Pharmaceutical composition and application thereof in preparation of medicine for treating ovarian cancer

Abstract

The invention provides a pharmaceutical composition and application thereof in preparation of medicines for treating ovarian cancer, and the pharmaceutical composition is prepared from the following components in parts by weight: 5-20 parts of cortex phellodendri, 5-20 parts of rhizoma atractylodis, 5-20 parts of radix achyranthis bidentatae, 5-20 parts of oldenlandia diffusa, 5-20 parts of radix trichosanthis, 5-20 parts of cassia twig, 20-40 parts of radix astragali and 20-40 parts of semen coicis. The pharmaceutical composition provided by the invention is suitable for ovarian cancer postoperative combined chemotherapy, and can significantly reduce the incidence rate of adverse reactions of chemotherapy, improve the chemotherapy effect and compliance, and reduce the toxic and side effects of chemotherapy drugs.

Description

Technical Field

[0001] This application relates to the field of traditional Chinese medicine technology, and in particular to a pharmaceutical composition and its use in the preparation of a drug for treating ovarian cancer. Background Technology

[0002] Ovarian cancer is a serious gynecological malignancy that threatens women's lives and health, with a 5-year survival rate of less than 45% and the highest mortality rate among gynecological malignancies. The current standard treatment for ovarian cancer is maximal cytoreductive surgery combined with platinum-based chemotherapy, which can achieve a relatively good remission rate. However, adverse reactions, recurrence, and drug resistance remain, affecting treatment outcomes. In recent years, targeted therapies, represented by PARP inhibitors, have been used for maintenance therapy in BRCA gene-mutated ovarian cancer, improving the prognosis of ovarian cancer patients. However, the number of patients benefiting from these therapies remains limited, and drug resistance remains an unavoidable issue. Achieving long-term remission and realizing the chronic management of ovarian cancer is an important direction for clinical exploration. Currently, there is a lack of traditional Chinese medicine compositions that can be used for postoperative combined chemotherapy or maintenance therapy after chemotherapy for ovarian cancer. Summary of the Invention

[0003] The purpose of this application is twofold. First, to provide a pharmaceutical composition and its use in the preparation of a drug for treating ovarian cancer. This pharmaceutical composition is suitable for postoperative combined chemotherapy for ovarian cancer, significantly reducing the incidence of adverse chemotherapy reactions, improving chemotherapy efficacy and patient compliance, and reducing the toxic side effects of chemotherapy drugs. Second, to provide a pharmaceutical composition and its use in the preparation of a drug for treating ovarian cancer. This pharmaceutical composition is suitable for maintenance therapy of ovarian cancer, reducing ovarian cancer recurrence and improving patients' quality of life. The specific technical solution is as follows:

[0004] The first aspect of this application provides a pharmaceutical composition, wherein the pharmaceutical composition comprises, by weight, 5-20 parts of Phellodendron bark, 5-20 parts of Atractylodes lancea rhizome, 5-20 parts of Achyranthes bidentata root, 5-20 parts of Hedyotis diffusa herb, 5-20 parts of Trichosanthes kirilowii root, 5-20 parts of Cinnamon twig, 20-40 parts of Astragalus membranaceus root, and 20-40 parts of Coix seed.

[0005] In some embodiments of this application, the pharmaceutical composition comprises, by weight, 5-15 parts of Phellodendron bark, 5-15 parts of Atractylodes lancea rhizome, 5-15 parts of Achyranthes bidentata root, 5-15 parts of Hedyotis diffusa herb, 5-15 parts of Trichosanthes kirilowii root, 5-15 parts of Cinnamon twig, 25-35 parts of Astragalus membranaceus root, and 25-35 parts of Coix seed.

[0006] The second aspect of this application provides another pharmaceutical composition, wherein the pharmaceutical composition comprises, by weight, 5-20 parts of Phellodendron bark, 5-20 parts of Atractylodes lancea rhizome, 5-20 parts of Achyranthes bidentata root, 5-20 parts of Hedyotis diffusa herb, 20-40 parts of Coix seed, 5-20 parts of ginseng, 5-20 parts of Poria cocos, and 5-20 parts of cinnamon bark.

[0007] In some embodiments of this application, the pharmaceutical composition comprises, by weight, 5-15 parts of Phellodendron bark, 5-15 parts of Atractylodes lancea rhizome, 5-15 parts of Achyranthes bidentata root, 5-15 parts of Hedyotis diffusa herb, 25-35 parts of Coix seed, 5-15 parts of ginseng, 5-15 parts of Poria cocos, and 5-15 parts of cinnamon bark.

[0008] In some embodiments of this application, the pharmaceutical composition further includes a pharmaceutically acceptable carrier or excipient.

