Traditional Chinese medicine composition for treating hectic fever sweating syndrome of breast cancer patient as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating hectic fever sweating syndrome of breast cancer patients and a preparation method and application thereof. The traditional Chinese medicine composition comprises the following main active components in parts by mass: 20-40 parts of light wheat, 5-15 parts of herba epimedii, 20-40 parts of glutinous rice roots, 5-15 parts of liquorice, 10-20 parts of cortex lycii radicis, 5-15 parts of radices stellariae dichotomae, 10-20 parts of radix paeoniae alba, 20-30 parts of nacre mother of pearl, 10-20 parts of vine of multiflower knotweed and 10-20 parts of spina date seeds. Real world research results show that the traditional Chinese medicine composition has a good treatment effect on hectic fever and sweating syndromes of breast cancer patients, can effectively relieve hectic fever and sweating symptoms, and is remarkable in clinical treatment effect and good in safety.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition for treating hot flashes and sweating syndrome in breast cancer patients, its preparation method, and its application. Background Technology

[0002] Hot flashes and sweating syndrome in breast cancer patients refers to a series of symptoms related to hormone level changes that occur during breast cancer treatment, mainly including hot flashes and night sweats. Breast cancer patients undergoing endocrine therapy often experience discomfort such as hot flashes and sweating, severely impacting their quality of life. Currently, although hormone therapy is established by international guidelines as the most effective treatment for these vasomotor symptoms, clinical studies have shown that it may increase the risk of breast cancer. Furthermore, symptomatic treatments for this specific group mainly include soy isoflavones and black cohosh extract, but the therapeutic effects are not ideal, and the safety profile remains unclear. In China, most breast cancer patients seek traditional Chinese medicine (TCM) treatment during endocrine therapy, but currently, there is a lack of publicly available and effective TCM treatment methods. Therefore, it is necessary to develop a TCM composition that can effectively treat hot flashes and sweating syndrome in breast cancer patients to meet their medication needs. Summary of the Invention

[0003] The first objective of this invention is to provide a traditional Chinese medicine composition for treating hot flashes and sweating syndrome in breast cancer patients. The second objective of this invention is to provide a method for preparing the traditional Chinese medicine composition. The third objective of this invention is to provide the application of the traditional Chinese medicine composition.

[0004] According to a first aspect of the present invention, a traditional Chinese medicine composition for treating hot flashes and sweating syndrome in breast cancer patients is provided, wherein its main active ingredients, by weight, include: 20-40 parts of wheat bran, 5-15 parts of epimedium, 20-40 parts of glutinous rice root, 5-15 parts of licorice, 10-20 parts of lycium bark, 5-15 parts of stellaria root, 10-20 parts of white peony root, 20-30 parts of pearl powder, 10-20 parts of fleeceflower stem, and 10-20 parts of jujube seed.

[0005] This invention addresses the fundamental pathological characteristic of hot flashes and sweating syndrome in breast cancer patients, which is actually an imbalance of the Chong and Ren meridians. Starting from the root cause of the disease, "imbalance of the Chong and Ren meridians," the main treatment methods are to regulate the Chong and Ren meridians, clear away deficiency heat, nourish blood, and calm the mind.

[0006] The herbal composition of this invention uses Epimedium to tonify kidney yang and regulate the Chong and Ren meridians, and Triticum aestivum to astringe yin and stop sweating, both serving as principal herbs; Glutinous rice root synergistically enhances sweating-stopping effects, while Stellaria dichotoma and Lycium chinense root bark clear away deficiency heat; Paeonia lactiflora softens the liver and nourishes blood, all serving as assistant herbs; Ziziphus jujuba seed, Polygonum multiflorum vine, and pearl powder calm the mind, all serving as adjuvant herbs; Glycyrrhiza uralensis harmonizes the properties of the herbs, tonifies the spleen and replenishes qi, and aids in the absorption of the medicine, serving as the guiding herb. The entire formula works synergistically to nourish yin and clear heat, nourish the heart and calm the mind, consolidate the exterior and stop sweating, and regulate the Chong and Ren meridians, effectively treating hot flashes and sweating syndrome in breast cancer patients.

[0007] The raw materials for this formula come from the following sources: Floating wheat: The dried, light, shriveled fruit of *Triticum aestivum* L., a plant belonging to the genus *Triticum* of the Poaceae family.

[0008] Epimedium: The stems and leaves of plants in the genus Epimedium of the Berberidaceae family, such as Epimedium brevicornum Maxim., Epimedium sagittatum., Epimedium wushanense., Epimedium koreanum Nakai., and Epimedium pubesens Maxim.

