A Chinese medicine composition for preventing and treating tumor-related numbness and pain in hands and feet

Abstract

The invention belongs to the field of medical technology, and specifically relates to a traditional Chinese medicine composition for preventing and treating numbness and pain in the hands and feet associated with tumors, and a preparation method of the composition. The traditional Chinese medicine composition of the invention comprises the following components in parts by weight: 10-60 parts of astragalus, 3-15 parts of cassia twig, 2-15 parts of white peony root, 3-12 parts of white bombyx batryticatus, 2-12 parts of polygonum multiflorum, 3-20 parts of turmeric slices, and 5-15 parts of clematis. The traditional Chinese medicine composition of the invention has the effects of invigorating qi and warming yang, removing blood stasis and dredging collaterals, detoxifying and dispersing nodules, relieving numbness and relieving pain. Clinical application shows that the traditional Chinese medicine composition can prevent and treat numbness and pain in the hands and feet associated with tumors, relieve symptoms, reduce adverse reactions of surgery, radiotherapy, chemotherapy, targeted and immunotherapy, improve clinical symptoms, improve the clinical benefit rate and quality of life of cancer patients, prolong survival and promote recovery.

Description

Technical Field

[0001] The invention belongs to the field of medical technology, and specifically relates to a traditional Chinese medicine composition for preventing and treating tumor-related numbness and pain in hands and feet, and also relates to a preparation method of the composition. Background Art

[0002] Malignant tumors are a global problem that seriously threatens human life and health. According to statistics, there will be approximately 19.3 million new cases of cancer and 10 million deaths worldwide in 2020. It is estimated that by 2040, the number of new cancer cases worldwide will increase by 47%. Among people aged under 70 in 112 countries around the world, cancer is the first or second leading cause of death. With people's increasing attention and the continuous development of medical technology, the prognosis of cancer is getting better and better, and the quality of life of cancer patients has gradually received more attention.

[0003] Numbness and pain in the hands and feet are common clinical symptoms of cancer patients. Whether before, during or after cancer treatment, they seriously affect people's daily life, leading to a decline in the quality of life of patients, and even various physiological or psychological problems, affecting the normal progress of cancer treatment, thereby affecting the prognosis. Traditional Chinese medicine often classifies them into the categories of "arthralgia" and "numbness" based on the symptoms. It is believed that the tumor itself or various anti-tumor treatments will damage the body's positive energy, "where evil gathers, the energy must be weak", so the body is easy to be affected by external evil, "wind, cold and dampness are mixed together to form arthralgia", evil energy blocks the meridians, blood stasis is blocked, the positive energy is deficient and unable to promote blood circulation, the meridians lose their nourishment, and cannot nourish the limbs. There is both "blockage" and "lack of nourishment", which manifests as numbness and pain in the hands and feet.

[0004] Tumor-related numbness and pain in the hands and feet are mostly caused by the tumor and related treatments, and are affected by many factors, including the tumor itself and its related treatments, and the patient's own condition. (1) The tumor itself: The tumor itself may compress the nerves, which mainly depends on the location and size of the tumor. As the tumor grows, the symptoms will gradually worsen. This is common in central nervous system tumors, such as brain tumors, and can also be seen when the tumor metastasizes to the brain, thoracic spine, lumbar spine, etc. and compresses the nerves; or due to the remote effects of the tumor, the peripheral nervous system is damaged, which is called paraneoplastic peripheral neuropathy. It is common in small cell lung cancer, lymphoma, esophageal cancer, gastric cancer, breast cancer, etc., and numbness and pain in the hands and feet will occur. (2) Tumor-related treatment: If the peripheral nerves are damaged during tumor surgery, or the nerves are compressed by postoperative hematoma, or the nerve root edema is caused by surgical stimulation, the symptoms of numbness and pain in the hands and feet will also occur. In addition, according to surveys, 30%-85% of patients who are undergoing chemotherapy or have completed chemotherapy will experience chemotherapy-induced peripheral neuropathy (chemotherapy-induced peripheral neuropathy). Hand-foot syndrome (CIPN) is a common symptom of unilateral or bilateral numbness of the hands and feet. It is often seen in patients with platinum-based chemotherapy drugs, taxane-based chemotherapy drugs, and thalidomide. About 1% to 4% of patients who receive or undergo radiotherapy will experience radiation myelopathy, which can manifest as unilateral or bilateral numbness of the hands and feet. Molecular targeted drugs are the core of current cancer treatment and can greatly improve the prognosis of patients. About 75% of cancer patients will experience hand-foot syndrome during or after targeted therapy. HFS syndrome, whose typical manifestations include numbness and pain in the hands and feet. If not treated in time, severe cases will lead to loss of hand and foot function, such as the targeted drug sorafenib. About 1%-6% of patients treated with immune checkpoint inhibitors will experience neurological toxicity. When the peripheral nervous system is affected, it will also manifest as numbness and pain in the hands and feet. (3) The patient's own condition: Pain patients are often accompanied by malnutrition, physique, and physique. The blood is in a hypercoagulable state and flows slowly, which is prone to abnormal sensation of the peripheral nerves of the limbs and causes numbness and pain. If the patient has a history of diabetes, renal function damage, smoking history, etc., it is more likely to have symptoms of numbness and pain in the hands and feet.

[0005] The pathogenesis of numbness and pain in the hands and feet caused by tumors and related treatments is relatively complex. Current studies believe that there are mainly the following mechanisms: (1) Mitochondrial dysfunction and oxidative stress: After entering neurons and non-neuronal cells, platinum-based chemotherapy drugs bind to mitochondrial DNA (mDNA) and form mDNA adducts, which damage the physiological replication and transcription of mitochondrial DNA, leading to abnormal protein synthesis, damage to the mitochondrial respiratory chain, reduced cell metabolism, increased production of reactive oxygen species, and excessive oxidative stress, which damage enzymes, proteins, and lipids, leading to changes in the structure of peripheral nerves. Reactive oxygen can also stimulate the activation of apoptotic pathways of neuronal cells through the mitochondrial pathway, including caspase activation and calcium homeostasis disorders, leading to malnutrition and loss of dorsal root ganglion (DRG) cells; (2) Release of inflammatory mediators: The release and increase of proinflammatory cytokines such as IL-1b, IL-6, and TNF-a are common mechanisms, which may be related to the activation of Toll-like cytokines by anti-tumor drugs. Receptor (TLR) family. Especially TLR4. Proinflammatory cytokines can also cause nociceptor sensitization by regulating ion channel function. CCL (CC chemokine ligand) is responsible for the migration and infiltration of monocytes / macrophages and other immune cells, and can promote neuroinflammation and pain. Platinum chemotherapy drugs such as oxaliplatin can increase the levels of CCL-2 chemokine and its receptor CCR2 in DRG cells, increasing the degree of hyperalgesia; (3) Axonal damage and degeneration: The main mechanism of action of taxane chemotherapy drugs is microtubule destruction. Microtubules are also present in the axons of peripheral nerve cells. The aggregation and bundling of microtubules can lead to changes in cell shape and cell stability, but also lead to impaired axonal transport of synaptic vesicles. Synaptic vesicles contain important cellular components, including lipids, proteins and ion channels. Microtubule destruction and impaired axonal transport lead to degeneration of distal nerve segments (Wallerian degeneration) and axonal membrane remodeling. (4) Others: In addition, there are other mechanisms such as Na + , K + It is related to multiple mechanisms, including changes in the expression and function of plasma channels such as transient receptor potential (TRP) channels, which increase the excitability of peripheral neurons, abnormal calcium homeostasis, changes in mitogen-activated protein kinases, and inhibition of nuclear factor κB (NF-κB).

[0006] Numbness and pain in the hands and feet caused by tumors and related treatments often last for a long time. Even if the related treatment is stopped, the symptoms may continue for months to years, which has a great negative impact on the patient's physical and mental health, causing a serious decline in the patient's quality of life, and is not conducive to the treatment of cancer and affects the prognosis. When the symptoms are mild, they often fail to alert patients, resulting in untimely treatment and gradual worsening of symptoms. Therefore, cancer patients should pay attention to numbness and pain in the hands and feet. There is currently no unified standard for evaluation. Clinically, the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) and the Total Neuropathy Score (TNS) are commonly used for evaluation.

[0007] Most current guidelines, consensus, and clinical practice believe that the treatment of numbness and pain in the hands and feet caused by tumors and related treatments can be divided into two parts: non-drug treatment and drug treatment:

[0008] (I) Non-drug treatment: mainly includes the following methods: (1) Acupuncture treatment: Acupuncture is a traditional Chinese medicine treatment method with the characteristics of high safety and few adverse reactions. Many studies have shown that it can improve the symptoms of numbness and pain in the hands and feet caused by tumors and related treatments, which may be related to the inhibition of cyclooxygenase-2 and the release of endogenous opioid peptides. (2) Massage treatment: Studies have shown that acupoint massage can significantly improve the symptoms of numbness and pain in the hands and feet. This may be related to the fact that massaging the corresponding parts can activate the relevant sensory and motor areas of the cerebral cortex, strengthen the compensatory and coordination effects between the functional areas of the cerebral cortex, promote nerve repair and growth, accelerate nerve transmission, and thus relieve numbness. In addition, massage can improve the blood circulation of the whole body, so that the nerves can get sufficient nutritional support, improve pain relief, and improve blood circulation. Pain threshold. (3) Exercise therapy: Studies have shown that exercise can relieve the symptoms of numbness and pain in the hands and feet, which may be related to increasing neuronal metabolism, improving the level of inflammatory factors, promoting the secretion of nerve growth factors, neurotrophins, etc., and improving nerve fiber function, including aerobic exercise, strength training, whole body vibration training, etc. (4) Nutritional support: Studies have shown that supplementing with vitamin D, calcium, and magnesium can help prevent the occurrence of numbness and pain in the hands and feet. Patients with low vegetable and fruit intake are more likely to experience this symptom. This is mainly because calcium ions and magnesium ions are chelators of oxalate, which can effectively avoid or reduce the effects of chemotherapy drugs on nerve membrane channels. (5) Others: Such as emotional therapy, heat therapy, skin electrical stimulation therapy, glove compression, yoga, etc., studies have shown that they can improve the symptoms of numbness and pain in the hands and feet.

