A traditional Chinese medicine composition for assisting in warming yang, removing blood stasis and relieving pain for tumor patients and a hot pack thereof

Abstract

The application discloses a traditional Chinese medicine composition for assisting tumor patients in warming yang, removing blood stasis and relieving pain and a hot compress bag thereof, and relates to the technical field of externally used hot compress traditional Chinese medicine.The traditional Chinese medicine composition comprises the following raw materials: prepared aconite, dried ginger, evodia, Sichuan pepper, cumin, astragalus, angelica, cassia, fried raphanus and fried licorice.This traditional Chinese medicine composition takes the thought of supporting yang as the core, follows the prescription logic of'supporting yang to consolidate the foundation and removing evil without damaging the healthy qi', precisely matches the physical characteristics of tumor patients 'deficiency of healthy qi as the root and evil toxin and blood stasis as the branch', and through the compatibility of medicinal materials for warming and supporting the congenital kidney yang, warming and dredging the meridian blood stasis and tonifying qi and nourishing blood to support the healthy qi, the core pathogenesis of 'yang deficiency-cold coagulation-toxin and blood stasis' of cancer patients is directly attacked, the yang deficiency constitution is regulated, the double goals of symptom relief and constitution improvement are realized, the pathological vicious circle is prevented, the regulation is more fundamental, and the limitation of only relieving the superficial symptoms without treating the root is avoided.

Description

Technical Field

[0001] This invention relates to the field of external hot compress traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition and its hot compress for assisting tumor patients in warming the yang, removing blood stasis, and relieving pain. Background Technology

[0002] Currently, among the external treatments for symptoms related to cancer patients, ordinary hot water bottles only provide simple heat stimulation without any drug treatment effect. Western medicine pain relief patches are prone to drug resistance and skin allergies, and do not improve the body's constitution. Hot compresses are a traditional Chinese medicine external treatment method. By applying heated medicine packs to specific parts of the body, heat conduction and drug penetration are used to achieve effects such as warming the meridians, dispelling cold, promoting blood circulation, and relieving pain. Conventional Chinese medicine hot compresses often focus on promoting blood circulation or dispelling cold, without following the core pathogenesis of "Yang governs Yin and Yin follows, and the disease is caused by the body's own Qi," and without taking into account the physical characteristics of cancer patients, which are "deficiency of vital Qi as the root cause and stagnation of pathogenic toxins as the manifestation."

[0003] Current external treatments for cancer patients' symptoms (especially conventional Chinese herbal hot compresses) are not guided by the core principle of supporting Yang, nor do they take into account the physical characteristics of cancer patients, which are characterized by "deficiency of vital energy as the root cause and stagnation of pathogenic factors as the manifestation." They lack the formulation thinking of "supporting Yang to consolidate the root and eliminating pathogenic factors without harming vital energy," and cannot alleviate the vicious cycle of "Yang deficiency-cold coagulation-stasis of pathogenic factors" in cancer patients. Furthermore, the imbalance between drug efficacy and skin safety results in poor conditioning of the Yang deficiency constitution of cancer patients. Symptoms such as cancer pain, gastrointestinal reactions after radiotherapy and chemotherapy, and abdominal / pelvic cold coagulation distending pain are relieved to a limited extent. They are difficult to synergize with conventional cancer treatments, and therefore have limited effect on improving the quality of life of patients. Summary of the Invention

[0004] To address the shortcomings of existing technologies, this invention provides a traditional Chinese medicine composition and its hot compress for assisting cancer patients in warming the Yang, removing blood stasis, and relieving pain, thus solving the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention provides the following technical solution: a traditional Chinese medicine composition for assisting tumor patients in warming the Yang, removing blood stasis, and relieving pain, wherein the traditional Chinese medicine composition comprises the following raw materials by weight: Prepared aconite root 10-20g, dried ginger 12-18g, evodia fruit 80-120g, Sichuan pepper 35-45g, fennel 8-12g, astragalus root 25-35g, angelica root 12-18g, cinnamon 6-10g, stir-fried radish seed 15-25g, prepared licorice root 4-8g; The total weight of the traditional Chinese medicine composition is 280-300g, and the amount of processed aconite root used does not exceed 20g.

[0006] Preferably, the optimal weight ratio of each herb in the traditional Chinese medicine composition is as follows: 15g of prepared aconite root, 15g of dried ginger, 100g of evodia fruit, 40g of Sichuan pepper, 10g of fennel, 30g of astragalus root, 15g of angelica root, 8g of cinnamon, 20g of stir-fried radish seed, and 6g of prepared licorice root.

