A traditional Chinese medicine composition for treating benign nodules, a preparation method and use thereof

Abstract

The application provides a traditional Chinese medicine composition for treating benign nodules and a preparation method and application thereof, and belongs to the field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from raw medicinal materials in the following weight ratio: Bistorta 12-18 parts, Agrimonia pilosa 24-36 parts, Laetiporus 9.6-14.4 parts, Forsythia 16-24 parts, Platycodon 12-18 parts, Fritillaria thunbergii Miq. 16-24 parts and Begonia fimbristipula 14.4-21.6 parts. The application also provides a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition aims at the core pathogenesis of phlegm and blood stasis syndrome of tuberculosic disease, has the effects of clearing heat, resolving nodules, resolving phlegm and removing blood stasis, and has the effects of tonifying qi and supporting healthy energy, is used for treating benign nodules of the lung, thyroid or breast, achieves the effect of treating different diseases in the same way, and has the advantages of accurate curative effect, small side effect and prevention of recurrence.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine composition for treating benign nodules, its preparation method, and its uses, belonging to the field of traditional Chinese medicine. Background Technology

[0002] In modern medicine, nodules (such as pulmonary nodules, thyroid nodules, and breast nodules) are common clinical conditions, often associated with inflammation, hyperplasia, or precancerous lesions. In Traditional Chinese Medicine (TCM) theory, nodules fall under the categories of "goiter," "breast nodules," and "lung obstruction." Qi stagnation and blood stasis syndrome is a common and crucial pattern for benign nodules in the lungs, thyroid, and breast. Its core pathogenesis lies in the deficiency of vital energy (Qi) caused by various factors such as improper diet, overwork, and impaired liver function, leading to Qi stagnation, which in turn causes phlegm accumulation and blood stasis. These four factors intertwine to form a tangible nodule. If this pathogenesis and cycle of "Qi stagnation → phlegm accumulation / blood stasis → phlegm and blood stasis intertwining → stagnation transforming into heat → damage to vital energy" is not controlled, it can lead to intense heat and toxicity, easily forming malignant tumors.

[0003] Thyroid nodules are a common endocrine disorder characterized by the abnormal proliferation of one or more lumps of thyroid cells. They can be found in people of all ages. Epidemiological surveys show that the prevalence of thyroid nodules is higher in women than in men, and the prevalence increases with age. People with high work stress, chronic mental tension, insomnia, and anxiety are more prone to developing thyroid nodules. Most patients with benign thyroid nodules have no obvious clinical symptoms, but some patients, especially those with solitary nodules, may experience symptoms such as hoarseness, difficulty swallowing, and shortness of breath if left untreated, especially when the nodule compresses surrounding tissues. It may also induce other complications such as cardiovascular disease and diabetes, and even lead to cancer. Currently, ultrasound is the most widely used and relied-upon examination for the clinical diagnosis of thyroid nodules. Western medicine treatments for thyroid nodules mainly include thyroid hormone inhibitor therapy, radioactive iodine therapy, radiofrequency ablation, percutaneous anhydrous ethanol injection, and surgery. While these treatments have some effectiveness, they also have drawbacks such as significant adverse reactions, the risk of permanent hypothyroidism, increased trauma to the body, and a higher risk of postoperative complications. Traditional Chinese medicine believes that thyroid nodules are caused by emotional distress, stagnation of liver qi, and the accumulation of body fluids into phlegm; or by improper diet, unsuitable environment, and impaired spleen function, leading to poor water metabolism and stagnation of qi and blood, resulting in pathological products such as qi stagnation, blood stasis, and phlegm accumulation, which form nodules in the neck. Qi is yang, and blood is yin; yin and yang are interdependent, and qi and blood nourish and depend on each other. Thyroid nodules of qi stagnation and blood stasis type are caused by stagnation of qi, leading to impaired blood circulation and a pathological state of blood stasis; stagnant blood easily forms lumps and nodules. Traditional Chinese medicine (TCM) treatments for benign thyroid nodules mainly include oral administration of Chinese herbal medicine, external application of plasters, and acupuncture. Although the methods differ, the treatment principles are to soothe the liver and regulate qi, resolve phlegm and dissipate nodules, clear heat and detoxify, promote blood circulation and diuresis, and warm yang and replenish qi (Sun Qianqian, et al., The effect of safflower Xiaoyao tablets combined with levothyroxine sodium tablets on the treatment of benign thyroid nodules with qi stagnation and blood stasis syndrome and its influence on thyroid function, Clinical Misdiagnosis and Mistreatment, September 2022, Vol. 35, No. 9).

