A traditional Chinese medicine composition for preventing and treating pleural and peritoneal effusions

Abstract

Ascites and pleural effusion are common complications, and clinical interventions primarily based on symptomatic treatment often result in poor prognoses. Guided by the new theory of "inflammation-cancer" transformation, this invention discloses a traditional Chinese medicine composition for the prevention and treatment of ascites and pleural effusion, along with its preparation methods for internal and external use. The composition comprises the following medicinal materials in parts by weight: Codonopsis pilosula 3-20 parts, Atractylodes macrocephala 3-20 parts, Cinnamomum cassia 3-18 parts, Trichosanthes kirilowii 3-18 parts, Panax notoginseng 3-12 parts, Lobelia chinensis 3-15 parts, Polygonum bistorta 3-15 parts, Euphorbia helioscopia 3-15 parts, and Lepidium apetalum 3-15 parts. This traditional Chinese medicine composition possesses the effects of strengthening the body's resistance, removing blood stasis, detoxifying, eliminating dampness, promoting diuresis, and reducing swelling. It is effective in preventing and treating inflammatory and malignant ascites and pleural effusion, as well as the associated symptoms such as dyspnea, chest pain, cough, loss of appetite, abdominal pain, abdominal distension, fatigue, and night sweats. It can be prepared as a decoction, granules, pills, capsules, or powder. This invention helps promote the absorption and drainage of pleural and peritoneal effusions, reduce inflammation and fight cancer, adjust and restore the physiological functions of internal organs, and improve the quality of life of patients.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and specifically relates to a traditional Chinese medicine composition for the prevention and treatment of pleural and peritoneal effusions and its preparation methods for internal and external use. Background Technology

[0002] Pleural and peritoneal effusions are common clinical complications. The presence of large amounts of fluid in the pleural and abdominal cavities severely affects the functions of the respiratory, circulatory, and digestive systems. Patients often experience symptoms such as dyspnea, chest pain, cough, loss of appetite, abdominal pain, and abdominal distension, leading to a poor prognosis and significantly impacting their quality of life. The most common type of pleural and peritoneal effusion is inflammatory pleural and peritoneal effusion, followed by malignant pleural and peritoneal effusion. Inflammatory pleural and peritoneal effusions are exudative, often caused by infectious diseases, and are frequently accompanied by increased inflammatory cells, high protein levels (>3g / dL), and elevated lactate dehydrogenase (LDH). Malignant pleural and peritoneal effusions are a common complication of advanced cancer, resulting from malignant exudates produced after direct invasion or metastasis of malignant tumors into the serous cavities (pleura or peritoneum), or from transudative pleural and peritoneal effusions caused by tumor invasion of the bone marrow or liver leading to hypoproteinemia, particularly common in adenocarcinoma.

[0003] Studies have shown that in the chest, tuberculous pleurisy accounts for 40%–60% of all exudative pleural effusions, with an incidence rate as high as 60%–70% in provinces with a high incidence of tuberculosis (such as Xinjiang, Tibet, and Guizhou). In addition, pleural effusions caused by bacterial or viral pneumonia account for 10%–20%. Approximately 50%–65% of malignant pleural effusions are caused by direct invasion of the pleura by lung adenocarcinoma or by hematogenous / lymphatic metastasis to the pleural cavity; approximately 15%–25% are unilateral pleural effusions caused by breast cancer, which may be accompanied by ipsilateral breast or axillary lymph node lesions; and approximately 5%–10% are caused by mediastinal lymphoma enlargement compressing lymphatic drainage or pleural infiltration. In the abdomen, cirrhosis is the most common cause of ascites, accounting for 75%–85% of all ascites cases. Cirrhosis caused by hepatitis (hepatitis B, hepatitis C, etc.) accounts for 50%–60% of all cases and is the most common form of inflammatory ascites. Malignant ascites is most commonly seen in peritoneal metastases, especially in ovarian cancer, with an incidence rate of about 30%-40%, while the incidence of ascites in advanced ovarian cancer is as high as 70%. Since signet ring cell carcinoma is prone to peritoneal dissemination, ascites caused by gastric cancer accounts for 20%-30%, and the ascites is often bloody, with elevated CEA and CA72-4 levels on examination. In addition, it can also be seen in advanced colorectal cancer and pancreatic cancer.

[0004] Modern medicine believes that the main mechanisms of pleural and peritoneal effusion formation are: (1) Under the mediation of inflammation or tumor, inflammatory factors (TNF-α, IL-6) or VEGF secreted by the tumor destroy the endothelial barrier, increase vascular permeability, and promote the extravasation of protein-rich fluid; (2) Tumor compression, infection or trauma leads to lymphatic obstruction, and fluid stagnates in the serosal cavity; (3) Tumor directly invades the serosal or peritoneum and implants, aggravating the effusion through angiogenesis, release of inflammatory mediators and lymphatic destruction; (4) Primary disease leads to increased hydrostatic pressure or decreased colloid osmotic pressure, resulting in fluid leakage from blood vessels; Regardless of the mechanism, the final imbalance of intravascular and extravascular fluid exchange and lymphatic drainage obstruction lead to local or systemic fluid metabolism disorder. Traditional Chinese medicine classifies pleural and peritoneal effusions into categories such as "edema," "phlegm retention," "abdominal distension," and "suspended fluid." Its occurrence is closely related to the dysfunction of the lungs, spleen, and kidneys, as well as the obstruction of the flow of qi, blood, and water. It believes that the core pathogenesis of pleural and peritoneal effusions is "deficiency of the root and excess of the branch": the root deficiency is the insufficiency of yang qi in the lungs, spleen, and kidneys, resulting in dysfunction of qi transformation; the branch excess is the internal retention of pathogenic toxins, phlegm retention, and blood stasis, which obstruct the water passages of the three jiaos.