[0007] A heat pack containing a traditional Chinese medicine composition for assisting cancer patients in warming the Yang, removing blood stasis, and relieving pain includes a double-layered pure cotton breathable cloth bag, the double-layered pure cotton breathable cloth bag having a size of 22cm×20cm. The inner layer of the double-layered pure cotton breathable cloth bag is a breathable bag for loading the traditional Chinese medicine composition, and the outer layer of the double-layered pure cotton breathable cloth bag is a heat-insulating and leak-proof bag. The heat-insulating and leak-proof bag has an opening and closing zipper on one side, and the breathable bag has ventilation holes.

[0008] Preferably, the pore size of the inner breathable bag is 0.5 cm, which is used to enhance drug penetration and heat dissipation.

[0009] Preferably, the method for preparing the hot-pressed bag includes the following steps: S1. Grind prepared aconite, dried ginger, cinnamon and roasted licorice into 40-mesh powder. The particle diameter of the powder is 400-500μm to obtain the first particle. S2. Then grind Evodia rutaecarpa, Sichuan pepper, fennel, Astragalus membranaceus, Angelica sinensis and stir-fried radish seeds into coarse powder of 80-100 mesh, with a particle diameter of 150-180μm, to obtain the second particle; S3. Mix the first particle and the second particle evenly for at least 8 minutes to obtain mixed particles. Then, put the mixed particles into the breathable bag of the double-layer pure cotton breathable cloth bag. After filling, seal the double-layer pure cotton breathable cloth bag with the zipper to obtain the hot pack.

[0010] Preferably, the breathable bag is made of 40-60 count combed pure cotton fabric with a breathability of 80%-90%, and the heat-insulating and leak-proof bag is made of 30-50 count thickened pure cotton fabric with an inner layer of food-grade heat-insulating cotton with a thickness of 0.1-0.2cm.

[0011] Preferably, the ventilated holes of the breathable bag are evenly distributed in an array, the pore diameter of the ventilated holes is 0.4-0.6cm, and the center-to-center distance between adjacent ventilated holes is 2-3cm, which is used to balance the drug penetration rate and heat dissipation effect, and to adapt to the safe use of large doses of warming yang medicinal materials.

[0012] Preferably, the length of the zipper is 15-18cm, the tooth pitch of the zipper is 0.3-0.5cm, and there is no gap between the inner breathable bag and the outer heat-insulating and leak-proof bag after closing, which is used to prevent the leakage of the medicinal powder of the Chinese medicine composition and facilitates the replacement of the Chinese medicine composition and the disassembly and cleaning of the double-layer pure cotton breathable cloth bag.

[0013] Preferably, the heating method of the hot wrap during use is as follows: Clinical treatment involves heating in a constant temperature heating chamber at 50-55℃ for 20 minutes; For home treatment, steam for 15 minutes or heat in a microwave on low for 2 minutes.

[0014] Preferably, the usage specifications of the hot-pressed bag are as follows: Before applying the hot compress, the temperature of the hot compress should be reduced to 40-42℃. When applying the compress, place 1-2 layers of thin pure cotton cloth underneath. Each application should last for 20 minutes, once a day, for 7 days as one course of treatment. Each hot compress package can be reused a maximum of 3 times. If the hot compress package shows signs of diminishing efficacy, off-odor, or mold growth, it should be discarded immediately and the herbal composition in the breathable bag replaced.

[0015] This invention provides a traditional Chinese medicine composition and its heat pack for assisting cancer patients in warming the Yang, removing blood stasis, and relieving pain. It has the following beneficial effects: (1) This invention takes the concept of supporting Yang as its core and follows the formulation logic of "supporting Yang to consolidate the foundation and eliminating evil without harming the body's vital energy". It precisely matches the physical characteristics of cancer patients, which are "deficiency of vital energy as the root and stagnation of evil toxins as the manifestation". Through the combination of medicinal materials that warm and support the innate kidney Yang, warm and unblock the meridians, and replenish Qi and nourish blood to support the body's vital energy, it directly targets the core pathogenesis of cancer patients, which is "Yang deficiency - cold coagulation - stagnation of toxins". It regulates the Yang deficiency constitution, achieves the dual goals of symptom relief and constitution improvement, prevents the vicious cycle of pathology, makes the treatment more fundamental, and avoids the limitation of only relieving the surface symptoms without treating the root cause.

[0016] (2) Differentiated pulverization processes are designed for different medicinal materials. Coarse powder is used to control the release of medicinal materials containing heat, dryness or toxicity, while fine powder is used to enhance transdermal absorption of core efficacy medicinal materials. At the same time, the heat and dryness are balanced by medicinal materials such as Astragalus membranaceus and Glycyrrhiza uralensis, taking into account both uniform release of efficacy and skin safety protection, avoiding risks such as irritation and burns, and achieving a dynamic balance between efficacy and safety. This allows cancer patients to obtain stable therapeutic effects in a gentle and burden-free conditioning, significantly improving tolerance and compliance.

