Traditional Chinese medicine compound composition for treating pulmonary nodule and application thereof

Abstract

The invention discloses a traditional Chinese medicine compound composition for treating pulmonary nodules and application thereof, and belongs to the field of traditional Chinese medicines. The traditional Chinese medicine compound composition comprises 25-30 parts of astragalus membranaceus, 25-35 parts of radix fici simplicissimae, 15-20 parts of bran-fried rhizoma atractylodis macrocephalae, 9-12 parts of rhizoma pinellinae praeparata, 15-20 parts of thunberg fritillary bulb, 5-10 parts of honey-fried ephedra, 10-12 parts of vinegar-processed curcuma zedoary, 10-15 parts of salvia chinensis, 25-30 parts of radix ranunculi ternati, 12-15 parts of radix curcumae, 10-15 parts of bran-fried fructus aurantii, 12-15 parts of malt, 12-15 parts of poria with hostwood, 25-30 parts of oyster, 10-15 parts of albizia flower, 10-15 parts of liquorice soaked earthworm, 10-20 parts of lucid ganoderma and 10-15 parts of loofah sponge The traditional Chinese medicine composition is used for treating pulmonary nodules, has the effects of invigorating spleen and tonifying lung qi, reducing phlegm and activating blood circulation to dissipate stagnation, has a good treatment effect on pulmonary nodules, is high in safety and can be popularized and applied, and a new traditional Chinese medicine formula is provided for treating lung deficiency and phlegm accumulation type pulmonary nodules.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine compound composition for treating pulmonary nodules and application thereof. Background Art

[0002] Pulmonary nodules are solid or subsolid lesions with clear boundaries, a diameter of ≤3 cm, and surrounded by air-filled lung tissue as seen on chest imaging. In recent years, with the public's awareness of physical examinations increasing significantly, the clinical detection rate of pulmonary nodules has been increasing year by year. Epidemiological studies have shown that the larger the diameter of a nodule, the greater the likelihood of cancer.

[0003] Pulmonary nodules are tangible masses, classified as "lung accumulation" in Traditional Chinese Medicine. They are located in the lungs and are closely related to the liver and spleen. The lungs govern qi, respiration, and regulate water flow. The spleen is the source of qi and blood production, and the liver governs dispersal. These three organs are crucial for the distribution of qi, blood, and body fluids. Emotional imbalance, dietary indiscriminateness, and internal injuries caused by fatigue can disrupt the function of these organs, leading to qi stagnation and the formation of tangible pathogens such as phlegm and blood stasis that accumulate in the lungs. These lingering effects eventually lead to the formation of pulmonary nodules.

[0004] Currently, clinical follow-up observation is mostly performed for low-risk nodules, and there is no effective early intervention method. If the nodules change, further puncture or even surgical treatment is performed. However, invasive diagnosis and treatment methods bring patients a higher risk of trauma, decreased lung function reserve and a greater economic burden, resulting in low patient compliance. Traditional Chinese medicine emphasizes prevention before illness and holistic treatment, and has obvious advantages in optimizing the management of lung nodules to prevent and control the occurrence and development of lung cancer. Although there are many clinical reports on the treatment of lung nodules with traditional Chinese medicine formulas, the efficacy is unstable and the reproducibility is low. Therefore, a drug for treating lung nodules is proposed to address the current shortcomings. Summary of the Invention

[0005] The purpose of the present invention is to provide a Chinese medicine compound composition for treating lung nodules and its application, so as to solve the problems existing in the above-mentioned prior art. The components of the composition act synergistically, and the whole formula has the effects of nourishing the lungs and strengthening the spleen to consolidate the foundation, soothing the liver and regulating qi to regulate the pivot, safely and effectively inhibiting the development of lung nodules, and reducing the risk probability of malignant nodules.

[0006] To achieve the above object, the present invention provides the following solutions:

[0007] The invention provides a traditional Chinese medicine compound composition for treating pulmonary nodules. The traditional Chinese medicine compound composition comprises the following components in parts by weight: 25-30 parts of astragalus, 25-35 parts of quinquefolium, 15-20 parts of stir-fried atractylodes macrocephala with bran, 9-12 parts of pinellia, 15-20 parts of thunbergia thunbergii, 5-10 parts of honeyed ephedra, 10-12 parts of vinegared zedoaria, 10-15 parts of lithospermum officinale, 25-30 parts of cat's claw, 12-15 parts of turmeric, 10-15 parts of stir-fried fructus aurantii with bran, 12-15 parts of malt, 12-15 parts of poria, 25-30 parts of oyster, 10-15 parts of julibrissin flower, 10-15 parts of earthworm soaked in liquorice, 10-20g of ganoderma lucidum and 10-15g of loofah.

[0008] Preferably, the composition includes the following components in parts by weight: 30 parts of astragalus, 30 parts of cinnamon bark, 20 parts of stir-fried atractylodes macrocephala, 12 parts of pinellia, 20 parts of thunbergia bulbs, 6 parts of honey ephedra, 12 parts of vinegar zedoaria, 15 parts of lithospermum officinale, 30 parts of cat's claw, 15 parts of turmeric, 10 parts of stir-fried fructus aurantii, 15 parts of malt, 15 parts of poria, 30 parts of oyster, 15 parts of julibrissin, 15 parts of earthworm soaked in licorice, 15 parts of ganoderma lucidum and 15 parts of loofah.

[0009] The present invention also provides application of the traditional Chinese medicine compound composition in medicine for treating pulmonary nodules.

[0010] Preferably, the pulmonary nodules are pulmonary nodules of the lung deficiency and phlegm accumulation type.

[0011] Preferably, the pulmonary nodules include small pulmonary nodules.

[0012] The present invention also provides a medicine for treating pulmonary nodules, which contains the traditional Chinese medicine compound composition and a pharmaceutically acceptable auxiliary agent.

[0013] Preferably, the dosage forms of the drug include decoction, extract, powder, granule, pill, tablet and soft capsule.

[0014] Preferably, the preparation method of the decoction comprises: mixing the components of the composition, soaking in water for 20-30 minutes, boiling over high heat and then simmering over low heat for 20-30 minutes, filtering out the medicinal liquid; adding water to the medicinal residue and repeating the decoction once, filtering out the medicinal liquid, and combining the two medicinal liquids to obtain the decoction.

[0015] Preferably, the preparation method of the granules comprises: crushing and mixing the components in the composition to obtain the granules.

[0016] The present invention discloses the following technical effects:

[0017] In the present invention, astragalus, five-fingered peach, white atractylodes, and ganoderma are monarchs, and they strengthen the spleen and stomach to dispel dampness, tonify the lung qi to consolidate the exterior, cultivate the soil to produce gold and consolidate the foundation; the ministerial medicines Pinellia, Fritillaria thunbergii, and oyster are used to resolve phlegm turbidity and disperse stagnation, and are matched with Curcuma zedoaria, Lithospermum officinale, and Herba Cat's Claw to promote blood circulation and dissipate blood stasis, eliminate symptoms and disperse stagnation, and eliminate tangible evil with phlegm and blood stasis; the auxiliary medicines honey ephedra promotes lung function and relieves depression, loofah drench the meridians and resolve phlegm, turmeric, fructus aurantii, and malt soothe the liver and regulate qi, lily flower and poria relieve depression and calm the mind, and regulate qi to help phlegm and blood stasis; the auxiliary medicine earthworm dredges the meridians and removes blood stasis, and liquorice harmonizes the various medicines and guides the medicines to the meridians. The whole prescription tonifies the lungs and spleen to strengthen the body, resolves phlegm and blood stasis to attack evil, soothes liver depression to regulate the mind, and uses both attack and tonification to promote qi circulation and unblock the meridians, which conforms to the pathogenesis of "lung deficiency and phlegm and blood stasis", and also resolves emotional depression, embodying the purpose of "treating both the form and spirit, and taking both the symptoms and the root cause into consideration" of traditional Chinese medicine. Treating both the symptoms and the root cause, strengthening the body and dispersing the nodules, can improve the body's immunity, safely and effectively inhibit the development of lung nodules, and reduce the risk of malignant nodules. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0019] Figure 1 This is a comparison of the experimental group on the reduction of the diameter, volume, and density of small pulmonary nodules;

[0020] Figure 2 The comparison results of the control group on the reduction of the diameter, volume and density of small lung nodules. DETAILED DESCRIPTION

[0021] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as limiting the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0022] It should be understood that the terms described herein are intended only to describe particular embodiments and are not intended to limit the present invention. In addition, for numerical ranges herein, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. The intermediate value within any stated value or stated range, and each smaller range between any other stated value or intermediate value within the stated range, is also encompassed within the present invention. The upper and lower limits of these smaller ranges may be independently included or excluded within the scope.

[0023] Unless otherwise indicated, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art. Although only preferred methods and materials are described herein, any methods and materials similar or equivalent to those described herein may also be used in the practice or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials associated with the documents. In the event of any conflict with any incorporated document, the contents of this specification shall prevail.

[0024] It will be apparent to those skilled in the art that various modifications and variations may be made to the specific embodiments described herein without departing from the scope or spirit of the invention. Other embodiments will be apparent to those skilled in the art from the description of the invention. The description and examples are intended to be exemplary only.

[0025] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0026] The invention provides a traditional Chinese medicine compound composition for treating pulmonary nodules. The compound composition comprises the following medicines: 25-30g of astragalus, 25-35g of cinnamon bark, 15-20g of stir-fried atractylodes macrocephala with bran, 9-12g of pinellia tuber, 15-20g of thunbergia thunbergii, 5-10g of honeyed ephedra, 10-12g of vinegared zedoaria, 10-15g of scutellaria baicalensis, 25-30g of cat's claw, 12-15g of turmeric, 10-15g of stir-fried fructus aurantii with bran, 12-15g of malt, 12-15g of poria, 25-30g of oyster, 10-15g of julibrissin flower, 10-15g of earthworm soaked in liquorice, 10-20g of ganoderma lucidum and 10-15g of luffa.