[0009] Glutinous rice root: The rhizome and fibrous roots of Oryza sativa L. var. glutinosa Matsum., a plant belonging to the genus Oryza in the family Poaceae.

[0010] Licorice: The dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L., plants belonging to the genus Glycyrrhiza in the legume family.

[0011] Lycium bark: The dried root bark of Lycium chinense Mill. or Lycium barbarum L., both belonging to the Solanaceae family.

[0012] Stellaria dichotoma L. var. lanceolata Bge., a plant belonging to the genus Stellaria in the family Caryophyllaceae.

[0013] White peony root: The root of Paeonia lactiflora Pall., a plant belonging to the genus Paeonia in the family Ranunculaceae.

[0014] Mother-of-pearl: The shells of *Cristaria plicata* (Leach), *Hyriopsis cumingii* (Lea), or *Pteria martensii* (Dunker), animals belonging to the genus *Cristaria* of the family Elaeagnidae.

[0015] Polygonum multiflorum Thunb., a plant belonging to the Polygonaceae family and the Polygonum genus, is a dried vine.

[0016] Sour jujube seed: The mature seed of Ziziphus jujuba Mill. var. spinosa (Bunge) Huex HFChou, a plant belonging to the genus Ziziphus in the family Rhamnaceae.

[0017] In some embodiments, the main active ingredients, by weight, include: 30 parts of floating wheat, 10 parts of epimedium, 30 parts of glutinous rice root, 10 parts of licorice, 15 parts of lycium bark, 10 parts of silver bupleurum, 15 parts of white peony root, 25 parts of pearl powder, 15 parts of fleeceflower stem, and 15 parts of jujube seed.

[0018] In some implementations, licorice root is prepared as roasted licorice root, and jujube seed is stir-fried jujube seed. Compared to licorice root, prepared licorice root has a sweeter taste and warmer properties, resulting in a stronger effect in tonifying the spleen and replenishing qi, and is better at harmonizing the properties of other herbs and relieving acute symptoms. Compared to jujube seed, stir-fried jujube seed has a better effect in nourishing blood and calming the mind.

[0019] In some embodiments, pharmaceutically acceptable excipients may also be added. Specifically, the excipients used are carriers or excipients commonly used in the art, including but not limited to maltodextrin, starch, lactose, glucose, sodium carboxymethyl cellulose, ethyl cellulose, methyl cellulose, malt, gelatin, polyols (such as propylene glycol, glycerol, mannitol), tablets, etc., to help improve the stability or activity of the drug, or to produce an acceptable taste or odor when taken orally.

[0020] In some embodiments, the dosage form of the traditional Chinese medicine composition is a decoction, oral liquid, granules, tablets, capsules, or pills. This facilitates clinical administration.

[0021] According to a second aspect of the present invention, a method for preparing the above-mentioned traditional Chinese medicine composition for treating hot flashes and sweating syndrome in breast cancer patients is provided. When the traditional Chinese medicine composition is a decoction, the preparation method includes the following steps: The raw materials are decocted twice with water. For the first decoction, add 8-10 times the amount of water as the total mass of the raw materials, heat to a boil, and maintain a gentle boil for 1-2 hours. After separation, the first decoction and the dregs are obtained. For the second decoction, take the dregs obtained from the first decoction, add 8-10 times the amount of water as the total mass of the raw materials, heat to a boil, and maintain a gentle boil for 1-2 hours. After separation, the second decoction and the dregs are obtained. Combine the first and second decoctions to obtain the final product.

[0022] According to a third aspect of the present invention, the use of the above-described traditional Chinese medicine composition for treating hot flashes and sweating syndrome in breast cancer patients is provided in the preparation of a medicament for treating hot flashes and sweating syndrome in breast cancer patients.

[0023] The beneficial effects of this invention include: The traditional Chinese medicine composition of the present invention has been used clinically for many years. Real-world research results show that the traditional Chinese medicine composition of the present invention has a good therapeutic effect on hot flashes and sweating syndrome in breast cancer patients, can effectively relieve hot flashes and sweating symptoms, and has significant clinical efficacy and good safety. Detailed Implementation

[0024] The present invention will be further described in detail below with reference to specific embodiments. Unless otherwise specified, all raw materials and reagents used in the present invention are commercially available.

[0025] Example 1 The traditional Chinese medicine decoction for treating hot flashes and sweating syndrome in breast cancer patients in this embodiment is prepared from the following raw materials: 30g of floating wheat, 10g of epimedium, 30g of glutinous rice root, 10g of prepared licorice root, 15g of lycium bark, 10g of silver bupleurum, 15g of white peony root, 25g of pearl powder, 15g of fleeceflower stem, and 15g of stir-fried jujube seed.

