A traditional Chinese medicine composition for treating adverse reactions of anti-tumor drugs

Abstract

The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating adverse reactions of anti-tumor drugs. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 15-30 parts of buffalo horn, 10-30 parts of rehmannia root, 10-20 parts of moutan bark, 10-30 parts of red peony root, 10-20 parts of Chinese angelica, 6-15 parts of phellodendron bark, 6-15 parts of amomum fruit, 10-30 parts of honeysuckle flower, 10-30 parts of dwarf lilyturf tuber, 10-30 parts of poria cocos, 10-30 parts of bighead atractylodes rhizome, 10-30 parts of pilose asiabell root, 10-30 parts of lotus seed, 10-30 parts of Chinese yam, 10-30 parts of hyacinth bean, 10-30 parts of coix seed, 10-30 parts of smoked plum, 10-30 parts of astragalus membranaceus, 10-30 parts of dictamnus dasycarpus root bark, and 6-15 parts of liquorice root. The prescription aims to treat the adverse reactions of anti-tumor drugs by clearing heat and cooling blood to detoxify, strengthening the spleen and resolving dampness to stop diarrhea, and can effectively prevent and treat the adverse reactions caused by anti-tumor drugs.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating adverse reactions of anti-tumor drugs. Background Art

[0002] The development of tumor treatment is rapid. At present, targeted therapeutic drugs have been developed for specific molecules detected in tumors. At the same time, tumor immunotherapy has gradually shown its advantages. These targeted drugs and immune checkpoint inhibitors (ICIs) are more targeted, have better efficacy, and fewer related adverse reactions compared with traditional chemotherapy drugs. However, with the widespread clinical application of these drugs and the continuous improvement of patients' expectations for quality of life, the adverse reactions of these new drugs have received increasing attention.

[0003] During the clinical process, we found that the most common adverse reactions of targeted drugs and immune checkpoint inhibitors are all manifested as rash, diarrhea, liver damage, oral mucositis, paronychia, interstitial pneumonia, nasal bleeding, etc., with rash and mucositis being the most common. For example, the most common adverse reactions of the first-generation targeted drug representative icotinib hydrochloride tablets (Conmana) are: rash (40%), diarrhea (18.5%), elevated transaminases (8%), and oral ulcers (3.5%); the most common adverse reactions of the third-generation targeted drug representative osimertinib mesylate tablets (Tagrisso) are: diarrhea (47%), rash (45%), paronychia (33%), dry skin (32%), and oral mucositis (24%); the most common adverse reactions of the immune checkpoint inhibitor representative drug nivolumab injection are in turn: fatigue (30%), rash (17%), pruritus (13%), diarrhea (13%), and stomatitis (common). These adverse reactions will affect the efficacy and the quality of life of patients, and in severe cases, may lead to patients reducing the dosage of the drug or discontinuing treatment by themselves.

[0004] Traditional Chinese medicine has made certain progress in preventing and treating adverse reactions of targeted or immune therapy. However, most of the current traditional Chinese medicine research is aimed at a single adverse reaction, such as only targeting rash or only targeting diarrhea. There is no research on drug preparations for multiple adverse reactions. In clinical practice, drugs for treating rash mainly consist of heat-clearing, detoxifying, and cooling-blood drugs, which are likely to aggravate diarrhea; while drugs for treating diarrhea that dry dampness and strengthen the spleen may aggravate rash, and patients have no choice. This phenomenon has become a major dilemma in clinical practice. Therefore, it is urgent to develop a traditional Chinese medicine preparation that can comprehensively treat multiple adverse reactions of targeted drugs.

[0005] The adverse reactions of tumor drugs are diverse. Traditional Chinese medicine classifies the skin adverse reactions caused by drugs into the categories of "drug-induced toxic rash" and "drug rash". As early as in "Plain Questions - Discussion on the Harmony between Man and Nature", it is mentioned that "all painful and itchy sores belong to the heart (fire)". Liu Wansu said that "all dryness, astringency, withering, and peeling belong to dryness". "General Treatise on the Causes and Symptoms of Various Diseases - Head and Body Sores" believes that "the lung governs qi and manifests on the skin and hair; the spleen governs muscles. When qi is deficient, the skin pores open and are invaded by wind and dampness; when there is internal heat, the spleen qi becomes warm, and when the spleen qi is warm, heat is generated in the muscles. When dampness and heat combine, sores appear on the head, face, and body", believing that skin sores are related to fire toxin, dampness and heat, and deficiency of body fluid and dryness-heat, etc.

[0006] Diarrhea is the most common digestive system adverse reaction caused by targeted drugs, and its clinical manifestations include increased frequency of defecation, changes in the nature of feces (such as watery stools, loose stools), etc. This disease belongs to the category of "diarrhea" in traditional Chinese medicine. "Complete Works of Jingyue" states: "The root cause of diarrhea is always related to the spleen and stomach. Those with a weak spleen are prone to diarrhea due to deficiency, and due to diarrhea, they become even more deficient, because the gate is not firmly closed." "Medical Classics Essential Readings" mentions that "diarrhea cannot occur without dampness", and spleen deficiency and damp pathogen are the basic pathogenesis of diarrhea.

[0007] Oral mucositis is a common adverse reaction of EGFR inhibitors, which is prone to occur in areas such as the floor of the mouth, lips, and tongue, and pain is the main clinical symptom. Traditional Chinese medicine believes that this disease belongs to the category of "aphtha". "Essentials of Stomatology" believes that the pathogenesis of aphtha is "excessive fire in the upper jiao, deficiency-cold in the middle jiao, and yin fire in the lower jiao". "On the Theory of Heat in the Middle Caused by Diet and Fatigue in Treatise on the Spleen and Stomach" states that "the qi of the spleen and stomach declines, the vital energy is insufficient, and the heart fire is particularly strong", and the basic pathogenesis is always the flaring up of deficiency fire.

[0008] Clinically, malignant tumors in different parts of the body, such as lung cancer, nasopharyngeal carcinoma, breast cancer, colorectal cancer, gastric cancer, liver cancer, melanoma, renal cell carcinoma, Hodgkin lymphoma, various sarcomas, etc., can choose one or more of chemotherapy, targeted therapy, immunotherapy in combination. Commonly used chemotherapy drugs include cyclophosphamide, paclitaxel, vincristine, doxorubicin, platinum compounds, etc.; commonly used targeted drugs such as gefitinib, erlotinib, osimertinib, crizotinib, alectinib, etc.; commonly used immune checkpoint inhibitors such as pembrolizumab, camrelizumab, nivolumab, tislelizumab, etc. However, during the treatment with western medicine, adverse reactions of varying degrees and forms will inevitably occur, and drug resistance will eventually appear.

[0009] In summary, due to the complex pathogenesis of adverse reactions of tumor drugs, with cold and heat interlacing and deficiency and excess mingling, it is necessary to regulate both cold and heat and take into account both deficiency and excess. This formula is composed of the addition and subtraction of classic traditional Chinese medicine formulas such as Xi Jiao Di Huang Tang, Shen Ling Bai Zhu San, Feng Sui Dan, Wu Mei Wan, and Dao Chi San. Summary of the Invention

[0010] The purpose of the present invention is to overcome the deficiencies of the prior art and provide a traditional Chinese medicine composition for preventing and treating adverse reactions of tumor drugs that comprehensively considers various adverse reactions, has good curative effects, short treatment courses, and small toxic and side effects.

