Traditional Chinese medicine composition for treating pulmonary nodules with phlegm stasis blockage type and preparation method thereof

Abstract

The present invention discloses a traditional Chinese medicine composition for treating pulmonary nodules with phlegm stasis blockage and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 3-10 parts of dried tangerine peel, 3-10 parts of pinellia ternata processed with rhizoma zingiberis recens, 10-15 parts of poria cocos, 5-10 parts of peach kernel, 8-15 parts of quartz, 8-15 parts of semen vaccariae, 15-30 parts of cat's claw herb, 6-10 parts of zedoary turmeric, 10-30 parts of coix seed, 10-30 parts of scutellaria barbata, and 2-10 parts of liquorice. The traditional Chinese medicine composition of the present invention can be used for treating pulmonary nodules with phlegm stasis blockage, has the characteristics of treating both the symptoms and root causes, high efficiency, good effect, and low cost, is convenient to use, and has good patient compliance.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating pulmonary nodules with phlegm stasis blockage and a preparation method thereof. Background Art

[0002] Pulmonary nodules refer to focal, round, well-defined or ill-defined, increased-density solid or subsolid pulmonary shadows surrounded by lung parenchyma and with a diameter ≤ 3 cm in the lung detected by imaging examination. They can be solitary or multiple, without atelectasis, hilar lymph node enlargement and pleural effusion. Pulmonary nodules with phlegm stasis blockage are mostly asymptomatic and only show ground-glass or mixed ground-glass high-density shadows in CT.

[0003] Pulmonary nodules belong to the category of "lung accumulation" in traditional Chinese medicine. They are mostly caused by the invasion of six pathogenic qi and haze toxins or the deficiency of lung qi. The basic pathogenesis is "qi stagnation, dampness obstruction, phlegm stasis and stagnation". The lung is the canopy of the five zang-organs, governing qi and respiration, communicating with all the vessels and regulating respiration, governing the ascending, descending, discharging and purifying of qi movement and assisting the transportation of body fluids. The lung is a delicate organ, and lung qi communicates with the sky. People acquire qi from nature and communicate with the air in nature through the mouth and nose. External pathogenic qi and haze toxins are likely to damage the lung and cause depletion of lung qi. The impairment of lung qi movement is the first to be affected, which can lead to stagnation of water and dampness, and then result in the binding and stagnation of phlegm turbidity and blood stasis, leading to lung accumulation. Over time, it can transform into toxins and develop into lung cancer. Or the lung qi is congenitally insufficient or acquired without nourishment, and combined with the invasion and depletion of six pathogenic qi and haze toxins, the anti-pathogenic ability of the lung decreases and its function is disordered, and the distribution of qi, blood and body fluids is abnormal. The binding and stagnation of phlegm turbidity and blood stasis ultimately lead to lung accumulation. Therefore, qi stagnation, dampness obstruction, phlegm stasis and stagnation are the basic pathogenesis of lung accumulation, and phlegm stasis blockage is the key pathogenesis of lung accumulation.

[0004] Sarcoidosis is a highly coordinated immune response, including antigen-driven CD4 + T cell activation, chemokine-driven accumulation of activated T cells in the lungs, local macrophage accumulation and granuloma formation in sequence. Its characteristic pathological change is non-caseating epitheloid cell granuloma, mainly composed of highly differentiated mononuclear-phagocytic cells (epitheloid cells and giant cells) and lymphocytes. A typical feature of active sarcoidosis is that the affected organs mainly express interferon-γ (IFN-γ), and also express other important cytokines such as interleukin-2 (IL-2), IL-12 and tumor necrosis factor-α (TNF-α). The typical non-caseating granuloma is sterile, and the center of the granuloma is mainly CD4 + T cells, while the periphery is mainly CD8 + T cells. Sarcoid granulomas may resolve or develop into fibrosis, mainly distributed along the lymphatic tract in the lungs. The pathogenesis of sarcoidosis is very complex and not yet fully understood. It involves innate immune responses, the role of T cells, and the influence of Th17 cells on IFN-γ release in adaptive immune responses and other unknown mechanisms.