[0009] In some embodiments of this application, the pharmaceutically acceptable carrier or excipient is selected from at least one of solvents, diluents, disintegrants, precipitation inhibitors, surfactants, flow aids, binders, lubricants, dispersants, suspending agents, isotonic agents, thickeners, emulsifiers, preservatives, stabilizers, hydrating agents, emulsification accelerators, buffers, absorbents, colorants, flavorings, sweeteners, ion exchangers, release agents, coating agents, flavoring agents, and antioxidants.

[0010] In some embodiments of this application, the pharmaceutical composition is formulated as a pharmaceutically acceptable preparation.

[0011] In some embodiments of this application, the pharmaceutical composition is formulated as any one of the following dosage forms: powder, decoction, tablet, capsule, pill, drop pill, or suspension.

[0012] A third aspect of this application provides a composition comprising: the pharmaceutical composition described in the first aspect of this application, and / or the pharmaceutical composition described in the second aspect of this application.

[0013] A fourth aspect of this application provides the use of a pharmaceutical composition described in the first or second aspect of this application, or a composition described in the third aspect of this application, in the preparation of a medicament for treating ovarian cancer; preferably, the medicament for treating ovarian cancer includes a medicament for adjuvant therapy during chemotherapy for ovarian cancer and / or a medicament for maintenance therapy for ovarian cancer.

[0014] In some embodiments of this application, the ovarian cancer is a damp-heat accumulation type of ovarian cancer; preferably, the damp-heat accumulation type of ovarian cancer is selected from at least one of ovarian serous cystadenocarcinoma, ovarian mucinous cystadenocarcinoma, and ovarian endometrioid carcinoma.

[0015] The beneficial effects of this application are:

[0016] The pharmaceutical composition provided in this application is suitable for combined chemotherapy after ovarian cancer surgery. It can significantly reduce the incidence of adverse reactions to chemotherapy, improve the efficacy and compliance of chemotherapy, and reduce the toxic side effects of chemotherapy drugs. When the pharmaceutical composition includes ginseng, poria cocos and cinnamon, it can be used for maintenance therapy after ovarian cancer chemotherapy, improve the quality of life of ovarian cancer patients, delay recurrence, and effectively improve the prognosis of ovarian cancer.

[0017] Of course, implementing any product or method of this application does not necessarily require achieving all of the advantages described above at the same time. Detailed Implementation

[0018] The technical solutions of this application will be clearly and completely described below with reference to the embodiments of this application. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. All other embodiments obtained by those skilled in the art based on this application are within the scope of protection of this application.

[0019] The first aspect of this application provides a pharmaceutical composition, wherein the pharmaceutical composition comprises, by weight, 5-20 parts of Phellodendron bark, 5-20 parts of Atractylodes lancea rhizome, 5-20 parts of Achyranthes bidentata root, 5-20 parts of Hedyotis diffusa herb, 5-20 parts of Trichosanthes kirilowii root, 5-20 parts of Cinnamon twig, 20-40 parts of Astragalus membranaceus root, and 20-40 parts of Coix seed.

[0020] The ovaries, belonging to the uterus and located in the lower abdomen (yin position), are susceptible to external dampness. If the liver, spleen, and kidneys are dysfunctional, and the Chong and Ren meridians are deficient, dampness generated by the internal organs and meridians descends to the uterus and Chong meridians. Over time, this dampness accumulates, solidifies, and transforms into toxins, generating internal damp-toxins. If the pathogenic factors are excessive and the body's resistance is weak, the body is unable to resist the pathogenic factors, leading to a buildup of damp-toxins and eventually cancer. Cancerous tumors obstruct the meridians, hindering the flow of qi and blood, depriving the internal organs of nourishment, and causing functional disorders. Cancerous toxins then migrate along the Chong and Ren meridians to the internal organs, accumulating in deficient areas and forming sites of ovarian cancer metastasis. Based on this, the inventors of this application propose the "damp-toxin theory" of ovarian cancer pathogenesis. Treatment focuses on eliminating damp-toxins and strengthening the body's resistance, with the elimination of damp-toxins being a consistent principle throughout the treatment process. Traditional Chinese medicine as an adjunct therapy can effectively compensate for the shortcomings of Western medicine, improve treatment efficacy, reduce side effects, prevent postoperative recurrence, improve overall condition, and thus improve the patient's quality of life.