[0004] Benign breast nodules are a common breast disease in women. The term encompasses a broad range of pathological diagnoses, including fibroadenomas, cysts, fibrocystic changes, papillomas, and ductal epithelial hyperplasia with or without dysplasia. The main clinical manifestations of benign breast nodules are breast pain, nodularity, or lumps. Currently, Western medicine often treats benign breast nodules with psychological counseling and lifestyle guidance, and in some cases, estrogen receptor modulators or surgery. However, hormone therapy can lead to menstrual disorders or even amenorrhea. Furthermore, this disease is often characterized by multiple nodules and recurrence after surgery. Multiple and repeated surgeries cause physical damage and significant psychological impact on patients (Yang Yanhuan, et al., Clinical study on the treatment of female benign breast nodules of qi stagnation and blood stasis type using Jieyu Sanjie formula, Liaoning Journal of Traditional Chinese Medicine, 2025, Vol. 52, No. 2).

[0005] Pulmonary nodules, as a common imaging feature of the lungs, have always been a focus of clinical attention in terms of benign / malignant differentiation and early intervention. In recent years, the value of TCM constitution and syndrome differentiation in the diagnosis and treatment of pulmonary nodules has gradually gained attention. Studies have shown that the imaging characteristics of pulmonary nodules (such as diameter, density, and number) are significantly associated with specific TCM constitutions and syndrome differentiations. For example, patients with Qi stagnation constitution often present with small nodules ≤4 mm in diameter, while those with blood stasis constitution are closely associated with nodules >8 mm in diameter. Patients with liver Qi stagnation syndrome commonly present with pure ground-glass nodules and multiple nodules (Zhu Jinchao, et al., Correlation analysis between pathological classification of pulmonary nodule biopsy and TCM constitution and syndrome differentiation, Journal of Guangzhou University of Chinese Medicine, January 2026, Vol. 43, No. 1).

[0006] While treatment strategies for benign nodules in the thyroid, breast, and lungs generally follow a "observation-based" approach, significant differences exist due to variations in organ function, location, and potential risks. For benign nodules in these areas, modern medicine focuses on scientific monitoring, precise diagnosis, and minimally invasive intervention, aiming to eliminate lesions while maximizing the preservation of organ function and aesthetics. Traditional Chinese medicine, on the other hand, generally believes that benign nodules do not require surgical treatment, emphasizing holistic regulation and the principle of "strengthening the body's resistance and eliminating pathogenic factors."

[0007] Traditional Chinese medicine (TCM) classification of nodules is complex, with the core pathogenesis being "qi stagnation, phlegm accumulation, and blood stasis, combined with deficiency of vital energy and accumulation of pathogenic factors." Clinically, it can be broadly classified into: liver qi stagnation type, phlegm accumulation and blood stasis type, qi deficiency and phlegm accumulation type, yin deficiency and fire excess type, and yang deficiency and cold stagnation type. The diagnostic points differ depending on the location of the nodules (thyroid, breast, lung nodules). "Observation and waiting" can easily bring enormous psychological stress to patients and carries the risk of disease progression; surgery / minimally invasive intervention has many side effects (such as immunosuppression and organ dysfunction) and a high recurrence rate.

[0008] Therefore, there is an urgent clinical need for a compound traditional Chinese medicine composition that can both "attack the pathogen" and "strengthen the body's resistance" for benign nodules, effectively eliminating existing nodules while regulating the internal environment and preventing their progression. Summary of the Invention

[0009] This invention provides a traditional Chinese medicine composition for treating benign nodules. This invention also provides a method for preparing this traditional Chinese medicine composition and its uses.

[0010] This invention provides a traditional Chinese medicine composition for treating benign nodules, which is prepared from the following raw materials in the indicated weight ratios:

[0011] 12-18 parts of Polygonum bistorta, 24-36 parts of Agrimonia pilosa, 9.6-14.4 parts of Cremastra appendiculata, 16-24 parts of Forsythia suspensa, 12-18 parts of Platycodon grandiflorus, 16-24 parts of Fritillaria thunbergii, and 14.4-21.6 parts of Calendula officinalis.

[0012] Preferably, it is prepared from the following raw materials in the indicated weight ratios:

[0013] 15 parts of Polygonum bistorta, 30 parts of Agrimonia pilosa, 12 parts of Cremastra appendiculata, 20 parts of Forsythia suspensa, 15 parts of Platycodon grandiflorus, 20 parts of Fritillaria thunbergii, and 18 parts of Calendula officinalis.

