A topical traditional Chinese medicine composition for treating hand-foot syndrome caused by antitumor drugs

Abstract

The application belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating hand-foot syndrome caused by antitumor drugs. The application takes 'clearing heat and resolving toxins, cooling blood and activating blood, and astringing and promoting muscle regeneration' as the core principle, constructs a whole-cycle management system from early prevention and intervention to late ulcer repair, and provides a traditional Chinese medicine treatment scheme with pertinence and practicability for patients with hand-foot syndrome caused by antitumor drugs. The traditional Chinese medicine composition is composed of Qingdai, Phellodendri Cortex, Scutellariae Radix, Sanguisorba officinalis, Arnebia euchroma, Boswellia sacra, Commiphora myrrha and Glycyrrhiza uralensis. The traditional Chinese medicine composition has the advantages of reducing the classification of hand-foot syndrome, effectively relieving the pain symptoms of patients, and steadily improving the quality of life of patients.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition and its application. Background Technology

[0002] Hand-foot syndrome (HFS), also known as palmar-plantar erythrodysesthesia syndrome (PPES), is a skin toxicity reaction caused by antitumor drugs, commonly affecting the palms and soles. Its clinical symptoms progress gradually, initially presenting as numbness, tingling, and decreased sensation. As the condition progresses, desquamation, erosion, and ulceration may occur, and in severe cases, bullous lesions may develop, significantly impacting the patient's quality of life. This condition is often caused by chemotherapy drugs such as capecitabine, cytarabine, cyclophosphamide, docetaxel, and vinorelbine, with capecitabine posing the highest risk. In recent years, with the increasing incidence of malignant tumors in my country, the clinical application of targeted anti-tumor drugs has become increasingly widespread. The number of patients with hand-foot syndrome caused by these drugs has grown rapidly. Studies show that hand-foot syndrome not only impairs hand and foot function and reduces quality of life, but also affects adherence to targeted anti-tumor drug therapy. Some patients may even discontinue treatment due to intolerance, ultimately impacting the effectiveness of anti-tumor treatment. Therefore, seeking safe and effective treatment options is of significant clinical importance for ensuring the continuity of cancer treatment and improving overall efficacy.

[0003] Current modern medicine primarily treats this condition symptomatically, including oral vitamins, COX-2 inhibitors, and dosage adjustments. However, overall efficacy is unsatisfactory, and the recurrence rate is high. In severe cases, it can lead to discontinuation or even termination of antitumor drug treatment, significantly impacting the efficacy of antitumor therapy and the patient's quality of life. Therefore, actively seeking an effective treatment for hand-foot syndrome induced by antitumor drugs is of great significance.

[0004] Traditional Chinese medicine (TCM) classifies hand-foot syndrome caused by anti-tumor drugs under the category of "Bi syndrome." Its core pathogenesis is "drug toxicity and damp-heat accumulating in the skin and collaterals, causing blood heat and stagnation, and resulting in malnourishment of the skin." Anti-tumor drugs are considered "drug toxicity," initially affecting the extremities, causing local blood and qi stagnation. Initial symptoms include erythema, burning pain, swelling, and numbness. This is followed by burns to blood vessels, leading to blisters and dark purple discoloration. Necrosis of the skin and flesh can result in cracking and ulceration. The pathological progression follows the pattern of "from qi to blood, from collaterals to skin." If not intervened in time, it further develops into blood heat and flesh necrosis, manifesting as oozing ulceration or blood stasis obstructing the collaterals, resulting in hardened, dark nails and severe pain. TCM's main treatment principles are "clearing heat and detoxifying, cooling blood and promoting blood circulation, and promoting tissue regeneration and wound healing."