[0011] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating adverse reactions of anti-tumor drugs, and the traditional Chinese medicine composition is prepared from traditional Chinese medicine raw materials with the following weight ratio: 15-30 parts of buffalo horn, 10-30 parts of rehmannia root, 10-20 parts of moutan bark, 10-30 parts of red peony root, 10-20 parts of angelica sinensis, 6-15 parts of phellodendron amurense, 6-15 parts of amomum villosum, 10-30 parts of honeysuckle flower, 10-30 parts of dwarf lilyturf tuber, 10-30 parts of poria cocos, 10-30 parts of atractylodes macrocephala, 10-30 parts of codonopsis pilosula, 10-30 parts of lotus seed, 10-30 parts of Chinese yam, 10-30 parts of hyacinth bean, 10-30 parts of coix seed, 10-30 parts of smoked plum, 10-30 parts of astragalus membranaceus, 10-30 parts of dictamnus dasycarpus, and 6-15 parts of liquorice.

[0012] Preferably, the traditional Chinese medicine composition is prepared from traditional Chinese medicine raw materials with the following weight ratio: 20-30 parts of buffalo horn, 15-30 parts of rehmannia root, 12-20 parts of moutan bark, 12-30 parts of red peony root, 10-18 parts of angelica sinensis, 6-12 parts of phellodendron amurense, 6-12 parts of amomum villosum, 15-30 parts of honeysuckle flower, 12-30 parts of dwarf lilyturf tuber, 15-30 parts of poria cocos, 12-30 parts of atractylodes macrocephala, 10-25 parts of codonopsis pilosula, 15-30 parts of lotus seed, 15-30 parts of Chinese yam, 15-30 parts of hyacinth bean, 15-30 parts of coix seed, 10-25 parts of smoked plum, 10-25 parts of astragalus membranaceus, 15-30 parts of dictamnus dasycarpus, and 6-12 parts of liquorice.

[0013] Preferably, the traditional Chinese medicine composition is prepared from traditional Chinese medicine raw materials with the following weight ratio: 25-30 parts of buffalo horn, 20-30 parts of rehmannia root, 14-20 parts of moutan bark, 14-30 parts of red peony root, 10-15 parts of angelica sinensis, 6-10 parts of phellodendron amurense, 6-10 parts of amomum villosum, 15-20 parts of honeysuckle flower, 13-25 parts of dwarf lilyturf tuber, 20-30 parts of poria cocos, 15-20 parts of atractylodes macrocephala, 10-20 parts of codonopsis pilosula, 20-25 parts of lotus seed, 20-30 parts of Chinese yam, 20-30 parts of hyacinth bean, 20-30 parts of coix seed, 10-20 parts of smoked plum, 10-20 parts of astragalus membranaceus, 20-30 parts of dictamnus dasycarpus, and 6-10 parts of liquorice.

[0014] Preferably, the traditional Chinese medicine composition is prepared from traditional Chinese medicine raw materials with the following weight ratio: 30 parts of buffalo horn, 20 parts of rehmannia root, 15 parts of moutan bark, 15 parts of red peony root, 12 parts of angelica sinensis, 10 parts of phellodendron amurense, 10 parts of amomum villosum, 20 parts of honeysuckle flower, 15 parts of dwarf lilyturf tuber, 20 parts of poria cocos, 15 parts of atractylodes macrocephala, 15 parts of codonopsis pilosula, 30 parts of lotus seed, 30 parts of Chinese yam, 30 parts of hyacinth bean, 30 parts of coix seed, 15 parts of smoked plum, 15 parts of astragalus membranaceus, 15 parts of dictamnus dasycarpus, and 10 parts of liquorice.

[0015] Second aspect, the present invention provides a traditional Chinese medicine preparation for treating adverse reactions of anti-tumor drugs. The traditional Chinese medicine preparation comprises a traditional Chinese medicine composition capable of treating adverse reactions of anti-tumor drugs and pharmaceutically acceptable excipients. The traditional Chinese medicine composition is prepared from traditional Chinese medicine raw materials with the following weight part ratios: 15-30 parts of buffalo horn, 10-30 parts of rehmannia root, 10-20 parts of moutan bark, 10-30 parts of red peony root, 10-20 parts of angelica sinensis, 6-15 parts of phellodendron bark, 6-15 parts of amomum villosum, 10-30 parts of honeysuckle flower, 10-30 parts of dwarf lilyturf tuber, 10-30 parts of poria cocos, 10-30 parts of atractylodes macrocephala, 10-30 parts of codonopsis pilosula, 10-30 parts of lotus seed, 10-30 parts of Chinese yam, 10-30 parts of hyacinth bean, 10-30 parts of coix seed, 10-30 parts of smoked plum, 10-30 parts of astragalus membranaceus, 10-30 parts of dictamnus dasycarpus root bark, and 6-15 parts of liquorice root.

[0016] Preferably, the traditional Chinese medicine composition is prepared from traditional Chinese medicine raw materials with the following weight part ratios: 20-30 parts of buffalo horn, 15-30 parts of rehmannia root, 12-20 parts of moutan bark, 12-30 parts of red peony root, 10-18 parts of angelica sinensis, 6-12 parts of phellodendron bark, 6-12 parts of amomum villosum, 15-30 parts of honeysuckle flower, 12-30 parts of dwarf lilyturf tuber, 15-30 parts of poria cocos, 12-30 parts of atractylodes macrocephala, 10-25 parts of codonopsis pilosula, 15-30 parts of lotus seed, 15-30 parts of Chinese yam, 15-30 parts of hyacinth bean, 15-30 parts of coix seed, 10-25 parts of smoked plum, 10-25 parts of astragalus membranaceus, 15-30 parts of dictamnus dasycarpus root bark, and 6-12 parts of liquorice root.

[0017] Preferably, the traditional Chinese medicine composition is prepared from traditional Chinese medicine raw materials with the following weight part ratios: 25-30 parts of buffalo horn, 20-30 parts of rehmannia root, 14-20 parts of moutan bark, 14-30 parts of red peony root, 10-15 parts of angelica sinensis, 6-10 parts of phellodendron bark, 6-10 parts of amomum villosum, 15-20 parts of honeysuckle flower, 13-25 parts of dwarf lilyturf tuber, 20-30 parts of poria cocos, 15-20 parts of atractylodes macrocephala, 10-20 parts of codonopsis pilosula, 20-25 parts of lotus seed, 20-30 parts of Chinese yam, 20-30 parts of hyacinth bean, 20-30 parts of coix seed, 10-20 parts of smoked plum, 10-20 parts of astragalus membranaceus, 20-30 parts of dictamnus dasycarpus root bark, and 6-10 parts of liquorice root.

[0018] Preferably, the traditional Chinese medicine composition is prepared from traditional Chinese medicine raw materials with the following weight part ratios: 30 parts of buffalo horn, 20 parts of rehmannia root, 15 parts of moutan bark, 15 parts of red peony root, 12 parts of angelica sinensis, 10 parts of phellodendron bark, 10 parts of amomum villosum, 20 parts of honeysuckle flower, 15 parts of dwarf lilyturf tuber, 20 parts of poria cocos, 15 parts of atractylodes macrocephala, 15 parts of codonopsis pilosula, 30 parts of lotus seed, 30 parts of Chinese yam, 30 parts of hyacinth bean, 30 parts of coix seed, 15 parts of smoked plum, 15 parts of astragalus membranaceus, 15 parts of dictamnus dasycarpus root bark, and 10 parts of liquorice root.

