Medicine for treating nasopharynx cancer as well as preparation method and application thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine compositions, in particular to a nasopharynx cancer treatment medicine and application thereof. The tea is prepared from the following raw materials in parts by weight: 8-12 parts of tea leaves, 25-40 parts of pollen typhae, 8-12 parts of bletilla striata, 8-12 parts of radix ophiopogonis, 5-8 parts of mint, 8-12 parts of Chinese wolfberry fruits, 15-30 parts of oldenlandia diffusa, 8-16 parts of wild chrysanthemum flowers, 5-10 parts of paris polyphylla, 8-15 parts of coix seeds, 3-5 parts of selaginella doederleinii hieron, 2-9 parts of radix fici simplicissimae and 42-85 parts of honey compound liquid. The honey complex liquid comprises honey, sucralfate, normal saline, benzydamine, Kangfuxin liquid, a compound borax solution, sodium bicarbonate, chlorhexidine, povidone iodine and granulocyte-macrophage colony stimulating factors. The medicine for treating nasopharynx cancer is dominated by a traditional Chinese medicine compound, has the effects of clearing away heat and toxic materials aiming at the fire-heat toxicity of radioactive rays, and has the effects of strengthening the middle warmer, moistening dryness, relieving pain and detoxifying.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine compositions, and more specifically, it relates to a therapeutic drug for nasopharyngeal carcinoma, its preparation method and application. Background Art

[0002] Nasopharyngeal carcinoma is a malignant tumor of the mucosal epithelium of the nasopharynx, mostly occurring in the top wall and side walls of the nasopharynx, especially the pharyngeal recess. Radiotherapy is the main treatment method for nasopharyngeal carcinoma. For stage I (T1N0M0) nasopharyngeal carcinoma, satisfactory curative effects can be obtained by taking simple radical radiotherapy. For stage II (T0-2N0-1M0) nasopharyngeal carcinoma, there is a great controversy over whether to add concurrent chemotherapy to radical radiotherapy. Among them, T2N1 has a high incidence of distant metastasis and should be combined with concurrent chemotherapy mainly based on cisplatin. For locally advanced (stage III-IVA) nasopharyngeal carcinoma, platinum-based concurrent chemotherapy is required. And according to the stage and individual conditions, the chemotherapy intensity is further increased on the basis of concurrent chemoradiotherapy (such as combining neoadjuvant chemotherapy or adjuvant chemotherapy). Compared with simple radiotherapy, concurrent chemoradiotherapy brings more and more severe toxic reactions.

[0003] Regarding the prevention and treatment of RTOM, a number of clinical studies have been carried out at home and abroad. However, no particularly effective drugs or regimens have been found. The US Food and Drug Administration has not approved any drugs for the prevention and treatment of RTOM. At present, conventional measures such as oral care, nutritional support, pain control, infection prevention and treatment, and mucosal repair are the main cornerstones. A safer and more effective prevention and treatment strategy is still worthy of further exploration.

[0004] Compared with western medicine-based oral care solutions, oral care solutions containing traditional Chinese medicine ingredients have achieved good clinical effects. Traditional Chinese medicine has been widely used in the prevention and treatment of RTOM, and the main principles are clearing heat and detoxifying, resolving phlegm and removing stasis, and replenishing qi and nourishing yin. A number of traditional Chinese medicine compounds guided by these principles have achieved good clinical prevention and treatment effects, such as Shuanghua Baihe Tablets with the main efficacy of clearing heat and detoxifying, and Kangfuxin Liquid with the efficacy of removing stasis and nourishing yin.

[0005] In the prior art, the ingredients of traditional Chinese medicine are complex and may interact with chemotherapy drugs, affecting the absorption, metabolism and excretion of chemotherapy drugs, thereby reducing the chemotherapy effect or increasing the toxic and side effects. The preventive effects of different oral care solutions on RTOM are inconsistent with the research results, which increases the difficulty of selecting oral care solutions. Summary of the Invention

[0006] The present invention provides a therapeutic drug for nasopharyngeal carcinoma and its treatment method. Guided by a traditional Chinese medicine compound, it plays a role in clearing heat and detoxifying against the fiery toxicity of radiation. The prepared therapeutic drug for nasopharyngeal carcinoma has the effects of tonifying the middle-jiao, moistening dryness, relieving pain, and detoxifying.