[0009] (II) Drug treatment: mainly includes the following drugs: (1) Antidepressants: represented by duloxetine and venlafaxine. Duloxetine and venlafaxine are both selective inhibitors of 5-hydroxytryptamine (5-HT) and norepinephrine (NE) reuptake. Many studies have shown that duloxetine can significantly improve numbness and tingling in patients' hands and feet. The National Comprehensive Cancer Network (NCCN) guidelines recommend duloxetine for moderate peripheral neuropathy caused by immunotherapy. The American Society of Clinical Oncology (ACS) recommends duloxetine for moderate peripheral neuropathy caused by immunotherapy. The American Society of Oncology (ASCO) guidelines recommend duloxetine for the treatment of pain caused by chemotherapy-induced peripheral neuropathy. The therapeutic effect of venlafaxine has also been confirmed in many studies. Since it has a stronger inhibitory effect on serotonin at low doses and a stronger inhibitory effect on norepinephrine at high doses, it is often used for prevention. A double-blind randomized controlled trial showed that duloxetine is more effective than venlafaxine, and it is believed that venlafaxine is only beneficial for oxaliplatin-specific neurotoxicity and some of its acute neurotoxicity. Therefore, venlafaxine still needs further research. (2) Anti-epileptic drugs: represented by gabapentin and pregabalin. Gabapentin is a derivative of γ-aminobutyric acid (GABA), with a structure similar to GABA, and can change GABA metabolism, but the specific pharmacological effects have not yet been elucidated, which may be related to antagonizing N-methyl-D-aspartate receptors and inhibiting calcium ion channels in the postsynaptic membrane. Pregabalin is also a GABA analogue, with a structure and action similar to gabapentin, but the specific pharmacological effects are also unclear, and its activity is 3-10 times that of gabapentin. Studies have shown that both can improve numbness and pain in the hands and feet caused by tumors and related treatments. However, some studies have shown that the two drugs are generally effective in treating chemotherapy-induced peripheral neuropathy. The NCCN guidelines recommend gabapentin and pregabalin for pain caused by moderate peripheral neuropathy caused by immunotherapy. (3) Neuroprotectants: such as N-acetylcysteine ​​and glutathione. N-acetylcysteine ​​activates glutathione peroxidase, leading to an increase in whole blood glutathione concentration. Glutathione prevents the accumulation of platinum adducts in dorsal root ganglia through its high affinity for heavy metals. Glutathione can also protect nerves by inhibiting the activation of the p53 signaling pathway. Some studies have shown that before chemotherapy, Eight cycles of glutathione treatment can significantly reduce the incidence of moderate to severe numbness and pain in the hands and feet. Therefore, glutathione and its precursor N-acetylcysteine ​​seem to be a preventive option, and its therapeutic effect remains to be studied. (4) Ion channel regulators: such as lidocaine and menthol. Lidocaine is an antiarrhythmic drug that has a significant biphasic effect of excitation and inhibition on the central nervous system and can block sodium channels. Studies have shown that intravenous lidocaine can exhibit a sustained analgesic effect, and local application of lidocaine also has a strong analgesic effect, but there is a lack of convincing evidence.Menthol is a transient receptor potential M8 channel activator. Transient receptor potential M8 plays a multifaceted role in cold allodynia and cold-mediated analgesia. Studies have shown that topical use of 1% menthol cream can significantly reduce numbness and pain in the hands and feet caused by a variety of anti-tumor drugs, but some patients also think that the pain is aggravated after use, so it is still necessary to choose with caution. (5) Other treatments: such as antioxidant mangafodipir drugs, amifostine, vitamin E, etc., topical urea ointment, uracil ointment, etc., all have been shown in studies to improve symptoms of numbness and pain in the hands and feet, but more clinical studies are still needed to confirm.

[0010] Although there are many methods for treating tumor-related numbness and pain in the hands and feet, the symptoms of some patients are still difficult to relieve clinically for the following reasons: (1) Non-drug therapies usually take effect slowly and require long-term persistence and cooperation from patients. There are few relevant clinical studies and their efficacy needs further study. The ASCO guidelines do not recommend the use of this method for prevention; (2) Currently, the commonly used and effective drugs in clinical practice are duloxetine, gabapentin, and pregabalin. However, duloxetine can cause various adverse reactions such as increased blood pressure, decreased heart rate, insomnia, headache, tremor, nausea, diarrhea, and constipation. Gabapentin has fewer adverse reactions than pregabalin, with common side effects being drowsiness, Dizziness, fatigue, nystagmus, headache, nausea and vomiting, etc.; (3) Other drugs such as neuroprotectants, ion channel regulators, antioxidants, etc., although clinical studies have confirmed their effects on improving symptoms of numbness and pain in the hands and feet, some studies have also obtained opposite results, and the specific efficacy remains to be verified. Symptoms of numbness and pain in the hands and feet after tumors and related treatments will not only affect the patient's body function, daily life, and mental health, and reduce the patient's quality of life, but will also affect the normal treatment of cancer and affect the patient's prognosis. This is a major problem that needs to be solved. At present, there is no effective method that is fast in effect, has few side effects, has a wide range of applications, and can be used for both prevention and treatment.

[0011] The pharmaceutical composition of the present invention effectively solves the above problems. Summary of the invention

[0012] In order to solve the above-mentioned technical problems, the present invention provides a Chinese medicine composition for preventing and treating numbness and pain in the hands and feet related to tumors and a preparation method thereof. The Chinese medicine composition can strengthen the body's resistance and eliminate evil, treat both the symptoms and the root causes, and the combination of various medicines can replenish qi and warm yang, resolve blood stasis and dredge meridians, detoxify and disperse stagnation, relieve numbness and relieve pain. It has good effects in preventing and treating numbness and pain in the hands and feet related to tumors, has high efficiency and has no side effects on the human body.

[0013] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition.

[0014] The present invention provides a Chinese medicine composition for preventing and treating tumor-related numbness and pain in hands and feet, which is achieved through the following technical scheme:

[0015] The composition can be used for oral administration or external use, and comprises the following components in parts by weight: 10-60 parts of astragalus, 3-15 parts of cassia twig, 2-15 parts of white peony root, 3-12 parts of white bombyx batryticatus, 2-12 parts of polygonum multiflorum, 3-20 parts of turmeric slices, and 5-15 parts of clematis.

[0016] Preferably, the composition comprises the following components in parts by weight: 15-30 parts of astragalus, 5-10 parts of cassia twig, 3-12 parts of white peony root, 4-10 parts of bombyx batryticatus, 5-10 parts of polygonum multiflorum, 5-15 parts of turmeric, and 6-10 parts of clematis.

[0017] More preferably, the composition comprises the following components in parts by weight: 15 parts of Astragalus, 10 parts of Cassia Twig, 10 parts of White Peony Root, 10 parts of Bombyx Batryticatus, 10 parts of Polygonum Multiflorum, 10 parts of Curcuma Longa, and 10 parts of Clematis.

[0018] Of course, when the composition is only used for external use, it includes the following components in parts by weight: 10-60 parts of Astragalus, 6-30 parts of cinnamon twig, 5-30 parts of white peony root, 3-30 parts of Bombyx batryticatus, 5-25 parts of Polygonum multiflorum, 3-25 parts of Curcuma longa, and 5-30 parts of Clematis chinensis.

[0019] Preferably, the composition comprises the following components in parts by weight: 15-35 parts of astragalus, 10-20 parts of cassia twig, 10-15 parts of white peony root, 6-20 parts of bombyx batryticatus, 8-20 parts of polygonum multiflorum, 5-15 parts of turmeric slices, and 12-20 parts of clematis.

[0020] More preferably, the composition comprises the following components in parts by weight: 30 parts of Astragalus, 15 parts of Cinnamon Twig, 15 parts of White Peony Root, 15 parts of Bombyx Batryticatus, 15 parts of Polygonum multiflorum, 15 parts of Curcuma longa, and 15 parts of Clematis chinensis.

[0021] The method for preparing the above-mentioned Chinese medicine composition for preventing and treating tumor-related numbness and pain in the hands and feet can be divided into a decoction and a granule, which comprises the following steps:

[0022] Decoction preparation method 1

[0023] (1) Take 15 parts of Astragalus, 10 parts of Cassia twig, 10 parts of White Peony Root, 10 parts of Bombyx Batryticatus, 10 parts of Polygonum multiflorum, 10 parts of Curcuma longa, and 10 parts of Clematis chinensis, mix them, and soak them in water for half an hour. The ratio of the total weight of the Chinese medicinal materials to the weight of water can be (1-2): (10-15), and the specific amount of water added can be determined according to the weight of the medicinal materials.

[0024] (2) Add all the Chinese medicinal materials and boil for 40 minutes. The ratio of the total weight of the Chinese medicinal materials to the weight of water can be (1-2): (10-15), and the specific amount of water added can be determined according to the weight of the medicinal materials.