[0021] During chemotherapy after ovarian cancer surgery, most of the dampness and toxins have been eliminated. However, chemotherapy drugs are considered to be heat-inducing, which depletes qi and yin. The pathogenesis at this stage is characterized by lingering dampness and toxins and deficiency of both qi and yin. Therefore, the treatment principle is to clear dampness and toxins, eliminate pathogenic factors, nourish yin and replenish qi, and strengthen the body's resistance. The treatment uses the Si Miao Jie Du Fang (Four Marvels Detoxification Formula), which is a modified version of the classic Chinese medicine formula Si Miao Wan (Phellodendron bark, Atractylodes lancea, Achyranthes bidentata, and Coix seed). In this formula, Phellodendron bark and Hedyotis diffusa are the principal herbs, working together to clear dampness and toxins, while Atractylodes lancea and Trichosanthes kirilowii are the assistant herbs. The formula consists of four herbs: Astragalus membranaceus (Huang Qi) and Coix lacryma-jobi (Yi Ren). Astragalus membranaceus (Huang Qi) tonifies the vital energy, while Coix lacryma-jobi (Yi Ren) clears heat, eliminates dampness, and detoxifies, helping to expel pathogens. As adjuvant herbs, Achyranthes bidentata (Niu Xi) nourishes the liver and kidneys and guides the medicine to the Chong and Ren meridians. Cinnamomum cassia (Gui Zhi) warms the meridians and unblocks the collaterals, guiding the medicines to the extremities. As guiding herbs, this formula is suitable for combined chemotherapy after ovarian cancer surgery. Clinical application has shown that the Four Wonders Detoxification Formula can significantly reduce the incidence of adverse reactions to chemotherapy, improve the efficacy and compliance of chemotherapy, and reduce the toxic side effects of chemotherapy drugs.

[0022] In this application, when the pharmaceutical composition includes Phellodendron bark, Atractylodes lancea rhizome, Achyranthes bidentata root, Hedyotis diffusa herb, Trichosanthes kirilowii root, Cinnamon twig, Astragalus membranaceus root, and Coix seed, the pharmaceutical composition is also called "Si Miao Jie Du Fang" (Four Wonders Detoxification Formula), which is suitable for adjuvant chemotherapy treatment of ovarian cancer of the damp-heat accumulation type.

[0023] In some embodiments of this application, the pharmaceutical composition comprises, by weight, 5-15 parts of Phellodendron bark, 5-15 parts of Atractylodes lancea rhizome, 5-15 parts of Achyranthes bidentata root, 5-15 parts of Hedyotis diffusa herb, 5-15 parts of Trichosanthes kirilowii root, 5-15 parts of Cinnamon twig, 25-35 parts of Astragalus membranaceus root, and 25-35 parts of Coix seed.

[0024] The second aspect of this application provides another pharmaceutical composition, wherein the pharmaceutical composition comprises, by weight, 5-20 parts of Phellodendron bark, 5-20 parts of Atractylodes lancea rhizome, 5-20 parts of Achyranthes bidentata root, 5-20 parts of Hedyotis diffusa herb, 20-40 parts of Coix seed, 5-20 parts of ginseng, 5-20 parts of Poria cocos, and 5-20 parts of cinnamon bark.

[0025] After chemotherapy, the dampness and toxicity weaken, and the deficiency of qi and yin is the main pathological characteristic of the maintenance phase. Therefore, the treatment principle is to greatly replenish qi and yin and dispel dampness and toxicity. The Simiao Peiyuan Formula is used for treatment. This formula is based on the Simiao Jiedu Formula, but removes Astragalus membranaceus, Cinnamomum cassia, and Trichosanthes kirilowii, and adds Ginseng to greatly replenish vital energy, Poria cocos to strengthen the spleen and eliminate dampness, and Cinnamomum cassia to warm the kidney yang and transform qi. It is used for maintenance treatment of ovarian cancer after chemotherapy, which can improve the quality of life of ovarian cancer patients, delay recurrence, and effectively improve the prognosis of ovarian cancer.

[0026] In this application, when the pharmaceutical composition includes Phellodendron bark, Atractylodes lancea rhizome, Achyranthes bidentata root, Hedyotis diffusa herb, Coix seed, Ginseng, Poria cocos, and Cinnamon, the pharmaceutical composition is also called "Si Miao Pei Yuan Fang" (Four Wonders Nourishing the Origin Formula), which is suitable for maintenance therapy of ovarian cancer of the damp-heat accumulation type.

[0027] In some embodiments of this application, the pharmaceutical composition comprises, by weight, 5-15 parts of Phellodendron bark, 5-15 parts of Atractylodes lancea rhizome, 5-15 parts of Achyranthes bidentata root, 5-15 parts of Hedyotis diffusa herb, 25-35 parts of Coix seed, 5-15 parts of ginseng, 5-15 parts of Poria cocos, and 5-15 parts of cinnamon bark.

[0028] In this application, the raw material components used in the first or second aspect, namely Phellodendron bark, Atractylodes lancea, Achyranthes bidentata, Hedyotis diffusa, Coix seed, Astragalus membranaceus, Trichosanthes kirilowii, Cinnamon twig, Ginseng, Poria cocos, and Cinnamon bark, all meet the quality standards for traditional Chinese medicine decoction pieces.

