A traditional Chinese medicine composition for reducing adverse reactions after radiotherapy and chemotherapy of tumor patients and a preparation method thereof

Abstract

The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for reducing adverse reactions after radiotherapy and chemotherapy of tumor patients and a preparation method thereof, comprising the following components in parts by weight: Radix Bupleuri 6-9 parts, Radix Paeoniae Alba 6-9 parts, Rhizoma Atractylodis Macrocephalae 6-9 parts, Poria 6-9 parts, Angelica sinensis 6-9 parts, Zingiber officinale 3 parts, Radix Rehmanniae Recens 3-6 parts, Gardenia 3-6 parts, Radix Paeoniae Rubra 3-6 parts, Radix Paeoniae Alba 12-20 parts, Rhizoma Chuanxiong 6 parts, and Radix Glycyrrhizae 3-6 parts; the traditional Chinese medicine composition can improve the spirit and movement state of mice, and the weight and food intake of mice are obviously increased, the number of dead mice is significantly reduced, and the tumor volume and weight of mice are significantly reduced; the spleen and thymus indexes, the number of white blood cells, red blood cells and platelets in peripheral blood, and the hemoglobin content are all significantly increased; the number of bone marrow cells and the CD4 + T / CD8 + T cell ratio in peripheral blood are all significantly increased; when applied to clinical patients, the traditional Chinese medicine composition can reduce adverse reactions after radiotherapy and chemotherapy of tumor patients, and has a broad application prospect.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition and preparation method for reducing adverse reactions after radiotherapy and chemotherapy in cancer patients. Background Technology

[0002] Traditional Chinese medicine (TCM) believes that the basic pathogenesis of tumors is internal deficiency of vital energy (Qi), with Qi stagnation as the primary factor, followed by phlegm and blood stasis, resulting in a complex mixture of deficiency and excess. The disease is characterized by a deficiency in the root and an excess in the branch, with spleen deficiency being the primary deficiency and Qi stagnation, phlegm-dampness, and blood stasis being the primary branch excess. The treatment principle is to soothe the liver and strengthen the spleen, and to replenish Qi and nourish blood. TCM classifies radiotherapy and chemotherapy drugs as "toxic pathogens." Tumor patients are inherently weak, and after radiotherapy and chemotherapy, these toxic pathogens invade, damaging the vital energy, leading to an imbalance of Yin and Yang, Qi and blood stasis, and symptoms such as chest tightness, shortness of breath, nausea, vomiting, five-center heat (heat in the palms, soles, and chest), poor appetite, fatigue, lethargy, insomnia, and numbness in the limbs. TCM treatment for tumor patients undergoing post-radiotherapy and chemotherapy can address the root pathogenesis, differentiating the Qi, blood, Yin, Yang, cold, heat, deficiency, and excess, and comprehensively regulating the patient's condition according to the principles of TCM holistic treatment. This aims to alleviate symptoms, improve quality of life, and leverage the unique synergistic and toxicity-reducing effects of TCM, which can, to some extent, prevent tumor recurrence and metastasis and prolong survival.

[0003] The use of traditional Chinese medicine to improve the immunity of cancer patients after radiotherapy and chemotherapy or to reduce the adverse reactions of radiotherapy and chemotherapy has been studied in this field. For example, invention patent CN104306805B discloses a traditional Chinese medicine composition for enhancing immunity after radiotherapy and chemotherapy, its preparation method and application, which is prepared from the following raw materials in parts by weight: 10-20 parts of ginseng, 20-40 parts of Ophiopogon japonicus, 10-20 parts of turtle shell, 10-20 parts of chicken gizzard lining, 20-40 parts of coix seed, and 10-20 parts of Poria cocos. It can significantly improve symptoms such as drowsiness, forgetfulness, memory loss, loss of appetite and low immunity in people undergoing radiotherapy and chemotherapy. In addition, the composition has the advantages of good safety and no toxic side effects, and is also suitable for people who have not undergone radiotherapy and chemotherapy. Invention patent CN114404490B discloses a traditional Chinese medicine for treating leukopenia after radiotherapy and chemotherapy for tumors, comprising the following parts by weight: 10-20 parts of Citrus aurantium, 10-20 parts of Citrus reticulata peel, 15-30 parts of stir-fried Atractylodes macrocephala, 15-30 parts of Eucommia ulmoides, 25-40 parts of Taxillus chinensis, 25-40 parts of Psoralea corylifolia, 25-40 parts of Astragalus membranaceus, 5-15 parts of Angelica sinensis, and 5-15 parts of Glycyrrhiza uralensis. This medicine can effectively prevent and treat leukopenia after radiotherapy and chemotherapy for tumors, improve the immune function of cancer patients, improve their quality of life, and also play a certain role in anti-tumor activity, achieving both symptomatic and root-cause treatment effects. It is evident that traditional Chinese medicine can reduce the adverse reactions after radiotherapy and chemotherapy.

[0004] The inventor's research group has long been dedicated to the research of traditional Chinese medicine. Addressing the adverse reactions experienced by cancer patients after radiotherapy and chemotherapy, based on the concept of "strengthening the body's resistance and nourishing the foundation," they unexpectedly obtained a traditional Chinese medicine composition for reducing adverse reactions after radiotherapy and chemotherapy in cancer patients. This composition, with its balanced principal and auxiliary herbs and reasonable proportions, significantly improves the mental and motor state of mice, significantly increases body weight and food intake, significantly reduces the number of dead mice, and significantly reduces tumor volume and mass. It also significantly increases spleen and thymus indices, peripheral blood white blood cell, red blood cell, and platelet counts, and hemoglobin levels; and increases bone marrow cell count and peripheral blood CD4 count. + T / CD8 + T-cell ratios were significantly increased; when the aforementioned traditional Chinese medicine composition was applied to clinical patients, their TCM clinical symptoms were significantly improved, and their quality of life, including physical, social, emotional, and psychological functioning scores, were significantly higher than before treatment; the patients' white blood cell count showed an increasing trend compared to before treatment; CD3... + CD4 + CD4 + / CD8 + All levels were higher than before treatment and also higher than the control group. The traditional Chinese medicine composition described in this invention has broad application prospects. Summary of the Invention

[0005] The primary objective of this invention is to provide a traditional Chinese medicine composition for reducing adverse reactions after radiotherapy and chemotherapy in cancer patients. The traditional Chinese medicine composition comprises the following parts by weight of the following herbs: Bupleurum chinense 6-9 parts, Paeonia lactiflora 6-9 parts, Atractylodes macrocephala 6-9 parts, Poria cocos 6-9 parts, Angelica sinensis 6-9 parts, fresh ginger 3 parts, Rehmannia glutinosa 3-6 parts, Gardenia jasminoides 3-6 parts, Paeonia suffruticosa 3-6 parts, Astragalus membranaceus 12-20 parts, Ligusticum chuanxiong 6 parts, and Glycyrrhiza uralensis 3-6 parts.

[0006] Preferably, the traditional Chinese medicine composition is prepared from the following parts by weight of the following herbs: Bupleurum chinense 6-9 parts, Paeonia lactiflora 6 parts, Atractylodes macrocephala 6-9 parts, Poria cocos 6-9 parts, Angelica sinensis 6 parts, Zingiber officinale 3 parts, Rehmannia glutinosa 3-6 parts, Gardenia jasminoides 3-6 parts, Paeonia suffruticosa 3-6 parts, Astragalus membranaceus 12-20 parts, Ligusticum chuanxiong 6 parts, and Glycyrrhiza uralensis 3 parts.

[0007] Preferably, the traditional Chinese medicine composition is prepared from the following parts by weight of medicine: Bupleurum chinense 6 parts, Paeonia lactiflora 6 parts, Atractylodes macrocephala 6 parts, Poria cocos 6 parts, Angelica sinensis 6 parts, fresh ginger 3 parts, Rehmannia glutinosa 3 parts, Gardenia jasminoides 3 parts, Paeonia suffruticosa 3 parts, Astragalus membranaceus 12 parts, Ligusticum chuanxiong 6 parts, and Glycyrrhiza uralensis 3 parts.