[0005] There are many methods for treating lung nodules, including lifestyle adjustments, drug therapy, surgical resection and other treatment methods. Among them, lifestyle adjustments have the disadvantages of slow effect and long time consumption. Drug therapy is the most commonly used in clinical practice. Commonly used therapeutic drugs include: glucocorticoids and immunosuppressants, but they are often accompanied by some side effects. Surgical resection is the first treatment option for high-risk lung nodules, and is not suitable for the treatment of medium- and low-risk lung nodules.

[0006] Therefore, studying treatment options for phlegm and blood stasis type lung nodules that have significant clinical efficacy, few side effects and are appropriate has become an important direction for current medical workers to work on. Summary of the invention

[0007] In view of the above situation, it is necessary to provide a Chinese medicine composition for treating phlegm and blood stasis type pulmonary nodules and a preparation method thereof.

[0008] The invention provides a traditional Chinese medicine composition for treating phlegm and blood stasis obstruction type pulmonary nodules. The traditional Chinese medicine composition is prepared from the following raw materials by weight: 3-10 parts of dried tangerine peel, 3-10 parts of French pinellia, 10-15 parts of tuckahoe, 5-10 parts of peach kernel, 8-15 parts of quartz, 8-15 parts of fenugreek, 15-30 parts of cat's claw, 6-10 parts of zedoaria, 10-30 parts of coix seeds, 10-30 parts of barbata scutellaria and 2-10 parts of liquorice.

[0009] In the present invention, the Pinellia tuber has a pungent and warm taste, and is in the spleen, stomach, and lung meridians; it can dry dampness and resolve phlegm, reduce adverse reactions and stop vomiting, and eliminate lumps and resolve lumps. Various processed products have obvious antitussive effects, which are similar to codeine but weaker in effect, and have a certain expectorant effect. It can inhibit the vomiting center and exert an antiemetic effect, and can significantly inhibit gastric juice secretion. Its water decoction and alcohol precipitation have significant preventive and therapeutic effects on gastric ulcers caused by multiple reasons. It can increase the activity of tyrosine aminotransferase in the liver and also promote bile secretion. Its diluted alcohol, water extract or its polysaccharide components and alkaloids have a wide range of anti-tumor effects.

[0010] Tangerine peel tastes bitter, pungent, warm, and enters the spleen and lung meridians; it can regulate qi and strengthen the spleen, dry dampness and resolve phlegm. Tangerine peel decoction has a significant promoting effect on salivary amylase activity, can inhibit the spontaneous activity of isolated rabbit duodenum, reduce contraction, and reduce tension; it has a direct inhibitory effect on isolated and intestinal gastric and intestinal motility.

[0011] Poria cocos tastes sweet, light and flat, and it enters the heart, lung, spleen and kidney meridians; it can promote diuresis and eliminate dampness, strengthen the spleen, and calm the mind and nerves. Poria cocos decoction, syrup, alcohol extract and ether extract have the effects of diuresis, sedation, anti-tumor and increasing myocardial contractility. The polysaccharides contained in Poria cocos have the effect of enhancing immune function.

[0012] Peach kernel tastes bitter, sweet and flat, and enters the heart, liver and large intestine meridians; peach kernel decoction and extract have analgesic, anti-inflammatory, antibacterial, antitussive and anti-asthmatic effects and anti-liver fibrosis effects.

[0013] Vaccaria segetalis tastes bitter and is of mild nature, and pertains to the Liver and Stomach meridians; it can activate blood circulation to promote menstruation, induce lactation and reduce swelling, and promote diuresis and relieve stranguria. The water extract and ether extract of Vaccaria segetalis both have anti-tumor effects.

[0014] Ranunculus ternatus tastes sweet, pungent and warm, and pertains to the Liver and Lung meridians; it can resolve phlegm and dissipate nodules, detoxify and reduce swelling. The water extract of this product has inhibitory effects on Staphylococcus aureus, Staphylococcus albus, Bacillus dysenteriae, etc., and can also inhibit drug-resistant Mycobacterium tuberculosis. In addition, it also has effects such as relieving cough, removing phlegm, anti-tumor, and enhancing immunity.

