Traditional Chinese medicine composition for treating chemotherapy-related hand-foot syndrome as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly discloses a traditional Chinese medicine composition for treating chemotherapy-related hand-foot syndromes. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 60-70 parts of bletilla striata, 30-40 parts of rhizoma polygonati, 30-40 parts of radix arnebiae seu lithospermi, 30-40 parts of trogopterus dung, 10-15 parts of nidus vespae, 15-20 parts of radix rubiae, 10-15 parts of radix angelicae, 10-15 parts of radix paeoniae rubra, 10-15 parts of lignum sappan, 10-15 parts of saffron crocus, 10-15 parts of cortex magnoliae officinalis, 10-15 parts of loofah sponge and 10-15 parts of caulis akebiae. The traditional Chinese medicine composition provided by the invention can obviously improve the symptoms of dry, numbness, chap, skin pigmentation and the like of hand and foot skins of patients with chemotherapy-related hand and foot syndromes.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and specifically discloses a traditional Chinese medicine composition for treating chemotherapy-related hand-foot syndrome, a preparation method thereof, and an application thereof. Background Art

[0002] Malignant tumors are a type of disease that threatens human life and health. Surgical treatment, radiotherapy, chemotherapy, and molecular targeted therapy play a crucial role in the treatment of cancer patients. With the development and progress of molecular biology technology and modern pharmaceutical technology, it has become possible to improve the quality of life and extend the survival period for most cancer patients. However, the occurrence of adverse reactions related to drug treatment often affects the quality of life of patients and even their treatment compliance. Such as hair loss, liver and kidney function damage, myelosuppression, gastrointestinal reactions, etc. In addition, some patients will also have some skin-related adverse reactions, such as mild rash and severe exfoliative dermatitis, cutaneous capillary reaction syndrome, etc. Among them, hand-foot syndrome (HFS) is the most common.

[0003] The clinical manifestations of HFS vary, mainly manifested as numbness and hypoesthesia of the hands and feet, and it is also common to see skin pigmentation, itching of the hands and feet, and even skin erythema, swelling, desquamation, chapping, indurated blisters or severe pain, etc. The main cause of HFS is the adverse reaction caused by the clinical application of anti-tumor drugs. Currently, anti-tumor drugs are mainly divided into the following two categories: First, cytotoxic drugs mainly include capecitabine, tegafur, fluorouracil, doxorubicin, oxaliplatin, etc.; the pathogenesis of such drugs is mainly that the metabolites in the drug metabolism process are easy to accumulate in the body and mostly accumulate in the hands and feet, thus leading to the occurrence of HFS; Second, small molecule targeted drugs such as apatinib, anlotinib, regorafenib, sorafenib, etc.; some scholars believe that small molecule targeted drugs inhibit the release of vascular endothelial growth factor, block the peripheral blood vessels of the limbs, damage the dermal blood vessels, resulting in the residual of harmful substances in the skin tissue and causing inflammatory reactions, and it may also be related to their easy aggregation in places with rich sweat glands.

[0004] Currently, the research on HFS is relatively limited. In 2017, the National University of Singapore and the Cancer Research Center found in their research that there is a correlation between increased serum and red blood cell folate levels, gene variations related to wound healing and cytoskeleton fixation, and an increased risk of HFS. Serum and red blood cell folate levels are independent predictors of HFS, which also provides a good judgment index for the treatment of HFS patients in clinical work. As for the treatment of HFS, the current main approach is a whole-process model including pre-medication education, early assessment and intervention of related symptoms, and symptomatic supportive treatment. Medication education mainly refers to providing relevant education on the possible adverse reactions that may occur during the medication process, such as HFS, and guiding in aspects of life, such as wearing loose clothes, adjusting diet, and avoiding friction; early assessment and intervention refer to early intervention such as local cold compress after the patient self-assesses related symptoms; supportive treatment mainly refers to adjusting the drug dosage according to clinical needs and applying oral medications such as celecoxib, mecobalamin, vitamin B 1 etc. at the same time, supplemented by local medications on the hands and feet surfaces, especially at the skin crease positions, such as vitamin E cream, urea cream, petrolatum ointment, moist burn cream, silymarin gel, 2% sildenafil cream, etc.; it can also keep the skin soft, prevent chapping, and help relieve symptoms. Although the above comprehensive treatment system can relieve the symptoms of patients to a certain extent, due to the lack of large-scale clinical efficacy evaluation, the curative effects are inconsistent and there are adverse reactions, so there is an urgent need to explore more effective treatment measures.