[0005] External treatment in Traditional Chinese Medicine (TCM) is a distinctive therapy. External compound herbal formulas follow the principle of "principal, assistant, adjuvant, and guide" in their formulation, delivering the medicinal power directly to the affected area through methods such as fumigation, wet compresses, and ointments. Compared to the localized symptomatic treatments of modern medicine, TCM external compound treatments utilize multiple mechanisms—"detoxifying, cooling the blood, clearing blockages, and nourishing the skin"—to achieve comprehensive management from early prevention and intervention to late-stage ulcer repair. This approach better addresses the complex characteristics of drug-induced skin reactions, which combine local severity with systemic pathogenesis. However, currently, there are no literature reports on standardized external compound preparations that simultaneously achieve both highly effective detoxification and long-term repair. Summary of the Invention

[0006] This invention addresses the problems existing in the prior art by providing an effective topical traditional Chinese medicine composition for patients with hand-foot syndrome caused by anti-tumor drugs, based on the core treatment principles of "clearing heat and detoxifying, cooling blood and promoting blood circulation, and astringing sores and promoting tissue regeneration." This composition can reduce the severity of hand-foot syndrome, alleviate patient pain, and improve patients' quality of life. Based on this, this invention was completed.

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition containing the following parts by weight of traditional Chinese medicinal materials: 1-30 parts of indigo naturalis, 3-30 parts of phellodendron bark, 3-30 parts of scutellaria root, 9-15 parts of burnet root, 5-15 parts of gromwell root, 3-10 parts of frankincense, 3-10 parts of myrrh, and 2-10 parts of licorice root.

[0008] Preferably, the traditional Chinese medicine composition contains the following parts by weight of traditional Chinese medicinal materials: 10-25 parts indigo naturalis, 10-25 parts phellodendron bark, 10-25 parts scutellaria root, 9-12 parts sanguisorba root, 6-12 parts gromwell root, 4-8 parts frankincense, 4-8 parts myrrh, and 3-8 parts licorice root.

[0009] More preferably, the traditional Chinese medicine composition contains the following parts by weight of traditional Chinese medicinal materials: 20 parts indigo naturalis, 20 parts phellodendron bark, 20 parts scutellaria root, 10 parts sanguisorba root, 10 parts gromwell root, 6 parts frankincense, 6 parts myrrh, and 5 parts licorice root.

[0010] In a second aspect, the present invention provides a traditional Chinese medicine preparation made from the traditional Chinese medicine composition described in the first aspect, the traditional Chinese medicine preparation containing the following traditional Chinese medicine raw materials in parts by weight: 1-30 parts indigo naturalis, 3-30 parts phellodendron bark, 3-30 parts scutellaria root, 9-15 parts sanguisorba root, 5-15 parts gromwell root, 3-10 parts frankincense, 3-10 parts myrrh, and 2-10 parts licorice root.

[0011] Furthermore, the traditional Chinese medicine preparation is one or more of the following: lotion, spray, gel, cream, powder, and / or oil.

[0012] Furthermore, in one embodiment of the present invention, the traditional Chinese medicine composition is weighed according to the weight proportions, and the raw materials are mixed with water and decocted to prepare a traditional Chinese medicine wash for patients to use.

[0013] Furthermore, the method for preparing the detergent includes the following steps: S01 Except for indigo naturalis, weigh the above Chinese medicinal materials according to their weight proportions, wash them, and soak them. S02: Boil the S01 soaking solution twice, 30 minutes each time; S03 Separate the medicinal liquid from the dregs, and add water to the dregs to continue decocting; S04 Combine multiple medicinal solutions, add indigo and mix well to obtain the lotion of this invention.

[0014] Furthermore, in step S01, the soaking solution added during soaking is 10 times the total weight of the raw materials, and the soaking time is 30-60 minutes. Furthermore, in step S02, the simmering process involves first bringing the soaking liquid to a boil over high heat, then reducing to a simmer and continuing to simmer 2-3 times, each time for 20-30 minutes.

[0015] Furthermore, the traditional Chinese medicine preparation contains pharmaceutically acceptable excipients required for the corresponding preparation.

[0016] Furthermore, the excipients are pharmaceutical excipients that enhance the efficacy of the active pharmaceutical ingredient, reduce its toxicity, and / or alleviate its side effects.

[0017] Furthermore, the traditional Chinese medicine wash prepared by this invention can be used externally for soaking hands and feet at 40°C, once in the morning and once in the evening, for 20 minutes each time.

[0018] Thirdly, the present invention provides the use of the traditional Chinese medicine composition described in the first aspect in the preparation of a medicament for treating hand-foot syndrome.

[0019] Furthermore, the hand-foot syndrome described is a hand-foot syndrome caused by anti-tumor drugs.