[0017] (3) The hot compress of the present invention is suitable for routine tumor treatment scenarios. By applying it precisely according to the principle of "applying it where the disease is located" and scientifically combining the timing of application, it can not only specifically relieve core symptoms such as cancer pain, gastrointestinal reactions after radiotherapy and chemotherapy, and abdominal / pelvic cold stagnation and distending pain, but also enhance the body's ability by supporting Yang and strengthening the body's resistance. It can form a synergistic effect with radiotherapy, chemotherapy, targeted therapy, etc., reduce treatment-related adverse reactions, achieve the goal of treating internal and external symptoms and synergistic effect, comprehensively improve the patient's physical condition and life experience, and make the improvement of quality of life more comprehensive and sustainable. Attached Figure Description

[0018] Figure 1 This is a flowchart illustrating the steps of processing traditional Chinese medicine and preparing the hot herbal poultice of the present invention. Figure 2 This is a schematic cross-sectional view of the herbal hot compress structure of the present invention; Figure 3 This is a line graph showing the pain threshold test results of the animal experiment using the traditional Chinese medicine herbal poultice of this invention; Figure 4 This is a line graph showing the overall effective rate of the traditional Chinese medicine hot compress for aversion to cold and cold limbs in clinical trials of this invention; Figure 5 This is a line graph of the VAS score for cancer pain in the clinical trial of the traditional Chinese medicine hot compress of this invention; Figure 6 This is a line graph showing the efficacy rate of the traditional Chinese medicine hot compress for pelvic / gastrointestinal cold-induced distending pain in clinical trials of this invention. Figure 7 This is a line graph showing the incidence of adverse skin reactions in clinical trials of the traditional Chinese medicine hot compress of this invention. Detailed Implementation

[0019] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0020] Please see Figure 1-2 This invention provides a traditional Chinese medicine composition and its heat pack for assisting tumor patients in warming yang, removing blood stasis, and relieving pain. To achieve the above objectives, this invention is implemented through the following technical solution: The traditional Chinese medicine composition comprises the following raw materials by weight: Prepared aconite root 10-20g, dried ginger 12-18g, evodia fruit 80-120g, Sichuan pepper 35-45g, fennel 8-12g, astragalus root 25-35g, angelica root 12-18g, cinnamon 6-10g, stir-fried radish seed 15-25g, prepared licorice root 4-8g; The total weight of the Chinese herbal composition is 280-300g, and the amount of processed aconite root used does not exceed 20g.

[0021] The optimal weight ratio of each herb in the traditional Chinese medicine composition is as follows: 15g of prepared aconite root, 15g of dried ginger, 100g of evodia fruit, 40g of Sichuan pepper, 10g of fennel, 30g of astragalus root, 15g of angelica root, 8g of cinnamon, 20g of stir-fried radish seeds, and 6g of prepared licorice root.

[0022] A hot compress made of traditional Chinese medicine composition to assist cancer patients in warming the Yang, removing blood stasis, and relieving pain includes a double-layered pure cotton breathable cloth bag (see reference). Figure 2 The double-layer pure cotton breathable cloth bag has a size of 22cm×20cm. The inner layer of the double-layer pure cotton breathable cloth bag is a breathable bag 1 containing the Chinese medicine composition, and the outer layer of the double-layer pure cotton breathable cloth bag is a heat-insulating and leak-proof bag 2. The heat-insulating and leak-proof bag has an opening and closing zipper 3 on one side, and the breathable bag has a ventilation hole 4.

[0023] The inner breathable bag has 0.5cm pores to enhance drug penetration and heat dissipation.

[0024] The preparation method of hot-pressed bread includes the following steps: S1. Grind prepared aconite, dried ginger, cinnamon and roasted licorice into 40-mesh powder. The particle diameter of the powder is 400-500μm to obtain the first particle. S2. Then grind Evodia rutaecarpa, Sichuan pepper, fennel, Astragalus membranaceus, Angelica sinensis and stir-fried radish seeds into coarse powder of 80-100 mesh, with a particle diameter of 150-180μm, to obtain the second particle; S3. Mix the first and second particles evenly for at least 8 minutes to obtain mixed particles. Then, pack the mixed particles into the breathable bag of a double-layer pure cotton breathable cloth bag. After packing, seal the double-layer pure cotton breathable cloth bag with the zipper to obtain a hot pack.

[0025] The breathable bag is made of 40-60 count combed pure cotton fabric with a breathability of 80%-90%. The heat-insulating and leak-proof bag is made of 30-50 count thickened pure cotton fabric, with an inner layer of food-grade heat-insulating cotton with a thickness of 0.1-0.2cm.

[0026] The breathable bags have a uniform array of pores with a diameter of 0.4-0.6 cm and a center-to-center distance of 2-3 cm between adjacent pores. This arrangement is designed to balance the drug penetration rate and heat dissipation, making them suitable for the safe use of large doses of warming medicinal materials.

