A traditional Chinese medicine composition for treating endometrial cancer and a preparation method and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating endometrial cancer and a preparation method and application thereof. The traditional Chinese medicine composition is mainly prepared from the following raw medicinal materials: oyster, turtle shell, tortoise plastron glue, honeysuckle, astragalus, atractylodes, radix trichosanthis, taxillus, curcuma zedoaria, chicken gizzard, oldenlandia, prunella vulgaris, onosma, water holly fruit, solanum nigrum and so on. The application further discloses a preparation method of the traditional Chinese medicine composition, a pharmaceutical preparation and application. The traditional Chinese medicine composition can effectively treat endometrial cancer, reduce tumor volume, reduce tumor weight, reduce the expression of Ki-67 in tumor tissues, and has the potential to improve the complete remission rate in the treatment of endometrial cancer for preserving the fertility function.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology. More specifically, it relates to a traditional Chinese medicine composition for treating endometrial cancer, its preparation method, and its application. Background Technology

[0002] Endometrial cancer is the second most common cancer of the female reproductive system, with approximately 4% of patients diagnosed before the age of 40, and over 70% of patients having never given birth at the time of diagnosis. Against the backdrop of delayed childbearing age, this epidemiological characteristic has led to a growing demand for fertility-preserving treatments.

[0003] Young patients face a severe conflict between cancer treatment and their desire to have children. Fertility-preserving therapy has become an important clinical option for young patients in the early stages of cancer. However, current progesterone-based fertility-preserving treatments are not effective for all patients, with a general response rate of 70.7% to 81.1%. Approximately 20% to 30% of patients experience progesterone resistance, and the median time to complete remission can reach 17.3 months. This not only increases the risk of disease progression but also prolongs the waiting window for conception, placing a heavy psychological and economic burden on patients.

[0004] Traditional Chinese medicine (TCM) theory holds that the pathogenesis of endometrial cancer is often characterized by liver and kidney yin deficiency, phlegm and blood stasis, and toxin accumulation. The goal of TCM treatment during the complete remission phase is to improve sensitivity to progesterone therapy, shorten the time to achieve complete remission, and thus increase the overall complete remission rate. This has positive clinical significance for overcoming progesterone resistance and helping more young patients achieve cancer cure and realize their dream of having children.

[0005] Therefore, it is necessary to find safer and more effective ways to treat endometrial cancer while preserving fertility. Summary of the Invention

[0006] To address the aforementioned technical problems, one objective of this invention is to provide a novel traditional Chinese medicine composition that can be used to treat endometrial cancer and improve the complete remission rate.

[0007] Another object of the present invention is to provide a method for preparing the above-mentioned traditional Chinese medicine composition.

[0008] Another object of the present invention is to provide a traditional Chinese medicine preparation comprising the above-mentioned traditional Chinese medicine composition.

[0009] Another object of the present invention is to provide the use of the above-mentioned traditional Chinese medicine composition and its pharmaceutical preparation in the preparation of a medicament for treating endometrial cancer.

[0010] To achieve the above objectives, the present invention adopts the following technical solution: In a first aspect, the present invention provides a traditional Chinese medicine composition for treating endometrial cancer, the traditional Chinese medicine composition being mainly made from the following raw materials: oyster shell, turtle shell, tortoise shell glue, honeysuckle, astragalus, atractylodes macrocephala, trichosanthes kirilowii, mulberry mistletoe, turmeric, chicken gizzard lining, oldenlandia diffusa, prunella vulgaris, scutellaria barbata, water lily seeds, black nightshade fruit, and purslane.

[0011] Preferably, the traditional Chinese medicine composition is mainly made from the following raw materials in parts by weight: 20-30 parts oyster shell, 10-20 parts turtle shell, 5-10 parts tortoise shell glue, 15-30 parts honeysuckle, 20-30 parts astragalus, 12-20 parts atractylodes macrocephala, 9-15 parts trichosanthes kirilowii, 12-15 parts mulberry mistletoe, 9-12 parts turmeric, 9-15 parts chicken gizzard lining, 15-30 parts oldenlandia diffusa, 9-15 parts prunella vulgaris, 9-15 parts hedyotis diffusa, 9-15 parts water lily seeds, 10-20 parts black nightshade fruit, and 15-30 parts purslane.

