Traditional Chinese medicine composition for treating prostatic cancer as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of medicine and health, and particularly relates to a traditional Chinese medicine composition for treating prostatic cancer and a preparation method and application thereof. The traditional Chinese medicine composition comprises the following raw materials: raw radix astragali, radix sophorae flavescentis, yam rhizome, turmeric, cowherb seed and rhizoma anemarrhenae, and can prevent, treat and relieve prostatic cancer through the mutual synergistic effect of the active ingredients of various traditional Chinese medicines; the traditional Chinese medicine composition can reduce tPSA of patients, relieve vasomotor symptoms and mental and psychological symptoms, control blood fat, improve immune functions and relieve fatigue conditions, is suitable for long-term use of prostate cancer patients, and is especially suitable for castration-resistant prostate cancer patients or combined application with endocrine drugs.

Description

Technical Field

[0001] The invention belongs to the technical field of medicine and health, and particularly relates to a Chinese medicine composition for treating prostate cancer, and a preparation method and application thereof. Background Art

[0002] Prostate cancer seriously endangers men's health. Global cancer statistics show that the incidence of prostate cancer is second only to lung cancer, and its mortality ranks fifth. Statistical analysis of cancer data in my country over the past 20 years shows that the number of cases and deaths from prostate cancer has increased significantly, becoming the number one malignant tumor of the male urinary system. This growth trend is related to many factors, including population aging, changes in lifestyle, social and economic development, and the popularization of prostate cancer screening methods such as prostate specific antigen (PSA). Relatively developed economic regions such as Beijing, Shanghai, Tianjin, and Zhejiang have gradually become the hardest hit areas for prostate cancer in the country.

[0003] For prostate cancer, there are treatment measures for patients with different conditions, such as observation and waiting, active monitoring, radical prostatectomy, radiotherapy, immunotherapy, endocrine therapy, etc. Early prostate cancer can obtain a longer prognosis and survival after radical surgery, but only one-third of the newly diagnosed prostate cancer patients in my country have clinically localized prostate cancer, which means that most patients are already in the middle and late stages when they first visit the doctor.

[0004] The growth of prostate cancer depends on male androgens, which interact with androgens on the surface of prostate cells. After the receptor binds, the "proliferation" program of the prostate will be activated. When it is no longer possible to treat with surgery or radiotherapy, endocrine therapy can only be used to inhibit tumor growth. Therefore, endocrine therapy is also the most basic and fundamental treatment for advanced prostate cancer. With the emergence of new endocrine therapies in recent years, various innovative drugs that can resist androgens or inhibit androgen synthesis have also been introduced and have become the main treatment strategy for advanced prostate cancer. Most prostate cancer patients can benefit from endocrine therapy in the early stages, but as the treatment progresses, prostate cancer cells gradually become tolerant to androgen deprivation, and androgen-dependent prostate cancer eventually develops into castration-resistant prostate cancer, resistance to endocrine drug treatment, and ultimately death. The expensive price of drugs will also cause huge economic and mental burdens on patients and their families. Some patients give up treatment because they cannot afford the huge treatment costs. Summary of the invention

[0005] In view of the above technical problems, the present invention provides a Chinese medicine composition for treating prostate cancer, a preparation method and application thereof. The Chinese medicine composition is used in combination with a Western medicine for treating prostate cancer to achieve the effects of reducing tPSA (total prostate cancer specific antigen), alleviating vasomotor symptoms and mental and psychological symptoms, controlling blood lipids, improving immune function and alleviating fatigue.

[0006] In order to achieve the above-mentioned object of the invention, the present invention adopts the following technical solutions: On the one hand, the present invention provides a traditional Chinese medicine composition for treating prostate cancer, wherein the raw materials thereof include, by weight: 24-36 parts of raw astragalus, 8-12 parts of sophora flavescens, 12-18 parts of radix polygoni multiflori, 8-12 parts of turmeric, 12-18 parts of fenugreek and 8-12 parts of rhizoma anemarrhenae.