[0019] Furthermore, the excipients are pharmaceutical excipients that can enhance the efficacy of the main drug, reduce toxicity and / or alleviate side effects.

[0020] Furthermore, the preparation of the traditional Chinese medicine composition can be an ointment, pill, elixir, decoction, granule, capsule, powder, tablet, etc.

[0021] Furthermore, the tumors include, but are not limited to, lung cancer, nasopharyngeal cancer, breast cancer, colorectal cancer, gastric cancer, liver cancer, melanoma, renal cell carcinoma, Hodgkin lymphoma, and various sarcomas.

[0022] Furthermore, the tumor drugs include, but are not limited to, one or more of chemotherapy drugs, targeted therapy drugs, and immunotherapy drugs.

[0023] Furthermore, the chemotherapy drugs include, but are not limited to, one or more of cyclophosphamide, paclitaxel, vincristine, doxorubicin, and platinum-based drugs.

[0024] Furthermore, the targeted therapy drugs include, but are not limited to, one or more of gefitinib, erlotinib, osimertinib, crizotinib, and alectinib.

[0025] Furthermore, the immunotherapy drugs include, but are not limited to, one or more of pembrolizumab, camrelizumab, nivolumab, and tislelizumab.

[0026] Furthermore, the adverse reactions of the tumor drugs include, but are not limited to, one or more of various rashes, oral mucositis, and diarrhea.

[0027] The main efficacy and pharmacological effects of each traditional Chinese medicine raw material in the present invention are as follows:

[0028] Buffalo horn: Bitter in taste and cold in nature, entering the heart and liver meridians, it can clear heat and cool blood, detoxify, and calm the mind, with similar effects to rhinoceros horn; it is used to treat high fever in febrile diseases, delirium, convulsions, mania; maculae, epistaxis, hematemesis due to blood heat running amok; carbuncles, sores, and sore throats.

[0029] The main chemical components of buffalo horn include cholesterol, peptides, various amino acids, and various trace elements. It has effects such as strengthening the heart, lowering blood pressure, increasing platelet count, shortening blood coagulation time, reducing capillary permeability, anti-inflammatory, and sedative. The Xijiao Dihuang Decoction with buffalo horn replacing rhinoceros horn as the monarch drug has the effects of cooling blood and dissipating stasis, clearing heat and detoxifying, and has achieved good curative effects in the clinical treatment of various inflammatory and allergic skin diseases, severe drug dermatitis, etc.

[0030] Rehmannia root: Sweet, bitter, and cold in nature, entering the heart, liver, and kidney meridians, it can clear heat and cool blood, nourish yin and promote fluid production; it is used to treat heat entering nutrient blood, crimson tongue with restlessness and thirst, maculae, epistaxis, hematemesis, yin deficiency with internal heat, consumptive fever due to yin deficiency, thirst due to fluid injury, internal heat with polydipsia, and constipation due to intestinal dryness.

[0031] The main chemical components in Rehmannia glutinosa are carbohydrates, cycloalkenes, amino acids, etc. Pharmacological studies have confirmed that it has antioxidant, anti-aging, immune excitation, hypoglycemic, anti-cancer, anti-cerebral ischemia, protecting the nerve center, promoting hematopoiesis, hemostasis, strengthening the heart, protecting the liver and antibacterial effects.

[0032] Moutan Cortex: Bitter, pungent, slightly cold in nature, entering the heart, liver and kidney meridians, it can clear heat and cool blood, activate blood circulation to remove stasis, stop bleeding, and clear and disperse latent heat; it is used to treat warm toxin macules, hematemesis and epistaxis due to blood heat, injury of yin in warm diseases, yin deficiency fever, feverishness in the evening and coolness in the morning, anhidrotic bone steaming, amenorrhea due to blood stasis, dysmenorrhea, traumatic injury, carbuncles and sores.

[0033] The chemical components of Moutan Cortex mainly include acetophenones, terpenoids and their glycosides, organic acids and other components, and it has anti-inflammatory, immunomodulatory, cardiovascular protective effects, etc.

[0034] Paeonia lactiflora Pall.: Bitter, slightly cold in nature, entering the liver meridian, it can clear heat and cool blood, disperse stasis and relieve pain, and is used to treat macules in warm diseases, hematemesis and epistaxis due to blood heat, red and swollen eyes, carbuncles and sores, hypochondriac pain due to liver depression, amenorrhea, dysmenorrhea, abdominal pain due to mass in the abdomen, traumatic injury.

[0035] Paeonia lactiflora Pall. contains rich glycoside compounds, mainly including paeoniflorin, albiflorin, paeonilide, paeonolide, paeonol, ethyl gallate, oxypaeoniflorin, paeoniflorigenone, albiflorin A, etc. These monoterpene glycosides are considered to be the main active components of Paeonia lactiflora Pall., so Paeonia lactiflora Pall. has anticoagulant, antithrombotic, anti-inflammatory, anti-tumor and other effects.

[0036] Angelica sinensis (Oliv.) Diels: Sweet, pungent, warm in nature, entering the liver, heart and spleen meridians, it can enrich blood and regulate menstruation, promote blood circulation to relieve pain, moisten the intestines and relieve constipation, dispel cold and relieve pain; it is used to treat various syndromes of blood deficiency, blood deficiency and blood stasis, irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to deficiency-cold, traumatic injury, carbuncles and sores, arthralgia due to wind-cold, constipation due to blood deficiency and intestinal dryness.

[0037] The main chemical components of Angelica sinensis (Oliv.) Diels are volatile oils, organic acids, polysaccharides, flavonoids, etc., which have good pharmacological effects on the hematopoietic system, cardiovascular system and immune system, and Angelica sinensis (Oliv.) Diels also has anti-tumor, anti-radiation, antioxidant and anti-inflammatory and analgesic effects in many aspects.

[0038] Phellodendron amurense Rupr.: Bitter, cold in nature, entering the kidney, bladder and large intestine meridians, it can clear heat and dry dampness, purge fire and detoxify, and eliminate bone steaming, and is used to treat leukorrhea due to damp-heat, dysuria with pain, diarrhea due to damp-heat, jaundice, beriberi due to damp-heat, flaccidity syndrome, bone steaming and hectic fever, night sweats, spermatorrhea, sores and toxic swellings, eczema and pruritus.

[0039] The main chemical components of Phellodendron amurense Rupr. include alkaloids, lactones, phenolic acids, terpenes, phenylpropanoids and other types of components, and it has anti-inflammatory, antibacterial, antioxidant, anti-tumor, hypoglycemic, nerve-protecting, antidiarrheal and other pharmacological effects.

[0040] Amomum villosum: Pungent in taste and warm in nature, it enters the spleen, stomach and kidney meridians, can promote qi circulation by resolving dampness, stop diarrhea due to deficiency-cold in the middle-jiao, and prevent miscarriage; it is used to treat damp obstruction in the middle-jiao, qi stagnation in the spleen and stomach, vomiting and diarrhea due to deficiency-cold in the spleen and stomach, nausea and restlessness during pregnancy due to qi stagnation, and fetal movement restlessness.

[0041] The chemical constituents of Amomum villosum include volatile components represented by bornyl acetate, camphor, borneol, etc. and non-volatile components such as polysaccharides, flavonoid glycosides, inorganic components and organic acids. It has anti-ulcer effect, antibacterial effect, regulating flora effect, hypoglycemic effect and antioxidant effect.