[0027] The above-mentioned Chinese medicine compound composition is named "Bufei Xiaojie Recipe", and its pharmacological properties are as follows:

[0028] Astragalus root is sweet and slightly warm in nature. It enters the spleen and lung meridians, tonifying qi and strengthening the spleen, benefiting the stomach and strengthening the exterior. This product contains astragalus polysaccharides, saponins, flavonoids, and other ingredients that have immune-enhancing, anti-oxidative, and anti-tumor effects. As the main ingredient in a prescription, it replenishes lung qi and strengthens the body's vital energy, providing a foundation for the other ingredients to function.

[0029] Five-fingered ginseng root (Citrus sinensis) is sweet and neutral in nature. It enters the spleen, lung, and liver meridians, tonifying the spleen and lungs, promoting qi and dampness, and relieving cough and phlegm. This product contains psoralen and bergamot lactone, which regulate the immune system and protect the liver. Combined with astragalus root, it synergistically nourishes the lungs and spleen, strengthening the body's vital energy. Its expectorant properties also help alleviate phlegm-damp symptoms in patients with lung nodules due to lung deficiency and phlegm accumulation.

[0030] Atractylodes macrocephala has a sweet and bitter taste and a warm nature. It enters the spleen and stomach meridians, benefiting the spleen and replenishing qi, while also clearing dampness and promoting diuresis. This herb contains volatile oils, polysaccharides, and lactone compounds. Modern pharmacology suggests it has diverse pharmacological effects, including digestive regulation, anti-inflammatory, immunomodulatory, anti-tumor, hypoglycemic, and liver protection. In this formula, it strengthens the spleen and aids digestion, helping to alleviate endogenous phlegm-dampness caused by spleen deficiency, thereby reducing phlegm-damp accumulation in the lungs and facilitating the treatment of pulmonary nodules.

[0031] Pinellia ternata is pungent and warm in nature, entering the spleen, stomach, and lung meridians. It has the effects of drying dampness and resolving phlegm, relieving adverse reactions and stopping vomiting, and dissolving lumps and nodules. This product contains amino acids, volatile oils, and alkaloids. Modern pharmacological research has shown that it has multiple pharmacological effects, including antitussive and expectorant, anti-tumor, anti-inflammatory, antibacterial, and sedative-hypnotic properties. In prescriptions, it is primarily used to resolve phlegm and dissolve nodules, improving symptoms of phlegm-dampness obstructing the lungs in patients with lung deficiency and phlegm accumulation-type pulmonary nodules, dissolving phlegm and dampness and thus alleviating the formation and progression of nodules.

[0032] Fritillaria thunbergii is bitter and cold in nature, entering the lung and heart meridians. It has the effects of clearing heat and resolving phlegm, dispersing nodules and reducing swelling. Modern pharmacological research has shown that it has multiple pharmacological effects, including anti-inflammatory, antitussive, expectorant, and anti-tumor effects. In this prescription, it synergizes with Pinellia ternata to enhance its phlegm-resolving and nodule-dispersing effects. Its heat-clearing effect also helps improve the pathological state of phlegm-heat accumulation and promotes the dissipation of lung nodules.

[0033] Honey Ephedra has a slightly bitter flavor and warm properties. It enters the lung and bladder meridians, and has the effect of promoting lung function and relieving asthma. This product contains ingredients such as ephedrine and pseudoephedrine, which have multiple pharmacological effects, including bronchodilator, anti-inflammatory, and anti-allergic properties. In prescriptions, it promotes lung function and relieves asthma, improving symptoms such as shortness of breath and cough. Its diaphoretic effect also helps dispel phlegm and dampness in the body.

[0034] Curcuma zedoaria is bitter and warm in nature, entering the liver and spleen meridians. It promotes qi circulation, resolves blood stasis, and relieves pain. This product contains ingredients such as curcumol and curcumone, and modern pharmacological research has shown that it possesses multiple pharmacological effects, including anti-tumor, anti-inflammatory, and anticoagulant properties. In prescriptions, it is used to promote blood circulation and dissipate blood stasis, improve lung stasis in patients with lung deficiency and phlegm accumulation-type pulmonary nodules, and promote the absorption and dissipation of nodules.

[0035] Lithospermum officinale is bitter and neutral in nature. It enters the lung, liver, and stomach meridians, and has the effects of clearing heat and dampness, promoting blood circulation and dispersing blood stasis, and softening and dispersing nodules. Modern pharmacological research has shown that it has multiple pharmacological effects, including anti-inflammatory, antibacterial, and anti-tumor effects. Its synergistic effect with Curcuma zedoaria in the formula further enhances its blood circulation and stasis-removing effects. Its heat-clearing and dampness-removing effects also help improve the pathological environment of phlegm and blood stasis, promoting the dissipation of nodules.

[0036] Cat's Claw is sweet and warm in nature, entering the lung and liver meridians. It has the effects of resolving phlegm and dispersing nodules, detoxifying and reducing swelling. Modern pharmacological research has shown that it has multiple pharmacological effects, including anti-tumor, anti-inflammatory, and immunomodulatory. In prescriptions, it is primarily used to dissipate nodules, directly targeting the pathological changes in lung nodules and promoting their absorption and dissipation.

[0037] Curcuma zedoaria is bitter and cold in nature, entering the liver, lung, and heart meridians. It has the effects of promoting blood circulation and relieving pain, promoting qi and relieving depression, and clearing the heart and relieving depression. This product contains volatile oils and curcumin, among other ingredients. Modern pharmacological research has shown that it has multiple pharmacological effects, including anti-inflammatory, antidepressant, and antioxidant properties. In this prescription, it promotes blood circulation, removes stasis, promotes qi and relieves depression, improves blood circulation in the lungs, soothes the liver and relieves depression, and alleviates the patient's anxiety.

[0038] Citrus aurantium fructus has a sour and bitter taste and a slightly cold nature. It enters the spleen and stomach meridians, promoting qi circulation, relieving fullness, and dissipating phlegm. This herb contains volatile oils and flavonoids, and modern pharmacological research has shown it to have multiple pharmacological effects, including regulating gastrointestinal function, anti-inflammatory, and anti-tumor properties. In prescriptions, it soothes the liver and regulates qi, helping to alleviate qi stagnation, promote qi and blood circulation, and alleviate the accumulation of phlegm and blood stasis caused by liver depression.

[0039] Barley malt is sweet and neutral in nature, entering the liver, spleen, and stomach meridians. It has the benefits of strengthening the spleen and appetite, promoting digestion, and soothing the stomach. Modern pharmacological research indicates that this product, containing amylase and maltose, has multiple pharmacological effects, including regulating gastrointestinal function and providing anti-inflammatory benefits. In prescriptions, it strengthens the spleen and aids digestion, helping to improve spleen and stomach function, reduce phlegm and dampness, and indirectly resolves phlegm and resolves stagnation.

[0040] Poria cocos has a sweet and mild flavor and a neutral nature. It enters the spleen and heart meridians, promoting diuresis and dispelling dampness, as well as tranquilizing the mind and nerves. This herb contains triterpenoids and polysaccharides, and modern pharmacological research has shown it to possess multiple pharmacological effects, including sedation, anxiolysis, and immunomodulation. In prescriptions, it is used to calm the mind, alleviate anxiety, improve sleep quality, and thus enhance overall immunity.

[0041] Oysters have a salty and astringent taste and a slightly cold nature. They enter the liver, gallbladder, and kidney meridians, and have the effects of softening and dispersing nodules, calming the liver and suppressing yang, and calming the mind. This herb contains proteins and minerals, and modern pharmacological research has shown it to have multiple pharmacological effects, including antioxidant, anti-fatigue, and immunomodulatory properties. In this formula, it provides a calming and soothing effect, while its softening and dispersing properties also help dissipate nodules.

[0042] Albizia Julibrissin flowers are sweet and neutral in nature, entering the liver and heart meridians. They have the effects of relieving depression, calming the mind, and regulating qi and soothing the stomach. Modern pharmacological research indicates that these flowers, containing volatile oils and flavonoids, possess various pharmacological effects, including anxiolytic, sedative, and antidepressant properties. In prescriptions, they are primarily used to alleviate anxiety and improve the psychological state of patients with pulmonary nodules, thereby assisting in the treatment of these conditions.

[0043] Earthworms are salty and cold in nature, entering the liver, spleen, and bladder meridians. They have the effects of clearing heat, calming convulsions, unblocking meridians, and relieving asthma. This product contains ingredients such as earthwormin and earthworm toxin, and modern pharmacological research has shown that they have multiple pharmacological effects, including anti-inflammatory, anticoagulant, and immunomodulatory. In prescriptions, they can help dispel phlegm and relieve cough, unblock meridians, and relieve asthma.

[0044] Ganoderma lucidum is sweet and neutral in nature, entering the lung, liver, heart, and kidney meridians. It has the effects of tonifying qi and calming the mind, relieving cough and asthma, and strengthening the body's health. This product contains Ganoderma lucidum polysaccharides and ganoderic acid, among other ingredients. Modern pharmacological research has shown that these ingredients have multiple pharmacological effects, including immune-enhancing, anti-tumor, antioxidant, and anti-fatigue properties. In this formula, they enhance the body's immune function, helping to improve the body's defense and repair capabilities against lung nodules.

[0045] Luffa loofah is sweet and neutral in nature, entering the lung, liver, and stomach meridians. It promotes blood circulation, reduces swelling, and relieves phlegm and cough. Modern pharmacological research indicates that it possesses multiple pharmacological effects, including anti-inflammatory, antioxidant, and immunomodulatory properties. In this formula, it promotes the circulation of qi and blood in the lungs, promoting the resolution of nodules.