[0005] In recent years, traditional Chinese medicine has achieved good results in the treatment of HFS, and RCT clinical studies on HFS have also confirmed the therapeutic effect of traditional Chinese medicine. Moreover, local application of traditional Chinese medicine lotion can directly reach the lesion site, effectively relieve local symptoms, and does not undergo gastrointestinal metabolism, reducing gastrointestinal reactions, giving full play to the advantages of traditional Chinese medicine of "simple, convenient, effective, and inexpensive".

[0006] There is no relevant record of HFS in traditional Chinese medical classics. According to its clinical symptoms, it can be classified into the category of "bi syndrome".

[0007] "Plain Questions: Treatise on Long Needling and Joints" states: "When the disease is in the muscles and all are painful, it is muscle bi syndrome." "Plain Questions: Generation of the Five Viscera" says:

[0008] "When blood coagulates in the skin, it is bi syndrome." The main pathogenesis characteristics of bi syndrome are deficiency in origin and excess in superficiality. Tumor patients are mostly deficient and have blood stasis, and in addition, anti-tumor drugs consume vital qi, so in treatment, the treatment principle of "treating the manifestation in emergency and the root cause in remission" should be followed. External treatment methods of traditional Chinese medicine can administer drugs through the body surface, penetrate pathogenic factors nearby, and directly reach the disease site, quickly solving the patient's pain.

[0009] It is stated in "Li Yue Pian Wen" that: "The principles of external treatment are the same as those of internal treatment, and the medicines for external treatment are the same as those for internal treatment. The only difference lies in the methods." "Medical Classics of the Golden Chamber" records that "Scabies sores occur in the center of the palms and soles, shaped like dogwood fruits, and occur in pairs on both hands. There are also cases where they cluster together, with yellowish-white pustules, itching and pain at all times, oozing yellowish juice when broken, recurring from time to time, and being extremely stubborn. It is caused by wind, dampness invading the skin pores." "Tinea manuum begins with purple and white spots, with white skin peeling off in layers, hard and thick, dry and cracked, spreading to the entire hand." Traditional Chinese medicine believes that chemotherapy drugs are highly toxic substances. They not only damage the spleen and stomach but also consume qi and blood. When the defensive qi is not solid, exogenous pathogenic factors such as wind, cold, and dampness invade, and the pathogenic factors gather locally, causing qi and blood stasis. Therefore, there is numbness and dullness in the hands and feet. In cases with more severe stasis, the skin may turn black. Over time, heat and toxin transform, and the toxic heat stasis blocks the channels, resulting in pain. There may even be severe skin toxicity reactions such as pain, swelling, erythema, desquamation, and chapping. Treatments such as oral administration, external washing and soaking, and ointments can be used. The hands and feet are the distal parts of the limbs. Methods such as external washing and soaking and applying ointments can directly reach the affected area and achieve good therapeutic effects. Professor Cui Guijie of Guang'anmen Hospital, China Academy of Chinese Medical Sciences, studied the literature and conducted in-depth clinical research on the dialectical classification of HFS, dividing it into qi stagnation and blood stasis syndrome, damp-heat and toxic heat syndrome, blood deficiency and wind dryness syndrome, and stasis-toxin blockage, and achieved good clinical efficacy through syndrome differentiation and treatment. Professor Lu Wenping, with her profound clinical skills, summarized and simplified HFS, classifying it into dry syndrome and wet syndrome for syndrome differentiation and treatment, with remarkable curative effects. "Dry syndrome" mainly refers to clinical manifestations such as dry, numb, chapped skin, and skin pigmentation in the early stage of the disease. According to clinical observations, oral administration of anti-tumor drugs such as capecitabine, fluorouracil, and doxorubicin mainly presents dry syndrome symptoms. Therefore, according to the treatment concept of "treating the same disease differently and different diseases with the same treatment" in traditional Chinese medicine, combined with the medication history of HFS patients, syndrome differentiation and treatment are particularly important. Summary of the Invention