[0042] Honeysuckle: Sweet in taste and cold in nature, it enters the lung, heart and stomach meridians, can clear heat and detoxify, disperse wind-heat, cool blood and stop dysentery, and is used to treat carbuncles, sores, boils, external contraction of wind-heat, initial stage of warm diseases, and dysentery with heat-toxin.

[0043] The chemical constituents of honeysuckle mainly include flavonoids, organic acids, volatile oils, phospholipid compounds, iridoid glycosides, etc. It has anti-inflammatory, antioxidant, anti-ultraviolet damage, lipid-lowering, hypoglycemic, antiviral and other effects. It is commonly used to treat various diseases such as fever, dysentery, erysipelas, pneumonia, sore throat, cellulitis and wind-heat pathogen. It is known as the "sacred medicine for sores".

[0044] Ophiopogon japonicus: Sweet and slightly bitter in taste, slightly cold in nature, it enters the lung, stomach and heart meridians, can nourish yin and moisten the lung, promote the production of body fluid to benefit the stomach, clear the heart and remove vexation, moisten the intestines and relieve constipation, and is used to treat syndromes of yin deficiency in the stomach, lung and heart.

[0045] The effective chemical constituents in Ophiopogon japonicus are steroidal saponins, homoisoflavones, saccharides, volatile oils and trace elements, etc. It has pharmacological effects such as protecting the cardiovascular system, reducing blood sugar and lipids, anti-inflammatory, antioxidant, anti-tumor, anti-aging and immunomodulation.

[0046] Poria cocos: Sweet and bland in taste, neutral in nature, it enters the heart, spleen and kidney meridians, can promote diuresis to eliminate dampness, strengthen the spleen, calm the heart, and is used to treat edema, phlegm retention, diarrhea due to spleen deficiency, palpitation and insomnia.

[0047] Poria cocos mainly contains polysaccharides, triterpenoids, sterols, volatile oils, proteins, etc. Its main active ingredients are two kinds, one is triterpenoids, and the other is polysaccharide compounds. It has curative effects on the urinary system, digestive system, central nervous system, immune system, etc., and has various pharmacological effects such as diuretic, liver-protecting, sedative, immune-enhancing, anti-inflammatory, anti-tumor and lipid-lowering.

[0048] Codonopsis pilosula: Sweet in taste and neutral in nature, it enters the spleen and lung meridians, can invigorate the spleen and lung qi, enrich the blood, promote the production of body fluid, strengthen healthy qi and dispel pathogenic factors, and is used to treat syndromes of qi deficiency in the spleen and lung, deficiency of both qi and blood, and deficiency of both qi and body fluid.

[0049] Codonopsis pilosula mainly contains chemical constituents such as alkaloids, alkynes, terpenoids, flavonoids, saccharides, etc., and has pharmacological effects on the nervous system, endocrine system, immune system, digestive system, etc.

[0050] Atractylodes macrocephala: Sweet, bitter, and warm in nature, it enters the spleen and stomach meridians, can invigorate qi and strengthen the spleen, dry dampness and promote diuresis, stop sweating, and prevent miscarriage; it is used to treat spleen qi deficiency, spontaneous sweating due to qi deficiency, and restlessness of the fetus due to spleen deficiency.

[0051] The chemical constituents of Atractylodes macrocephala mainly include Atractylodes volatile oil, atractylenolide, and atractylodes polysaccharide. It also has effects such as protecting the liver, regulating gastrointestinal motility, anti-inflammatory, anti-tumor, regulating the immune system, lowering blood sugar, and regulating immune metabolism.

[0052] Lotus seed: Sweet, astringent, and neutral in nature, it enters the spleen, kidney, and heart meridians, can tonify the kidney and consolidate essence, invigorate the spleen and stop diarrhea, arrest vaginal discharge, nourish the heart and calm the mind, and communicate the heart and kidney, and is used to treat spermatorrhea, leukorrhea, diarrhea due to spleen deficiency, palpitation and insomnia.

[0053] Lotus seed mainly contains chemical constituents such as alkaloids, flavonoids, glycosides, terpenoids, steroids, fatty acids, proteins, minerals, and vitamins, and has pharmacological activities such as regulating lipid and losing weight, antibacterial, anti-inflammatory, antioxidant, and hemostatic.

[0054] Chinese yam: Sweet and neutral in nature, it enters the spleen, lung, and kidney meridians, can benefit qi and nourish yin, invigorate the spleen, lung, and kidney, and consolidate essence and arrest discharge, and is used to treat spleen deficiency, lung deficiency, kidney deficiency, and qi-yin deficiency syndrome of consumptive thirst.

[0055] Chinese yam contains rich active ingredients such as steroidal saponins, polysaccharides, allantoin, flavonoids, and phenolic glycosides. The diversity of its chemical constituents endows it with various pharmacological effects, such as protecting the liver, anti-inflammatory, immune regulation, reducing uric acid, anti-tumor, and therapeutic effects in kidney diseases.

[0056] Hyacinth bean: Sweet and slightly warm in nature, it enters the spleen and stomach meridians, can invigorate the spleen and regulate the middle, and resolve dampness, and is used to treat spleen qi deficiency, vomiting and diarrhea due to summer dampness.

[0057] Hyacinth bean contains protein (bioactive substances), carbohydrates, steroids and glycosides, vitamins, and minerals, etc., and has pharmacological effects such as antibacterial, antiviral, improving immune function, anti-tumor, antioxidant activity, and protecting nerve cells.

[0058] Coix seed: Sweet, light, and cool in nature, it enters the spleen, stomach, and lung meridians, can promote diuresis and percolate dampness, invigorate the spleen, relieve arthralgia, and clear heat and expel pus, and is used to treat edema, dysuria, beriberi, diarrhea due to spleen deficiency, damp arthralgia with muscle spasm, lung abscess, and intestinal abscess.

[0059] Coix seed contains starch, fatty acids and esters, polysaccharides, proteins, as well as various nutrients such as phenolic acids, sterols, flavonoids, lactams, triterpenes, alkaloids, and adenosine. The main active ingredients are esters, unsaturated fatty acids, carbohydrates, and lactams, etc.; it has pharmacological effects such as anti-tumor, analgesic and anti-inflammatory, regulating glucose and lipid metabolism, enhancing immunity, lowering blood pressure, antioxidant, anti-aging, and skin whitening.

[0060] Black Plum: Sour, astringent, and neutral in nature, entering the large intestine, liver, spleen, and lung meridians. It can relieve cough by astringing the lung, stop diarrhea by astringing the intestine, relieve pain due to roundworms, promote the production of body fluid and quench thirst, stir-fry with charcoal to strengthen the function of arresting bleeding and preventing leakage, externally apply to dissipate sore toxins and harmonize the stomach to stop vomiting, and is used to treat chronic cough due to lung deficiency, chronic diarrhea and dysentery, abdominal pain due to roundworm syncope, as well as vomiting, consumptive thirst with deficiency heat, uterine bleeding that does not stop, hematochezia, externally apply to treat protruding pterygium and head sores.

[0061] The chemical constituents of black plum mainly include organic acids, terpenoids, sterols, volatile components, amino acids, saccharides, lipids, flavonoids, alkaloids, etc. It has various pharmacological effects such as antibacterial, antitussive, sedative and hypnotic, anti-convulsive, antiviral, anti-allergic reaction, anti-tumor, antioxidant, anti-fibrosis, reducing blood lipid, inhibiting melanin, antibiotic treatment of colitis, reducing blood sugar, preventing and treating stones, and hemostasis.