[0007] In a first aspect, the present invention provides a drug for treating nasopharyngeal carcinoma, which is prepared from the following raw materials by weight: 8 to 12 parts of tea leaves, 25 to 40 parts of pollen pollen, 8 to 12 parts of bletilla striata, 8 to 12 parts of ophiopogon japonicus, 5 to 8 parts of mint, 8 to 12 parts of wolfberry, 15 to 30 parts of oldenlandia diffusa, 8 to 16 parts of wild chrysanthemum, 5 to 10 parts of seven-leaf parsnip, 8 to 15 parts of coix seeds, 3 to 5 parts of cyperus rotundus, 2 to 9 parts of quinquefolius quinquefolius, and 42 to 85 parts of honey compound liquid, wherein the honey compound liquid comprises honey, sucralfate, normal saline, benzydamine, Kangfuxin liquid, compound borax solution, sodium bicarbonate, chlorhexidine, povidone iodine and granulocyte-macrophage colony stimulating factor.

[0008] Preferably, the invention is made of the following raw materials by weight: 8-10 parts of tea leaves, 30-40 parts of pollen, 10-12 parts of bletilla striata, 8-10 parts of ophiopogon japonicus, 6-8 parts of mint, 10-12 parts of wolfberry, 15-25 parts of oldenlandia diffusa, 10-16 parts of wild chrysanthemum, 8-10 parts of seven-leaf gentian, 11-15 parts of coix seeds, 3-5 parts of cyperus rotundus, 4-9 parts of quinquefolius quinquefolius, and 45-85 parts of honey compound liquid.

[0009] Preferably, the invention is made of the following raw materials by weight: 10-12 parts of tea leaves, 30-40 parts of pollen, 10-12 parts of bletilla striata, 8-12 parts of ophiopogon japonicus, 7-8 parts of mint, 10-12 parts of wolfberry, 25-30 parts of oldenlandia diffusa, 12-16 parts of wild chrysanthemum, 8-10 parts of seven-leaf gentian, 12-15 parts of coix seeds, 4-5 parts of cyperus rotundus, 7-9 parts of quinquefolius quinquefolius, and 48-80 parts of honey compound liquid.

[0010] Preferably, the invention is made of the following raw materials by weight: 10 parts of tea leaves, 30 parts of pollen, 10 parts of bletilla striata, 8 parts of ophiopogon japonicus, 7 parts of mint, 10 parts of wolfberry, 25 parts of oldenlandia diffusa, 12 parts of wild chrysanthemum, 8 parts of seven-leaf gentian, 12 parts of coix seed, 4 parts of cyperus rotundus, 7 parts of quinquefolius quinquefolius, and 48 parts of honey compound liquid.

[0011] Preferably, the invention is made of the following raw materials by weight: 12 parts of tea leaves, 40 parts of pollen, 12 parts of bletilla striata, 12 parts of ophiopogon japonicus, 8 parts of mint, 10 parts of wolfberry, 25 parts of oldenlandia diffusa, 15 parts of wild chrysanthemum, 9 parts of seven-leaf gentian, 12 parts of coix seed, 5 parts of cypress, 9 parts of quinquefolia, and 55 parts of honey compound liquid.

[0012] In a second aspect, the present invention provides a method for preparing a drug for treating nasopharyngeal carcinoma, comprising the following steps:

[0013] (1) Weigh tea leaves, pollen, bletilla striata, ophiopogon japonicus, mint, wolfberry, oldenlandia diffusa, wild chrysanthemum, seven-leaf parsnip, coix seed, cypress, and quinquefolia in parts by weight and set aside;

[0014] (2) Mix the weighed traditional Chinese medicine raw materials, decoct them with water, and filter the obtained decoction to obtain the product.

[0015] (3) Weigh the honey composite solution: honey, sucralfate, normal saline, benzydamine, Kangfuxin solution, compound borax solution, sodium bicarbonate, chlorhexidine, povidone iodine, and granulocyte-macrophage colony-stimulating factor. Mix the traditional Chinese medicine filtrate with the honey composite solution and stir evenly to prepare the drug for treating nasopharyngeal carcinoma.

[0016] Preferably, the honey composite solution is composed of the following raw materials by weight: 5 - 10 parts of honey, 1 - 3 parts of sucralfate, 2 - 5 parts of normal saline, 2 - 4 parts of benzydamine, 1 - 3 parts of Kangfuxin solution, 2 - 5 parts of compound borax solution, 1 - 1.5 parts of sodium bicarbonate, 0.5 - 1.2 parts of chlorhexidine, 2.3 - 2.8 parts of povidone iodine, and 1 - 2 parts of granulocyte-macrophage colony-stimulating factor.

[0017] Preferably, the honey composite solution is composed of the following raw materials by weight: 6 - 10 parts of honey, 1.5 - 3 parts of sucralfate, 2.8 - 5 parts of normal saline, 3 - 4 parts of benzydamine, 1.5 - 3 parts of Kangfuxin solution, 4 - 5 parts of compound borax solution, 1.2 - 1.5 parts of sodium bicarbonate, 0.8 - 1.2 parts of chlorhexidine, 2.5 - 2.8 parts of povidone iodine, and 1 - 2 parts of granulocyte-macrophage colony-stimulating factor.