[0015] Coix lacryma-jobi tastes sweet, light and cool, and pertains to the Spleen, Stomach and Lung meridians; it can promote diuresis and percolate dampness, strengthen the spleen and stop diarrhea, relieve arthralgia, expel pus, and detoxify and dissipate nodules. The alcohol and acetone extracts in Coix lacryma-jobi have obvious inhibitory effects on cancer cells. And its fatty oil can reduce serum calcium and blood sugar levels, and has effects such as antipyretic, sedative, analgesic, and immune regulation.

[0016] Scutellaria barbata tastes pungent, bitter and cold, and pertains to the Lung, Liver and Kidney meridians; it can clear heat and detoxify, promote blood circulation and remove stasis, and induce diuresis. It is applicable to furuncles, carbuncles and sores, swelling and pain of the throat, traumatic injuries, edema, jaundice, snake and insect bites, etc.

[0017] Curcuma zedoaria tastes pungent, bitter and warm, and pertains to the Liver and Spleen meridians; it can break blood and promote qi movement, eliminate stasis and relieve pain. The volatile oil preparation of Curcuma zedoaria has anti-cancer effects and can inhibit the growth of a variety of pathogenic bacteria; Curcuma zedoaria oil has anti-inflammatory, anti-gastric ulcer, liver protection and other effects. The water extract of Curcuma zedoaria can inhibit platelet aggregation, promote the restoration of microarterial blood flow, and promote the restoration of local microcirculation; the water extract and alcohol precipitation solution of Curcuma zedoaria have an inhibitory effect on in vivo thrombus formation. In addition, Curcuma zedoaria has a direct inactivating effect on respiratory syncytial virus.

[0018] Quartz tastes sweet and warm, and pertains to the Lung, Kidney and Heart; it can warm the Lung and Kidney, soothe the mind, and promote urination. The silicon (Si) absorbed by the human body not only has special curative effects on heart diseases and cancer, but also can maintain the elasticity of blood vessel walls to prevent hardening.

[0019] Glycyrrhiza uralensis tastes sweet and is of mild nature, and pertains to the Heart, Lung, Spleen and Stomach meridians; it can invigorate the spleen and replenish qi, clear heat and detoxify, resolve phlegm and relieve cough, relieve spasm and pain, and coordinate the properties of various drugs. Glycyrrhizic acid and flavonoids are the two main active ingredients of Glycyrrhiza uralensis. Glycyrrhizic acid and flavonoid components have effects of relieving cough, removing phlegm, and relieving asthma. In addition, glycyrrhizic acid and flavonoid components also have effects such as anti-arrhythmia, reducing the tension of the intestinal tract, reducing the contraction amplitude, and relieving spasm.

[0020] In the traditional Chinese medicine composition of the present invention, Pinellia ternata prepared with Rhizoma Zingiberis Recens and Prunus persica are the monarch drugs, Citrus reticulata Blanco and Vaccaria segetalis are the ministerial drugs, Poria cocos, Quartz, Ranunculus ternatus, Curcuma zedoaria, Coix lacryma-jobi, Scutellaria barbata are the assistant drugs, and Glycyrrhiza uralensis is the guiding drug. The raw materials used in this traditional Chinese medicine composition are combined according to their efficacy and have a synergistic effect.

[0021] Banxia is good at drying dampness and resolving phlegm to treat damp phlegm in the internal organs, and it can also eliminate lumps and resolve knots, and enter the lung, stomach, and spleen meridians; peach kernel has the effects of promoting blood circulation and removing blood stasis, relieving cough and relieving asthma, and enters the heart, liver, lung, and large intestine meridians. The combination of the two can achieve the effect of resolving phlegm, promoting blood circulation and resolving knots. Tangerine peel can regulate qi and relieve stagnation, dry dampness and resolve phlegm, so as to enhance the function of drying dampness and resolving phlegm. At the same time, when qi moves, dampness is difficult to gather, and the source of phlegm is eliminated; Vaccaria can promote blood circulation, dredge meridians and eliminate carbuncle, enter the blood, and is good at unblocking blood vessels, which can enhance the function of promoting blood circulation, unblocking collaterals and resolving knots. The two medicines are ministers to help the monarch to strengthen the power of phlegm, promoting blood circulation and resolving knots.