[0014] The traditional Chinese medicine composition of the present invention is prepared into a commonly used pharmaceutical formulation by adding pharmaceutically acceptable excipients or auxiliary ingredients, with the active ingredient being the raw drug powder, water or organic solvent extract.

[0015] The preparations mentioned therein are tablets, capsules, pills, granules, and oral liquids.

[0016] The present invention also provides a method for preparing the traditional Chinese medicine composition for treating benign nodules, comprising the following steps:

[0017] a. Weigh the raw materials according to the specified weight ratio;

[0018] b. Powder or extract with water or organic solvents, then add pharmaceutically acceptable excipients or auxiliary ingredients to prepare commonly used pharmaceutical formulations.

[0019] The water extraction method described in step b is as follows:

[0020] Add water and decoct twice, the first time for 60 minutes and the second time for 45 minutes. Combine the decoctions, filter the decoctions, combine the filtrates, and concentrate to an extract with a relative density of 1.07~1.11.

[0021] The present invention also provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating benign nodules.

[0022] The benign nodules mentioned above are benign nodules of the qi stagnation and blood stasis type.

[0023] The nodules mentioned are pulmonary nodules, thyroid nodules, or breast nodules.

[0024] In this invention's herbal composition, the raw material *Polygonum bistorta*, according to the *Shennong Bencao Jing* (Shennong's Classic of Materia Medica), is described as having a bitter and pungent taste, and being cold in nature. It is used to treat abdominal masses, cold and heat evil qi, and to open the nine orifices, promoting urination and defecation. Known for its heat-clearing and mass-dispersing properties, it is the principal herb. *Agrimonia pilosa* (also known as *Lysimachia christinae* or *Lysimachia foenum-graecum*) is used in large quantities to invigorate qi, replenish deficiency, and support the body's vital energy; it is the assistant herb, working in conjunction with *Polygonum bistorta*. The two herbs work synergistically, one attacking and the other tonifying, eliminating masses and dispersing nodules without harming the body's vital energy. *Cremastra appendiculata*, *Forsythia suspensa*, *Fritillaria thunbergii*, and *Cephalotaxus fortunei* clear heat, detoxify, resolve phlegm, and disperse nodules, assisting *Polygonum bistorta* and enhancing its mass-dispersing power; they are the adjuvant herbs. *Platycodon grandiflorus*, bitter and pungent, promotes qi circulation and relieves pain; when used with other heat-clearing herbs, it prevents excessive coldness, and its pungent taste enhances its mass-dispersing effect; it is the guiding herb. All the herbs work together to clear heat, disperse nodules, resolve phlegm, and remove blood stasis.

[0025] in:

[0026] Bistorta is the dried rhizome of Polygonum bistorta L., a plant in the Polygonaceae family. It has the effects of clearing heat and detoxifying, reducing swelling and dissipating nodules.

[0027] Agrimony is the dried aerial part of Agrimonia pilosa Ledeb., a plant in the Rosaceae family. It has detoxifying and restorative effects.

[0028] Mountain pseudobulbs are the dried pseudobulbs of *Cremastra appendiculata* (D.Don) Makino, *Pleione bulbocodioides* (Franch.) Rolfe, or *Pleione yunnanensis* Rolfe, belonging to the Orchidaceae family. They possess the effects of clearing heat and detoxifying, resolving phlegm and dissipating nodules.

[0029] Forsythia suspensa (Thunb.) Vahl, a plant in the Oleaceae family, is a dried fruit. It has the effects of clearing heat and detoxifying, reducing swelling and dissipating nodules, and dispersing wind-heat.

[0030] Platycodon grandiflorum (Jacq.) A.DC., a plant in the Campanulaceae family, is a dried root. It has the effects of clearing the lungs, relieving sore throat, eliminating phlegm, and draining pus.

[0031] Fritillaria thunbergii Miq., a plant in the Liliaceae family, is a dried bulb. It has the effects of clearing heat, resolving phlegm, relieving cough, detoxifying, dispersing nodules, and reducing swelling.

[0032] Bidens biternata (Loureiro) Merrill & Sherff, a plant in the Asteraceae family, is a dried whole herb. It has the effects of dispelling wind, clearing heat, and detoxifying.