[0027] The length of the zipper is 15-18cm, and the tooth pitch of the zipper is 0.3-0.5cm. When closed, there is no gap between the inner breathable bag and the outer heat-insulating and leak-proof bag, which is used to prevent the leakage of medicinal powder from the Chinese medicine composition and facilitates the replacement of the Chinese medicine composition and the disassembly and cleaning of the double-layer pure cotton breathable cloth bag.

[0028] The heating method for hot bread during use is as follows: Clinical treatment involves heating in a constant temperature heating chamber at 50-55℃ for 20 minutes; For home treatment, steam for 15 minutes or heat in a microwave on low for 2 minutes.

[0029] The usage guidelines for hot bread rolls are as follows: Before applying the hot compress, the temperature of the hot compress should be reduced to 40-42℃. When applying the compress, place 1-2 layers of thin pure cotton cloth underneath. Each application should last for 20 minutes, once a day, for 7 days as one course of treatment. When using this product, it is necessary to clearly identify the clinical application site, the common pain sites of tumors (right upper abdomen, lower abdomen, corresponding gastrointestinal tract sites), and key acupoints for supporting Yang (Guanyuan, Zusanli, Shenshu, Zhongji, Shenque) to guide precise application and enhance the effect of supporting Yang and dispelling pathogens.

[0030] Each hot compress can be reused a maximum of 3 times. If the hot compress shows signs of diminishing efficacy, off-odor, or mold growth, it should be discarded immediately and the herbal composition in the breathable bag replaced.

[0031] Example 1 The formula of the Chinese herbal medicine composition is as follows: Prepared aconite root 15g, dried ginger 15g, Evodia rutaecarpa 100g, Sichuan pepper 40g, fennel 10g, astragalus root 30g, angelica root 15g, cinnamon 8g, stir-fried radish seed 20g, prepared licorice root 6g, with a total weight of 289g.

[0032] Preparation process: S1: Pulverize prepared aconite, dried ginger, cinnamon, and roasted licorice root into 40-mesh powder with a particle diameter of 450μm to obtain the first particle; S2: Grind Evodia rutaecarpa, Sichuan pepper, fennel, Astragalus membranaceus, Angelica sinensis, and stir-fried radish seeds into 90-mesh coarse powder with a particle diameter of 165μm to obtain the second particle; S3: Mix the first and second particles together for 10 minutes until uniform, then pack them into the inner breathable bag of a double-layered pure cotton breathable cloth bag and seal it with the zipper.

[0033] Thermal wrapping structural parameters: Double-layer cloth bag dimensions: 22cm × 20cm; Inner breathable bag: 40-count combed pure cotton fabric, breathability 85%, breathable holes are evenly distributed in an array, the hole diameter is 0.5cm, and the center-to-center distance between adjacent breathable holes is 2.5cm; Outer heat-insulating and leak-proof bag: 30-count thickened pure cotton fabric, with 0.15cm thick food-grade heat-insulating cotton laminated on the inside; Zipper opening and closing: 16cm in length, 0.4cm tooth pitch, no gap when closed.

[0034] Example 2 The formula of the Chinese herbal medicine composition is as follows: Prepared aconite root 18g, dried ginger 16g, Evodia rutaecarpa 90g, Sichuan pepper 42g, fennel 11g, astragalus root 32g, angelica root 16g, cinnamon 9g, stir-fried radish seed 22g, prepared licorice root 7g, with a total weight of 293g.

[0035] Preparation process: S1: Pulverize prepared aconite, dried ginger, cinnamon, and roasted licorice root into 40-mesh powder with a particle diameter of 480μm to obtain the first particle; S2: Grind Evodia rutaecarpa, Sichuan pepper, fennel, Astragalus membranaceus, Angelica sinensis, and stir-fried radish seeds into 80-mesh coarse powder with a particle diameter of 180μm to obtain the second particle; S3: Mix the first and second particles together for 8 minutes until uniform, then pack them into the inner breathable bag of a double-layered pure cotton breathable cloth bag and seal it with the zipper.

[0036] Thermal wrapping structural parameters: Double-layer cloth bag dimensions: 22cm × 20cm; Inner breathable bag: 50-count combed pure cotton fabric, breathability rate 82%, breathable holes are evenly distributed in an array, the hole diameter is 0.4cm, and the center-to-center distance between adjacent breathable holes is 2cm; Outer heat-insulating and leak-proof bag: 40-count thickened pure cotton fabric, with 0.12cm thick food-grade heat-insulating cotton laminated on the inside; Zipper opening and closing: 15cm in length, 0.3cm tooth pitch, no gap when closed.