[0018] Preferably, the honey composite solution is composed of the following raw materials by weight: 10 parts of honey, 1.5 parts of sucralfate, 2.8 parts of normal saline, 3 parts of benzydamine, 3 parts of Kangfuxin solution, 4 parts of compound borax solution, 1.5 parts of sodium bicarbonate, 0.8 parts of chlorhexidine, 2.5 parts of povidone iodine, and 2 parts of granulocyte-macrophage colony-stimulating factor.

[0019] In the third aspect, the present invention provides a drug for treating nasopharyngeal carcinoma for use in a drug for treating oral mucositis in nasopharyngeal carcinoma patients undergoing radiotherapy and chemotherapy.

[0020] Preferably, the method for using the drug for treating oral mucositis in nasopharyngeal carcinoma patients undergoing radiotherapy and chemotherapy is as follows: According to the theory of the flow of qi and blood in meridians, use the drug for treating nasopharyngeal carcinoma to perform oral care at 9:00 - 11:00, the hour of Si, when saliva secretion is most vigorous, and at 17:00 - 19:00, the hour of You, which is related to oral diseases.

[0021] Preferably, the method for using the drug for treating oral mucositis in nasopharyngeal carcinoma patients undergoing radiotherapy and chemotherapy is as follows: Evenly apply the drug for treating nasopharyngeal carcinoma to the oral mucosa to make the drug for treating nasopharyngeal carcinoma fully contact with the oral mucosa, apply it 2 - 3 times a day, and continuously apply it for 28 - 30 days.

[0022] In summary, the present invention has the following beneficial effects:

[0023] 1. In the present invention, the antibacterial properties of honey depend on various factors. When encountering bacteria, the osmotic pressure of honey is higher than that of bacteria, driving bacteria to dehydrate and even die. At the same time, the acidic pH can also inhibit the growth of most bacteria, inhibit the activity of proteases, increase the activity of fibroblasts and epithelial cells, thereby promoting the healing of wounds; the high viscosity of honey provides a physical protection barrier conducive to self-repair for the wound surface and can also prevent cross-infection; when honey is used as an oral care solution, it will stay in the mouth for a period of time, thus stimulating the secretion of saliva. Under the action of saliva, hydrogen peroxide will be produced. A lower concentration of hydrogen peroxide can stimulate the formation of blood vessels and granulation tissue to accelerate the healing of the wound surface.

[0024] 2. The honey composite solution of the present invention contains various bioactive components such as flavonoids, monophenols, polyphenols, catalase, ascorbic acid, etc., which is the basis for its antioxidant activity. This antioxidant property can reduce cell damage caused by free radicals by protecting antioxidant enzymes and reducing oxidative stress, thereby reducing the inflammatory response.

[0025] 3. The traditional Chinese medicine composition and the honey composite solution in the present invention can play an anti-inflammatory role through mechanisms such as inhibiting the formation of reactive oxygen species, the nuclear factor-activated B-cell k-light chain enhancement (NF-kB) signaling pathway, and leukocyte infiltration. It can improve the activity of macrophages and lymphocytes, reduce the concentration of prostaglandins, and promote the body to produce antibodies to enhance the immune function. To a certain extent, it has the effect of preventing OM. Patients undergoing radiotherapy and chemotherapy have good tolerance to honey, and honey is inexpensive and widely sourced, making it more easily acceptable to patients.

[0026] 4. The present invention uses the integrated traditional Chinese and Western medicine method to prevent oral mucositis in patients with nasopharyngeal carcinoma undergoing radiotherapy and chemotherapy. It is a simple, safe, effective, and evidence-based method for preventing oral mucositis in patients with nasopharyngeal carcinoma undergoing radiotherapy and chemotherapy, so as to avoid the waste of unnecessary medical resources and reduce the pain and economic burden of patients. It provides a simple and easy-to-operate traditional Chinese medicine nursing technique for the treatment of patients with nasopharyngeal carcinoma undergoing radiotherapy and chemotherapy, and better improves the quality of life of patients with nasopharyngeal carcinoma undergoing radiotherapy and chemotherapy with oral mucositis.

[0027] It should be understood that the above general description and the following detailed description are only exemplary and explanatory, and cannot limit the protection scope of the present invention. Detailed implementation mode

[0028] The following further details the present invention in conjunction with embodiments. It should be specifically noted that: for those not specifying specific conditions in the following embodiments, they are carried out according to conventional conditions or conditions recommended by the manufacturer. Unless otherwise specified, the raw materials used in the following embodiments can be obtained from ordinary commercial sources.