[0029] In some embodiments of this application, the pharmaceutical composition described in the first aspect of this application and / or the pharmaceutical composition described in the second aspect of this application further include a pharmaceutically acceptable carrier or excipient.

[0030] In some embodiments of this application, the pharmaceutically acceptable carrier or excipient is selected from at least one of solvents, diluents, disintegrants, precipitation inhibitors, surfactants, flow aids, binders, lubricants, dispersants, suspending agents, isotonic agents, thickeners, emulsifiers, preservatives, stabilizers, hydrating agents, emulsification accelerators, buffers, absorbents, colorants, flavorings, sweeteners, ion exchangers, release agents, coating agents, flavoring agents, and antioxidants.

[0031] In some embodiments of this application, the pharmaceutical compositions described in the first aspect of this application and / or the pharmaceutical compositions described in the second aspect of this application are formulated as pharmaceutically acceptable preparations.

[0032] In some embodiments of this application, the pharmaceutical composition described in the first aspect of this application and / or the pharmaceutical composition described in the second aspect of this application are formulated as any one of the dosage forms of powder, decoction, tablet, capsule, pill, drop pill or suspension.

[0033] A third aspect of this application provides a composition comprising: the pharmaceutical composition described in the first aspect of this application, and / or the pharmaceutical composition described in the second aspect of this application.

[0034] In this application, the pharmaceutical composition included in the first aspect may contain a pharmaceutically acceptable carrier or excipient, or may be formulated into a pharmaceutically acceptable formulation; the pharmaceutical composition included in the second aspect may contain a pharmaceutically acceptable carrier or excipient, or may be formulated into a pharmaceutically acceptable formulation.

[0035] A fourth aspect of this application provides the use of a pharmaceutical composition described in the first or second aspect of this application, or a composition described in the third aspect of this application, in the preparation of a medicament for treating ovarian cancer; preferably, the medicament for treating ovarian cancer includes a medicament for adjuvant therapy during chemotherapy for ovarian cancer and / or a medicament for maintenance therapy for ovarian cancer.

[0036] The pharmaceutical composition described in the first aspect of this application, namely "Si Miao Jie Du Fang", is preferably used to prepare a drug for adjuvant therapy during chemotherapy for ovarian cancer; the pharmaceutical composition described in the second aspect of this application, namely "Si Miao Pei Yuan Fang", is preferably used to prepare a drug for maintenance therapy for ovarian cancer.

[0037] In some embodiments of this application, the ovarian cancer is a damp-heat stagnation type ovarian cancer; preferably, the damp-heat stagnation type ovarian cancer is selected from at least one of ovarian serous cystadenocarcinoma, ovarian mucinous cystadenocarcinoma, and ovarian endometrioid carcinoma. The pharmaceutical compositions described in the first or second aspect of this application, and the compositions described in the third aspect of this application, can be applied to all patients with various types of ovarian cancer who meet the criteria for damp-heat stagnation type according to traditional Chinese medicine diagnosis.

[0038] Unless otherwise specified or defined, the terms used in this application shall have their general meanings known to those skilled in the art.

[0039] As used in this application, the term "treatment" has its general meaning, and in this application specifically refers to the treatment of an animal individual that may be suffering from ovarian cancer or adverse reactions to chemotherapy after ovarian cancer surgery with the drug of this application, in order to produce therapeutic, curative, alleviating, or reducing effects on the disease.

[0040] As used in this application, the term "pharmaceutical composition" has its general meaning and, in this application, may refer to a composition of the raw materials, i.e., the original plant medicinal materials, or a composition of extracts of the aforementioned raw materials, or a preparation further processed from the extracts, such as a pharmaceutical preparation. Conventional techniques in the pharmaceutical field, particularly in the field of formulation, can be used to obtain the active ingredients of the raw materials for the pharmaceutical composition of this application through extraction, separation, and purification methods commonly used in pharmaceutical production. These ingredients can then be optionally mixed with one or more pharmaceutically acceptable excipients and formulated into the desired dosage form to prepare the pharmaceutical composition of this application.

[0041] The pharmaceutical composition of this application can be a pharmaceutical preparation suitable for oral administration. The pharmaceutical composition of this application can be formulated into various forms such as powders, decoctions, tablets, capsules, pills, drop pills, or suspensions. All of the above dosage forms can be prepared according to conventional methods in the pharmaceutical field. For example, the preparation method of a decoction can be as follows: after mixing all raw material components, decoct with water (the ratio of the total mass of the raw material components to the mass of water is 1:(1-10)) for 0.5-2 hours, then remove the solids to obtain the decoction.

