Traditional Chinese medicine composition for treating peripheral neuropathy caused by chemotherapy, fumigation and washing agent and application

Abstract

The invention relates to a traditional Chinese medicine composition for treating peripheral neuropathy caused by chemotherapy, a fumigating and washing agent and application, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5 to 30 parts of herba schizonepetae, 5 to 30 parts of radix saposhnikoviae, 5 to 30 parts of radix sophorae flavescentis, 5 to 30 parts of cortex phellodendri, 5 to 30 parts of caulis spatholobi, 5 to 30 parts of honeysuckle stem, 5 to 30 parts of semen persicae, 5 to 30 parts of flos carthami and 20 to 60 parts of herba speranskiae tuberculatae. Through clinical verification, the composition has an ideal treatment effect on peripheral neuropathy caused by chemotherapy.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and particularly to a traditional Chinese medicine composition, a fumigating and washing agent and an application for treating chemotherapy-induced peripheral neuropathy. Background Art

[0002] Malignant tumors seriously endanger human life and health. With the continuous progress of medical technology, the treatment methods for malignant tumors are becoming increasingly rich and diverse. Chemotherapy is one of the most common treatment methods, but its toxic and side effects cannot be ignored. It can cause various complications such as nervous system disorders, bone marrow suppression, gastrointestinal reactions, and low immunity, which limit the use of chemotherapy drugs, prolong the treatment process of patients, and reduce the quality of daily life of patients.

[0003] Chemotherapy-induced peripheral neuropathy (CIPN) is a dose-dependent toxic reaction and one of the common adverse reactions of using chemotherapy drugs for anti-cancer treatment. It mostly manifests as sensory abnormalities mainly including numbness, pain, tactile and cold sensitivity, and motor nerve abnormalities mainly including tremors and poor limb coordination. It is reported that the incidence of CIPN during chemotherapy in cancer patients can be as high as 68.1% in the first month, about 60% in the third month, and up to 30% in the sixth month and later. This seriously reduces the quality of life of cancer patients, resulting in dose reduction, delay and discontinuation of chemotherapy. The drugs that induce the occurrence of CIPN mainly include: platinum-based (such as oxaliplatin, carboplatin, cisplatin), taxanes, capecitabine, vinca alkaloids, bortezomib, cetuximab, etc., among which oxaliplatin, paclitaxel and bortezomib are the most common.

[0004] CIPN belongs to the categories of "Bi syndrome" and "numbness" in traditional Chinese medicine. Based on its disease location characteristics that mostly start from the extremities of hands and feet and gradually spread to the upper and lower limbs, it can be classified as a disease of the limb meridians. The anti-tumor effect of chemotherapy drugs is actually to fight poison with poison. By using toxic drugs to severely attack cancer poisons and damage vital energy, drug poisons cause damage, and residual poisons remain in the four extremities of the body, resulting in blood stasis and sluggishness. Over time, it blocks the collaterals, causing pain due to obstruction and numbness due to lack of nourishment. As stated in "Plain Questions • Bi Lun": "Those who do not feel pain or numbness have the disease for a long time and are deeply involved. The circulation of nutrient qi and defensive qi is sluggish, and the meridians are sometimes sparse, so there is obstruction. The skin is not nourished, so there is numbness." Currently, it is not recommended to use any drugs to prevent CIPN. Except that duloxetine is recommended (recommendation strength: medium) for treating painful CIPN, the evidence quality of anti-convulsants (such as gabapentin, pregabalin, etc.) and tricyclic antidepressants (such as amitriptyline, etc.) for treating CIPN is relatively low, and they are not recommended for use in treatments outside of clinical trials.

[0005] Therefore, there is an urgent need to provide a traditional Chinese medicine composition and a fumigating and washing agent for treating chemotherapy-induced peripheral neuropathy, which adopt an external fumigating and washing treatment method, are easy to operate, have no toxic and side effects, do not require oral administration, and can relieve the metabolic pressure on the liver and kidneys of patients. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition, a fumigating and washing agent and an application for treating chemotherapy-induced peripheral neuropathy.