[0020] Furthermore, the treatment of hand-foot syndrome includes reducing the severity of hand-foot syndrome, alleviating pain in patients with hand-foot syndrome, and improving the quality of life of patients with hand-foot syndrome.

[0021] The medicinal properties and effects of each Chinese medicinal herb in this invention are as follows: Indigo naturalis: Salty in taste and cold in nature. It enters the liver meridian. It has the effects of clearing heat and detoxifying, cooling blood and eliminating spots, purging fire and calming convulsions. It is used for febrile diseases with rashes, hematemesis due to blood heat, chest pain and hemoptysis, canker sores, mumps, sore throat, and infantile convulsions.

[0022] Phellodendron bark: Bitter in taste and cold in nature. It enters the kidney and bladder meridians. It has the effects of clearing heat and drying dampness, purging fire and eliminating steaming heat, detoxifying and healing sores. It is used for damp-heat diarrhea, jaundice with red urine, leukorrhea and vulvar itching, painful urination with heat, beriberi with weakness and paralysis, bone steaming fever, night sweats, seminal emission, sores and carbuncles, eczema and damp sores.

[0023] Scutellaria baicalensis: Bitter in taste and cold in nature. It enters the lung, gallbladder, spleen, large intestine, and small intestine meridians. It has the effects of clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus. It is used for damp-heat syndrome, summer-heat syndrome, chest tightness and nausea, damp-heat fullness, diarrhea, jaundice, lung-heat cough, high fever and thirst, hematemesis due to blood heat, carbuncles and boils, and threatened abortion.

[0024] Purple gromwell root: Sweet and salty in taste, cold in nature. It enters the heart and liver meridians. It has the effects of clearing heat and cooling blood, promoting blood circulation and detoxifying, and promoting rash eruption and eliminating spots. It is used for blood heat and toxicity, purplish-black rashes, incomplete measles eruption, sores, eczema, and burns.

[0025] Sanguisorba officinalis: Bitter, sour, and astringent in taste. Slightly cold in nature. It enters the liver and large intestine meridians. It has the effects of cooling the blood and stopping bleeding, detoxifying and astringing sores. It is used for bloody stools due to blood heat, hemorrhoidal bleeding, bloody dysentery, metrorrhagia, burns, carbuncles and boils.

[0026] Frankincense: pungent and bitter in taste, warm in nature. It enters the heart, liver, and spleen meridians. It has the effects of promoting blood circulation, relieving pain, reducing swelling, and promoting tissue regeneration. It is used for chest pain, stomach pain, dysmenorrhea, amenorrhea, postpartum blood stasis, abdominal masses, rheumatic pain, muscle spasms, traumatic injuries, carbuncles, and sores.

[0027] Myrrh: pungent and bitter in taste, neutral in nature. It enters the heart, liver, and spleen meridians. It has the functions of dispersing blood stasis and relieving pain, reducing swelling and promoting tissue regeneration. It is used for chest pain, stomach pain, dysmenorrhea, amenorrhea, postpartum blood stasis, abdominal masses, rheumatic pain, traumatic injuries, carbuncles, and sores.

[0028] Licorice: Sweet in taste and neutral in nature. It enters the heart, lung, spleen, and stomach meridians. It has the effects of tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, relieving spasms and pain, and harmonizing the effects of other herbs. It is used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with excessive phlegm, abdominal and limb spasms and pain, carbuncles and boils, and to alleviate the toxicity and harshness of other drugs.