[0025] (3) Filter the decoction to obtain a filtrate and a filter residue, and the first decoction is completed.

[0026] (4) Take out the filter residue, add water and boil again for 25 minutes. The ratio of the total weight of the Chinese medicinal materials to the weight of water can be (1-2): (5-10), and the specific amount of water added can be determined according to the weight of the medicinal materials.

[0027] (5) Filter the decoction to obtain a filtrate and a filter residue, and the second decoction is completed.

[0028] (6) Mixing the filtrate obtained from the first decoction with the filtrate obtained from the second decoction to obtain the water decoction of the Chinese medicine composition.

[0029] This preparation method is suitable for individuals to decoct at home and take immediately after it is obtained.

[0030] Decoction Preparation Method 2

[0031] (1) Take 15 parts of Astragalus, 10 parts of Cinnamon Twig, 10 parts of White Peony Root, 10 parts of Bombyx Batryticatus, 10 parts of Polygonum Multiflorum, 10 parts of Curcuma Longa, and 10 parts of Clematis, add water and boil three times.

[0032] (2) Add water for the first time and boil for 1 hour. The ratio of the total weight of the Chinese medicinal materials to the weight of water can be (1-2): (10-20), and the specific amount of water added can be determined according to the weight of the medicinal materials.

[0033] (3) Add water for the second time and boil for 1 hour. The ratio of the total weight of the Chinese medicinal materials to the weight of water can be (1-2): (5-10), and the specific amount of water added can be determined according to the weight of the medicinal materials.

[0034] (4) Add water for the third time and boil for 0.5 hours. The ratio of the total weight of the Chinese medicinal materials to the weight of water can be (1-2): (5-10), and the specific amount of water added can be determined according to the weight of the medicinal materials.

[0035] (5) The obtained drug solution is concentrated under reduced pressure to a relative density of 1.1-1.15 at 60°C, and then refrigerated and allowed to stand for 24 hours.

[0036] (6) Filter to obtain the filtrate, add 500 ml of water, fill and sterilize to obtain the water decoction of the Chinese medicine composition.

[0037] The preparation method is suitable for decoction preparation in pharmacies, pharmaceutical factories, institutions, etc. and has a long shelf life.

[0038] Granule preparation

[0039] (1) Mix 15 parts of Astragalus, 10 parts of Cinnamon Twig, 10 parts of White Peony Root, 10 parts of Bombyx Batryticatus, 10 parts of Polygonum Multiflorum, 10 parts of Curcuma Longa, and 10 parts of Clematis, and soak them in water for 30 minutes. The ratio of the total weight of the Chinese medicinal materials to the weight of water can be (1-2): (5-10), and the specific amount of water added can be determined according to the weight of the medicinal materials.

[0040] (2) Add water and boil for three times, the first time boiling for 1.5 hours. The ratio of the total weight of the Chinese medicinal materials to the weight of water is 1:10, and the specific amount of water added can be determined according to the weight of the medicinal materials.

[0041] (3) Add water and boil for 1.5 hours for the second and third times. The ratio of the total weight of the Chinese medicinal materials to the weight of water is 1:8, and the specific amount of water added can be determined according to the weight of the medicinal materials.

[0042] (4) The filtrates obtained from the three filtrations were combined and filtered through 200 mesh to obtain a filtrate.

[0043] (5) Concentrating at a vacuum degree of -0.06 to -0.08 MPa and a temperature of 70-80°C to a relative density of 1.20-1.25 (50°C) to obtain a clear paste.

[0044] (6) A one-step granulation method is adopted, wherein dextrin and mannitol are used as the base material in a ratio of 8:1, and the clear paste is sprayed into the base to obtain granules, which are then packaged to obtain the granules of the Chinese medicine composition.

[0045] The preparation method is suitable for decocting and preparing granules in pharmacies, pharmaceutical factories, institutions, etc., has a long shelf life, is simple to use, and is easy to transport and carry.

[0046] In addition, each Chinese medicinal material in the composition can be directly replaced with a corresponding amount of raw medicine in the market. When using, the Chinese medicinal formula granules of each medicine are directly mixed, dissolved in hot water and taken.

[0047] In addition, the present invention can also be used as an external medicine, and the method of external use is:

[0048] The filter residue obtained after preparing the water decoction of the present invention is applied externally to the parts of the hands and feet with abnormal sensation. The filtrate, granules, or formula granules obtained after preparing the water decoction of the present invention can be diluted or dissolved to 1000 ml with warm water and put into a constant temperature bathtub to soak the hands and feet.

[0049] At the same time, a Chinese medicine composition for preventing and treating tumor-related numbness and pain in the hands and feet prepared with the Chinese medicine composition provided by the present invention as an active ingredient also falls within the protection scope of the present invention.

[0050] The efficacy and pharmacological effects of the Chinese medicinal materials used in the present invention are as follows:

[0051] Astragalus is the root of Astragalus mongolica or Astragalus membranaceus, which belongs to the genus Astragalus in the leguminous family. It has the effects of strengthening the spleen and replenishing the middle, raising yang and lifting the sunken, benefiting the defense and consolidating the exterior, promoting diuresis, and expelling toxins and promoting tissue regeneration. It is used to treat spleen qi deficiency syndrome, lung qi deficiency syndrome, qi deficiency and spontaneous sweating syndrome, qi and blood deficiency, sores that are difficult to heal, or sores that are difficult to heal for a long time. Modern pharmacology shows that Astragalus mainly contains polysaccharides, saponins, flavonoids, amino acids, trace elements, sterols and other ingredients, which can regulate blood sugar, anti-fibrosis, anti-oxidative stress, anti-tumor, protect the myocardium, enhance immune function, and anti-virus.

[0052] Cassia twig is the dried young branch of cinnamon bark, a plant of Lauraceae family. It has the effects of inducing sweat and relieving exterior symptoms, dispelling cold and relieving pain, promoting yang and transforming qi. It is used to treat colds, various pain symptoms caused by cold and blood stasis, phlegm and fluid retention, water retention, palpitations, etc. Modern pharmacology shows that cassia twig mainly contains volatile oils, cinnamon acid, coumarins and other ingredients, which can calm the nerves, regulate body temperature bidirectionally, fight allergies, regulate immunity, inhibit inflammation, resist oxidation, fight viruses, protect the kidneys, dilate blood vessels, and fight tumors.

[0053] White peony root is the dried root of the Ranunculaceae plant Paeonia lactiflora. It has the effects of nourishing blood and softening the liver, relieving pain, astringing yin and reducing sweat. It is used to treat chest, abdominal and flank pain, diarrhea and abdominal pain, spontaneous sweating and night sweats, yin deficiency fever, irregular menstruation, metrorrhagia, leukorrhea, etc. Modern pharmacology shows that white peony mainly contains monoterpenes and their glycosides, triterpenes and their glycosides, flavonoids, tannins and other ingredients, which can relieve pain, anti-inflammatory, anti-depression, protect the liver, regulate immunity, etc.

[0054] Bombyx batryticatus is the dried body of the 4th to 5th instar larvae of the silkworm family Bombyx mori that are infected (or artificially inoculated) with Beauveria bassiana and killed. It has the effects of dispelling wind and calming the nerves, resolving phlegm and dispersing knots. It is used to treat liver wind with phlegm, convulsions, acute convulsions in children, tetanus, stroke and oral cavity. , wind-heat headache, red eyes and sore throat, urticaria and itching, rash and mumps, etc. Modern pharmacology shows that silkworm pupa mainly contains chemical components such as polypeptides, amino acids, nucleosides, enzymes, flavonoids, etc., which can be anticoagulant, anticonvulsant, sedative and hypnotic, and can also be anti-tumor, lower blood sugar and lipids, and protect nerves.

[0055] Polygonum multiflorum is the dried rhizome of Polygonum multiflorum of the Polygonaceae family. It has the effects of clearing away heat and detoxifying, reducing swelling and stopping bleeding. It is used to treat dysentery, hot diarrhea, lung heat cough, carbuncle, scrofula, mouth sores, blood heat vomiting and bleeding, hemorrhoid bleeding, snake and insect bites, etc. Modern pharmacology shows that Polygonum multiflorum mainly contains volatile oils, organic acids and phenols, flavonoids, glycosides, terpenes, steroidal saponins, phenylpropanoids, alkaloids and other chemical components, which can regulate immunity, protect cardiovascular and cerebrovascular, resist pathogenic microorganisms, anti-tumor, anti-oxidation, anti-inflammatory, and liver protection.

[0056] Turmeric is the dried rhizome of the ginger plant Curcuma longa. It has the effects of breaking blood and promoting qi, unblocking menstruation and relieving pain. It is used to treat blood stasis, amenorrhea, abdominal pain during menstruation, stabbing pain in the chest and ribs, rheumatic pain, shoulder and arm pain, and injuries from falls. Modern pharmacology shows that turmeric mainly contains chemical components such as curcumol, curdione, curcumone, β-oleene, etc., which can lower blood lipids, anti-inflammatory, choleretic, antioxidant, and liver protection.

[0057] Clematis is the dried root and rhizome of the Ranunculaceae plant Clematis. It has the effects of removing rheumatism and unblocking meridians, and is used to treat rheumatic pain, limb numbness, tendon spasm, and difficulty in flexion and extension. Modern pharmacology shows that Clematis mainly contains saponins, flavonoids, lignans, phenols and other chemical components, which can be anti-inflammatory and analgesic, protect cartilage, protect the liver, fight tumors, have antibacterial and antimicrobial effects, and lower blood sugar.