[0005] The principle of Western medicine in treating pleural and peritoneal effusions is to focus on systemic treatment with local treatment as an adjunct. While treating the primary disease, it uses glucocorticoids and prednisone for anti-inflammatory and anti-infective purposes, intracavitary administration, sodium restriction and diuresis, and puncture drainage, which have good immediate effects but high recurrence rates and poor overall efficacy. At present, the treatment approach of traditional Chinese medicine is mainly to warm the yang and strengthen the spleen, promote qi circulation and diuresis. Studies have shown that clinicians such as Tang Shuming and Zhu Xianru have achieved an effective rate of over 70% in treating pleural and peritoneal effusions by modifying classic Chinese medicine formulas. However, their formulas are limited by single syndrome types, have low universality, and are difficult to promote.

[0006] A search revealed that currently disclosed Chinese patents for traditional Chinese medicine compositions for treating pleural and peritoneal effusions primarily target breast cancer, chronic heart failure, nephrotic syndrome with hypoalbuminemia, and pleural and peritoneal effusions caused by cancer alone. There is a lack of feasible treatment plans that, guided by the new "inflammation-cancer" transformation theory, comprehensively address both common inflammatory and malignant pleural and peritoneal effusions. Summary of the Invention

[0007] In 1863, Rudolf Virchow discovered a large number of inflammatory cell infiltrations in tumor tissue, proposing the hypothesis that tumors originate from chronic inflammation. With the in-depth research and widespread acceptance of the innovative theory of "inflammation-cancer" transformation in tumors, the applicant of this invention, based on the progress in research on the molecular mechanisms of "inflammation-cancer" transformation and the evolution of syndromes throughout the entire course of tumor patients, has innovatively established a theoretical system for preventing and treating inflammation-cancer transformation and malignant tumor-related complications through "balanced blocking, supporting the body's resistance and detoxifying." To address the aforementioned problems, based on multiple scientific research projects, clinical and basic research, the applicant of this invention proposes that the core TCM pathogenesis of inflammatory pleural and peritoneal effusions and malignant pleural and peritoneal effusions is "deficiency of vital energy and stagnation of toxins, dampness and turbidity." A TCM composition for preventing and treating pleural and peritoneal effusions and its preparation methods for internal and external use have been invented. This TCM composition supports the body's resistance, removes blood stasis and detoxifies, eliminates dampness, promotes diuresis and reduces swelling, and has good preventive and / or therapeutic effects on inflammatory pleural and peritoneal effusions and malignant pleural and peritoneal effusions with high efficacy and no side effects on the human body.

[0008] This invention is achieved through the following technical solution: a traditional Chinese medicine composition for preventing and treating pleural and peritoneal effusions and its preparation methods for internal and external use. The traditional Chinese medicine composition is made from the following raw materials in the following weight / volume parts: Codonopsis pilosula 3-20 parts, Atractylodes macrocephala 3-20 parts, Cinnamomum cassia 3-18 parts, Trichosanthes kirilowii 3-18 parts, Panax notoginseng 3-12 parts, Lobelia chinensis 3-15 parts, Bistorta officinalis 3-15 parts, Euphorbia helioscopia 3-15 parts, and Lepidium apetalum 3-15 parts.

[0009] Preferably, the composition comprises the following components in parts by weight: Codonopsis pilosula 5-18 parts, Atractylodes macrocephala 5-18 parts, Cinnamomum cassia 5-15 parts, Trichosanthes kirilowii 5-15 parts, Panax notoginseng 5-10 parts, Lobelia chinensis 5-12 parts, Bistorta officinalis 5-12 parts, Euphorbia helioscopia 5-12 parts, and Lepidium apetalum 5-12 parts.

[0010] More preferably, the composition comprises the following components in parts by weight: 10 parts Codonopsis pilosula, 10 parts Atractylodes macrocephala, 10 parts Cinnamomum cassia, 10 parts Trichosanthes kirilowii, 5 parts Panax notoginseng, 10 parts Lobelia chinensis, 10 parts Polygonum bistorta, 10 parts Euphorbia helioscopia, and 10 parts Lepidium apetalum.

[0011] The above-mentioned traditional Chinese medicine composition for preventing and treating pleural and peritoneal effusions, and its preparation method for internal and external use, wherein the traditional Chinese medicine composition is prepared into any clinically acceptable formulation according to existing processes. The formulation includes: decoction, granules, pills, capsules, and powders, comprising the following steps:

[0012] Preparation method of decoction:

[0013] (1) Take 10 parts of Codonopsis pilosula, 10 parts of raw Atractylodes macrocephala, 10 parts of Cinnamomum cassia, 10 parts of Trichosanthes kirilowii, 5 parts of Panax notoginseng, 10 parts of Lobelia chinensis, 10 parts of Bistorta officinalis, 10 parts of Euphorbia helioscopia, and 10 parts of Lepidium apetalum, mix them together, and soak them in water for half an hour. The ratio of the total weight of the Chinese medicinal materials to the weight of water can be (1-2):(10-15), and the specific amount of water added can be determined according to the weight of the medicinal materials.