[0022] Poria strengthens the spleen and eliminates dampness, and when paired with dried tangerine peel, it can eliminate the source of phlegm. Quartz, cat's claw, zedoaria, coix seed, and Scutellaria barbata can be used together to disperse nodules and dissolve blood stasis. Among them, zedoaria can also break up qi and has a strong power to move qi. As the saying goes, when qi moves, body fluid moves, and when qi moves, blood moves. When qi is regulated, blood vessels are unobstructed. When qi and blood vessels are regulated, phlegm and blood stasis are difficult to cause trouble. Licorice harmonizes all the medicines and is a guiding medicine.

[0023] The invention focuses on dissolving phlegm, blood stasis and nodules, regulating qi and blood, and uses the herbs such as Pinellia ternata and dried orange peel to dry dampness and resolve phlegm in the formula, and adds Poria cocos and licorice to strengthen the spleen, while preventing the regeneration of phlegm and dampness; uses the herbs such as peach kernel, Vaccaria segetalis, quartz to dredge meridians, dissolve blood stasis and resolve nodules, and adds the effect of Curcuma zedoaria to break up qi and resolve nodules, so that qi stagnation is removed and blood vessels are harmonized, and the phlegm and blood stasis obstruction type lung accumulation is treated together. Therefore, the various medicines in the prescription play the effects of dissolving phlegm, activating blood circulation, promoting qi and resolving nodules, and are mainly used to treat phlegm and blood stasis obstruction type lung nodules.

[0024] The Chinese medicine composition of the present invention is novel and unique in formula, and is used for treating pulmonary nodules of phlegm and blood stasis type, and has the characteristics of treating both the symptoms and the root causes, having few side effects, high efficiency, good effect, and low cost, and is convenient to use and has good patient compliance. At the same time, it also has a significant therapeutic effect on pulmonary nodules of phlegm and blood stasis type that turns into heat and toxicity over a long period of time.

[0025] Furthermore, the above-mentioned Chinese medicine composition is made of the following raw materials, by weight: 10 parts of tangerine peel, 10 parts of French pinellia, 15 parts of Poria, 10 parts of peach kernel, 15 parts of quartz, 15 parts of fenugreek, 20 parts of cat's claw, 10 parts of Curcuma, 30 parts of coix seed, 10 parts of Scutellaria barbata, and 6 parts of licorice.

[0026] Furthermore, in the above-mentioned Chinese medicine composition, among its raw materials, the amount of the drug for dispersing nodules is greater than the amount of the drug for resolving phlegm and unblocking meridians in the prescription.

[0027] Furthermore, in the above-mentioned Chinese medicine composition, the coix seed is raw coix seed.

[0028] Furthermore, the above-mentioned Chinese medicine composition also contains pharmaceutically acceptable excipients and is made into decoction, granules, capsules or pills.

[0029] The present invention also discloses a method for preparing the Chinese medicine composition as described in any one of the above, comprising:

[0030] Weigh each raw material according to the ratio;

[0031] Using the fine powder of the raw material or the water extract of the raw material as the active ingredient, and adding pharmaceutically acceptable excipients to make decoctions, granules, capsules or pills.

[0032] The additional aspects and advantages of the present invention will be partly given in the following description, partly become obvious from the following description, or be understood through the practice of the present invention. Detailed Embodiments

[0033] To make the objectives, features and advantages of the present invention more obvious and understandable, the following detailed description of the specific embodiments of the present invention will be given in combination with the examples. Several embodiments of the present invention are given in the examples. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the present invention more thorough and comprehensive.

