Traditional Chinese medicine composition for treating renal clear cell carcinoma as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating renal clear cell carcinoma as well as a preparation method and application thereof, and belongs to the technical field of medicines. The traditional Chinese medicine composition provided by the invention comprises ginseng, astragalus membranaceus, bighead atractylodes rhizome, poria cocos, sculellaria barbata, oldenlandia diffusa, curcuma zedoary, dogwood, glossy privet fruit and selfheal. The traditional Chinese medicine composition provided by the invention is scientific and reasonable in compatibility, and can strengthen body resistance to eliminate pathogenic factors, clear away heat and toxic materials, promote blood circulation to remove blood stasis and soften hardness to dissipate stagnation. Clinical experiment results show that the traditional Chinese medicine composition provided by the invention can be used for effectively treating the renal clear cell carcinoma, and the treatment effective rate is superior to that of targeted medicine sorafenib; the traditional Chinese medicine composition is safe to take, has no obvious toxic or side effect, and has excellent performance in the aspects of improving traditional Chinese medicine syndromes of patients, improving life quality and reducing tumor marker level. The invention provides a new thought and method for treating the clear cell renal carcinoma, and has remarkable clinical significance and important popularization value.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical technologies, and particularly to a traditional Chinese medicine composition for treating renal clear cell carcinoma, its preparation method and application. Background Art

[0002] Renal clear cell carcinoma is the most common pathological type in renal carcinoma, with its incidence accounting for 70%-80% of renal carcinoma. Renal clear cell carcinoma is highly invasive and prone to metastasis, with no obvious early symptoms. Most patients are in the advanced stage at the time of diagnosis and have a poor prognosis. Currently, surgical resection is the main treatment method for renal clear cell carcinoma, but for patients with advanced or metastatic renal clear cell carcinoma, the surgical effect is limited and often accompanied by serious complications. In recent years, targeted therapy and immunotherapy have made certain progress in the treatment of renal clear cell carcinoma, but these treatment methods have problems such as high costs and large side effects, which limit their wide application.

[0003] Traditional Chinese medicine has a long history and rich experience in the treatment of tumors. Its overall concept and treatment principle of syndrome differentiation and treatment provide new ideas and methods for the treatment of renal clear cell carcinoma. Through the functions of strengthening the healthy qi and eliminating pathogenic factors, regulating the body's immune function, and alleviating symptoms, traditional Chinese medicine can improve the quality of life and survival rate of patients. Therefore, developing an effective traditional Chinese medicine composition for treating renal clear cell carcinoma has important clinical significance. Summary of the Invention

[0004] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating renal clear cell carcinoma, its preparation method and application, so as to solve the problems existing in the above-mentioned prior art. The traditional Chinese medicine composition provided by the present invention has a scientific and reasonable compatibility, can effectively treat renal clear cell carcinoma, and is safe in medication with no obvious toxic and side effects.

[0005] To achieve the above purpose, the present invention provides the following solutions:

[0006] The present invention provides a traditional Chinese medicine composition for treating renal clear cell carcinoma, which comprises the following raw material components by weight:

[0007] 10-15 parts of ginseng, 15-20 parts of astragalus membranaceus, 10-15 parts of atractylodes macrocephala, 10-15 parts of poria cocos, 15-20 parts of scutellaria barbata, 15-20 parts of oldenlandia diffusa, 10-15 parts of curcuma zedoaria, 10-15 parts of cornel, 10-15 parts of glossy privet fruit and 10-15 parts of prunella vulgaris.

[0008] Preferably, it comprises the following raw material components by weight:

[0009] 12 parts of ginseng, 18 parts of astragalus membranaceus, 12 parts of atractylodes macrocephala, 12 parts of poria cocos, 18 parts of scutellaria barbata, 18 parts of oldenlandia diffusa, 12 parts of curcuma zedoaria, 12 parts of cornel, 12 parts of glossy privet fruit and 12 parts of prunella vulgaris.

[0010] Ginseng: Sweet in taste, slightly bitter, warm in nature. It acts on the spleen, lung, heart, and kidney meridians. It has the effects of greatly tonifying primordial qi, restoring pulse and securing collapse, invigorating the spleen and benefiting the lung, promoting fluid production and nourishing blood, and calming the mind and enhancing intelligence. In the formula, it serves as the sovereign drug, used for tonifying healthy qi, enhancing the body's resistance, and strengthening healthy qi to eliminate pathogenic factors.

