Traditional Chinese medicine composition for treating benign nodules and preparation method and application thereof

Abstract

The invention 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 the following raw material medicines in parts by weight: 12 to 18 parts of bistort rhizome, 24 to 36 parts of hairyvein agrimony, 9.6 to 14.4 parts of pseudobulbus cremastrae seu pleiones, 16 to 24 parts of fructus forsythiae, 12 to 18 parts of platycodon grandiflorum, 16 to 24 parts of thunberg fritillary bulb and 14.4 to 21.6 parts of spanishneedles herb. The invention further provides a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition aims at the core pathogenesis of qi stagnation and blood stasis syndromes of sarcoidosis, namely phlegm and blood stasis, and heat from depression to qi, has the effects of clearing heat, eliminating stagnation, reducing phlegm, removing blood stasis, tonifying qi and strengthening the body resistance, is used for treating benign nodules of lung, thyroid or mammary gland, achieves the effect of treating different diseases at the same time, and has the advantages of being definite in curative effect, small in side effect and capable of preventing relapse.

Description

TECHNICAL FIELD

[0001] The present application relates to a traditional Chinese medicine composition for treating benign nodules and a preparation method and use thereof, and belongs to the field of traditional Chinese medicines. BACKGROUND

[0002] Nodules (such as lung nodules, thyroid nodules, breast nodules, etc.) referred to by modern medicine are common clinical diseases, and are mostly related to inflammation, hyperplasia or precancerous lesions. In the theory of traditional Chinese medicine, nodules belong to the category of "swellings", "breast masses" and "pulmonary obstruction", and the common and key syndrome type of benign nodules in the lung, thyroid, breast and other parts is qi stagnation and blood stasis. The core pathogenesis is that the deficiency of vital qi caused by improper diet, overwork, liver failing to disperse and other reasons leads to qi stagnation, and then phlegm is formed from the condensation of fluid, blood stasis is formed, and the four are mutually glued together, eventually forming a tangible knot. The pathogenesis evolution and circulation of "qi stagnation → phlegm condensation / blood stasis → phlegm and blood stasis mutual knotting → stagnation and heat → damage to the normal" will not be controlled, and then the heat and toxin will be intense, which is easy to form malignant tumors.

[0003] Thyroid nodule is a common endocrine disease in clinic, which is caused by abnormal proliferation of thyroid cells and produces one or more masses. It can be seen in people of all ages. Epidemiological surveys show that the prevalence of thyroid nodules in women is higher than that in men, and the prevalence of thyroid nodules shows an increasing trend with age. People who work under great pressure, are in a state of long-term mental tension, have insomnia, and are anxious are more likely to develop thyroid nodules. Most patients with benign thyroid nodules have no obvious clinical symptoms, but some patients, especially those with single nodules, may develop hoarseness, dysphagia, and dyspnea when the nodules compress the surrounding tissues. They may also induce other complications such as cardiovascular disease, diabetes, and even cancer. At present, the most widely used and most dependent examination for the clinical diagnosis of thyroid nodules is ultrasonography. The main treatment methods for thyroid nodules in Western medicine include thyroid hormone suppressor therapy, radioactive iodine therapy, radiofrequency ablation therapy, percutaneous anhydrous ethanol injection therapy, and surgical therapy. Although these methods have certain effects, they have some drawbacks such as large adverse reactions, easy to cause permanent hypothyroidism, increase the risk of postoperative complications, and so on. Traditional Chinese medicine believes that thyroid nodules are caused by emotional internal injury, stagnation of liver qi, easy condensation of body fluid into phlegm or improper diet, unsuitable water and soil, failure of the spleen to transport, failure of water and dampness to transport, and stagnation of qi and blood. The pathological products of qi stagnation and blood stasis form nodules in the front of the neck. Qi is yang, and blood is yin. Yin and yang are mutually rooted, and qi and blood are mutually dependent. Qi stagnation and blood stasis type thyroid nodules are caused by stagnation of qi movement, leading to blood flow disorder and blood stasis. Blood stasis accumulates and does not disperse, easily forming lumps and nodules. The main methods for treating benign thyroid nodules in traditional Chinese medicine are oral administration of traditional Chinese medicine, external application of plaster, and acupuncture therapy. Although the methods are different, the treatment principles are to soothe the liver and regulate qi, resolve phlegm and resolve nodules, clear heat and resolve toxins, promote blood circulation and drain water, and warm yang and tonify qi (Sun Qianqian, et al. Effect of Honghua Xiaoyao Tablets Combined with Levothyroxine Sodium Tablets on Benign Thyroid Nodules with Qi Stagnation and Blood Stasis Syndrome and Influence on Thyroid Function. Clinical Misdiagnosis and Treatment. September 2022, Vol. 35, No. 9).