[0037] Example 3 The formula of the Chinese herbal medicine composition is as follows: Prepared aconite root 12g, dried ginger 13g, Evodia rutaecarpa 110g, Sichuan pepper 38g, fennel 9g, astragalus root 28g, angelica root 13g, cinnamon 7g, stir-fried radish seed 18g, prepared licorice root 5g, with a total weight of 283g.

[0038] Preparation process: S1: Pulverize prepared aconite, dried ginger, cinnamon, and roasted licorice root into 40-mesh powder with a particle diameter of 420μm to obtain the first particle; S2: Grind Evodia rutaecarpa, Sichuan pepper, fennel, Astragalus membranaceus, Angelica sinensis, and stir-fried radish seeds into 100-mesh coarse powder with a particle diameter of 150μm to obtain the second particle; S3: Mix the first and second particles together for 12 minutes until uniform, then pack them into the inner breathable bag of a double-layered pure cotton breathable cloth bag and seal it with the zipper.

[0039] Thermal wrapping structural parameters: Double-layer cloth bag dimensions: 22cm × 20cm; Inner breathable bag: 60-count combed pure cotton fabric, breathability 90%, breathable holes are evenly distributed in an array, 0.6cm in diameter, and the center-to-center distance between adjacent breathable holes is 3cm; Outer heat-insulating and leak-proof bag: 50-count thickened pure cotton fabric, with 0.2cm thick food-grade heat-insulating cotton laminated on the inside; Zipper opening and closing: 18cm in length, 0.5cm tooth pitch, no gap when closed.

[0040] Comparative Example 1 Traditional Chinese medicine composition (conventional formula for promoting blood circulation and dispelling cold): Chuanxiong 20g, Honghua 15g, Aiye 30g, Shengjiang 20g, Xiangfu 15g, Yanhusuo 15g, Duhuo 10g, total weight 125g (excluding processed Fuzi, Huangqi and other yang-tonifying herbs).

[0041] Preparation process: All medicinal materials are uniformly pulverized to 40 mesh powder, mixed and stirred for 8 minutes, and then packed into a single-layer pure cotton bag (without heat insulation and leak-proof layer, without zipper, only sewn closed).

[0042] Usage method: Same as the heating and application specifications in Example 1.

[0043] Comparative Example 2 The proportions of the traditional Chinese medicine composition are exactly the same as in Example 1 (total weight 289g).

[0044] Preparation process: All medicinal materials are uniformly pulverized to 80 mesh coarse powder, mixed and stirred for 10 minutes, and then packed into a double-layer pure cotton breathable cloth bag with the same structure as in Example 1.

[0045] Usage method: exactly the same as in Example 1.

[0046] Comparative Example 3 A double-layered pure cotton breathable cloth bag with the same structure as in Example 1, but without any Chinese medicine composition in the inner layer (blank cloth bag).

[0047] Usage: Same as the heating and application procedure in Example 1 (simple warm stimulation only).

[0048] Test case animal experiments Test animals: 60 male SPF-grade Kunming animals, weighing 20-22g, were included in the experiment after 3 days of acclimatization feeding.

[0049] Modeling method: A pain model was established using the hot plate method. Mice were placed on a hot plate at 55±0.5℃, and the latency of licking the paw was recorded (as an indicator of pain threshold). Sixty mice with a latency of 5-30 seconds were selected and randomly divided into 6 groups (Example 1-3 groups and Comparative Example 1-3 groups), with 10 mice in each group.

[0050] Intervention method: Each group was treated with the corresponding heat pack (comparative example 3 was a blank cloth bag) using the heating method (clinical simulated heating conditions: 52℃ for 20 min). After the temperature dropped to 41℃, the pack was applied to the abdomen of the mice (corresponding to the human epigastric target area) for 20 min each time, once a day, for 7 consecutive days.

[0051] Observation indicators: Pain threshold: The latency of mice to lick their paws (in seconds) was measured before intervention, 3 days after intervention, and 7 days after intervention. Each measurement was taken at 5-minute intervals, and the average value was used. Skin safety: After daily intervention, observe whether adverse reactions such as redness, swelling, or damage occur on the skin of mice at the application site.

[0052] Table 1 shows the test results of the animal experiments (refer to...). Figure 3 ): ; The hot compresses in Examples 1-3 of this invention can significantly increase the pain threshold of mice in a pain model, and the analgesic effect is superior to conventional Chinese medicine hot compresses, hot compresses without differentiation and pulverization, and simple hot compresses. At the same time, through the differentiated pulverization design and the combination of balancing medicinal materials in the formulation, this invention significantly reduces the incidence of adverse skin reactions, has higher safety, and has no adverse effects on the liver and kidney function of animals.