[0026] Take the above components and prepare a traditional Chinese medicine decoction according to existing methods for preparing traditional Chinese medicine decoctions.

[0027] For example, the specific method for preparing traditional Chinese medicine decoctions is as follows: The raw materials are decocted twice with water. For the first decoction, add water equivalent to 10 times the total mass of the raw materials, heat to a boil, and maintain a gentle boil for 1 hour. After separation, the first decoction and the dregs are obtained. For the second decoction, take the dregs obtained after the first decoction, add water equivalent to 8 times the total mass of the raw materials, heat to a boil, and maintain a gentle boil for 1 hour. After separation, the second decoction and the dregs are obtained. Combine the first and second decoctions to obtain the final product.

[0028] Example 2 The traditional Chinese medicine decoction for treating hot flashes and sweating syndrome in breast cancer patients in this embodiment is prepared from the following raw materials: 40g of floating wheat, 15g of epimedium, 20g of glutinous rice root, 15g of licorice, 10g of lycium bark, 15g of silver bupleurum, 10g of white peony root, 20g of pearl powder, 20g of fleeceflower stem, and 10g of jujube seed.

[0029] Its preparation method is the same as that of Example 1.

[0030] Example 3 The traditional Chinese medicine decoction for treating hot flashes and sweating syndrome in breast cancer patients in this embodiment is prepared from the following raw materials: 20g of floating wheat, 5g of epimedium, 40g of glutinous rice root, 5g of licorice, 20g of lycium bark, 5g of silver bupleurum, 20g of white peony root, 30g of pearl powder, 10g of fleeceflower stem, and 20g of jujube seed.

[0031] Its preparation method is the same as that of Example 1.

[0032] To verify the therapeutic effect of the traditional Chinese medicine composition of the present invention on hot flashes and sweating syndrome in breast cancer patients, a real-world study was conducted using the traditional Chinese medicine composition of the present invention. The study process and results are as follows: 1. Data Source Information was collected from the outpatient information management system of the Breast Disease Department of Guangdong Provincial Hospital of Traditional Chinese Medicine regarding patients who had taken the herbal composition of this invention for at least 7 days between June 28, 2024 and May 29, 2025, and who had at least one follow-up visit. Data preprocessing was performed using Excel to create a clinical electronic database of this herbal composition.

[0033] 2. Test subjects (1) Case screening inclusion criteria Female patients who have been diagnosed with malignant breast cancer and are currently taking or have taken endocrine therapy within the past 2 years; The patient is diagnosed with a disorder of the Chong and Ren meridians according to traditional Chinese medicine when using the herbal composition of the present invention for the first time. Expected survival ≥ 6 months; Patients with symptoms of hot flashes and sweating; Those who have at least one follow-up evaluation record after taking the traditional Chinese medicine composition of the present invention.

[0034] (2) Exclusion criteria Pregnant women and breastfeeding women; Those who are allergic to the Chinese medicine they are taking.

[0035] 3. Data Extraction (1) Basic Information Basic information includes the patient's age, medical ID, date of visit, and attending physician.

[0036] (2) Diagnostic information Diagnostic information includes surgical procedure, size of invasive carcinoma tumor, surgical pathology (estrogen receptor, progesterone receptor, human epidermal growth factor receptor-2, Ki-67), lymph node status, Western medicine diagnosis, traditional Chinese medicine diagnosis, and traditional Chinese medicine syndrome.

[0037] (3) Medication information All patients were treated with the traditional Chinese medicine decoction prepared according to Example 1 of this invention. The dosage was approximately 200 mL twice daily. The treatment course was 7-30 days (the specific course was determined based on the patient's follow-up appointment time; some patients could have a follow-up appointment after one week, some after two weeks, and some after one month).

[0038] 4. Efficacy evaluation The efficacy evaluation information includes assessments of hot flashes (mild, moderate, severe) and the frequency of nighttime hot flashes. Patients complete a hot flash symptom diary before and after traditional Chinese medicine treatment, and the hot flashes and sweating symptoms are assessed, specifically including: (1) The severity of vasomotor symptoms is assessed as follows: 1. Mild (feeling heat, no sweating); 2. Moderate (feeling heat, sweating, able to continue activity); 3. Severe (feeling heat, sweating, leading to cessation of activity).

[0039] (2) Frequency of vasomotor symptoms.

[0040] (3) Average weekly vasomotor symptom severity score (msVMS-SS) for moderate and severe symptoms = (2 × number of moderate vasomotor symptoms) + (3 × number of severe vasomotor symptoms).

[0041] (4) Total VMS-SS (tVMS-SS) = (1 × number of mild vasomotor symptoms) + (2 × number of moderate vasomotor symptoms) + (3 × number of severe vasomotor symptoms).