[0010] In view of the above technical problems, the present invention provides the following technical solutions:

[0011] The present invention provides a traditional Chinese medicine composition for treating chemotherapy-related hand-foot syndrome, which is prepared from the following raw materials by weight: 60 - 70 parts of Bletilla striata, 30 - 40 parts of Polygonatum sibiricum, 30 - 40 parts of Lithospermum erythrorhizon, 30 - 40 parts of Trogopterus dung, 10 - 15 parts of Nidus Vespae, 15 - 20 parts of Rubia cordifolia, 10 - 15 parts of Angelica dahurica, 10 - 15 parts of Paeonia lactiflora, 10 - 15 parts of Sappanwood, 10 - 15 parts of Crocus sativus, 10 - 15 parts of Magnolia officinalis, 10 - 15 parts of Luffa cylindrica, 10 - 15 parts of Akebia quinata.

[0012] Preferably, it is prepared from the following raw materials by weight: 60 parts of Bletilla striata, 30 parts of Polygonatum sibiricum, 30 parts of Lithospermum erythrorhizon, 30 parts of Trogopterus dung, 10 parts of Nidus Vespae, 15 parts of Rubia cordifolia, 15 parts of Angelica dahurica, 15 parts of Paeonia lactiflora, 15 parts of Sappanwood, 15 parts of Crocus sativus, 15 parts of Magnolia officinalis, 15 parts of Luffa cylindrica, 15 parts of Akebia quinata.

[0013] The present invention also provides a preparation method of the above traditional Chinese medicine composition, including the following steps:

[0014] Weigh Bletilla striata, Polygonatum sibiricum, Lithospermum erythrorhizon, Trogopterus dung, Nidus Vespae, Rubia cordifolia, Angelica dahurica, Paeonia lactiflora, Sappanwood, Crocus sativus, Magnolia officinalis, Luffa cylindrica, and Akebia quinata by weight parts, mix them, decoct with water, filter and concentrate the obtained decoction to obtain the product.

[0015] Preferably, the specific process of decocting with water is as follows: add water in an amount 8 - 12 times the total weight of the medicinal materials, decoct 2 - 3 times, and each time for 1.0 - 2.0 h.

[0016] The present invention also provides the use of the above traditional Chinese medicine composition in the preparation of a drug for treating chemotherapy - related hand - foot syndrome based on the dry - syndrome dialectical classification.

[0017] Preferably, the traditional Chinese medicine composition is used for the preparation of a drug for treating hand - foot syndrome caused by cytotoxic drugs.

[0018] Preferably, the cytotoxic drugs are capecitabine, tegafur - gimeracil - oteracil potassium, fluorouracil, doxorubicin or oxaliplatin.

[0019] The present invention also provides a traditional Chinese medicine preparation for treating chemotherapy - related hand - foot syndrome, which comprises the above traditional Chinese medicine composition and pharmaceutically acceptable excipients or carriers.