[0007] In the Chinese medicine composition, astragalus is warm in nature, sweet in taste, and enters the lung and spleen meridians. It has the functions of replenishing qi and strengthening the exterior, promoting diuresis and expelling toxins, discharging pus, and healing sores and promoting tissue regeneration. It is mainly used for qi deficiency and fatigue, poor appetite and loose stools, sinking of middle qi, chronic diarrhea and prolapse of the anus, bloody stool and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to qi deficiency, carbuncle that is difficult to heal, long-term sores that do not heal, blood deficiency and jaundice, and internal heat and thirst. Sophora flavescens tastes bitter, is cold in nature, clears away heat and dampness, kills insects, and has the functions of diuresis. It is used for heat dysentery, blood in stool, jaundice, urine retention, leucorrhea, vaginal swelling and itching, eczema, wet sores, skin itching, scabies and leprosy, and external treatment of trichomoniasis vaginitis, etc. Radix Dioscoreae is bitter in taste and neutral in nature. It can remove dampness and turbidity, dispel wind and relieve numbness. It is used for stranguria, leucorrhea, excessive leucorrhea, rheumatic pain, joint discomfort, and pain in the waist and knees. Turmeric tastes spicy, warm, non-toxic, and can break blood, promote qi circulation, and relieve pain. Its functions are to promote qi circulation, promote menstruation, and relieve pain. It can be used for various pain syndromes caused by qi stagnation and blood stasis. Wangbuliuxing is bitter in taste and neutral in nature. It has the effects of promoting blood circulation and menstruation, promoting lactation and reducing swelling, promoting diuresis and relieving stranguria. It is used for amenorrhea, dysmenorrhea, lack of milk, swelling and pain in breast abscess, and pain and astringency in stranguria. Anemarrhena asphodeloides tastes bitter and is cold in nature. It has the functions of nourishing yin and reducing fire, moistening dryness and lubricating the intestines. It can be used to treat restlessness, thirst, bone steaming, fatigue fever, lung heat and cough, dry and hard stool and difficulty urinating.

[0008] Prostate cancer is located in the lower part of the body and is closely related to the liver, spleen and kidney. "Deficiency, toxicity and turbidity" are the pathological elements of the disease, and "spleen deficiency, dampness and turbidity and toxicity accumulation" are the core pathological mechanisms of prostate cancer. The Chinese medicine composition of the present invention uses raw astragalus as the main medicine for invigorating qi and strengthening the spleen, sophora flavescens and Radix Dioscoreae as the ministerial medicine for detoxification and turbidity removal, turmeric and Vaccariae as the adjuvant medicine for blood stasis and stagnation, and Anemarrhena as the guiding medicine for nourishing yin and moistening dryness. The combination of these Chinese medicinal materials can make the active ingredients in each medicinal material produce synergistic effects and enhance each other, thereby "removing evil and strengthening the root", and preventing, alleviating and treating prostate cancer.

[0009] Clinical efficacy observation data proves that the Chinese medicine composition of the present invention has strong pharmacological effects, has significant effects in preventing, alleviating and / or treating prostate cancer, can reduce patients' tPSA, alleviate vasomotor symptoms and mental and psychological symptoms, control blood lipids, improve immune function, and alleviate fatigue. The Chinese medicine composition has small toxic and side effects, good safety, and can be taken for a long time. Its raw material source is abundant, low-cost, safe for clinical use, and the dosage is small, easy to use, so it has good application value.

[0010] Among them, the Radix Dichroae can be selected from Radix Dichroae or Radix Dichroae.

[0011] Preferably, the raw materials of the traditional Chinese medicine composition include, by weight, 27 to 33 parts of raw astragalus, 9 to 11 parts of sophora flavescens, 13.5 to 16.5 parts of radix polygoni multiflori, 9 to 11 parts of turmeric, 13.5 to 16.5 parts of fenugreek and 9 to 11 parts of rhizoma anemarrhenae.