[0008] Preferably, the traditional Chinese medicine composition is prepared from the following parts by weight of the following herbs: Bupleurum chinense 9 parts, Paeonia lactiflora 6 parts, Atractylodes macrocephala 6 parts, Poria cocos 6 parts, Angelica sinensis 6 parts, fresh ginger 3 parts, Rehmannia glutinosa 6 parts, Gardenia jasminoides 3 parts, Paeonia suffruticosa 3 parts, Astragalus membranaceus 12 parts, Ligusticum chuanxiong 6 parts, and Glycyrrhiza uralensis 3 parts.

[0009] Preferably, the traditional Chinese medicine composition is prepared from the following parts by weight of the following herbs: Bupleurum chinense 6 parts, Paeonia lactiflora 6 parts, Atractylodes macrocephala 6 parts, Poria cocos 6 parts, Angelica sinensis 6 parts, fresh ginger 3 parts, Rehmannia glutinosa 3 parts, Gardenia jasminoides 6 parts, Paeonia suffruticosa 6 parts, Astragalus membranaceus 20 parts, Ligusticum chuanxiong 6 parts, and Glycyrrhiza uralensis 3 parts.

[0010] Preferably, the traditional Chinese medicine composition is prepared from the following parts by weight of the following herbs: Bupleurum chinense 9 parts, Paeonia lactiflora 6 parts, Atractylodes macrocephala 6 parts, Poria cocos 6 parts, Angelica sinensis 6 parts, fresh ginger 3 parts, Rehmannia glutinosa 3 parts, Gardenia jasminoides 6 parts, Paeonia suffruticosa 6 parts, Astragalus membranaceus 12 parts, Ligusticum chuanxiong 6 parts, and Glycyrrhiza uralensis 3 parts.

[0011] Preferably, the traditional Chinese medicine composition is prepared from the following parts by weight of the following herbs: Bupleurum chinense 6 parts, Paeonia lactiflora 6 parts, Atractylodes macrocephala 9 parts, Poria cocos 9 parts, Angelica sinensis 6 parts, fresh ginger 3 parts, Rehmannia glutinosa 6 parts, Gardenia jasminoides 3 parts, Paeonia suffruticosa 3 parts, Astragalus membranaceus 12 parts, Ligusticum chuanxiong 6 parts, and Glycyrrhiza uralensis 3 parts.

[0012] Preferably, the traditional Chinese medicine composition is prepared from the following parts by weight of the following herbs: Bupleurum chinense 6 parts, Paeonia lactiflora 9 parts, Atractylodes macrocephala 9 parts, Poria cocos 9 parts, Angelica sinensis 9 parts, fresh ginger 3 parts, Rehmannia glutinosa 3 parts, Gardenia jasminoides 3 parts, Paeonia suffruticosa 6 parts, Astragalus membranaceus 12 parts, Ligusticum chuanxiong 6 parts, and Glycyrrhiza uralensis 6 parts.

[0013] The second objective of this invention is to provide a method for preparing the aforementioned traditional Chinese medicine composition, wherein Bupleurum chinense, Paeonia lactiflora, Atractylodes macrocephala, Poria cocos, Angelica sinensis, Zingiber officinale, Rehmannia glutinosa, Gardenia jasminoides, Paeonia suffruticosa, Astragalus membranaceus, Ligusticum chuanxiong, and Glycyrrhiza uralensis are weighed according to selected weight proportions, mixed, and then extracted using conventional extraction methods, or extracted separately using conventional extraction methods and then mixed, to obtain the final product.

[0014] A third objective of this invention is to provide a traditional Chinese medicine preparation for reducing adverse reactions after radiotherapy and chemotherapy in cancer patients, comprising the traditional Chinese medicine composition described above or the traditional Chinese medicine composition prepared by the preparation method described above, and optionally one or more pharmaceutically acceptable carriers.

[0015] The traditional Chinese medicine preparations mentioned include gels, creams, tablets, capsules, powders, mixtures, pills, granules, solutions, syrups, decoctions, suppositories, aerosols, plasters, ointments, injections, sprays, liniments, tinctures, wet compresses, pastes, or lotions;

[0016] The pharmaceutically acceptable carrier is selected from at least one of the following pharmaceutically acceptable solvents, solubilizers, co-solvents, emulsifiers, colorants, binders, disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, flow aids, flavoring agents, preservatives, suspending agents, coating materials, fragrances, anti-adhesives, binding agents, penetration enhancers, pH adjusters, buffers, plasticizers, surfactants, thickeners, inclusion agents, humectants, absorbents, diluents, flocculants and anti-flocculation agents, filter aids, release inhibitors, polymeric framework materials, and film-forming materials.

[0017] This formula uses Bupleurum to soothe the liver and regulate Qi, while Angelica sinensis and Paeonia lactiflora are used as assistant herbs to nourish and invigorate blood, thus replenishing the liver's essence. The principal and assistant herbs work together, combining their functions to soothe and nourish, allowing the liver Qi to flow smoothly and dissipate stagnation. Prolonged liver stagnation inevitably weakens the spleen, leading to impaired spleen function and insufficient production of Qi and blood, often resulting in deficiency of both. Astragalus membranaceus tonifies Qi, Atractylodes macrocephala strengthens the spleen, and Poria cocos drains dampness; these three herbs invigorate the spleen Qi and directly replenish the middle Jiao. Since the liver and kidneys share a common origin and essence and blood mutually transform, Rehmannia glutinosa enters the liver and kidneys, nourishing water to nourish wood, and together with Angelica sinensis and Paeonia lactiflora, it benefits essence and nourishes blood. These four herbs replenish the liver and kidneys, strengthen the spleen and stomach to benefit Qi and blood. Ligusticum chuanxiong is added to invigorate blood, promote Qi circulation, and remove blood stasis to treat blood stasis; these are all adjuvant herbs. Excess Qi can lead to heat; Gardenia jasminoides and Paeonia suffruticosa clear the liver and cool it, relieving the heat of Qi stagnation, also serving as adjuvant herbs. Ginger warms the stomach and harmonizes the middle Jiao, dispersing stagnation; Glycyrrhiza uralensis tonifies Qi, replenishes the middle Jiao, and harmonizes the other herbs; these two are the guiding herbs. The combination of these herbs achieves the effects of soothing the liver and strengthening the spleen, as well as replenishing qi and nourishing blood. Preliminary clinical studies have shown that this traditional Chinese medicine composition has a significant effect on replenishing qi and nourishing blood in cancer patients with "liver stagnation and spleen deficiency" after radiotherapy and chemotherapy, and also has significant effects on improving adverse reactions and enhancing the body's immunity, which can reduce the tumor metastasis rate after radiotherapy and chemotherapy in cancer patients.

[0018] The beneficial effects of this invention are as follows: This invention provides a traditional Chinese medicine composition for reducing adverse reactions after radiotherapy and chemotherapy in cancer patients. This composition can improve the mental and motor state of mice, significantly increase body weight and food intake, significantly reduce the number of dead mice, and significantly reduce tumor volume and mass in mice; it also significantly increases spleen and thymus indices, the number of white blood cells, red blood cells, platelets, and hemoglobin in peripheral blood; and it significantly increases the number of bone marrow cells and CD4+ in peripheral blood. + T / CD8 + T-cell ratios were significantly increased; when the aforementioned traditional Chinese medicine composition was applied to clinical patients, their TCM clinical symptoms were significantly improved, and their quality of life, including physical, social, emotional, and psychological functioning scores, were significantly higher than before treatment; the patients' white blood cell count showed an increasing trend compared to before treatment; CD3... + CD4 + CD4 + / CD8 + All levels were higher than before treatment and also higher than the control group. The traditional Chinese medicine composition described in this invention has broad application prospects. Detailed Implementation

[0019] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0020] It should be noted that, unless otherwise specified, the drugs and reagents used in the following examples can all be purchased commercially.

[0021] Adverse drug reactions (ADRs) are any reactions that occur during drug treatment and are unrelated to the therapeutic purpose. The World Health Organization defines ADRs as any senseless harmful reaction that occurs at doses appropriate for the prevention, diagnosis, and treatment of disease. Different anti-tumor drugs also have their own characteristics and patterns of ADRs.