[0062] Astragalus membranaceus: Sweet in taste and slightly warm in nature, entering the spleen and lung meridians. It can replenish qi and strengthen the spleen, raise yang and lift prolapse, benefit the defensive qi and consolidate the exterior, promote diuresis and reduce swelling, support detoxification and promote granulation, and generate blood by replenishing qi, and is used to treat spleen qi deficiency syndrome, lung qi deficiency, spontaneous sweating due to qi deficiency, qi and blood deficiency, sores and ulcers that are difficult to ulcerate and heal, or those that are difficult to heal for a long time after ulceration, arthralgia syndrome, sequelae of stroke, etc. with qi deficiency and blood stasis.

[0063] The main chemical constituents of Astragalus membranaceus are polysaccharides, saponins, flavonoids, amino acids, alkaloids, etc. It has effects such as anti-tumor, protecting the cardiovascular and cerebrovascular system, enhancing the body's immune function, protecting the respiratory function, protecting metabolic (liver, kidney) tissues, regulating blood pressure, anti-aging, preventing and treating osteoporosis, etc.

[0064] Dictamnus dasycarpus Turcz.: Bitter in taste and cold in nature, entering the spleen, stomach, and bladder meridians. It can clear heat and dry dampness, expel wind and detoxify, and dredge arthralgia due to damp-heat, and is used to treat sore toxins, eczema, scabies, damp-heat jaundice, and rheumatic heat arthralgia.

[0065] Dictamnus dasycarpus Turcz. contains various chemical constituents, including alkaloids, limonoids, flavonoids, sesquiterpenes and their glycosides, sterols, etc. Dictamnus dasycarpus Turcz. has a wide range of pharmacological effects, including anti-inflammatory, anti-fungal, anti-atherosclerotic, hemostatic, anti-cancer, neuroprotective, and antioxidant effects.

[0066] Licorice Root: Sweet in taste and neutral in nature, entering the heart, lung, spleen, and stomach meridians. It can invigorate the spleen and replenish qi, resolve phlegm and relieve cough, relieve spasm and pain, clear heat and detoxify, and harmonize various medicines, and is used to treat insufficiency of heart qi, intermittent pulse, palpitation, spleen qi deficiency, cough and asthma, abdominal pain, spasms and pain in the extremities, sores and ulcers due to febrile diseases, sore throat, poisoning by drugs or food, and harmonize the properties of medicines.

[0067] Licorice Root has diverse chemical constituents, including triterpenoid saponin compounds, flavonoid compounds, coumarin compounds, as well as polysaccharides, fats and other chemical constituents, and has a wide range of pharmacological effects such as anti-tumor, anti-inflammatory, antibacterial, antiviral, neuroprotective, and liver protection.

[0068] Xi-Jiao Di-Huang Decoction clears heat, cools the blood, and detoxifies. In the formula, rhinoceros horn (now replaced by buffalo horn) with bitter and salty cold properties is used as the sovereign drug, directly entering the blood aspect, cooling the blood in the heart and clearing heat-toxin, so that heat is cleared, toxin is resolved, and blood is calmed. The minister drug is raw rehmannia root with bitter, cold, and sweet properties, clearing heat and cooling the blood, nourishing yin, both assisting the sovereign drug in clearing heat and cooling the blood, and restoring the lost yin and blood. The combination of the sovereign and minister drugs focuses on clearing heat, supplemented by tonifying and consolidating. Paeony root bark and moutan bark are used as assistant drugs, clearing heat and cooling the blood, promoting blood circulation to disperse stasis, and achieving the effect of resolving macules. The combination of these four drugs forms a formula for clearing heat-toxin, cooling the blood, and dispersing stasis. Angelica sinensis is used as an assistant to nourish blood and moisten dryness, and dictamnus cortex is used to clear heat and dry dampness, dispel wind and detoxify, mainly targeting the rash reaction.

[0069] Feng-Sui Dan regulates the heart and kidney, harmonizes water and fire, and can treat all cases of flaring up of deficient fire. In the formula, phellodendron bark is used as the sovereign drug. Because of its bitter and cold properties, bitterness can strengthen the kidney, and when the kidney function is strengthened, yin water will not overflow; coldness can clear and purge, and when the autumn season arrives, dragon fire will not flare up. With the coordination of water and fire, how can essence not be in its proper position? Licorice root is used as an assistant. Because sweetness can relieve urgency, purge various fires and the internal restlessness of liver fire, and can also make water and earth combine as one family to achieve the firmness of sealing and storing. For fructus amomi, because of its pungent and warm properties, it is good at entering the kidney. What the kidney dislikes is dryness, and the only thing that can moisten it is pungency. Fructus amomi penetrates the triple energizer, reaches body fluids, and can receive the essence of the five zang-organs and six fu-organs and return it to the kidney. When the qi of the kidney is received, the marrow in the kidney will be stored. "The holy drug for sores" honeysuckle flower is used as an assistant to clear heat and detoxify, and ophiopogon root is used to nourish yin and clear heat, mainly targeting oral mucositis.

[0070] Shen-Ling Bai-Zhu Powder supplements the spleen and stomach, and benefits the lung qi. In the formula, ginseng, atractylodes macrocephala, and poria cocos are used to boost qi, strengthen the spleen, and seep dampness, serving as the sovereign drugs. Dioscorea opposita and nelumbo nucifera seeds assist ginseng in boosting qi and strengthening the spleen, and also have the effect of stopping diarrhea; dolichos lablab and coix lacryma-jobi assist atractylodes macrocephala and poria cocos in strengthening the spleen and seeping dampness, jointly serving as the minister drugs. Fructus amomi is used as an assistant to arouse the spleen and harmonize the stomach, and platycodon grandiflorum is used to promote the lung qi and benefit qi, to regulate the water passage, and also carry the herbs upward to benefit the lung qi. Licorice root strengthens the spleen and harmonizes the middle, and harmonizes all the herbs, serving as the envoy drug. The combination of these herbs together exerts the effects of supplementing the spleen and stomach, seeping damp turbidity, promoting qi movement, and regulating qi stagnation. Astragalus membranaceus is added to enhance qi-boosting and spleen-strengthening, and fructus mume is used to promote the production of body fluids and quench thirst, astringe and stop diarrhea, mainly targeting diarrhea.

[0071] The treatment principle of the traditional Chinese medicine composition of the present invention is to achieve the purpose of treating the adverse reactions of anti-tumor drugs by clearing heat, cooling the blood, detoxifying, strengthening the spleen, promoting digestion, and stopping diarrhea. Especially for the adverse reactions caused by anti-tumor drugs such as targeted drugs and immunotherapy drugs, the most common ones are rashes, diarrhea, oral mucositis, etc. in patients with symptoms belonging to heat invading nutrient blood and spleen deficiency with dampness exuberance, and the treatment effect is the best. Looking at the traditional Chinese medicine formula of this prescription, there are a total of 20 herbs. Its medicinal properties are mild. Clearing heat, cooling the blood, and detoxifying and strengthening the spleen, promoting digestion, and stopping diarrhea are carried out simultaneously. It regulates cold and heat, and takes into account deficiency and excess, and can effectively prevent and treat the adverse reactions of anti-tumor drugs (targeted drugs, immune checkpoint inhibitors). Detailed Embodiment

[0072] The following details the embodiments of the present invention. The following embodiments are implemented on the premise of the technical solution of the present invention, and the detailed implementation methods and specific operation processes are given. However, the protection scope of the present invention is not limited to the following embodiments.