[0053] Clinical trials Test content: Case source: Sixty patients with advanced cancer admitted to the oncology department of a tertiary hospital were selected. All were pathologically diagnosed and diagnosed by traditional Chinese medicine as having the syndrome of "Yang deficiency and cold coagulation, Qi stagnation and blood stasis". The cases included 20 cases of liver cancer, 30 cases of gastric cancer, 25 cases of colorectal cancer, 15 cases of ovarian cancer, 10 cases of cervical cancer, and 20 cases of pancreatic cancer. Among them, 95 cases had gastrointestinal reactions after radiotherapy and chemotherapy, 100 cases had cancer pain, and there were no bone metastases or obvious heat signs.

[0054] Group design: Using the randomized controlled trial principle, 120 patients were divided into 6 groups (Example 1-3 groups and Comparative Example 1-3 groups), with 20 patients in each group; There were no statistically significant differences in general characteristics such as gender, age, disease type, and disease severity among the groups of patients (P>0.05), indicating that they were comparable. Inclusion and exclusion criteria: (1) Inclusion criteria: Meets the diagnostic criteria for mid-to-late stage cancer; meets the TCM syndrome of "Yang deficiency and cold coagulation, Qi stagnation and blood stasis" (fear of cold and cold limbs, cancer pain relieved by warmth, loose stools, cold distension in the epigastrium / pelvis, pale tongue with white coating, deep and slow pulse); expected survival ≥3 months, willing to participate in this study and sign informed consent form; (2) Exclusion criteria: those with yin deficiency and fire excess, bleeding tendency, skin damage, unhealed radiotherapy area, severe liver and kidney dysfunction, and allergy to test drugs or materials.

[0055] Intervention methods: (1) All groups maintained their original routine tumor treatment (radiotherapy, chemotherapy, targeted therapy, etc.); (2) Examples 1-3: The corresponding hot compresses were used and the intervention was performed according to the usage guidelines (applied at 40-42℃, with a thin layer of pure cotton cloth underneath, 20 minutes each time, once a day, 7 days as one course of treatment), and applied 1 hour after radiotherapy and chemotherapy; (3) Comparative Examples 1-3: The corresponding hot compresses / blank cloth bags were used respectively, and the intervention time, frequency and application site were the same as those of the Example Group.

[0056] Observation indicators: (1) Improvement of cold intolerance and cold limbs: The symptom scoring method (0-3 points, the higher the score, the more severe the symptoms) was used. A difference of ≥2 points before and after the intervention was considered significant, 1-2 points was considered effective, and <1 points was considered ineffective. The total effective rate was calculated. (2) Cancer pain relief: The VAS pain scoring method (0-10 points, the higher the score, the more severe the pain) was used to record the scores before and after the intervention and the reduction in scores; (3) Relief of gastrointestinal reactions after radiotherapy and chemotherapy: Observe symptoms such as nausea, vomiting, abdominal distension, and loss of appetite. The disappearance or significant reduction of symptoms after intervention is considered effective, and the effective rate is calculated. (4) Relief of cold and distending pain in pelvic / gastrointestinal tumors: The symptom scoring method (0-4 points) was used. The intervention was effective if the score decreased by ≥50%. The effective rate was calculated. (5) Safety indicators: Observe adverse skin reactions (redness, swelling, itching, etc.) during the intervention period, and test blood routine, liver and kidney function and coagulation function before and after the intervention.

[0057] Table 2 presents the test results of the clinical trial (refer to...). Figure 4-7 ): ; Effects of improving cold intolerance and cold limbs: Example 1 group: 13 cases showed significant effect, 6 cases showed effect, and 1 case showed no effect, with a total effective rate of 95%; Example 2 group: 12 cases showed significant effect, 7 cases showed effect, and 1 case showed no effect, with a total effective rate of 95%; Example 3 group: 11 cases showed significant effect, 7 cases showed effect, and 2 cases showed no effect, with a total effective rate of 90%; Comparative Example 1: 4 cases showed significant improvement, 6 cases showed improvement, and 10 cases showed no improvement, with a total effective rate of 50%; Comparative group 2: 8 cases showed significant effect, 6 cases showed effect, and 6 cases showed no effect, with a total effective rate of 70%; Comparative group 3: 3 cases showed significant effect, 5 cases showed effect, and 12 cases showed no effect, with a total effective rate of 40%.

[0058] Cancer pain relief effect: Before intervention: There was no significant difference in VAS scores among the groups (P>0.05), with an average score of 6.6±1.5. After intervention: The VAS scores of groups 1-3 in Examples were 2.1±1.1, 2.4±1.2, and 2.3±1.1, respectively, with an average reduction of 4.3-4.5 points; the score of group 1 in Comparative Example 1 was 4.7±1.3, with an average reduction of 1.9 points; the score of group 2 in Comparative Example 2 was 3.8±1.2, with an average reduction of 2.8 points; and the score of group 3 in Comparative Example 3 was 5.1±1.4, with an average reduction of 1.5 points.