[0046] The present invention uses Astragalus, Prunus mume, Atractylodes macrocephala, and Ganoderma lucidum as the main drugs, which can invigorate the spleen and stomach to eliminate dampness, tonify the lung qi to consolidate the exterior, cultivate the earth to generate gold and consolidate the foundation; the auxiliary drugs Pinellia ternata, Fritillaria thunbergii, and Oyster can resolve turbid phlegm and disperse stagnation, and are combined with Curcuma zedoaria, Lithospermum officinale, and Herba Lycopodii to promote blood circulation and dissipate blood stasis, eliminate symptoms and disperse stagnation, and eliminate tangible evil of phlegm and blood stasis; the auxiliary drugs Honey Ephedra can promote lung function and relieve depression, Luffa spinulosa can dredge the meridians and resolve phlegm, Curcuma zedoaria, Fructus Aurantii Immaturus, and Malt can soothe the liver and regulate qi, Flos Albizia Julibrissin can relieve depression and calm the mind, and regulate qi to help eliminate phlegm and blood stasis; the auxiliary drug Earthworm can dredge the meridians and remove blood stasis, and Licorice can harmonize the various drugs and guide the drugs to the meridians. The whole prescription can invigorate the lungs and spleen to strengthen the body, resolve phlegm and blood stasis to attack evil, soothe liver depression to regulate the mind, and use both attack and tonification to promote qi circulation and unblock the meridians, which is consistent with the pathogenesis of "lung deficiency and phlegm and blood stasis", and can also resolve emotional depression, embodying the purpose of "treating both the physical and mental aspects and taking both the symptoms and the root causes into consideration" of traditional Chinese medicine. Treating both the symptoms and the root cause, strengthening the body and dispersing the nodules, can improve the body's immunity, safely and effectively inhibit the development of lung nodules, and reduce the risk of malignant nodules.

[0047] Example 1 A Chinese medicinal compound for treating pulmonary nodules

[0048] A traditional Chinese medicine compound for treating pulmonary nodules, comprising the following ingredients: 25g of Astragalus, 25g of Prunus mume, 15g of Atractylodes macrocephala stir-fried with bran, 9g of Pinellia ternata, 15g of Fritillaria thunbergii, 5g of Ephedra sinica with honey, 10g of Curcuma zedoaria with vinegar, 10g of Lithospermum officinale, 25g of Herba Cat's Claws, 12g of Curcuma aromatica, 10g of stir-fried Fructus Aurantii Immaturus with bran, 12g of Malt, 12g of Poria, 25g of Oyster, 10g of Flos Albiziae, 10g of Pheretima terrestris soaked in liquorice, 10g of Ganoderma lucidum, and 10g of Luffa.

[0049] The method for preparing the Chinese herbal compound decoction is as follows: mixing the various drugs, boiling them conventionally, soaking them in water for 30 minutes, boiling them for 20 minutes, filtering out the medicinal liquid, adding water to the medicinal residue, boiling them for 15 minutes, filtering out the medicinal liquid, and combining the two medicinal liquids to obtain the decoction;

[0050] The method for preparing the traditional Chinese medicine compound granules is as follows: crushing the raw materials of the traditional Chinese medicine formula into granules, mixing them, and obtaining the granules.

[0051] Example 2 A Chinese medicinal compound for treating pulmonary nodules

[0052] A traditional Chinese medicine compound for treating pulmonary nodules, comprising the following ingredients: 26g of Astragalus, 25g of Prunus mume, 17g of Atractylodes macrocephala stir-fried with bran, 10g of Pinellia ternata, 15g of Fritillaria thunbergii, 8g of Ephedra sinica with honey, 10g of Curcuma zedoaria with vinegar, 12g of Lithospermum officinale, 26g of Herba Cat's Claws, 13g of Curcuma aromatica, 12g of stir-fried Fructus Aurantii Immaturus with bran, 13g of Malt, 13g of Poria, 25g of Oyster, 12g of Flos Albizia Julibrissin, 12g of Pheretima terrestris soaked in liquorice, 12g of Ganoderma lucidum, and 12g of Luffa.

[0053] The method for preparing the Chinese herbal compound decoction or granules is the same as that in Example 1.

[0054] Example 3 A Chinese herbal compound for treating pulmonary nodules

[0055] A traditional Chinese medicine compound for treating pulmonary nodules, comprising the following medicines:

[0056] Astragalus 30g, five-fingered ginseng 30g, stir-fried Atractylodes macrocephala with bran 20g, French Pinellia 12g, Thunbergia thunbergii 20g, honeyed ephedra 6g, vinegared Curcuma 12g, Lithospermum officinale 15g, cat's claw 30g, Curcuma 15g, stir-fried Citrus aurantium with bran 10g, malt 15g, Poria 15g, oyster 30g, Albizia julibrissin 15g, licorice-soaked earthworm 15g, Ganoderma lucidum 15g, and loofah 15g.

[0057] The method for preparing the Chinese herbal compound decoction or granules is the same as that in Example 1.

[0058] Example 4 A Chinese medicinal compound for treating pulmonary nodules

[0059] A traditional Chinese medicine compound for treating pulmonary nodules, comprising the following ingredients: 28g of Astragalus, 32g of Prunus mume, 20g of Atractylodes macrocephala stir-fried with bran, 10g of Pinellia ternata, 18g of Fritillaria thunbergii, 9g of Ephedra sinica with honey, 11g of Curcuma zedoaria with vinegar, 14g of Lithospermum officinale, 28g of Herba Cat's Claws, 13g of Curcuma aromatica, 14g of stir-fried Fructus Aurantii Immaturus with bran, 14g of Malt, 14g of Poria, 27g of Oyster, 14g of Albizia julibrissin, 13g of Pheretima terrestris soaked in liquorice, 18g of Ganoderma lucidum, and 15g of Luffa.

[0060] The method for preparing the Chinese herbal compound decoction or granules is the same as that in Example 1.

[0061] Example 5 A Chinese herbal compound for treating pulmonary nodules

[0062] A traditional Chinese medicine compound for treating pulmonary nodules, comprising the following ingredients: 30g of Astragalus, 35g of Prunus mume, 20g of Atractylodes macrocephala stir-fried with bran, 12g of Pinellia ternata, 20g of Fritillaria thunbergii, 10g of Ephedra sinica with honey, 12g of Curcuma zedoaria with vinegar, 15g of Lithospermum officinale, 30g of Herba Cat's Claws, 15g of Curcuma aromatica, 15g of stir-fried Fructus Aurantii Immaturus with bran, 15g of Malt, 15g of Poria, 30g of Oyster, 15g of Albizia julibrissin, 15g of Earthworm soaked in liquorice, 20g of Ganoderma lucidum, and 15g of Luffa.

[0063] The method for preparing the Chinese herbal compound decoction or granules is the same as that in Example 1.

[0064] The Chinese medicine compound granules prepared in the above Example 3 were used to conduct experiments on two groups of patients with small lung nodules due to lung deficiency and phlegm accumulation in 2019 and 2021. See the following Application Examples 1 and 2 for details.

[0065] Application Example 1

[0066] 1. Diagnosis and treatment plan

[0067] Disease classification: pulmonary nodules (lung deficiency and phlegm accumulation type).

[0068] 2. Diagnostic criteria and assessment tools:

[0069] 2.1 Diagnostic criteria

[0070] ① Western medicine diagnostic standards

[0071] Patients who meet the diagnostic criteria of the "Chinese Expert Consensus on the Diagnosis and Treatment of Pulmonary Nodules (2018 Edition)";

[0072] ② Traditional Chinese Medicine syndrome diagnosis

[0073] The diagnostic criteria refer to the relevant content on pulmonary nodules in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (2002)" promulgated by the State Food and Drug Administration.

[0074] 2.2 Evaluation Tools

[0075] ① Risk score of small pulmonary nodules: This study used the appearance of small pulmonary nodules, such as the number, density, diameter, morphology, edge, and nodule-lung plane, as indicators for observing the efficacy of pulmonary nodules. Based on the relevant content of the "Chinese Expert Consensus on the Diagnosis and Treatment of Pulmonary Nodules (2018 Edition)" on assessing the risk of pulmonary nodules, a quantitative table for pulmonary nodule risk assessment was formulated, in which solid nodules were assigned 1 point, ground glass nodules were assigned 2 points, and mixed nodules were assigned 3 points. The number of pulmonary nodules was assigned 1 point, 2 points, and ≥3 points, respectively. 3 points; lung nodule diameters of ≤4mm, 5-6mm, 7-8mm, and 9-10mm are assigned 0, 1, 2, and 3 points, respectively; lung nodule morphology is assigned 0, 1, and 2 points, respectively, for round, quasi-round, and irregular; lung nodule margins are assigned 0 and 2 points, respectively, for smoothness and tumor signs (including spiculation, lobulation, pleural indentation, and vascular bundles); lung nodule-lung interface is assigned 0 and 2 points, respectively, for clear and neat edges, even smooth, and for clear but rough edges, even with spiculation. The highest score is given for each of the above items, and the same assessment item is not cumulatively scored. A higher lung nodule risk assessment score indicates a higher risk, and a lower score indicates a lower risk.

[0076] ② The Self-Rating Anxiety Scale (SAS) score can be used to screen for generalized anxiety. It consists of 20 items, each rated on a four-level scale: 1 (never or rarely), 2 (sometimes), 3 (most of the time), and 4 (most of the time). The total score ranges from 0 to 80, with the anxiety rating cutoff at 50 points. 50-59 points indicate mild anxiety, 60-69 points indicate moderate anxiety, and 70 points or above indicate severe anxiety. Higher scores indicate a more pronounced tendency to anxiety.