[0029] Embodiment

[0030] Embodiment 1

[0031] A drug for treating nasopharyngeal carcinoma is prepared from the following raw materials by weight: 8 parts of tea leaves, 25 parts of pollen typhae, 8 parts of bletilla striata, 8 parts of radix ophiopogonis, 5 parts of mentha haplocalyx briq., 8 parts of wolfberry fruit, 15 parts of oldenlandia diffusa willd., 8 parts of wild chrysanthemum flower, 5 parts of paris polyphylla sm., 8 parts of coix seed, 3 parts of herba sarcandrae, 2 parts of ficus hirta vahl., and 42 parts of honey compound solution;

[0032] The honey compound solution is composed of the following raw materials by weight: 5 parts of honey, 1 part of sucralfate, 2 parts of normal saline, 2 parts of benzydamine, 1 part of rehabilitation new solution, 2 parts of compound borax solution, 1 part of sodium bicarbonate, 0.5 part of chlorhexidine, 2.3 parts of povidone iodine and 1 part of granulocyte-macrophage colony-stimulating factor.

[0033] A preparation method of a drug for treating nasopharyngeal carcinoma comprises the following steps:

[0034] (1) Weigh tea leaves, pollen typhae, bletilla striata, radix ophiopogonis, mentha haplocalyx briq., wolfberry fruit, oldenlandia diffusa willd., wild chrysanthemum flower, paris polyphylla sm., coix seed, herba sarcandrae, ficus hirta vahl. according to the weight parts for standby;

[0035] (2) Mix the weighed traditional Chinese medicine raw materials, add water for decocting, and filter the obtained decoction to obtain the product;

[0036] (3) Weigh the honey compound solution: honey, sucralfate, normal saline, benzydamine, rehabilitation new solution, compound borax solution, sodium bicarbonate, chlorhexidine, povidone iodine and granulocyte-macrophage colony-stimulating factor, mix the traditional Chinese medicine filtrate with the honey compound solution, and stir evenly to prepare the drug for treating nasopharyngeal carcinoma.

[0037] Example 2

[0038] A drug for treating nasopharyngeal carcinoma is prepared from the following raw materials by weight: 9 parts of tea leaves, 30 parts of pollen typhae, 9 parts of bletilla striata, 9 parts of radix ophiopogonis, 6 parts of mentha haplocalyx briq., 9 parts of wolfberry fruit, 21 parts of oldenlandia diffusa willd., 10 parts of wild chrysanthemum flower, 7 parts of paris polyphylla sm., 12 parts of coix seed, 4 parts of herba sarcandrae, 5 parts of ficus hirta vahl., and 54 parts of honey compound solution;

[0039] The honey compound solution is composed of the following raw materials by weight: 8 parts of honey, 2 parts of sucralfate, 4 parts of normal saline, 3 parts of benzydamine, 2 parts of rehabilitation new solution, 3 parts of compound borax solution, 1 part of sodium bicarbonate, 0.8 part of chlorhexidine, 2.5 parts of povidone iodine and 1 part of granulocyte-macrophage colony-stimulating factor.

[0040] A preparation method of a drug for treating nasopharyngeal carcinoma comprises the following steps:

[0041] (1) Weigh tea leaves, pollen typhae, bletilla striata, radix ophiopogonis, mentha haplocalyx briq., wolfberry fruit, oldenlandia diffusa willd., wild chrysanthemum flower, paris polyphylla sm., coix seed, herba sarcandrae, ficus hirta vahl. according to the weight parts for standby;

[0042] (2) Mix the weighed traditional Chinese medicine raw materials, decoct with water, and filter the obtained decoction to obtain it;

[0043] (3) Weigh the honey composite solution: honey, sucralfate, physiological saline, benzydamine, Kangfuxin solution, compound borax solution, sodium bicarbonate, chlorhexidine, povidone iodine, and granulocyte-macrophage colony-stimulating factor. Mix the traditional Chinese medicine filtrate with the honey composite solution and stir evenly to prepare the therapeutic drug for nasopharyngeal carcinoma.

[0044] Example 3

[0045] A therapeutic drug for nasopharyngeal carcinoma is prepared from the following raw materials by weight: 10 parts of tea leaves, 30 parts of typha pollen, 9 parts of bletilla striata, 10 parts of ophiopogon japonicus, 6 parts of mentha haplocalyx, 10 parts of wolfberry fruit, 21 parts of oldenlandia diffusa, 12 parts of wild chrysanthemum, 8 parts of paris polyphylla, 12 parts of coix lacryma-jobi, 4 parts of selaginella doederleinii, 5 parts of ficus hirta, and 78 parts of honey composite solution;

[0046] The honey composite solution is composed of the following raw materials by weight: 8 parts of honey, 3 parts of sucralfate, 2 parts of physiological saline, 2 parts of benzydamine, 1 part of Kangfuxin solution, 2 parts of compound borax solution, 1.5 parts of sodium bicarbonate, 1.2 parts of chlorhexidine, 2.8 parts of povidone iodine, and 2 parts of granulocyte-macrophage colony-stimulating factor.