[0012] Women's constitution is based on the liver and kidneys, and endometrial cancer patients generally suffer from liver and kidney deficiency and imbalance of the Chong and Ren meridians. Kidney deficiency, imbalance of the Chong and Ren meridians, insufficient essence and blood, and lack of nourishment for the liver easily lead to qi stagnation and phlegm accumulation, obstructing the meridians, hindering blood circulation, and causing phlegm and blood stasis to combine and form masses. Insufficient vital energy allows cancerous toxins to invade and linger. The combination of phlegm, toxins, and blood stasis eventually forms a tumor. Therefore, treatment should focus on soothing the liver and kidneys, supporting the body's resistance and eliminating pathogenic factors, and resolving phlegm and blood stasis. Young patients with endometrial cancer who are also obese, have polycystic ovary syndrome, or are infertile often have a pathogenesis involving phlegm-dampness retention and blood stasis. Phlegm is a pathological product of impaired fluid circulation and is related to the spleen and kidneys. When the spleen fails to function properly, it cannot ascend clear fluids and descend turbid fluids, thus failing to properly distribute and transform fluids, resulting in the internal generation of phlegm-dampness. The kidneys govern water and support and regulate the metabolism of body fluids throughout the body. When kidney essence is insufficient, water loses its control, and fluids overflow as phlegm. For these patients, traditional Chinese medicine treatment, in addition to regulating the liver and kidneys, should also focus on strengthening the spleen to ensure its proper function and normal production and transportation of body fluids.

[0013] This formula uses oyster shell, turtle shell, and tortoise shell glue as the chief ingredients. These three are salty and cold in nature, excelling at softening hard masses, dispersing nodules, nourishing yin, and suppressing yang, directly targeting the nodules of endometrial cancer. Oyster shell and turtle shell are particularly effective at softening hard masses, while tortoise shell glue excels at nourishing yin. The three herbs combined soften hard masses without harming yin, and nourish yin without retaining pathogenic factors. Honeysuckle, oldenlandia diffusa, prunella vulgaris, black nightshade fruit, purslane, and trichosanthes kirilowii are used as assistant ingredients. These six herbs work synergistically to clear heat and detoxify to eliminate tumors, nourish yin and generate fluids to prevent dryness and heat. The formula combines clearing and detoxifying with yin-protecting properties, ensuring that heat and toxins are eliminated without harming the body's vital energy, thus assisting the chief ingredients in achieving the effect of softening hard masses and dispersing nodules. Astragalus membranaceus and atractylodes macrocephala are used as adjuvant ingredients to invigorate qi and strengthen the spleen, supporting the body's vital energy; mulberry mistletoe tonifies the liver and kidneys, consolidating the foundation and nourishing the source. These three herbs combined support the body's vital energy to resist pathogenic factors, ensuring that the attack on pathogenic factors does not harm the body's vital energy. Curcuma zedoaria, Polygonum hydropiper, Hedyotis diffusa, and chicken gizzard membrane are used as adjuvant and guiding ingredients. The combination of these four herbs focuses on promoting blood circulation, eliminating masses, removing blood stasis, clearing the meridians, and eliminating stagnation, thus assisting the principal herb in dispersing nodules. Furthermore, their active nature allows them to guide the other herbs directly to the uterus, breaking up stagnation and allowing the medicinal effects to be realized.

[0014] For example, the traditional Chinese medicine composition may be mainly made from the following raw materials in parts by weight: 30 parts oyster shell, 15 parts turtle shell, 5 parts tortoise shell glue, 15 parts honeysuckle, 30 parts astragalus, 15 parts atractylodes macrocephala, 9 parts trichosanthes kirilowii, 12 parts mulberry mistletoe, 9 parts turmeric, 9 parts chicken gizzard lining, 15 parts oldenlandia diffusa, 12 parts prunella vulgaris, 15 parts hedyotis diffusa, 12 parts water lily seeds, 10 parts black nightshade fruit, and 30 parts purslane.