[0077] ③ The PHQ-9 (Personal Depression Questionnaire-9): This is a depression screening tool modified from the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). It consists of nine items, each rated on a four-point scale: 0 (never), 1 (a few days), 2 (more than half the time), and 3 (almost every day). The total score ranges from 0 to 27, with 5, 10, and 20 representing the cutoffs for mild, moderate, and severe anxiety. Scores of 0-4 indicate no depression, 5-9 indicate mild depression, 10-14 indicate moderate depression, and 15-27 indicate severe depression.

[0078] ④ Pulmonary nodule risk assessment: The malignancy risk ratio of the nodule is determined based on the location, size, and composition of the pulmonary nodule. A pulmonary nodule with a malignancy risk ratio of less than 5% is considered extremely low; a pulmonary nodule with a malignancy risk ratio between 5% and 40% is considered low; a pulmonary nodule with a malignancy risk ratio between 41% and 56% is considered moderate; a pulmonary nodule with a malignancy risk ratio between 66% and 85% is considered high; and a pulmonary nodule with a malignancy risk ratio greater than 85% is considered extremely high.

[0079] 2.3 Symptoms

[0080] Main symptoms: cough and sputum, chest tightness, shortness of breath, chest and flank discomfort;

[0081] Secondary symptoms: fatigue, pale complexion;

[0082] Tongue coating: pale or dark tongue with little coating;

[0083] Pulse: deep, thin, strong or tight.

[0084] Patients with two main symptoms and one or more secondary symptoms can be diagnosed.

[0085] 3. Reference standards for clinical cure, improvement, effectiveness, and deterioration of TCM syndromes:

[0086] Clinical cure: clinical symptoms and signs disappear or almost disappear, and the syndrome score decreases by ≥95.

[0087] Markedly effective: Clinical symptoms and signs are significantly improved, and the syndrome score is reduced by ≥70%.

[0088] Effective: Clinical symptoms and signs are significantly improved, and the syndrome score is reduced by ≤70%.

[0089] Ineffective (worsening): Clinical symptoms and signs worsen.

[0090] 4. Dosage regimen

[0091] Pure Chinese medicine treatment, the experimental group orally took the Chinese medicine compound granules prepared in Example 3, 30g of Astragalus, 30g of Wuzhimaotao, 20g of Atractylodes macrocephala, 12g of French Pinellia, 20g of Thunbergia thunbergii, 6g of honeyed ephedra, 12g of vinegared Curcuma, 15g of Lithospermum officinale, 30g of Cat's Claw, 15g of Curcuma, 10g of fried Citrus aurantium, 15g of malt, 15g of Poria, 30g of Oyster, 15g of Albizia julibrissin, 15g of Liquorice-soaked Earthworm, 15g of Ganoderma lucidum, and 15g of Luffa to make 12g of Chinese medicine compound granules, 6g (one bag) at a time, twice a day, for a course of treatment of 3 months.

[0092] 5. Clinical patient information

[0093] This study included 40 patients with pulmonary nodules who met the research criteria in 2019.

[0094] 5.1 Inclusion criteria

[0095] (1) Meet the diagnostic criteria of traditional Chinese and Western medicine for pulmonary nodules and sign the informed consent form;

[0096] (2) Pulmonary nodules are pure ground glass nodules or mixed nodules with a diameter of 5 to 10 mm, or solid nodules with a diameter of 6 to 10 mm;

[0097] (3) Those with good compliance who can persist in taking Bufei Xiaojie prescription with modifications for 3 months;

[0098] (4) Those who can cooperate in completing various observation scales and dynamically review chest CT;

[0099] (5) Both men and women, aged between 20 and 75 years old.

[0100] 5.2 Exclusion criteria

[0101] (1) Small pulmonary nodules with a diameter of less than 5 mm, or pulmonary nodules with a diameter of more than 10 mm;

[0102] (2) Patients with atelectasis, hilar lymphadenopathy, and pleural effusion, or those with advanced malignant tumors of other systems;

[0103] (3) Patients with severe heart, liver, kidney and other organ diseases, or those with neurological diseases who are unable to cooperate;

[0104] (4) Currently participating in other clinical research.

[0105] If any of the above conditions are met, the applicant will be excluded.

[0106] 5.3 Rejection / termination criteria

[0107] (1) Those who experience severe adverse drug reactions during medication;

[0108] (2) Those who voluntarily withdraw from the study;

[0109] (3) Those with poor compliance, unable to persist in taking the Bufei Xiaojie prescription for treatment, or unable to undergo dynamic chest CT review, or unable to cooperate in filling out the observation form;

[0110] (4) Patients with pulmonary nodules that continue to grow and are at risk of malignant transformation and urgently need surgical treatment;

[0111] (5) Those who received other traditional Chinese medicine treatment during the study period.

[0112] 6. Results and Analysis

[0113] 6.1 Efficacy of Bufei Xiaojie Recipe on the Risk Assessment Score of Small Pulmonary Nodules

[0114] The results showed that the total effective rate of Bufei Xiaojie prescription on the risk of malignant transformation of small lung nodules of lung deficiency and phlegm accumulation type was 32.5%, the cure rate was 5%, the significant effective rate was 5%, the effective rate was 22.5%, and the ineffective rate was 67.5%. The specific situation is shown in Table 1.

[0115] Table 1 Statistics on the efficacy of Bufei Xiaojie prescription in the treatment of small lung nodules after 3 months of intervention

[0116]

[0117] 6.2 Comparison of the risk of small pulmonary nodules before and 3 months after intervention

[0118] Normality tests were performed on the pulmonary nodule risk assessment scores before and after the intervention. Data did not meet normal distribution requirements, so a paired sample rank sum test was used. The results showed that the pulmonary nodule risk assessment scores after the intervention were significantly lower than those before the intervention, indicating that the Bufei Xiaojie prescription significantly reduced the risk of pulmonary nodules in patients with lung deficiency and phlegm accumulation. Specific results are shown in Table 2.

[0119] Table 2 Comparison of pulmonary nodule risk scores before and after intervention (n=40)

[0120]

[0121] 6.3 Efficacy of Bufei Xiaojie Decoction on TCM Syndrome Score

[0122] The results showed that in the middle stage of the intervention, the total effective rate of the Bufei Xiaojie prescription for TCM syndromes was 80%, the significant effective rate was 0, and the ineffective rate was 20%. After 3 months of intervention, the total effective rate was 97.5%, the significant effective rate was 20%, the effective rate was 77.5%, and the ineffective rate was 2.5%. See Table 3 for details.

[0123] Table 3 Improvement of TCM symptoms during the middle and 3-month intervention period with Bufei Xiaojie prescription

[0124]

[0125] 6.3.1 Comparison of TCM syndrome scores before and during the intervention period

[0126] The changes in TCM syndrome scores before and during the Bufei Xiaojie prescription intervention were found to be normally distributed by normality test. Therefore, a paired t-test was used to analyze the TCM syndrome efficacy before and during the intervention period. The results showed that the TCM syndrome scores of patients with small pulmonary nodules decreased during the intervention period compared with those before the Bufei Xiaojie prescription intervention, which was statistically significant (P < 0.01). See Table 4 for details.

[0127] Table 4 Comparison of TCM syndrome efficacy before and during the intervention period (n=40)

[0128]

[0129] 6.3.2 Comparison of TCM Syndrome Scores at Mid-Intervention and 3-Month Intervention

[0130] Normality tests revealed that the TCM syndrome scores for the Bufei Xiaojie formula at the mid-term and three-month intervention periods did not meet normal distribution requirements. Therefore, a paired-sample rank sum test was used to assess the efficacy of TCM syndrome scores at the mid-term and three-month intervention periods. The results showed that TCM syndrome scores were significantly lower after the three-month intervention period than at the mid-term, indicating that the TCM syndromes of patients with small pulmonary nodules improved significantly after three months of Bufei Xiaojie formula intervention compared to the mid-term period. See Table 5 for details.

[0131] Table 5 Comparison of TCM syndrome efficacy between mid-term intervention and 3-month intervention (n=40)

[0132]

[0133] 6.3.3 Comparison of TCM syndrome scores before and after 3 months of intervention

[0134] Normality tests confirmed changes in the TCM syndrome scores of patients with pulmonary nodules before and after the Bufei Xiaojie prescription intervention, so a paired t-test was used to compare the TCM syndrome efficacy before and after the intervention. The results showed that the TCM syndrome scores of patients with pulmonary nodules decreased significantly after the Bufei Xiaojie prescription intervention, with statistically significant t-test analysis (P < 0.01). See Table 6 for details.

[0135] Table 6 Comparison of TCM syndrome efficacy before intervention and 3 months after intervention (n=40)

[0136]

[0137] 6.4 Efficacy of Bufei Xiaojie Recipe on Self-Rating Anxiety Scale (SAS) Scores

[0138] The results showed that the total effective rate of Bufei Xiaojie prescription on the anxiety score of patients with lung deficiency and phlegm accumulation type of pulmonary nodules in the middle period of intervention was 10%, the significant effective rate was 0, the effective rate was 10%, and the ineffective rate was 90%; after 3 months of intervention, the total effective rate on the anxiety score of patients with pulmonary nodules was 40%, the significant effective rate was 0, the effective rate was 40%, and the ineffective rate was 60%. It can be seen that with the increase of intervention time, the total effective rate of Bufei Xiaojie prescription on the anxiety state of patients with lung deficiency and phlegm accumulation type of pulmonary nodules also increased. The specific situation is shown in Table 7.