[0047] A preparation method of a therapeutic drug for nasopharyngeal carcinoma includes the following steps:

[0048] (1) Weigh tea leaves, typha pollen, bletilla striata, ophiopogon japonicus, mentha haplocalyx, wolfberry fruit, oldenlandia diffusa, wild chrysanthemum, paris polyphylla, coix lacryma-jobi, selaginella doederleinii, and ficus hirta by weight for standby;

[0049] (2) Mix the weighed traditional Chinese medicine raw materials, decoct with water, and filter the obtained decoction to obtain it;

[0050] (3) Weigh the honey composite solution: honey, sucralfate, physiological saline, benzydamine, Kangfuxin solution, compound borax solution, sodium bicarbonate, chlorhexidine, povidone iodine, and granulocyte-macrophage colony-stimulating factor. Mix the traditional Chinese medicine filtrate with the honey composite solution and stir evenly to prepare the therapeutic drug for nasopharyngeal carcinoma.

[0051] Example 4

[0052] A therapeutic drug for nasopharyngeal carcinoma is prepared from the following raw materials by weight: 11 parts of tea leaves, 38 parts of typha pollen, 11 parts of bletilla striata, 9 parts of ophiopogon japonicus, 6 parts of mentha haplocalyx, 8 parts of wolfberry fruit, 15 parts of oldenlandia diffusa, 16 parts of wild chrysanthemum, 10 parts of paris polyphylla, 10 parts of coix lacryma-jobi, 3 parts of selaginella doederleinii, 2 parts of ficus hirta, and 45 parts of honey composite solution;

[0053] The honey compound solution is composed of the following raw materials by weight: 8 parts of honey, 2 parts of sucralfate, 4 parts of normal saline, 3 parts of benzydamine, 2 parts of Kangfuxin solution, 4 parts of compound borax solution, 1 part of sodium bicarbonate, 0.5 part of chlorhexidine, 2.5 parts of povidone iodine, and 1 part of granulocyte-macrophage colony-stimulating factor.

[0054] A preparation method of a nasopharyngeal carcinoma treatment drug includes the following steps:

[0055] (1) Weigh tea leaves, cattail pollen, bletilla striata, ophiopogon japonicus, mint, wolfberry fruit, oldenlandia diffusa, wild chrysanthemum, paris polyphylla, coix seed, sabina chinensis, and ficus hirta by weight, and set aside;

[0056] (2) Mix the weighed traditional Chinese medicine raw materials, decoct with water, and filter the obtained decoction to obtain it;

[0057] (3) Weigh the honey compound solution: honey, sucralfate, normal saline, benzydamine, Kangfuxin solution, compound borax solution, sodium bicarbonate, chlorhexidine, povidone iodine, and granulocyte-macrophage colony-stimulating factor. Mix the traditional Chinese medicine filtrate with the honey compound solution and stir evenly to obtain the nasopharyngeal carcinoma treatment drug.

[0058] Example 5

[0059] A nasopharyngeal carcinoma treatment drug is made from the following raw materials by weight: 12 parts of tea leaves, 25 parts of cattail pollen, 8 parts of bletilla striata, 10 parts of ophiopogon japonicus, 7 parts of mint, 10 parts of wolfberry fruit, 21 parts of oldenlandia diffusa, 12 parts of wild chrysanthemum, 8 parts of paris polyphylla, 10 parts of coix seed, 4 parts of sabina chinensis, 5 parts of ficus hirta, and 48 parts of honey compound solution;

[0060] The honey compound solution is composed of the following raw materials by weight: 10 parts of honey, 1 part of sucralfate, 5 parts of normal saline, 4 parts of benzydamine, 3 parts of Kangfuxin solution, 2 parts of compound borax solution, 1.5 parts of sodium bicarbonate, 0.5 part of chlorhexidine, 2.3 parts of povidone iodine, and 2 parts of granulocyte-macrophage colony-stimulating factor.

[0061] A preparation method of a nasopharyngeal carcinoma treatment drug includes the following steps:

[0062] (1) Weigh tea leaves, cattail pollen, bletilla striata, ophiopogon japonicus, mint, wolfberry fruit, oldenlandia diffusa, wild chrysanthemum, paris polyphylla, coix seed, sabina chinensis, and ficus hirta by weight, and set aside;

[0063] (2) Mix the weighed traditional Chinese medicine raw materials, decoct with water, and filter the obtained decoction to obtain it;

[0064] (3) Weigh the honey compound solution: honey, sucralfate, normal saline, benzydamine, Kangfuxin solution, compound borax solution, sodium bicarbonate, chlorhexidine, povidone iodine, and granulocyte-macrophage colony-stimulating factor. Mix the traditional Chinese medicine filtrate with the honey compound solution and stir evenly to obtain the therapeutic drug for nasopharyngeal carcinoma.

