CN116407595A - Traditional Chinese medicine composition for treating triple negative breast cancer, traditional Chinese medicine preparation and application thereof - Google Patents
Traditional Chinese medicine composition for treating triple negative breast cancer, traditional Chinese medicine preparation and application thereof Download PDFInfo
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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Abstract
The invention provides a traditional Chinese medicine composition for treating triple negative breast cancer, a traditional Chinese medicine preparation and application thereof. The Chinese medicinal composition comprises radix Codonopsis, atractylodis rhizoma, rhizoma arisaematis preparata, fructus Gardeniae preparata, semen Sojae Preparatum, bulbus Fritillariae Thunbergii, bulbus Fritillariae Cirrhosae, radix Platycodi, rhizoma Ligustici Chuanxiong, folium Citri Tangerinae, bombyx Batryticatus, gekko Swinhonis, radix Ranunculi Ternati, fructus Schisandrae chinensis, and Glycyrrhrizae radix. The traditional Chinese medicine composition is subjected to traditional Chinese medicine formula screening according to the traditional Chinese medicine theory and the theory of dialectical treatment, has strict formula, has the effects of inhibiting tumor cell proliferation, reducing toxicity, enhancing efficacy and relieving discomfort of patients aiming at patients with triple negative breast cancer of which the syndrome is syndrome of deficiency-vital energy according to the dialectical of traditional Chinese medicine, can strengthen the primordial qi in the consolidation treatment stage after operation or radiotherapy and chemotherapy, prevents recurrence and metastasis, prolongs the life cycle of the patients and improves the life quality of the patients.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating triple negative breast cancer, a traditional Chinese medicine preparation and application thereof.
Background
Breast cancer is one of the common malignant tumors of women worldwide, the incidence rate is first worldwide, and the first cancer mortality rate of women is the first, so that serious threat is caused to female life. Triple negative breast cancer is taken as a subtype of breast cancer, namely, a type of breast cancer with negative expression of estrogen receptor (estrogen receptor, ER), progestogen receptor (progesterone receptor, PR) and human epidermal growth factor (human epidermal growth factor receptor-2, her-2), and accounts for 15% -20% of all breast cancers, and compared with Luminal and Her-2 over-expression type breast cancer, the triple negative breast cancer has the characteristics of easy recurrence and metastasis, lack of corresponding treatment targets, high lymph node positive rate, light incidence age and the like, has higher risk coefficient, poor clinical prognosis, is recurrence peak 1-3 years after treatment, and is the treatment difficulty in all breast cancers at present. Because TNBC is different from common breast cancer, the current scheme for treating breast cancer has no treatment effect on triple-negative breast cancer, for example, the current effective medicaments for treating breast cancer, namely trastuzumab and tamoxifen, can well treat patients with breast cancer with Her-2 and ER over-expression, but have no curative effect on patients with triple-negative breast cancer, and the current treatment on triple-negative breast cancer is mainly surgical excision and chemotherapy, and lacks effective medicaments for treating triple-negative breast cancer. The traditional Chinese medicine has rich experience in breast cancer treatment, has unique advantages in a plurality of aspects of reducing recurrence and metastasis, controlling illness state, improving symptoms and the like through overall grasp, diagnosis and treatment and accurate individuation treatment, and therefore has great significance in summarizing and developing the value of the traditional Chinese medicine in triple negative breast cancer treatment.
In the early single-arm study of the inventor, the traditional Chinese medicine is shown to prolong the progression-free survival time of the triple negative breast cancer and improve the life quality of patients. However, the study design of single-arm study is not standardized, and in the clinical observation process, the individual differences of the curative effects among patients are found to be large. Consult "surgical Authenticity", lei Ji (heart collection of ulcer) and "surgical Quansheng Ji" to find multi-purpose Jie Ji, zhi Zi and Gao Ye, etc. medicinal herbs are as discussed in "Wen Bing tiao Bian", which is just in line with the feature of breast cancer being located in the upper energizer. The traditional treatment of triple negative breast cancer is mainly started from liver, spleen and kidney, and triple negative breast cancer is not treated from triple focal position of breast cancer, so that the applicant develops a traditional Chinese medicine composition for treating triple negative breast cancer based on the past research results, upper focal position and upper focal medication characteristics of breast cancer and adjusts the prescription through years of research and clinical practice experience summary, and develops a random control experiment to verify the clinical curative effect of the triple negative breast cancer.