[0139] Table 7 Statistics on the efficacy of Bufei Xiaojie prescription on anxiety in patients with lung deficiency and phlegm accumulation type pulmonary nodules [cases (%)]

[0140]

[0141] 6.4.1 Comparison of anxiety scores before and during the intervention

[0142] Before and during the mid-intervention period, anxiety scores in patients with pulmonary nodules of the lung deficiency and phlegm accumulation type did not conform to a normal distribution. Therefore, a paired-sample rank sum test was used to analyze changes in anxiety scores in patients with pulmonary nodules before and during the mid-intervention period. The results showed that anxiety scores in patients with pulmonary nodules during the mid-intervention period were significantly lower than those before the intervention period, indicating that anxiety symptoms in patients with pulmonary nodules were significantly improved after the Bufei Xiaojie prescription intervention. Specific results are shown in Table 8.

[0143] Table 8 Comparison of anxiety scores before and during the intervention period (n=40)

[0144]

[0145] 6.4.2 Comparison of anxiety scores between mid-intervention and 3 months after intervention

[0146] Anxiety scores in patients with pulmonary nodules of the lung deficiency and phlegm accumulation type did not conform to a normal distribution between the mid-term and 3-month intervention periods with the Bufei Xiaojie formula. Therefore, a paired-sample rank sum test was used to analyze changes in anxiety scores between the mid-term and 3-month intervention periods. The results showed that anxiety scores in patients with pulmonary nodules were significantly lower at the 3-month intervention period compared with the mid-term, indicating that anxiety symptoms in patients with pulmonary nodules were significantly improved after 3 months of Bufei Xiaojie formula intervention compared with the mid-term intervention period. Specific results are shown in Table 9.

[0147] Table 9 Comparison of anxiety scores between the mid-intervention period and the 3-month intervention period (n=40)

[0148]

[0149] 6.4.3 Comparison of Anxiety Scores Before and Three Months After the Intervention

[0150] Anxiety scores in patients with pulmonary nodules of the lung deficiency and phlegm accumulation type did not meet normal distribution before and after the three-month Bufei Xiaojie prescription intervention. Therefore, a paired-sample rank sum test was used to analyze the change in anxiety scores in patients with pulmonary nodules after the three-month intervention. The results showed that the anxiety scores of patients with pulmonary nodules were significantly lower after the three-month intervention compared with before the intervention, indicating that the anxiety symptoms of patients with pulmonary nodules were significantly improved after the three-month Bufei Xiaojie prescription intervention compared with before the intervention. Specific results are shown in Table 10.

[0151] Table 10 Comparison of anxiety scores before intervention and 3 months after intervention (n=40)

[0152]

[0153] 6.5 Efficacy of Bufei Xiaojie Decoction on PHQ-9 Depression Screening Scale Scores

[0154] The results showed that in the middle stage of the intervention, the total effective rate of the Bufei Xiaojie prescription on the depression score of patients with lung deficiency and phlegm accumulation type of pulmonary nodules was 80%, the cure rate was 2.5%, the significant effective rate was 17.5%, the effective rate was 60%, and the ineffective rate was 20%; after 3 months of intervention, the total effective rate of the Bufei Xiaojie prescription on the depression score of patients with pulmonary nodules was 92.5%, the cure rate was 57.5%, the significant effective rate was 22.5%, the effective rate was 12.5%, and the ineffective rate was 7.5%. It can be seen that with the increase of the intervention time of the Bufei Xiaojie prescription, the depressive symptoms of patients with lung deficiency and phlegm accumulation type of pulmonary nodules were significantly improved compared with before the intervention. The specific results are shown in Table 11.

[0155] Table 11 The efficacy of Bufei Xiaojie prescription on depressive symptoms in patients with lung deficiency and phlegm accumulation type pulmonary nodules [(cases / %)]

[0156]

[0157] 6.5.1 Comparison of depression scores before and during the intervention

[0158] The depression scores of patients with pulmonary nodules of the lung deficiency and phlegm accumulation type before and during the Bufei Xiaojie prescription intervention did not meet normal distribution requirements. Therefore, a paired sample rank sum test was used to analyze the changes in depression scores between before and during the intervention period. The results showed that the depression scores of patients with pulmonary nodules of the lung deficiency and phlegm accumulation type were significantly lower during the mid-intervention period compared with before the intervention period, indicating that the depressive symptoms of patients with pulmonary nodules were significantly improved after the Bufei Xiaojie prescription intervention compared with before the intervention period. Specific results are shown in Table 12.

[0159] Table 12 Comparison of depression scores before and during the intervention period (n=40)

[0160]

[0161] 6.5.2 Comparison of depression scores between mid-intervention and 3-month intervention

[0162] Depression scores in patients with pulmonary nodules of the lung deficiency and phlegm accumulation type did not conform to a normal distribution at the mid-term and 3-month follow-up of the Bufei Xiaojie Recipe intervention. Therefore, a paired-sample rank sum test was used to analyze changes in depression scores between the mid-term and 3-month follow-up periods. The results showed that depression scores in patients with pulmonary nodules of the lung deficiency and phlegm accumulation type were significantly lower after the 3-month intervention period compared with the mid-term follow-up period, indicating that depressive symptoms in these patients improved significantly after the 3-month Bufei Xiaojie Recipe intervention period compared with the mid-term follow-up period. Specific results are shown in Table 13.

[0163] Table 13 Comparison of depression scores between the mid-intervention period and the 3-month intervention period (n=40)

[0164]

[0165] 6.5.3 Comparison of depression scores before and after the intervention

[0166] Depression scores in patients with pulmonary nodules of the lung deficiency and phlegm accumulation type did not conform to a normal distribution before and three months after the Bufei Xiaojie Recipe intervention. Therefore, a paired-sample rank sum test was used to analyze changes in depression scores between before and three months after the intervention. The results showed that depression scores in patients with pulmonary nodules of the lung deficiency and phlegm accumulation type were significantly lower after the three-month intervention compared with before the intervention, indicating that depressive symptoms in these patients were significantly improved after the three-month Bufei Xiaojie Recipe intervention compared with before the intervention. Specific results are shown in Table 14.

[0167] Table 14 Comparison of depression scores before intervention and 3 months after intervention (n=40)

[0168]

[0169] 6.6 Safety of the Bufei Xiaojie Formula

[0170] During the study, 40 patients with small lung nodules of lung deficiency and phlegm accumulation took the Bufei Xiaojie prescription orally for 3 months without any obvious adverse reactions.

[0171] Application Example 2

[0172] Based on experimental results from 2019, the inventors' team used the "Bufei Xiaojie Recipe" to treat patients with lung deficiency and phlegm accumulation type lung nodules for four months in 2021. Combined with WeChat group management, the team focused on "preventive measures, early diagnosis, comprehensive treatment, and modern management." They treated nearly 10,000 patients with lung nodules, achieving a stabilization rate of 80-90% and a clinical resolution rate of 15-20%. This has benefited a vast number of patients with lung nodules and created significant economic and broad social benefits. The following illustrates this with selected case studies.

[0173] 1. Research subjects

[0174] 1.1 Source of subjects

[0175] Patients with small pulmonary nodules who visited the outpatient clinics and wards of the Department of Pulmonary Diseases / Department of Respiratory and Critical Care Medicine of Guangzhou University of Chinese Medicine Shenzhen Hospital (Futian) and the outpatient clinic of Peking University Shenzhen Hospital from September 2021 to February 2024.

[0176] 1.2 Diagnostic criteria

[0177] 1.2.1 Western medicine diagnostic criteria

[0178] The clinical manifestations of patients with small pulmonary nodules are mostly nonspecific, so the diagnosis of small pulmonary nodules mainly relies on chest CT. According to the Chinese Expert Consensus on the Diagnosis and Treatment of Pulmonary Nodules (2018 edition), the diagnostic criteria for small pulmonary nodules are increased lung density shadows with a diameter of 5 to 10 mm.

[0179] 1.2.3 Diagnostic criteria based on TCM syndrome differentiation

[0180] According to the relevant syndrome standards of Traditional Chinese Medicine Internal Medicine and combined with the clinical experience of the instructor, the following syndrome standards for small lung nodules are formulated, which are divided into 5 types according to the syndrome type.

[0181] ① Lung deficiency and phlegm accumulation syndrome: deep and weak cough, white phlegm or phlegm that cannot be coughed up, accompanied by cough, asthma and excessive phlegm, sawing sound in the throat at night, dizziness, dry stool, restlessness and madness, chest and diaphragm fullness, flank distension, headache and vomiting, sudden unbearable pain in the chest, back, hands and feet, neck, waist and hips, internal tendons and bones, pulling and burning pain, restlessness, or headache that cannot be lifted, restlessness, drowsiness and excessive sleep, loss of appetite, heavy hands and feet, cold and numb legs, blocked qi and meridians, or mental fatigue, low voice, sallow or pale complexion, easy to catch cold, easy to cough when having a cold, pale tongue, thick and greasy tongue coating, thready and weak pulse, or deep and weak pulse.

[0182] ② Phlegm and Stasis Obstructing the Lungs: Cough with excessive white or foamy sputum, gurgling sound in the throat, wheezing and inability to lie flat, chest fullness, stuffiness, pale and dark complexion, cyanosis of the lips and nails, dark or purple tongue, thickened sublingual tendons, greasy or turbid tongue coating, and a wiry and slippery pulse. Phlegm and Heat Obstructing the Lungs: Cough, wheezing, rough breathing, yellow or white sputum that is sticky and difficult to cough up, chest fullness and irritability, bulging eyes, or fever and sweating, or slight aversion to cold, yellow urine and dry stools, thirst, dark red tongue, yellow or greasy tongue coating, and a slippery and rapid pulse.