[0022] Example 1

[0023] A traditional Chinese medicine composition for treating adverse reactions after radiotherapy and chemotherapy in cancer patients, the composition comprising the following components: Bupleurum chinense 6 parts, Paeonia lactiflora 6 parts, Atractylodes macrocephala 6 parts, Poria cocos 6 parts, Angelica sinensis 6 parts, Zingiber officinale 3 parts, Rehmannia glutinosa 3 parts, Gardenia jasminoides 3 parts, Paeonia suffruticosa 3 parts, Astragalus membranaceus 12 parts, Ligusticum chuanxiong 6 parts, Glycyrrhiza uralensis 3 parts.

[0024] Example 2

[0025] A traditional Chinese medicine composition for treating adverse reactions after radiotherapy and chemotherapy in cancer patients, the composition comprising the following components: Bupleurum chinense 9 parts, Paeonia lactiflora 6 parts, Atractylodes macrocephala 6 parts, Poria cocos 6 parts, Angelica sinensis 6 parts, Zingiber officinale 3 parts, Rehmannia glutinosa 6 parts, Gardenia jasminoides 3 parts, Paeonia suffruticosa 3 parts, Astragalus membranaceus 12 parts, Ligusticum chuanxiong 6 parts, Glycyrrhiza uralensis 3 parts.

[0026] Example 3

[0027] A traditional Chinese medicine composition for treating adverse reactions after radiotherapy and chemotherapy in cancer patients, the composition comprising the following components: Bupleurum chinense 6 parts, Paeonia lactiflora 6 parts, Atractylodes macrocephala 6 parts, Poria cocos 6 parts, Angelica sinensis 6 parts, Zingiber officinale 3 parts, Rehmannia glutinosa 3 parts, Gardenia jasminoides 6 parts, Paeonia suffruticosa 6 parts, Astragalus membranaceus 20 parts, Ligusticum chuanxiong 6 parts, Glycyrrhiza uralensis 3 parts.

[0028] Example 4

[0029] A traditional Chinese medicine composition for treating adverse reactions after radiotherapy and chemotherapy in cancer patients, the composition comprising the following components: Bupleurum chinense 9 parts, Paeonia lactiflora 6 parts, Atractylodes macrocephala 6 parts, Poria cocos 6 parts, Angelica sinensis 6 parts, Zingiber officinale 3 parts, Rehmannia glutinosa 3 parts, Gardenia jasminoides 6 parts, Paeonia suffruticosa 6 parts, Astragalus membranaceus 12 parts, Ligusticum chuanxiong 6 parts, Glycyrrhiza uralensis 3 parts.

[0030] Example 5

[0031] A traditional Chinese medicine composition for treating adverse reactions after radiotherapy and chemotherapy in cancer patients, the composition comprising the following components: Bupleurum chinense 6 parts, Paeonia lactiflora 6 parts, Atractylodes macrocephala 9 parts, Poria cocos 9 parts, Angelica sinensis 6 parts, Zingiber officinale 3 parts, Rehmannia glutinosa 6 parts, Gardenia jasminoides 3 parts, Paeonia suffruticosa 3 parts, Astragalus membranaceus 12 parts, Ligusticum chuanxiong 6 parts, Glycyrrhiza uralensis 3 parts.

[0032] Example 6

[0033] A traditional Chinese medicine composition for treating adverse reactions after radiotherapy and chemotherapy in cancer patients, the composition comprising the following components: Bupleurum chinense 6 parts, Paeonia lactiflora 9 parts, Atractylodes macrocephala 9 parts, Poria cocos 9 parts, Angelica sinensis 9 parts, Zingiber officinale 3 parts, Rehmannia glutinosa 3 parts, Gardenia jasminoides 3 parts, Paeonia suffruticosa 6 parts, Astragalus membranaceus 12 parts, Ligusticum chuanxiong 6 parts, Glycyrrhiza uralensis 6 parts.

[0034] Example 7

[0035] The traditional Chinese medicine compositions in Examples 1-6 can be decocted directly or prepared into powders, granules, pills, tablets, or capsules by adding pharmaceutically acceptable excipients such as flavoring agents, binders, solvents, and lubricants.

[0036] Example 8 Animal Experiment

[0037] 1. Experimental Procedure

[0038] 1.1 Establishment and grouping of mouse tumor radiotherapy and chemotherapy models

[0039] Sixty four-week-old BALB / c mice were purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd. and housed at the Animal Experiment Center of Gansu University of Traditional Chinese Medicine. After one week of acclimatization feeding, each mouse was subcutaneously injected with approximately 1 × 10⁻⁶ mg / L. 7 A suspension of 4T1 mouse breast cancer cells, when the tumor volume is greater than 50 mm 3 Mice were randomly divided into a control group, a radiotherapy and chemotherapy group, a low-dose traditional Chinese medicine (TCM) group, a medium-dose TCM group, and a high-dose TCM group. After grouping, mice in the radiotherapy and chemotherapy group, the low-dose TCM group, the medium-dose TCM group, and the high-dose TCM group were irradiated with X-rays once at a dose of 4 Gy, and then injected intraperitoneally with cyclophosphamide (50 mg / kg / d) for 3 consecutive days. Simultaneously, mice in the low-dose TCM group, the medium-dose TCM group, and the high-dose TCM group were administered the same dose of the adult TCM composition from Example 1 via gavage every morning for 20 days. Mice in the control group received an equal volume of physiological saline via intraperitoneal injection and gavage.

[0040] Table 1. Modeling methods and drug dosages for different experimental groups

[0041]

[0042] 1.2 Observation Indicators and Measurement Methods

[0043] (1) General observation of mice: The mental state, diet, and water intake of each group of mice were observed and recorded every day. The average daily food intake of each mouse in each group was calculated by weighing the total food intake of each group of mice on the day before the end of the experiment.

[0044] (2) Tumor volume and weight: After drug intervention, blood was drawn after intraperitoneal anesthesia with 10% chloral hydrate, the patient was euthanized, the solid tumor tissue was carefully dissected, accurately weighed, and the length and width of the solid tumor were measured. The volume of the solid tumor was calculated using the following formula: Tumor volume = length × width 2 ×0.5.

[0045] (3) Body weight and organ index analysis: After the drug intervention, the mice were weighed, and their spleen and thymus were removed. The connective tissue around the organs was cleaned and weighed immediately. The organ index (%) was calculated according to the following formula: Organ index (%) = organ weight (mg) / body weight (g) × 100%.

[0046] (4) Hematological parameters detection: Prepare 1.5 mL centrifuge tubes containing anticoagulant in advance. One day before the end of drug intervention, the tail tip of each mouse was quickly cut off from the base of the tail with surgical scissors, 50 μL of peripheral blood was collected and quickly dripped into the centrifuge tube, mixed thoroughly, and allowed to stand for 3 min. White blood cells (WBC), red blood cells (RBC), hemoglobin (HGB) and platelets (PLT) were analyzed using a hematology analyzer.

[0047] (5) Extraction and counting of bone marrow cells: Both intact femurs were removed, and the surrounding connective tissue was cleaned away. A small amount of bone tissue was removed from both ends of the femur using surgical scissors to expose the bone marrow cavity. A small amount of PBS was drawn into a 1mL syringe, and the needle tip was carefully inserted into one end of the bone marrow cavity. PBS was slowly injected to flush out all the bone marrow. The bone marrow cell suspension was collected by cell sieve filtration into a 15mL centrifuge tube and centrifuged at 1500rpm for 10min. The supernatant was discarded, and 3mL of erythrocyte lysate was added. After mixing, the mixture was allowed to stand for 5min, and then centrifuged at 1500rpm for 5min. The supernatant was discarded, and the cells were washed twice with PBS, centrifuged at 1500rpm for 5min, and the supernatant was discarded again. Finally, 5mL of PBS was added to resuspend the cells evenly. 10μL of the cell suspension was slowly added to a cell counting chamber for cell counting. The counting was repeated 3 times, and the average value was taken.