[0015] For example, the traditional Chinese medicine composition may be mainly made from the following raw materials in parts by weight: 20 parts oyster shell, 10 parts turtle shell, 5 parts tortoise shell glue, 15 parts honeysuckle, 20 parts astragalus, 12 parts atractylodes macrocephala, 9 parts trichosanthes kirilowii, 12 parts mulberry mistletoe, 9 parts turmeric, 9 parts chicken gizzard lining, 15 parts oldenlandia diffusa, 9 parts prunella vulgaris, 9 parts hedyotis diffusa, 9 parts water lily seeds, 10 parts black nightshade fruit, and 15 parts purslane.

[0016] For example, the traditional Chinese medicine composition may be mainly made from the following raw materials in parts by weight: 30 parts oyster shell, 20 parts turtle shell, 10 parts tortoise shell glue, 30 parts honeysuckle, 30 parts astragalus, 20 parts atractylodes macrocephala, 15 parts trichosanthes kirilowii, 15 parts mulberry mistletoe, 12 parts turmeric, 15 parts chicken gizzard lining, 30 parts oldenlandia diffusa, 15 parts prunella vulgaris, 15 parts hedyotis diffusa, 15 parts water lily seeds, 20 parts black nightshade fruit, and 30 parts purslane.

[0017] The basic formula of each raw material in the above-mentioned traditional Chinese medicine composition of the present invention can be adjusted based on the actual clinical symptoms to enhance the adaptability of the composition of the present invention and improve the therapeutic effect.

[0018] Secondly, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition for treating endometrial cancer, the method comprising the following steps: Weigh out each ingredient according to the formula, soak in water for 30-40 minutes, and decoct twice. For the first decoction, bring to a boil over high heat and then simmer over low heat for 40 minutes. For the second decoction, bring to a boil over high heat and then simmer over low heat for 30 minutes. After each decoction, filter the liquid and combine the two filtrates to obtain the final product.

[0019] Furthermore, to facilitate storage and use in the preparation of various drug dosage forms, the above preparation method may also include a step of concentrating the filtrate into a clear extract.

[0020] Thirdly, the present invention provides a traditional Chinese medicine preparation for treating endometrial cancer, wherein the traditional Chinese medicine preparation uses the above-mentioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above-mentioned preparation method as the active ingredient.

[0021] Furthermore, depending on the actual dosage form requirements, the traditional Chinese medicine preparation may also include pharmaceutically acceptable excipients, such as binders, disintegrants, lubricants, fillers, suspending agents, etc. Various preparations are then manufactured using conventional pharmaceutical processes, such as decoctions, granules, pills, capsules, tablets, powders, oral liquids, etc.

[0022] The present invention also provides the application of the above-mentioned traditional Chinese medicine composition or preparation in the preparation of a drug for treating endometrial cancer.

[0023] In addition, unless otherwise specified, all raw materials of the traditional Chinese medicine composition of the present invention can be obtained commercially available. Any traditional Chinese medicine composition of any range described in the present invention, including any value between the endpoints and any sub-ranges formed by the endpoints or any value between the endpoints, can achieve the purpose of treating endometrial cancer.

[0024] The beneficial effects of this invention are as follows: The traditional Chinese medicine composition of this invention can effectively treat endometrial cancer, reduce tumor volume and weight, decrease Ki-67 expression in tumor tissue, and has the potential to improve the complete remission rate in fertility-preserving treatment of endometrial cancer. Attached Figure Description

[0025] Figure 1 The tumor growth curves of each group of mice are shown.

[0026] Figure 2 This invention demonstrates the effect of the traditional Chinese medicine composition on Ki-67 expression in mouse xenograft tissue.