[0183] ③Syndrome of phlegm-dampness obstructing the lungs: recurrent cough with heavy and muddy sound, copious phlegm, cough due to phlegm, which is relieved after coughing up phlegm, which is sticky or thick in lumps, white or gray in color, and more phlegm in the morning or after meals, aggravated by sweet and greasy food, chest tightness and abdominal distension, nausea and loss of appetite, fatigue, loose stools, white and greasy tongue coating, and slippery pulse.

[0184] ④ Lung and spleen deficiency syndrome: chest tightness, shortness of breath, weak voice, weak cough, white sputum in small amounts, fatigue, shortness of breath, laziness, limb fatigue, sallow or pale complexion, spontaneous sweating, fear of wind, abdominal distension, especially after eating, poor appetite or even no appetite, bland taste in the mouth, loose stools, weight loss or obesity, edema, etc. Tongue and pulse may be pale with a white coating, and the pulse may be slow, weak, or weak.

[0185] ⑤ Qi and Yin deficiency syndrome: weak cough, shortness of breath, low voice, clear and thin sputum, occasional hemoptysis, fatigue, spontaneous sweating and night sweats, or poor appetite and loose stools, red and tender tongue, thin fur, and weak and rapid pulse. If there are no obvious clinical symptoms, the syndrome type is classified based on the tongue and pulse.

[0186] 1.3 Inclusion criteria

[0187] (1) Meet the diagnostic criteria of traditional Chinese and Western medicine for pulmonary nodules and sign the informed consent form;

[0188] (2) the diameter of the pulmonary nodule is between 5 and 10 mm;

[0189] (3) Those with good compliance who can persist in taking Bufei Xiaojie prescription with modifications for 4 months;

[0190] (4) Able to complete various observation scales, draw blood, and regularly review chest CT scans and provide chest CT data in DICOM format;

[0191] (5) Both men and women, aged between 18 and 80 years old.

[0192] 1.4 Exclusion criteria

[0193] (1) Small pulmonary nodules with a diameter of <5 mm or pulmonary nodules with a diameter of >10 mm;

[0194] (2) Patients with atelectasis, hilar lymphadenopathy, and pleural effusion, or those with advanced malignant tumors of other systems;

[0195] (3) Patients with severe heart, liver, kidney and other organ diseases, or those with neurological diseases who are unable to cooperate;

[0196] (4) Currently participating in other clinical research.

[0197] If any of the above conditions are met, the applicant will be excluded.

[0198] 1.5 Rejection / termination criteria

[0199] (1) Those who experience severe adverse drug reactions during medication;

[0200] (2) Those who voluntarily withdraw from the study;

[0201] (3) Patients with poor compliance who cannot persist in taking Bufei Xiaojie prescription with modifications; or those who cannot undergo dynamic chest CT review, or those who cannot cooperate with filling out the observation form, or those who cannot provide chest CT data, and cannot cooperate with CAC testing and liver and kidney function monitoring;

[0202] (4) Patients with pulmonary nodules that continue to grow and are at risk of malignant transformation and urgently need surgical treatment;

[0203] (5) Those who received other traditional Chinese medicine treatment during the study period.

[0204] 2. Research Plan

[0205] 2.1 Intervention measures

[0206] The experimental group received pure TCM treatment, with oral administration of Bufei Xiaojie prescription for 4 months. The control group received no treatment and received regular follow-up.

[0207] 2.2 Efficacy Observation Indicators

[0208] 2.2.1 Pulmonary nodule risk assessment score

[0209] In this study, the appearance of small pulmonary nodules, such as the number, density, diameter, morphology, edge, and nodule-lung plane, was used as the efficacy observation index of pulmonary nodules. According to the relevant content of the "Chinese Expert Consensus on the Diagnosis and Treatment of Pulmonary Nodules (2018 Edition)" on assessing the risk of pulmonary nodules, a pulmonary nodule risk assessment quantitative table was developed, in which solid nodules (assigned 1 point), ground glass nodules (assigned 2 points), and mixed nodules (assigned 3 points) were assigned; the number of pulmonary nodules was assigned according to 1 (1 point), 2 (2 points), and ≥3 (2 points). ); lung nodule diameter was ≤4mm (0 point), 5-6mm (1 point), 7-8mm (2 points), and 9-10mm (3 points); lung nodule morphology was round (0 point), quasi-round (1 point), and irregular (2 points); lung nodule margin was smooth (0 point), with tumor signs such as spiculation, lobulation, pleural indentation, and vascular bundles (2 points); and the lung nodule-lung interface was assigned 0 points or even smooth edges and 2 points or clear but rough edges or even spiculation, respectively. Each of the above items was scored as the highest possible, and the same assessment item was not cumulatively scored. A higher lung nodule risk assessment score indicates a higher risk, and a lower score indicates a lower risk. Changes in the lung nodule risk assessment score were then observed in the treatment and control groups.

[0210] 2.2.2 TCM Syndrome Score Observation Indicators

[0211] This study used the primary and secondary TCM syndromes in the TCM syndrome diagnostic criteria as the primary content of the TCM syndrome scoring scale. Based on the severity of the symptoms, primary symptoms were assigned values ​​of 0, 2, 4, or 6, while secondary symptoms were assigned values ​​of 0, 1, 2, or 3, respectively (see Table 15). By observing changes in TCM syndrome scores in the treatment and control groups, the effect of the Bufei Xiaojie recipe on the TCM syndrome scores of patients with small pulmonary nodules was evaluated.

[0212] Table 15 TCM syndrome score scale for lung nodules of lung deficiency and phlegm accumulation type

[0213]

[0214]

[0215] Note: The tongue meridian refers to the sublingual vein.

[0216] 2.2.3 Observation indicators of anxiety, depression, and fatigue

[0217] Clinically, patients with pulmonary nodules often experience anxiety, depression, tension, and fatigue. Studies have shown that over 60% of patients with pulmonary nodules experience anxiety, depression, and fatigue. Therefore, this study used the Self-Rating Anxiety Scale (SAS), the PHQ-9 Depression Screening Scale, and the Subjective Fatigue Scale as indicators of anxiety, depression, and fatigue. By observing changes in anxiety, depression, and fatigue scores in the treatment and control groups, this study evaluated the Bufei Xiaojie Recipe's intervention effect on anxiety, depression, and fatigue in patients with small pulmonary nodules.

[0218] 2.2.4 Risk and Benign and Malignant Assessment Indicators

[0219] 2.2.4.1CTAI (Computer-Aided Imaging)

[0220] This study used an AI artificial intelligence imaging lung nodule auxiliary diagnosis system (Zhuhai Shengmei Biological), uploaded the chest CT data in DICOM format to the AI ​​system, and automatically analyzed the treatment group and the control group. Both groups completed follow-up comparisons before and after 4 months. If the same patient had multiple nodules that met the inclusion criteria, the nodule with the largest diameter and the highest risk probability recorded in the pulmonary nodule assessment scale was used as the observation indicator. According to the Chinese Expert Consensus on the Diagnosis and Treatment of Lung Nodules (2018 Edition), the larger the density, volume, and diameter, the greater the probability of malignancy, and the lower the probability of malignancy. The AI ​​system can directly measure the rate of change of diameter, volume, and density, so the trend of change is used as an overall comparison. A negative value is recorded as 1 for effectiveness, and a positive value is recorded as 2 for ineffectiveness. The changes in 2D diameter size between the experimental group and the control group were compared to evaluate the intervention effect of the Bufei Xiaojie prescription in reducing the malignancy probability of small lung nodules.

[0221] 2.2.4.2 Circulating chromosomally abnormal cells (CAC)

[0222] Based on precision medicine for early lung cancer diagnosis, a CAC count of 3 was defined as a positive test result. A CAC count of less than 3 indicates a low risk of malignancy, while a CAC count between 3 and 9 indicates a high risk. A CAC count greater than 9 indicates an extremely high risk. Comparing CAC changes between the experimental and control groups evaluated the effectiveness of the Bufei Xiaojie formula in reducing the risk of malignancy in small lung nodules.

[0223] 2.2.5 Safety Observation Indicators

[0224] This study used two liver function tests and three kidney function tests as safety observation indicators, and evaluated the safety of the prescription by observing the changes in liver and kidney function in the treatment and control groups.

[0225] 2.2.6 Efficacy evaluation criteria

[0226] The following efficacy evaluation criteria are determined with reference to the "Guiding Principles for Clinical Research of New Chinese Medicines". The specific contents are as follows:

[0227] 2.1.6.1 Evaluation criteria for therapeutic efficacy of small pulmonary nodules

[0228] (1) Cure: The patient's pulmonary nodule risk assessment score is reduced to 0 points;

[0229] (2) Significantly effective: The patient's pulmonary nodule risk assessment score decreased by at least 50% compared with before intervention;

[0230] (3) Effective: The patient's pulmonary nodule risk assessment score decreased by 25% to 49% compared with before intervention;

[0231] (4) Ineffective: The patient's pulmonary nodule risk assessment score decreased by less than 25% compared with before the intervention, or the risk assessment score increased compared with before the intervention.

[0232] Pulmonary nodule risk assessment score reduction rate = (pulmonary nodule risk assessment score before intervention - pulmonary nodule risk assessment score after intervention) / pulmonary nodule risk assessment score before intervention * 100%

[0233] Total effective rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases * 100%

[0234] 2.1.6.2 TCM Syndrome Therapeutic Efficacy Evaluation Criteria

[0235] (1) Cured: The patient's TCM clinical symptoms basically disappeared, and the syndrome score decreased by at least 90%;

[0236] (2) Significantly effective: The patient's TCM clinical symptoms were significantly improved, and the syndrome score was reduced by at least 70%;

[0237] (3) Effective: The patient's TCM clinical symptoms improved compared to before, and the syndrome score decreased by 30% to 70%;

[0238] (4) Ineffective: The patient's TCM clinical symptoms did not improve significantly or worsened, and the symptom score decreased by less than 30%.