Disclosure of Invention
In view of the above problems in the prior art, a first object of the present invention is to provide a traditional Chinese medicine composition for treating triple negative breast cancer. The traditional Chinese medicine composition is suitable for patients after triple negative breast cancer operation or radiotherapy and chemotherapy, is also suitable for patients incapable of tolerating chemotherapy or incapable of operation due to poor physical conditions and large tumor load, can play roles in inhibiting tumor cell proliferation, reducing toxicity and enhancing efficiency and relieving discomfort, and can strengthen primordial qi, prolong the survival time of the patients and improve the life quality of the patients in the consolidation treatment stage after operation or radiotherapy and chemotherapy.
The second aim of the invention is to provide a traditional Chinese medicine preparation for treating triple negative breast cancer.
The third object of the invention is to provide an application of the traditional Chinese medicine composition or the traditional Chinese medicine preparation in preparing medicines for treating triple negative breast cancer.
In order to achieve the first object, the present invention adopts the technical scheme that:
the invention discloses a traditional Chinese medicine composition for treating triple negative breast cancer, which comprises radix codonopsitis, bighead atractylodes rhizome, rhizoma arisaematis preparata, fructus gardeniae preparata, fermented soybean, fritillaria thunbergii, fritillaria cirrhosa, platycodon grandiflorum, ligusticum wallichii, folium citri reticulatae, silkworm larva, gecko, radix ranunculi ternati, schisandra chinensis and raw liquorice.
Breast cancer is located in the upper energizer, but the therapeutic treatment is different from other upper energizer diseases. In the aspect of treatment medication, the upper jiao is considered for treating breast cancer, and according to the aspects of ' upper jiao is like feather, not light but not rising ', the product of medicinal qingling ' is selected, and the characteristics of diseases of breast and breast cancer are combined, so that the breast belongs to liver and stomach two channels, liver, spleen and kidney dysfunction, and is incoordinated with phlegm, blood stasis and toxin, and breast cancer is caused. The traditional Chinese medicine composition has the advantages of small side effect, simple preparation, convenient administration, simple material acquisition and low price, and is suitable for long-term administration of patients. The composition of the invention can be used for treating patients with triple negative breast cancer at the postoperative consolidation treatment stage, or patients which cannot tolerate chemotherapy or can not tolerate operation due to poor physical condition and large tumor load.
The main functions of the medicinal materials adopted in the formula of the invention are as follows:
radix codonopsis pilosulae: radix Codonopsis of Campanulaceae is perennial herb, sweet, and flat. Enter spleen and lung meridians. Strengthening spleen, benefiting lung, nourishing blood and promoting fluid production. Can be used for treating spleen and lung qi deficiency, anorexia, cough, asthma, deficiency of qi and blood, sallow complexion, palpitation, short breath, thirst due to body fluid deficiency, and internal heat and diabetes.
White atractylodes rhizome: belongs to perennial herb plants of the genus Atractylodes in the family of Compositae, bitter and sweet, warm. Invigorating spleen, invigorating qi, eliminating dampness, promoting diuresis, relieving sweating, and preventing miscarriage. Can be used for treating spleen deficiency, anorexia, dyspepsia, diarrhea, edema, spontaneous perspiration, and fetal movement.
Preparing rhizoma arisaematis: bitter, pungent and warm; is toxic. Has effects of eliminating dampness and phlegm, dispelling pathogenic wind and relieving spasm, resolving hard mass, detumescence and detoxication, and relieving pain, and can be used for relieving carbuncle and swelling phlegm core, traumatic injury, snake bite, etc.