[0059] The effect of radiotherapy and chemotherapy on relieving gastrointestinal reactions: The effectiveness rates of groups 1-3 in Examples were 95%, 90%, and 90%, respectively. The efficacy rate of comparative example 1 was 55%, that of comparative example 2 was 75%, and that of comparative example 3 was 50%.

[0060] Relief effect of cold-induced bloating and pain in pelvic / gastrointestinal tumors: The effectiveness rates of groups 1-3 in Examples were 92%, 90%, and 88%, respectively. The efficacy rate of comparative example 1 was 45%, that of comparative example 2 was 70%, and that of comparative example 3 was 35%.

[0061] Security: Examples 1-3: Only one case in Example 2 group experienced mild skin redness, with an adverse reaction rate of 1.7%, which resolved spontaneously one day after discontinuation of the drug; Comparative Example 1: 3 cases experienced skin redness, with an adverse reaction rate of 15%; Comparative group 2: 6 cases experienced skin redness and 2 cases experienced itching, with an adverse reaction rate of 40%; Comparative Group 3: No adverse skin reactions; No significant abnormalities were observed in blood routine tests, liver and kidney function, and coagulation function in all groups before and after the intervention. No serious adverse reactions such as burns, bleeding, or damage to the spleen and stomach occurred.

[0062] The traditional Chinese medicine compositions and their hot compresses in Examples 1-3 of this invention have significant effects on improving the symptoms of cold limbs, cancer pain, gastrointestinal reactions after radiotherapy and chemotherapy, and abdominal / pelvic cold stagnation and distending pain in patients with advanced tumors of the syndrome of "Yang deficiency and cold coagulation, qi stagnation and blood stasis". The total effective rate is about 90%, and the incidence of adverse reactions is extremely low, with high safety. Compared to the comparative example: Compared to the conventional Chinese herbal hot compress (Comparative Example 1), this invention, through its formulation design guided by the concept of supporting Yang, precisely addresses the core pathogenesis of cancer patients, resulting in significantly improved treatment efficacy and symptom relief rate. Compared to Comparative Example 2, which uses undifferentiated pulverized hot compresses, this invention employs a differentiated pulverization process that combines controlled release of coarse powder from warm-drying / toxic medicinal materials with enhanced efficacy from fine powder of core functional medicinal materials. This process significantly reduces the risk of skin irritation while ensuring therapeutic efficacy. Compared to Comparative Example 3, which only applied heat, this invention has the dual effects of heat stimulation and drug penetration, which can not only relieve surface symptoms, but also fundamentally regulate the Yang deficiency constitution, resulting in significant comprehensive therapeutic advantages. Typical case presentation from clinical trials: Case 1: The patient was a 58-year-old female with advanced gastric cancer. After radiotherapy and chemotherapy, she experienced severe abdominal distension, aversion to cold and cold limbs. Her VAS pain score was 7. Her tongue was pale with a white coating and her pulse was deep and slow. After 3 days of intervention with Benreyanbao, her abdominal distension was significantly relieved and she was able to eat semi-liquid food normally. After 7 days of intervention, her aversion to cold and cold limbs disappeared and her VAS pain score dropped to 2. There were no adverse reactions. Case 2: The patient was a 65-year-old male with advanced colorectal cancer. He had significant pelvic coldness and distension, and frequent nausea and vomiting after radiotherapy and chemotherapy. His appetite was extremely poor. After 5 days of intervention with this hot compress, his nausea and vomiting were relieved, and he was able to eat a light diet. After 7 days of intervention, the symptoms of pelvic coldness and distension basically disappeared, his mental state improved, and he was able to move around independently.

[0063] Therefore, we can conclude that: 1. Compared with ordinary hot water bottles: This herbal composition hot compress has the dual effects of warm stimulation and drug penetration. With the core idea of ​​supporting Yang, it can not only relieve symptoms but also improve physical condition. It has an intervention effect on the fundamental problem of "deficiency of Qi" in cancer patients. All efficacy indicators are significantly better than ordinary hot compress. 2. Compared with Western medicine pain relief patches: No drug resistance, 82% lower incidence of adverse reactions, and can simultaneously improve systemic symptoms of Yang deficiency such as aversion to cold, fatigue, and abdominal distension, which is in line with the concept of "treating the root cause of the disease" and has a better comprehensive conditioning effect on multiple symptoms; 3. Compared with traditional Chinese medicine hot compresses: The dosage of core medicinal materials is strengthened, the formulation is more targeted, and the innovative use of differentiated pulverization mesh design takes into account both drug release and skin safety. It has a more significant effect on relieving severe cold swelling and pain caused by "Yang deficiency and cold coagulation, Qi stagnation and blood stasis" in cancer patients. Animal experiments and clinical trial data have confirmed that its efficacy and safety are better, and its synergistic effect with radiotherapy and chemotherapy is more prominent.

[0064] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention.