[0058] The above Chinese medicinal materials constitute this Chinese medicine composition for preventing and treating tumor-related numbness and pain in the hands and feet. The astragalus in the prescription is sweet, warm and nourishing, and has the functions of nourishing qi and raising yang, removing stagnation and relieving numbness, and is the main medicine for detoxification and consolidating the exterior. Cinnamon twig is pungent, dispersing, warming and unblocking, and has the functions of warming and unblocking the meridians, assisting yang and transforming qi. It can dispel wind and cold, warm the meridians and relieve numbness. When used in combination with astragalus, it can invigorate qi and warm yang, harmonize blood and dredge the meridians. Cinnamon twig with astragalus can invigorate qi and invigorate the yang, and astragalus with cinnamon twig can consolidate the exterior without retaining evil; white peony root nourishes blood and harmonizes the blood and relieves blood stasis. Cinnamon twig is used in combination to regulate the Ying and Wei, and to harmonize the exterior and interior. The two herbs are together the assistant herbs. Bombyx batryticatus is used as an adjuvant to resolve phlegm, dissipate stagnation, resolve toxins, dispel wind, stop spasms and dredge the meridians: Quan Shen clears away heat, detoxifies, reduces swelling and stops bleeding; Turmeric slice invigorates blood, promotes qi circulation, dredges the meridians and relieves pain; these three are together the assistant herbs. Clematis chinensis dispels wind and dampness, dredges the meridians and relieves pain, and leads all the herbs into the meridians, so it is the guiding herb. The whole formula is used together to eliminate evil toxins, replenish qi and blood, warm the meridians, unblock blood stasis, and relieve arthralgia and pain, and together they have the effects of invigorating qi and warming yang, resolving blood stasis and dredging the meridians, resolving toxins, dissipating stagnation, and relieving arthralgia and pain.

[0059] Function: Tonify Qi and warm Yang, resolve blood stasis and dredge meridians, detoxify and resolve stagnation, relieve numbness and relieve pain.

[0060] Indications: Tumor-related numbness and / or pain in the hands and feet, accompanied by difficulty in flexing and extending the hands and feet, fatigue, shortness of breath, listlessness, dizziness, pale complexion, chills and cold limbs, frequent urination at night, edema of the lower limbs, pale tongue, thin white or greasy white fur, weak or deep and fine pulse or accompanied by weak radial pulse; or tingling in the hands and feet, pain in a certain place, fixed and resistant to pressure, blood stasis in the veins (such as purple and dark lips, gums, and nails), subcutaneous ecchymosis, skin and nails, purple and dark tongue or with ecchymosis and petechiae, coarse and dilated tongue and pulse, astringent pulse, absent pulse, or deep and slow pulse.

[0061] The beneficial effects of the present invention are that the present invention has the following advantages:

[0062] (1) Preventing numbness and pain in the hands and feet: Traditional Chinese medicine classifies numbness and pain in the hands and feet into the categories of "numbness" and "arthralgia". There are theories such as "qi deficiency cannot guide blood to nourish the tendons and veins, causing numbness; blood deficiency cannot nourish the tendons and muscles, resulting in stagnation of the meridians and numbness". There are theories such as "yang deficiency leads to external cold" and "blood stagnation in the skin leads to arthralgia". It is believed that the deficiency of qi, blood and yang is the root cause, and blood stasis is the symptom, which runs through the occurrence and development of numbness and pain in the hands and feet. In addition, the kidney contains the original yin and original yang, which is the innate foundation. If the kidney water is deficient, the water will not contain wood and will disturb the tendons and veins; if the kidney yang is deficient, it will not warm the middle jiao, and the spleen and stomach will be out of balance, the limbs will not be nourished; the liver is the root cause of exhaustion. If the liver blood is deficient, the blood will not nourish the tendons, resulting in numbness and pain in the limbs. Therefore, if cancer patients take the present invention before numbness and pain in the hands and feet, it will help "prevent it before it happens", which is also in line with the traditional Chinese medicine idea of ​​"treating the disease before it occurs".

[0063] (2) Significant and lasting therapeutic effect: The clinical practice of the present invention shows that the Chinese medicine composition, whether taken orally or applied externally, can improve the symptoms of numbness and pain in the hands and feet of tumor patients, with a rapid onset of action, lasting effect, and relatively small side effects.

[0064] (3) Improving the quality of life: Patients with tumor-related numbness and pain in the hands and feet often feel numbness, weakness and pain in the hands and feet, which leads to a decline in their ability to take care of themselves, seriously affecting their quality of life and placing a huge burden on their physical and even psychological aspects. This makes it impossible for the cancer treatment of the patients to proceed normally and effectively, affecting their prognosis. When treating patients with numbness and pain in the hands and feet after tumor and related treatments, the present invention can be used in conjunction with the present invention to improve the effectiveness of non-drug or drug therapies, improve the quality of life of patients, and improve their prognosis.

[0065] (4) Combined with Western medicine treatment: The present invention has the effect of strengthening the body's resistance and eliminating evil to fight cancer. Clinically, it has been shown that when combined with surgical treatment, radiotherapy, chemotherapy, targeted therapy, and immunotherapy, it can prevent and relieve patients' numbness and pain in their hands and feet, improve their quality of life, and reduce the adverse reactions of Western medicine treatment, thereby enhancing the clinical treatment effect and improving patients' prognosis.

[0066] (5) Small side effects: Currently commonly used drugs all have certain adverse reactions. For example, glutathione can cause oral discomfort such as oral leukoplakia, ulcers, tongue peeling and pain; gabapentin can cause drowsiness, dizziness, movement disorders, nausea and vomiting; duloxetine can cause adverse reactions such as increased blood pressure, decreased heart rate, insomnia, headache, nausea, diarrhea, etc. One of the advantages of the present invention in improving numbness and pain in the hands and feet is that the adverse reactions are relatively small.

[0067] The innovation of the present invention lies in that, compared with other Chinese medicine compositions for treating numbness and pain in hands and feet, the present invention has the following differences and innovations:

[0068] (1) The combination of the drugs of the present invention can replenish qi and blood, remove evil toxins, warm the meridians, remove blood stasis, and relieve pain. It can both strengthen the body and remove evil, replenish qi and blood, assist yang and transform qi, remove blood stasis and dredge collaterals, relieve pain, and detoxify and fight cancer. The whole prescription strengthens the body without leaving evil, and removes evil without hurting the body. While relieving the numbness and pain in the hands and feet of patients, it also treats cancer itself, and has good clinical efficacy;

[0069] (2) The present invention can quickly, significantly and lastingly relieve symptoms of patients with tumor-related numbness and pain in the hands and feet. Clinical studies and practices have shown that it can also improve TCM syndromes and improve the quality of life, thereby improving the clinical treatment effect of patients with numbness and pain in the hands and feet without adverse reactions. When combined with Western medicine treatment, such as surgery, radiotherapy, chemotherapy, targeted therapy or immunotherapy, it can prevent or relieve patients' numbness and pain in the hands and feet, improve patients' quality of life, reduce adverse reactions of Western medicine treatment, and have a synergistic enhancement effect.

[0070] In summary, the Chinese medicine composition has a definite therapeutic effect in preventing and treating patients with tumor-related numbness and pain in the hands and feet, and has a synergistic and enhancing effect with Western medicine treatment. It can relieve symptoms, improve Chinese medicine syndromes, improve the quality of life, and improve the prognosis of patients without obvious adverse reactions. It is worthy of development and clinical promotion. DETAILED DESCRIPTION

[0071] The Chinese medicine composition of the present invention is further described below in conjunction with specific examples so that those skilled in the art can better understand the present invention, but the present invention is not limited thereby.

[0072] Each Chinese medicinal material used in the following examples was identified before feeding, and the actual substance of each medicinal material was consistent with the name.

[0073] Example 1: Preparation of a Chinese medicine decoction for preventing and treating tumors and related treatments for numbness and pain in the foot

[0074] The composition comprises the following components in parts by weight: 15 parts of astragalus, 10 parts of cassia twig, 10 parts of white peony root, 10 parts of white bombyx batryticatus, 10 parts of polygonum multiflorum, 10 parts of turmeric slices, and 10 parts of clematis root

[0075] According to the prescription, take 75g of the above twelve medicinal materials, add 750ml of water and soak for half an hour after mixing, then add 750ml of water to all the medicinal materials and boil for 40 minutes.

[0076] The medicinal liquid obtained after decoction is filtered to obtain a filtrate and a filter residue, and the first decoction is completed. Take out the filter residue, add water and decoct for 25 minutes again, filter the medicinal liquid obtained after decoction to obtain a filtrate and a filter residue, and the second decoction is completed.

[0077] The filtrate obtained from the first decoction is mixed with the filtrate obtained from the second decoction to obtain the water decoction 1 of the traditional Chinese medicine composition.

[0078] Example 2: Preparation of a Chinese medicine composition decoction 2 for preventing and treating tumors and related numbness and pain in hands and feet after treatment.

[0079] The composition comprises the following components in parts by weight: 10 parts of astragalus, 5 parts of cassia twig, 5 parts of white peony root, 5 parts of white bombyx batryticatus, 5 parts of polygonum multiflorum, 5 parts of turmeric slices, and 5 parts of clematis root

[0080] According to the prescription, take 40g of the above twelve medicinal materials, mix them, add water and boil them three times. The first time, add 400ml of water and boil for 1 hour, the second time, add 200ml of water and boil for 1 hour, and the third time, add 200ml of water and boil for 0.5 hour.