[0020] In the traditional Chinese medicine composition provided by the present invention, Bletilla striata is bitter, sweet and cool, enters the lung meridian, tonifies the lung, stops bleeding, reduces swelling, generates muscle and astringes sores, and is used as the monarch drug; Polygonatum sibiricum invigorates the spleen and replenishes qi, tonifies the lung and kidney, enabling the generation of qi and blood to have a source; Lithospermum erythrorhizon cools the blood and promotes blood circulation, detoxifies and promotes eruption, Trogopterus dung is bitter, sweet and warm in nature, and belongs to the liver and spleen meridians. The combination of these three drugs enables the generation of qi and blood to have a source, promotes blood circulation and dredges meridians, improves local blood circulation, and promotes skin metabolism, and can also assist Bletilla striata to better play its role, and they are used as the ministerial drugs together; Nidus Vespae, Rubia cordifolia, Angelica dahurica, Paeonia lactiflora, Sappanwood, and Crocus sativus all have the effects of dispelling wind, promoting blood circulation, dredging meridians and relieving pain, and are used as the assistant drugs together; Magnolia officinalis, Luffa cylindrica, and Akebia quinata relax muscles and tendons, promote qi flow and remove dampness, and are used as the guiding drugs together. The combination of the above - mentioned drugs can supplement healthy qi, nourish blood and promote blood circulation, dredge meridians and relieve pain, thereby improving blood circulation in the skin lesion area, promoting its metabolism, and repairing the skin lesion. This traditional Chinese medicine composition can be used to treat chemotherapy - related hand - foot syndrome with dry - syndrome dialectical classification, manifested as dryness, numbness, chapping, skin pigmentation, etc. of the hand and foot skin.

[0021] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0022] The traditional Chinese medicine composition provided by the present invention can significantly improve the dry - syndrome symptoms such as dryness, numbness, chapping, skin pigmentation, etc. of the hand and foot skin in patients with chemotherapy - related hand - foot syndrome. Description of the Drawings

[0023] Figure 1 It is a diagram of the hand skin state of the patient before treatment;

[0024] Figure 2 The hand skin condition diagram of the patient after 2 weeks of using the traditional Chinese medicine composition provided by the embodiment of the present invention. Detailed implementation manners

[0025] In order to enable those skilled in the art to better understand and implement the technical solutions of the present invention, the present invention will be further described below in conjunction with specific embodiments, but the exemplified embodiments shall not be construed as limiting the present invention.

[0026] Embodiment 1

[0027] A traditional Chinese medicine composition for treating chemotherapy-related hand-foot syndrome, which is made from the following raw materials: 70 g of Bletilla striata, 40 g of Polygonatum sibiricum, 40 g of Lithospermum erythrorhizon, 40 g of Trogopterus dung, 15 g of Nidus Vespae, 20 g of Rubia cordifolia, 15 g of Angelica dahurica, 15 g of Paeonia lactiflora, 15 g of Sappanwood, 15 g of Crocus sativus, 15 g of Magnolia officinalis, 15 g of Luffa cylindrica, 15 g of Akebia quinata.

[0028] Embodiment 2

[0029] A traditional Chinese medicine composition for treating chemotherapy-related hand-foot syndrome, which is made from the following raw materials: 60 g of Bletilla striata, 30 g of Polygonatum sibiricum, 30 g of Lithospermum erythrorhizon, 30 g of Trogopterus dung, 10 g of Nidus Vespae, 15 g of Rubia cordifolia, 10 g of Angelica dahurica, 10 g of Paeonia lactiflora, 10 g of Sappanwood, 10 g of Crocus sativus, 10 g of Magnolia officinalis, 10 g of Luffa cylindrica, 10 g of Akebia quinata.

[0030] Embodiment 3

[0031] A traditional Chinese medicine composition for treating chemotherapy-related hand-foot syndrome, which is made from the following raw materials: 60 g of Bletilla striata, 30 g of Polygonatum sibiricum, 30 g of Lithospermum erythrorhizon, 30 g of Trogopterus dung, 10 g of Nidus Vespae, 15 g of Rubia cordifolia, 15 g of Angelica dahurica, 15 g of Paeonia lactiflora, 15 g of Sappanwood, 15 g of Crocus sativus, 15 g of Magnolia officinalis, 15 g of Luffa cylindrica, 15 g of Akebia quinata.