[0042] When the pharmaceutical compositions of this application are administered as drugs to human or animal subjects, they may be administered on their own, i.e., without any of the pharmaceutically acceptable excipients described above, by administering the pharmaceutical compositions of this application directly to the patient in their original form; or they may be administered to humans or animals in combination with pharmaceutically acceptable excipients, for example, 1-99% (more preferably, for example, 10-90%) of a pharmaceutical composition (which may be in the form of an extract of the active pharmaceutical ingredient of this application) or a pharmaceutical composition (which may be in the form of an extract of the active pharmaceutical ingredient of this application).

[0043] The actual dosage level and administration time of the pharmaceutical composition or active ingredient in the pharmaceutical composition of this application can be adaptively modified so that the amount of active ingredient can effectively achieve the desired therapeutic response for a specific test individual, composition and administration method, without toxicity to the test individual.

[0044] As used in this application, the term "individual" or "animal individual" has its general meaning and, in this application, may refer to an animal individual that has or may have ovarian cancer, or an animal individual used for a specific purpose, such as for scientific research. Specifically, the individual refers to an animal individual, particularly a mammalian individual, such as a human, pig, dog, cat, cow, sheep, horse, rat, mouse, rabbit, guinea pig, monkey, etc.

[0045] The method of taking the "Four Wonders Detoxification Formula" of this application is as follows: Take 10g of Phellodendron bark, 10g of Oldenlandia diffusa, 10g of Atractylodes lancea, 10g of Achyranthes bidentata, 30g of Coix seed, 30g of Astragalus membranaceus, 10g of Trichosanthes kirilowii, and 10g of Cinnamomum cassia, decoct them in 480g of water for 1 hour, remove the solids, and obtain a decoction. Take one dose per day, divided into two doses in the morning and evening, with a daily dosage of 120g of Chinese herbal medicine slices.

[0046] The method of taking the "Four Wonders Nourishing Vitality Formula" of this application is as follows: Take 10g of Phellodendron bark, 10g of Oldenlandia diffusa, 10g of Atractylodes lancea, 10g of Achyranthes bidentata, 30g of Coix seed, 10g of ginseng, 10g of Poria cocos, and 10g of cinnamon, decoct them in 400g of water for 1 hour, remove the solids, and obtain a decoction. Take one dose per day, divided into two doses in the morning and evening, with a daily dosage of 100g of Chinese herbal medicine slices.

[0047] Unless otherwise specified, the experimental materials and methods used in the following examples are conventional. Additionally, unless otherwise specified, "parts" and "%" refer to mass measurements.

[0048] Example 1: Clinical efficacy and safety study of Simiao Detoxification Formula combined with chemotherapy in the postoperative treatment of ovarian cancer.

[0049] 1. Research Subjects

[0050] This study included patients with damp-heat stagnation type ovarian cancer who underwent surgery for ovarian cancer between January 2019 and December 2023. Inclusion criteria: ① Patients with pathologically diagnosed ovarian cancer after surgery; ② Patients who underwent surgery and received 6 cycles of TC / TP (paclitaxel + platinum) chemotherapy post-surgery; ③ Patients who did not receive any other treatments besides chemotherapy and traditional Chinese medicine during treatment, such as radiotherapy, immunotherapy, or targeted therapy.

[0051] Exclusion criteria: ① Individuals with serious non-tumor diseases and functional impairments in major organs such as the liver, kidneys, and heart; ② Individuals with other malignant tumors; ③ Individuals with mental illness and impaired consciousness who are unable to complete the quality of life questionnaire.

[0052] 2. General situation and grouping

[0053] A total of 143 patients with ovarian cancer of the damp-heat accumulation type were included after surgery. Pathological classification: serous cystadenocarcinoma (94 cases), mucinous cystadenocarcinoma (37 cases), and endometrioid carcinoma (12 cases); FIGO surgical pathological staging: stage II (102 cases) and stage III (31 cases). 112 patients received TC / TP (paclitaxel + platinum) chemotherapy combined with Simiao Detoxification Formula for 6 cycles (experimental group); 31 patients received only TC / TP (paclitaxel + platinum) chemotherapy for 6 cycles (control group). There were no statistically significant differences in age, pathological classification, and clinical stage between the two groups (P>0.05), making them comparable.

[0054] 3. Treatment methods

[0055] The control group received TC / TP chemotherapy for 6 consecutive cycles; the experimental group received TC / TP chemotherapy plus the Simiao Detoxification Formula, taken twice daily, morning and evening. The Simiao Detoxification Formula consists of: 10g each of Phellodendron bark, Atractylodes rhizome, Achyranthes root, Hedyotis diffusa, Trichosanthes root, and Cinnamon twig; and 30g each of Astragalus root and Coix seed. The decoction is prepared by decocting in 480g of water for 1 hour, removing the solids, and taking the decoction twice daily, morning and evening.