[0073] Embodiment 1

[0074] The weight ratio of the traditional Chinese medicine prescription is as follows: 30 parts of buffalo horn, 30 parts of rehmannia root, 15 parts of cortex moutan, 15 parts of radix paeoniae rubra, 12 parts of angelica sinensis, 10 parts of phellodendron amurense, 10 parts of fructus amomi, 20 parts of honeysuckle flower, 20 parts of radix ophiopogonis, 20 parts of poria cocos, 15 parts of atractylodes macrocephala, 15 parts of codonopsis pilosula, 30 parts of lotus seed, 30 parts of Dioscorea opposita, 30 parts of dolichos lablab, 30 parts of coix seed, 15 parts of fructus mume, 15 parts of astragalus membranaceus, 20 parts of cortex dictamni, 10 parts of liquorice root.

[0075] Decoction method of the medicinal broth: First, soak the above-mentioned prescription herbs (except fructus amomi) in 2500 ml of warm water for half an hour, then bring to a boil over high heat for 8 minutes, and then switch to low heat and decoct for 40 minutes. Fructus amomi is added in the last 10 minutes.

[0076] Example 2

[0077] The weight ratio of the traditional Chinese medicine prescription is as follows: 15 parts of buffalo horn, 15 parts of rehmannia root, 12 parts of cortex moutan, 12 parts of radix paeoniae rubra, 12 parts of angelica sinensis, 10 parts of phellodendron amurense, 10 parts of fructus amomi, 15 parts of honeysuckle flower, 15 parts of radix ophiopogonis, 30 parts of poria cocos, 20 parts of atractylodes macrocephala, 15 parts of codonopsis pilosula, 30 parts of lotus seed, 30 parts of Dioscorea opposita, 30 parts of dolichos lablab, 30 parts of coix seed, 30 parts of fructus mume, 15 parts of astragalus membranaceus, 15 parts of cortex dictamni, 10 parts of liquorice root.

[0078] Decoction method of the medicinal broth: First, soak the above-mentioned prescription herbs (except fructus amomi) in 2500 ml of warm water for half an hour, then bring to a boil over high heat for 6 minutes, and then switch to low heat and decoct for 40 minutes. Fructus amomi is added in the last 10 minutes.

[0079] Example 3

[0080] The weight ratio of the traditional Chinese medicine prescription is as follows: 30 parts of buffalo horn, 20 parts of rehmannia root, 15 parts of cortex moutan, 15 parts of radix paeoniae rubra, 12 parts of angelica sinensis, 10 parts of phellodendron amurense, 10 parts of fructus amomi, 30 parts of honeysuckle flower, 15 parts of radix ophiopogonis, 20 parts of poria cocos, 15 parts of atractylodes macrocephala, 15 parts of codonopsis pilosula, 15 parts of lotus seed, 20 parts of Dioscorea opposita, 20 parts of dolichos lablab, 20 parts of coix seed, 15 parts of fructus mume, 15 parts of astragalus membranaceus, 15 parts of cortex dictamni, 10 parts of liquorice root.

[0081] Decoction method of the medicinal broth: First, soak the above-mentioned prescription herbs (except fructus amomi) in 2500 ml of warm water for half an hour, then bring to a boil over high heat for 10 minutes, and then switch to low heat and decoct for 40 minutes. Fructus amomi is added in the last 10 minutes.

[0082] Clinical efficacy observation of Example 4

[0083] 72 patients with adverse reactions to tumor drugs in the outpatient and inpatient wards of the Traditional Chinese Medicine Department of Beijing Chest Hospital from May 2020 to April 2023 were clinically observed. They were randomly divided into two groups, with 36 cases in each of the traditional Chinese medicine group and the control group. All subjects signed the informed consent form and their clinical medical record information was recorded in detail.

[0084] The patients in the traditional Chinese medicine group took the prescription obtained in Example 1 of the present invention, one dose per day, decocted and taken orally, warm taken twice at about half an hour after breakfast and dinner respectively, 200 ml each time, 4 weeks as a course of treatment, and continuously observed for 3 courses (patients with severe conditions need combined traditional Chinese and Western medicine treatment); the control group was given routine symptomatic relief treatment with Western medicine according to clinical needs.

[0085] Follow-up period: 12 weeks;

[0086] Follow-up frequency: namely at baseline, 4 weeks, 8 weeks, and 12 weeks, a total of 4 times.

[0087] Western medicine diagnostic criteria:

[0088] The diagnostic criteria for adverse reactions of oncology drugs were formulated with reference to the Common Terminology Criteria for Adverse Events of the National Cancer Institute of the United States (NCI-CTCAE v5.0), and the degree was between grade 2 and grade 3, that is:

[0089] ① Various rashes (covering 10 - 30% of the body surface area, with or without symptoms; covering > 30% of the body surface area, accompanied by moderate to severe symptoms);

[0090] ② Oral mucositis (moderate pain / ulcer, not affecting oral intake, requiring diet adjustment; severe pain, affecting oral intake);

[0091] ③ Diarrhea (increasing by 4 - 6 times per day; moderate increase in the output from the stoma; increasing by ≥ 7 times per day, severe increase in the output from the stoma, requiring hospitalization).

[0092] ①, ②, and ③ coexist simultaneously in different degrees.

[0093] Traditional Chinese medicine diagnostic and syndrome differentiation criteria:

[0094] With reference to the syndrome differentiation criteria in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial)" in 2002 and the syndrome differentiation criteria for heat invading nutrient blood and spleen deficiency with dampness accumulation in the "Diagnostic and Therapeutic Criteria for Traditional Chinese Medical Diseases and Syndromes", that is, the patient has local or systemic rashes, red in color, raised above the skin surface, with or without blisters on the skin surface, even large blisters, epidermal necrosis, and loosening, oral ulcers, the number of bowel movements increases more than 4 times per day, the tongue is pale red or red, the tongue coating is thin or less, and the pulse is thready and rapid.

[0095] Case exclusion criteria:

[0096] (1) Those not caused by oncology drugs; (2) Those with simple skin reactions, or simple oral mucositis, or simple diarrhea; (3) Those who have received other drug treatments within 3 months after being diagnosed with adverse reactions of oncology drugs; (4) Those accompanied by severe diseases of other systems, such as renal failure, heart failure, etc.; (5) Those allergic to the drugs used in this study; (6) Those who cannot adhere to taking medicine or cannot adhere to follow-up.

[0097] Efficacy criteria:

[0098] The efficacy was evaluated according to the "Guiding Principles for Clinical Research of New Chinese Medicines (Trial)" in 2002 and the "Diagnostic and Therapeutic Criteria for Traditional Chinese Medical Syndromes and Diseases". Cure: The rash completely subsided, the oral mucositis completely disappeared, and the frequency of defecation was controlled at 1 - 2 times per day; Improvement: The rash subsided by more than 50%, the oral mucositis occurred occasionally, and the frequency of defecation was controlled at 3 - 4 times per day; Not cured: The improvement criteria were not met. The total clinical effective rate = (number of cured cases + number of improved cases) / total number of cases × 100% (see Tables 1 and 2).