[0012] Preferably, the raw materials of the traditional Chinese medicine composition include, by weight, 30 parts of raw astragalus, 10 parts of sophora flavescens, 15 parts of radix polygoni multiflori, 10 parts of turmeric, 15 parts of fenugreek and 10 parts of rhizoma anemarrhenae.

[0013] In actual clinical use, the composition has a weight of 1 g per weight portion, and 1 to 2 doses are used per day depending on the condition of the disease.

[0014] In a second aspect, the present invention also provides a method for preparing the above-mentioned Chinese medicine composition: the above-mentioned raw materials are soaked in water, boiled and extracted twice, each time for 0.5 to 1 hour, and filtered to obtain the composition.

[0015] Preferably, the mass of the water used for soaking is 5 to 10 times the mass of the raw material, and more preferably 7 to 8 times.

[0016] Preferably, the soaking time is 1 to 3 hours, more preferably 2 hours.

[0017] Preferably, the mass of water added during the second decoction extraction is 3 to 7 times the mass of the raw material, and more preferably 5 to 7 times.

[0018] After two decoctions, combine the filtrates from the two filtrations to obtain the product.

[0019] Preferably, the preparation method further comprises concentrating and / or drying the obtained extract to facilitate transportation, storage and use.

[0020] Preferably, the temperature is controlled at 80-100° C. during the concentration process.

[0021] Optionally, concentrate to a relative density of 1.1 to 1.3.

[0022] Preferably, the preparation method further comprises crushing the raw material before soaking. Exemplarily, the raw material is crushed into coarse powder (passing through a 24-mesh sieve).

[0023] In a third aspect, the present invention also provides the use of the above-mentioned Chinese medicine composition or the Chinese medicine composition prepared by the above-mentioned preparation method in the preparation of a drug for treating prostate cancer.

[0024] Preferably, the drug is a drug for patients with castration-resistant prostate cancer.

[0025] Preferably, the drug is a drug used in combination with an endocrine drug. The combined use of the Chinese medicine composition and the endocrine drug can further reduce tPSA, thereby achieving a better effect of treating prostate cancer.

[0026] Preferably, the drug is an oral preparation, including but not limited to tablets, powders, granules, capsules, oral liquids, etc.

[0027] In a fourth aspect, the present invention also provides the use of the above-mentioned Chinese medicine composition or the Chinese medicine composition prepared by the above-mentioned preparation method in the preparation of a drug for alleviating the side effects after endocrine therapy.

[0028] After endocrine therapy, the levels of testosterone (T) and free testosterone (FT) in the serum of prostate cancer patients are reduced, thereby controlling or delaying the development of tumors and improving the survival of patients. However, at the same time, adverse reactions such as blood lipid metabolism disorders, endocrine abnormalities, decreased immune function, fatigue, and psychological symptoms such as depression, irritability, and insomnia can also be caused. The Chinese medicine composition can effectively reduce the above-mentioned adverse reactions after endocrine therapy, improve psychological symptoms, and improve the survival and quality of life of patients.

[0029] Preferably, the drug is a drug for patients with castration-resistant prostate cancer.

[0030] Preferably, the drug is a drug used in combination with an endocrine drug. The combined use of the Chinese medicine composition and the endocrine drug can further reduce tPSA, and can significantly reduce adverse reactions such as dyslipidemia, endocrine abnormalities, fatigue, etc. caused by endocrine drugs, and can effectively improve mental and psychological symptoms and enhance the body's immune function, providing a new option for drug treatment of prostate cancer, and providing a new method for prostate cancer patients to improve clinical symptoms, improve quality of life, and prolong survival.

[0031] Preferably, the drug is an oral preparation, including but not limited to tablets, powders, granules, capsules, oral liquids, etc.

[0032] Preferably, the above-mentioned oral preparation further comprises a pharmaceutically acceptable excipient.