[0032] Embodiment 4

[0033] A traditional Chinese medicine composition for treating chemotherapy-related hand-foot syndrome, which is made from the following raw materials: 68 g of Bletilla striata, 35 g of Polygonatum sibiricum, 32 g of Lithospermum erythrorhizon, 35 g of Trogopterus dung, 12 g of Nidus Vespae, 18 g of Rubia cordifolia, 10 g of Angelica dahurica, 12 g of Paeonia lactiflora, 12 g of Sappanwood, 15 g of Crocus sativus, 12 g of Magnolia officinalis, 10 g of Luffa cylindrica, 10 g of Akebia quinata.

[0034] The traditional Chinese medicine compositions in the above Embodiments 1-4 are prepared according to the following preparation method: Weigh each raw material drug, add water equivalent to 10 times the total weight of the medicinal materials, decoct twice, each time for 2.0 h, combine the two decoction liquids, filter, and concentrate to obtain.

[0035] Embodiment 5

[0036] A traditional Chinese medicine composition for treating chemotherapy-related hand-foot syndrome, which is only different from Example 1 in the preparation method. Specifically: Weigh each raw material medicine, add water equivalent to 12 times the total weight of the medicinal materials, decoct 3 times, each time for 1.0 h, combine the decoction liquids of the three times, filter, and concentrate to obtain it.

[0037] Experimental Example

[0038] 1. Clinical data

[0039] Select 28 patients with malignant tumors who were hospitalized in the First Affiliated Hospital of Henan University of Science and Technology from March 2019 to December 2021 and were diagnosed with HFS after using chemotherapy drugs and clinically differentiated as dry syndrome. Among them, there were 17 males and 11 females, 13 patients over 65 years old, and 15 patients less than or equal to 65 years old. The patients were randomly divided into a control group and a treatment group, with 12 patients in the control group and 16 patients in the treatment group. The patients in the control group and the treatment group were compared in terms of the severity of the disease and the course of the disease, and there was no significant difference between the two (P>0.05), which was comparable.

[0040] 2. Diagnostic criteria:

[0041] (1) Have a medical history of malignant tumor diagnosed by pathological diagnosis;

[0042] (2) Have a history of using chemotherapy drugs;

[0043] (3) Present the following symptoms: dryness, numbness, chapping, skin pigmentation, etc. of the hands and feet.

[0044] 3. Methods

[0045] The treatment group used the traditional Chinese medicine composition prepared in Example 3 of the present invention (the effects of the traditional Chinese medicine compositions prepared in Examples 1-5 are basically the same, so here only the traditional Chinese medicine composition prepared in Example 3 is taken as an example to illustrate the effect). When spraying the medicine, first wash the affected area with warm water, and then spray the traditional Chinese medicine spray of the present invention 5-6 times a day, and continuously use the medicine for 5 days as 1 course of treatment;

[0046] The control group was treated with western medicine, urea ointment was given and evenly applied to the wound surface 3-5 times a day; at the same time, mecobalamin tablets were given for oral treatment, dosage: 1 tablet (0.5 mg) once, 3 times a day.

[0047] 4. Efficacy evaluation indicators

[0048] 4.1. Clinical efficacy

[0049] Cured: HFS completely disappears and can work and live normally;

[0050] Improved: The HFS grade drops by 1 level or more;

[0051] Invalid: There is no change in HFS, or it even worsens, with the HFS grade increasing by 1 level or more.

[0052] Grade 1: Slight skin changes or dermatitis with paresthesia, but it does not affect daily activities;

[0053] Grade 2: Skin changes are as before, accompanied by pain, slightly affecting daily activities, and the skin surface is intact;

[0054] Grade 3: Ulcerative dermatitis or skin changes accompanied by severe pain, seriously affecting daily activities, with obvious tissue damage (such as desquamation, blisters, bleeding, edema).