[0239] Symptom efficacy index = (TCM syndrome score before intervention - TCM syndrome score after intervention) / TCM syndrome score before intervention * 100%

[0240] Total effective rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases * 100%

[0241] 2.1.6.3 Evaluation criteria for anxiety / depression / fatigue efficacy

[0242] (1) Cured: clinical manifestations of anxiety / depression / fatigue basically disappear, and anxiety / depression / fatigue scores decrease by at least 90%;

[0243] (2) Significant effect: clinical manifestations of anxiety / depression / fatigue were significantly improved, and the anxiety / depression / fatigue score decreased by at least 70;

[0244] (3) Effective: clinical manifestations of anxiety / depression / fatigue improved compared to before, and anxiety / depression / fatigue scores decreased by 30% to 70%;

[0245] (4) Ineffective: There was no significant improvement in the clinical manifestations of anxiety / depression / fatigue, or the symptoms worsened, and the anxiety / depression / fatigue score decreased by less than 30%.

[0246] Anxiety / depression / fatigue efficacy index = (anxiety / depression / fatigue score before intervention - anxiety / depression / fatigue score after intervention) / anxiety / depression / fatigue score before intervention * 100%.

[0247] Total effective rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases * 100%.

[0248] 2.2.7 Risk and Benign and Malignant Assessment Indicators

[0249] Due to a lack of literature documenting the risk reduction and benign and malignant efficacy rates in the treatment group, quantitative data analysis was performed using only the effective and ineffective data. This analysis evaluated the Bufei Xiaojie formula's effect on the density, volume, and diameter of small pulmonary nodules after four months of intervention. The effective rate for the risk probability and 2D diameter of small pulmonary nodules was calculated as (risk probability after four months / number of cases with reduced 2D diameter) / total case group * 100%.

[0250] 2.2.8 Safety evaluation standards

[0251] Observe the changes in liver and kidney function in 80 patients with small pulmonary nodules. If any adverse reactions occur, record them truthfully.

[0252] 2.2.9 Statistical methods

[0253] The control group and treatment group of patients with small pulmonary nodules included in this study were collected, and the risk assessment score of the appearance connotation of small pulmonary nodules, the score of traditional Chinese medicine syndrome, the score of the Self-Rating Anxiety Scale (SAS), the score of the PHQ-9 depression screening scale, the subjective fatigue scale, the CTAI analysis of nodules (risk probability, 2D diameter measurement size, diameter change rate, volume change rate, density change rate) and liver and kidney function data were compared before and after 4 months. An Excel database was established, and SPSS27.0 software was used for statistical analysis. General descriptive statistics were performed on the gender, age, and disease course of patients with small pulmonary nodules. Because this study is a two-group cohort study, paired samples can be formed in pairs. Therefore, the data were first tested for normality using the differences before and after the intervention and before and after the follow-up. If normal distribution was satisfied, the chi-square test was used for unordered qualitative variables such as gender, and the Z test was used for continuous variables such as age and disease course. If normal distribution was not satisfied, the rank sum test was used. The results were expressed as the median and interquartile range (25% and 75% quantiles) or the mean plus or minus the standard deviation (x±s). If P < 0.01, it indicated a significant difference; if P < 0.05, it indicated a statistically significant difference; if P > 0.05, it indicated an insignificant difference.

[0254] 3. Research Results

[0255] 3.1 Patient basic information

[0256] In terms of gender, the experimental group had 21 males and 19 females, while the control group had 17 males and 23 females. The chi-square test showed that the gender differences between the control and experimental groups were both >0.05, indicating no statistical significance and comparability (see Table 16). In terms of age, the experimental group had an age of 76 and a minimum of 29, with an average age of 46.20 ± 12.95 years. The control group had an age of 72 and a minimum of 27, with an average age of 49.95 ± 13.35 years. The age differences between the control and experimental groups were both >0.05, indicating no statistical significance and comparability (see Table 16). In terms of disease duration, the longest course in the experimental group was 4 years, the shortest was 1 day, and the median duration was 8.93±11.20 months. The longest course in the control group was 5 years, the shortest was 1 day, and the median duration was 11.08±17.21 months. Z-tests showed that the differences in disease duration between the control and experimental groups were both P values ​​> 0.05, indicating no statistical significance and comparability (see Table 17). Due to the exclusion and dropout of 20 patients, complete study data could not be obtained and they were not included in the final efficacy and safety statistical analysis.

[0257] Table 16 Gender comparison between the experimental group and the control group (people)

[0258]

[0259] Table 17 Comparison of age and disease course between the experimental group and the control group

[0260]

[0261] 3.2 Efficacy indicators

[0262] 3.2.1 Comparison of the efficacy of risk assessment scores between the experimental and control groups

[0263] The results showed that the total effective rate of the experimental group on the risk of malignant transformation of small lung nodules was 27.5%, the cure rate was 5%, the significant effective rate was 12.5%, the effective rate was 10%, and the ineffective rate was 72.5%; the total effective rate of the control group on the risk of malignant transformation of small lung nodules after 4 months was 15%, the cure rate was 2.5%, the significant effective rate was 0%, the effective rate was 12.5%, and the ineffective rate was 85%, see Table 18.

[0264] Table 18 Efficacy of risk assessment scores in the experimental and control groups (n=40)

[0265]

[0266] Normality tests revealed that the pulmonary nodule risk scores in the experimental and control groups did not meet normal distribution requirements. Therefore, a rank sum test was used to analyze the efficacy of the pulmonary nodule risk assessment. The results showed no statistically significant difference between the two groups before four months, indicating comparability (P > 0.05). After four months, the two groups showed statistical significance (P < 0.05). After four months of Bufei Xiaojie prescription intervention for pulmonary nodules, the risk assessment scores of patients with pulmonary nodules decreased compared to pre-intervention and compared to the control group, with statistically significant differences (P < 0.05). Specific results are shown in Table 19.

[0267] Table 19 Comparison of the efficacy of pulmonary nodule risk assessment scores between the experimental group and the control group (n=40)

[0268]

[0269] 3.2.2 Comparison of TCM syndrome efficacy between the experimental and control groups

[0270] The total effective rate of the experimental group for TCM syndromes was 45%, the cure rate was 0%, the significant effective rate was 5%, the effective rate was 40%, and the ineffective rate was 55%; the total effective rate of the control group for TCM syndromes was 10%, the cure rate was 0%, the significant effective rate was 0%, the effective rate was 10%, and the ineffective rate was 90%. See Table 20 for details.

[0271] Table 20 TCM symptom score efficacy of the experimental group and the control group (n=40)

[0272]

[0273]

[0274] The TCM symptom scores of the experimental and control groups did not meet the normal distribution requirement after normality testing, so the rank sum test was used to analyze the efficacy of TCM symptom scores. There was no statistically significant difference between the two groups before four months, and the groups were comparable (P>0.05). After four months of Bufei Xiaojie prescription intervention for small lung nodules, the TCM symptom scores of patients with small lung nodules decreased significantly compared with those before intervention, with a statistically significant difference (P<0.01). The TCM symptom scores in the treatment group decreased compared with those in the control group, with a statistically significant difference (P<0.05). Specific results are shown in Table 21.

[0275] Table 21 Comparison of the efficacy of TCM symptom scores in the experimental group and the control group (n=40)

[0276]

[0277] 3.2.3 Comparison of depression score efficacy between the experimental group and the control group

[0278] The results showed that the total effective rate of the experimental group on depression scores was 45%, the cure rate was 5%, the significant effective rate was 7.5%, the effective rate was 32.5%, and the ineffective rate was 55%; the total effective rate of the control group on depression scores was 5%, the cure rate was 2.5%, the significant effective rate was 5%, the effective rate was 32.5%, and the ineffective rate was 87.5%. See Table 22 for details.

[0279] Table 22 Depression score efficacy of the experimental group and the control group (n=40)

[0280]

[0281] Normality tests revealed that the depression scores of the experimental and control groups did not meet normal distribution requirements, so a rank sum test was used to analyze the depression score efficacy. The results showed that there was no statistically significant difference between the two groups before four months, indicating that the groups were comparable (P>0.05). After four months of Bufei Xiaojie prescription treatment for small pulmonary nodules, the depression scores of patients with small pulmonary nodules decreased significantly compared to before intervention, with a statistically significant difference (P<0.01). The depression scores of the treatment group decreased significantly compared to those in the control group, with a statistically significant difference (P<0.01). Specific results are shown in Table 23.

[0282] Table 23 Comparison of the efficacy of depression scores between the experimental group and the control group (n=40)

[0283]

[0284] 3.2.4 Comparison of anxiety efficacy between the experimental group and the control group

[0285] The results showed that the total effective rate of the experimental group on anxiety scores was 40%, the cure rate was 22.5%, the significant effective rate was 2.5%, the effective rate was 15%, and the ineffective rate was 60%; the total effective rate of the control group on anxiety scores was 12.5%, the cure rate was 10%, the significant effective rate was 0%, the effective rate was 2.5%, and the ineffective rate was 87.5%. See Table 24 for details.

[0286] Table 24 Anxiety score efficacy of the experimental group and the control group (n=40)

[0287]

[0288] The anxiety scores of the experimental and control groups did not meet the normal distribution after normality testing, so the rank sum test was used to analyze the changes in depression scores. The results showed that there was no statistically significant difference between the two groups before four months, and the two groups were comparable (P>0.05). After four months of Bufei Xiaojie prescription treatment for small lung nodules, the anxiety scores of patients with small lung nodules decreased compared with those before intervention, and the difference was statistically significant (P<0.05). The anxiety scores of the treatment group decreased significantly compared with the control group, and the difference was statistically significant (P<0.01). Specific results are shown in Table 25.