[0033] The "pharmaceutically acceptable excipient" available in the pharmaceutical composition of the present invention can be any conventional excipient in the field of pharmaceutical preparations, and the selection of a specific excipient will depend on the mode of administration or the type and state of disease used to treat a specific patient. The preparation method of a suitable pharmaceutical composition for a specific mode of administration is completely within the knowledge of a person skilled in the art of medicine. For example, the pharmaceutically acceptable excipients include conventional diluents, carriers, fillers, adhesives, wetting agents, disintegrants, absorption promoters, surfactants, adsorption carriers and lubricants in the pharmaceutical field. If necessary, flavoring agents, preservatives and sweeteners can also be added to the pharmaceutical composition. DETAILED DESCRIPTION

[0034] In order to make the purpose, technical scheme and advantages of the present invention clearer, the present invention is further described in detail below in conjunction with specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work fall within the scope of protection of the present invention.

[0035] The raw Astragalus, Sophora flavescens, Herba Cynomorii, Curcuma longa, Vaccaria segetalis and Rhizoma Anemarrhenae used in the following examples all meet the requirements of the Chinese Pharmacopoeia (Volume 1).

[0036] Example 1 The embodiment of the present invention provides a traditional Chinese medicine composition for treating prostate cancer. Each dose is prepared from the following raw materials: 30g of raw astragalus, 10g of sophora flavescens, 15g of ophiopogon japonicus, 10g of turmeric, 15g of fenugreek and 10g of anemarrhena.

[0037] Preparation method: The above raw materials were crushed into coarse powder (passed through a 24-mesh sieve), soaked in 630 g of room temperature water (24°C ± 1°C) for 2 h, then decocted for 45 min, filtered, and the resulting residue was decocted again with 540 g of water for 30 min, filtered; the two filtrates were combined and concentrated at 80-100°C to a relative density of 1.2 to obtain the product.

[0038] Example 2 The embodiment of the present invention provides a traditional Chinese medicine composition for treating prostate cancer. Each dose is prepared from the following raw materials: 27g of raw astragalus, 9g of sophora flavescens, 13.5g of ophiopogon japonicus, 9g of turmeric, 13.5g of fenugreek and 9g of anemarrhena.

[0039] Preparation method: The above raw materials were crushed into coarse powder (passed through a 24-mesh sieve), soaked in 648 g of room temperature water (24°C ± 1°C) for 2 h, then decocted for 45 min, filtered, and the resulting residue was decocted again with 405 g of water for 30 min, filtered; the two filtrates were combined and concentrated at 80-100°C to a relative density of 1.2 to obtain the product.

[0040] Example 3 The embodiment of the present invention provides a traditional Chinese medicine composition for treating prostate cancer. Each dose is prepared from the following raw materials: 33g of raw astragalus, 11g of sophora flavescens, 16.5g of ophiopogon japonicus, 11g of turmeric, 16.5g of fenugreek and 11g of anemarrhena.

[0041] Preparation method: The above raw materials were crushed into coarse powder (passed through a 24-mesh sieve), soaked in 693 g of room temperature water (24°C ± 1°C) for 2 h, then decocted for 45 min, filtered, and the resulting residue was decocted again with 693 g of water for 30 min, filtered; the two filtrates were combined and concentrated at 80-100°C to a relative density of 1.2 to obtain the product.

[0042] Example 4 The embodiment of the present invention provides a traditional Chinese medicine composition for treating prostate cancer. Each dose is prepared from the following raw materials: 24g of raw astragalus, 8g of sophora flavescens, 12g of ophiopogon japonicus, 8g of turmeric, 12g of fenugreek and 8g of anemarrhena.

[0043] Preparation method: The above raw materials were crushed into coarse powder (passed through a 24-mesh sieve), soaked in 360 g of room temperature water (24°C ± 1°C) for 3 h, then decocted for 30 min, filtered, and the resulting residue was decocted again with 216 g of water for 30 min, filtered; the two filtrates were combined and concentrated at 80-100°C to a relative density of 1.1 to obtain the product.