[0014] (2) Add all the medicinal materials and decoct for 40 minutes. The ratio of the total weight of the medicinal materials to the weight of the water can be (1-2):(10-15), and the specific amount of water added can be determined according to the weight of the medicinal materials.

[0015] (3) Filter the decoction obtained after boiling to obtain filtrate and residue. The first decoction is then complete.

[0016] (4) Remove the filter residue and boil it again for 25 minutes. The ratio of the total weight of the Chinese medicinal materials to the weight of the water can be (1-2):(5-10), and the specific amount of water added can be determined according to the weight of the medicinal materials.

[0017] (5) Filter the decoction obtained after decoction to obtain filtrate and residue. The second decoction is then completed.

[0018] (6) The filtrate obtained from the first decoction is mixed with the filtrate obtained from the second decoction to obtain the decoction of the Chinese herbal medicine composition.

[0019] Granule preparation method:

[0020] (1) Take 10 parts of Codonopsis pilosula, 10 parts of raw Atractylodes macrocephala, 10 parts of Cinnamomum cassia, 10 parts of Trichosanthes kirilowii, 5 parts of Panax notoginseng, 10 parts of Lobelia chinensis, 10 parts of Polygonum bistorta, 10 parts of Euphorbia helioscopia, and 10 parts of Lepidium apetalum, mix them together, and soak them in water for 30 minutes. The ratio of the total weight of the Chinese medicinal materials to the weight of the water can be (1-2):(5-10), and the specific amount of water added can be determined according to the weight of the medicinal materials.

[0021] (2) Add water and decoct three times. The first decoction is 1.5 hours. The ratio of the total weight of the Chinese medicinal materials to the weight of water is 1:10. The specific amount of water added can be determined according to the weight of the medicinal materials.

[0022] (3) Add water and decoct for 1.5 hours for the second and third times. The ratio of the total weight of the Chinese medicinal materials to the weight of water is 1:8. The specific amount of water added can be determined according to the weight of the medicinal materials.

[0023] (4) Combine the filtrates obtained from the three filtrations and filter through a 200-mesh filter to obtain the filtrate.

[0024] (5) Concentrate at a vacuum of -0.06 to -0.08 MPa and a temperature of 70 to 80°C until the relative density is 1.20 to 1.25 (50°C) to obtain a clear paste.

[0025] (6) Using a one-step granulation method, dextrin and mannitol are used as the base material in a ratio of 8:1. The paste is sprayed in to obtain granules, which are then packaged to obtain the Chinese medicine composition granules.

[0026] Honey pill preparation method:

[0027] (1) Take 10 parts of Codonopsis pilosula, 10 parts of raw Atractylodes macrocephala, 10 parts of Cinnamomum cassia, 10 parts of Trichosanthes kirilowii, 5 parts of Panax notoginseng, 10 parts of Lobelia chinensis, 10 parts of Bistorta officinalis, 10 parts of Euphorbia helioscopia, and 10 parts of Lepidium apetalum.

[0028] (2) After the above-mentioned medicinal materials are mixed and pulverized, they are passed through a 100-mesh or 120-mesh sieve to make extremely fine medicinal powder. The medicinal powder and honey are made into honey pills in a weight ratio of 1:1.2-1.8.

[0029] (3) Each pill is 3g, take 6g each time, twice a day.

[0030] Capsule preparation method:

[0031] (1) Take 10 parts of Codonopsis pilosula, 10 parts of raw Atractylodes macrocephala, 10 parts of Cinnamomum cassia, 10 parts of Trichosanthes kirilowii, 5 parts of Panax notoginseng, 10 parts of Lobelia chinensis, 10 parts of Bistorta officinalis, 10 parts of Euphorbia helioscopia, and 10 parts of Lepidium apetalum.

[0032] (2) After the above-mentioned medicinal materials are mixed and pulverized, they are passed through a 100-mesh or 120-mesh sieve to make extremely fine powder, and then the powder is filled into empty capsules.

[0033] (3) Each pill is 0.3g, take 6 pills each time, 3 times a day.

[0034] Powder preparation method:

[0035] (1) Take 10 parts of Codonopsis pilosula, 10 parts of raw Atractylodes macrocephala, 10 parts of Cinnamomum cassia, 10 parts of Trichosanthes kirilowii, 5 parts of Panax notoginseng, 10 parts of Lobelia chinensis, 10 parts of Bistorta officinalis, 10 parts of Euphorbia helioscopia, and 10 parts of Lepidium apetalum.

[0036] (2) After the above-mentioned medicinal materials are mixed and pulverized, they are passed through a 100-mesh or 120-mesh sieve to make extremely fine medicinal powder.

[0037] (3) Use a vibrating sieve to classify the powder to ensure uniformity. Mix the screened powder with honey or vinegar and apply it to the chest or abdomen once in the morning and once in the evening.

[0038] Meanwhile, traditional Chinese medicine compositions for preventing and treating pleural and peritoneal effusions, made using the traditional Chinese medicine composition provided by this invention as the active ingredient, also fall within the scope of protection of this invention.

[0039] Based on the 2020 edition of the Chinese Pharmacopoeia and domestic and international research, the efficacy and pharmacological effects of the Chinese medicinal materials used in this invention are as follows:

[0040] Codonopsis pilosula, the dried root of *Codonopsis pilosula*, *Codonopsis lanceolata*, or *Codonopsis chuanxiong*, plants belonging to the Campanulaceae family, has the effects of strengthening the spleen and stomach, nourishing blood and promoting body fluids, and relieving phlegm and cough. It is used to treat spleen and lung qi deficiency, poor appetite and fatigue, cough and wheezing, qi and blood deficiency, sallow complexion, palpitations and shortness of breath, thirst due to fluid depletion, and internal heat and thirst. Modern pharmacology shows that Codonopsis pilosula mainly contains codonopsis saponins, codonopsis polysaccharides, various amino acids, and trace elements such as zinc, iron, and manganese, which can play a role in regulating immunity, anti-tumor, anti-oxidation, protecting the cardiovascular system, and regulating gastrointestinal function.