[0048] (6) Peripheral blood CD4 + T / CD8 +T cell ratio: Take 50 μL of whole blood and add 10 μL each of phycoerythrin-labeled anti-mouse CD8a antibody and allophycocyanin-labeled anti-mouse CD4 antibody. After vortexing and incubating in the dark for 30 min, add 2 mL of hemolysin, vortex and incubate for another 30 min. Centrifuge at 2000 rpm for 5 min, discard the supernatant, add 2 mL of PBS, vortex and mix well, and then detect CD4 using flow cytometry. + T / CD8 + The ratio of T cells.

[0049] 2 Experimental Results

[0050] 2.1 General observation of mice

[0051] As shown in Table 2, the body weight of mice in each group before modeling was 19.26±1.08g, with no statistically significant difference. Twenty days after modeling, compared with the control group, the mice in the radiotherapy and chemotherapy group exhibited poor mental state, sluggish movement, tendency to curl up, emaciation, loose skin, sparse, bristly, and dull hair, reduced food and water intake, significantly decreased body weight and food consumption, and a higher mortality rate. In contrast, the low, medium, and high dose groups of traditional Chinese medicine showed significantly improved mental and motor condition compared to the radiotherapy and chemotherapy group, with significant increases in body weight and food consumption, and a significantly reduced mortality rate.

[0052] Table 2 General information of mice in different groups

[0053]

[0054] Note: Compared with the control group, ## P < 0.01; Compared with the radiotherapy and chemotherapy group: *P < 0.05, **P < 0.01

[0055] 2.2 Tumor volume and mass in mice

[0056] As shown in Table 3, compared with the control group, the tumor volume and mass of mice in the radiotherapy and chemotherapy group were significantly reduced (P<0.01); compared with the radiotherapy and chemotherapy group, the tumor volume and mass of mice in the low, medium and high dose groups of traditional Chinese medicine were significantly reduced, among which the medium dose group of traditional Chinese medicine had the most obvious effect, and the difference was statistically significant (P<0.01).

[0057] Table 3. Tumor growth in mice of different groups

[0058]

[0059] Note: Compared with the control group, ## P < 0.01; Compared with the radiotherapy and chemotherapy group: *P < 0.05, **P < 0.01

[0060] 2.3 Spleen and thymus index in mice

[0061] As shown in Table 4, compared with the control group, the spleen and thymus indices of mice in the radiotherapy and chemotherapy group were significantly reduced (P<0.01); compared with the radiotherapy and chemotherapy group, the spleen and thymus indices of mice in the low, medium and high dose groups of traditional Chinese medicine were significantly increased, among which the high dose group of traditional Chinese medicine had the most obvious effect, and the difference was statistically significant (P<0.01).

[0062] Table 4. Spleen and thymus indices of mice in different groups

[0063]

[0064] Note: Compared with the control group, ## P < 0.01; Compared with the radiotherapy and chemotherapy group: *P < 0.05, **P < 0.01

[0065] 2.4 Mouse hematological parameters

[0066] As shown in Table 5, compared with the control group, the number of white blood cells, red blood cells, platelets and hemoglobin in the peripheral blood of mice in the radiotherapy and chemotherapy group were significantly reduced (P<0.01); compared with the radiotherapy and chemotherapy group, the number of white blood cells, red blood cells, platelets and hemoglobin in the peripheral blood of mice in the low, medium and high dose groups of traditional Chinese medicine were significantly increased, among which the medium dose group of traditional Chinese medicine had the most obvious effect (P<0.01).

[0067] Table 5 Hematological parameters of mice in different groups

[0068]

[0069] Note: Compared with the control group, ## P < 0.01; Compared with the radiotherapy and chemotherapy group: *P < 0.05, **P < 0.01

[0070] 2.5 Number of bone marrow cells and peripheral blood CD4 in mice + T / CD8 + T cell ratio

[0071] As shown in Table 6, compared with the control group, the number of bone marrow cells and the amount of CD4+ in the peripheral blood of mice in the radiotherapy and chemotherapy group were significantly different. + T / CD8 + The T cell ratio decreased significantly (P < 0.01); compared with the radiotherapy and chemotherapy group, the number of bone marrow cells and the level of CD4+ in peripheral blood of mice in the low, medium, and high dose groups of traditional Chinese medicine were significantly lower. + T / CD8 + The T cell ratios were significantly increased in all groups, with the medium-dose group of traditional Chinese medicine showing the most significant effect (P<0.01).

[0072] Table 6. Number of bone marrow cells and peripheral blood CD4 in mice from different groups. + T / CD8 + T cell ratio

[0073]

[0074] Note: Compared with the control group, ## P < 0.01; Compared with the radiotherapy and chemotherapy group: **P < 0.01

[0075] Example 9 Clinical Data

[0076] Experiment location: Affiliated Hospital of Gansu University of Traditional Chinese Medicine

[0077] 1. Clinical research protocol

[0078] 1.1 Clinical Data

[0079] Sixty patients with malignant tumors admitted to the Affiliated Hospital of Gansu University of Traditional Chinese Medicine from July 2018 to June 2023 were randomly divided into an experimental group and a control group, with 30 patients in each group. The experimental group consisted of 16 males and 14 females, aged 45-67 (55.25±1.18) years; 10 cases of lung cancer, 8 cases of breast cancer, 5 cases of liver cancer, and 7 cases of other malignant tumors. The control group consisted of 17 males and 13 females, aged 47-66 (56.36±1.21) years; 11 cases of lung cancer, 7 cases of breast cancer, 6 cases of liver cancer, and 6 cases of other malignant tumors. There were no statistically significant differences in clinical data between the two groups (P>0.05), indicating comparability. This study was approved by the hospital's ethics committee, and informed consent was obtained from patients and their families.

[0080] 1.2 Inclusion Criteria

[0081] The patient was confirmed to have a malignant tumor by imaging and postoperative pathology; the patient met the indications for radiotherapy and chemotherapy; the patient's expected survival time was more than 1 year.

[0082] 1.3 Exclusion Criteria

[0083] Patients with mental disorders; patients with multiple malignant tumors; patients with hematological diseases; patients with neurological diseases; and patients who withdrew from the study midway.

[0084] 1.4 Grouping and Treatment Methods

[0085] Sixty patients were divided into an experimental group (n=30) and a control group (n=30). The experimental group received oral Chinese medicine twice daily, taken 0.5 hours after breakfast and dinner, starting on the day of or after radiotherapy and chemotherapy, for four consecutive weeks. The control group received only postoperative radiotherapy and chemotherapy; except for the absence of the Chinese medicine, other general symptomatic and supportive treatments were the same as the experimental group. Other treatments, diet, and lifestyle remained unchanged during the medication period.

[0086] 1.5 Observation Indicators and Efficacy Evaluation

[0087] (1) Traditional Chinese Medicine Symptom Scale Scoring: The TCM symptom improvement assessment criteria were formulated with reference to the "Guidelines for Diagnosis and Treatment of Common Malignant Tumors in China" and the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs". The improvement of symptoms was assessed based on the change in the total score before and after treatment. A decrease in score value > 2 / 3 was considered significant, a decrease in score value between 2 / 3 and 1 / 3 was considered effective, and a decrease in score value < 1 / 3 was considered ineffective. The total effective rate = (significantly effective + effective) / total number of cases × 100%. (2) The SF-36 scale was used to assess the patients' quality of life. The scale is divided into four items: physical, social, emotional, and psychological functioning. Each item has a maximum score of 100 points. The higher the score, the higher the quality of life. (3) Laboratory tests: Peripheral blood cell analysis was used to detect white blood cells; flow cytometry was used to detect T lymphocyte subsets; CD3 was detected. + CD4 + and CD4 + / CD8 + ratio.

[0088] 2. Clinical study results

[0089] 2.1 Traditional Chinese Medicine Symptom Scoring

[0090] After treatment, the total scores of TCM symptoms in both groups decreased significantly. In the experimental group, 3 cases (10%) showed significant improvement, 20 cases (66.7%) showed improvement, and 7 cases (23.3%) showed no improvement, with a total effective rate of 76.7%. In the control group, 17 cases (56.7%) showed improvement, and 13 cases (43.3%) showed no improvement, with a total effective rate of 56.7%. The difference in total effective rate between the experimental and control groups was statistically significant (P < 0.05).