[0044] Example 5 The embodiment of the present invention provides a traditional Chinese medicine composition for treating prostate cancer. Each dose is prepared from the following raw materials: 36g of raw astragalus, 12g of sophora flavescens, 18g of ophiopogon japonicus, 12g of turmeric, 18g of fenugreek and 12g of anemarrhena.

[0045] Preparation method: The above raw materials were crushed into coarse powder (passed through a 24-mesh sieve), soaked in 1080 g of room temperature water (24°C ± 1°C) for 2 h, then decocted for 1 h, filtered, and the resulting residue was decocted again with 756 g of water for 45 min, filtered; the two filtrates were combined and concentrated at 80-100°C to a relative density of 1.3 to obtain the product.

[0046] Effect Example 1 This effect example provides the clinical efficacy observation of the Chinese medicine composition for treating prostate cancer in Example 1 of the present invention in preventing / treating prostate cancer.

[0047] 1. Research subjects Outpatients and inpatients in the Department of Oncology, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, China from January 2018 to December 2023, who were clearly diagnosed with prostate cancer, met the diagnosis and inclusion criteria, were aged 18-80 years, and voluntarily accepted observation and treatment were selected.

[0048] 180 patients with prostate cancer who met the inclusion criteria were collected and randomly divided into a control group (maintaining castration level group) and a treatment group (on the basis of the control group, oral administration of the Chinese medicine composition for treating prostate cancer in Example 1 for combined treatment), with 90 cases in each group. There was no significant difference in the course of disease, age distribution, etc. between the two groups, and they were comparable.

[0049] 2. Treatment methods Treatment of the control group: Standard treatment of Western medicine was used, as follows: ① Continuously suppress testosterone levels - medical castration therapy, subcutaneous injection of goserelin acetate sustained-release implant once every 28 days; ② Depending on the patient's condition, treatment with flutamide, bicalutamide, estramustine, steroid hormone therapy or new endocrine drugs (abiraterone, enzalutamide, darolutamide, apalutamide, etc.) can be selected; for some patients, local treatment measures such as cytoreductive prostatectomy or radiotherapy to the prostate can be considered on the premise that they are fully informed.

[0050] ③ Bone-related treatment: Apply zoledronic acid 4 mg every 4 weeks to prevent bone-related events.

[0051] Treatment methods of the treatment group: On the basis of the control group, the patients were given oral administration of the decoction of the Chinese medicine composition for treating prostate cancer in Example 1 for combined treatment, that is, the patients were treated with standard Western medicine methods and at the same time, they were also orally administered the decoction prepared by the present invention, 1 dose per day, divided into 2 doses per day.

[0052] 3. Observation indicators and methods The tPSA, vasomotor symptoms, psychological symptoms, blood lipids, immune function and fatigue scores were observed before and after treatment.

[0053] 4. Research Results SPSS 26.0 software package was used for data analysis. ±s), t-test was used for comparison between groups, and paired t-test was used for comparison before and after. Chi-square test was used for analysis of count data. Rank sum test was used for rank data. P<0.05 was considered statistically significant.

[0054] 4.1 Effect of Chinese medicine combination on patients’ tPSA values The results of tPSA value determination of patients in the control group and treatment group are shown in Table 1.

[0055] Table 1 Comparison of tPSA values ​​before and after treatment ( ±s; unit: ng / mL; n=90)

[0056] Note: ▽ indicates P < 0.05 compared with the control group.

[0057] Before treatment, there was no statistically significant difference in tPSA values ​​between the two groups of patients, which was comparable (consistent baseline, statistical analysis can be performed). After 3 months of treatment with different treatment regimens, tPSA values ​​of both groups decreased. The comparison of tPSA values ​​between the two groups was P<0.05, and the difference was statistically significant.