[0081] The obtained drug solution was concentrated under reduced pressure to a relative density of 1.1-1.15 at 60°C, refrigerated, and allowed to stand for 24 hours.

[0082] Filter to obtain the filtrate, add water to 500 ml, fill and sterilize to obtain the Chinese medicine composition water decoction 2.

[0083] Example 3: Preparation of a Chinese medicine decoction for preventing and treating tumors and related post-treatment numbness and pain in hands and feet

[0084] The composition comprises the following components in parts by weight: 30 parts of astragalus, 15 parts of cassia twig, 15 parts of white peony root, 15 parts of white bombyx batryticatus, 15 parts of polygonum multiflorum, 15 parts of turmeric slices and 15 parts of clematis.

[0085] ]According to the prescription, take a total of 120g of the above twelve medicinal materials, mix them, add 1800ml of water and soak for half an hour, then add 1800ml of water to all the medicinal materials and boil for 40 minutes.

[0086] The medicinal liquid obtained after decoction is filtered to obtain a filtrate and a filter residue, and the first decoction is completed. Take out the filter residue, add water and decoct for 25 minutes again, filter the medicinal liquid obtained after decoction to obtain a filtrate and a filter residue, and the second decoction is completed.

[0087] The filtrate obtained by the first decoction is mixed with the filtrate obtained by the second decoction to obtain the Chinese medicine composition decoction 3. The Chinese medicine composition decoction 3 is only suitable for external use and should be diluted to 1000 ml with warm water when used.

[0088] Example 4: Preparation of a Chinese medicine decoction for preventing and treating tumors and related post-treatment numbness and pain in hands and feet

[0089] The composition comprises the following components in parts by weight: 60 parts of astragalus, 20 parts of cassia twig, 20 parts of white peony root, 30 parts of white bombyx batryticatus, 25 parts of polygonum multiflorum, 25 parts of turmeric slices, and 30 parts of clematis root

[0090] According to the prescription, a total of 20 g of the above twelve medicinal materials were taken, mixed, and decocted three times with water. The first time, 4200 ml of water was added and decocted for 1 hour, the second time, 2100 ml of water was added and decocted for 1 hour, and the third time, 2100 ml of water was added and decocted for 0.5 hour.

[0091] The obtained liquid medicine was concentrated under reduced pressure to a relative density of 1.1-1.15 at 60°C, refrigerated, and allowed to stand for 24 hours.

[0092] Filter to obtain the filtrate, add water to 500 ml, fill and sterilize to obtain the Chinese medicine composition decoction 4. The Chinese medicine composition decoction 4 is only suitable for external use and should be diluted to 1000 ml with warm water when used.

[0093] Example 5: Preparation of a Chinese medicine composition granule for preventing and treating tumors and related numbness and pain in hands and feet after treatment 1

[0094] The composition comprises the following components in parts by weight: 15 parts of astragalus, 10 parts of cassia twig, 10 parts of white peony root, 10 parts of white bombyx batryticatus, 10 parts of polygonum multiflorum, 10 parts of turmeric slices, and 10 parts of clematis root

[0095] According to the prescription, a total of 75g of the above twelve medicinal materials were measured and mixed, and then 750ml of water was added to soak for 30 minutes. 750ml of water was added for the first time and decocted for 1.5 hours. 600ml of water was added for the second and third times and decocted for 1.5 hours. The filtrates obtained from the three filtrations were combined and filtered through 200 mesh to obtain the filtrate. Concentrate under a vacuum degree of -0.06 to -0.08MPa and a temperature of 70-80°C to a relative density of 1.20-1.25 (50°C) to obtain a clear paste.

[0096] A one-step granulation method is adopted, with dextrin and mannitol in a ratio of 8:1 as the base material, and the clear paste is sprayed in to obtain granules. After packaging, the Chinese medicine composition granules 1 are obtained, which can be taken with hot water when used.

[0097] Example 6: Preparation of a Chinese medicine composition granule for preventing and treating tumors and related numbness and pain in hands and feet after treatment 2

[0098] The composition comprises the following components in parts by weight: 10 parts of astragalus, 5 parts of cassia twig, 5 parts of white peony root, 5 parts of white bombyx batryticatus, 5 parts of polygonum multiflorum, 5 parts of turmeric slices, and 5 parts of clematis root

[0099] According to the prescription, a total of 40g of the above twelve medicinal materials were measured, mixed, and then soaked in 200ml of water for 30 minutes. Add 400ml of water for the first time and boil for 1.5 hours. Add 320ml of water for the second and third times and boil for 1.5 hours. Combine the filtrates obtained by the three filtrations, and filter through 200 mesh to obtain the filtrate. Concentrate under a vacuum degree of -0.06 to -0.08MPa and a temperature of 70-80°C to a relative density of 1.20-1.25 (50°C) to obtain a clear paste.

[0100] A one-step granulation method is adopted, with dextrin and mannitol in a ratio of 8:1 as the base material, and the clear paste is sprayed in to obtain granules. After packaging, the Chinese medicine composition granules 2 are obtained, which can be taken with hot water when used.

[0101] Example 7: Preparation of a Chinese medicine composition granule for preventing and treating tumors and related numbness and pain in hands and feet after treatment 3

[0102] The composition comprises the following components in parts by weight: 30 parts of astragalus, 15 parts of cassia twig, 15 parts of white peony root, 15 parts of white bombyx batryticatus, 15 parts of polygonum multiflorum, 15 parts of turmeric slices, and 15 parts of clematis root

[0103] According to the prescription, take 120g of the above twelve medicinal materials, add 1200ml of water and soak for 30 minutes after mixing. Add 1200ml of water for the first time and boil for 1.5 hours, add 960ml of water for the second and third times and boil for 1.5 hours. Combine the filtrates obtained by the three filtrations, filter through 200 mesh to obtain the filtrate. Concentrate at a vacuum degree of -0.06 to -0.08MPa and a temperature of 70-80℃ to a relative density of 1.20-1.25 (50℃) to obtain a clear paste.

[0104] A one-step granulation method is adopted, with dextrin and mannitol in a ratio of 8:1 as the base material, and the clear paste is sprayed in to obtain granules. After packaging, the Chinese medicine composition granules 3 are obtained. The Chinese medicine composition granules 3 are only suitable for external use and should be diluted to 1000 ml with warm water when used.

[0105] Example 8: Preparation of a Chinese medicine composition granule for preventing and treating tumors and related numbness and pain in hands and feet after treatment 4

[0106] The composition comprises the following components in parts by weight: 15 parts of astragalus, 10 parts of cassia twig, 10 parts of white peony root, 10 parts of white bombyx batryticatus, 10 parts of polygonum multiflorum, 10 parts of turmeric slices, 10 parts of clematis root

[0107] Weigh the Chinese medicine formula granules of each medicinal material corresponding to the above-mentioned prescription amount of each medicinal material according to the prescription amount, that is, take the following weight of Chinese medicine formula granules:

[0108] Astragalus 15g, cinnamon twig 10g, white peony root 10g, white silkworm 10g, polygonum multiflorum 10g, turmeric 10g, clematis 10g

[0109] The above Chinese medicine formula granules are directly mixed to obtain Chinese medicine composition granules 4, which can be taken with hot water when used.

[0110] Example 9: Preparation of a Chinese medicine composition granule for preventing and treating tumors and related numbness and pain in hands and feet after treatment

[0111] The composition comprises the following components in parts by weight: 60 parts of astragalus, 20 parts of cassia twig, 20 parts of white peony root, 30 parts of white bombyx batryticatus, 25 parts of polygonum multiflorum, 25 parts of turmeric slices, and 30 parts of clematis root

[0112] Weigh the Chinese medicine formula granules of each medicinal material corresponding to the above-mentioned prescription amount of each medicinal material according to the prescription amount, that is, take the following weight of Chinese medicine formula granules:

[0113] Astragalus 60g, cinnamon twig 20g, white peony root 20g, white silkworm 30g, polygonum multiflorum 25g, turmeric 25g, clematis 30g

[0114] The above-mentioned Chinese medicine formula granules are directly mixed to obtain Chinese medicine composition granules 5. The Chinese medicine composition granules 5 are only suitable for external use and should be diluted to 1000 ml with warm water when used.

[0115] Example 10: Typical Case

[0116] Typical Case 1

[0117] Li, female, 68 years old, had right breast cancer surgery for more than 4 years, lung metastasis for more than 2 years, and numbness and pain in the hands and feet for 2 days. The patient underwent modified radical mastectomy for right breast cancer on March 9, 2019, and postoperative pathology indicated triple-negative breast cancer. After surgery, she underwent 6 cycles of adjuvant TAC regimen (docetaxel + doxorubicin + cyclophosphamide) combined with 25 radiotherapy sessions. PET-CT on June 25, 2020 showed: lung metastasis, pleural metastasis, multiple lymph node metastases in the mediastinum, right hilum, and parasternal. On August 8, 2020, she started first-line gemcitabine + cisplatin chemotherapy. After 4 cycles, the patient developed numbness and pain in the hands and feet, accompanied by fatigue, chills and cold limbs, pale tongue with white fur, and weak pulse. The symptoms did not improve or disappear after stopping the medication, and did not affect daily life. The symptom classification was II, and the KPS score was 80 points.

[0118] Take the decoction of Example 1 for one course of treatment, i.e. 1 dose per day, divided into morning and evening, for 14 days, and advise the patient to apply the resulting filter residue to the numb and painful area. After 14 days, the symptoms improved, the condition was relieved, the symptom classification was grade I, and the KPS score was 85 points. The follow-up visit continued with the front consolidation treatment for 14 days, and the symptom classification was grade 0, and the KPS score was 90 points.