[0091] Table 7. Improvement of TCM clinical symptoms in the two groups before and after treatment.

[0092]

[0093] Note: Compared with the control group, # P < 0.05

[0094] Table 8. Improvement of TCM clinical symptoms in the two groups before and after treatment.

[0095]

[0096] Note: Compared with the control group, # P < 0.05

[0097] 2.2 Comparison of quality of life before and after treatment

[0098] Before treatment, there were no statistically significant differences in physical, social, emotional, and psychological functioning scores between the two groups (P > 0.05). After 4 weeks of treatment, the physical, social, emotional, and psychological functioning scores of both groups were significantly higher than before treatment, and the experimental group was higher than the control group (P < 0.01).

[0099] Table 9 Comparison of quality of life scores before and after treatment ( point)

[0100]

[0101]

[0102] Note: Compared with the control group, # P < 0.01, *P < 0.01 compared to before treatment.

[0103] 2.3 Comparison of white blood cell counts before and after treatment

[0104] Before treatment, there was no statistically significant difference in white blood cell count between the two groups (P>0.05); after 4 weeks of treatment, the white blood cell count in the control group decreased compared with that before treatment, while the white blood cell count in the experimental group showed an increasing trend compared with that before treatment (P<0.05).

[0105] Table 10 Comparison of white blood cell counts before and after treatment

[0106]

[0107] Note: Compared with the control group, # P < 0.05, *P < 0.05 compared to before treatment.

[0108] 2.4 Assessment of immune function

[0109] After treatment, CD3 in the control group + CD4 + CD4 + / CD8 + All were lower than before treatment, with the experimental group having lower CD3 levels. + CD4 + CD4 + / CD8 + All values ​​were higher than before treatment (P<0.05), and the experimental group was higher than the control group, with statistically significant differences (P<0.05).

[0110] Table 11 Comparison of immune function before and after treatment

[0111]

[0112] Note: Compared with the control group, # P < 0.05, *P < 0.05 compared to before treatment.

[0113] Typical Cases

[0114] Case 1:

[0115] General Information: Patient Wang, female, 62 years old, KPS score: 90. On April 5, 2021, the patient presented with a painful mass in her left breast, discovered incidentally. Physical examination revealed an irregularly shaped mass measuring 3cm x 3cm from the nipple at the 2 o'clock position in the left breast. The mass was slightly firm, with indistinct borders and an uneven surface. No enlarged lymph nodes were palpable in the left axilla. No abnormalities were found in the right breast. Blood routine examination: WBC 2.9*10 9 / L, NEUT 1.5*10 9 / L, HGB 110.0g / L, PLT 125*10 9 / L. T lymphocyte subset analysis: CD3 + 56.31%, CD4 + 36.14%, CD4 + / CD8 + 1.67%. Left breast mass biopsy: Ductal carcinoma in situ, intermediate nuclear grade, with ductal necrosis and calcification, two foci (diameter <1mm) and one invasive foci (diameter 1.3mm) were observed around the mass. Immunohistochemical results: Invasive ductal carcinoma cells, ER (2+80%), PR (2+60%), HER2 (1+), Ki-67 (+25%), E-cadherin (membrane+), P120 (membrane+), CK5 / 6 (-), P63 (-), calponin (-), AR (2+80%). Symptoms: The patient is an elderly female, experiencing fatigue, shortness of breath, dizziness, dull pain in both sides of the lower back and ribs, difficulty falling asleep, poor appetite, indigestion, normal bowel movements, red tongue with a thin yellow coating and teeth marks on the edges, weak pulse at the cun and guan positions on the left, and a deep, slippery, and slightly rapid pulse at the chi position on the right, and a weak pulse at the cun and guan positions on the right.

[0116] Traditional Chinese Medicine Diagnosis: Breast cancer TCM syndrome type: Liver stagnation and spleen deficiency, qi and blood deficiency.

[0117] Western medicine diagnosis: Left breast cancer (cT2N1M0, stage IIB)

[0118] Western medicine treatment: Cycles 1-4 of AC-T chemotherapy were administered starting May 12, 2021: THP 90mg day 1, CTX 800mg day 1. Cycles 5-8 of AC-T chemotherapy were administered on July 18, 2021, August 8, 2021, August 29, 2021, and September 19, 2021: albumin-bound paclitaxel 400mg day 1 (all 8 chemotherapy sessions were performed at Gansu Provincial Cancer Hospital).

[0119] Traditional Chinese Medicine Treatment: Soothe the liver and relieve depression, strengthen the spleen and replenish qi, nourish yin and blood. One dose of a self-prepared herbal formula per day (taken concurrently with chemotherapy, and for one week after the last chemotherapy session).

[0120] Prescription: Bupleurum 12g, White Peony Root 12g, Atractylodes Macrocephala 12g, Poria 12g, Angelica Sinensis 12g, Fresh Ginger 6g, Prepared Rehmannia Root 6g, Gardenia Fruit 6g, Moutan Bark 6g, Astragalus 24g, Ligusticum Chuanxiong 12g, Licorice Root 6g.

[0121] Treatment evaluation: PR

[0122] After treatment, the patient's symptoms of fatigue and shortness of breath improved, dizziness was significantly relieved, and the dull pain in the lower back and ribs basically disappeared. The patient's appetite was good, sleep was better than before, bowel movements were normal, the tongue was pale red with a thin white coating, the left pulse was deep and slippery, and the right pulse was slippery.

[0123] Blood routine test: WBC 5.7*10 9 / L, NEUT 3.6*10 9 / L, HGB 127.0g / L, PLT 240*10 9 / L.

[0124] T lymphocyte subset analysis: CD3 + 60.31%, CD4 + 41.14%, CD4 + / CD8 + 1.74%.

[0125] Case 2:

[0126] General Information: Patient Li, male, 52 years old, KPS score: 80. The patient presented with cough and sputum production without any obvious cause on January 10, 2021. Chest CT showed: bronchial transection and mass in the right upper lobe, suggestive of central lung cancer; mediastinal lymph node metastasis; diffuse hyperplasia of the left adrenal gland, follow-up recommended. Bronchoscopic biopsy: invasive carcinoma, suggestive of adenocarcinoma. PET / CT: soft tissue mass in the right upper lobe, multiple lymph nodes in the right hilum and mediastinum, and multiple areas of increased bone metabolism throughout the body. Consideration: right lung cancer, multiple lymph node metastases, and multiple bone metastases. Blood routine: WBC 2.0*10 9 / L, NEUT 1.2*10 9 / L, HGB 127.0g / L, PLT 110*10 9 / L. T lymphocyte subset analysis: CD3 + 53.87%, CD4 + 32.34%, CD4 + / CD8 + 1.22%. Symptoms include: chest pain, chest tightness and shortness of breath, aversion to wind and cold, bitter taste in the mouth, dry eyes, feeling of heaviness and weakness in both lower limbs when walking, numbness and coldness in the hands and feet, good appetite, bloating, poor sense of taste, preference for hot food, poor sleep, red tongue with white and greasy coating and cracks, weak left pulse and deep and slippery right pulse.

[0127] Traditional Chinese Medicine Diagnosis: Lung Accumulation; Traditional Chinese Medicine Syndrome: Liver Qi Stagnation and Spleen Deficiency, Qi and Blood Deficiency.

[0128] Western medical diagnosis: Malignant tumor in the upper lobe of the left lung (T4N2M1, stage IV)

[0129] Western medicine treatment: Four cycles of AC-T chemotherapy were initiated on January 29, 2021. Brain metastases underwent SBRT on August 14, 2021, completing the radiotherapy plan: GTVDT: 30 Gy / 5 fractions, single dose: 6 Gy. (All procedures were performed at Gansu Provincial Cancer Hospital)

[0130] Traditional Chinese Medicine Treatment: Soothe the liver and relieve depression, strengthen the spleen and replenish qi, nourish yin and blood. One dose of a self-prescribed herbal formula per day (taken concurrently during radiotherapy, and for one week after the last radiotherapy session).