[0058] It can be seen from the results that standard Western medicine treatment and its combined treatment with the Chinese medicine composition of the present invention can significantly reduce the tPSA value in the blood and have a significant inhibitory effect on the expression of tPSA. The combined use of the Chinese medicine composition of the present invention and standard Western medicine treatment can further enhance the drug's killing effect on tumors.

[0059] 4.2 Effect of Chinese herbal medicine combination on vasomotor symptom scores in patients with prostate cancer According to the PADAM symptom scoring table of Saint Louis University Medical Center, the vasomotor symptoms of patients in the control group and the treatment group were scored. The results are shown in Table 2.

[0060] Table 2 Vasomotor symptom scores before and after treatment ( ±s; unit: minutes; n=90)

[0061] Note: ▽ indicates P < 0.05 compared with the control group.

[0062] Before treatment, there was no significant difference in vasomotor symptom scores between the two groups, which were comparable. After 3 months of treatment with different treatment regimens, the vasomotor symptom scores of the two groups decreased, and the comparison of vasomotor symptom scores between the two groups was P<0.05, which was statistically significant.

[0063] It can be seen from the results that both standard Western medicine treatment and its combination with the Chinese medicine composition of the present invention can significantly reduce the vasomotor symptom score, have a protective effect on cardiovascular system, and can reduce the adverse reactions of endocrine therapy. The combination of the Chinese medicine composition of the present invention and standard Western medicine treatment has a more significant effect in reducing the vasomotor symptom score.

[0064] 4.3 Effect of Chinese herbal medicine combination on the psychological symptom scores of prostate cancer patients According to the PADAM symptom scoring table of Saint Louis University Medical Center, the patients and their mental and psychological symptoms in the control group and the treatment group were scored. The results are shown in Table 3.

[0065] Table 3 Changes in mental and psychological symptom scores before and after treatment ( ±s; unit: minutes; n=90)

[0066] Note: ▽ indicates P < 0.05 compared with the control group.

[0067] Before treatment, there was no significant difference in the scores of mental and psychological symptoms between the two groups of patients, which was comparable. After 3 months of treatment with different treatment regimens, the scores of mental and psychological symptoms in both groups of patients decreased, and the comparison of vasomotor symptom scores between the two groups was statistically significant (P<0.05).

[0068] It can be seen from the results that both standard Western medicine treatment and its combination with the Chinese medicine composition of the present invention can significantly reduce the scores of mental and psychological symptoms and alleviate the adverse reactions of endocrine therapy. The combination of the Chinese medicine composition of the present invention and standard Western medicine treatment has a more significant effect in reducing the scores of mental and psychological symptoms.

[0069] 4.4 Effect of Chinese herbal medicine combination on blood lipids in patients with prostate cancer 4.4.1 Cholesterol status The results of cholesterol levels in the control group and the treatment group are shown in Table 4.

[0070] Table 4 Comparison of cholesterol changes before and after treatment ( ±s; unit: mmol / L; n=90)

[0071] Note: ▽ indicates P < 0.05 compared with the control group.

[0072] Before treatment, there was no significant difference in cholesterol between the two groups, which was comparable. After 3 months of treatment with different treatment regimens, the cholesterol of both groups decreased, and the difference between the two groups was statistically significant (P<0.05).

[0073] 4.4.2 Triglyceride (TG) The triglyceride results of the control group and the treatment group are shown in Table 5.

[0074] Table 5 Comparison of triglyceride changes before and after treatment ( ±s; unit: mmol / L; n=90)

[0075] Note: ▽ indicates P < 0.05 compared with the control group.

[0076] Before treatment, there was no significant difference in triglyceride between the two groups of patients, which was comparable. After 3 months of treatment with different treatment regimens, the triglyceride levels of both groups of patients decreased, and the comparison of triglyceride levels between the two groups was P<0.05, which was statistically significant.

[0077] 4.4.3 Changes in high-density lipoprotein (HDL) The results of high-density lipoprotein in the control group and the treatment group are shown in Table 6.