[0041] Raw Atractylodes macrocephala is the dried rhizome of the plant Atractylodes macrocephala, belonging to the Asteraceae family. It has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus. It is used to treat spleen deficiency with poor appetite, abdominal distension and diarrhea, phlegm retention with dizziness and palpitations, edema, spontaneous sweating, and threatened abortion. Modern pharmacology shows that raw Atractylodes macrocephala mainly contains chemical components such as atractylodes lactone, scopolamine, and Atractylodes macrocephala polysaccharides, as well as amino acids, zinc, copper, and trace elements such as iron. It can enhance spleen and stomach function, promote the secretion of digestive juices, and has anti-inflammatory, antioxidant, and tumor cell growth and proliferation inhibitory effects.

[0042] Cinnamon twigs are the dried young branches of the cinnamon tree (Cinnamomum cassia), a plant in the Lauraceae family. They possess diaphoretic and muscle-relaxing properties, warm the meridians, invigorate yang, and regulate qi. They are used to treat phlegm retention, edema, palpitations, abdominal pain, joint pain, cold pain in the stomach and abdomen, common cold due to wind-cold, and amenorrhea due to blood stasis. Modern pharmacology shows that cinnamon twigs mainly contain cinnamic acid, cinnamyl alcohol, quercetin, kaempferol, polyphenolic compounds, and coumarins, which can exert anti-inflammatory, analgesic, antioxidant, cardiovascular protective, and blood circulation-improving effects.

[0043] Trichosanthes root, or dried root of *Trichosanthes kirilowii* or *Trichosanthes spp.*, belongs to the Cucurbitaceae family. It has the effects of clearing heat and purging fire, promoting body fluid production and quenching thirst, reducing swelling and draining pus. It is used to treat feverish thirst, dry cough due to lung heat, internal heat and thirst, and carbuncles and boils. Modern pharmacology shows that Trichosanthes root mainly contains trichosanthes saponins, trichosanthes flavonoids, polysaccharides and oligosaccharides, amino acids, trace elements, etc., which can inhibit the release of inflammatory mediators, reduce inflammatory responses, enhance the body's immune function, relieve cough and asthma, protect cells from oxidative damage, and inhibit the growth and spread of tumor cells.

[0044] Panax notoginseng, the dried root and rhizome of the plant Panax notoginseng (family Araliaceae), has the effects of dispersing blood stasis, stopping bleeding, reducing swelling, and relieving pain. It is used to treat hemoptysis, hematemesis, epistaxis, hematochezia, metrorrhagia, traumatic bleeding, chest and abdominal pain, and swelling and pain from falls. Modern pharmacology shows that Panax notoginseng mainly contains saponins, notoginsenosides, quercetin, Panax notoginseng polysaccharides, selenium, zinc, and other components, which can effectively treat inflammatory diseases and hemorrhagic diseases, exert vasodilatory, blood pressure lowering, myocardial ischemia improvement, anti-tumor activity, and anti-inflammatory effects.

[0045] Lobelia chinensis, the dried whole herb of the plant Lobelia chinensis (family Campanulaceae), has the effects of clearing heat and detoxifying, promoting diuresis and reducing swelling. It is used to treat carbuncles, boils, snake and insect bites, abdominal distension and edema, damp-heat jaundice, and eczema. Modern pharmacology shows that Lobelia chinensis mainly contains lobeline, oxylobate, quercetin, kaempferol, lobeline steroid, caffeic acid, ferulic acid, and other components, which have anti-inflammatory, analgesic, and anti-tumor effects.

[0046] Bistorta officinalis, the dried rhizome of the Polygonaceae plant Bistorta officinalis, has the effects of clearing heat and detoxifying, reducing swelling, and stopping bleeding. It is used to treat dysentery, diarrhea due to heat, cough and asthma due to lung heat, carbuncles and scrofula, oral ulcers, hematemesis due to blood heat, hemorrhoidal bleeding, and snake and insect bites. Modern pharmacology shows that Bistorta officinalis mainly contains flavonoids, anthraquinones and their derivatives, stilbene compounds, glycosides, lignans, steroids, and other chemical components, which have effects such as lowering blood pressure, improving cardiovascular function, enhancing the body's endurance and stress resistance, anti-inflammatory, and antioxidant properties.

[0047] Euphorbia helioscopia, or the whole herb of an annual plant belonging to the genus Euphorbia in the family Euphorbiaceae, has diuretic, anti-edema, expectorant, antitussive, detoxifying, and insecticidal effects. It is used to treat edema, cough with phlegm, malaria, bacillary dysentery, scrofula, tuberculous fistula, and osteomyelitis. Modern pharmacology shows that Euphorbia helioscopia mainly contains flavonoids such as quercetin, quercetin-3-digalactoside, and hyperoside, as well as terpenoids such as helioscopia terpenes, which exert effects such as inhibiting the release of inflammatory mediators, inhibiting bacterial and fungal activity, and anti-allergic properties.