[0011] Astragalus membranaceus: Sweet in taste, slightly warm in nature. It acts on the spleen and lung meridians. It has the effects of boosting qi and raising yang, strengthening the exterior and consolidating the surface, promoting diuresis and reducing edema, and supporting detoxification and promoting granulation. In the formula, it serves as the ministerial drug, assisting ginseng in tonifying healthy qi, enhancing the body's immune function, and at the same time promoting diuresis and reducing edema to relieve the edema symptoms caused by tumors.

[0012] Atractylodes macrocephala: Bitter and sweet in taste, warm in nature. It acts on the spleen and stomach meridians. It has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis. In the formula, it serves as the ministerial drug, strengthening the spleen and promoting digestion, enhancing the function of the spleen and stomach, promoting the source of qi and blood generation, and providing a basis for strengthening healthy qi to eliminate pathogenic factors.

[0013] Poria cocos: Sweet and bland in taste, neutral in nature. It acts on the heart, spleen, and kidney meridians. It has the effects of promoting diuresis and percolating dampness, strengthening the spleen and calming the heart. In the formula, it serves as the ministerial drug, promoting diuresis and percolating dampness to relieve the retention of dampness caused by tumors, and at the same time strengthening the spleen and calming the heart to improve the mental state of patients.

[0014] Scutellaria barbata: Bitter and pungent in taste, cold in nature. It acts on the lung, liver, and kidney meridians. It has the effects of clearing heat and detoxifying, promoting blood circulation to remove stasis and inducing diuresis. In the formula, it serves as the adjuvant drug, clearing heat and detoxifying, promoting blood circulation to dissipate stasis, directly targeting the pathological characteristics of tumors, and inhibiting tumor growth.

[0015] Hedyotis diffusa: Bitter and sweet in taste, cold in nature. It acts on the lung, liver, and large intestine meridians. It has the effects of clearing heat and detoxifying, promoting diuresis and relieving stranguria, and anti-cancer. In the formula, it serves as the adjuvant drug, acting synergistically with Scutellaria barbata to enhance the effects of clearing heat and detoxifying and anti-cancer.

[0016] Curcuma zedoaria: Pungent and bitter in taste, warm in nature. It acts on the liver and spleen meridians. It has the effects of promoting qi circulation and breaking blood stasis, eliminating accumulation and relieving pain. In the formula, it serves as the adjuvant drug, promoting qi and blood circulation, promoting blood circulation to dissipate stasis, improving the symptoms of qi stagnation and blood stasis caused by tumors, and promoting the dissipation of tumors.

[0017] Cornus officinalis: Sour and astringent in taste, slightly warm in nature. It acts on the liver and kidney meridians. It has the effects of tonifying the liver and kidney, astringing and consolidating. In the formula, it serves as the adjuvant drug, tonifying the liver and kidney, enhancing the healthy qi of the body, and at the same time astringing and consolidating to prevent the leakage of essence qi.

[0018] Ligustrum lucidum: Sweet and bitter in taste, cool in nature. It acts on the liver and kidney meridians. It has the effects of nourishing the liver and kidney, clearing the liver and improving eyesight. In the formula, it serves as the adjuvant drug, nourishing the liver and kidney, and enhancing the healthy qi of the body.

[0019] Prunella vulgaris: Pungent and bitter in taste, cold in nature. It acts on the liver and gallbladder meridians. It has the effects of clearing liver fire, dispersing stagnation. In the formula, it serves as the guiding drug, clearing liver fire, dispersing stagnation, improving the symptoms of liver fire flaring up caused by tumors, and at the same time guiding the drug to enter the liver meridian to enhance the overall efficacy of the formula.

[0020] The present invention also provides a preparation method of the above-mentioned traditional Chinese medicine composition, comprising the following steps:

[0021] Weigh the raw material components of the traditional Chinese medicine composition, mix them evenly, soak them in water, heat to boiling, maintain gentle boiling for decoction, filter, and separately collect the filtrate and the residue;

[0022] Add water to the residue, heat to boiling, maintain gentle boiling for decoction, filter, collect the secondary filtrate, and combine the filtrate and the secondary filtrate to obtain the traditional Chinese medicine composition.