[0078] Table 6 Comparison of changes in high-density lipoprotein before and after treatment ( ±s; unit: mmol / L; n=90)

[0079] Note: ▽ indicates P < 0.05 compared with the control group.

[0080] Before treatment, there was no significant difference in high-density lipoprotein between the two groups of patients, which was comparable. After 3 months of treatment with different treatment regimens, high-density lipoprotein in both groups of patients increased, and the comparison of high-density lipoprotein between the two groups was P<0.05, which was statistically significant.

[0081] 4.4.4 Changes in low-density lipoprotein (LDL) The results of low-density lipoprotein in the control group and the treatment group are shown in Table 7.

[0082] Table 7 Comparison of changes in low-density lipoprotein before and after treatment ( ±s; unit: mmol / L; n=90)

[0083] Note: ▽ indicates P < 0.05 compared with the control group.

[0084] Before treatment, there was no significant difference in low-density lipoprotein between the two groups of patients, which was comparable. After 3 months of treatment with different treatment regimens, low-density lipoprotein in both groups of patients decreased, and the comparison of low-density lipoprotein between the two groups was P<0.05, which was statistically significant.

[0085] 4.4.5 Improvement of blood lipids The improvement of blood lipids in the two groups after treatment was further compared according to the following criteria: Markedly effective: After treatment, blood lipid tests should reach any of the following: TC (total cholesterol) decreased by ≥20%, TG decreased by ≥40%, HDL-C increased by ≥10mg / dl, TC-HDL-C / HDL-C decreased by ≥20%; Effective: TC decreased by 10%-20%, TG decreased by 20%-40%, HDL-C increased by 4-10 mg / dl, and TC-HDL-C / HDL-C decreased by 10%-20%; Invalid, does not meet the validity criteria.

[0086] Effective rate (%) = (number of effective patients + number of effective patients) ÷ total number of patients × 100% The results are shown in Table 8.

[0087] Table 8 Improvement of blood lipids after treatment ( ±s; n=90)

[0088] From the results in Tables 4 to 8, it can be seen that standard western medicine treatment and its combination with the Chinese medicine composition of the present invention can significantly reduce the levels of cholesterol, triglycerides, and low-density lipoprotein in the blood, increase the level of high-density lipoprotein, and have a regulatory effect on blood lipid levels. The combination of the Chinese medicine composition of the present invention and standard western medicine treatment can more effectively improve blood lipid conditions, and the effective rate of the treatment group is higher than that of the control group (70% vs 63%, P < 0.05).

[0089] 4.5 Immune function Before treatment, the P values ​​of CD3+, CD3+ / CD4+, CD3+ / CD8+, B lymphocytes, and NNK cells in the two groups were all greater than 0.05, with no statistically significant difference, and were comparable. After treatment, compared with the control group, the levels of CD3+, CD3+ / CD4+, CD3+ / CD8+, and NK cells in the treatment group changed significantly, with statistically significant differences (P < 0.05), and there was no significant difference in B lymphocytes (P > 0.05). See Tables 9 to 13 for details.

[0090] Table 9 Comparison of CD3+ before and after treatment ( ±s; unit: %; n=90)

[0091] Note: ▽ indicates P < 0.05 compared with the control group.

[0092] Table 10 Comparison of CD3+ / CD4+ before and after treatment ( ±s; n=90)

[0093] Note: ▽ indicates P < 0.05 compared with the control group.

[0094] Table 11 Comparison of CD3+ / CD8+ before and after treatment ( ±s; n=90)

[0095] Note: ▽ indicates P < 0.05 compared with the control group.

[0096] Table 12 Comparison of B lymphocytes before and after treatment ( ±s; unit: %; n=90)

[0097] Table 13 Comparison of NK cells before and after treatment ( ±s; unit: %; n=90)

[0098] Note: ▽ indicates P < 0.05 compared with the control group.