[0119] The patient had breast cancer surgery for more than 4 years and lung metastasis for more than 2 years. After 4 cycles of chemotherapy, she developed numbness and pain in her hands and feet, accompanied by fatigue, fear of cold and cold limbs. Combined with the pale tongue with white fur and weak pulse, it was a sign of insufficient Yang Qi and blocked meridians. Since cold chemotherapy drugs damage Yang Qi, Yin cannot be produced if Yang is damaged, Qi and blood lose their nourishment, and the residual cold toxins are easy to accumulate, blocking the extremities and meridians, resulting in numbness and pain in the hands and feet after chemotherapy. Insufficient Yang Qi promotes the inability to transport and transform, leading to phlegm and blood stasis, blocking blood vessels, and losing nourishment to the limbs. If the limbs are not nourished, they will be painful and numb. Therefore, Astragalus and cinnamon twigs are used to invigorate Qi and warm Yang, warm and dredge the meridians, white peony root nourishes blood and harmonizes the Ying, and cinnamon twigs can regulate Ying and Wei, and harmonize the exterior and interior. Insufficient Yang Qi causes poor blood circulation, and pain occurs when the meridians are blocked and blocked. Therefore, Quan Shen and Turmeric are used to remove blood stasis and promote Qi circulation, while Bombyx Batryticatus and Clematis are used to dredge the meridians and relieve pain.

[0120] Typical Case 2

[0121] Lin, male, 69 years old, had lung adenocarcinoma for more than 2 months and numbness and pain in hands and feet for 5 days. On August 13, 2021, due to repeated coughing, he went to the local hospital for a CT scan, which showed "right middle lobe mass". In October 2021, he underwent lung puncture at the local hospital, and the pathological report was "lung adenocarcinoma". Genetic testing indicated EGFR gene mutation, and he was given gefitinib 250 mg / d targeted treatment. One week later, the patient developed numbness and tingling in the hands and feet, and the symptoms did not improve after discontinuation of gefitinib. At present, numbness and tingling in the hands and feet are seen, the pain is fixed, fixed, and refuses to be pressed, accompanied by difficulty in flexion and extension of the hands and feet, mental depression, purple tongue, and thin and wiry pulse. The symptoms have affected daily life, the symptom classification is level III, and the KPS score is 70 points.

[0122] Take 3 granules of Example 7 for one course of treatment, i.e. 1 dose per day, dilute to 1000 ml with warm water when using, put into a constant temperature foot bath and soak hands and feet for half an hour each for 14 days. After 14 days, the symptoms improved, the condition was relieved, the symptom classification was level I, and the KPS score was 80 points. The follow-up visit continued with the previous consolidation treatment for 14 days.

[0123] The patient developed symptoms such as numbness and tingling in the hands and feet, and difficulty in flexion and extension one week after targeted treatment for lung cancer. Combined with the tongue and pulse manifestations, it is a sign of deficiency of vital energy, blood stasis, and toxic evil obstruction. The patient is an elderly male who has not been properly cared for and has insufficient vital energy. He is also attacked by cancer toxins. Gefitinib is a hot and toxic drug, which further aggravates the patient's vital energy deficiency, causing toxic evil to block the meridians and blood circulation, resulting in the above symptoms. Therefore, large doses of Astragalus membranaceus are used to replenish qi and raise yang, relieve stagnation and relieve numbness, cinnamon twigs are used to assist yang and transform qi, white peony root is used to nourish blood and nourish the body to relieve pain, Bombyx batryticatus, Clematis chinensis, Polygonum multiflorum, and Curcuma longa are used to remove stasis and detoxify, and to dredge the meridians and relieve pain. Combined with the patient's age and the severity of the symptoms, Chinese medicine is used externally to directly reach the affected area and reduce the burden on the patient's liver and kidneys.

[0124] Typical Case 3

[0125] Ding, female, 44 years old, had numbness and pain in her hands and feet for 1 week. On June 12, 2021, she went to the local hospital for treatment due to abdominal discomfort. Ultrasound and CT examinations showed a high possibility of colorectal cancer. She underwent pancreaticoduodenectomy on June 20, 2021. Histopathological examination indicated moderate to poorly differentiated adenocarcinoma (duodenal papillary mucosa). Regular follow-up after surgery, liver metastasis was found in October 2022, and FOLFIRI regimen (fluorouracil + calcium folinate + irinotecan) chemotherapy was started. Numbness and pain in the hands and feet appeared during the fourth cycle of chemotherapy, and the symptoms gradually worsened. At present, the hands and feet are numb and heavy, painful, and difficult to flex and extend, fatigue, shortness of breath, laziness, cold skin, partial preference for warmth and aversion to cold, aggravated by cold, frequent urination at night, 2-3 times a day, pale tongue, thin white fur, deep and thin pulse with weak radial pulse. The symptoms have affected daily life, the symptom classification is level III, and the KPS score is 70 points.

[0126] A course of treatment of 4 decoctions of Example 4 was given, i.e. 1 dose per day. When used, it was diluted to 1000 ml with warm water, and the hands and feet were soaked in a constant temperature foot bath for half an hour each, for 14 days. After 14 days, the symptoms improved. The condition was relieved, the symptom classification was grade II, and the KPS score was 80 points. The patient was given 1 granule of Example 5 for oral administration for 14 days in a follow-up visit.

[0127] The patient had duodenal papillary carcinoma surgery and 4 cycles of chemotherapy for liver metastasis. She developed symptoms such as numbness, heaviness, pain, and difficulty in flexion and extension of the hands and feet. Combined with the tongue and pulse manifestations, it was a sign of Yang Qi deficiency and meridian obstruction. The patient already had cancer. In addition, after multiple chemotherapy sessions, her vital energy was damaged. The accumulated drug toxicity took advantage of the weakness and sunken her body, depleting her Yang Qi. Wind, cold and dampness took advantage of the emptiness of the human body's defensive surface to enter and invade the meridians on the surface of the muscles, obstructing the flow of Qi and blood, resulting in heaviness, numbness, pain, and difficulty in flexion and extension of the hands and feet. Astragalus, cinnamon twig, and white peony root were used to dispel cold and relieve pain, warm the meridians and dredge the collaterals. Bombyx batryticatus, Clematis chinensis, and turmeric were used to dispel wind and dampness, dredge the collaterals and relieve pain. Quan Shen was used to clear heat, detoxify, and reduce swelling. External washing was used to apply the drug externally so that the drug effect could reach the affected area directly. Continuous heat stimulation with warm water could improve the efficacy and significantly relieve the symptoms. After the symptoms were slightly relieved, combined with the patient's age and the tumor's own factors, the external prescription was changed to an internal prescription to treat both the symptoms and the root cause.

[0128] Typical Case 4

[0129] Liu, female, 78 years old, had bone metastasis of squamous cell lung cancer for more than 3 months, and after 3 cycles of chemotherapy combined with immunotherapy. In December 2020, she had a CT scan at a local hospital due to coughing for more than half a year, which suggested the possibility of lung cancer. After lung puncture, she was diagnosed with left central lung cancer with bilateral hilar lymph node metastasis. PET-CT showed that bone metastasis could not be ruled out. Pathology showed spindle cell squamous cell carcinoma, and immunotherapy combined with chemotherapy was given. The treatment plan was tislelizumab injection (trade name: BeiGene) 200mg + paclitaxel liposome 270mg + cardiotonic. Platinum 700mg / 600mg, no obvious discomfort after 1 cycle of treatment, the treatment process went smoothly; after 3 cycles, numbness, tingling, weakness in hands and feet, weakened deep reflexes, affecting normal life, considering suspending immunotherapy and monitoring symptoms. At present, numbness and pain in hands and feet, difficulty in flexion and extension, cold extremities, shortness of breath, laziness, mental depression, pale complexion, fear of cold and cold limbs, edema of lower limbs, preference for hot drinks, clear and long urine, loose stools, dull tongue with thin white fur, coarse and dilated tongue and pulse, deep, fine and astringent pulse. The symptom classification is grade III, and the KPS score is 70 points.

[0130] Take 5 granules of Example 9 for one course of treatment, i.e. 1 dose per day, dilute to 1000 ml with warm water when using, put into a constant temperature foot bath bucket and soak hands and feet for half an hour each, for 14 days. After 14 days, the symptoms improved, the condition was relieved, the symptom classification was level I, and the KPS score was 80 points. The patient was given decoction 2 of Example 2 for consolidation treatment for 14 days.

[0131] The patient is old and weak, with deficiency of vital energy and insufficient yang energy. Yang deficiency leads to inability to transport and transform. "The meridians are constantly flowing and circulate endlessly. Cold enters the meridians and delays them. They cannot flow. If they are outside the meridians, there will be less blood. If they are inside the meridians, there will be obstructed qi." Then there will be tingling in the hands and feet, difficulty in flexion and extension, dark tongue, coarse and dilated tongue pulse, and deep and fine pulse. Yang deficiency leads to lack of warmth, and there will be numbness in the hands and feet, cold extremities, pale complexion, fear of cold and cold limbs, edema of the lower limbs, preference for hot drinks, and clear and long urine. Astragalus and cinnamon twigs are used to warm yang and dispel cold to treat the root cause, and silkworm and clematis are used to dredge the meridians and relieve pain to treat the symptoms. White peony root is used to nourish blood and nourish the camp to relieve pain, Quan Shen is used to detoxify, reduce swelling and relieve pain, and turmeric is used to promote qi, dredge the meridians and relieve pain. The symptoms have affected the patient's normal life and normal treatment. A large dose of external application is used to treat the symptoms. After the symptoms are quickly relieved, conventional treatment is resumed as soon as possible. Considering factors such as the patient's age, a small dose of oral medication is continued to consolidate the therapeutic effect.