[0004] Breast benign nodules are common breast diseases in women. Breast benign nodules include a wide range of pathological diagnoses, such as fibroadenoma, cyst, fibrocystic change, papilloma, and ductal epithelial hyperplasia with or without atypia. The main clinical manifestations of breast benign nodules are breast pain, nodule state or mass. At present, Western medicine mainly adopts psychological counseling and guidance of living habits for breast benign nodules, and some use estrogen receptor modulators or surgical treatment. However, hormone therapy can cause menstrual disorders and even amenorrhea in patients. Moreover, this disease is often characterized by multiple occurrences and postoperative recurrence, and multiple surgeries and repeated surgeries cause physical damage and a greater psychological impact on patients (Yang Yanhua, et al. Clinical Study on Jieyu Sanjie Decoction in the Treatment of Female Breast Benign Nodules with Qi Stagnation and Blood Stasis. Liaoning Journal of Traditional Chinese Medicine. 2025, Vol. 52, No. 2).

[0005] Lung nodules as a common imaging sign in the lung, its benign and malignant differentiation and early intervention has been the focus of clinical attention, in recent years, the value of TCM constitution and syndrome in the diagnosis and treatment of lung nodules has gradually been paid attention to. Studies have shown that the imaging features of lung nodules (such as diameter, density, number) are significantly associated with specific TCM constitution and syndrome, such as patients with qi depression constitution often show small nodules with a diameter of ≤4 mm, while blood stasis constitution is closely related to nodules with a diameter of >8 mm, and patients with liver stagnation and qi stagnation syndrome often have pure ground glass nodules and multiple nodules (Zhu Jinchao, et al. Correlation analysis of lung nodule biopsy pathological type and TCM constitution and syndrome. Journal of Guangzhou University of Chinese Medicine, January 2026, Vol. 43 No. 1).

[0006] Although benign nodules of the thyroid, breast and lung have both common cores of following the "observation-based" strategy, and significant differences due to the differences in organ function, location and potential risks, the core of the modern medical treatment idea for benign nodules in the lung, thyroid and breast is scientific monitoring, accurate diagnosis and minimally invasive intervention, striving to eliminate lesions while maximizing the protection of organ function and aesthetics. However, TCM believes that benign nodules usually do not require surgical treatment, and emphasizes the principles of body regulation and "strengthening the body and eliminating evil".

[0007] The TCM typing of nodules is complex, and the core pathogenesis is "qi stagnation, phlegm condensation and blood stasis, and deficiency of the body and gathering of evil". The clinical typing is roughly divided into: liver depression and qi stagnation type, phlegm condensation and blood stasis type, qi deficiency and phlegm condensation type, yin deficiency and fire exuberance type, and yang deficiency and cold condensation type. Among them, the nodules in different parts (thyroid, breast, lung nodules) are different, and the diagnostic points are also different. "Observation and waiting" can bring great psychological pressure to patients and has the risk of disease progression; surgery / minimally invasive intervention has many side effects (such as immune suppression, organ function damage), and is prone to recurrence.

[0008] Therefore, there is an urgent need in the clinic for a compound Chinese medicine composition for benign nodules that can balance "attacking evil" and "strengthening the body", which can effectively eliminate existing nodules, and can also regulate the internal environment and prevent its progression. SUMMARY

[0009] The present application provides a kind of traditional Chinese medicine composition for treating benign nodules.The present application also provides the preparation method and use of the traditional Chinese medicine composition.

[0010] The present application provides a kind of traditional Chinese medicine composition for treating benign nodules, which is prepared from the following weight ratio of raw materials:

[0011] Bistorta 12-18 parts, Agrimonia 24-36 parts, Leucobryum 9.6-14.4 parts, Forsythia 16-24 parts, Platycodon 12-18 parts, Fritillaria 16-24 parts, and Gazania 14.4-21.6 parts.

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

[0013] Bistorta 15 parts, Agrimonia 30 parts, Huperzia 12 parts, Forsythia 20 parts, Platycodon 15 parts, Fritillaria 20 parts, Kalanchoe 18 parts.

[0014] The traditional Chinese medicine composition in the application is prepared from the raw medicinal powder, water or organic solvent extract of the raw medicinal materials as active ingredients, and pharmaceutically acceptable adjuvants or auxiliary ingredients.

[0015] The preparation is a tablet, a capsule, a pill, a granule or an oral liquid.

[0016] The application also provides a preparation method of the traditional Chinese medicine composition for treating benign nodules.

[0017] a. weigh the raw medicinal materials in the following weight ratio;

[0018] b. powder or extract with water or an organic solvent, and then add pharmaceutically acceptable adjuvants or auxiliary ingredients to prepare a commonly used pharmaceutical preparation.