[0065] Comparative Example 1

[0066] Prepared according to the same preparation method as in Example 1, except that no traditional Chinese medicine components are added.

[0067] Comparative Example 2

[0068] Prepared according to the same preparation method as in Example 1, except that no honey compound solution is added.

[0069] Comparative Example 3

[0070] Prepared according to the same preparation method as in Example 1, except that no honey is added to the compound solution.

[0071] 1. Using the therapeutic drug for nasopharyngeal carcinoma prepared in Examples 1 - 5, perform oral care at 9:00 - 11:00, the hour of Si, when saliva secretion is most vigorous, and at 17:00 - 19:00, the hour of You, related to oral diseases, according to the theory of the flow of qi and blood in the meridians. Evenly apply the therapeutic drug for nasopharyngeal carcinoma to the oral mucosa to ensure full contact between the therapeutic drug and the oral mucosa.

[0072] 2. Record the incidence rate of RTOM, the severity of RTOM, the oral pain situation, KPS score, the occurrence of nutritional risk, oral Beck score, oral ulcers, oral odor, and the change in pH value after oral care, as well as the addition of other drugs and safety before and after the intervention for preventing oral mucositis in nasopharyngeal carcinoma patients undergoing radiotherapy and chemotherapy at 7 days, 14 days, 28 days after the intervention, and before discharge for the two groups of treatment plans. Use SPSS 26.0 for statistical analysis to compare the incidence rate of RTOM, the severity of RTOM, the oral pain situation, KPS score, the occurrence of nutritional risk, oral Beck score, oral ulcers, oral odor, the change in pH value after oral care, the addition of other drugs, and safety before and after the intervention at 7 days, 14 days, 28 days after the intervention, and before discharge for the two groups of patients.

[0073] 3. Select 100 patients with locally advanced (stage III - IVA) nasopharyngeal carcinoma who were admitted to the First Ward of the Oncology Department of Hechi People's Hospital from June 2024 to June 2027 for concurrent radiotherapy and chemotherapy and met the inclusion and exclusion criteria. Group them according to the random numbers read, with 50 patients in each of the experimental group and the control group.

[0074] Neoadjuvant chemotherapy with the recommended regimen for 2 - 3 cycles has been completed, and patients scheduled to receive the radical concurrent chemoradiotherapy regimen specified in the trial;

[0075] Karnofsky Performance Status (KPS) score ≥ 70 points;

[0076] Complete blood count: white blood cells ≥ 4 × 10⁹ / L, neutrophils ≥ 2 × 10⁹ / L, hemoglobin

[0077] ≥ 100 g / L, platelets ≥ 100 × 10⁹ / L;

[0078] Liver and kidney function: transaminases ≤ 1.5 ULN (upper limit of normal value), bilirubin ≤ 1.0 ULN, creatinine ≤ 1.0 ULN, creatinine clearance rate ≥ 60 ml / min;

[0079] Expected survival period ≥ 6 months;

[0080] Aged 18 - 75 years old, both men and women are eligible.

[0081] 4. A randomized controlled trial with a 1:1 ratio of the experimental group to the control group, using the incidence of grade III RTOM as the main outcome measure for observation. According to literature search, the incidence rate of the control group is about 40% - 56%. Combining with practical experience, the estimated incidence rate of the control group in this trial is 45%. Therefore, clinically relevant effect sizes are used. If the experimental group can further reduce the incidence rate by 30% based on the control group, this test should be a one-sided test, and the significance level α is set at 0.025. Assuming the power 1 - β = 90%. Using the above parameters and substituting them into the PASS15 software, it is calculated that there are 44 cases in each of the experimental group and the control group. Calculating the dropout rate at 10%, finally 50 cases are included in each of the two groups.

[0082] Incidence rate of RTOM: The diagnostic criteria for radiation-induced oral mucositis refer to the diagnostic criteria in "Principles and Practice of Radiation Oncology": ① The irradiated area of the patient involves part or all of the oral cavity; ② Exclude oral mucosal damage caused by other reasons; ③ During or after radiotherapy, the patient shows symptoms such as dry mouth and thirst, oropharyngeal pain, difficulty swallowing food, etc. and / or signs such as reduced saliva, mucosal edema, congestion, ulceration, etc. Meeting the above conditions ① + ② + ③ can make a clinical diagnosis of RTOM. The grading evaluation criteria for RTOM refer to the grading criteria of the Radiation Therapy Oncology Group (RTOG) in the United States. The occurrence and grading of RTOM are evaluated every day after a single radiotherapy session during radiotherapy.