[0007] To solve the above problems, the technical solutions adopted by the present invention are as follows: On the one hand, the present invention provides a traditional Chinese medicine composition for treating chemotherapy-induced peripheral neuropathy. The key technical point lies in that it is composed of the following raw materials in parts by weight: 5-30 parts of Schizonepeta tenuifolia Briq., 5-30 parts of Saposhnikovia divaricata (Turcz.) Schischk., 5-30 parts of Sophora flavescens Ait., 5-30 parts of Phellodendron amurense Rupr., 5-30 parts of Spatholobus suberectus Dunn, 5-30 parts of Lonicera japonica Thunb., 5-30 parts of Prunus persica (L.) Batsch, 5-30 parts of Carthamus tinctorius L., 20-60 parts of Speranskia tuberculata (Bunge) Baill.

[0008] As a more preferred embodiment of the present invention, it is composed of the following raw materials in parts by weight: 5-15 parts of Schizonepeta tenuifolia Briq., 5-15 parts of Saposhnikovia divaricata (Turcz.) Schischk., 5-15 parts of Sophora flavescens Ait., 5-15 parts of Phellodendron amurense Rupr., 5-15 parts of Spatholobus suberectus Dunn, 5-15 parts of Lonicera japonica Thunb., 5-15 parts of Prunus persica (L.) Batsch, 5-15 parts of Carthamus tinctorius L., 20-40 parts of Speranskia tuberculata (Bunge) Baill.

[0009] As a more preferred embodiment of the present invention, it is composed of the following raw materials in parts by weight: 10 parts of Schizonepeta tenuifolia Briq., 10 parts of Saposhnikovia divaricata (Turcz.) Schischk., 10 parts of Sophora flavescens Ait., 10 parts of Phellodendron amurense Rupr., 10 parts of Spatholobus suberectus Dunn, 10 parts of Lonicera japonica Thunb., 10 parts of Prunus persica (L.) Batsch, 10 parts of Carthamus tinctorius L., 30 parts of Speranskia tuberculata (Bunge) Baill.

[0010] On the other hand, the present invention provides a traditional Chinese medicine fumigating and washing agent for treating chemotherapy-induced peripheral neuropathy, which is prepared by the following method: mixing the above traditional Chinese medicine composition with water and decocting, and the obtained decoction is the traditional Chinese medicine fumigating and washing agent.

[0011] As a preferred embodiment of the present invention, the dosage ratio of the traditional Chinese medicine composition to water is 1 g:(15-20) mL.

[0012] As a preferred embodiment of the present invention, the traditional Chinese medicine composition and water are soaked for 20-40 min and then decocted.

[0013] As a preferred embodiment of the present invention, the decocting time is 15-20 min.

[0014] On the other hand, the present invention provides the application of the above traditional Chinese medicine composition in the preparation of a drug for treating chemotherapy-induced peripheral neuropathy.

[0015] The beneficial effects produced by adopting the above technical solutions are as follows: Cancer patients have weak vital energy, and chemotherapy drugs severely damage qi and blood after invading the body. In addition, they are affected by external pathogens, and the circulation of qi and blood is blocked, or qi and blood are deficient, unable to nourish the tendons, veins and skin of the limbs, resulting in numbness, pain, coldness and other discomforts in the extremities. I developed a self-made Tongbi prescription, which consists of Radix Polygoni Multiflori, safflower, peach kernel, schizonepeta, saposhnikovia divaricata, honeysuckle vine, Millettia reticulata, Sophora flavescens, and Phellodendron amurense.

[0016] The existing Chinese medicine prescriptions commonly used to treat such diseases, in addition to blood-activating and stasis-removing drugs, are often combined with a large number of warming yang drugs. The Chinese medicine composition formula for treating peripheral neuropathy caused by chemotherapy provided by the present invention does not contain warming yang Chinese medicine, and mainly includes Schizonepeta and Saposhnikovia, which are warm in nature and pungent in taste, taking the meaning of "the pungent nature of the collateral is used to release", using their pungent and dispersing nature to release the evil qi in the collateral, so that the qi is unblocked and the stagnation is eliminated; including vine drugs such as honeysuckle vine and Millettia reticulata, taking the analogy, taking the meaning that their shape is like collaterals that can open the meridians and enter the collaterals, so that the collaterals are unblocked and the poison is removed; including Sophora flavescens and Phellodendron amurense, which are cool in nature and clear away heat and detoxify, so that the poison is dispersed and the collaterals are unblocked.