[0131] Prescription: Bupleurum 9g, White Peony Root 6g, Atractylodes Rhizome 6g, Poria 6g, Angelica Root 6g, Fresh Ginger 3g, Prepared Rehmannia Root 6g, Gardenia Fruit 3g, Moutan Bark 3g, Astragalus Root 12g, Ligusticum Rhizome 6g, Licorice Root 3g.

[0132] Treatment evaluation: PR

[0133] After treatment, the patient's chest pain was significantly relieved, chest tightness and shortness of breath were significantly improved, bitter taste in the mouth and dry eyes basically disappeared, hands and feet were not warm, there was no numbness in the limbs, appetite was good, taste was normal, sleep was good, bowel movements were normal, tongue was red with a white and moist coating, left pulse was slippery, and right pulse was deep and slippery.

[0134] Blood routine test: WBC 5.0*10 9 / L, NEUT 4.3*10 9 / L, HGB 148.0g / L, PLT 268*10 9 / L.

[0135] T lymphocyte subset analysis: CD3 + 58.12%, CD4 + 37.81%, CD4 + / CD8 + 1.41%.

[0136] Case 3:

[0137] General Information: Patient Wang, female, 58 years old, KPS score: 90. In January 2022, the patient incidentally discovered a left breast mass, approximately the size of a date pit, accompanied by mild pain and good mobility. There was no nipple discharge. She did not pay much attention to it until February 27, 2022, when she presented with a breast ultrasound. The ultrasound revealed a hypoechoic nodule in the left breast (BI-RADS 4c), multiple abnormally enlarged lymph nodes in the left lobe (metastasis to be ruled out), and no obvious abnormalities in the right breast (BI-RADS I). Physical Examination: Both breasts were symmetrical without deformity, the skin was smooth, the nipples were symmetrical without retraction, and there was no nipple discharge. A 4.1*2.4cm mass was palpable in the upper outer quadrant of the left breast. It was firm, smooth, with relatively clear borders, and not adhered to the skin, surrounding tissues, or chest wall. It was mobile. No enlarged lymph nodes were palpable in the bilateral axillae or supraclavicular fossa. Blood Routine: WBC 4.7*10 9 / L, NEUT 3.1*10 9 / L, HGB 109.0g / L, PLT 201*10 9 / L. T lymphocyte subset analysis: CD3 + 61.28%, CD4 + 39.12%, CD4 + / CD8 + 1.17%. A fine-needle aspiration biopsy of the left breast mass revealed: (left breast) invasive ductal carcinoma, grade 2. (left axillary lymph node) metastasis to the lymph nodes. Immunohistochemical staining: Cancer cells showed E-cadherin (membrane+), P120 (membrane+), CK8 / 18 (+), CK5 / 6 (-), GATA3 (+), ER (90%, strong+), PR (90%, strong+), C-erbB-2 (1+), Syn (-), Ki-67 (10%+). Negative expression of calponin and P63 around the invasively growing ducts, nests, and cords suggested the disappearance of myoepithelial cells. Cancer cells in the axillary lymph node metastases showed CK8 / 18 (+), ER (90%, strong+), PR (90%, strong+), C-erbB-2 (1+), Ki-67 (10%+). Symptoms include: fatigue, chest tightness, shortness of breath, difficulty swallowing, irritability, occasional headaches and dizziness, excessive sweating, hot palms and soles, weakness and heaviness in the lower limbs as if walking on cotton, poor appetite, normal sleep, regular bowel movements, red tongue with yellow and greasy coating and petechiae on the tongue, weak pulse at the cun position, deep and rapid pulse at the guan position, and deep, wiry and slippery pulse at the chi position.

[0138] Traditional Chinese Medicine Diagnosis: Breast cancer TCM syndrome type: Liver stagnation and spleen deficiency, qi and blood deficiency.

[0139] Western medicine diagnosis: Malignant breast tumor (T4N2M0, stage III)

[0140] Western medicine treatment: Six cycles of neoadjuvant chemotherapy (TAC) were administered on March 8, 2022, March 29, 2022, April 21, 2022, May 12, 2022, June 5, 2022, and July 3, 2022. The specific drug dosage was: albumin-bound paclitaxel 460mg + cyclophosphamide 0.8g + epirubicin 160mg. Post-breast-conserving surgery radiotherapy was performed from September 26, 2022 to November 3, 2022. The gross tumor volume (GTV) was the silver-marked area of ​​the tumor bed in the left breast after surgery, with a total radiation dose (DT) of 60.2 Gy / 28 fractions (2.15 Gy / fraction). The central tumor volume (CTV) was the left whole breast and the left supraclavicular and infraclavicular regions, with a total radiation dose (DT) of 50.4 Gy / 28 fractions (1.8 Gy / fraction). (All treatments were conducted at Gansu Provincial Cancer Hospital.)

[0141] Traditional Chinese Medicine Treatment: Soothe the liver and relieve depression, strengthen the spleen and replenish qi, nourish yin and blood. One dose of a self-prepared herbal formula per day (taken concurrently with radiotherapy and chemotherapy, and for one week after the last radiotherapy session).

[0142] Prescription: Bupleurum 12g, White Peony Root 12g, Atractylodes Macrocephala 12g, Poria 12g, Angelica Sinensis 12g, Fresh Ginger 6g, Prepared Rehmannia Root 6g, Gardenia 12g, Moutan Bark 12g, Astragalus 40g, Ligusticum Chuanxiong 12g, Licorice Root 6g.

[0143] Treatment evaluation: PR

[0144] After treatment, the patient's symptoms were as follows: fatigue was significantly relieved, chest tightness and shortness of breath basically disappeared, there was no foreign body sensation in the throat, mood was better than before, headache and dizziness did not recur, sweating was reduced, heat in the palms and soles was significantly improved, appetite was good, sleep was good, bowel movements were normal, tongue was red with a slightly thick white coating, left pulse was deep, and right pulse was deep and slippery.

[0145] Blood routine test: WBC 5.9*10 9 / L, NEUT 4.6*10 9 / L, HGB 110.0g / L, PLT 209*10 9 / L.

[0146] T lymphocyte subset analysis: CD3 + 65.83%, CD4 + 42.64%, CD4 + / CD8 + 1.36%.

[0147] Case 4:

[0148] General Information: Patient Ma, male, 68 years old, KPS score: 90. The patient began experiencing progressively worsening choking while eating in May 2022, accompanied by retrosternal pain and discomfort. Gastroscopy revealed the esophageal inlet 16cm from the incisors, and mucosal bulging causing luminal narrowing and thickening 34-36cm from the incisors. The initial diagnosis was esophageal lesion of undetermined nature, chronic atrophic gastritis. Bronchoscopy revealed thickened and congested mucosa in the left lower lobe of the lung, with luminal narrowing extending upwards to approximately 0.5cm of the lower membranous portion of the left main bronchus. External compression changes were also observed in the lower membranous portion and medial wall of the left main bronchus, with the upper margin 2.5cm from the carina. Pathological Results: (Esophageal) Malignant tumor, predominantly poorly differentiated carcinoma; (Left lower lobe) Chronic inflammation of the bronchial mucosa with fibrous tissue hyperplasia, with scattered atypical cells observed, suggestive of cancerous tissue. Immunohistochemistry of esophageal tumor cells showed: INI-1 (++, not deleted), CK7 (++), BRG-1 (+, not deleted), Syn (+, a few cells), P40 (+, a few cells), P63 (+, a few cells), CK5 / 6 (+, a few cells), Ki-67 (+, approximately 50% localized), RB (+, some cells), P53 (+, some cells), Vimentin (+, some cells), CD56 (+), NUT (-), INSM1 (-), CgA (-), CDX-2 (-). Blood routine test: WBC 2.9*10 9 / L, NEUT 3.6*10 9 / L, HGB 90.0g / L, PLT 186*10 9 / L. T lymphocyte subset analysis: CD3 + 54.27%, CD4 + 37.85%, CD4 + / CD8 + 1.41%. CT scan showed: 1. Multiple liver cysts; bilateral renal cysts; left pleural effusion with atelectasis and inflammation of adjacent lung tissue; high-density shadows at the relative margins of L2-L3 vertebrae, suggestive of endplate inflammation; no abnormalities were found on CT scans of the gallbladder, pancreas, and spleen. 2. Findings in the middle and lower esophagus and surrounding mediastinum, suggestive of esophageal cancer with multiple enlarged lymph nodes in the mediastinum and left hilar region; stenosis of the opening segments of the left main bronchus and upper and lower lobe bronchi; lesion surrounding the thoracic aorta; inflammation in the lower lobes of both lungs; calcification in the medial segment of the right middle lobe; bilateral pulmonary bullae; calcification along the course of the left coronary artery; left pleural effusion; liver cysts; bilateral renal cysts; 3. No obvious lesions were found on cranial CT scan. No abnormalities were found on whole-body bone scan. Symptoms included: fatigue, dizziness, numbness in the limbs, insomnia, frequent awakenings at night, and normal bowel and bladder function. The tongue is dark in color with a white, greasy coating and teeth marks. The left pulse is floating and slippery at the cun and guan positions, and weak at the chi position. The right pulse is normal and slightly slippery.