[0083] Severity of RTOM: The grading and dose of RTOM for different cumulative radiation fractions.

[0084] Oral pain condition: During radiotherapy, the descriptive pain grading evaluation standard (VRS) is used daily;

[0085] The oral pain condition was evaluated by the following method. It was specifically divided into four grades: Grade 0: painless; Grade I: mild, the pain can be tolerated and sleep is not disturbed; Grade II: moderate, the pain is obvious, cannot be tolerated, requires taking painkillers, and sleep is affected; Grade III: severe, the pain is intense, cannot be tolerated, requires painkillers, and sleep is severely disturbed.

[0086] KPS score: The researchers adopted the KPS functional status scoring standard to evaluate the physical status at the baseline period and at the end of the treatment.

[0087] Occurrence of nutritional risk: The researchers adopted the NRS2002 scale developed by the European Society for Parenteral and Enteral Nutrition (ESPEN), see Appendix 5 for details. The patients were screened for nutritional risk every week, and a total score of ≥3

[0088] points indicated the presence of malnutrition risk.

[0089] Oral Beck score: The researchers used the modified Beck oral scoring scale to evaluate the oral condition from aspects such as lips, gums, oral mucosa, tongue, teeth, saliva, etc. Each item was scored 1, 2, 3, and 4 points respectively, as well as the total score value and its specific representative meaning.

[0090] Oral ulcer: For the grading of oral ulcers, according to the grading standard of the WHO, the oral ulcer grades were divided into Grade 0 - IV.

[0091] Oral odor: Referring to the Rosenberg standard, with the patient's main complaint combined with the examiner's olfactory discrimination as the diagnostic method, a 0 - 5 - level scoring method was adopted.

[0092] Change in pH value after oral care: The oral pH test paper pieces were respectively placed in the center under the patient's tongue or in the middle of the oral tongue surface. The paper should be soaked before observing the color depth of the test paper for comparison to determine the pH value within the oral mucosa. When the patient's oral pH value was detected more than three times

[0093] exceeded the normal range, it could be determined that the change in oral pH value was abnormal.

[0094] Situation of adding other drugs and safety: Record the use of antibacterial drugs and painkillers by the two groups of patients during radiotherapy. Monitor the adverse events that occurred during the research period of the patients from the baseline to the end of the treatment, mainly including: A: Symptoms and signs: such as nausea, vomiting, dizziness, headache, palpitation, sore throat, skin and mucosal reactions, allergic reactions, etc. B: Tests and examinations: including the three major routine tests, liver and kidney functions, and dynamic evaluation of acute hematological toxicity (hemoglobin, white blood cells, platelets, neutrophils, etc.), liver and kidney toxicity (transaminases, creatinine, etc.), and cardiac toxicity (electrocardiogram, echocardiogram, etc.) through electrocardiogram.

[0095] The results are as follows:

[0096] Table 1 Comparison of short-term curative effects between the control group and the observation group [cases (%)]

[0097]

[0098] Table 2 Comparison of oral pain scores between the two groups [n (%)] (d21)

[0099]

[0100]

[0101] Table 3 Comparison of radioactive skin bacterial infection rates between the two groups [n (%)] (d14)

[0102] Group Number of cases Negative Positive Control group 50 35 15 Observation group 50 40 10

[0103] As described above, the above is only an exemplary specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by those skilled in the art within the technical scope disclosed by the present invention should be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.

Claims

1. A drug for treating nasopharyngeal carcinoma, characterized in that, It is made from the following raw materials by weight parts: 8 - 12 parts of tea leaves, 25 - 40 parts of Typha angustifolia, 8 - 12 parts of Bletilla striata, 8 - 12 parts of Ophiopogon japonicus, 5 - 8 parts of Mentha haplocalyx, 8 - 12 parts of Lycium barbarum, 15 - 30 parts of Hedyotis diffusa, 8 - 16 parts of Chrysanthemum indicum, 5 - 10 parts of Paris polyphylla, 8 - 15 parts of Coix lacryma-jobi, 3 - 5 parts of Selaginella doederleinii, 2 - 9 parts of Ficus hirta, 42 - 85 parts of honey composite solution, and the honey composite solution includes honey, sucralfate, physiological saline, benzydamine, Kangfuxin solution, compound borax solution, sodium bicarbonate, chlorhexidine, povidone iodine and granulocyte-macrophage colony-stimulating factor.