[0017] Bone-penetrating grass is the main drug of this prescription. The "Compendium of Materia Medica" says that it "penetrates bones and opens the orifices". It is pungent and warm in nature, and can dispel wind and dampness, dredge menstruation and relieve pain. Safflower, peach kernel, schizonepeta, and fangfeng are all assistant drugs. Safflower and peach kernel can "regulate blood and qi, and ward off all epidemics", so as to activate blood circulation and remove blood stasis, and dredge the meridians to treat blood, and stasis will be removed and pain will be stopped; schizonepeta and fangfeng are warm in nature and pungent in taste, taking the meaning of "the network is pungent for drainage", and use their pungent and dispersing nature to dredge the evil qi in the network, so that the qi will be unblocked and stagnation will be eliminated. Honeysuckle vine, Millettia spatholobi, Sophora flavescens, and Phellodendron chinense are all assistant drugs. Honeysuckle vine and Millettia spatholobi are vine products, and they are taken as collaterals that can dredge the meridians and enter the network, and run through the collaterals to promote the health and make the network clear and remove poison; Sophora flavescens and Phellodendron chinense can clear away heat and dampness, detoxify and cool blood, and disperse poison and make the network unblocked. The above drugs are used together to achieve the effects of removing wind and dredge the network, activating blood circulation and relieving pain.

[0018] In addition, when using the medicine, the patient should fumigate first and then soak and wash, so as to maximize the therapeutic effect of the medicine.

[0019] The description of each raw material in the composition of the present invention is as follows: Herba Tougucao: Euphorbiaceae Speranskia tuberculata (Bunge) Baill., Impatiens balsamina L., Bignoniaceae Incarvilleasinensis Lam., Leguminosae Vicia amoena Fisch., and Ericaceae Gaultheria yunnanensis (Franch.) Rehd.. Enter the liver and kidney meridians. Pungent, bitter, warm. Slightly toxic. Expel wind and dampness, detoxify and relieve pain.

[0020] Safflower: The dried flower of the Compositae plant Carthamus tinctorius L. It belongs to the heart and liver meridians. Pungent in flavor and warm in nature. It promotes blood circulation to activate meridians and dispels stasis to relieve pain.

[0021] Peach Kernel: The dried ripe seed of the Rosaceae plant Prunus persica (L.) Batsch or Prunus davidiana (Carr.) Franch. It belongs to the heart, liver, and large intestine meridians. Bitter and sweet in flavor and neutral in nature. It promotes blood circulation to remove stasis and lubricates the intestines to relieve constipation.

[0022] Schizonepeta: The dried aerial part of the Labiatae plant Schizonepeta tenuifolia Briq. It belongs to the lung and liver meridians. Pungent in flavor and slightly warm in nature. It induces sweating to disperse wind and penetrates rashes.

[0023] Ledebouriella Root: The dried root of the Umbelliferae plant Saposhnikovia divaricata (Turcz.) Schischk. It belongs to the bladder, liver, and spleen meridians. Pungent and sweet in flavor and warm in nature. It induces sweating to dispel wind, overcomes dampness, and stops convulsions.

[0024] Honeysuckle Stem: The dried stem and branch of the Caprifoliaceae plant Lonicera japonica Thunb. It belongs to the lung and stomach meridians. Sweet in flavor and cold in nature. It clears heat and detoxifies, dispels wind and dredges collaterals.

[0025] Suberect Spatholobus Stem: The dried vine stem of the Leguminosae plant Spatholobus suberectus Dunn (also known as Spatholobus macranthus, Spatholobus ferrugineus, Spatholobus trifoliatus, or Spatholobus pumilus). It belongs to the liver and kidney meridians. It enriches blood, promotes blood circulation, and dredges collaterals.

[0026] Sophora Root: The dried root of the Leguminosae plant Sophora flavescens Ait. It belongs to the heart, liver, stomach, large intestine, and bladder meridians. Bitter in flavor and cold in nature. It clears heat and dries dampness, kills parasites, and promotes diuresis.