[0027] Figure 3 The diagram shows the complete remission curve of the traditional Chinese medicine composition of the present invention combined with Western medicine as a fertility-preserving treatment regimen for endometrial cancer. Detailed Implementation

[0028] To more clearly illustrate the present invention, the following description, in conjunction with preferred embodiments, further clarifies the invention. Those skilled in the art should understand that the specific descriptions below are illustrative rather than restrictive, and should not be construed as limiting the scope of protection of the present invention.

[0029] Example 1: A traditional Chinese medicine composition for treating endometrial cancer Raw material formula: 30g oyster shell, 15g turtle shell, 5g tortoise shell glue, 15g honeysuckle, 30g astragalus, 15g atractylodes macrocephala, 9g trichosanthes root, 12g mulberry mistletoe, 9g turmeric, 9g chicken gizzard lining, 15g oldenlandia diffusa, 12g prunella vulgaris, 15g scutellaria barbata, 12g water lily seeds, 10g black nightshade fruit, 30g purslane.

[0030] Weigh each ingredient according to the formula, soak in water for 30-40 minutes, and decoct twice. For the first decoction, bring to a boil over high heat and then simmer over low heat for 40 minutes. For the second decoction, bring to a boil over high heat and then simmer over low heat for 30 minutes. Filter after each decoction and combine the two filtrates to obtain the final product.

[0031] Example 2: A traditional Chinese medicine composition for treating endometrial cancer Raw material formula: 20g oyster shell, 10g turtle shell, 5g tortoise shell glue, 15g honeysuckle, 20g astragalus, 12g atractylodes macrocephala, 9g trichosanthes root, 12g mulberry mistletoe, 9g turmeric, 9g chicken gizzard lining, 15g oldenlandia diffusa, 9g prunella vulgaris, 9g scutellaria barbata, 9g water lily seeds, 10g black nightshade fruit, 15g purslane.

[0032] Weigh each raw material according to the formula, soak in water for 30-40 minutes, and decoct twice. For the first decoction, bring to a boil over high heat and then simmer over low heat for 40 minutes. For the second decoction, bring to a boil over high heat and then simmer over low heat for 30 minutes. Filter after each decoction, combine the two filtrates, and then concentrate into a clear extract (a clear extract with a relative density of 1.24-1.30 measured at 50℃). Dry under reduced pressure to obtain the final product.

[0033] Example 3: A traditional Chinese medicine preparation (granules) for treating endometrial cancer. Raw material formula: 30g oyster shell, 20g turtle shell, 10g tortoise shell glue, 30g honeysuckle, 30g astragalus, 20g atractylodes macrocephala, 15g trichosanthes root, 15g mulberry mistletoe, 12g turmeric, 15g chicken gizzard lining, 30g oldenlandia diffusa, 15g prunella vulgaris, 15g scutellaria barbata, 15g water lily seeds, 10g black nightshade fruit, 30g purslane.

[0034] The preparation method is the same as in Example 2, and further includes preparing the extract into granules according to the granulation process.

[0035] Example 4: Efficacy experiment of the traditional Chinese medicine composition of the present invention in treating endometrial cancer. I. Animal Experiments 1. Laboratory animals Thirty female BABL / C nude mice, aged 8-10 weeks, weighing 20±2g, were selected.

[0036] 2. Experimental drugs (1) The herbal composition of this invention comprises: 30g oyster shell, 15g turtle shell, 5g tortoise shell glue, 15g honeysuckle, 30g astragalus, 15g atractylodes macrocephala, 9g trichosanthes root, 12g mulberry mistletoe, 9g turmeric, 9g chicken gizzard lining, 15g oldenlandia diffusa, 12g prunella vulgaris, 15g hedyotis diffusa, 12g water lily seeds, 10g black nightshade fruit, and 30g purslane. The herbal pieces were purchased from the pharmacy of Guang'anmen Hospital, China Academy of Chinese Medical Sciences. They were soaked in 10 times their volume of water for 30 minutes, decocted twice, and the decoctions were combined, heated and concentrated, and then stored in a refrigerator at 4 ℃ for later use. The medium-dose concentration was calculated by converting the human dosage to the mouse equivalent dose; 0.5 times the medium-dose concentration was set as the low-dose concentration, and 2 times the medium-dose concentration was set as the high-dose concentration.