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

[0020] Water is added and boiled twice, the first boiling is for 60 minutes and the second boiling is for 45 minutes, the decoction is combined, filtered, and the filtrate is combined and concentrated to a relative density of 1.07-1.11 of the extract.

[0021] The application also provides the use of the traditional Chinese medicine composition in the preparation of a drug for treating benign nodules.

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

[0023] The nodules are lung nodules, thyroid nodules or breast nodules.

[0024] In the traditional Chinese medicine composition, the raw medicinal material Bistorta is from Shennong's Herbal Classic: bitter, pungent, cold. It is used for treating accumulation in the heart and abdomen, cold and heat evil, and opening nine orifices and promoting urination and defecation. It is good at clearing heat and resolving masses, so it is used as the monarch drug. The raw medicinal material Agrimonia is used as the minister drug to tonify qi, invigorate the spleen and support the healthy qi. It is combined with Bistorta to attack and tonify, and the two drugs are used together. Bistorta and Agrimonia are the monarch and minister drugs, respectively, which can resolve masses without damaging the healthy qi. Huperzia, Forsythia, Fritillaria and Kalanchoe can clear heat, resolve toxins, resolve phlegm and resolve masses, and assist Bistorta to enhance the resolving mass function. Platycodon is bitter and pungent, and it can promote qi and relieve pain. It is used with many heat-clearing drugs to prevent excessive cold and coolness, and the pungent taste can enhance the resolving mass function. All the drugs are used together to clear heat, resolve masses, resolve phlegm and resolve blood stasis.

[0025] In the application,

[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] ③ Safety evaluation

[0100] 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.

[0101] 2.2 Thyroid nodule subgroup

[0102] (1) Source of cases:

[0103] 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).

[0104] Table 4. Comparison of baseline characteristics among patients in the thyroid nodule subgroup

[0105]

[0106] (2) Case selection criteria

[0107] ① Western medicine diagnostic criteria:

[0108] 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 graded ≤3 (mildly suspicious).

[0109] ② Traditional Chinese Medicine diagnostic criteria:

[0110] 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.

[0111] Secondary symptoms: general weakness, loss of appetite, irritability, fatigue, dry mouth, bitter taste, or incomplete bowel movements.

[0112] 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.

[0113] (3) Inclusion criteria

[0114] ① Meets the above diagnostic criteria, regardless of gender or age;

[0115] ②According to traditional Chinese medicine, this is a syndrome of qi stagnation and blood stasis;

[0116] ③ Those who agree to participate in this research voluntarily.

[0117] (3) Exclusion criteria

[0118] ① History of thyroid surgery;

[0119] ②Pregnant or breastfeeding women;

[0120] ③ Patients with serious primary diseases of the heart, liver, kidneys, and hematopoietic system;

[0121] ④ Those with other thyroid diseases;

[0122] ⑤ Individuals with severe psychological or emotional disorders;

[0123] ⑥ Those deemed unsuitable to participate in this study by the researchers.

[0124] (4) Treatment methods

[0125] 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.

[0126] 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 Jinzhan Yinpan). The herbs were decocted in water and taken orally, each dose for 3 days, 3 times a day.

[0127] ③ Treatment period: Both groups of patients underwent treatment for 90 consecutive days using the above method.

[0128] Observation indicators

[0129] Key indicator: Comparison of the maximum diameter of thyroid nodules before and after treatment.

[0130] Secondary indicator: TCM syndrome score.

[0131] ③ Safety indicators: adverse event records.

[0132] (6) Criteria for evaluating therapeutic efficacy

[0133] Cured: Symptoms basically disappeared and nodules disappeared after treatment.

[0134] 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%).

[0135] 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%).

[0136] 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%).

[0137] Overall effective rate = (number of cured cases + number of cases with significant effect + number of effective cases) / total number of cases × 100%.

[0138] (7) Results

[0139] ① Comparison of the maximum diameter of thyroid nodules and TCM syndrome scores before and after treatment in the two groups of patients.

[0140] 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.

[0141] Table 5. Comparison of maximum diameter of thyroid nodules and TCM syndrome scores between the two groups before and after treatment ( ±S)

[0142] 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.

[0143] ②Comprehensive therapeutic effect analysis

[0144] 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.

[0145] Table 6. Analysis of overall treatment efficacy for patients

[0146]

[0147] ③ Safety evaluation

[0148] 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.

[0149] 2.3 Breast nodule subgroup

[0150] (1) Source of cases:

[0151] 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).

[0152] Table 7 Comparison of baseline characteristics among patients in the breast nodule subgroup

[0153]

[0154] (2) Case selection criteria

[0155] ① Western medicine diagnostic criteria:

[0156] A palpable breast mass, confirmed by breast ultrasound and / or mammography, is classified as ≤3 (likely benign) according to the BI-RADS classification system.