[0149] Traditional Chinese Medicine Diagnosis: Esophageal obstruction; Traditional Chinese Medicine syndrome type: Liver stagnation and spleen deficiency, qi and blood deficiency.

[0150] Western medicine diagnosis: Malignant esophageal tumor (T4, Nx, Mx)

[0151] Western medicine treatment: Four cycles of TC chemotherapy were initiated on August 24, 2022. (All treatments were conducted at Gansu Provincial Cancer Hospital)

[0152] Traditional Chinese Medicine Treatment: Soothe the liver and relieve depression, strengthen the spleen and replenish qi, nourish yin and blood. One dose of a self-prepared herbal formula per day (taken concurrently with chemotherapy, and for one week after the last chemotherapy session).

[0153] Prescription: Bupleurum 18g, White Peony Root 12g, Atractylodes Macrocephala 12g, Poria 12g, Angelica Sinensis 12g, Fresh Ginger 6g, Prepared Rehmannia Root 6g, Gardenia 12g, Moutan Bark 12g, Astragalus 24g, Ligusticum Chuanxiong 12g, Licorice Root 6g.

[0154] Treatment evaluation: PR

[0155] After treatment, the patient's symptoms were as follows: fatigue was significantly relieved, dizziness and blurred vision were slightly improved, sleep was better than before, bowel movements were normal, the tongue was pale with a thin white coating and no teeth marks were visible, the left pulse was slippery and the right pulse was normal.

[0156] Blood routine test: WBC 5.9*10 9 / L, NEUT 7.6*10 9 / L, HGB 120.0g / L, PLT 260*10 9 / L.

[0157] T lymphocyte subset analysis: CD3 + 58.54%, CD4 + 40.22%, CD4 + / CD8 + 1.63%.

[0158] Case 5:

[0159] General Information: Patient Yang, female, 52 years old, KPS score: 80. During a physical examination on May 18, 2022, ultrasound revealed a mass in the left breast. A 1.5*1.5cm mass was palpable at the 7 o'clock position in the lower outer quadrant of the left breast, 3.0cm from the nipple. The mass was slightly hard, with indistinct borders, and relatively mobile, without adhesion to surrounding tissues. Pathological examination of the left breast mass biopsy showed invasive ductal carcinoma, nonspecific type, grade II. Immunohistochemical results: tumor cells ER (3+90%), PR (2+50%), HER2 (2+), Ki-67 (+50%), E-cadherin (+), P120 (membrane+), CK5 / 6 (-), P63 (-), calponin (-), AR (3+90%), GATA-3 (+), SOX-10 (-), TRPS1 (partially+), CK8 / 18 (+). Blood routine test: WBC 3.9*109 / L, NEUT 5.2*10 9 / L, HGB 100.0g / L, PLT 200*10 9 / L. T lymphocyte subset analysis: CD3 + 63.12%, CD4 + 46.38%, CD4 + / CD8 + 1.38%. Symptoms include: palpitations, tinnitus, hot flashes in the palms, soles, and chest, sweating, especially in the back, dysmenorrhea, lower abdominal pain during menstruation, and lower back pain; menstruation has now ceased. The patient prefers hot food, suffers from insomnia, is easily startled at night, has normal bowel movements and urination, has a red tongue with little coating, and a thready and rapid pulse.

[0160] Traditional Chinese Medicine Diagnosis: Breast cancer TCM syndrome type: Liver stagnation and spleen deficiency, qi and blood deficiency.

[0161] Western medicine diagnosis: Malignant tumor in the lower outer quadrant of the breast (T1N0M0, stage I)

[0162] Western medicine treatment: Four cycles of adjuvant chemotherapy with the TCH regimen were performed on June 21, 2022, July 11, 2022, August 1, 2022, and August 22, 2022, followed by two cycles of trastuzumab molecular targeted therapy. (All treatments were conducted at Gansu Provincial Cancer Hospital)

[0163] Traditional Chinese Medicine Treatment: Soothe the liver and relieve depression, strengthen the spleen and replenish qi, nourish yin and blood. One dose of a self-prepared herbal formula per day (taken concurrently with chemotherapy, and for 4 weeks after the last chemotherapy session).

[0164] Prescription: Bupleurum 6g, White Peony Root 6g, Atractylodes Macrocephala 9g, Poria 9g, Angelica Sinensis 6g, Fresh Ginger 3g, Prepared Rehmannia Root 6g, Gardenia Fruit 3g, Moutan Bark 3g, Astragalus 12g, Ligusticum Chuanxiong 6g, Licorice Root 3g.

[0165] Treatment evaluation: PR

[0166] After treatment, the patient's symptoms were as follows: no recurrence of palpitations and tinnitus, improvement in the five-center heat symptoms, good mood, significantly reduced sweating, no recovery of menstruation, good appetite, good sleep, regular bowel movements, pale red tongue with a thin white coating, and a thready pulse.

[0167] Blood routine test: WBC 5.5*10 9 / L, NEUT 7.0*10 9 / L, HGB 112.0g / L, PLT232*10 9 / L.

[0168] T lymphocyte subset analysis: CD3 + 67.23%, CD4 + 49.18%, CD4 + / CD8 + 1.48%.

[0169] Case 6:

[0170] General Information: Patient Su, female, 59 years old, KPS score: 90. In November 2022, the patient incidentally discovered left nipple retraction and occasionally experienced pain and discomfort when stretching her left arm in the morning. Ultrasound findings: solid mass in the left breast (BI-RADS 4), hypoechoic nodule in the right breast (BI-RADS 4), and enlarged left axillary lymph nodes. Mammography findings: right breast mass, nature to be determined; suspicious calcification in the left breast; BI-RADS classification: bilateral breast 4C. Pathological examination of the left breast mass via biopsy revealed invasive ductal carcinoma, nonspecific type, grade II, with focal calcification. Immunohistochemical results showed tumor cells were ER(-), PR(-), HER2(3+), Ki-67(+30%), E-cadherin (membrane+), P120 (membrane+), CK5 / 6(-), P63(-), calponin(-), AR(2+40%), and β-Catenin (membrane+). FISH was positive. Pathological examination of the right breast mass via biopsy revealed invasive ductal carcinoma, nonspecific type, grade II, with focal coagulative necrosis. Immunohistochemical results showed tumor cells with ER (3+90%), PR (2+60%), HER2 (1+), Ki-67 (+10%), E-cadherin (membrane+), P120 (membrane+), CK5 / 6 (-), P63 (-), calponin (-), AR (1+50%), and β-Catenin (+). Blood routine examination showed WBC 3.5*10. 9 / L, NEUT 5.1*10 9 / L, HGB 99.0g / L, PLT 165*10 9 / L. T lymphocyte subset analysis: CD3 + 60.45%, CD4 + 42.72%, CD4 + / CD8 + 1.11%. Symptoms include: stabbing pain in both breasts, chest tightness, shortness of breath, tinnitus, blurred vision, fatigue, numbness in the hands, weakness and soreness in the lower limbs, poor appetite, bloating, normal sleep, and regular bowel movements. The tongue is pale with a yellow, greasy coating and cracks; the left pulse is weak, and the right pulse is soft and slippery.