[0055] 4.2, Pain relief rate

[0056] Evaluated by the Numerical Rating Scale (NRS).

[0057] Complete remission (CR): Completely painless, with an NRS score of 0;

[0058] Partial remission (PR): The pain is significantly reduced compared to before, with the NRS score decreasing by ≥1 / 2;

[0059] Mild remission (MR): Although the pain is reduced compared to before, there is still obvious pain, with the NRS score decreasing by <1 / 2;

[0060] No response (NR): The degree of pain has not been reduced, and the NRS score has not decreased.

[0061] 4.3, Quality of life score

[0062] The Quality of Life (QOL) score for cancer patients is used:

[0063] (1) Appetite: ① Almost unable to eat; ② Food intake <1 / 2 of normal; ③ Food intake is 1 / 2 of normal; ④ Slightly less food intake; ⑤ Normal food intake.

[0064] (2) Spirit: ① Very poor; ② Poor; ③ Affected, but sometimes good and sometimes bad; ④ Fair; ⑤ Normal, the same as before the illness.

[0065] (3) Sleep: ① Difficult to fall asleep; ② Very poor sleep; ③ Poor sleep; ④ Slightly poor sleep; ⑤ Generally normal.

[0066] (4) Fatigue: ① Often fatigued; ② Feeling weak; ③ Sometimes often fatigued; ④ Sometimes slightly fatigued; ⑤ No sense of fatigue.

[0067] (5) Pain: ① Severe pain with a passive position or pain lasting more than 6 months; ② Severe pain; ③ Moderate pain; ④ Mild pain; ⑤ Painless.

[0068] (6) Family understanding and cooperation: ① Completely not understood; ② Poor; ③ General; ④ Good family understanding and care; ⑤ Good.

[0069] (7) Understanding and cooperation of colleagues (including leaders): ① Completely not understood, no one takes care; ② Poor; ③ General; ④ Understood and taken care of by a few people; ⑤ Understood and taken care of by most people.

[0070] (8) One's own understanding of cancer: ① Disappointed, completely not cooperative; ② Anxious, reluctantly cooperative; ③ Anxious and cooperative in general; ④ Anxious, but can cooperate well; ⑤ Optimistic, confident.

[0071] (9) Attitude towards treatment: ① Have no hope for treatment; ② Half-believe and half-doubt about treatment; ③ Hope to see the curative effect, but afraid of side effects; ④ Hope to see the curative effect and can still cooperate; ⑤ Confident and actively cooperate.

[0072] (10) Daily life: ① Bedridden; ② Can move, mostly need to be bedridden; ③ Can move, sometimes bedridden; ④ Normal life, unable to work; ⑤ Normal life and work.

[0073] (11) Side effects of treatment: ① Seriously affect daily life; ② Affect daily life; ③ Can not affect daily life after symptomatic treatment; ④ Can not affect daily life without symptomatic treatment; ⑤ Do not affect daily life.

[0074] (12) Facial expressions: Divided into 5 grades from ① to ⑤.

[0075] Quality of life grading: The full score of quality of life is 60 points. Good is 51 - 60 points, better is 41 - 50 points, general is 31 - 40 points, poor is 21 - 30 points, and extremely poor quality of life is <20 points.

[0076] Improvement: The quality of life score increases by ≥10 points;

[0077] Stable: The quality of life score increases by <10 points;

[0078] Decrease: The quality of life score decreases by ≥10 points.

[0079] 5. Results

[0080] 5.1 Clinical efficacy

[0081] The results are shown in Table 1.

[0082] Table 1 Clinical efficacy results of each group

[0083] Grouping Total number of cases (n) Cured Improved Invalid Total effective rate (%) Control group 12 1(8.33) 2(16.67) 9(75.00) 25％ Treatment group 16 3(18.75) 8(50.00) 5(31.25) 68.75％

[0084] Note: Total effective rate = (cured + improved) / total number of cases * 100%.