2. The nasopharyngeal carcinoma treatment drug according to claim 1, wherein, It is made from the following raw materials by weight parts: 8 - 10 parts of tea leaves, 30 - 40 parts of Typha angustifolia, 10 - 12 parts of Bletilla striata, 8 - 10 parts of Ophiopogon japonicus, 6 - 8 parts of Mentha haplocalyx, 10 - 12 parts of Lycium barbarum, 15 - 25 parts of Hedyotis diffusa, 10 - 16 parts of Chrysanthemum indicum, 8 - 10 parts of Paris polyphylla, 11 - 15 parts of Coix lacryma-jobi, 3 - 5 parts of Selaginella doederleinii, 4 - 9 parts of Ficus hirta, 45 - 85 parts of honey composite solution.

3. The nasopharyngeal carcinoma treatment drug according to claim 1, characterized in that, It is made from the following raw materials by weight parts: 10 - 12 parts of tea leaves, 30 - 40 parts of Typha angustifolia, 10 - 12 parts of Bletilla striata, 8 - 12 parts of Ophiopogon japonicus, 7 - 8 parts of Mentha haplocalyx, 10 - 12 parts of Lycium barbarum, 25 - 30 parts of Hedyotis diffusa, 12 - 16 parts of Chrysanthemum indicum, 8 - 10 parts of Paris polyphylla, 12 - 15 parts of Coix lacryma-jobi, 4 - 5 parts of Selaginella doederleinii, 7 - 9 parts of Ficus hirta, 48 - 80 parts of honey composite solution.

4. The preparation method of the nasopharyngeal carcinoma therapeutic drug according to any one of claims 1-3, characterized in that, It includes the following steps: (1) Weigh tea leaves, Typha angustifolia, Bletilla striata, Ophiopogon japonicus, Mentha haplocalyx, Lycium barbarum, Hedyotis diffusa, Chrysanthemum indicum, Paris polyphylla, Coix lacryma-jobi, Selaginella doederleinii, Ficus hirta by weight parts for standby; (2) Mix the weighed traditional Chinese medicine raw materials, decoct with water, and filter the obtained decoction to get it; (3) Weigh the honey composite solution: honey, sucralfate, physiological saline, benzydamine, Kangfuxin solution, compound borax solution, sodium bicarbonate, chlorhexidine, povidone iodine and granulocyte-macrophage colony-stimulating factor, mix the traditional Chinese medicine filtrate with the honey composite solution, and stir evenly to prepare the drug for treating nasopharyngeal carcinoma.

5. The preparation method of the drug for treating nasopharyngeal carcinoma according to claim 4, wherein, The honey composite solution is composed of the following raw materials by weight parts: 5 - 10 parts of honey, 1 - 3 parts of sucralfate, 2 - 5 parts of physiological saline, 2 - 4 parts of benzydamine, 1 - 3 parts of Kangfuxin solution, 2 - 5 parts of compound borax solution, 1 - 1.5 parts of sodium bicarbonate, 0.5 - 1.2 parts of chlorhexidine, 2.3 - 2.8 parts of povidone iodine and 1 - 2 parts of granulocyte-macrophage colony-stimulating factor.

6. The preparation method of the nasopharyngeal carcinoma therapeutic drug according to claim 4, characterized in that, The honey composite solution is composed of the following raw materials by weight parts: 6 - 10 parts of honey, 1.5 - 3 parts of sucralfate, 2.8 - 5 parts of physiological saline, 3 - 4 parts of benzydamine, 1.5 - 3 parts of Kangfuxin solution, 4 - 5 parts of compound borax solution, 1.2 - 1.5 parts of sodium bicarbonate, 0.8 - 1.2 parts of chlorhexidine, 2.5 - 2.8 parts of povidone iodine and 1 - 2 parts of granulocyte-macrophage colony-stimulating factor.

7. The drug for treating nasopharyngeal carcinoma described in claim 1 is used in the drug for treating oral mucositis in nasopharyngeal carcinoma patients undergoing radiotherapy and chemotherapy.

8. Use of the drug for treating nasopharyngeal carcinoma according to claim 7, characterized in that, The method for using the drug for treating oral mucositis in patients with nasopharyngeal carcinoma undergoing radiotherapy and chemotherapy is as follows: According to the theory of the flow of qi in the meridians and collaterals at different times, using the drug for treating nasopharyngeal carcinoma, oral care is carried out at the time of Siyi (9:00 - 11:00) when saliva secretion is most vigorous and at the time of You (17:00 - 19:00) related to oral diseases.

9. The use of the drug for treating nasopharyngeal carcinoma according to claim 7, wherein The method for using the drug for treating oral mucositis in patients with nasopharyngeal carcinoma undergoing radiotherapy and chemotherapy is as follows: The drug for treating nasopharyngeal carcinoma is evenly applied to the oral mucosa to make the drug for treating nasopharyngeal carcinoma fully contact with the oral mucosa, and it is applied 2 - 3 times a day for 28 - 30 consecutive days.

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