[0027] Amur Corktree Bark: The dried bark of the Rutaceae plant Phellodendron chinense Schneid. or Phellodendron amurense Rupr. It belongs to the kidney and bladder meridians. Bitter in flavor and cold in nature. It clears heat and dries dampness, purges fire and removes steaming, and detoxifies and treats sores. Detailed Implementation Modes

[0028] To make the objectives, technical solutions, and advantages of the present invention clearer, the following describes the invention clearly and completely in conjunction with specific embodiments.

[0029] Example 1 A traditional Chinese medicine composition for treating chemotherapy-induced peripheral neuropathy, which is composed of the following raw materials in parts by weight: 5 parts of Schizonepeta tenuifolia Briq., 5 parts of Saposhnikovia divaricata (Turcz.) Schischk., 5 parts of Sophora flavescens Ait., 5 parts of Phellodendron amurense Rupr., 15 parts of Spatholobus suberectus Dunn, 15 parts of Lonicera japonica Thunb., 15 parts of Prunus persica (L.) Batsch, 15 parts of Carthamus tinctorius L., and 20 parts of Speranskia tuberculata (Bunge) Baill.

[0030] Example 2 A traditional Chinese medicine composition for treating chemotherapy-induced peripheral neuropathy, which is composed of the following raw materials in parts by weight: 10 parts of Schizonepeta tenuifolia Briq., 10 parts of Saposhnikovia divaricata (Turcz.) Schischk., 10 parts of Sophora flavescens Ait., 10 parts of Phellodendron amurense Rupr., 10 parts of Spatholobus suberectus Dunn, 10 parts of Lonicera japonica Thunb., 10 parts of Prunus persica (L.) Batsch, 10 parts of Carthamus tinctorius L., and 30 parts of Speranskia tuberculata (Bunge) Baill.

[0031] Example 3 A traditional Chinese medicine composition for treating chemotherapy-induced peripheral neuropathy, which is composed of the following raw materials in parts by weight: 15 parts of Schizonepeta tenuifolia Briq., 15 parts of Saposhnikovia divaricata (Turcz.) Schischk., 15 parts of Sophora flavescens Ait., 15 parts of Phellodendron amurense Rupr., 15 parts of Spatholobus suberectus Dunn, 5 parts of Lonicera japonica Thunb., 5 parts of Prunus persica (L.) Batsch, 5 parts of Carthamus tinctorius L., and 40 parts of Speranskia tuberculata (Bunge) Baill.

[0032] Example 4 A traditional Chinese medicine composition for treating chemotherapy-induced peripheral neuropathy, which is composed of the following raw materials in parts by weight: 15 parts of Schizonepeta tenuifolia Briq., 15 parts of Saposhnikovia divaricata (Turcz.) Schischk., 15 parts of Sophora flavescens Ait., 15 parts of Phellodendron amurense Rupr., 15 parts of Spatholobus suberectus Dunn, 15 parts of Lonicera japonica Thunb., 15 parts of Prunus persica (L.) Batsch, 15 parts of Carthamus tinctorius L., and 40 parts of Speranskia tuberculata (Bunge) Baill.

[0033] Example 5 A traditional Chinese medicine fumigating and washing agent, and its preparation method is as follows: Take 110 g of the traditional Chinese medicine composition in Example 1, add 1650 mL of water, soak for 20 min, boil with high heat and then turn to low heat and decoct for 15 min to obtain the traditional Chinese medicine fumigating and washing agent.

[0034] Usage method: Pour the above-mentioned traditional Chinese medicine fumigating and washing agent into a foot bath bucket, and then place the affected limb directly above the decocted medicinal liquid, about 3 - 5 cm away from the liquid surface. Wrap a bath towel above the affected limb to keep the affected limb and the traditional Chinese medicine liquid in the same space to prevent the loss of the medicinal liquid steam. After the medicinal liquid temperature is appropriate (38℃ - 42℃), carry out fumigation and washing (first hands and then feet, and the water volume is preferably enough to submerge the wrists and ankles). Each time the fumigation and washing time is 45 min, twice a day.