[0048] Lepidium seed, the dried, mature seed of *Euphorbia helioscopia* or *Euphorbia pekinensis*, both belonging to the Brassicaceae family, has the effects of purging lung heat and relieving asthma, promoting diuresis and reducing edema. It is used to treat phlegm accumulation in the lungs, cough with excessive phlegm, chest and rib distension, inability to lie flat, abdominal edema, and difficulty urinating. Modern pharmacology shows that *Euphorbia helioscopia* mainly contains fritillary alkaloids, fritillary alkaloids, fritillary alkaloids saponins, quercetin, amino acids, and other chemical components, which exert anti-inflammatory, antitussive, expectorant, immunomodulatory, and tumor cell growth-inhibiting effects.

[0049] The above-mentioned herbs, when combined, work synergistically to strengthen the body's resistance, resolve blood stasis, detoxify, eliminate dampness, promote diuresis, and reduce swelling. They can effectively prevent or alleviate pleural and peritoneal effusions caused by inflammatory diseases such as tuberculous pleurisy, pneumonia, and hepatitis-related cirrhosis, as well as pleural and peritoneal effusions caused by malignant tumors such as lung adenocarcinoma, breast cancer, and peritoneal metastases. The main symptoms include dyspnea, chest pain, cough, loss of appetite, abdominal pain, abdominal distension, fatigue, and night sweats. This herbal composition has significant effects in promoting the absorption and excretion of pleural and peritoneal effusions, reducing inflammation and fighting cancer, regulating and restoring the physiological functions of the internal organs, improving prognosis, enhancing the patient's quality of life, and prolonging survival. Detailed Implementation

[0050] The traditional Chinese medicine composition of the present invention will be further described below with reference to specific embodiments, so that those skilled in the art can better understand the present invention, but this does not limit the present invention.

[0051] All the Chinese medicinal materials used in the following examples comply with the relevant provisions of the Chinese Pharmacopoeia 2020 edition. Before feeding, each medicinal material was identified and confirmed to be consistent with its name, and its quality met the pharmacopoeia standards.

[0052] Example 1: Preparation of a decoction of a traditional Chinese medicine composition for the prevention and treatment of pleural and peritoneal effusions.

[0053] The composition comprises the following components in parts by weight: Codonopsis pilosula 10 parts, Atractylodes macrocephala 10 parts, Cinnamomum cassia 10 parts, Trichosanthes kirilowii 10 parts, Panax notoginseng 5 parts, Lobelia chinensis 10 parts, Polygonum bistorta 10 parts, Euphorbia helioscopia 10 parts, and Lepidium apetalum 10 parts. Take 85g of the above nine medicinal herbs according to the prescription, mix them, add 400ml of water and soak for 30 minutes. Add 400ml of water to all the herbs and decoct for 40 minutes. Filter the decoction to obtain a filtrate and a residue; this completes the first decoction. Remove the residue, add 600ml of water again and decoct for 25 minutes. Filter the decoction to obtain a filtrate and a residue; this completes the second decoction. Mix the filtrate from the first decoction with the filtrate from the second decoction to obtain the decoction of the aforementioned Chinese herbal composition. Take it warm when using.

[0054] Example 2: Preparation of a traditional Chinese medicine composition granule for the prevention and treatment of pleural and peritoneal effusions

[0055] The composition comprises the following components in parts by weight: Codonopsis pilosula 10 parts, Atractylodes macrocephala 10 parts, Cinnamomum cassia 10 parts, Trichosanthes kirilowii 10 parts, Panax notoginseng 5 parts, Lobelia chinensis 10 parts, Polygonum bistorta 10 parts, Euphorbia helioscopia 10 parts, and Lepidium apetalum 10 parts. Take 85g of the above nine medicinal herbs according to the prescription, mix them, and decoct three times with water. For the first decoction, add 900ml of water and decoct for 1.5 hours; for the second and third decoctions, add 700ml of water and decoct for 1.5 hours each. Combine the filtrates obtained from the three filtrations and filter through a 200-mesh sieve to obtain the filtrate. Concentrate under a vacuum of -0.06 to -0.08 MPa and a temperature of 70-80℃ until the relative density is 1.20-1.25 (50℃) to obtain a clear extract. A one-step granulation method is used, with dextrin and mannitol in a ratio of 8:1 as the base material. The extract is sprayed in to obtain granules, which are then packaged to obtain the Chinese herbal composition granules. They can be taken by dissolving them in hot water.

[0056] Example 3: Preparation of a traditional Chinese medicine composition pill for the prevention and treatment of pleural and peritoneal effusion.

[0057] The composition comprises the following components in parts by weight: Codonopsis pilosula 10 parts, Atractylodes macrocephala 10 parts, Cinnamomum cassia 10 parts, Trichosanthes kirilowii 10 parts, Panax notoginseng 5 parts, Lobelia chinensis 10 parts, Polygonum bistorta 10 parts, Euphorbia helioscopia 10 parts, and Lepidium apetalum 10 parts. Take 85g of the above nine medicinal herbs according to the prescription, mix and pulverize them, then pass them through a 100-mesh or 120-mesh sieve to obtain an extremely fine powder. Mix the powder with honey in a weight ratio of 1:1.2-1.8 to make honey pills, each weighing 3g. Take 6g each time, twice daily.