[0099] Table 1 Pharmacodynamic statistics

[0100] Number of cases Cured Improved Not cured Total effective rate (%) Traditional Chinese medicine group 36 7 25 4 88.9％ Control group 36 1 18 17 52.8％

[0101] Table 2 Effective rates of adverse reactions of oncology drugs at different follow - up nodes

[0102]

[0103] Result analysis:

[0104] After the patients were treated with the prescription in Example 1, the total effective rate was 88.9%. And most patients had obvious remission of adverse reactions 4 weeks after taking the medicine. Among them, the oral ulcer had the fastest remission and the highest effective rate. The remission rate reached 69.4% 4 weeks after taking the medicine, and the total effective rate was 97.2%. The rash remission was relatively slow and the effective rate was low. However, currently on the market, there is only a treatment plan for a certain adverse reaction, which can only treat the rash or relieve diarrhea simply. There is no comprehensive treatment plan for multiple adverse reactions caused by oncology drugs at the same time. Therefore, this prescription is very meaningful for filling this clinical gap.

[0105] Typical cases:

[0106] Case 1: Shi XX, female, 52 years old. Initial diagnosis date: August 20, 2020. Chief complaint: Generalized rash for more than 1 month. Medical history: In June 2020, after the patient drank water, she had severe choking cough, accompanied by chest tightness and dyspnea. PET-CT examination in the local hospital showed a space-occupying lesion in the dorsal segment of the lower lobe of the left lung, showing high metabolism, and it might be peripheral lung cancer; there was metabolism in the left hilar and mediastinal lymph nodes, and metastasis might be present; multiple nodules in both lungs, with high metabolism, and multiple pulmonary metastases might be present. On June 12, 2020, CT-guided lung puncture biopsy was performed in Beijing Chest Hospital. The postoperative pathology showed adenocarcinoma. The gene test result was EGFR20-Ins. Targeted therapy was given with oral administration of almonertinib mesylate tablets (110 mg, once a day). On July 16, 2020, a follow-up chest CT showed that the lesion had shrunk compared with before, and the efficacy evaluation was SD. The patient's cough and dyspnea symptoms were relieved, but drug adverse reactions such as rash, oral ulcer, and diarrhea occurred. On August 20, 2020, the patient visited the Traditional Chinese Medicine Department. Current symptoms: Generalized scattered rashes (covering > 30% of the body surface area), obvious on the head, face, chest and back, red in color, itchy, some had scabbed and formed lumps, with desquamation, oral ulcers, severe pain, affecting eating, loose stools, 4 - 6 times a day, dry mouth, restlessness, fatigue, slightly dry cough, dark red tongue with thin coating and less fluid, thready and slippery pulse. Western medicine diagnosis: 1. Left lung adenocarcinoma; 2. Drug-induced rash; 3. Oral mucositis; 4. Diarrhea. Traditional Chinese medicine diagnosis: Lung cancer; drug toxic rash; oral ulcer; diarrhea. Syndrome type and treatment method: The syndrome belongs to the syndrome of heat invading nutrient blood and spleen deficiency with dampness excess. The treatment is to clear heat, cool blood and detoxify, and strengthen the spleen and resolve dampness to stop diarrhea. After taking the traditional Chinese medicine formula decoction of Example 1 of the present invention for 4 weeks, the rash basically subsided, the oral ulcer healed, and the frequency of bowel movements decreased to 3 - 4 times; after 8 weeks, it was basically cured; then the dose was reduced (one dose every two days) and consolidated until 12 weeks. No adverse reactions such as rash, stomatitis, and diarrhea occurred again. On December 10, 2020, a follow-up chest CT showed that the lesion had significantly shrunk, and the efficacy evaluation was PR.

[0107] Case 2: Huang XX, male, 68 years old, first visit on November 7, 2022. Chief complaint: Diarrhea for more than 2 months. Medical history: The patient had cough and blood in sputum on July 15, 2022. Chest CT examination in the local hospital showed a space-occupying lesion (2.2×3.5 cm) in the upper lobe of the right lung. Surgical resection was performed at Beijing Chest Hospital on July 20, 2022. Postoperative pathology showed adenocarcinoma, and gene detection showed E·1GFR 19-Del+. The stage was T2N1M0 b. Osimertinib mesylate tablets (80 mg, orally once a day) were given for targeted therapy on August 15, 2022. Two weeks after taking the medicine, the patient developed diarrhea, with the number of stools ≥7 times a day, accompanied by scattered rashes all over the body, oral mucositis, and palpitations. Therefore, the dose of osimertinib tablets was reduced (40 mg, orally once a day), but the number of stools was still 4-5 times a day. Taking Zhengchangsheng, montmorillonite powder, etc. had no obvious effect. Chest CT reexamination on October 20, 2022 showed changes after right lung cancer surgery, basically the same as before. The patient visited the Traditional Chinese Medicine Department on October 25, 2022. Current symptoms: Diarrhea, 4-5 stools a day, accompanied by scattered rashes all over the body (covering 10-30% of the body surface area), red in color, itchy, desquamating, multiple oral ulcers (affecting oral intake), palpitations, fatigue, dry mouth, pale red tongue with thin and greasy coating, thready and taut pulse. Western medicine diagnosis: 1. Adenocarcinoma of the right lung; 2. Diarrhea; 3. Drug rash; 4. Oral mucositis. Traditional Chinese medicine diagnosis: Lung cancer; diarrhea; drug rash; oral ulcer. Syndrome type and treatment method: The syndrome belongs to the syndrome of heat invading nutrient blood and spleen deficiency with dampness accumulation. The treatment is to clear heat, cool blood, detoxify, strengthen the spleen, and resolve dampness to stop diarrhea. After taking the traditional Chinese medicine formula decoction of Example 2 of the present invention for 4 weeks, the number of stools decreased to 2-3 times, the oral ulcers healed, and the rashes improved significantly compared with before. Then the dose of osimertinib tablets was increased to 80 mg per day; after 8 weeks, the number of stools was controlled at 3-4 times per day, the oral ulcers did not relapse, and the rashes basically subsided; when taking the medicine for 12 weeks, the number of stools was controlled at 1-2 times per day, and the oral ulcers and rashes did not relapse. Chest CT reexamination on January 18, 2023 showed changes after right lung cancer surgery, basically the same as before.

