyrrhiza uralensis 10 parts, Zingiber officinale 10 parts, Ziziphus jujuba 10 parts, Sparganium stoloniferum 10 parts, Curcuma zedoaria 15 parts, Gleditsia sinensis thorns 30 parts, Fritillaria cirrhosa 20 parts, Coix lacryma-jobi 30 parts, and Bombyx mori 15 parts.

3. The traditional Chinese medicine composition for treating pulmonary nodules according to claim 1, characterized in that, It also contains dragon bone and oyster shell, and includes the following ingredients by weight: Bupleurum chinense 8-12 parts, Cinnamomum cassia 8-12 parts, Ginseng 8-12 parts, Scutellaria baicalensis 8-12 parts, Pinellia ternata 8-12 parts, Paeonia lactiflora 13-18 parts, Glycyrrhiza uralensis 8-12 parts, Zingiber officinale 8-12 parts, Ziziphus jujuba 8-12 parts, Sparganium stoloniferum 8-12 parts, Curcuma zedoaria 13-18 parts, Gleditsia sinensis thorns 25-35 parts, Fritillaria cirrhosa 17-23 parts, Coix lacryma-jobi 25-35 parts, Bombyx mori 13-18 parts, Dragon bone 13-18 parts, and Oyster shell 13-18 parts.

4. The traditional Chinese medicine composition for treating pulmonary nodules according to claim 1, characterized in that, It also contains perilla stem, and includes the following ingredients by weight: Bupleurum chinense 8-12 parts, Cinnamomum cassia 8-12 parts, Ginseng 8-12 parts, Scutellaria baicalensis 8-12 parts, Pinellia ternata 8-12 parts, Paeonia lactiflora 13-18 parts, Glycyrrhiza uralensis 8-12 parts, Zingiber officinale 8-12 parts, Ziziphus jujuba 8-12 parts, Sparganium stoloniferum 8-12 parts, Curcuma zedoaria 13-18 parts, Gleditsia sinensis thorns 25-35 parts, Fritillaria cirrhosa 17-23 parts, Coix lacryma-jobi 25-35 parts, Bombyx mori 13-18 parts, and Perilla stem 13-18 parts.

5. The traditional Chinese medicine composition for treating pulmonary nodules according to any one of claims 1-4, characterized in that, The fritillaria mentioned is Fritillaria thunbergii.

6. The traditional Chinese medicine composition for treating pulmonary nodules according to any one of claims 1-4, characterized in that, The Pinellia ternata mentioned is the processed Pinellia ternata.

7. A traditional Chinese medicine preparation for treating pulmonary nodules, characterized in that, It is prepared from the traditional Chinese medicine composition according to any one of claims 1-4.

8. A traditional Chinese medicine decoction for treating pulmonary nodules, characterized in that, It is prepared from the traditional Chinese medicine composition according to any one of claims 1-4.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a treatment for pulmonary nodules.

10. The traditional Chinese medicine composition according to any one of claims 1-4 is used in the preparation of a treatment for pulmonary nodules classified as phlegm-blood stasis syndrome according to traditional Chinese medicine.

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