[0056] 4. Observation Indicators

[0057] (1) The incidence of adverse reactions such as gastrointestinal reactions, bone marrow suppression, and liver function damage in the two groups during the treatment period.

[0058] (2) Serum levels of human epididymal secretory protein 4 (HE4) and carbohydrate antigen 125 (CA125) in the two groups before and after treatment.

[0059] (3) TCM syndrome scoring, including assessment of symptoms such as poor appetite, fatigue, and dull complexion, scored from 0 to 3 points according to four levels: none, mild, moderate, and severe.

[0060] (4) Karnofsky Performance Status (KPS) score: The KPS score is used to assess the patient's physical condition. The higher the score, the better the patient's health condition. The differences in KPS between the two groups of patients before the start of treatment and after 6 courses of treatment were compared.

[0061] (5) Quality of Life Assessment: The quality of life of patients was assessed using the Ovarian Cancer Patient Quality of Life Measurement Scale. This scale is mainly divided into 5 parts (physiological status, social status, emotional status, functional status, and additional concerns related to ovarian cancer), including a total of 39 items. Each assessment item is divided into four levels: "None," "Some," "Some," and "Very Much," corresponding to 3, 2, 1, and 0 points respectively. The higher the total score, the higher the quality of life. The differences in KPS between the two groups of patients were compared before the start of treatment and after 6 cycles of treatment.

[0062] 5. Results

[0063] (1) The results of the comparison of adverse reaction rates are shown in Table 1.

[0064] Table 1. Comparison of adverse reaction rates between the two groups after intervention with the Simiao Detoxification Formula [n(%)]

[0065]

[0066] Note: *P<0.05 compared with the control group;

[0067] As can be seen from the results in the table above, the incidence of gastrointestinal reactions, liver function damage, bone marrow suppression, and oral ulcers in the experimental group were significantly lower than those in the control group (P<0.05).

[0068] (2) The results of the comparison of serum tumor markers are shown in Table 2.

[0069] Table 2 Comparison of HE4 and CA125 levels between the two groups after intervention with the Simiao Detoxification Formula.

[0070]

[0071] Note: *P<0.05 compared with the control group; △ P < 0.05.

[0072] The results in the table above show that there was no statistically significant difference in HE4 and CA125 levels between the two groups before treatment (P>0.05); after treatment, both groups showed a significant decrease compared to before treatment (P<0.05), and the experimental group showed a significantly lower level than the control group (P<0.05).

[0073] (3) Traditional Chinese Medicine Symptom Scoring

[0074] The TCM symptom scores of the two groups of patients are shown in Table 3.

[0075] Table 3 Comparison of TCM symptom scores between the two groups after intervention with the Simiao Detoxification Formula.

[0076]

[0077] Note: Compared with the control group, △ *P>0.05, #P<0.05.

[0078] The results in the table above show that there was no statistically significant difference in the TCM symptom scores between the two groups before treatment (P>0.05), indicating comparability. After treatment, the TCM symptom scores in the experimental group were significantly lower than those before treatment and in the control group (P<0.05).

[0079] (4) KPS score

[0080] The comparison results of the KPS scores of the two groups of patients are shown in Table 4.

[0081] Table 4 Comparison of KPS scores between the two groups [score, M (P25, P75)]

[0082]

[0083] Note: Compared with the control group before treatment, *P>0.05; compared with the control group after treatment, #P<0.05; compared with the experimental group before treatment, △ P<0.05.

[0084] The results in the table above show that there was no statistically significant difference in KPS scores between the two groups before treatment (P > 0.05), indicating comparability. Within-group comparison: There was no statistically significant difference in scores before and after treatment in the control group (P > 0.05), while the score in the experimental group was significantly higher after treatment than before treatment (P < 0.05). Between-group comparison: The KPS score in the experimental group was significantly higher than that in the control group after treatment (P < 0.05).

[0085] The efficacy of the two groups of patients was evaluated by the KPS score, and the results are shown in Table 5: the total effective rates of the control group and the experimental group were 61.29% and 91.07%, respectively, and the total effective rate of the experimental group was significantly higher than that of the control group (P<0.01).

[0086] Table 5 Comparison of KPS scores and treatment efficacy between the two groups of patients (cases)

[0087]

[0088] (5) The results of the quality of life assessment comparison are shown in Table 6.

[0089] Table 6 Comparison of quality of life scores between the two groups of patients (scores, X±S)

[0090]

[0091] Note: Compared with the control group before and after treatment, *P>0.05; compared with the experimental group after treatment, △ P<0.05.