[0033] The herbal composition of this invention targets the core pathogenesis of sarcoidosis with qi stagnation and blood stasis syndrome, namely "phlegm and blood stasis intermingling and stagnation transforming into heat". It has the effects of clearing heat and dispersing nodules, resolving phlegm and removing blood stasis, while also tonifying qi and strengthening the body. It is used to treat benign nodules of the lung, thyroid or breast, achieving the effect of "treating different diseases with the same method". It also has the advantages of definite curative effect, few side effects and prevention of recurrence. Detailed Implementation

[0034] Example 1: Preparation of the herbal granules of the present invention

[0035] Weigh out the following raw materials: 15g of Polygonum bistorta, 30g of Agrimonia pilosa, 12g of Cremastra appendiculata, 20g of Forsythia suspensa, 15g of Platycodon grandiflorus, 20g of Fritillaria thunbergii, and 18g of Calendula officinalis.

[0036] Preparation process: Add water to the above seven ingredients and decoct twice. The first decoction is for 60 minutes and the second decoction is for 45 minutes. Combine the decoctions, filter the decoctions, combine the filtrates, and concentrate them to an extract with a relative density of 1.07~1.11 (around 70℃). Add appropriate amounts of dextrin and steviol glycosides, mix well, and make into granules to obtain the final product.

[0037] Example 2: Preparation of the traditional Chinese medicine composition of the present invention

[0038] Weigh the raw materials: 12g of Polygonum bistorta, 24g of Agrimonia pilosa, 9.6g of Cremastra appendiculata, 16g of Forsythia suspensa, 12g of Platycodon grandiflorus, 16g of Fritillaria thunbergii, and 14.4g of Calendula officinalis. Grind them into powder, compress them into tablets, and obtain tablets.

[0039] Example 3: Preparation of the traditional Chinese medicine composition of the present invention

[0040] Weigh out the raw materials: 18g of Polygonum bistorta, 36g of Agrimonia pilosa, 14.4g of Cremastra appendiculata, 24g of Forsythia suspensa, 18g of Platycodon grandiflorus, 24g of Fritillaria thunbergii, and 21.6g of Calendula officinalis. Add water, decoct, extract and concentrate to prepare an oral liquid.

[0041] The following clinical trials demonstrate the beneficial effects of this invention.

[0042] Experimental Example 1: Clinical Trial of the Traditional Chinese Medicine Composition of the Invention

[0043] Clinical practice has demonstrated the safety and effectiveness of the herbal composition of this invention in treating benign lung, thyroid, and breast nodules through "treating different diseases with the same method".

[0044] 1. Overview of the research plan

[0045] 1.1 Study Subjects: 180 patients who visited the Shuangliu District Traditional Chinese Medicine Hospital in Chengdu were selected as the study subjects. Based on the location of the nodules, they were divided into three subgroups: pulmonary nodules, thyroid nodules, and breast nodules, with 60 cases in each group.

[0046] 1.2 Grouping Method: Within each subgroup, patients were randomly assigned to the experimental group and the control group in a 1:1 ratio using a random number table, with 30 patients in each group. See the reports for each subgroup for details.

[0047] 1.3 Intervention measures:

[0048] (1) Control group: Targeted health education on benign nodules was conducted once a month (including smoking cessation, emotional management, dietary guidance, etc.), without any drug intervention.

[0049] (2) Experimental group: On the basis of the same health education as the control group, the drug of this invention (hereinafter referred to as "Quanlang Sanjie Fang") was added for treatment. The prescription is: 15g of Quanshen, 30g of Xianhecao, 12g of Shancigu, 20g of Lianqiao, 15g of Jiegeng, 20g of Zhebeimu, and 18g of Jinzhanyinpan. It is decocted in water and taken orally. Each dose is taken for 3 days, 3 times a day, for 90 consecutive days.

[0050] 1.4 Observation indicators and evaluation criteria: See the reports of each subgroup for details.

[0051] 1.5 Statistical Methods: Statistical analysis was performed using SPSS 22.0 software. Count data were described as percentages, and comparisons were performed using the chi-square test. 2 Inspection; the form of description of measurement data is ( (±s), and compare using a t-test. P < 0.05 was considered statistically significant.

[0052] 2. Clinical observation reports of each subgroup

[0053] 2.1 Pulmonary nodule subgroup

[0054] (1) Source of cases:

[0055] Sixty patients with benign pulmonary nodules who met the criteria were selected as the study subjects, regardless of gender, and were randomly divided into an experimental group and a control group using a random number table. The characteristics of the control group and the experimental group are shown in Table 1 below. Statistical analysis showed no significant differences between the two groups in terms of gender, age, and disease duration (P > 0.05), making them comparable (see Table 1).

[0056] Table 1. Comparison of baseline characteristics among patients in the pulmonary nodule subgroup.

[0057]

[0058] (2) Case selection criteria

[0059] ① Western medicine diagnostic criteria:

[0060] Nodular shadows or lesions were visible on high-resolution CT (HRCT) of the chest, and the diagnosis was a solitary, non-calcified pulmonary nodule with a maximum diameter of less than 5 mm to 15 mm. The morphological characteristics of the nodule were assessed as low risk.