[0034] Example 1

[0035] A traditional Chinese medicine composition for treating pulmonary nodules with phlegm stasis obstruction is made from the following raw materials:

[0036] Pinellia ternata (Thunb.) Breit. processed with Rhizoma Zingiberis Recens 10 g, Citrus reticulata Blanco 10 g, Poria cocos (Schw.) Wolf 15 g, Prunus persica (L.) Batsch 10 g, Quartz 15 g, Vaccaria segetalis (Neck.) Garcke 15 g, Ranunculus ternatus Thunb. 20 g, Rhizoma Curcumae 10 g, Coix lacryma-jobi L. var. ma-yuen (Roman.) Stapf 30 g, Scutellaria barbata D. Don 10 g, Glycyrrhiza uralensis Fisch. 6 g.

[0037] Soak the above medicine in water for half an hour until it is thoroughly moistened, then boil it for 30 - 40 minutes, and collect the extract for oral administration.

[0038] Example 2

[0039] A traditional Chinese medicine composition for treating pulmonary nodules with phlegm stasis obstruction is made from the following raw materials:

[0040] Pinellia ternata (Thunb.) Breit. processed with Rhizoma Zingiberis Recens 10 g, Citrus reticulata Blanco 10 g, Poria cocos (Schw.) Wolf 15 g, Prunus persica (L.) Batsch 10 g, Quartz 15 g, Vaccaria segetalis (Neck.) Garcke 15 g, Ranunculus ternatus Thunb. 20 g, Rhizoma Curcumae 10 g, Coix lacryma-jobi L. var. ma-yuen (Roman.) Stapf 30 g, Scutellaria barbata D. Don 10 g, Glycyrrhiza uralensis Fisch. 6 g.

[0041] After subjecting the above raw materials to processes such as decocting, concentrating, and drying, they are processed into granules.

[0042] Example 3

[0043] A traditional Chinese medicine composition for treating pulmonary nodules with phlegm stasis obstruction is made from the following raw materials:

[0044] Pinellia ternata (Thunb.) Breit. processed with Rhizoma Zingiberis Recens 5 g, Citrus reticulata Blanco 4 g, Poria cocos (Schw.) Wolf 10 g, Prunus persica (L.) Batsch 8 g, Quartz 10 g, Vaccaria segetalis (Neck.) Garcke 12 g, Ranunculus ternatus Thunb. 15 g, Rhizoma Curcumae 10 g, Coix lacryma-jobi L. var. ma-yuen (Roman.) Stapf 20 g, Scutellaria barbata D. Don 10 g, Glycyrrhiza uralensis Fisch. 2 g.

[0045] After soaking the medicine in water until it is thoroughly moistened for half an hour, decoct it for 30 to 40 minutes, and after collection and extraction, it can be taken orally.

[0046] Example 4

[0047] A traditional Chinese medicine composition for treating pulmonary nodules with phlegm stasis blockage is made from the following raw materials:

[0048] Pinellia ternata processed with Rhizoma Zingiberis Recens 3g, Citrus reticulata Blanco 3g, Poria cocos 12g, Prunus persica 5g, Quartz 8g, Vaccaria segetalis 8g, Herba Ranunculi Ternati 30g, Rhizoma Curcumae 6g, Coix lacryma-jobi 10g, Scutellaria barbata 30g, Glycyrrhiza uralensis Fisch. 10g.

[0049] After soaking the medicine in water until it is thoroughly moistened for half an hour, decoct it for 30 to 40 minutes, and after collection and extraction, it can be taken orally.

[0050] The experimental protocol is as follows.

[0051] 1. General information

[0052] Select 50 patients with pulmonary nodules with phlegm stasis blockage who meet the criteria. According to the random number table method, they are divided into two groups, with 25 cases in the treatment group and 25 cases in the control group. The two groups are comparable in terms of age, gender, disease course, etc.

[0053] 2. Diagnostic criteria

[0054] Refer to the Chinese expert consensus on the diagnosis and treatment of pulmonary nodules in 2018: Imaging manifestations are focal, round, solid or subsolid pulmonary shadows with a diameter ≤ 3 cm, which can be solitary or multiple, without atelectasis, hilar lymphadenopathy, and pleural effusion.