[0092] The results in the table above show that there were no statistically significant differences in the scores before treatment between the two groups, or between the scores before and after treatment in the control group (P > 0.05); however, the score in the experimental group was significantly higher after treatment than before treatment (P < 0.05). Intergroup comparison: the quality of life score in the experimental group was significantly higher after treatment than before treatment (P < 0.05).

[0093] Example 2: Sequential application of Simiao Detoxification Formula and Simiao Nourishing Essence Formula in adjuvant chemotherapy and maintenance therapy after ovarian cancer surgery.

[0094] The patient, a 38-year-old female, presented to our hospital in March 2020 with intermittent lower abdominal pain for half a month. A CT scan of the lower abdomen revealed a solid mass in the pelvic cavity. After comprehensive evaluation, she underwent staged surgery at the applicant's hospital. Postoperative pathology revealed well-differentiated endometrioid adenocarcinoma of the left ovary, FIGO stage III. Postoperatively, she received TC chemotherapy combined with the Si Miao Jie Du Fang formula (10g each of Phellodendron bark, Atractylodes lancea, Achyranthes bidentata, Hedyotis diffusa, Trichosanthes kirilowii, and Cinnamon twig; 30g each of Astragalus membranaceus and Coix lacryma-jobi, decocted in 480g water for 1 hour, the solids removed, and taken twice daily, continuously throughout the chemotherapy period). During chemotherapy, the patient's general condition was good, with no significant gastrointestinal side effects, occasional nausea and poor appetite, no bone marrow suppression, and no significant impact on her work or daily life. She successfully completed 6 cycles of chemotherapy, maintaining good adherence and quality of life throughout the treatment. After treatment, imaging evaluation showed no obvious recurrence or metastasis, tumor marker levels were normal, and blood routine tests indicated no bone marrow suppression. Follow-up after discharge revealed symptoms such as poor mental state, fatigue, general heaviness, lethargy, frequent sighing, loss of appetite, restless sleep, and loose stools. Considering the patient's qi and yin deficiency and weakened damp-heat after chemotherapy, the treatment followed the principles of maintenance therapy after ovarian cancer surgery. The patient was prescribed the Simiao Peiyuan Decoction (10g each of Phellodendron bark, Atractylodes rhizome, Achyranthes root, Hedyotis diffusa, Ginseng, Poria cocos, and Cinnamon bark, plus 30g of Coix seed, decocted in 400g water for 1 hour, the solids removed, and taken twice daily). This formula greatly replenished qi and yin and eliminated damp-heat. After more than two years of treatment, the fatigue gradually subsided, appetite and sleep improved, imaging showed no obvious recurrence or metastasis, and tumor marker levels remained normal. The patient is now more than four years post-surgery, consistently undergoing regular follow-ups, with good general condition and quality of life, and no recurrence.

[0095] Example 3: Sequential application of Simiao Detoxification Formula and Simiao Nourishing Essence Formula in adjuvant targeted therapy after recurrent ovarian cancer surgery.

[0096] The patient, a 58-year-old female, first visited in July 2021. Chief complaint: "More than 3 years after ovarian cancer surgery, I have been experiencing lower abdominal distension for one month." She presented to our hospital with this complaint. In 2018, a physical examination at a local hospital revealed a solid mass in the pelvic cavity. She underwent comprehensive staging surgery, and postoperative pathology revealed poorly differentiated serous carcinoma of the left ovary, focal infiltration of poorly differentiated carcinoma on the uterine serosal surface, and lymph node metastasis. She received 6 cycles of TC regimen chemotherapy postoperatively and had regular follow-up visits. One year ago, her CA125 level increased, accompanied by tumor recurrence and metastasis, and she continued 7 cycles of TC regimen chemotherapy at a local hospital. One month ago, the patient experienced lower abdominal distension and underwent a CT scan at a local hospital, which revealed a solid mass in the pelvic cavity. Seeking further diagnosis and treatment, the patient visited our hospital. After a comprehensive evaluation, the patient underwent tumor cytoreductive surgery at our hospital. Postoperative BRCA1 / 2 gene testing showed no mutations and HRD (-). The patient was given TC regimen chemotherapy, combined with bevacizumab targeted therapy and Simiao Jiedu Decoction (10g each of Phellodendron bark, Atractylodes lancea, Achyranthes bidentata, Hedyotis diffusa, Trichosanthes kirilowii, and Cinnamomum cassia, 30g each of Astragalus membranaceus and Coix lacryma-jobi, decocted in 480g of water for 1 hour, the solids were removed, and the decoction was taken twice a day, morning and evening). Tumor marker levels were monitored regularly. During the treatment, the patient's general condition was good, with mild gastrointestinal adverse reactions, no significant bone marrow suppression, and a good mood. Tumor markers were within the normal reference range. After discharge, the patient continued outpatient follow-up and developed symptoms such as fatigue, frequent sighing, and poor appetite. Considering the patient's advanced age and physical weakness, coupled with the aggressive chemotherapy, resulting in deficiency of Qi and Yin, the patient was prescribed the Simiao Peiyuan Decoction (10g each of Phellodendron bark, Atractylodes lancea, Achyranthes bidentata, Hedyotis diffusa, Ginseng, Poria cocos, and Cinnamon, plus 30g of Coix seed, decocted in 400g of water for 1 hour, the solids were removed, and the decoction was taken twice daily, morning and evening, warm). This formula greatly replenished Qi and Yin and dispelled dampness and toxins. After more than a year of treatment, the fatigue gradually subsided, and the patient's appetite and sleep improved. Imaging showed no obvious recurrence or metastasis, and tumor marker levels were normal. The patient is now 3 years post-secondary surgery, undergoing regular follow-up. The patient's general condition and quality of life are good, and there has been no recurrence.