[0037] (2) Medroxyprogesterone acetate tablets: 160 mg / tablet, crushed into powder and dissolved by stirring and shaking in 0.5% sodium carboxymethyl cellulose (CMC-Na) solution to form a uniform milky white suspension, stored at 4 ℃ for later use. Administer the equivalent dose of medroxyprogesterone acetate by gavage.

[0038] 3. Modeling After 3 days of acclimatization, 0.2 mL of tumor cell suspension (approximately 3.2 × 10⁻⁶ cells) was measured using a 1 mL syringe under sterile conditions in a laminar flow hood. 6 Each mouse was placed on ice for temporary storage. Subsequently, the skin on the back of the right forelimb of the nude mouse was sterilized with an alcohol swab, and the prepared 0.2 mL suspension was injected subcutaneously into the right scapular region of each mouse. After inoculation, the nude mice were returned to their original cages, and the injection sites were monitored daily for any abnormalities such as inflammation or damage, while the growth rate of the tumor was recorded. The presence or palpable small nodules at the injection site were considered criteria for tumor formation.

[0039] 4. Intervention After tumor formation, patients were randomly divided into 5 groups based on body weight and tumor volume: ① simple tumor-bearing group, ② low-dose traditional Chinese medicine group, ③ medium-dose traditional Chinese medicine group, ④ high-dose traditional Chinese medicine group, and ⑤ medroxyprogesterone acetate group.

[0040] The medication was administered for 14 days. Specific dosages were as follows: ① Tumor-bearing group: 0.5% CMC-Na administered by gavage. ② Low-dose traditional Chinese medicine group: 243g ÷ 60kg × 9.1 times × average mouse weight 0.02kg × 0.5 = 0.369g per mouse per day, 0.4 mL per day, with a crude drug concentration of 3.69g / mL. ③ Medium-dose traditional Chinese medicine group: Human equivalent dose of traditional Chinese medicine administered by gavage (243g ÷ 60kg × 9.1 times × average mouse weight 0.02kg = 0.737g per mouse per day). ④ High-dose traditional Chinese medicine group: 243g ÷ 60kg × 9.1 times × average mouse weight 0.02kg × 2 = 1.474g per mouse per day. ⑤ Medroxyprogesterone group: medroxyprogesterone equivalent to human dose (160mg ÷ 60kg × 9.1 × average mouse weight 0.02kg = 0.486mg) was administered by gavage.

[0041] 5. Observation indicators: (1) Tumor inhibition rate; (2) Tumor volume; (3) Ki-67 expression in tumor tissue.

[0042] 6. Results like Figure 1 As shown in Table 1, the tumor growth rate in each treatment group was slowed down to varying degrees compared to the tumor-bearing group, exhibiting a dose-dependent tumor inhibition trend. Among them, the high-dose group of the traditional Chinese medicine composition of this invention showed the most prominent tumor inhibition effect. Figure 2 As shown, compared with the tumor-bearing group alone, the average optical density of Ki-67 decreased in the low, medium, and high dose groups of the traditional Chinese medicine composition of this invention, as well as in the medroxyprogesterone acetate group. This suggests that the traditional Chinese medicine can reduce Ki-67 expression in tumor tissue and inhibit the proliferation activity of tumor cells.

[0043] Table 1. Effects of traditional Chinese medicine on terminal tumor volume and weight of transplanted tumors in mice (χ² ± s)

[0044] Note: Compared with the tumor-bearing group alone, *P<0.05, **P<0.01.

[0045] II. Clinical Research 1. Diagnostic criteria Western medicine diagnostic criteria: Meets the diagnostic criteria in the FIGO 2018 Cancer Report: Endometrial Cancer Diagnosis and Treatment Guidelines: Endometrial cancer IA G1-G2 stage.