[0061] ② Traditional Chinese Medicine diagnostic criteria:

[0062] Main symptoms: Occasionally experiencing chest tightness, or discomfort from coughing and phlegm.

[0063] Secondary symptoms: general weakness, loss of appetite, irritability, fatigue, dry mouth, bitter taste, or incomplete bowel movements.

[0064] Simultaneously presenting two or more primary and secondary symptoms, combined with tongue and pulse findings: dark tongue, or visible ecchymosis, white or greasy tongue coating, and wiry and slippery pulse.

[0065] (3) Inclusion criteria

[0066] ① Meets the above diagnostic criteria, regardless of gender or age;

[0067] ②According to traditional Chinese medicine, this is a syndrome of qi stagnation and blood stasis;

[0068] ③ Those who agree to participate in this research voluntarily.

[0069] (3) Exclusion criteria

[0070] ① History of lung surgery;

[0071] ②Pregnant or breastfeeding women;

[0072] ③ Patients with serious primary diseases of the heart, liver, kidneys, and hematopoietic system;

[0073] ④ Those with other lung diseases;

[0074] ⑤ Individuals with severe psychological or emotional disorders;

[0075] ⑥ Those deemed unsuitable to participate in this study by the researchers.

[0076] (4) Treatment methods

[0077] ① The control group received monthly health education on benign pulmonary nodules, smoking cessation education, and emotional counseling, but no other interventions were provided.

[0078] ② In addition to the intervention in the control group, the experimental group was given the additional traditional Chinese medicine composition of this invention, "Quanlang Sanjie Fang" (15g of Quanshen, 30g of Xianhecao, 12g of Shancigu, 20g of Lianqiao, 15g of Jiegeng, 20g of Zhebeimu, and 18g of Jinzhan Yinpan). The herbs were decocted in water and taken orally, each dose for 3 days, 3 times a day.

[0079] ③ Treatment period: Both groups of patients underwent treatment for 90 consecutive days using the above method.

[0080] (5) Observation indicators

[0081] ①Main indicators: Comparison of the largest lung nodule diameter and the largest cross-sectional area before and after treatment.

[0082] ② Secondary indicator: TCM syndrome score.

[0083] ③ Safety indicators: adverse event records.

[0084] (6) Criteria for evaluating therapeutic efficacy

[0085] Cured: Symptoms basically disappeared and nodules disappeared after treatment.

[0086] Significant effect: The reduction rate of the largest lung nodule diameter and the largest cross-sectional area before and after treatment (≥50%), and the reduction rate of the total score of TCM syndrome (≥70%).

[0087] Effective: The reduction rate of the largest lung nodule diameter and the largest cross-sectional area before and after treatment (≥20%), and the reduction rate of the total TCM syndrome score (≥30%).

[0088] Ineffective: The reduction rate of the largest lung nodule diameter and the largest cross-sectional area before and after treatment (<20%), and / or the reduction rate of the total score of TCM syndrome (<30%).

[0089] Overall effective rate = (Number of cured cases + Number of significantly effective cases + Number of effective cases) / Total number of cases × 100%

[0090] (7) Results

[0091] ① Comparison of the maximum diameter and area of ​​pulmonary nodules and TCM syndrome scores between the two groups of patients before and after treatment.

[0092] In the experimental group, the maximum diameter and area of ​​nodules were significantly reduced compared to before treatment (P<0.05), and the reduction was significantly greater than that in the control group (P<0.05). Both groups showed a decrease in TCM syndrome scores, but the degree of improvement in the experimental group was far greater than that in the control group (significant difference between groups, P<0.05), as shown in Table 2.

[0093] Table 2 Comparison of maximum diameter and area of ​​pulmonary nodules and TCM syndrome scores between the two groups before and after treatment ( ±S)

[0094]

[0095] Note: Compared with the same group before and after treatment, the experimental group showed P < 0.05; compared with the control group after treatment, the experimental group showed P < 0.05.

[0096] ②Comprehensive therapeutic effect analysis

[0097] The total effective rate in the experimental group was 73.33%, which was significantly higher than that in the control group (43.33%) (P<0.05). The specific distribution of efficacy is shown in Table 3.

[0098] Table 3. Analysis of overall treatment efficacy for patients

[0099]

[0100] ③ Safety evaluation

[0101] During the entire 90-day study period, one patient in the experimental group experienced mild gastrointestinal discomfort (occasional feeling of fullness in the epigastric region), which resolved spontaneously without special treatment and did not affect continued treatment. Vital signs remained stable in both groups, and no clinically significant abnormalities were observed in safety indicators such as blood routine tests and liver function.