[0035] Example 6 A traditional Chinese medicine fumigating and washing agent, and its preparation method is as follows: Take 110 g of the traditional Chinese medicine composition in Example 2, add 1980 mL of water, soak for 30 min, boil with high heat and then turn to low heat and decoct for 18 min to obtain the traditional Chinese medicine fumigating and washing agent.

[0036] Usage method: Pour the above traditional Chinese medicine fumigation lotion into a foot bath bucket, then place the affected limb directly above the decocted medicinal liquid for fumigation, at a distance of about 3 - 5 cm from the liquid surface. Wrap a bath towel above the affected limb to keep the affected limb and the traditional Chinese medicine liquid in the same space to prevent the loss of the medicinal liquid steam. After the medicinal liquid reaches an appropriate temperature (38°C - 42°C), perform fumigation and washing (first hands and then feet, and the water volume should preferably submerge the wrists and ankles). Each time, the fumigation and washing time is 45 minutes, twice a day.

[0037] Example 7 A traditional Chinese medicine fumigation lotion is prepared as follows: Take 110 g of the traditional Chinese medicine composition in Example 3, add 2200 mL of water, soak for 40 minutes, bring to a boil over high heat, and then simmer for 20 minutes to obtain the traditional Chinese medicine fumigation lotion.

[0038] Usage method: Pour the above traditional Chinese medicine fumigation lotion into a foot bath bucket, then place the affected limb directly above the decocted medicinal liquid for fumigation, at a distance of about 3 - 5 cm from the liquid surface. Wrap a bath towel above the affected limb to keep the affected limb and the traditional Chinese medicine liquid in the same space to prevent the loss of the medicinal liquid steam. After the medicinal liquid reaches an appropriate temperature (38°C - 42°C), perform fumigation and washing (first hands and then feet, and the water volume should preferably submerge the wrists and ankles). Each time, the fumigation and washing time is 45 minutes, twice a day.

[0039] Example 8 A traditional Chinese medicine fumigation lotion is prepared as follows: Take 110 g of the traditional Chinese medicine composition in Example 3, add 1760 mL of water, soak for 35 minutes, bring to a boil over high heat, and then simmer for 16 minutes to obtain the traditional Chinese medicine fumigation lotion.

[0040] Usage method: Pour the above traditional Chinese medicine fumigation lotion into a foot bath bucket, then place the affected limb directly above the decocted medicinal liquid for fumigation, at a distance of about 3 - 5 cm from the liquid surface. Wrap a bath towel above the affected limb to keep the affected limb and the traditional Chinese medicine liquid in the same space to prevent the loss of the medicinal liquid steam. After the medicinal liquid reaches an appropriate temperature (38°C - 42°C), perform fumigation and washing (first hands and then feet, and the water volume should preferably submerge the wrists and ankles). Each time, the fumigation and washing time is 45 minutes, twice a day.

[0041] Effect example Clinical data 1. Test subjects Select 2000 testers according to the following inclusion criteria. Inclusion criteria: (1) Pathologically or cytologically diagnosed as malignant tumor; (2) Meet the diagnostic criteria for chemotherapy-induced peripheral neuropathy; (3) Gender is not limited, and the age is between 20 - 80 years old; (4) Those who develop peripheral neuropathy within 1 month after receiving chemotherapy drugs; (5) Survival period ≥ 3 months and KPS score ≥ 60 points; (6) No history of other primary or secondary nervous system diseases (such as diabetes) in the past; (7) No obvious abnormalities or mild disorders were found in blood routine, liver and kidney functions, electrocardiogram and other examinations; (8) Can communicate normally, have no mental and cognitive problems, and have the ability of self - health assessment; (9) Those who voluntarily accept the treatment of this program, have good compliance, and sign the informed consent form.

[0042] 2. Research design and administration method There were 1000 people in the treatment group and 1000 people in the control group. Before treatment, there were no statistically significant differences in the gender, age, and disease course of the two groups of patients.