[0289] Table 25 Comparison of the efficacy of anxiety scores between the experimental group and the control group (n=40)

[0290]

[0291]

[0292] 4.1.5 Comparison of fatigue score efficacy between the experimental and control groups

[0293] The results showed that the total effective rate of the experimental group for fatigue score was 15%, the cure rate was 0%, the significant effective rate was 2.5%, the effective rate was 12.5%, and the ineffective rate was 85%; the total effective rate of the control group for TCM syndrome was 5%, the cure rate was 0%, the significant effective rate was 2.5%, the effective rate was 2.5%, and the ineffective rate was 95%. The specific contents are shown in Table 26.

[0294] Table 26 Fatigue score efficacy of the experimental group and the control group (n=40)

[0295]

[0296] Normality tests revealed that fatigue scores in the experimental and control groups did not meet normal distribution requirements, so a rank sum test was used to analyze changes in fatigue scores. The results showed no statistically significant difference between the two groups before four months, indicating comparability between the two groups (P > 0.05). After four months of Bufei Xiaojie prescription treatment for small pulmonary nodules, fatigue scores in patients with these conditions decreased compared to before intervention, with a statistically significant difference (P < 0.05). Fatigue scores in the treatment group decreased compared to those in the control group, with a statistically significant difference (P < 0.05). Specific results are shown in Table 27.

[0297] Table 27 Comparison of the efficacy of fatigue scores in the experimental group and the control group (n=40)

[0298]

[0299] 3.3 Analysis of risk and benign and malignant evaluation indicators

[0300] 3.3.1 Comparison of 2D diameter changes in the experimental and control groups using CTAI

[0301] The results showed that the total effective rate of the experimental group for the 2D diameter size of small lung nodules was 72.5%, and the ineffective rate was 27.5%; the total effective rate of the control group for the 2D diameter size was 12.5%, and the ineffective rate was 87.5%. The specific details are shown in Table 28.

[0302] Table 28 Changes in 2D diameter size in the experimental group and the control group

[0303]

[0304] The 2D diameters of the experimental and control groups did not meet the normal distribution requirement after normality testing, so the rank sum test was used to analyze changes in 2D diameters. The results showed no statistically significant difference between the two groups before four months, and the groups were comparable (P>0.05). After four months of Bufei Xiaojie prescription intervention for small lung nodules, the 2D diameters of patients with small lung nodules decreased compared to before intervention, with a statistically significant difference (P<0.05). The 2D diameters of the treatment group decreased compared to the control group, with a statistically significant difference (P<0.05). Specific results are shown in Table 29.

[0305] Table 29 Comparison of 2D diameter changes between the experimental group and the control group [n=40, mm (P25, P75)]

[0306]

[0307] 3.3.2 Comparison of risk probability changes between the experimental and control groups

[0308] The results showed that the total effective rate of reducing risk probability in the experimental group was 42.5%, and the ineffective rate was 57.5%; the total effective rate of reducing risk probability change in the control group was 35%, and the ineffective rate was 65%. See Table 30 for details.

[0309] Table 30 Changes in risk probability in the treatment group and the control group

[0310]

[0311] Normality tests revealed that the risk probabilities in the experimental and control groups did not meet normal distribution requirements, so a rank sum test was used to analyze changes in risk probabilities. The results showed no statistically significant difference between the two groups before four months, indicating comparability (P > 0.05). After four months of Bufei Xiaojie prescription intervention for small pulmonary nodules, the risk probabilities of patients with small pulmonary nodules decreased compared with those before intervention, with a statistically significant difference (P < 0.01). The risk probabilities in the treatment group were significantly lower than those in the control group (P < 0.05). Specific results are shown in Table 30.

[0312] Table 30 Comparison of risk probability changes between the experimental group and the control group [n=40, median (P25, P75)]

[0313]

[0314] 3.3.3 Comparison of circulating abnormal cells (CAC) between the experimental and control groups

[0315] The results showed that the total effective rate of the experimental group in reducing the number of CAC was 67.5%, and the ineffective rate was 32.5%; the total effective rate of the control group in reducing the number of CAC was 37.5%, and the ineffective rate was 62.5%. The specific details are shown in Table 31.

[0316] Table 31 Changes in circulating abnormal cells (CAC) in the experimental and control groups (n=40)

[0317]

[0318] Normality tests revealed that the reduction in risk in the experimental and control groups did not meet normal distribution requirements, so a rank sum test was used to analyze changes in circulating abnormal cells. The results showed no statistically significant difference between the two groups before four months, indicating comparability (P > 0.05). After four months of Bufei Xiaojie prescription treatment for small lung nodules, the number of CAC cells in patients with these nodules decreased compared with pre-intervention, with a statistically significant difference (P < 0.01). After four months, the number of CAC cells in the treatment group decreased compared with the control group, with a statistically significant difference (P < 0.05). Specific results are shown in Table 32.

[0319] Table 32 Comparison of changes in circulating abnormal cells (CAC) between the experimental group and the control group [median (P25, P75)]

[0320]

[0321] 3.3.4 Comparison of CTAI (change rate of pulmonary nodule diameter, volume, and density) between the experimental and control groups

[0322] The results showed that the total effective rate of the experimental group in reducing the diameter of small pulmonary nodules was 70%, and the ineffective rate was 30%; the total effective rate in reducing the volume of small pulmonary nodules was 67.5%, and the ineffective rate was 32.5%; the effective rate in reducing the density of small pulmonary nodules was 75%, and the ineffective rate was 25%. Figure 1 The total effective rate of the control group in reducing the diameter of pulmonary nodules was 20%, and the ineffective rate was 80%; the total effective rate in reducing the volume of pulmonary nodules was 17.5%, and the ineffective rate was 82.5%; the effective rate in reducing the density of pulmonary nodules was 17.5%, and the ineffective rate was 82.5%. For details, see Figure 2 .

[0323] Comparison of changes in the diameter, volume, and density of pulmonary nodules between the experimental and control groups was confirmed by normality testing, so the chi-square test was used to analyze the changes in diameter, volume, and density of pulmonary nodules between the two groups. The results showed that after four months of Bufei Xiaojie prescription treatment, the diameter, volume, and density of pulmonary nodules in patients with pulmonary nodules were significantly reduced compared to pre-intervention. The diameter, volume, and density of pulmonary nodules in the experimental group were significantly reduced compared to those in the control group, with statistically significant differences (P < 0.01). Specific results are shown in Table 33.

[0324] Table 33 Comparison of the change rate of diameter, volume and density between the experimental group and the control group

[0325]

[0326] 3.4 Safety of Bufei Xiaojie Recipe in Treating Small Pulmonary Nodules

[0327] The 80 patients with small pulmonary nodules had no obvious adverse reactions during the experimental study of the present invention, and no obvious abnormalities in liver and kidney function were found. Because the liver and kidney function of the 80 patients with small pulmonary nodules in the present invention were negative before and after the intervention, no statistical processing was performed.

[0328] The embodiments described above are merely descriptions of preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Without departing from the spirit of the present invention, various modifications and improvements made to the technical solutions of the present invention by persons skilled in the art should fall within the scope of protection defined by the claims of the present invention.

Claims

1. A Chinese medicinal compound composition for treating pulmonary nodules, characterized in that: The invention comprises the following components in parts by weight: 25-30 parts of astragalus, 25-35 parts of quinquefolium, 15-20 parts of stir-fried atractylodes macrocephala, 9-12 parts of pinellia, 15-20 parts of thunbergia, 5-10 parts of honeyed ephedra, 10-12 parts of vinegared zedoaria, 10-15 parts of lithospermum officinale, 25-30 parts of cat's claw, 12-15 parts of turmeric, 10-15 parts of stir-fried fructus aurantii, 12-15 parts of malt, 12-15 parts of poria, 25-30 parts of oyster, 10-15 parts of julibrissin flower, 10-15 parts of earthworm soaked in licorice, 10-20g of ganoderma lucidum and 10-15g of loofah.

2. The Chinese medicine compound composition according to claim 1, wherein The invention comprises the following components in parts by weight: 30 parts of astragalus, 30 parts of yam, 20 parts of stir-fried atractylodes macrocephala, 12 parts of pinellia, 20 parts of thunbergia bulbs, 6 parts of honeyed ephedra, 12 parts of vinegared zedoaria, 15 parts of lithospermum officinale, 30 parts of cat's claw, 15 parts of turmeric, 10 parts of stir-fried fructus aurantii, 15 parts of malt, 15 parts of poria, 30 parts of oyster, 15 parts of julibrissin, 15 parts of earthworm soaked in licorice, 15 parts of ganoderma lucidum and 15 parts of loofah.

3. Use of the Chinese medicine compound composition as claimed in claim 1 or 2 in medicine for treating pulmonary nodules.

4. The use according to claim 3, characterized in that The pulmonary nodules are of the lung deficiency and phlegm accumulation type.

5. The use according to claim 4, characterized in that The pulmonary nodules include small pulmonary nodules.

6. A drug for treating pulmonary nodules, characterized in that: The medicine contains the Chinese medicine compound composition according to claim 1 or 2 and a pharmaceutically acceptable adjuvant.

7. The drug according to claim 6, characterized in that The dosage forms of the medicine include decoction, extract, powder, granule, pill, tablet and soft capsule.

8. The drug according to claim 7, wherein The preparation method of the decoction comprises: mixing the components of the composition, adding water to soak for 20-30 minutes, boiling over high heat and then decocting over low heat for 20-30 minutes, filtering out the medicinal liquid; adding water to the medicinal residue and repeating the decocting once, filtering out the medicinal liquid, and combining the two medicinal liquids to obtain the decoction.

9. The drug according to claim 7, wherein The preparation method of the granules comprises: crushing and mixing the components in the composition to obtain the granules.

Images