[0055] 3. Inclusion criteria:

[0056] (1) Meet the diagnostic criteria for pulmonary nodules, with a diameter ≤ 1 cm;

[0057] (2) The shape of the nodule shows a solid nodule or pure ground-glass nodule on chest CT;

[0058] (3) Syndrome differentiation by traditional Chinese medicine is the phlegm stasis intermingled type;

[0059] (4) Aged between 18 and 80 years old;

[0060] (5) Voluntarily seek traditional Chinese medicine treatment.

[0061] 4. Exclusion criteria

[0062] (1) Diffuse nodules (≥ 10);

[0063] (2) Patients whose diseases have seriously affected their daily lives or who have obvious symptoms of other diseases;

[0064] (3)Patients with severe diseases such as heart, liver, kidney and hematopoietic system;

[0065] (4)Pregnant women, lactating women and psychiatric patients;

[0066] (5)Those allergic to the drugs in this study.

[0067] 5. Exclusion criteria

[0068] (1)Those who did not take the medicine as required for various reasons during the process of taking traditional Chinese medicine;

[0069] (2)Those who took other traditional Chinese medicines or western medicines during the medicine-taking process;

[0070] (3)Those whose curative effect and safety judgment were significantly affected by other diseases during the medicine-taking process;

[0071] 6. Termination criteria

[0072] (1)Serious adverse events occurred during the intervention period;

[0073] (2)Complications and special physiological changes;

[0074] 7. Treatment methods

[0075] Treatment group: Conventional treatment (psychological counseling, health education, instructing patients to have a balanced nutritional diet, quit smoking and stay away from harmful environments such as second-hand smoke) combined with traditional Chinese medicine treatment. The traditional Chinese medicine composition in Example 1 was used. Taking 2 months as 1 course of treatment, after 1 course of treatment, chest CT was reexamined 6 months later.

[0076] Control group: Conventional treatment (psychological counseling, health education, instructing patients to have a balanced nutritional diet, quit smoking and stay away from harmful environments such as second-hand smoke) was adopted.

[0077] 8. Efficacy indicators

[0078] According to the grading of the lung nodule diagnosis criteria, the efficacy judgment criteria were formulated for the imaging changes of the patients' chest CT.

[0079] (1)Based on the changes in the volume of lung nodules before and after treatment in the two groups, the efficacy judgment criteria are shown in Table 1.

[0080] Table 1

[0081]

[0082] (2)Efficacy judgment of the malignant risk score of lung nodules before and after treatment in the two groups

[0083] Referring to the Mayo model prediction formula, the changes in the malignant risk score of nodules before and after treatment were calculated. Multiple nodules were graded according to the nodule with the highest risk level. The calculation formula is as follows:

[0084] Malignant probability ( P ) = e x / (1 + e x ), X = -6.8272 + (0.0391 × age) + (0.7917 × smoking history) + (1.3388 × history of malignant tumors) + (0.1274 × diameter) + (1.0407 × spiculation) + (0.7838 × upper lobe of the lung); e is the natural coefficient; the unit of age is years; the unit of diameter is mm; having a smoking history is counted as 1, not having it is counted as 0; having spiculation is counted as 1, not having it is counted as 0; being located in the upper lobe of the lung is counted as 1, otherwise as 0.

[0085] (3) The TCM syndrome efficacy of the symptoms and signs of patients with pulmonary nodules before and after treatment in the two groups is determined as shown in Table 2 below.

[0086] Table 2

[0087]

[0088] 9. Statistical analysis

[0089] After the basic information, relevant data and various data of the subjects are collected, sorted and proofread, the SPSS 26.0 statistical software is used for data sorting and analysis. If the measurement data conform to the normal distribution, is used to represent. The paired-samples t-test is used for within-group comparison between the two groups, and the independent-samples t-test is used for between-group comparison. The count data are expressed as frequency (percentage), and the chi-square test is used for between-group comparison. P < 0.05 indicates that the difference is statistically significant.

[0090] Experimental results

[0091] (1) Between-group comparison of the general information of the two groups of patients

[0092] Through the chi-square test and independent-samples t-test for the two groups of patients, it is found that there is no statistically significant difference in the between-group comparison of gender, disease course and age between the two groups of patients (P > 0.05). Tables 3, 4 and 5 below show the between-group comparison of the general information of the two groups of patients.