[0102] 2.2 Thyroid nodule subgroup

[0103] (1) Source of cases:

[0104] Sixty patients with benign thyroid nodules who met the criteria were selected as the study subjects, regardless of gender, and were randomly divided into an experimental group and a control group using a random number table. The characteristics of the control and experimental groups are shown in Table 4 below. Statistical analysis showed no significant differences between the two groups in terms of gender, age, and disease duration (P > 0.05), making them comparable (see Table 4).

[0105] Table 4. Comparison of baseline characteristics among patients in the thyroid nodule subgroup

[0106]

[0107] (2) Case selection criteria

[0108] ① Western medicine diagnostic criteria:

[0109] A palpable mass in the neck was confirmed by thyroid ultrasound. The maximum diameter of the nodule was <10mm, and according to the ACR TI-RADS classification system, it was rated ≤3 (mildly suspicious).

[0110] ② Traditional Chinese Medicine diagnostic criteria:

[0111] Main symptoms: Nodules in the neck that move up and down with swallowing; larger nodules may cause a pulling sensation in the neck; no redness, swelling, heat or pain in the thyroid gland.

[0112] Secondary symptoms: general weakness, loss of appetite, irritability, fatigue, dry mouth, bitter taste, or incomplete bowel movements.

[0113] Simultaneously presenting two or more primary and secondary symptoms, combined with tongue and pulse findings: dark tongue, or visible ecchymosis, white or greasy tongue coating, and wiry and slippery pulse.

[0114] (3) Inclusion criteria

[0115] ① Meets the above diagnostic criteria, regardless of gender or age;

[0116] ②According to traditional Chinese medicine, this is a syndrome of qi stagnation and blood stasis;

[0117] ③ Those who agree to participate in this research voluntarily.

[0118] (3) Exclusion criteria

[0119] ① History of thyroid surgery;

[0120] ②Pregnant or breastfeeding women;

[0121] ③ Patients with serious primary diseases of the heart, liver, kidneys, and hematopoietic system;

[0122] ④ Those with other thyroid diseases;

[0123] ⑤ Individuals with severe psychological or emotional disorders;

[0124] ⑥ Those deemed unsuitable to participate in this study by the researchers.

[0125] (4) Treatment methods

[0126] ① The control group received monthly health education on benign thyroid nodules, emotional counseling, and was advised to maintain a light diet and avoid spicy and stimulating foods. No other interventions were performed.

[0127] ② In addition to the intervention of the control group, the experimental group was given the "Quanlang Sanjie Formula" of this invention (15g of Quanshen, 30g of Xianhecao, 12g of Shancigu, 20g of Lianqiao, 15g of Jiegeng, 20g of Zhebeimu, and 18g of Jinzhanyinpan). The herbs were decocted in water and taken orally, each dose for 3 days, 3 times a day.

[0128] ③ Treatment period: Both groups of patients underwent treatment for 90 consecutive days using the above method.

[0129] Observation indicators

[0130] Key indicator: Comparison of the maximum diameter of thyroid nodules before and after treatment.

[0131] Secondary indicator: TCM syndrome score.

[0132] ③ Safety indicators: adverse event records.

[0133] (6) Criteria for evaluating therapeutic efficacy

[0134] Cured: Symptoms basically disappeared and nodules disappeared after treatment.

[0135] Significant effect: The reduction rate of the maximum diameter of the thyroid nodule before and after treatment (≥50%), and the reduction rate of the total score of TCM syndrome (≥70%).

[0136] Effective: The reduction rate of the maximum diameter of the thyroid nodule before and after treatment (≥20%), and the reduction rate of the total score of TCM syndrome (≥30%).

[0137] Ineffective: The reduction rate of the maximum diameter of the thyroid nodule before and after treatment (<20%), and / or the reduction rate of the total score of TCM syndrome (<30%).

[0138] Overall effective rate = (number of cured cases + number of cases with significant effect + number of effective cases) / total number of cases × 100%.

[0139] (7) Results

[0140] ① Comparison of the maximum diameter of thyroid nodules and TCM syndrome scores before and after treatment in the two groups of patients.

[0141] The maximum diameter of thyroid nodules in the experimental group was significantly smaller than that before treatment (P<0.05), and the reduction was significantly greater than that in the control group (P<0.05). Both groups showed a decrease in TCM syndrome scores, with the treatment group showing a significantly greater improvement than the control group (P<0.05), as shown in Table 5.