[0042] 5. Statistical Analysis Patient-specific before-and-after assessments were conducted, and statistical analysis was performed using SPSS software. Qualitative data were described as frequencies and proportions; quantitative data were described as the number of cases, mean ± standard deviation (if normally distributed), or median (if non-normally distributed). If the change followed (or approximately followed) a normal distribution, a paired-samples t-test was used; if the change did not follow a normal distribution, the Wilcoxon Signed-Rank Test was used as a robust non-parametric test. P A value <0.05 indicates a statistically significant difference.

[0043] 6. Research Results (1) Include patient baseline characteristics Baseline medication and post-treatment data were included for a total of 50 patients. Patient baseline characteristics are shown in Table 1.

[0044] Table 1 Baseline characteristics of included patients

[0045] As shown in Table 1, the average age of the included patients was 49.04 ± 8.694 years, the tumor stage was mainly T2, the estrogen receptor, progesterone receptor, and human epidermal growth factor receptor-2 were mainly positive, Ki-67 was mainly >15%, and the lymph node status was mainly N0.

[0046] (2) Results of efficacy evaluation Table 2 shows the vasomotor symptom scores of patients before and after taking the traditional Chinese medicine composition of the present invention.

[0047] Table 2. Vasomotor symptom scores of patients before and after treatment.

[0048] Note: * indicates that the data after treatment is statistically significant compared with the initial diagnosis data.

[0049] msVMS-SS: Mean weekly severity score of vasomotor symptoms for moderate and severe cases.

[0050] tVMS-SS: Overall mean weekly vasomotor symptom severity score.

[0051] As shown in Table 2, the data before and after treatment did not conform to a normal distribution, so the Wilcoxon signed-rank test was used. After treatment, the number of moderate hot flashes, severe hot flashes, and nocturnal hot flashes in patients decreased significantly, and both the msVMS-SS score and tVMS-SS score decreased significantly, with statistically significant p-values. This indicates that the traditional Chinese medicine composition of the present invention has a good therapeutic effect on hot flash and sweating syndrome in breast cancer patients and can effectively relieve the symptoms of hot flash and sweating.

[0052] 7. Safety evaluation results No adverse reactions were reported in any of the patients during the course of treatment, indicating that the traditional Chinese medicine composition of the present invention has good safety.

[0053] The above research results show that the traditional Chinese medicine composition of the present invention has significant clinical efficacy and good safety in treating hot flashes and sweating syndrome in breast cancer patients.

Claims

1. A traditional Chinese medicine composition for treating hot flashes and sweating syndrome in breast cancer patients, characterized in that, Its main active ingredients, by weight, include: 20-40 parts of wheat bran, 5-15 parts of epimedium, 20-40 parts of glutinous rice root, 5-15 parts of licorice, 10-20 parts of lycium bark, 5-15 parts of stellaria root, 10-20 parts of white peony root, 20-30 parts of mother-of-pearl, 10-20 parts of fleeceflower stem, and 10-20 parts of jujube seed.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, Its main active ingredients, by weight, include: 30 parts of floating wheat, 10 parts of epimedium, 30 parts of glutinous rice root, 10 parts of licorice, 15 parts of lycium bark, 10 parts of silver bupleurum, 15 parts of white peony root, 25 parts of pearl powder, 15 parts of fleeceflower stem, and 15 parts of jujube seed.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The licorice mentioned is roasted licorice, and the jujube seed is stir-fried jujube seed.

4. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Pharmaceutically acceptable excipients can also be added.

5. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The dosage form of the traditional Chinese medicine composition is decoction, oral liquid, granules, tablets, capsules or pills.

6. A method for preparing the traditional Chinese medicine composition for treating hot flashes and sweating syndrome in breast cancer patients according to any one of claims 1-5, characterized in that, When the traditional Chinese medicine composition is a decoction, its preparation method includes the following steps: The raw materials are decocted twice with water. For the first decoction, add 8-10 times the amount of water as the total mass of the raw materials, heat to a boil, and maintain a gentle boil for 1-2 hours. After separation, the first decoction and the dregs are obtained. For the second decoction, take the dregs obtained from the first decoction, add 8-10 times the amount of water as the total mass of the raw materials, heat to a boil, and maintain a gentle boil for 1-2 hours. After separation, the second decoction and the dregs are obtained. Combine the first and second decoctions to obtain the final product.

7. The use of the traditional Chinese medicine composition for treating hot flashes and sweating syndrome in breast cancer patients according to any one of claims 1-5 in the preparation of a medicament for treating hot flashes and sweating syndrome in breast cancer patients.

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