[0046] Traditional Chinese Medicine syndrome diagnosis criteria: conforms to the syndrome of liver and kidney yin deficiency, phlegm and blood stasis.

[0047] 2. Inclusion criteria ① Meets the Western medicine diagnostic criteria for endometrial cancer; ② Meets the traditional Chinese medicine diagnostic criteria for endometrial cancer; ③ Age ≤ 45 years, with a strong desire to have children; ④ Both estrogen and progesterone receptors are positive; ⑤ Peripheral blood CA125 is normal; ⑥ Molecular subtype is non-specific; ⑦ No contraindications to progesterone therapy; ⑧ Fertility function was assessed before treatment, with no other fertility-related factors; ⑨ Informed consent was signed, and there are good follow-up conditions.

[0048] 3. Exclusion Criteria ① Patients with serious internal medical conditions and severely impaired liver and kidney function; ② Patients with allergies or contraindications to therapeutic drugs; ③ Patients with other types of endometrial cancer or other malignant tumors of the reproductive system; ④ Patients with breast cancer or other hormone-dependent tumors that cannot use progesterone; ⑤ Patients who request hysterectomy or other treatment methods other than conservative drug treatment; ⑥ Patients with deep vein thrombosis, stroke, or myocardial infarction.

[0049] 4. Rejection and shedding criteria Patients were excluded if they met any of the following criteria: participating in multiple clinical trials simultaneously; failing to take medication and receive treatment as prescribed; experiencing intolerable adverse reactions; being lost to follow-up; or voluntarily withdrawing their informed consent.

[0050] 5. General Information The cases were collected from outpatients and inpatients who visited Guang'anmen Hospital of the China Academy of Chinese Medical Sciences, Peking University People's Hospital, and Beijing Chaoyang Hospital affiliated to Capital Medical University between January 1, 2023, and June 30, 2025. A total of 60 patients who met the inclusion and exclusion criteria were included.

[0051] 6. Treatment methods Western medicine treatment: Standardized treatment was given in accordance with the "Expert Consensus on Fertility-Preserving Treatment for Early Endometrial Cancer (2022 Edition)". Traditional Chinese medicine treatment: Oyster shell 30g, turtle shell 15g, tortoise shell glue 5g, honeysuckle 15g, astragalus 30g, atractylodes macrocephala 15g, trichosanthes root 9g, mulberry mistletoe 12g, turmeric 9g, chicken gizzard lining 9g, oldenlandia diffusa 15g, prunella vulgaris 12g, rockwort 15g, water lily seed 12g, black nightshade fruit 10g, purslane 30g. A decoction was prepared according to the method in Example 1. 300ml of the decoction was taken orally, one dose per day, twice a day, for 5 days with a 2-day break.

[0052] 7. Observation Indicators and Methods (1) CR rate (complete remission rate); (2) Time to achieve complete remission.

[0053] 8. Results like Figure 3As shown, the CR rate was 83.3%, and the median time to complete remission (mTTCR) was 9 months [(s = 1.452, 95% CI (6.153-11.847)). 41 patients (68.3%) did not achieve CR within 6 months, indicating progesterone resistance. Of these 41 progesterone-resistant patients, 31 eventually achieved CR, resulting in a CR rate of 75.61%, and the mTTCR was 16 months [s = 1.889, 95% CI (12.298-19.702)]. This indicates that the herbal composition of this invention can also promote tumor remission in patients resistant to Western medicine.

[0054] Improving the complete remission rate is the primary prerequisite for successful fertility-preserving treatment of endometrial cancer. Previous studies have shown that the complete remission rate of patients with early-stage endometrial cancer receiving progestin-only therapy is mostly between 70% and 80%, and a considerable proportion of patients still have primary drug resistance or poor response.