[0023] Preferably, the soaking time is 30 - 60 min.

[0024] Preferably, the time for maintaining gentle boiling for decoction is 20 - 30 min.

[0025] The present invention also provides an application of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating renal clear cell carcinoma.

[0026] The present invention also provides a drug for treating renal clear cell carcinoma, and the drug uses the above-mentioned traditional Chinese medicine composition as the main raw material.

[0027] Preferably, it further comprises pharmaceutically acceptable excipients.

[0028] Preferably, the dosage form of the drug is any one of decoction, pill, plaster, granule, and tablet.

[0029] Preferably, the dosage form of the drug is decoction.

[0030] The present invention discloses the following technical effects:

[0031] I. Strengthening healthy qi and eliminating pathogenic factors, treating both the principal and secondary aspects of the disease

[0032] In the traditional Chinese medicine composition of the present invention, drugs for tonifying healthy qi such as ginseng and astragalus membranaceus are used as the monarch and minister drugs to enhance the disease resistance of the body; at the same time, drugs with the effects of clearing heat and detoxifying and anti-cancer such as scutellaria barbata and oldenlandia diffusa are used as the assistant and envoy drugs to directly treat according to the pathological characteristics of tumors. This treatment plan that treats both the principal and secondary aspects of the disease can not only improve the clinical symptoms of patients, but also effectively inhibit the growth and metastasis of tumors.

[0033] II. High safety, no obvious toxic and side effects

[0034] Compared with targeted therapy and immunotherapy, no obvious toxic and side effects are seen during the treatment with the traditional Chinese medicine composition of the present invention, and patients have good tolerance. This indicates that while improving the survival rate of patients, the traditional Chinese medicine composition can significantly improve the quality of life of patients and has high clinical application value.

[0035] III. Multi-target action mechanism

[0036] Through the synergistic effect of various active ingredients, the traditional Chinese medicine composition of the present invention exerts multiple effects such as immunomodulation, anti-inflammation, antioxidant, inhibition of tumor cell proliferation and induction of apoptosis. For example, the saponin components in ginseng can enhance the immune function of the body, while the flavonoid compounds in Scutellaria barbata and Hedyotis diffusa have significant anti-cancer activities. This multi-target mechanism of action gives it unique advantages in the treatment of renal clear cell carcinoma.

[0037] IV. Significant clinical efficacy

[0038] In clinical verification, the total effective rate of the treatment group reached 75.00%, significantly higher than 58.33% of the control group (P < 0.05). In addition, the treatment group showed significant advantages in improving traditional Chinese medicine syndromes, enhancing the quality of life and reducing the levels of tumor markers. These results indicate that the traditional Chinese medicine composition of the present invention has high clinical application value in the treatment of renal clear cell carcinoma. Detailed implementation manners

[0039] The various exemplary implementation manners of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, characteristics and implementation schemes of the present invention.

[0040] It should be understood that the terms described in the present invention are only for describing particular implementation manners and are not used to limit the present invention. In addition, for the numerical ranges in the present invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any intermediate value within any stated value or stated range, as well as each smaller range between any other stated value or intermediate value within the stated range, is also included in the present invention. The upper and lower limits of these smaller ranges may be independently included or excluded within the range.

[0041] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the present invention pertains. Although the present invention only describes preferred methods and materials, any methods and materials similar or equivalent to those described herein can also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials related to the documents. In case of conflict with any incorporated document, the content of this specification shall prevail.

[0042] Without departing from the scope or spirit of the present invention, various improvements and changes can be made to the specific implementation manners of the specification of the present invention, which are obvious to those skilled in the art. Other implementation manners obtained from the specification of the present invention are obvious to those skilled in the art. The specification and embodiments of the present invention are only exemplary.

[0043] The terms "comprising", "including", "having", "containing", etc. as used in this text are all open-ended terms, meaning including but not limited to.