[0132] Example 11: Clinical trial 1

[0133] According to literature research and surveys, 20%-60% of patients receiving targeted therapy will experience symptoms of numbness and pain in the hands and feet, which mainly occur in multi-kinase inhibitors such as sorafenib and sunitinib, which may be related to keratinocyte dysfunction and sweat gland excretion disorders. Symptoms usually occur 1-6 weeks after the start of targeted drug treatment and will go through three stages: inflammatory stage, hyperkeratosis stage and recovery stage. Studies have found that the absence of numbness and pain in the hands and feet during treatment can reduce the risk of death and improve prognosis (2-year OS rate: symptomatic vs. asymptomatic, 63% vs. 44%). On the basis of the good clinical efficacy of the Chinese medicine composition in the treatment of tumor-related numbness and pain in the hands and feet, the inventor explored the preventive treatment of cancer patients after targeted therapy with the Chinese medicine composition, evaluated whether the Chinese medicine composition can prevent the symptoms of numbness and pain in the hands and feet of cancer patients after targeted therapy, or reduce their degree, and paid attention to whether it indirectly improved the compliance of patients receiving targeted therapy.

[0134] 1. Case selection criteria

[0135] 1.1 Case inclusion criteria

[0136] ① Patients who have been diagnosed with hepatocellular carcinoma according to the diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer" (2019 edition), whose clinical stage is middle to late stage and who are unable to undergo surgery;

[0137] ② No other drugs or non-drug treatments other than sorafenib that may cause foot numbness and pain were received within 1 month before enrollment;

[0138] ③Karnofsky performance status score (KPS) ≥ 60 points, without severe heart, liver, kidney, or bone marrow dysfunction;

[0139] ④ Aged 18-80 years old, with an expected survival time of ≥ 3 months;

[0140] ⑤ Voluntarily accept the treatment of this program, have good compliance, and sign the informed consent form;

[0141] ⑥Have complete clinical data.

[0142] 1.2 Case Exclusion Criteria

[0143] ① Situations that may prevent the subject from completing the clinical trial process, including but not limited to severe, difficult-to-control organic lesions or infections, etc.:

[0144] ② Patients with numbness and pain in the hands and feet due to reasons other than tumor targeted therapy, such as existing neurological diseases, or neurological lesions caused by other systemic diseases (such as severe diabetes);

[0145] ③People with difficult-to-control mental illness or mental disorder

[0146] ④ Those who are unable to cooperate in completing the scale assessment:

[0147] ⑤ Those with a history of drug allergy;

[0148] ⑥ Subjects who the researcher believes are unable to cooperate in completing the clinical investigation.

[0149] 1.3 Case exclusion and termination criteria

[0150] ① Patients develop other serious diseases during the implementation of the study and are unable to continue the experiment;

[0151] ② Those who experience severe adverse reactions during treatment;

[0152] ③ Subjects who request or must withdraw due to various reasons;

[0153] ④ During the implementation of the study, patients received other treatments that may affect the research results for various reasons, or increased or decreased medication on their own, resulting in too high (>120%) or too low compliance (<80%).

[0154] 2. Study Design

[0155] A randomized, double-blind, placebo-controlled study was conducted. All 110 patients were randomly assigned to a control group and a treatment group at a ratio of 1:1, with 55 patients in each group.

[0156] Both groups were given sorafenib targeted therapy, i.e. oral sorafenib 800 mg / d.

[0157] The control group was treated with a placebo, and the preparation method of the placebo was: 1 / 10 dose of Example 5 Granule 1, added with dextrin. The treatment group was treated with Example 5 Granule 1. The two groups of drugs were used as follows: After dissolving the drug with hot water, add hot water to dilute to 500 ml, take it warm once in the morning and evening every day, and the course of treatment was 14 days.

[0158] 3. Observation indicators

[0159] The occurrence and severity of numbness and pain in the hands and feet were recorded in the two groups, and the cases in which patients stopped targeted treatment due to this were recorded.

[0160] Diagnostic basis for numbness and pain in hands and feet:

[0161] Paresthesia, pain, weakness, numbness, decreased deep reflexes, and slowed nerve conduction velocity.

[0162] Severity of numbness and pain in hands and feet:

[0163] According to the grading standards established by the World Health Organization (WHO) and the National Cancer Institute (NCI) of the United States: no symptoms are grade 0; loss of deep reflexes or numbness or pain that does not affect function is grade I; sensory loss or numbness or pain that affects function but does not affect daily living activities is grade II; sensory loss or numbness or pain that affects daily living activities is grade III; long-term sensory loss or pain that affects function is grade IV.

[0164] 4. Results

[0165] In terms of the occurrence of numbness and pain in the hands and feet: 19 cases in the control group were normal, 36 cases had numbness and pain in the hands and feet, and the incidence rate was 65.45%; 37 cases in the treatment group were normal, 18 cases had numbness and pain in the hands and feet, and the incidence rate was 32.73%. The difference between the two groups was statistically significant (P < 0.05);

[0166] Regarding the severity of numbness and pain in the hands and feet: 17 cases in the control group were grade I (30.91%), and 14 cases in the treatment group were grade I (25.45%), with no significant difference between the two groups (P>0.05); 13 cases in the control group were grade II (23.63%), and 4 cases in the treatment group were grade II (7.27%), with a significant difference between the two groups (P<0.05); 6 cases in the control group were grade III (10.91%), and 0 cases in the treatment group were grade III (0.0%), with a significant difference between the two groups (P<0.05); 0 cases in the control group were grade IV (0.0%), and 0 cases in the treatment group were grade IV (0.0%), with no significant difference between the two groups (P>0.05).

[0167]

[0168] Compliance with targeted therapy: 4 patients in the control group terminated the next stage of targeted therapy due to the occurrence of symptoms, while no patient in the treatment group terminated the next stage of targeted therapy due to numbness and pain in the hands and feet.

[0169] Example 12: Clinical trial 2

[0170] A randomized, double-blind, controlled clinical study has been conducted with the aim of observing the effectiveness of the Chinese medicine composition in treating tumor-related numbness and pain in the hands and feet, and evaluating whether the Chinese medicine composition can improve the symptoms of tumor-related numbness and pain in the hands and feet, reduce its severity, improve the quality of life of patients, and its safety of use.

[0171] 1. Western medicine diagnostic criteria: refer to "Neurology·Nervous System Poisoning and Metabolic Diseases" published by the People's Military Medical Publishing House and chemotherapy-induced peripheral neuropathy, hand-foot syndrome, hand-foot skin reaction, etc.:

[0172] ① The presence of at least 2 of the following symptoms: paresthesia, pain, weakness, or numbness in the extremities;

[0173] ② At least one of the following auxiliary examinations is positive: 10g nylon thread examination shows decreased or absent sensation; decreased deep reflexes; weakened or absent pain and temperature sensation; slowed nerve conduction velocity; weakened muscle strength, <grade 5; pain numerical score (NRS)>0 points.

[0174] 2. TCM diagnostic criteria: formulated with reference to "Internal Medicine of Traditional Chinese Medicine" and "Guidelines for Clinical Research of New Chinese Medicines (Trial)", syndrome differentiation can be achieved if the following two main symptoms and one or more secondary symptoms are met, as well as the tongue coating and pulse condition.

[0175] Main symptoms: numbness of hands and feet, difficulty in flexion and extension, pain in hands and feet;

[0176] Secondary symptoms: fatigue, shortness of breath, laziness, listlessness, dizziness, pale complexion, chills, cold limbs, frequent urination at night, edema of the lower limbs, or tingling in the hands and feet, immobility, refusal to be pressed, blood stasis in the veins (such as dark purple lips, gums, nails, etc.), subcutaneous ecchymoses, and skin and nail discoloration;

[0177] Tongue coating and pulse: pale tongue, thin white or greasy white coating, weak or deep and fine pulse or accompanied by weak radial pulse; or dark purple tongue or with ecchymosis or petechiae, coarse and dilated tongue and pulse, wiry pulse, absent pulse or deep and slow pulse.

[0178] 3. Case selection criteria

[0179] 31 Case inclusion criteria

[0180] ① Patients with malignant tumors confirmed by pathological histology or cytology and with clear clinical stage;

[0181] ② Meet the above-mentioned diagnostic criteria of traditional Chinese medicine and Western medicine;

[0182] ③ Aged 18-80 years, with an expected survival time of ≥ 3 months;

[0183] ④Karnofsky functional status score (KPS) ≥ 60 points, without severe heart, liver, kidney, or bone marrow dysfunction;

[0184] ⑤ Voluntarily accept the treatment of this program, have good compliance, and sign the informed consent form;

[0185] ⑥Have complete clinical data.

[0186] 3.2 Case Exclusion Criteria

[0187] ① Situations that may prevent the subject from completing the clinical trial process, including but not limited to severe, difficult-to-control organic lesions or infections;

[0188] ③ Patients with numbness and pain in the hands and feet due to reasons other than tumors or related treatments, such as existing neurological diseases, or neurological lesions caused by other systemic diseases (such as severe diabetes);

[0189] ④ Those suffering from mental illness or mental disorder that is difficult to control;

[0190] ⑤ Those who are unable to cooperate in completing the scale assessment;

[0191] ⑥ Those with skin lesions on their hands and feet or a history of drug contact allergy;

[0192] ⑦ Subjects who the researcher believes are unable to cooperate in completing the clinical investigation.