[0055] In this study, the overall complete remission (CR) rate after standard treatment with traditional Chinese medicine combined with Western medicine reached 83.3% (95% CI: 71.5%–91.7%), with a median time to complete remission of 9 months. Compared with the meta-analysis results cited in current domestic consensus, the CR rate of progesterone therapy alone was 76.3% (95% CI: 70.7%–81.1%), and the CR rate of LNG-IUS combined with GnRH-a / progesterone therapy was 72.9% (95% CI: 60.4%–82.5%). Although there are differences among different studies in terms of inclusion criteria, treatment regimens, and follow-up periods, and the confidence intervals partially overlap, the point estimate of the combined treatment regimen in this study is higher than that of previous historical data, suggesting that the combination of traditional Chinese and Western medicine has the potential to improve the complete remission rate.

[0056] Example 5 Typical Case Case: Ms. Sun, female, 28 years old. First visit on April 14, 2025, chief complaint: diagnosed with endometrial cancer 1 year and 4 months ago, with poor results from fertility-preserving treatment.

[0057] Present Illness: In December 2023, the patient underwent hysteroscopy due to irregular menstruation. Pathology showed endometrial cancer, grade I, IHC: ER (80%, +++), PR (90%, +++), P53 (wild-type), MSH-2 (+), MSH-6 (+), PMS-2 (+), MLH-1 (+), Ki-67 (50%). The patient had a strong desire to have children and underwent fertility-preserving treatment after being fully informed. Considering the patient's hyperlipidemia, medroxyprogesterone acetate and atorvastatin calcium were prescribed. A follow-up hysteroscopy in June 2024 showed pathology consistent with post-treatment changes in endometrial cancer, with partial remission (30% complete remission area, 70% partial remission area). The treatment plan was adjusted to leuprorelin + Mirena. A follow-up hysteroscopy in December 2024 showed pathology: partial remission (30% complete remission area, 70% partial remission area). Genetic testing revealed a TP53 gene mutation. Due to poor treatment efficacy, the regimen was adjusted to 4 cycles of bevacizumab plus epirubicin chemotherapy. A follow-up hysteroscopy in April 2025 revealed partial remission (20% complete response area, 80% partial response area). Current condition: Good appetite and sleep, regular bowel movements. Tongue and pulse: Pale red tongue with thin white coating, wiry pulse. Past medical history: Hyperlipidemia. Family history: Grandmother had thyroid cancer. Prescription: Oyster shell 30g, turtle shell 15g, tortoise shell glue 5g, honeysuckle 15g, astragalus 30g, raw atractylodes macrocephala 15g, trichosanthes root 12g, mulberry mistletoe 12g, turmeric 9g, chicken gizzard lining 9g, oldenlandia diffusa 15g, prunella vulgaris 12g, scutellaria barbata 15g, water lily seed 12g, black nightshade fruit 10g, purslane 15g, 21 doses. Follow-up visits every 2 months, with adjustments made according to the patient's condition.

[0058] A follow-up hysteroscopy in June 2025 showed pathology consistent with post-treatment changes in endometrial cancer, with partial remission of the lesion (50% complete reaction area and 50% partial reaction area). A follow-up hysteroscopy in December 2025 showed pathology consistent with post-treatment changes in endometrial cancer, with partial remission of the lesion (70% complete reaction area and 30% partial reaction area).

[0059] In this case, during the initial stage of Western medicine treatment alone, the patient's complete remission rate remained stagnant between 20% and 30%, suggesting that endometrial cancer exhibits primary or acquired resistance to progestins and chemotherapy drugs. After combining this traditional Chinese medicine compound with continued Western medicine convalescent therapy, the complete remission rate increased to 50% within 2 months and further to 70% after 8 months, indicating that this traditional Chinese medicine compound has a synergistic therapeutic effect in overcoming drug resistance and promoting the complete regression of endometrial cancer lesions.