[0157] ② Traditional Chinese Medicine diagnostic criteria:

[0158] Main symptoms: stabbing or throbbing pain in the breast, or no pain at all, accompanied by a lump that is firm or hard.

[0159] Secondary symptoms: general weakness, loss of appetite, irritability, fatigue, dry mouth, bitter taste or constipation, irregular menstruation / or menstrual clots.

[0160] 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.

[0161] (3) Inclusion criteria

[0162] ① Meets the above diagnostic criteria, regardless of age;

[0163] ②According to traditional Chinese medicine, this is a syndrome of qi stagnation and blood stasis;

[0164] ③ Those who agree to participate in this research voluntarily.

[0165] (3) Exclusion criteria

[0166] ① History of breast surgery;

[0167] ②Pregnant or breastfeeding women;

[0168] ③ Patients with serious primary diseases of the heart, liver, kidneys, and hematopoietic system;

[0169] ④ Those with other breast diseases;

[0170] ⑤ Individuals with severe psychological or emotional disorders;

[0171] ⑥ Those deemed unsuitable to participate in this study by the researchers.

[0172] (4) Treatment methods

[0173] 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.

[0174] 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 Jinzhan Yinpan). The herbs were decocted in water and taken orally, each dose for 3 days, 3 times a day.

[0175] ③ Treatment period: Both groups of patients underwent treatment for 90 consecutive days using the above method.

[0176] (5) Observation indicators

[0177] ①Main indicators: VAS score for breast pain, comparison of the largest diameter of breast nodules.

[0178] ② Secondary indicator: TCM syndrome score.

[0179] ③ Safety indicators: adverse event records.

[0180] (6) Criteria for evaluating therapeutic efficacy

[0181] Cured: Symptoms and nodules have basically disappeared after treatment.

[0182] 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%.

[0183] 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%.

[0184] 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%).

[0185] Overall effective rate = (number of cured cases + number of cases with significant effect + number of effective cases) / total number of cases × 100%.

[0186] (7) Results

[0187] 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.

[0188] 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.

[0189] Table 8. Comparison of maximum diameter of thyroid nodules and TCM syndrome scores between the two groups before and after treatment ( ±S)

[0190] 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.

[0191] ②Comprehensive therapeutic effect analysis

[0192] 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.

[0193] Table 9. Analysis of overall treatment efficacy for patients

[0194] ③ Safety evaluation

[0195] 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.

[0196] 3. Discussion of Results

[0197] 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, characterized in that: It is prepared from the following raw medicinal materials with the following weight ratio: ​ Bistorta 12-18 parts, Agrimonia pilosa 24-36 parts, Leucoviton 9.6-14.4 parts, Forsythia suspense 16-24 parts, Platycodon grandiflorum 12-18 parts, Fritillaria thunbergii Miq. 16-24 parts, Kalanchoe blossfeldiana 14.4-21.6 parts.

2. The traditional Chinese medicine composition for treating benign nodules according to claim 1, characterized in that: It is prepared from the following raw medicinal materials with the following weight ratio: Bistorta 15 parts, Agrimonia pilosa 30 parts, Leucoviton 12 parts, Forsythia suspense 20 parts, Platycodon grandiflorum 15 parts, Fritillaria thunbergii Miq. 20 parts, Kalanchoe blossfeldiana 18 parts.

3. The traditional Chinese medicine composition for treating benign nodules according to claim 1 or 2, characterized in that: It is prepared from the raw medicinal material of the crude drug powder, water or organic solvent extract as the active ingredient, and the addition of pharmaceutically acceptable adjuvants or auxiliary ingredients into the commonly used preparations in pharmacy.

4. The traditional Chinese medicine composition for treating benign nodule according to claim 3, characterized in that: The preparation is tablet, capsule, pill, granule, oral liquid.

5. A method for preparing the 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. Weighing each weight ratio of raw medicinal materials; b. Powdering or adding water, organic solvent extraction, and then adding pharmaceutically acceptable adjuvants or auxiliary ingredients to prepare commonly used preparations in pharmacy.

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 in step b is: Water decoction twice, the first decoction for 60 minutes, the second decoction for 45 minutes, combine the decoction, filter the decoction, combine the filtrate, and concentrate to the relative density of 1.07-1.11 of the extract.

7. The use of the traditional Chinese medicine composition of any one of claims 1-4 in the preparation of a drug for treating benign nodules.

8. Use according to claim 7, characterized in that: The benign nodules are qi stagnation and blood stasis type benign nodules.

9. Use according to claim 7 or 8, characterized in that: The nodules are pulmonary nodules, thyroid nodules or breast nodules.

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