[0142] Table 5. Comparison of maximum diameter of thyroid nodules and TCM syndrome scores between the two groups before and after treatment ( ±S)

[0143]

[0144] Note: Compared with the same group before and after treatment, the experimental group showed P < 0.05; compared with the control group after treatment, the experimental group showed P < 0.05.

[0145] ②Comprehensive therapeutic effect analysis

[0146] The total effective rate in the experimental group was 86.67%, which was significantly higher than that in the control group (36.67%) (P<0.05). The specific distribution of efficacy is shown in Table 6.

[0147] Table 6. Analysis of overall treatment efficacy for patients

[0148]

[0149] ③ Safety evaluation

[0150] Throughout the 90-day study period, the vital signs of patients in both the experimental and control groups remained stable, and no clinically significant abnormalities were observed in safety indicators such as blood routine tests and liver function.

[0151] 2.3 Breast nodule subgroup

[0152] (1) Source of cases:

[0153] Sixty eligible female patients with benign breast nodules were selected as the study subjects and randomly divided into an experimental group and a control group using a random number table. The details of the control and experimental groups are shown in Table 7. Statistical analysis revealed no significant differences between the two groups in terms of gender, age, and disease duration (P > 0.05), making them comparable (see Table 7).

[0154] Table 7 Comparison of baseline characteristics among patients in the breast nodule subgroup

[0155]

[0156] (2) Case selection criteria

[0157] ① Western medicine diagnostic criteria:

[0158] A palpable breast mass, confirmed by breast ultrasound and / or mammography, is classified as ≤3 (likely benign) according to the BI-RADS classification system.

[0159] ② Traditional Chinese Medicine diagnostic criteria:

[0160] Main symptoms: stabbing or throbbing pain in the breast, or no pain at all, accompanied by a lump that is firm or hard.

[0161] Secondary symptoms: general weakness, loss of appetite, irritability, fatigue, dry mouth, bitter taste or constipation, irregular menstruation / or menstrual clots.

[0162] Simultaneously presenting two or more primary and secondary symptoms, combined with tongue and pulse findings: dark tongue, or visible ecchymosis, white or greasy tongue coating, and wiry and slippery pulse.

[0163] (3) Inclusion criteria

[0164] ① Meets the above diagnostic criteria, regardless of age;

[0165] ②According to traditional Chinese medicine, this is a syndrome of qi stagnation and blood stasis;

[0166] ③ Those who agree to participate in this research voluntarily.

[0167] (3) Exclusion criteria

[0168] ① History of breast surgery;

[0169] ②Pregnant or breastfeeding women;

[0170] ③ Patients with serious primary diseases of the heart, liver, kidneys, and hematopoietic system;

[0171] ④ Those with other breast diseases;

[0172] ⑤ Individuals with severe psychological or emotional disorders;

[0173] ⑥ Those deemed unsuitable to participate in this study by the researchers.

[0174] (4) Treatment methods

[0175] ① The control group received monthly health education on benign breast nodules, emotional counseling, and was advised to maintain a light diet and avoid spicy and stimulating foods, without any other interventions.

[0176] ② In addition to the intervention of the control group, the experimental group was given the "Quanlang Sanjie Formula" of this invention (15g of Quanshen, 30g of Xianhecao, 12g of Shancigu, 20g of Lianqiao, 15g of Jiegeng, 20g of Zhebeimu, and 18g of Jinzhanyinpan). The herbs were decocted in water and taken orally, each dose for 3 days, 3 times a day.

[0177] ③ Treatment period: Both groups of patients underwent treatment for 90 consecutive days using the above method.

[0178] (5) Observation indicators

[0179] ①Main indicators: VAS score for breast pain, comparison of the largest diameter of breast nodules.

[0180] ② Secondary indicator: TCM syndrome score.

[0181] ③ Safety indicators: adverse event records.

[0182] (6) Criteria for evaluating therapeutic efficacy

[0183] Cured: Symptoms and nodules have basically disappeared after treatment.

[0184] Significant efficacy: After treatment, the VAS score for breast pain decreased by >50%, the maximum diameter of breast nodules decreased by ≥50% before and after treatment, and the total score of TCM syndrome decreased by ≥70%.

[0185] Effective: The VAS score for breast pain decreased by >20% after treatment, the maximum diameter of breast nodules decreased by ≥20% before and after treatment, and the total score of TCM syndrome decreased by ≥30%.

[0186] Ineffective: No improvement in breast pain after treatment, a reduction rate of the maximum diameter of breast nodules before and after treatment (<20%), and / or a reduction rate of the total score of TCM syndrome (<30%).