[0099] It can be seen from the results of Tables 9 to 13 that standard Western medicine treatment and its combination with the Chinese medicine composition of the present invention can significantly increase the levels of CD3+, CD3+ / CD4+, CD3+ / CD8+, and NK cells, and have a regulatory effect on immune function, and the combination of the Chinese medicine composition of the present invention and standard Western medicine treatment can more effectively improve immune function.

[0100] 4.6 Effect of Chinese herbal medicine combination on fatigue scale scores in patients with prostate cancer According to the Piper Fatigue Scale, the patients in the control group and the treatment group were scored, and the results are shown in Table 14.

[0101] Before treatment, there was no significant difference in fatigue scale scores between the treatment group and the control group (P=0.542>0.05), which showed comparability. After 3 months of treatment with different treatment regimens, the total scores of the two groups decreased compared with those before treatment, and the degree of decrease in the treatment group was higher than that in the control group, and the differences were statistically significant (P =0.000<0.05, P =0.001<0.05). In terms of behavior, emotion, feeling, and cognition, the improvement in the treatment group was better than that in the control group, and the differences were statistically significant.

[0102] Table 14 Changes in Piper Fatigue Scale scores of the two groups of patients ( ±s; unit: minutes; n=90)

[0103] Note: * and △ indicate intra-group comparison before and after treatment, P < 0.05; ※ indicates inter-group comparison, P < 0.05.

[0104] It can be seen from the results that both standard Western medicine treatment and its combination with the Chinese medicine composition of the present invention can significantly improve fatigue scores and reduce the adverse reactions of endocrine therapy, and the combination of the Chinese medicine composition of the present invention and standard Western medicine treatment can more effectively improve fatigue scores.

[0105] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modification, equivalent substitution or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating prostate cancer, characterized in that: The raw materials of the traditional Chinese medicine composition include, by weight, 24-36 parts of raw astragalus, 8-12 parts of sophora flavescens, 12-18 parts of radix polygoni multiflori, 8-12 parts of turmeric, 12-18 parts of fenugreek and 8-12 parts of rhizoma anemarrhenae.

2. The Chinese medicine composition according to claim 1, characterized in that: The raw materials of the traditional Chinese medicine composition include, by weight, 27 to 33 parts of raw astragalus, 9 to 11 parts of sophora flavescens, 13.5 to 16.5 parts of radix polygoni multiflori, 9 to 11 parts of turmeric, 13.5 to 16.5 parts of fenugreek and 9 to 11 parts of rhizoma anemarrhenae.

3. The Chinese medicine composition according to claim 2, characterized in that: The raw materials of the traditional Chinese medicine composition include, by weight, 30 parts of raw astragalus, 10 parts of sophora flavescens, 15 parts of radix polygoni multiflori, 10 parts of turmeric, 15 parts of fenugreek and 10 parts of rhizoma anemarrhenae.

4. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The raw material is soaked in water and then boiled and extracted twice, each time for 0.5-1 hour, and filtered to obtain the product.

5. The preparation method according to claim 4, characterized in that: The mass of the water used for soaking is 5 to 10 times the mass of the raw material; and / or The soaking time is 1 to 3 hours; and / or The mass of water added during the second decoction extraction is 3 to 7 times the mass of the raw material; and / or The preparation method further comprises concentrating and / or drying the obtained extract; and / or The preparation method further comprises crushing the raw material before soaking.

6. Use of the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine composition prepared by the preparation method according to claim 4 or 5 in the preparation of a medicament for treating prostate cancer.

7. The use according to claim 6, characterized in that: The drug is a drug for patients with castration-resistant prostate cancer; and / or The drug is a drug used in combination with an endocrine drug; and / or The medicine is an oral preparation.

8. Use of the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine composition prepared by the preparation method according to claim 4 or 5 in the preparation of a drug for alleviating side effects after endocrine therapy.

9. The use according to claim 8, characterized in that: The drug is a drug for patients with castration-resistant prostate cancer; and / or The drug is a drug used in combination with an endocrine drug; and / or The medicine is an oral preparation.

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