Claims

1. A hot compress containing a traditional Chinese medicine composition for assisting tumor patients in warming Yang, removing blood stasis, and relieving pain, characterized in that: The traditional Chinese medicine composition is made from the following raw materials by weight: Prepared aconite root 10-20g, dried ginger 12-18g, evodia fruit 80-120g, Sichuan pepper 35-45g, fennel 8-12g, astragalus root 25-35g, angelica root 12-18g, cinnamon 6-10g, stir-fried radish seed 15-25g, prepared licorice root 4-8g; The preparation method of hot-pressed bread includes the following steps: S1. Grind prepared aconite, dried ginger, cinnamon and roasted licorice into 40-mesh powder. The particle diameter of the powder is 400-500μm to obtain the first particle. S2. Then grind Evodia rutaecarpa, Sichuan pepper, fennel, Astragalus membranaceus, Angelica sinensis and stir-fried radish seeds into coarse powder of 80-100 mesh, with a particle diameter of 150-180μm, to obtain the second particle; S3. Mix the first and second particles evenly for at least 8 minutes to obtain mixed particles. Then, pack the mixed particles into the breathable bag of a double-layer pure cotton breathable cloth bag. After packing, seal the double-layer pure cotton breathable cloth bag with an openable zipper to obtain a hot pack.

2. The hot compress of a traditional Chinese medicine composition for assisting tumor patients in warming yang, removing blood stasis, and relieving pain, as described in claim 1, is characterized in that: The weights of each herb in the herbal composition are as follows: 15g of prepared aconite root, 15g of dried ginger, 100g of evodia fruit, 40g of Sichuan pepper, 10g of fennel, 30g of astragalus root, 15g of angelica root, 8g of cinnamon, 20g of stir-fried radish seed, and 6g of prepared licorice root.

3. The hot compress of a traditional Chinese medicine composition for assisting tumor patients in warming yang, removing blood stasis, and relieving pain, as described in claim 1, is characterized in that: The heat pack includes a double-layered pure cotton breathable bag, the double-layered pure cotton breathable bag having a size of 22cm×20cm. The inner layer of the double-layered pure cotton breathable bag is a breathable bag for loading the traditional Chinese medicine composition, and the outer layer of the double-layered pure cotton breathable bag is a heat-insulating and leak-proof bag. The heat-insulating and leak-proof bag has an opening and closing zipper on one side. The breathable bag has ventilation holes, and the ventilation holes of the inner layer of the breathable bag have a diameter of 0.5cm, which is used to enhance drug penetration and heat dissipation.

4. The hot compress of a traditional Chinese medicine composition for assisting tumor patients in warming yang, removing blood stasis, and relieving pain, as described in claim 3, is characterized in that: The heat-insulating and leak-proof bag is made of 30-50 count thickened pure cotton fabric, with an inner layer of food-grade heat-insulating cotton with a thickness of 0.1-0.2cm. The breathable bag is made of 40-60 count combed pure cotton fabric with a breathability rate of 80%-90%.

5. The hot compress of a traditional Chinese medicine composition for assisting tumor patients in warming yang, removing blood stasis, and relieving pain according to claim 1, characterized in that: The breathable bags have a uniform array of vents with a center-to-center distance of 2-3 cm between adjacent vents. This is used to balance the drug penetration rate and heat dissipation effect, and to ensure the safe use of large doses of warming medicinal materials.

6. The hot compress of a traditional Chinese medicine composition for assisting tumor patients in warming yang, removing blood stasis, and relieving pain according to claim 1, characterized in that: The length of the zipper is 15-18cm, and the tooth pitch of the zipper is 0.3-0.5cm. It is used to prevent the leakage of the medicinal powder of the Chinese medicine composition and to facilitate the replacement of the Chinese medicine composition and the disassembly and cleaning of the double-layer pure cotton breathable cloth bag.

7. The hot compress of a traditional Chinese medicine composition for assisting tumor patients in warming yang, removing blood stasis, and relieving pain according to claim 1, characterized in that: The heating method for the hot pack during use is as follows: Clinical treatment involves heating in a constant temperature heating chamber at 50-55℃ for 20 minutes; For home treatment, steam for 15 minutes or heat in a microwave on low for 2 minutes.

8. The hot compress of a traditional Chinese medicine composition for assisting tumor patients in warming yang, removing blood stasis, and relieving pain according to claim 1, characterized in that: The usage specifications for the hot compress are as follows: Before applying the hot compress, the temperature of the hot compress should be reduced to 40-42℃. When applying the compress, place 1-2 layers of thin pure cotton cloth underneath. Each application should last for 20 minutes, once a day, for 7 days as one course of treatment. Each hot compress package can be reused a maximum of 3 times. If the hot compress package shows signs of diminishing efficacy, off-odor, or mold growth, it should be discarded immediately and the herbal composition in the breathable bag replaced.

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