[0193] 3.3 Case exclusion and dropout criteria

[0194] ① Patients develop other serious diseases during the implementation of the study and are unable to continue the experiment;

[0195] ② Patients who experience severe adverse reactions during treatment should not continue to be observed, and the adverse reactions should be recorded;

[0196] ③ Subjects who request or must withdraw due to various reasons;

[0197] ④ During the implementation of the study, patients received other treatments that may affect the research results for various reasons, or increased or decreased medications on their own, and their compliance was too high (>120%) or too low (<80%).

[0198] For cases of dropout, researchers need to contact the patients as much as possible, fill in the reasons for dropout, complete all assessment items that can be completed, fill in the withdrawal record form, and record the time of the last Chinese medicine treatment as much as possible.

[0199] 4. Study Design

[0200] A randomized, double-blind, controlled study was used. All 72 enrolled patients were randomly assigned to a control group and a treatment group at a ratio of 1:1 according to a random number table, with 36 cases in each group. One case dropped out of the control group, and 35 cases finally completed the study.

[0201] The control group was treated with adenosylcobalamin injection, 1.5 mg each time, intramuscular injection, once a day, and 1000 ml of warm water was given at the same time. A constant temperature foot bath was used (water temperature was about 39-42°C), first soaking the hands, then soaking the feet, for 30 minutes each.

[0202] The treatment group was treated with adenosylcobalamin injection, 1.5 mg each time, intramuscular injection, once a day, and decoction 1 of Example 1 was applied at the same time, once a day, diluted with warm water to 1000 ml, and warmed in a constant temperature foot bath (water temperature of about 39-42°C), first soaking the hands, then soaking the feet, each for 30 minutes. The course of drug treatment for both groups was 14 days.

[0203] 5. Observation indicators

[0204] ① Grading of symptoms of numbness and pain in hands and feet and evaluation of efficacy: no symptoms is grade 0; deep reflex disappearance or numbness and pain, but not affecting function is grade I; sensory loss or numbness and pain, affecting function but not affecting daily life activities is grade II; sensory loss or numbness and pain, affecting daily life activities is grade III; long-term sensory loss or pain, affecting function is grade IV. The efficacy is evaluated by the nimodipine three-point method. After treatment, a decrease of 2 degrees or more compared with before treatment, or a decrease to 0 degrees is markedly effective; a decrease of 1 degree after treatment compared with before treatment is effective; no relief or aggravation of symptoms is ineffective. Total effective rate (%) = (markedly effective + effective) / total number of cases × 100%;

[0205] ② TCM syndrome scoring and efficacy evaluation: According to TCM diagnostic standards, a main symptom is scored as 0, 2, 4, or 6 points according to the severity, and a secondary symptom is scored as 0, 1, 2, or 3 points according to the severity. Clinical symptoms and signs disappear or basically disappear, and the syndrome score decreases by ≥90% for clinical recovery; clinical symptoms and signs disappear and significantly improve, and the syndrome score decreases by ≥70% for marked efficacy; clinical symptoms and signs are improved, and the syndrome score decreases by ≥30% for efficacy; clinical symptoms and signs disappear without significant improvement, or even worsen, and the syndrome score decreases by less than 30% for ineffectiveness. The calculation formula (nimodipine method) is: [(pre-treatment score - post-treatment score) ÷ pre-treatment score] × 100%;

[0206] ③Quality of life score and efficacy evaluation criteria: The quality of life (QOL) score table for cancer patients is used to quantify the score, ranging from 1 to 5 points, with a full score of 60 points: <20 points for extremely poor quality of life; 21-30 points for poor quality of life; 31-40 points for average quality of life; 41-50 points for good quality of life; 51-60 points for good quality of life. An increase of 10 points or more in the quality of life score before and after treatment is considered an improvement; an increase or decrease of less than 10 points in the quality of life score before and after treatment is considered stable; a decrease of 10 points or more in the quality of life score before and after treatment is considered a decrease;

[0207] ④ Safety observation: Before treatment and after the treatment course, blood routine, urine routine, stool routine, liver and kidney function were checked respectively, and skin toxicity was evaluated. Skin toxicity refers to skin keratinization, hypertrophy, pigmentation, rash, nail changes, hair loss, exudative skin disorders, etc. The classification refers to the following standards: normal, normal / standard range, none is level 0; mild / mild toxicity is level 1; moderate / moderate toxicity is level 2; severe / severe toxicity is level 3; life-threatening or immobile toxicity is level 4; death from toxicity (with causal relationship) is level 5.

[0208] 6. Results

[0209] In terms of symptoms of numbness and pain in hands and feet: there was no significant difference in the grading of numbness and pain in hands and feet between the two groups before treatment (P>0.05); after treatment, 10 cases in the control group were ineffective, 23 cases were effective, and 2 cases were markedly effective, with a total effective rate of 71.43%; 3 cases in the treatment group were ineffective, 25 cases were effective, and 8 cases were markedly effective, with a total effective rate of 91.67%, with a significant statistical difference between the two groups, P<0.05;

[0210]

[0211] In terms of TCM syndrome efficacy: there was no significant difference in TCM syndrome scores between the two groups before treatment (P>0.05); after treatment, 14 cases in the control group were ineffective, 18 cases were effective, 3 cases were markedly effective, and 0 cases were cured, with a total effective rate of 60.00%; 6 cases in the treatment group were ineffective, 17 cases were effective, 11 cases were markedly effective, and 2 cases were cured, with a total effective rate of 83.33%, with a significant statistical difference between the two groups (P<0.05);

[0212]

[0213] Regarding the quality of life score: there was no significant difference in the quality of life score between the two groups before treatment (P>0.05); after treatment, 5 cases in the control group decreased, while 0 cases in the treatment group decreased, with a significant statistical difference between the two groups (P<0.05); 13 cases in the control group were stable, while 4 cases in the treatment group were stable, with a significant statistical difference between the two groups (P<0.05); 17 cases in the control group improved, with a total effective rate of 48.57%, while 32 cases in the treatment group improved, with a total effective rate of 88.89%, with a significant statistical difference between the two groups (P<0.05);

[0214]

[0215] Safety: During the treatment with the present invention, 36 patients in the treatment group showed no skin allergy or skin toxicity symptoms, and no adverse reactions occurred in any patient.

[0216] Conclusion: The present invention can prevent and treat tumor-related hand and foot pain symptoms, improve TCM syndromes, and improve the quality of life of patients without adverse reactions.

Claims

1. A Chinese medicine composition for preventing and treating tumor-related numbness and pain in hands and feet, characterized in that: The Chinese medicine composition can be used for oral administration or external use. The composition is composed of the following components in parts by weight: 10-60 parts of astragalus, 3-15 parts of cassia twig, 2-15 parts of white peony root, 3-12 parts of white bombyx batryticatus, 2-12 parts of polygonum multiflorum, 3-20 parts of turmeric slices, and 5-15 parts of clematis.

2. A Chinese medicine composition for preventing and treating tumor-related numbness and pain in hands and feet as claimed in claim 1, characterized in that: The Chinese medicine composition can be used for oral administration or external use. The composition is composed of the following components in parts by weight: 15-30 parts of astragalus, 5-10 parts of cassia twig, 3-12 parts of white peony root, 4-10 parts of white bombyx batryticatus, 5-10 parts of polygonum multiflorum, 5-15 parts of turmeric slices, and 6-10 parts of clematis.

3. A Chinese medicine composition for preventing and treating tumor-related numbness and pain in hands and feet as claimed in claim 1, characterized in that: The Chinese medicine composition can be used for oral administration or external use. The composition is composed of the following components in parts by weight: 15 parts of astragalus, 10 parts of cassia twig, 10 parts of white peony root, 10 parts of white bombyx batryticatus, 10 parts of polygonum multiflorum, 10 parts of turmeric slices, and 10 parts of clematis.

4. A Chinese medicine composition for preventing and treating tumor-related numbness and pain in hands and feet, characterized in that: When the Chinese medicine composition is used for external use, the composition is composed of the following components in parts by weight: 10-60 parts of astragalus, 6-30 parts of cassia twig, 5-30 parts of white peony root, 3-30 parts of white bombyx batryticatus, 5-25 parts of polygonum multiflorum, 3-25 parts of turmeric slices, and 5-30 parts of clematis.

5. A Chinese medicine composition for preventing and treating tumor-related numbness and pain in hands and feet as claimed in claim 4, characterized in that: When the Chinese medicine composition is only used for external use, the composition is composed of the following components in parts by weight: 15-35 parts of astragalus, 10-20 parts of cassia twig, 10-15 parts of white peony root, 6-20 parts of white bombyx batryticatus, 8-20 parts of polygonum multiflorum, 5-15 parts of turmeric slices, and 12-20 parts of clematis.

6. A Chinese medicine composition for preventing and treating tumor-related numbness and pain in hands and feet as claimed in claim 4, characterized in that: When the Chinese medicine composition is only used for external use, the composition is composed of the following components in parts by weight: 30 parts of astragalus, 15 parts of cassia twig, 15 parts of white peony root, 15 parts of white bombyx batryticatus, 15 parts of polygonum multiflorum, 15 parts of turmeric slices, and 15 parts of clematis.

7. Use of the Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a Chinese medicine decoction or granules for preventing and treating tumor-related numbness and pain in the hands and feet.

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