[0058] Example 4: Preparation of a traditional Chinese medicine composition capsule for the prevention and treatment of pleural and peritoneal effusions

[0059] The composition comprises the following components in parts by weight: Codonopsis pilosula 10 parts, Atractylodes macrocephala 10 parts, Cinnamomum cassia 10 parts, Trichosanthes kirilowii 10 parts, Panax notoginseng 5 parts, Lobelia chinensis 10 parts, Polygonum bistorta 10 parts, Euphorbia helioscopia 10 parts, and Lepidium apetalum 10 parts. Take 85g of the above nine medicinal herbs according to the prescription, mix and pulverize them, then pass them through a 100-mesh or 120-mesh sieve to obtain an extremely fine powder. Fill the powder into empty capsules, each containing 0.3g. Take 6 capsules each time, three times a day.

[0060] Example 5: Preparation of a traditional Chinese medicine powder for the prevention and treatment of pleural and peritoneal effusions

[0061] The composition comprises the following components in parts by weight: Codonopsis pilosula 10 parts, Atractylodes macrocephala 10 parts, Cinnamomum cassia 10 parts, Trichosanthes kirilowii 10 parts, Panax notoginseng 5 parts, Lobelia chinensis 10 parts, Polygonum bistorta 10 parts, Euphorbia helioscopia 10 parts, and Lepidium apetalum 10 parts. Take 85g of the above nine medicinal herbs according to the prescription, mix and pulverize them, then pass them through a 100-mesh or 120-mesh sieve to obtain an extremely fine powder. Use a vibrating sieve to grade the powder to ensure uniformity. Mix the sieved powder with honey or vinegar and apply it to the chest or abdomen twice a day, morning and evening.

[0062] Example 6: Typical Case:

[0063] Case 1: (Chemotherapy) Ms. Wu, female, experienced lower back pain and soreness without obvious cause in August 2023. In September 2023, she palpated a mass in her groin, about the size of a peanut. On September 21, 2023, an ultrasound at another hospital showed a hypoechoic mass in the left groin area, suggestive of enlarged lymph nodes. Cervical HPV 16+ was detected, and TCT indicated high-grade squamous intraepithelial lesion. Colposcopy at another hospital showed HSIL / CINIII cervical cancer with focal carcinoma (squamous cell tumor). On October 7, 2023, an MRI at another hospital showed a cervical mass, suggestive of malignancy, possibly cervical cancer, with possible metastasis to the pelvic and left groin lymph nodes. Abnormal signal was also observed in the left bone. On October 27, 2023, a biopsy of the groin mass was performed, and the pathology report indicated squamous cell carcinoma. October 30, 2023: Cervical pathology consultation at another hospital: (3 o'clock, 6 o'clock, 9 o'clock, 12 o'clock, and cervical canal tissue) Poorly differentiated cervical carcinoma, morphologically consistent with poorly differentiated squamous cell carcinoma. Immunohistochemical results: PD-L1 (SP263) (TPS<1%), PD-L1 (SP263NeR) (-). Two cycles of paclitaxel + cisplatin chemotherapy were administered on November 3 and November 28, 2023. December 21, 2023: CT findings are as follows: 1. Cervical cancer, the largest cervical section is approximately 4.3 × 3.1 cm, with moderate to high enhancement, some blurred margins, relatively clear lateral borders, possibly involving the fornix downwards; the nodule in the left perineum has slightly increased in size, now approximately 2.8 × 2.0 cm; the uterus is not enlarged, and no uterine cavity effusion was observed. 2. Extensive and irregular thickening and enhancement of the gallbladder wall, larger than before, suggestive of malignancy; irregular infiltrative soft tissue shadow in the porta hepatis, larger than before, indicating a tendency for metastasis. 3. Blurred, slightly low-density nodular shadow in the right kidney, with indistinct borders, approximately 2.1 cm in diameter, suggestive of metastasis. The lateral branch of the right adrenal gland is fuller than before, requiring vigilance for metastasis. 4. Multiple enlarged lymph nodes in the bilateral iliac vascular region and left inguinal region, smaller than before; the largest in the left inguinal region has a short diameter of approximately 1.9 cm; retroperitoneal and mesenteric intraperitoneal lymph nodes are slightly smaller than before. 5. Thickening of the peritoneum and mesentery, with blurred patchy and linear shadows; ascites. Current symptoms: abdominal discomfort, abdominal distension, a feeling of blockage in the stomach after eating, yellow complexion, poor appetite, nausea and vomiting. Stabbing pain from the stomach to the lower ribs, palpitations, fatigue, lower back pain after prolonged sitting, poor sleep, easily awakened due to upper abdominal pain. Bowel movements occur every 4-5 days, are formed, and slightly dry. Urine is yellow, and there is dry and bitter mouth. The tongue is dark red with teeth marks on the edges, and the coating is white and greasy. The pulse is deep and thready.

[0064] Analysis of the syndrome: The patient's vital energy is deficient, toxins accumulate in the uterus, and the flow of qi and blood in the meridians is disordered, leading to blood stasis and fluid retention in the abdomen. The cancer toxins have invaded the internal organs, causing prolonged imbalance and deficiency of qi and blood, hence the fatigue. Spleen deficiency and impaired digestion lead to water retention, resulting in abdominal discomfort, bloating, and poor appetite; food accumulates in the stomach, causing reflux. Spleen deficiency also prevents blood from nourishing the face, resulting in a yellowish complexion. Qi and blood stagnation in the belt meridian causes stabbing pain in the hypochondrium. Prolonged stagnation generates heat, causing dry stools, dry mouth, and a bitter taste. Combined with a dark red tongue with teeth marks on the edges, a white and greasy coating, and a deep and thready pulse, the diagnosis is a deficiency of both qi and yin, with mutual accumulation of toxins and blood stasis.