[0029] The treatment principle in this invention: This invention's traditional Chinese medicine formula is based on the core principles of "clearing heat and detoxifying, cooling blood and promoting blood circulation, and astringing sores and promoting tissue regeneration." In the formula, Indigo Naturalis clears heat and detoxifies, cools blood and eliminates rashes. The *Essential Medicines and Their Dosages* states that Indigo Naturalis's effects are: "Clearing heat and detoxifying, and also cooling blood." Its blue color enters the liver, and its salty taste enters the blood, making it particularly effective at clearing stagnant fire in the blood, thus it is a key medicine for treating "heat-toxin rashes." Scutellaria baicalensis and Phellodendron amurense clear heat, dry dampness, purge fire and detoxify. Scutellaria baicalensis excels at clearing excess fire in the upper and middle jiao, especially lung fire. The lungs govern the skin and hair, and are adept at clearing heat from the skin surface. Phellodendron amurense, being cold in nature, excels at clearing damp heat in the lower jiao. These three herbs combine extreme bitterness and coldness to directly purge the entangled fire toxins in the three jiaos, forming the basis for treating all heat-toxin sores and ulcers. Their aim is to "treat heat with cold," suppressing its spread, and they together serve as the principal herbs. Lithospermum erythrorhizon clears heat, cools the blood, invigorates blood circulation, and detoxifies. The *Mingyi Bielu* records that it "treats abdominal swelling, distension, and pain; when combined with ointments, it treats sores and facial eczema in children." Lithospermum erythrorhizon specifically enters the blood, assisting the principal herb in enhancing its blood-cooling and detoxifying effects, while also restraining the excessive coldness of blood-cooling herbs that could cause stagnation, thus ensuring the blood is cool without stagnating. Sanguisorba officinalis cools the blood, stops bleeding, detoxifies, and astringes sores. The *Rihua Zi Bencao* records that it "drains pus, stops vomiting blood...treats traumatic injuries." Its nature is descending, making it particularly effective in treating various symptoms caused by lower abdominal heat. Externally, it can astringe sores, assisting the principal herb in enhancing its blood-cooling and detoxifying effects; both act as assistant herbs. Frankincense and myrrh are a classic herbal pair for invigorating blood circulation, relieving pain, reducing swelling, and promoting tissue regeneration. The *Medical Records of Integrating Chinese and Western Medicine* states that "when used together, these two herbs are essential for clearing the internal organs and unblocking the meridians." Their pungent and warming properties can counteract the cold and cooling properties of the principal and assistant herbs, ensuring that the entire formula is neither too cold nor too cooling, achieving the wonderful effect of "using both cold and warm properties, and combining clearing and astringing." The two herbs complement each other, serving as adjuvant herbs. Licorice root, with its sweet and mild properties, harmonizes the other herbs, acting as the guiding herb.

[0030] Beneficial effects Compared to modern medical treatment models, traditional Chinese medicine compound prescriptions are based on multiple mechanisms such as "detoxifying drugs, cooling blood and heat, clearing the meridians and relieving blood stasis, and nourishing the skin". They construct a full-cycle management system from early prevention and intervention to late-stage ulcer repair, which is more in line with the complex characteristics of skin reactions caused by drug toxicity, which have both local severe symptoms and systemic pathogenesis.

[0031] This invention's formulation, based on the core principles of "clearing heat and detoxifying, cooling blood and promoting blood circulation, and astringing sores and promoting tissue regeneration," provides a targeted and practical traditional Chinese medicine treatment plan for patients with hand-foot syndrome caused by anti-tumor drugs. This herbal composition can significantly reduce the severity of hand-foot syndrome, effectively relieve patients' pain symptoms, and steadily improve their quality of life. Furthermore, it boasts the advantages of high safety and no significant toxic side effects. Detailed Implementation

[0032] The specific embodiments of the present invention will be further described below. It should be noted that these descriptions are for the purpose of aiding understanding the present invention, but do not constitute a limitation thereof. Furthermore, the technical features involved in the embodiments described below can be combined with each other as long as they do not conflict with each other.

[0033] Unless otherwise specified, the experimental methods used in the following embodiments are conventional methods, and the experimental materials used in the following embodiments are all available through conventional commercial channels.

[0034] Example 1: Preparation of the traditional Chinese medicine composition wash of the present invention Traditional Chinese medicine formula: Indigo naturalis 15g, Phellodendron bark 15g, Scutellaria baicalensis 15g, Sanguisorba officinalis 9g, Lithospermum erythrorhizon 9g, Boswellia carterii 6g, Commiphora myrrha 6g, Glycyrrhiza uralensis 6g.

[0035] Preparation method: S01 Except for indigo naturalis, weigh the above Chinese medicinal materials according to their weight proportions, wash them, and soak them. S02 The Chinese herbal medicine raw materials soaked in S01 are decocted twice at a ratio of 1:10, each time for 30 minutes; S03 When decocting, first bring the soaking liquid to a boil over high heat, then simmer over low heat. S04 Separate the medicinal liquid from the dregs, and add water to the dregs to continue decocting; S05 Combine multiple medicinal solutions, add indigo and mix well to obtain the lotion of this invention.