[0043] Treatment group: Pour the traditional Chinese medicine fumigation and washing agent in Example 6 into a foot bath bucket. Place the affected limb directly above the decocted liquid for fumigation, about 3 - 5 cm away from the liquid surface. Wrap a bath towel above the affected limb to keep the affected limb and the traditional Chinese medicine liquid in the same space to prevent the loss of the medicinal liquid steam. After the medicinal liquid temperature is appropriate (38℃ - 42℃), conduct fumigation and washing (first hands and then feet, and the water volume is preferably enough to submerge the wrists and ankles). Each time of fumigation and washing is 45 minutes, twice a day.

[0044] Control group: Give mecobalamin tablets orally, 3 times a day, 0.5 mg each time; 3. Treatment time Treatment starts from the onset of the disease and lasts for 12 weeks. After the course of treatment, evaluate the curative effect (conduct a telephone follow - up once every 2 weeks during the research process to ensure the compliance of patients).

[0045] 4. Curative effect evaluation indicators: The NCI - CTCAE grading curative effect standard is used for evaluation, and the CIPN grading standard is shown in Table 1.

[0046] Table 1 CIPN grading standard 5. Curative effect determination criteria Evaluate the clinical curative effect of patients according to the grading of neurotoxicity, specifically as follows: Marked effect: After treatment, the NCI - CTCAE grade decreased by 2 levels or more compared with that before treatment, or dropped to grade 0; Effective: After treatment, the NCI - CTCAE grade decreased by 1 level compared with that before treatment; Ineffective: After treatment, the NCI - CTCAE grade did not decrease or worsened.

[0047] Total effective rate = (marked effect + effective) / total number of people.

[0048] 6. The treatment results are shown in Table 2.

[0049] Table 2 Comparison of treatment results In terms of safety: Among the 1000 patients in the treatment group during the treatment with the present invention, no skin allergy or skin toxicity symptoms were observed, and no adverse reactions occurred in all patients.

[0050] The content of the present invention will be specifically described below in combination with typical cases and further elaborated on the present invention, but the typical cases in no way limit the present invention.

[0051] Gao XX, male, 62 years old, was admitted to the hospital mainly due to "intermittent cough, expectoration, and shortness of breath after activity for more than 2 months", and the hospital admission number was 11***62.

[0052] After the patient was admitted to the hospital, relevant examinations were completed: CT (2024-01-16): A mass in the left lower pulmonary hilum and the left lower lobe of the lung (about 6.1*5.6 cm in size), suspected of lung cancer; multiple enlarged lymph nodes in the mediastinum (the largest short diameter is about 2.7 cm), suspected of metastasis. Bone scan: No obvious bone malignant lesions were found. Pathological results: Left lower lung biopsy (24-03030): Tissue compression, suspected of small cell carcinoma, and immunohistochemistry was recommended. Immunohistochemical results: AE1 / AE3 (+), syn (+), TTF-1 (+), P40 (-). CgA (weak +), CD56 (+), Ki67 (positive cell count 90%). Small cell carcinoma.

[0053] The patient's diagnosis was clear, and the first cycle of EP regimen chemotherapy (etoposide 0.1 g D1-5 + cisplatin 120 mg) was performed on January 26, 2024. Then, the 2nd - 3rd cycle of EP regimen chemotherapy was performed on February 28, 2024 and March 27, 2024. Radiotherapy was performed 28 times from the beginning of April 2024 to the end of April 2024. The 4th - 7th cycle of EP regimen chemotherapy was performed on May 24, 2024, June 29, 2024, July 25, 2024, and August 22, 2024.

[0054] CT (2024-09-14): After the treatment of lung cancer, the tissue shadow in the left pulmonary hilum increased, and it was larger compared with that on July 24, 2024. Multiple enlarged lymph nodes in the mediastinum (short diameter about 2.4 cm), and some of them were larger than the previous film. The curative effect evaluation was PD. After excluding contraindications, the patient was given the first cycle of treatment with second-line paclitaxel 270 mg combined with adebilizumab 1200 mg on September 20, 2024. It was planned to perform the second cycle of paclitaxel combined with adebilizumab on October 15, 2024, but the patient complained of severe numbness and tingling in the hands and feet, which affected normal life.