[0065] Diagnosis: Accumulation, bloating.

[0066] Treatment principle: Tonify Qi and promote blood circulation, promote diuresis and remove blood stasis.

[0067] Prescription: Codonopsis pilosula 10g, Atractylodes macrocephala 10g, Cinnamomum cassia 10g, Trichosanthes kirilowii 10g, Panax notoginseng 5g, Lobelia chinensis 10g, Bistorta officinalis 10g, Euphorbia helioscopia 10g, Lepidium apetalum 10g. 28 doses, one dose daily, decocted in water and taken once a day, divided into morning and evening doses. Second visit: The patient reported improved abdominal discomfort, bloating, and pain, but still felt a feeling of blockage in the stomach after eating. Bowel movements were once every 1-2 days, and the stool was dry. The previous prescription was modified by adding Raphanus sativus 10g, chicken gizzard lining 10g to strengthen the spleen, aid digestion, and relieve bloating, Albizia julibrissin bark 20g, Polygonum multiflorum 20g to calm the mind and relieve depression, and Sargentodoxa cuneata 10g to promote blood circulation. 14 doses, same dosage as before. Third visit: The patient's symptoms were significantly relieved.

[0068] Case 2 (Postoperative Radiotherapy and Chemotherapy): Ms. Shi, female, underwent one cycle of TP chemotherapy before surgery for cervical squamous cell carcinoma. She underwent surgery at another hospital on February 15, 2021. Postoperative pathology: squamous cell carcinoma. She received four cycles of TP chemotherapy and 25 fractions of radiotherapy postoperatively. In November 2021, a follow-up examination revealed lymph node metastasis. She began candunilinumab treatment in October 2022 and discontinued it in August 2023. In November 2023, bilateral pleural effusion was drained. Pleural effusion smear and sediment showed erythrocytes, lymphocytes, neutrophils, mesothelial cells, and a few mildly atypical cells. On December 5, 2023, a CT scan of the entire abdomen and pelvis showed increased abdominium effusion, thickened peritoneum with multiple nodules and cord-like structures, suggestive of metastasis, newly appearing compared to previous scans. Bilateral inguinal lymph nodes showed some enlargement and some shrinkage, suggesting possible metastasis. Liver cyst, right kidney cyst. Increased bilateral pleural effusion compared to before. Current symptoms: chest tightness, shortness of breath, cough with thick yellow sputum. Fatigue, excessive sweating, especially in the upper body, palpitations, edema in both lower limbs after prolonged walking, especially the left leg; fair appetite, difficulty falling asleep, light sleep with frequent awakenings, bowel movements once a day, sometimes unformed. Heat intolerance, dry mouth, occasional bitter taste in the mouth. Red tongue with a yellow, greasy coating, deep, slippery pulse.

[0069] Analysis of the syndrome differentiation: The patient has suffered from deficiency of both Qi and Blood due to surgery, radiotherapy, and chemotherapy, resulting in dysfunction of Qi's ascending and descending functions, abnormal Qi and Blood circulation, damage to the internal organs by cancer toxins, obstruction of fluid metabolism, and impaired organ function. Cancer toxins combine with Qi, phlegm, and blood stasis, circulating and transforming along the meridians, hence the metastatic tumors; heat in the upper Jiao (upper burner) forces upwards, causing stagnation of Lung Qi, disrupting its dispersing and descending functions, hence chest tightness, shortness of breath, cough with phlegm, fatigue, and sweating; Spleen deficiency leads to insufficient Qi and Blood production, coupled with impaired Lung Qi circulation, resulting in obstruction by cancer toxins, phlegm, and blood stasis, causing water retention in the abdomen, hence pleural effusion, ascites, and lower limb edema. The patient's red tongue with a yellow, greasy coating and deep, slippery pulse indicate phlegm-heat obstructing the lungs and spleen deficiency with water retention.

[0070] Diagnosis: Accumulation, bloating.

[0071] Treatment principle: Strengthen the spleen, replenish qi and promote diuresis, clear the lungs, lower qi and resolve phlegm.

[0072] Prescription: Codonopsis pilosula 10g, Atractylodes macrocephala 10g, Cinnamomum cassia 10g, Trichosanthes kirilowii 10g, Panax notoginseng 5g, Lobelia chinensis 10g, Bistorta officinalis 10g, Euphorbia helioscopia 10g, Lepidium apetalum 10g, Albizia julibrissin bark 20g, Polygonum multiflorum 20g. One dose daily, divided into morning and evening administrations. After 28 days, a follow-up CT scan showed a reduction in bilateral pleural effusion and abdominopelvic effusion. Chest tightness and shortness of breath improved, edema lessened, but the left leg was still severely affected. Sleep was normal, and bowel movements occurred once a day, sometimes loose. The tongue was pale red with a white, greasy coating, and the pulse was deep and slippery. The Euphorbia helioscopia was increased to 30g to enhance its diuretic effect, and Atractylodes macrocephala was increased to 30g to strengthen the spleen and stomach. 28 doses were prescribed. At the third visit, the patient's previous symptoms had all improved, but fatigue, chest tightness, shortness of breath, and excessive sweating remained. The previous prescription was modified by adding Schisandra chinensis (vinegar-processed) 10g. 14 doses were prescribed. With regular follow-up, the patient's condition remained relatively stable and their quality of life improved.