[0036] Instructions for use: Soak hands and feet in the herbal wash for 20 minutes each time, once in the morning and once in the evening, then rinse with clean water.

[0037] Example 2 Clinical Study Research Methods A prospective, randomized, controlled study design was adopted to conduct a standardized clinical study to verify the efficacy of an optimized treatment regimen for patients with hand-foot syndrome induced by anti-tumor drugs.

[0038] 2. Research Subjects 2.1 Case source and grouping Sixty patients with hand-foot syndrome caused by anti-tumor drugs who were treated at the outpatient or inpatient department of the Fourth People's Hospital of Shanghai affiliated to Tongji University were selected and randomly divided into a control group and a treatment group, with 30 patients in each group.

[0039] 2.2 Diagnostic Criteria 2.2.1 Western Medicine Diagnostic Criteria Referring to the "Guidelines for the Diagnosis and Treatment of Common Malignant Tumors in China" issued by the Ministry of Health of the People's Republic of China, the staging criteria refer to the "NCCN Clinical Practice Guidelines (Chinese Edition) 2012 First Edition": the grading criteria for hand-foot syndrome refer to the NCI's grading criteria for acute and subacute toxic reactions to antitumor drugs.

[0040] The NCI classification is divided into three levels: Grade I: Mild skin changes or dermatitis (such as erythema, desquamation) accompanied by sensory abnormalities (such as numbness, tingling, burning sensation), but not affecting daily activities; Grade II: As described above, skin changes are accompanied by pain, mildly affecting daily activities, and the skin surface remains intact; Grade III: Ulcerative dermatitis or skin changes, accompanied by severe pain that significantly affects daily life, with obvious tissue damage (such as desquamation, blisters, bleeding, edema).

[0041] 2.2.2 Traditional Chinese Medicine Diagnostic Criteria Referring to the "Expert Consensus on TCM Syndrome Differentiation, Treatment Methods and Prescriptions for Hand-Foot Syndrome" (issued by the Oncology Branch of the China Association for the Promotion of Traditional Chinese Medicine Research and the Professional Committee of Traditional Medicine for Oncology of the Chinese Anti-Cancer Association), the following heat-toxin accumulation type was defined: Red: The skin is a broad, bright red with indistinct borders; or an abscess may have formed. Swelling: A feeling of swelling in the hands and feet, often accompanied by or without pain and itching; or accompanied by granulomas; Heat: A subjective feeling of localized heat; Pain: Burning pain in the skin of the hands and feet.

[0042] Tongue and pulse: Thin yellow coating, rapid pulse.

[0043] 2.3 Inclusion and Exclusion Criteria 2.3.1 Inclusion Criteria (1) Patients whose malignant tumors are confirmed by pathology or cytology; (2) Individuals who develop grade I or higher hand-foot syndrome after receiving antitumor drug treatment; (3) No serious dysfunction of vital organs such as the heart, liver, and kidneys: (4) Expected survival > 3 months; (5) Age 18-80 years old; (6) Good compliance; (7) Voluntarily participate and sign the informed consent form.

[0044] Those who meet all of the above conditions are eligible for inclusion and will be included in this study.

[0045] 2.3.2 Exclusion Criteria (1) Those with serious diseases of the heart, liver, kidneys, brain, etc.; (2) Patients with other types of diseases in their hands and feet; (3) Individuals with allergic constitutions; (4) Currently undergoing other Chinese and Western medicine treatments.

[0046] If any of the above criteria are met, the patient will be excluded and not included in this study.

[0047] 2.4 Criteria for Shedding and Rejection (1) Patients with poor compliance who are unable to continue to cooperate with the treatment plan of this study; (2) Those who experience severe adverse reactions and cannot tolerate them; (3) Those who die due to worsening of their condition; (4) Voluntarily withdraw from this research; (5) Individuals who naturally drop out or are lost to follow-up.

[0048] 3. Treatment methods Experimental group: The traditional Chinese medicine wash prepared in Example 1 of this invention has the following specific composition: 15g of indigo naturalis, 15g of phellodendron bark, 15g of scutellaria baicalensis, 9g of sanguisorba officinalis, 9g of gromwell root, 6g of frankincense, 6g of myrrh, and 6g of licorice.