[0187] Overall effective rate = (number of cured cases + number of cases with significant effect + number of effective cases) / total number of cases × 100%.

[0188] (7) Results

[0189] ① Comparison of VAS scores for breast pain, maximum diameter of breast nodules, and TCM syndrome scores between the two groups of patients before and after treatment.

[0190] The experimental group showed significantly better results than the control group in relieving breast pain (VAS score decreased by 65.4%) (P<0.05). The maximum diameter of breast nodules in the experimental group was significantly smaller than before treatment (P<0.05), and the reduction was significantly greater in the experimental group than in the control group (P<0.05). Both groups showed a decrease in TCM syndrome scores, but the improvement in the treatment group was significantly greater than that in the control group, with a statistically significant difference (P<0.05), as shown in Table 8.

[0191] Table 8. Comparison of maximum diameter of thyroid nodules and TCM syndrome scores between the two groups before and after treatment ( ±S)

[0192]

[0193] Note: VAS, Visual Analogue Scale; P < 0.05 between the experimental group and the same group before and after treatment; P < 0.05 between the experimental group and the control group after treatment.

[0194] ②Comprehensive therapeutic effect analysis

[0195] The total effective rate in the experimental group was 76.67%, which was significantly higher than that in the control group (56.67%) (P<0.05). The specific distribution of efficacy is shown in Table 9.

[0196] Table 9. Analysis of overall treatment efficacy for patients

[0197]

[0198] ③ Safety evaluation

[0199] Throughout the 90-day study period, the vital signs of patients in both the experimental and control groups remained stable, and no clinically significant abnormalities were observed in safety indicators such as blood routine tests and liver function.

[0200] 3. Discussion of Results

[0201] The aforementioned clinical trials demonstrate that Quanlang Sanjie Formula can significantly reduce the volume of benign nodules in the lungs, thyroid gland, and breast, and effectively improve TCM syndromes related to qi stagnation and blood stasis. It also has good safety profile and is worthy of further clinical application. The experimental results support the clinical value of the TCM composition of this invention in treating nodules in different locations based on the theory of "treating different diseases with the same method".

Claims

1. A traditional Chinese medicine composition for treating benign nodules of the qi stagnation and blood stasis type, characterized in that: It is prepared from the following raw materials in the indicated weight ratios: 12-18 parts of Polygonum bistorta, 24-36 parts of Agrimonia pilosa, 9.6-14.4 parts of Cremastra appendiculata, 16-24 parts of Forsythia suspensa, 12-18 parts of Platycodon grandiflorus, 16-24 parts of Fritillaria thunbergii, and 14.4-21.6 parts of Calendula officinalis. The nodules mentioned are lung nodules, thyroid nodules, or breast nodules.

2. The traditional Chinese medicine composition for treating benign nodules according to claim 1, characterized in that: It is prepared from the following raw materials in the indicated weight ratios: 15 parts of Polygonum bistorta, 30 parts of Agrimonia pilosa, 12 parts of Cremastra appendiculata, 20 parts of Forsythia suspensa, 15 parts of Platycodon grandiflorus, 20 parts of Fritillaria thunbergii, and 18 parts of Calendula officinalis.

3. The traditional Chinese medicine composition for treating benign nodules according to claim 1 or 2, characterized in that: It is a pharmaceutically commonly used formulation prepared by adding pharmaceutically acceptable excipients or auxiliary ingredients to the active ingredient, which is the original drug powder, water or organic solvent extract of the active pharmaceutical ingredient.

4. The traditional Chinese medicine composition for treating benign nodules according to claim 3, characterized in that: The preparations mentioned are tablets, capsules, pills, granules, and oral liquids.

5. A method for preparing a traditional Chinese medicine composition for treating benign nodules according to any one of claims 1-4, characterized in that: It includes the following steps: a. Weigh the raw materials according to the specified weight ratio; b. Powder or extract with water or organic solvents, then add pharmaceutically acceptable excipients or auxiliary ingredients to prepare commonly used pharmaceutical preparations.

6. The method for preparing the traditional Chinese medicine composition for treating benign nodules according to claim 5, characterized in that: The water extraction method described in step b is as follows: Add water and decoct twice, the first time for 60 minutes and the second time for 45 minutes. Combine the decoctions, filter the decoctions, combine the filtrates, and concentrate to an extract with a relative density of 1.07~1.

11.

7. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a medicament for treating benign nodules of qi stagnation and blood stasis type; wherein the nodules are pulmonary nodules, thyroid nodules or breast nodules.

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