[0044] The compatibility of the traditional Chinese medicine composition formula of the present invention follows the treatment principle of "strengthening healthy qi to eliminate pathogenic factors" in traditional Chinese medicine. In the formula, ginseng, astragalus root, atractylodes macrocephala, and poria cocos are used as the monarch drugs to tonify healthy qi and enhance the disease resistance of the body. Scutellaria barbata, oldenlandia diffusa, zedoary turmeric, cornel fruit, glossy privet fruit, and selfheal spike herb are used as the assistant and guiding drugs to clear heat and detoxify, dissipate stasis and resolve masses, and promote diuresis and relieve stranguria, directly targeting the pathological characteristics of tumors for treatment. Strengthening healthy qi without retaining pathogenic factors, eliminating pathogenic factors without damaging healthy qi, achieving the purpose of strengthening healthy qi to eliminate pathogenic factors and treating cancer and dissipating tumors. In the formula, attention is paid not only to tonifying healthy qi and enhancing the disease resistance of the body (treating the root cause), but also to clearing heat and detoxifying, dissipating stasis and resolving masses, and improving the clinical symptoms of patients (treating the superficial symptoms). Through treating both the root cause and the superficial symptoms, a comprehensive treatment effect is achieved.

[0045] Ginseng, as the monarch drug of this formula, contains various active ingredients such as ginsenosides (Rg3, Rh2, etc.), which can significantly enhance the immune function of the body, improve the activities of T cells, B cells, and natural killer cells (NK cells), and enhance the body's immune surveillance and clearance ability against tumor cells. Among them, Rg3 can inhibit the angiogenesis of tumor cells, reduce the nutrient supply of tumors, and thus inhibit tumor growth. Astragalus polysaccharide in astragalus root can enhance the activities of macrophages and T cells, promote the secretion of cytokines (such as IL-2, TNF-α), and thus enhance the body's immune response. Atractylodes macrocephala and poria cocos have the effects of regulating immunity, anti-inflammation, and antioxidation, can improve the internal environment of the body, reduce the inflammatory response caused by tumors, and enhance the overall resistance of the body. Scutellaria barbata and oldenlandia diffusa contain various anti-cancer active ingredients such as flavonoids and polysaccharides, which can inhibit the proliferation of tumor cells, induce apoptosis of tumor cells, and at the same time have antioxidant and anti-inflammatory effects, reducing the oxidative stress damage caused by tumors. Curcumol in zedoary turmeric has significant anti-tumor effects, can inhibit the growth and metastasis of tumor cells, induce apoptosis of tumor cells, and at the same time has anti-inflammatory and immune regulatory effects. Selfheal spike herb, as the assistant drug of this formula, contains selfheal spike herb polysaccharide and flavonoids, which can inhibit the proliferation of tumor cells, induce apoptosis of tumor cells, and at the same time have anti-inflammatory and antioxidant effects, reducing the inflammatory response caused by tumors.

[0046] Example 1

[0047] A traditional Chinese medicine composition for treating renal clear cell carcinoma, comprising the following raw materials: 12 g of ginseng, 18 g of astragalus root, 12 g of atractylodes macrocephala, 12 g of poria cocos, 18 g of scutellaria barbata, 18 g of oldenlandia diffusa, 12 g of zedoary turmeric, 12 g of cornel fruit, 12 g of glossy privet fruit, and 12 g of selfheal spike herb.

[0048] Preparation method: Mix the above raw medicinal materials together, put them into a medicine pot, add 552 mL of water to submerge them, soak for 45 minutes, heat to boiling, and then keep simmering for 25 minutes. Filter to obtain filtrate A and residue; add 276 mL of water to the residue to submerge it, heat to boiling, and then keep simmering for 25 minutes. Filter to obtain filtrate B. Combine filtrate A and filtrate B and mix well to obtain the traditional Chinese medicine composition for treating renal clear cell carcinoma.

[0049] Example 2

[0050] A traditional Chinese medicine composition for treating renal clear cell carcinoma, comprising the following raw materials: 10 g of ginseng, 15 g of astragalus membranaceus, 10 g of atractylodes macrocephala, 10 g of poria cocos, 15 g of scutellaria barbata, 15 g of oldenlandia diffusa, 10 g of zedoary turmeric, 10 g of cornel fruit, 10 g of glossy privet fruit, 10 g of selfheal spike.