[0085] 5.2 Pain relief rate

[0086] The results are shown in Table 2.

[0087] Table 2 Pain relief rates of each group

[0088]

[0089] Note: Total effective rate = (CR + PR + MR) / total number of cases * 100%.

[0090] 5.3 Quality of life score

[0091] The results are shown in Table 3.

[0092] Table 3 Quality of life scores of each group

[0093] Grouping Number of cases (n) Improve Stable Decrease Total effective rate (%) Control group 12 4(33.33) 7(58.33) 1(8.33) 91.67％ Treatment group 16 10(62.50) 5(31.25) 1(6.25) 93.75％

[0094] Note: Total effective rate = (improvement + stability) / total number of cases * 100%.

[0095] Figure 1-2 The figures respectively show the hand skin condition diagrams of the patient before treatment and 2 weeks after using the traditional Chinese medicine composition provided in Example 3 of the present invention. By comparison, it can be seen that after using the traditional Chinese medicine composition provided by the present invention, symptoms such as dryness, numbness, chapping, and skin pigmentation of the patient's hands and feet are significantly improved.

[0096] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and its equivalent technologies, the present invention is also intended to include these changes and modifications.

Claims

1. A Chinese medicine composition for treating chemotherapy-related hand-foot syndrome, characterized in that: The invention is prepared from the following raw materials by weight: 60-70 parts of bletilla striata, 30-40 parts of polygonatum, 30-40 parts of lithospermum officinale, 30-40 parts of aconiti lobata, 10-15 parts of nectarine, 15-20 parts of madder, 10-15 parts of angelica dahurica, 10-15 parts of red peony root, 10-15 parts of sappan wood, 10-15 parts of saffron, 10-15 parts of magnolia bark, 10-15 parts of luffa, and 10-15 parts of akebia.

2. The Chinese medicine composition for treating chemotherapy-related hand-foot syndrome according to claim 1, characterized in that: The invention is prepared from the following raw materials by weight: 60 parts of bletilla striata, 30 parts of polygonatum, 30 parts of lithospermum officinale, 30 parts of aconiti lobata, 10 parts of nectarine, 15 parts of madder, 15 parts of angelica dahurica, 15 parts of red peony root, 15 parts of sappan wood, 15 parts of saffron, 15 parts of magnolia bark, 15 parts of luffa, and 15 parts of akebia.

3. A method for preparing a Chinese medicine composition for treating chemotherapy-related hand-foot syndrome according to claim 1 or 2, characterized in that: The following steps are involved: Weigh bletilla striata, polygonatum sibiricum, lithospermum officinale, aconiti lobata, nectarine, madder, angelica dahurica, red peony root, sappan wood, saffron, magnolia bark, luffa loofah, and akebia according to weight proportions, mix them, add water and boil, and filter and concentrate the obtained decoction to obtain the product.

4. The preparation method according to claim 3, characterized in that: The specific process of decocting with water is as follows: adding water in an amount equivalent to 8-12 times the total weight of the medicinal materials, decocting 2-3 times, each time for 1.0-2.0 hours.

5. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating chemotherapy-related hand-foot syndrome based on dry syndrome differentiation.

6. The use according to claim 5, characterized in that: The traditional Chinese medicine composition is used for preparing medicine for treating hand-foot syndrome caused by cytotoxic drugs.

7. The use according to claim 6, characterized in that: The cytotoxic drug is capecitabine, S-1, fluorouracil, doxorubicin or oxaliplatin.

8. A Chinese medicine preparation for treating chemotherapy-related hand-foot syndrome, characterized in that: It comprises the Chinese medicine composition according to claim 1 or 2, and a pharmaceutically acceptable auxiliary material or carrier.

Images