[0093] Table 3 Inclusion case situation

[0094]

[0095] Table 4 Comparison of the genders of the included cases

[0096]

[0097] Table 5 Age situation of the included cases

[0098]

[0099] (2) Comparison of pulmonary nodule data between the two groups of patients before treatment. For the comparison of the size of pulmonary nodules, see Table 6. For the comparison of the location and density of pulmonary nodules, see Table 7.

[0100] Table 6 Comparison of the volume of pulmonary nodules in two groups of patients before treatment

[0101]

[0102] There are more patients with multiple pulmonary nodules. The ratio of multiple pulmonary nodules to solitary pulmonary nodules is approximately 2.84:1; there are more nodules in the right lung than in the left lung, and among the right lungs, the upper lobe of the right lung has the most, accounting for about 50% of the right lung; there are more patients with ground-glass nodules than those with solid nodules, accounting for about 61.7% of the total number of patients. See Table 7 for details.

[0103] Table 7 Comparison of the location and density of pulmonary nodules in two groups of patients before treatment

[0104]

[0105] The comparison results of the maximum diameter of pulmonary nodules in the two groups of patients before and after treatment are shown in Tables 8 and 9.

[0106] Table 8 Comparison of the maximum diameter of pulmonary nodules in the treatment group (before and after treatment)

[0107]

[0108] Table 9 Comparison of the maximum diameter of pulmonary nodules in the control group (before and after treatment)

[0109]

[0110] Note: Compared with before treatment, P < 0.05.

[0111] (3) Clinical efficacy comparison of the malignant risk scores of pulmonary nodules in the two groups of patients before and after treatment

[0112] One month after treatment, the markedly effective rate and effective rate of the treatment group were higher than those of the control group (P < 0.05). See Table 10 for details.

[0113] Table 10 Intragroup comparison of malignant risk scores before and after treatment

[0114]

[0115] The clinical efficacy evaluation of the traditional Chinese medicine syndromes of pulmonary nodules in the two groups of patients before and after treatment n(%) is shown in Table 11.

[0116] Table 11 Intragroup comparison of traditional Chinese medicine syndrome scores before and after treatment

[0117]

[0118] (4) Safety evaluation

[0119] During the trial, the two groups of patients underwent routine blood, urine, and stool tests before and after treatment, as well as liver and kidney function and electrocardiogram tests to evaluate the safety of the drug. Results: No results were found that were normal before treatment and abnormal after treatment, indicating that the prescription is safe.

[0120] Typical clinical cases

[0121] Case 1: A 59-year-old male patient was diagnosed with multiple nodules in both lungs for 9 days during a physical examination at the hospital. The larger one was located in the dorsal segment of the left lower lobe of the lung, showing a solid density of about 7*4mm in size. The trachea and bronchus were unobstructed, and no clear enlarged lymph nodes were found in the hilum of both lungs and the mediastinum. The patient had no obvious discomfort when he visited the hospital, and his mental appetite was good, his bowel movements were normal, and his sleep was good. Diagnosis: pulmonary sarcoidosis, the Chinese medicine decoction of Example 1 was given for two months, and a chest CT scan was performed six months later, showing: rough textures in both lungs, multiple micro- and small nodules in both lungs, the larger one was located in the dorsal segment of the left lower lobe of the lung, showing a solid density of about 5*3mm in size. No increase was observed after a follow-up visit six months later.

[0122] Case 2: Patient female, 61 years old, the patient suspected of catching a cold and coughing a week ago, the intravenous anti-inflammatory effect of the local clinic was not good, and the cough was slightly relieved by taking Fenghan Ganmao Granules and Xuanfei Zhisou Mixture on her own. The chest CT scan of the previous hospital showed: multiple micro-nodules in both lungs, the larger one was located in the outer segment of the right middle lobe of the lung, with a solid density of about 6*4mm, and an average CT value of about -354.6HU. Symptoms during the visit: cough, coughing when itchy throat, day and night, white and sticky sputum, no dry mouth and bitter mouth, no chest tightness and asthma, general spirit, and the rest of the situation can be diagnosed as cough and pulmonary sarcoidosis. I took the Chinese medicine decoction of embodiment 1 for two months, and the chest CT was checked after two months: the texture of both lungs was rough and chaotic, and multiple micro-nodules in both lungs were seen, the larger one was located in the outer segment of the right middle lobe of the lung, with a solid density of about 4*2mm. Follow-up after 6 months did not increase.