[0171] Traditional Chinese Medicine Diagnosis: Breast cancer TCM syndrome type: Liver stagnation and spleen deficiency, qi and blood deficiency.

[0172] Western medicine diagnosis: Bilateral malignant breast tumors (T2N2M0, stage IIIA)

[0173] Western medicine treatment: Eight cycles of dual-targeted therapy were administered on May 6, 2023, May 29, 2023, June 19, 2023, July 10, 2023, August 1, 2023, August 22, 2023, September 11, 2023, and October 3, 2023. (All treatments were conducted at Gansu Provincial Cancer Hospital)

[0174] Traditional Chinese Medicine (TCM) treatment: Soothe the liver and relieve depression, strengthen the spleen and replenish qi, nourish yin and blood. One dose of a self-prescribed herbal formula per day (taken concurrently during dual-targeted therapy, and for one week after the last targeted therapy).

[0175] Prescription: Bupleurum 6g, White Peony Root 9g, Atractylodes Rhizome 9g, Poria 9g, Angelica Root 9g, Fresh Ginger 3g, Prepared Rehmannia Root 3g, Gardenia Fruit 3g, Moutan Bark 6g, Astragalus Root 12g, Ligusticum Rhizome 6g, Licorice Root 6g.

[0176] Treatment evaluation: PR

[0177] After treatment, the patient presented with the following symptoms: no obvious discomfort in the breasts and both sides of the ribs; improvement in chest tightness and shortness of breath; significant relief from fatigue and weakness; tinnitus symptoms that have basically disappeared; improvement in blurred vision; and the disappearance of numbness in the limbs. The patient also had a good appetite, good sleep, regular bowel movements, a pale tongue with a white and greasy coating, a weak pulse on the left, and a slippery pulse on the right.

[0178] Blood routine test: WBC 5.9*10 9 / L, NEUT 5.5*10 9 / L, HGB 145.0g / L, PLT 289*10 9 / L.

[0179] T lymphocyte subset analysis: CD3 + 64.65%, CD4 + 45.35%, CD4 + / CD8 + 1.30%.

Claims

1. A traditional Chinese medicine composition for reducing adverse reactions after radiotherapy and chemotherapy of tumor patients, characterized in that, The traditional Chinese medicine composition is prepared from the following ingredients by weight: 6-9 parts of Radix Bupleuri, 6-9 parts of Radix Paeoniae Alba, 6-9 parts of Rhizoma Atractylodis Macrocephalae, 6-9 parts of Poria, 6-9 parts of Angelica sinensis, 3 parts of ginger, 3-6 parts of Radix Rehmanniae Preparata, 3-6 parts of Gardenia, 3-6 parts of Radix Paeoniae Rubra, 12-20 parts of Radix Paeoniae Alba, 6 parts of Rhizoma Chuanxiong, and 3 parts of Radix Glycyrrhizae.

2. The traditional Chinese medicine composition of claim 1, wherein, The traditional Chinese medicine composition is prepared from the following ingredients by weight: 6 parts of Radix Bupleuri, 6 parts of Radix Paeoniae Alba, 6 parts of Rhizoma Atractylodis Macrocephalae, 6 parts of Poria, 6 parts of Angelica sinensis, 3 parts of ginger, 3 parts of Radix Rehmanniae Preparata, 3 parts of Gardenia, 3 parts of Radix Paeoniae Rubra, 12 parts of Radix Paeoniae Alba, 6 parts of Rhizoma Chuanxiong, and 3 parts of Radix Glycyrrhizae.

3. The traditional Chinese medicine composition of claim 1, wherein, The traditional Chinese medicine composition is prepared from the following ingredients by weight: 9 parts of Radix Bupleuri, 6 parts of Radix Paeoniae Alba, 6 parts of Rhizoma Atractylodis Macrocephalae, 6 parts of Poria, 6 parts of Angelica sinensis, 3 parts of ginger, 6 parts of Radix Rehmanniae Preparata, 3 parts of Gardenia, 3 parts of Radix Paeoniae Rubra, 12 parts of Radix Paeoniae Alba, 6 parts of Rhizoma Chuanxiong, and 3 parts of Radix Glycyrrhizae.

4. The traditional Chinese medicine composition of claim 1, wherein, The traditional Chinese medicine composition is prepared from the following ingredients by weight: 6 parts of Radix Bupleuri, 6 parts of Radix Paeoniae Alba, 6 parts of Rhizoma Atractylodis Macrocephalae, 6 parts of Poria, 6 parts of Angelica sinensis, 3 parts of ginger, 3 parts of Radix Rehmanniae Preparata, 6 parts of Gardenia, 6 parts of Radix Paeoniae Rubra, 20 parts of Radix Paeoniae Alba, 6 parts of Rhizoma Chuanxiong, and 3 parts of Radix Glycyrrhizae.

5. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following ingredients by weight: 9 parts of Radix Bupleuri, 6 parts of Radix Paeoniae Alba, 6 parts of Rhizoma Atractylodis Macrocephalae, 6 parts of Poria, 6 parts of Angelica sinensis, 3 parts of ginger, 3 parts of Radix Rehmanniae Preparata, 6 parts of Gardenia, 6 parts of Radix Paeoniae Rubra, 12 parts of Radix Paeoniae Alba, 6 parts of Rhizoma Chuanxiong, and 3 parts of Radix Glycyrrhizae.

6. The traditional Chinese medicine composition of claim 1, wherein, The traditional Chinese medicine composition is prepared from the following ingredients by weight: 6 parts of Radix Bupleuri, 6 parts of Radix Paeoniae Alba, 9 parts of Rhizoma Atractylodis Macrocephalae, 9 parts of Poria, 6 parts of Angelica sinensis, 3 parts of ginger, 6 parts of Radix Rehmanniae Preparata, 3 parts of Gardenia, 3 parts of Radix Paeoniae Rubra, 12 parts of Radix Paeoniae Alba, 6 parts of Rhizoma Chuanxiong, and 3 parts of Radix Glycyrrhizae.

7. A method for preparing the traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following ingredients by weight: 6-9 parts of Radix Bupleuri, 6-9 parts of Radix Paeoniae Alba, 6-9 parts of Rhizoma Atractylodis Macrocephalae, 6-9 parts of Poria, 6-9 parts of Angelica sinensis, 3 parts of ginger, 3-6 parts of Radix Rehmanniae Preparata, 3-6 parts of Gardenia, 3-6 parts of Radix Paeoniae Rubra, 12-20 parts of Radix Paeoniae Alba, 6 parts of Rhizoma Chuanxiong, and 3 parts of Radix Glycyrrhizae are weighed according to the selected weight ratio, mixed, and then extracted by a conventional extraction method or extracted separately by a conventional extraction method and then mixed to obtain the traditional Chinese medicine composition.

8. A traditional Chinese medicine preparation for reducing adverse reactions after radiotherapy and chemotherapy of tumor patients, characterized in that, The traditional Chinese medicine composition of claim 1 or prepared by the preparation method of claim 7, and optionally one or more pharmaceutically acceptable carriers; The traditional Chinese medicine preparation is a gel, a cream, a tablet, a capsule, a powder, a mixture, a pill, a granule, a syrup, a decoction, a suppository, an aerosol, a plaster, an ointment, an injection, a spray, a tincture, a wet compress, a paste; The pharmaceutically acceptable carrier is at least one selected from a pharmaceutically acceptable solubilizer, an emulsifier, a coloring agent, a binder, a disintegrant, a filler, a lubricant, a wetting agent, an osmotic pressure regulator, a stabilizer, a flavoring agent, a preservative, a suspending agent, a coating material, an anti-adhesion agent, a penetration enhancer, a pH regulator, a buffer, a surfactant, a thickening agent, a flocculating agent and a deflocculating agent, a filter aid, a release retardant.

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