[0108] Case 3: Ai XX, male, 56 years old, first visit on September 30, 2021. Chief complaint: Skin rash for more than 1 month. In March 2019, the patient had cough without obvious incentive, coughed up a small amount of white sputum, the sputum was not easy to cough out, accompanied by blood in the sputum, a very small amount, pink. Chest CT examination in a local hospital showed consolidation in the anterior segment of the upper lobe of the left lung. The patient then visited Beijing Chest Hospital. After admission, bronchoscopy was performed on the patient (April 14, 2021): A neoplasm in the anterior branch of the apical area of the left lingular lobe blocked the bronchus: bronchogenic carcinoma. Biopsy of the bronchial mucosa of the left lingular lobe and bronchoscopy brushing (April 20, 2021) of the patient both showed squamous cell carcinoma. The NGS test result of the patient was negative, and immunohistochemical detection was performed to further clarify the PD-L1 expression of the tumor tissue, which was PD-L1 22C3 (5%). Staging examination showed metastasis to the sternum and metastasis to the second thoracic vertebra. Enhanced CT of the head and abdomen showed no obvious signs of metastasis. The diagnosis of stage IV squamous cell carcinoma of the lung was clear. From April 23, May 14, and June 17, 2021, the patient was given 3 cycles of chemotherapy combined with immunotherapy: nab-paclitaxel 400mg D1 + cisplatin 60mg D1-2 + tislelizumab 200mg. After the first chemotherapy, the patient had a decreased appetite (CTCAE grade 2) and febrile neutropenia. After the second and third chemotherapy, the patient did not have obvious discomfort symptoms. From July 21, 2021, the patient was given the fourth cycle of chemotherapy combined with immunotherapy (the same regimen as before). Two weeks after the end of the fourth treatment, scattered red skin rashes appeared on both lower extremities of the patient, slightly higher than the skin surface, accompanied by slight itching (CTCAE grade 1). From August 25, 2021, the patient was given the fifth cycle of chemotherapy combined with immunotherapy (the same regimen as before). After treatment, the patient's systemic skin rash worsened compared with before, and the affected areas increased (covering > 30% of the body surface area). All were red skin rashes, higher than the skin surface, and blisters could be seen on some skin surfaces. It was considered immune-related, graded G3, accompanied by slight itching, graded G1. One week ago (September 22, 2021), the patient began to take oral prednisone acetate tablets 45mg qd for treatment. After taking the medicine, some blisters scabbed and fell off, but the rash area still continued to increase. Therefore, a consultation with the traditional Chinese medicine department was requested. Current symptoms: Generalized skin rash all over the body (covering > 30% of the body surface area), red in color, higher than the skin surface, some were pustular, scabbed, desquamated, loose stools 3-5 times a day, multiple oral ulcers, accompanied by pain, affecting eating, sleep was okay, the tongue was light red with a thin coating, and the pulse was slippery and rapid. Western medicine diagnosis: 1. Advanced squamous cell carcinoma of the left lung; 2. Drug-induced skin rash; 3. Oral mucositis; 4. Diarrhea. Traditional Chinese medicine diagnosis: Lung cancer; drug-induced rash; oral ulcer; diarrhea. Syndrome type and treatment method: The syndrome belongs to the syndrome of heat entering the nutrient-blood and spleen deficiency with dampness accumulation. The treatment principle is to clear heat, cool blood, detoxify, strengthen the spleen, and resolve dampness and stop diarrhea.After taking the decoction of the Chinese medicine formula in Example 3 of the present invention for 2 weeks, the rash significantly subsided, the oral ulcer healed, and the frequency of bowel movements decreased to 1-2 times. The hormone was gradually reduced until discontinued; after 4 weeks, it was basically cured; then it was reduced (taking one dose every two days) and consolidated for 12 weeks, and no adverse reactions such as rash, stomatitis, and diarrhea occurred again. The chest CT examination on December 28, 2021 showed that the lesion significantly shrank, and the curative effect evaluation was PR.

[0109] The above are only preferred embodiments of the present invention, and do not impose any form of limitation on the present invention. Any simple modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention are all within the protection scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition for treating adverse reactions of anti-tumor drugs, wherein the traditional Chinese medicine composition is prepared from traditional Chinese medicine raw materials with the following weight part ratios: 15-30 parts of buffalo horn, 10-30 parts of rehmannia root, 10-20 parts of cortex moutan, 10-30 parts of red peony root, 10-20 parts of angelica sinensis, 6-15 parts of phellodendron amurense, 6-15 parts of fructus amomi, 10-30 parts of honeysuckle flower, 10-30 parts of dwarf lilyturf tuber, 10-30 parts of poria cocos, 10-30 parts of atractylodes macrocephala, 10-30 parts of codonopsis pilosula, 10-30 parts of lotus seed, 10-30 parts of Chinese yam, 10-30 parts of hyacinth bean, 10-30 parts of coix seed, 10-30 parts of smoked plum, 10-30 parts of astragalus membranaceus, 10-30 parts of dictamnus dasycarpus turcz, 6-15 parts of liquorice; the tumor is lung cancer.

2. The traditional Chinese medicine composition for treating adverse reactions of anti-tumor drugs according to claim 1, wherein, The traditional Chinese medicine composition is prepared from traditional Chinese medicine raw materials with the following weight part ratios: 20-30 parts of buffalo horn, 15-30 parts of rehmannia root, 12-20 parts of cortex moutan, 12-30 parts of red peony root, 10-18 parts of angelica sinensis, 6-12 parts of phellodendron amurense, 6-12 parts of fructus amomi, 15-30 parts of honeysuckle flower, 12-30 parts of dwarf lilyturf tuber, 15-30 parts of poria cocos, 12-30 parts of atractylodes macrocephala, 10-25 parts of codonopsis pilosula, 15-30 parts of lotus seed, 15-30 parts of Chinese yam, 15-30 parts of hyacinth bean, 15-30 parts of coix seed, 10-25 parts of smoked plum, 10-25 parts of astragalus membranaceus, 15-30 parts of dictamnus dasycarpus turcz, 6-12 parts of liquorice.

3. A preparation of the traditional Chinese medicine composition for treating adverse reactions of anti-tumor drugs as described in claim 1, wherein the traditional Chinese medicine composition is prepared from traditional Chinese medicine raw materials with the following weight part ratios: 15-30 parts of buffalo horn, 10-30 parts of rehmannia root, 10-20 parts of cortex moutan, 10-30 parts of red peony root, 10-20 parts of angelica sinensis, 6-15 parts of phellodendron amurense, 6-15 parts of fructus amomi, 10-30 parts of honeysuckle flower, 10-30 parts of dwarf lilyturf tuber, 10-30 parts of poria cocos, 10-30 parts of atractylodes macrocephala, 10-30 parts of codonopsis pilosula, 10-30 parts of lotus seed, 10-30 parts of Chinese yam, 10-30 parts of hyacinth bean, 10-30 parts of coix seed, 10-30 parts of smoked plum, 10-30 parts of astragalus membranaceus, 10-30 parts of dictamnus dasycarpus turcz, 6-15 parts of liquorice; the tumor is lung cancer.

4. The preparation of the traditional Chinese medicine composition for treating adverse reactions of anti-tumor drugs according to claim 3, characterized in that, The preparation of the traditional Chinese medicine composition is made from the composition for treating adverse reactions of anti-tumor drugs as described in claim 1 and pharmaceutically acceptable excipients.

5. The preparation of the traditional Chinese medicine composition for treating adverse reactions of anti-tumor drugs according to claim 3, wherein, The preparation of the traditional Chinese medicine composition is an ointment, pill, pellet, decoction, granule, capsule, powder, tablet.

6. Use of a traditional Chinese medicine composition in the preparation of a drug for treating adverse reactions of anti-tumor drugs, wherein the traditional Chinese medicine composition is prepared from traditional Chinese medicine raw materials with the following weight parts ratio: 15 - 30 parts of buffalo horn, 10 - 30 parts of rehmannia root, 10 - 20 parts of moutan bark, 10 - 30 parts of red peony root, 10 - 20 parts of angelica sinensis, 6 - 15 parts of phellodendron bark, 6 - 15 parts of amomum villosum, 10 - 30 parts of honeysuckle flower, 10 - 30 parts of dwarf lilyturf tuber, 10 - 30 parts of poria cocos, 10 - 30 parts of atractylodes macrocephala, 10 - 30 parts of codonopsis pilosula, 10 - 30 parts of lotus seed, 10 - 30 parts of Chinese yam, 10 - 30 parts of hyacinth bean, 10 - 30 parts of coix seed, 10 - 30 parts of smoked plum, 10 - 30 parts of astragalus membranaceus, 10 - 30 parts of dictamnus dasycarpus, 6 - 15 parts of liquorice; the tumor is lung cancer.

7. The application according to claim 6, characterized in that The anti-tumor drug is selected from one or more of targeted therapy drugs and immunotherapy drugs.

8. The application according to claim 6, wherein The adverse reactions of the anti-tumor drug are skin rash, oral mucositis and diarrhea.

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