[0123] Case 3: A 49-year-old male patient had repeated coughs for more than 2 years, which worsened for 4 days. The patient developed coughs due to smoking 4 years ago, but did not pay attention to them. 4 days ago, the cough worsened, accompanied by sputum. He then underwent chest CT in the hospital, which showed: coarsening of the texture of both lungs, scattered patches, cords, and strips of increased density in both lungs, and some unclear boundaries; a few small nodules were seen in the upper lobes of both lungs, with clear boundaries and no calcification, and the larger ones were about 4mm in diameter. The trachea and bronchus were unobstructed, and no obvious enlarged lymph nodes were found in the hilum of both lungs and the mediastinum. Symptoms during outpatient visits: cough, coughing with sputum, liking to clear the throat, white and sticky sputum, itchy throat, no chest tightness and shortness of breath, easy fatigue, fatigue aggravated after activity, weak spirit, normal appetite, normal bowel movements, poor sleep, pale tongue with white greasy coating, and stringy and slippery pulse; diagnosis: cough, pulmonary sarcoidosis. The patient was given the Chinese medicine decoction of Example 1 for two months, and a chest CT scan was performed 6 months later, showing: increased texture in both lungs, a few solid nodules in the right lung, clear boundaries, and a diameter of about 3 mm, unobstructed trachea and bronchus, and no clear enlarged lymph nodes in both hilum and mediastinum.

[0124] According to the experimental situation, when any one of the traditional Chinese medicine compositions in Embodiments 2 to 4 of the present invention is used for the above experiments, it has the efficacy of treating pulmonary nodules with phlegm stasis blockage type.

[0125] In the description of this specification, the description referring to terms such as "one embodiment", "some embodiments", "examples", "specific examples", or "some examples", etc. means that the specific features, structures, materials, or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic expressions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described can be combined in a suitable manner in any one or more embodiments or examples.

[0126] The above-described embodiments only represent several implementation manners of the present invention, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the invention patent of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the invention patent of the present invention should be subject to the appended claims.

Claims

1. A Chinese medicine composition for treating phlegm and blood stasis type pulmonary nodules, characterized in that: The prescription is made of the following raw materials by weight: 3-10 parts of dried tangerine peel, 3-10 parts of pinellia, 10-15 parts of poria, 5-10 parts of peach kernel, 8-15 parts of quartz, 8-15 parts of fenugreek, 15-30 parts of cat's claw, 6-10 parts of zedoaria, 10-30 parts of coix seed, 10-30 parts of barbata, and 2-10 parts of licorice. The amount of the drug for dispersing nodules is greater than the amount of the drug for resolving phlegm and unblocking meridians in the prescription.

2. The Chinese medicine composition according to claim 1, characterized in that The invention is made from the following raw materials by weight: 10 parts of dried tangerine peel, 10 parts of French pinellia, 15 parts of tuckahoe, 10 parts of peach kernel, 15 parts of quartz, 15 parts of fenugreek, 20 parts of cat's claw, 10 parts of zedoaria, 30 parts of coix seed, 10 parts of barbata scabra, and 6 parts of licorice.

3. The Chinese medicine composition according to claim 1, characterized in that: The coix seeds are raw coix seeds.

4. The Chinese medicine composition according to claim 1, characterized in that: The invention also contains pharmaceutically acceptable auxiliary materials and is prepared into decoction, granules, capsules or pills.

5. A method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: include: Weigh each raw material according to the ratio; The fine powder of the raw material or the water extract of the raw material is used as the active ingredient, and pharmaceutically acceptable auxiliary materials are added to prepare decoction, granules, capsules or pills.

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