[0049] Usage: Soak hands and feet in a traditional Chinese medicine wash at 40℃ for 20 minutes each time, twice a day, morning and evening, then rinse with clean water.

[0050] Treatment duration: 7 days.

[0051] Control group: The control group was prepared by adding pigment and water to 1 / 10 of the dosage of the herbal wash used in the experimental group. It was applied once in the morning and once in the evening for 20 minutes each time, and then rinsed off with clean water.

[0052] Observation indicators (1) Classification of hand-foot syndrome; (2) NRS score; (3) KPS score.

[0053] 5. Evaluation of therapeutic effect Hand-foot syndrome grading: The three-tier grading system of NCI hand-foot syndrome was used to evaluate the efficacy by comparing the grading of hand-foot syndrome before and after treatment.

[0054] Cured: After medication, the NCI classification dropped to level 0; Effective: The NCI classification is reduced by 1 grade or more after medication compared to before medication; Ineffective: No change in NCI classification after medication compared to before medication.

[0055] Overall effectiveness rate = cure rate + effectiveness rate

[0056] 6. Research Results 6.2 Baseline Data The experimental group consisted of 30 patients with a mean age of 62.10 ± 4.30 years, and the control group consisted of 30 patients with a mean age of 64.20 ± 3.40 years. There was no statistically significant difference in the general condition between the two groups (P > 0.05), indicating that the two groups were comparable.

[0057] 6.3 Evaluation of therapeutic effect (1) NCI classification of hand-foot syndrome As shown in Table 1, the total effective rate of NCI classification in the treatment group of the traditional Chinese medicine preparation of the present invention was 93.33%, which was significantly different from that in the control group. That is, the traditional Chinese medicine lotion of the present invention can significantly reduce the NCI classification of patients with hand-foot syndrome caused by anti-tumor drugs and improve their quality of life. Statistical analysis showed that the difference between the two groups was statistically significant (P<0.05).

[0058] Table 1 Overall Effectiveness of Improving NCI Classification of Hand-Foot Syndrome Note: P < 0.05 is considered a negative value for intergroup comparisons. (2) NRS score As shown in Table 2, compared with the control group, the treatment group of the traditional Chinese medicine preparation of the present invention can significantly improve the pain symptoms of patients with hand-foot syndrome caused by anti-tumor drugs and reduce the NRS score. Statistical analysis showed that the difference between the two groups was statistically significant (P<0.05).

[0059] Table 2 NRS scores before and after treatment Note: P < 0.05 for within-group comparisons is marked with #, and P < 0.05 for between-group comparisons is marked with *. (3) KPS score As shown in Table 3, compared with the control group, the treatment group of the traditional Chinese medicine preparation of the present invention can significantly improve the quality of life of patients with hand-foot syndrome caused by anti-tumor drugs. Statistical analysis showed that the difference between the two groups was statistically significant (P<0.05).

[0060] Table 3. KPS scores before and after treatment Note: P < 0.05 for within-group comparisons is marked with #, and P < 0.05 for between-group comparisons is marked with *. 7. Conclusion For patients with hand-foot syndrome caused by anti-tumor drugs, the traditional Chinese medicine preparation of this invention can not only significantly reduce the grade of hand-foot syndrome and improve the quality of life of patients, but also significantly alleviate the pain symptoms of patients with hand-foot syndrome, and has the advantages of high safety and no obvious toxic side effects.

[0061] Example 2: Typical Clinical Case Basic Information Name: Deng, Gender: Male, Age: 69 General situation In October 2024, the patient was admitted to the hospital due to rectal bleeding, without abdominal pain or distension. A gastroscopy and colonoscopy revealed chronic non-atrophic gastritis with erosion, rectal metastasis (MT), and cold resection of rectal polyps. Pathology indicated (rectal) adenocarcinoma, moderately differentiated; mucosal polypoid hyperplasia. A PET-CT scan revealed: a. CA at the lower end of the sigmoid colon and rectosigmoid junction, invading the serosa and surrounding fat spaces; b. peripheral lymph node metastasis; multiple liver metastases. Genetic testing showed: KRAS, NRAS, BRAF V600E wild-type, HER2 amplification positive, PD-L1 negative: TPS <1%, CPS <1. After completing relevant examinations, the patient began chemotherapy with cetuximab + oxaliplatin + capecitabine on November 26, 2024. After four cycles of chemotherapy, the patient began experiencing redness, swelling, and pain in the hands and feet, along with a feeling of heat in the hands and feet, accompanied by local numbness and itching, severely impacting the patient's quality of life. He then went to our hospital for treatment.