[0055] Subsequently, the traditional Chinese medicine composition formula of the Tongbi Prescription of the present invention was used for hand and foot fumigation and washing: The traditional Chinese medicine fumigation and washing agent obtained in Example 6 was poured into a foot bath bucket, and then the affected limb was placed directly above the decocted medicinal liquid for fumigation, about 3-5 cm away from the liquid surface. A bath towel was wrapped above the affected limb to keep the affected limb and the traditional Chinese medicine liquid in the same space to prevent the loss of the medicinal liquid vapor. After the medicinal liquid temperature was appropriate (38°C - 42°C), fumigation and washing were carried out (hands first and then feet, and the water volume was preferably sufficient to submerge the wrists and ankles). The fumigation and washing time was 45 minutes each time, twice a day. It was used for about 3 months along with the taxane chemotherapy cycle.

[0056] On November 9, 2024, the patient was admitted to the hospital again, and the third cycle of paclitaxel combined with adebilizumab regimen was planned. The patient reported that after using the Tongbi Prescription of the traditional Chinese medicine composition formula for hand and foot fumigation and washing, the numbness and stabbing pain in the hands and feet were significantly relieved compared with before, and it did not affect normal life. According to the grading of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), the score decreased from grade 3 to grade 2.

[0057] Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements for some of the technical features; and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for treating chemotherapy-induced peripheral neuropathy, characterized in that, It is composed of the following raw materials in parts by weight: 5-30 parts of Schizonepeta tenuifolia Briq., 5-30 parts of Saposhnikovia divaricata (Turcz.) Schischk., 5-30 parts of Sophora flavescens Aiton, 5-30 parts of Phellodendron amurense Rupr., 5-30 parts of Spatholobus suberectus Dunn, 5-30 parts of Lonicera japonica Thunb. stem, 5-30 parts of Prunus persica (L.) Batsch seed, 5-30 parts of Carthamus tinctorius L., 20-60 parts of Speranskia tuberculata (Bunge) Baill..

2. The traditional Chinese medicine composition for treating chemotherapy-induced peripheral neuropathy according to claim 1, wherein, It is composed of the following raw materials in parts by weight: 5-15 parts of Schizonepeta tenuifolia Briq., 5-15 parts of Saposhnikovia divaricata (Turcz.) Schischk., 5-15 parts of Sophora flavescens Aiton, 5-15 parts of Phellodendron amurense Rupr., 5-15 parts of Spatholobus suberectus Dunn, 5-15 parts of Lonicera japonica Thunb. stem, 5-15 parts of Prunus persica (L.) Batsch seed, 5-15 parts of Carthamus tinctorius L., 20-40 parts of Speranskia tuberculata (Bunge) Baill..

3. The traditional Chinese medicine composition for treating chemotherapy-induced peripheral neuropathy according to claim 1, wherein It is composed of the following raw materials in parts by weight: 10 parts of Schizonepeta tenuifolia Briq., 10 parts of Saposhnikovia divaricata (Turcz.) Schischk., 10 parts of Sophora flavescens Aiton, 10 parts of Phellodendron amurense Rupr., 10 parts of Spatholobus suberectus Dunn, 10 parts of Lonicera japonica Thunb. stem, 10 parts of Prunus persica (L.) Batsch seed, 10 parts of Carthamus tinctorius L., 30 parts of Speranskia tuberculata (Bunge) Baill..

4. A traditional Chinese medicine fumigation and washing agent for treating chemotherapy-induced peripheral neuropathy, characterized in that, It is prepared by the following method: Mix the traditional Chinese medicine composition according to any one of claims 1-3 with water and decoct it, and the obtained decoction is a traditional Chinese medicine lotion for fumigation and washing.

5. The traditional Chinese medicine fumigating and washing agent for treating chemotherapy-induced peripheral neuropathy according to claim 4, wherein, The dosage ratio of the traditional Chinese medicine composition to water is 1 g:(15-20) mL.

6. The traditional Chinese medicine fumigating and washing agent for treating chemotherapy-induced peripheral neuropathy according to claim 4, wherein The traditional Chinese medicine composition is soaked in water for 20-40 min and then decocted.

7. The traditional Chinese medicine fumigating and washing agent for treating chemotherapy-induced peripheral neuropathy according to claim 4 or 6, wherein The decocting time is 15-20 min.

8. Use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a drug for treating chemotherapy-induced peripheral neuropathy.

Images