[0060] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. For those skilled in the art, other variations or modifications can be made based on the above description. It is impossible to exhaustively list all the implementation methods here. All obvious variations or modifications derived from the technical solutions of the present invention are still within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating endometrial cancer, characterized in that, The traditional Chinese medicine composition is mainly made from the following raw materials: oyster shell, turtle shell, tortoise shell glue, honeysuckle, astragalus, atractylodes macrocephala, trichosanthes kirilowii, mulberry mistletoe, turmeric, chicken gizzard lining, oldenlandia diffusa, prunella vulgaris, rock hemp seed, water lily seed, black nightshade fruit, and purslane.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is mainly made from the following raw materials in parts by weight: oyster shell 20-30 parts, turtle shell 10-20 parts, tortoise shell glue 5-10 parts, honeysuckle 15-30 parts, astragalus 20-30 parts, atractylodes macrocephala 12-20 parts, trichosanthes kirilowii 9-15 parts, mulberry mistletoe 12-15 parts, turmeric 9-12 parts, chicken gizzard lining 9-15 parts, oldenlandia diffusa 15-30 parts, prunella vulgaris 9-15 parts, scutellaria barbata 9-15 parts, water lily seed 9-15 parts, black nightshade fruit 10-20 parts, and purslane 15-30 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is mainly made from the following raw materials in parts by weight: 30 parts oyster shell, 15 parts turtle shell, 5 parts tortoise shell glue, 15 parts honeysuckle, 30 parts astragalus, 15 parts atractylodes macrocephala, 9 parts trichosanthes kirilowii, 12 parts mulberry mistletoe, 9 parts turmeric, 9 parts chicken gizzard lining, 15 parts oldenlandia diffusa, 12 parts prunella vulgaris, 15 parts hedyotis diffusa, 12 parts water lily seeds, 10 parts black nightshade fruit, and 30 parts purslane.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is mainly made from the following raw materials in parts by weight: 20 parts oyster shell, 10 parts turtle shell, 5 parts tortoise shell glue, 15 parts honeysuckle, 20 parts astragalus, 12 parts atractylodes macrocephala, 9 parts trichosanthes kirilowii, 12 parts mulberry mistletoe, 9 parts turmeric, 9 parts chicken gizzard lining, 15 parts oldenlandia diffusa, 9 parts prunella vulgaris, 9 parts hedyotis diffusa, 9 parts water lily seeds, 10 parts black nightshade fruit, and 15 parts purslane.

5. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is mainly made from the following raw materials in parts by weight: 30 parts oyster shell, 20 parts turtle shell, 10 parts tortoise shell glue, 30 parts honeysuckle, 30 parts astragalus, 20 parts atractylodes macrocephala, 15 parts trichosanthes kirilowii, 15 parts mulberry mistletoe, 12 parts turmeric, 15 parts chicken gizzard lining, 30 parts oldenlandia diffusa, 15 parts prunella vulgaris, 15 parts hedyotis diffusa, 15 parts water lily seeds, 20 parts black nightshade fruit, and 30 parts purslane.

6. A method for preparing the traditional Chinese medicine composition for treating endometrial cancer according to any one of claims 1-5, characterized in that, The preparation method includes the following steps: Weigh out each ingredient according to the formula, soak in water for 30-40 minutes, and decoct twice. For the first decoction, bring to a boil over high heat and then simmer over low heat for 40 minutes. For the second decoction, bring to a boil over high heat and then simmer over low heat for 30 minutes. After each decoction, filter the liquid and combine the two filtrates to obtain the final product.

7. The preparation method according to claim 6, characterized in that, The preparation method also includes the step of concentrating the filtrate into a clear paste.

8. A traditional Chinese medicine preparation for treating endometrial cancer, characterized in that, The traditional Chinese medicine preparation uses the traditional Chinese medicine composition according to any one of claims 1-5 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 6 or 7 as the active ingredient; Preferably, the traditional Chinese medicine preparation further includes pharmaceutically acceptable excipients.

9. The traditional Chinese medicine preparation according to claim 8, characterized in that, The dosage forms of the traditional Chinese medicine preparations are decoctions, granules, pills, capsules, tablets, powders, or oral liquids.

10. The use of the traditional Chinese medicine composition for treating endometrial cancer according to any one of claims 1-5 or the traditional Chinese medicine preparation for treating endometrial cancer according to any one of claims 8-9 in the preparation of a medicament for treating endometrial cancer.

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