[0062] Treatment plan Based on the above information, the patient was diagnosed with hand-foot syndrome caused by anti-tumor drugs.

[0063] The diagnosis according to Traditional Chinese Medicine is: Bi syndrome - heat toxin accumulation syndrome.

[0064] The treatment principle is to clear heat and detoxify, cool the blood and promote blood circulation, and promote wound healing and tissue regeneration, using traditional Chinese medicine.

[0065] The herbal composition consists of: 15g of Indigo Naturalis, 15g of Phellodendron Bark, 15g of Scutellaria baicalensis, 9g of Sanguisorba officinalis, 9g of Lithospermum erythrorhizon, 6g of Boswellia carterii, 6g of Commiphora myrrha, and 6g of Glycyrrhiza uralensis. This herbal wash is used for external application by soaking hands and feet at 40°C, once in the morning and once in the evening, for 20 minutes each time, followed by rinsing with clean water.

[0066] Follow-up visit The patient returned for a follow-up visit one week later. The redness and swelling in the hands and feet had significantly decreased compared to before. There were no obvious symptoms of pain or itching. The temperature of the hands and feet had returned to normal, and the numbness had also improved significantly.

Claims

1. A traditional Chinese medicine composition, said traditional Chinese medicine composition comprising the following traditional Chinese medicines in parts by weight: 1-30 parts Indigo Naturalis, 3-30 parts Phellodendron Bark, 3-30 parts Scutellaria baicalensis, 9-15 parts Sanguisorba officinalis, 5-15 parts Lithospermum erythrorhizon, 3-10 parts Frankincense, 3-10 parts Myrrh, and 2-10 parts Licorice.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The traditional Chinese medicine composition consists of the following parts by weight of traditional Chinese medicine: 10-25 parts indigo naturalis, 10-25 parts phellodendron bark, 10-25 parts scutellaria root, 9-12 parts sanguisorba root, 6-12 parts gromwell root, 4-8 parts frankincense, 4-8 parts myrrh, and 3-8 parts licorice root.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following parts by weight: 20 parts indigo naturalis, 20 parts phellodendron bark, 20 parts scutellaria root, 10 parts sanguisorba root, 10 parts gromwell root, 6 parts frankincense, 6 parts myrrh, and 5 parts licorice root.

4. A traditional Chinese medicine preparation made from the traditional Chinese medicine composition as described in claim 1, characterized in that, The traditional Chinese medicine preparation is one or more of the following: lotion, spray, gel, cream, powder and / or oil.

5. The traditional Chinese medicine preparation as described in claim 4, characterized in that, The traditional Chinese medicine preparation is a lotion, and the preparation method of the lotion includes the following steps: S01 Except for indigo naturalis, weigh the above Chinese medicinal materials according to their weight proportions, wash them, and soak them. S02: Boil the S01 soaking solution twice, 30 minutes each time; S03 Separate the medicinal liquid from the dregs, and add water to the dregs to continue decocting; S04 combines multiple medicinal solutions, adds indigo and mixes well to obtain a wash.

6. The traditional Chinese medicine preparation as described in claim 4, characterized in that, The traditional Chinese medicine preparation contains pharmaceutically acceptable excipients required for the corresponding preparation; the excipients are pharmaceutical excipients that enhance the efficacy, reduce toxicity, and / or alleviate the side effects of the main drug.

7. The use of the traditional Chinese medicine composition as described in claim 1 in the preparation of a medicament for treating hand-foot syndrome, characterized in that, The hand-foot syndrome mentioned is a hand-foot syndrome caused by anti-tumor drugs.

8. The application as described in claim 7, characterized in that, The treatment of hand-foot syndrome includes lowering the severity of hand-foot syndrome, reducing pain in patients with hand-foot syndrome, and improving their quality of life.

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