[0073] Case 3 (Chemotherapy + Immunotherapy): Mr. Wang, male, was diagnosed with malignant colon cancer at a local hospital in August 2020. He underwent colectomy at the same hospital on August 17, 2020, followed by 8 cycles of chemotherapy with a regimen of lobaplatin + fluorouracil. In December 2021, multiple metastases were found in the pleural and peritoneal cavities. He then underwent chemotherapy + targeted therapy (capecitabine + oxaliplatin + bevacizumab) at a local hospital. He has now completed 2 cycles of treatment. Pathology findings: moderately differentiated adenocarcinoma of the ascending colon, ulcerative type, cut area: 6×1.5cm, periintestinal lymph node metastases—5 / 24); Immunohistochemistry: MLH1 (+), MSH2 (+0), msh6 (+), pms2 (+), HER-2 (O). CT scan showed: 1. nodular lesion in the left upper lobe of the lung; 2. postoperative colon cancer with peritoneal and pleural metastases, right lower lobe atelectasis, pleural effusion, and ascites. December 31, 2021: Tumor markers: CEA 152.65 ng / ml↑, CA72-4 12.49 ng / ml↑; February 9, 2022: Tumor markers: CEA 218.26↑, CA72-4 18.82↑, ferritin 335.66↑. Current symptoms: Severe pain in the right intercostal space, right supraclavicular region, and right shoulder, affecting sleep. Poor appetite, weight loss, abdominal distension, worse after meals, hiccups and belching. Occasional cough with white, sticky sputum, more pronounced in the morning. Normal bowel movements and urination, significant sensitivity to cold. Dark red tongue with a white, greasy coating, slippery pulse.

[0074] Analysis of the syndrome differentiation: The patient has suffered from prolonged illness, resulting in deficiency of Yang Qi, invasion of cancerous toxins, disharmony of the internal organs, stagnation of Qi, and dysfunction of the lungs, spleen, and kidneys. The Triple Burner (San Jiao) is dysfunctional, leading to phlegm, blood stasis, and toxins accumulating in the water channels of the Triple Burner, disrupting the normal distribution of fluids. This results in the accumulation of dampness in the abdomen, forming ascites and pleural effusion. The cancerous toxins and blood stasis combine, obstructing the meridians, causing pain due to blockage. The combination of cancerous toxins and stagnant fluids further weakens the spleen Yang, impairing its function of transporting and transforming fluids, hence the symptoms of poor appetite, abdominal distension, hiccups, and belching. The lungs, being the "upper source of water," are also impaired, leading to cough and phlegm. Combined with the patient's dark red tongue, white and greasy coating, and slippery pulse, this indicates a combination of toxins and blood stasis, and deficiency of spleen and kidney Yang.

[0075] Diagnosis: Accumulation, bloating.

[0076] Treatment principle: Remove blood stasis and detoxify, replenish qi and promote diuresis.

[0077] Prescription: Codonopsis pilosula 10g, Atractylodes macrocephala 10g, Cinnamomum cassia 10g, Trichosanthes kirilowii 10g, Panax notoginseng 5g, Lobelia chinensis 10g, Bistorta officinalis 10g, Euphorbia helioscopia 10g, Lepidium apetalum 10g. 28 doses, one dose daily, decocted in water and taken twice a day, morning and evening. After 28 days, the patient reported significant relief of symptoms, including pain, abdominal distension, and cold intolerance; appetite and sleep were good; and bowel movements were regular. The prescription was modified by adding Patrinia scabiosaefolia 10g, Taraxacum mongolicum 10g, Sargentodoxa cuneata 10g, Eupolyphaga sinensis 6g, Raphanus sativus 10g, and Gallus gallus domesticus gizzard lining 10g. 28 doses, decocted and taken as above. Subsequent follow-up showed improvement in symptoms and a stable condition.

Claims

1. A traditional Chinese medicine composition for preventing and treating pleuroperitoneal effusion, characterized in that, The composition is composed of the following components in weight fraction: 3-20 parts of radix codonopsis, 3-20 parts of raw atractylodes, 3-18 parts of cassia twig, 3-18 parts of radix trichosanthis, 3-12 parts of panax, 3-15 parts of lobelia, 3-15 parts of bupleurum, 3-15 parts of euphorbia, and 3-15 parts of lepidium.

2. The traditional Chinese medicine composition for preventing and treating pleural and peritoneal effusion as described in claim 1, characterized in that, The composition is composed of the following components in weight fraction: 5-18 parts of radix codonopsis, 5-18 parts of raw atractylodes, 5-15 parts of cassia twig, 5-15 parts of radix trichosanthis, 5-10 parts of panax, 5-12 parts of lobelia, 5-12 parts of bupleurum, and 5-12 parts of lepidium.

3. The traditional Chinese medicine composition for preventing and treating pleural and peritoneal effusion as described in claim 1, characterized in that, The composition is composed of the following components in weight fraction: 10 parts of radix codonopsis, 10 parts of raw atractylodes, 10 parts of cassia twig, 10 parts of radix trichosanthis, 5 parts of panax, 10 parts of lobelia, 10 parts of bupleurum, and 10 parts of lepidium.

4. A traditional Chinese medicine composition for preventing and treating pleural effusion and ascites, characterized in that, The active ingredient is the traditional Chinese medicine composition as claimed in any one of claims 1-3.

5. Use of the traditional Chinese medicine composition as claimed in any one of claims 1-3 in the preparation of traditional Chinese medicine decoction, granules, pills, capsules, and powder for preventing and treating pleural and abdominal effusion.