[0051] Preparation method: Mix the above raw medicinal materials together, put them into a medicine pot, add 460 mL of water to submerge them, soak for 30 minutes, heat to boiling, and then keep simmering for 20 minutes. Filter to obtain filtrate A and residue; add 230 mL of water to the residue to submerge it, heat to boiling, and then keep simmering for 20 minutes. Filter to obtain filtrate B. Combine filtrate A and filtrate B and mix well to obtain the traditional Chinese medicine composition for treating renal clear cell carcinoma.

[0052] Example 3

[0053] A traditional Chinese medicine composition for treating renal clear cell carcinoma, comprising the following raw materials: 15 g of ginseng, 20 g of astragalus membranaceus, 15 g of atractylodes macrocephala, 15 g of poria cocos, 20 g of scutellaria barbata, 20 g of oldenlandia diffusa, 15 g of zedoary turmeric, 15 g of cornel fruit, 15 g of glossy privet fruit, 15 g of selfheal spike.

[0054] Preparation method: Mix the above raw medicinal materials together, put them into a medicine pot, add 660 mL of water to submerge them, soak for 60 minutes, heat to boiling, and then keep simmering for 30 minutes. Filter to obtain filtrate A and residue; add 330 mL of water to the residue to submerge it, heat to boiling, and then keep simmering for 30 minutes. Filter to obtain filtrate B. Combine filtrate A and filtrate B and mix well to obtain the traditional Chinese medicine composition for treating renal clear cell carcinoma.

[0055] Comparative Example 1

[0056] A traditional Chinese medicine composition for treating renal clear cell carcinoma, which is only different from Example 1 in that ginseng in the raw materials is replaced by codonopsis pilosula and astragalus membranaceus is replaced by ganoderma lucidum.

[0057] Comparative Example 2

[0058] A traditional Chinese medicine composition for treating renal clear cell carcinoma, which is only different from Example 1 in that scutellaria barbata in the raw materials is replaced by Dioscorea bulbifera.

[0059] Comparative Example 3

[0060] A traditional Chinese medicine composition for treating clear cell renal carcinoma, which is only different from that in Example 1 in that the raw materials of the traditional Chinese medicine composition are: 20 g of Scutellaria barbata, 20 g of Hedyotis diffusa, 12 g of Atractylodes macrocephala, 12 g of Poria cocos, 12 g of Curcuma zedoaria, 12 g of Cornus officinalis, 12 g of Glossy Privet Fruit, and 12 g of Spica Prunellae.

[0061] Effect Verification Example 1

[0062] 1. Case Data

[0063] 120 patients with clear cell renal carcinoma were selected, all of whom were patients diagnosed with clear cell renal carcinoma by postoperative pathological examination in a certain tertiary hospital. They were randomly divided into a treatment group and a control group, with 60 patients in each group. The treatment group was given the traditional Chinese medicine composition prepared in Example 1 of the present invention, and the control group was given western medicine treatment. There were no significant differences in age, gender, disease condition, etc. between the two groups of patients, and they were comparable.

[0064] 2. Diagnostic Criteria

[0065] 2.1 Western Medicine Diagnostic Criteria:

[0066] Diagnosed as clear cell renal carcinoma by referring to the TNM staging standard of renal carcinoma formulated by the International Union Against Cancer (UICC) and combining imaging examinations (such as CT, MRI, etc.) and pathological examination results.

[0067] 2.2 Traditional Chinese Medicine Syndrome Diagnostic Criteria:

[0068] Diagnosed as the kidney deficiency stasis toxin type by referring to the syndrome differentiation and typing of renal carcinoma in "Traditional Chinese Medicine Oncology".

[0069] Main symptoms: low back pain, soreness and weakness of the waist, dull complexion, purple or ecchymotic tongue, deep, thin and unsmooth pulse.

[0070] Secondary symptoms: dizziness and tinnitus, insomnia and dreaminess, poor appetite and loose stools.

[0071] 3. Treatment Plan

[0072] Treatment group: Take the traditional Chinese medicine composition prepared in Example 1 of the present invention, 1 dose per day, warm it and take it twice, morning and evening, and continuously take it for 3 months as 1 course of treatment.