[0097] The above description is only a preferred embodiment of this application and is not intended to limit this application. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

Claims

1. A pharmaceutical composition, wherein, The pharmaceutical composition, by weight, comprises: 5-20 parts of Phellodendron bark, 5-20 parts of Atractylodes lancea rhizome, 5-20 parts of Achyranthes bidentata root, 5-20 parts of Hedyotis diffusa herb, 5-20 parts of Trichosanthes kirilowii root, 5-20 parts of Cinnamon twig, 20-40 parts of Astragalus membranaceus root, and 20-40 parts of Coix seed.

2. The pharmaceutical composition according to claim 1, wherein, The pharmaceutical composition, by weight, comprises: 5-15 parts of Phellodendron bark, 5-15 parts of Atractylodes lancea rhizome, 5-15 parts of Achyranthes bidentata root, 5-15 parts of Hedyotis diffusa herb, 5-15 parts of Trichosanthes kirilowii root, 5-15 parts of Cinnamon twig, 25-35 parts of Astragalus membranaceus root, and 25-35 parts of Coix seed.

3. A pharmaceutical composition, wherein, The pharmaceutical composition, by weight, comprises: 5-20 parts of Phellodendron bark, 5-20 parts of Atractylodes lancea rhizome, 5-20 parts of Achyranthes bidentata root, 5-20 parts of Hedyotis diffusa herb, 20-40 parts of Coix seed, 5-20 parts of ginseng, 5-20 parts of Poria cocos, and 5-20 parts of cinnamon bark.

4. The pharmaceutical composition according to claim 3, wherein, The pharmaceutical composition, by weight, comprises: 5-15 parts of Phellodendron bark, 5-15 parts of Atractylodes lancea rhizome, 5-15 parts of Achyranthes bidentata root, 5-15 parts of Hedyotis diffusa herb, 25-35 parts of Coix seed, 5-15 parts of ginseng, 5-15 parts of Poria cocos, and 5-15 parts of cinnamon bark.

5. The pharmaceutical composition according to any one of claims 1-4, wherein, The pharmaceutical composition further includes a pharmaceutically acceptable carrier or excipient; preferably, the pharmaceutically acceptable carrier or excipient is selected from at least one of solvents, diluents, disintegrants, precipitation inhibitors, surfactants, flow aids, binders, lubricants, dispersants, suspending agents, isotonic agents, thickeners, emulsifiers, preservatives, stabilizers, hydrating agents, emulsification accelerators, buffers, absorbents, colorants, flavorings, sweeteners, ion exchangers, release agents, coating agents, flavoring agents, and antioxidants.

6. The pharmaceutical composition according to any one of claims 1-4, wherein, The pharmaceutical composition is formulated as a pharmaceutically acceptable preparation.

7. The pharmaceutical composition according to claim 6, wherein, The pharmaceutical composition is formulated as any one of the following dosage forms: powder, decoction, tablet, capsule, pill, drop pill, or suspension.

8. A composition wherein, The composition comprises: the pharmaceutical composition of claim 1 or 2, and / or the pharmaceutical composition of claim 3 or 4.

9. Use of the pharmaceutical composition of any one of claims 1-7 or the composition of claim 8 in the preparation of a medicament for treating ovarian cancer; preferably, the medicament for treating ovarian cancer comprises a medicament for adjuvant therapy during chemotherapy for ovarian cancer and / or a medicament for maintenance therapy for ovarian cancer.

10. The use according to claim 9, wherein, The ovarian cancer is a damp-heat accumulating type of ovarian cancer; preferably, the damp-heat accumulating type of ovarian cancer is selected from at least one of ovarian serous cystadenocarcinoma, ovarian mucinous cystadenocarcinoma, and ovarian endometrioid carcinoma.

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