[0073] Control group: According to the specific situation of the patients, give the targeted therapeutic drug sorafenib, and the treatment cycle is 3 months.

[0074] 4. Efficacy Judgment Criteria

[0075] 4.1 Short-term Efficacy: According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1 version), it is divided into complete remission (CR), partial remission (PR), stable disease (SD), and progressive disease (PD).

[0076] Efficiency = (CR + PR) / Total number of cases × 100%.

[0077] 4.2 Therapeutic effect of traditional Chinese medicine syndromes: Referring to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines", the therapeutic effect index of traditional Chinese medicine syndromes was calculated using the nimodipine method = (Score before treatment - Score after treatment) / Score before treatment × 100%.

[0078] Cured: Therapeutic effect index of traditional Chinese medicine syndromes ≥ 95%;

[0079] Markedly effective: Therapeutic effect index of traditional Chinese medicine syndromes ≥ 70%;

[0080] Effective: Therapeutic effect index of traditional Chinese medicine syndromes ≥ 30%;

[0081] Ineffective: Therapeutic effect index of traditional Chinese medicine syndromes < 30%.

[0082] 5. Treatment results

[0083] According to the above treatment plan, the treatment group and the control group were orally administered the traditional Chinese medicine composition prepared in Example 1 of the present invention and the western medicine targeted drug sorafenib for the treatment of 120 patients with clear cell renal carcinoma. After 1 course of treatment, the therapeutic effect was statistically analyzed. The specific results are as follows:

[0084] Table 1 Statistical results of short-term therapeutic effects of each group

[0085] Group Number of cases Complete remission Partial remission Stable Progression Response rate / % Treatment group 60 5 40 10 5 75.00 Control group 60 3 32 15 10 58.33

[0086] The results in Table 1 show that the total effective rate of the treatment group was 75.00%, which was significantly higher than 58.33% of the control group (P < 0.05), indicating that the traditional Chinese medicine composition of the present invention has a significant advantage in inhibiting tumor growth.

[0087] Table 2 Statistical results of therapeutic effects of traditional Chinese medicine syndromes in each group

[0088]

[0089]

[0090] Table 3 Changes in scores of traditional Chinese medicine syndromes before and after treatment

[0091] Group Score before treatment (mean ± SD) Score after treatment (mean ± SD) Difference (mean ± SD) P value Treatment group 20.5±3.2 5.8±2.1 14.7±1.8 <0.05 Control group 20.3±3.1 10.2±2.5 10.1±1.6 <0.05

[0092] It can be seen from Table 2 and Table 3 that the effective rate of traditional Chinese medicine syndromes in the treatment group was 83.33%, which was significantly higher than 66.67% of the control group (P < 0.05), indicating that the traditional Chinese medicine composition of the present invention has a significant effect in improving the traditional Chinese medicine syndromes of patients.

[0093] Table 4 Changes in quality of life scores before and after treatment

[0094] Group Score before treatment (mean ± SD) Score after treatment (mean ± SD) Difference (mean ± SD) P value Treatment group 65.2±7.8 85.6±2.1 20.4±3.2 <0.05 Control group 64.8±8.1 75.3±7.2 10.5±2.8 <0.05

[0095] According to the results in Table 4, the quality of life score of the treatment group after treatment was significantly higher than that of the control group (P < 0.05), indicating that the traditional Chinese medicine composition of the present invention can significantly improve the quality of life of patients.

[0096] Table 5 Changes in the levels of tumor markers (CEA, CA19-9) before and after treatment

[0097]

[0098] The results in Table 5 show the changes in the levels of tumor markers: the levels of CEA and CA19-9 in the treatment group decreased significantly after treatment, and were better than those of the control group (P < 0.05), indicating that the traditional Chinese medicine composition of the present invention has a significant effect in inhibiting tumor activity.

[0099] Effect verification example 2

[0100] Sixty patients with clear cell renal carcinoma were selected and treated with the traditional Chinese medicine composition prepared in Comparative Example 1. The treatment plan and the efficacy judgment criteria were the same as those of the treatment group in Effect Verification Example 1.

[0101] Table 6 Short-term efficacy

[0102] Number of cases Complete remission Partial remission Stable Progression Response rate / % 60 2 28 18 12 50.00

[0103] Table 7 Efficacy of traditional Chinese medicine syndromes

[0104] Number of cases Cured Markedly effective Effective Ineffective Effective rate of traditional Chinese medicine syndromes / % 60 4 12 22 22 63.33

[0105] Table 8 Scores of traditional Chinese medicine syndromes

[0106]

[0107]

[0108] Table 9 Quality of life scores

[0109] Score before treatment (mean ± SD) Score after treatment (mean ± SD) Difference (mean ± SD) P value 65.1±8.2 77.2±7.5 12.1±3.7 <0.05

[0110] Table 10 Changes in the levels of tumor markers

[0111]

[0112] In Effect Verification Example 2, the traditional Chinese medicine composition of Comparative Example 1 was significantly lower than the traditional Chinese medicine composition of Example 1 of the present invention in terms of short-term efficacy, efficacy of traditional Chinese medicine syndromes, improvement of quality of life, and reduction of the levels of tumor markers in the treatment of clear cell renal carcinoma, indicating that its efficacy is relatively weak, further confirming the scientific nature of the compatibility of various medicinal materials in the traditional Chinese medicine composition of the present invention and the importance of the synergistic effect.

[0113] In summary, the traditional Chinese medicine composition of the present invention has shown remarkable clinical effects in the treatment of clear cell renal carcinoma. Its compatibility follows the treatment principle of "strengthening healthy qi and eliminating pathogenic factors" in traditional Chinese medicine. By combining the supplementation of healthy qi with clearing heat and detoxifying, and promoting blood circulation to remove stasis and dissipate nodules, it achieves the treatment of both the symptoms and the root causes. Judging from the clinical verification results, the total effective rate of the treatment group is significantly higher than that of the control group, and it also shows obvious advantages in improving the traditional Chinese medicine syndromes of patients, enhancing the quality of life, and reducing the levels of tumor markers.

[0114] The above-described embodiments are only descriptions of the preferred embodiments of the present invention, and do not limit the scope of the present invention. Without departing from the design spirit of the present invention, various deformations and improvements made by those of ordinary skill in the art to the technical solutions of the present invention shall fall within the protection scope determined by the claims of the present invention.

Claims

1. A Chinese medicine composition for treating renal clear cell carcinoma, characterized in that: By weight, it includes the following raw material components: 10-15 parts of ginseng, 15-20 parts of astragalus, 10-15 parts of atractylodes, 10-15 parts of tuckahoe, 15-20 parts of scutellaria barbata, 15-20 parts of oldenlandia diffusa, 10-15 parts of zedoaria, 10-15 parts of cornus officinalis, 10-15 parts of glossy privet fruit and 10-15 parts of selfheal.

2. The Chinese medicine composition according to claim 1, characterized in that By weight, it includes the following raw material components: 12 parts of ginseng, 18 parts of astragalus, 12 parts of atractylodes, 12 parts of tuckahoe, 18 parts of barbata, 18 parts of oldenlandia diffusa, 12 parts of zedoaria, 12 parts of cornus officinalis, 12 parts of glossy privet fruit and 12 parts of selfheal.

3. A method for preparing the Chinese medicine composition according to claim 1 or 2, characterized in that: The following steps are involved: Weigh the raw material components of the Chinese medicine composition, mix them evenly, soak them in water, heat them to boiling, keep them boiling slightly, filter them, and collect the filtrate and the residue respectively; Add water to the filter residue, heat to boiling, keep decocting at a slight boiling point, filter, collect the secondary filtrate, and combine the filtrate with the secondary filtrate to obtain the traditional Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that: The soaking time is 30-60 minutes.

5. The preparation method according to claim 3, characterized in that: The time for maintaining the slight boiling is 20-30 minutes.

6. Use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating renal clear cell carcinoma.

7. A drug for treating renal clear cell carcinoma, characterized in that: The medicine uses the Chinese medicine composition according to claim 1 or 2 as the main raw material.

8. The drug according to claim 7, characterized in that Pharmaceutically acceptable excipients are also included.

9. The drug according to claim 8, characterized in that The dosage form of the medicine is any one of decoction, pill, paste, granule and tablet.

10. The drug according to claim 9, characterized in that The dosage form of the medicine is decoction.

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