Fructus Gardeniae preparata: the processed product of Gardenia jasminoides Ellis of Rubiaceae has bitter and cold nature, and can cool blood and stop bleeding, and is mainly used for treating hematemesis and epistaxis and diabetes insipidus.
Fermented soybean: is fermented product of mature seed of soybean of Leguminosae, and has bitter taste, pungent taste, and cooling property. Enter lung and stomach meridians. Has effects in relieving exterior syndrome, relieving restlessness, dispersing depressed vital energy, and removing toxic substances. Can be used for treating headache, dysphoria, chest distress, dysphoria, and insomnia.
Thunberg fritillary bulb: bitter and cold. Clearing heat, resolving phlegm, relieving cough, detoxicating, resolving hard mass and resolving carbuncle. Can be used for treating cough due to wind-heat, phlegm-fire, pulmonary abscess, acute mastitis, scrofula, and skin sore.
Bulbus Fritillariae Cirrhosae: is a perennial herb of the genus fritillaria of the family Liliaceae, bitter, sweet and slightly cold. Clearing heat and moistening lung, resolving phlegm and relieving cough, resolving masses and resolving carbuncles. Can be used for treating cough due to lung heat, dry cough with little phlegm, cough due to yin deficiency, blood in phlegm, scrofula, acute mastitis, and pulmonary abscess.
Radix Platycodi: bitter and pungent. Enter lung meridian. Disperse lung, relieve sore throat, eliminate phlegm and expel pus. Can be used for treating cough with excessive phlegm, chest distress, pharyngalgia, hoarseness, pulmonary abscess, and pus discharge.
Ligusticum wallichii: pungent and warm. Enter liver, gallbladder and pericardium meridians. Promoting blood circulation, activating qi-flowing, dispelling pathogenic wind and relieving pain. Can be used for treating chest pain, hypochondrium pain, traumatic injury, menoxenia, amenorrhea, dysmenorrhea, abdominal pain, headache, and rheumatalgia.
Orange leaf: pungent and bitter in flavor, flat in nature, has the actions of soothing liver, regulating qi, relieving swelling, resolving masses, relieving swelling toxin, and treating mammary abscess, and can be used for treating hypochondriac distending pain, especially breast distending pain or caking.
Bombyx Batryticatus: salty, pungent and neutral; enter liver and stomach meridians. Wind-extinguishing and spasm-stopping, phlegm-resolving and mass-resolving, wind-dispelling and pain-relieving. Can be used for treating mumps, liver wind, phlegm, rubella, pruritus, convulsion, conjunctival congestion, and pharyngalgia.
Gecko: salty, cold, and slightly toxic. Has effects of dispelling pathogenic wind, activating collaterals, resolving hard mass, and removing toxic substance. Is mainly used for treating apoplexy paralysis, wind pain in the joints, wind phlegm convulsion epilepsy, scrofula and malignant sore.
Radix Ranunculi Ternati: is annual herb of Ranunculaceae, ranunculus, sweet and pungent; temperature is high; sex level; liver-tonifying; lung meridian; the main functions are as follows: detoxification; resolving phlegm and resolving masses. Mainly treats scrofula; tuberculosis; pharyngitis; furuncle is caused by external injury; snake bite; malaria; migraine; toothache.
Chinese magnoliavine fruit: is dry mature fruit of Schisandra chinensis or Schisandra chinensis of Magnoliaceae Schisandra sphenanthera Rehd.et Wils. Has effects of astringing, invigorating qi, promoting salivation, invigorating kidney, and calming heart. Can be used for treating palpitation, insomnia, nocturnal emission, enuresis, frequent urination, chronic diarrhea, spontaneous perspiration, night sweat, cough, asthma, and internal heat.
Raw licorice: is a leguminous perennial herb with sweet taste. Has effects in invigorating spleen, replenishing qi, clearing away heat and toxic materials, and relieving pain. Can be used for treating weakness of spleen and stomach, asthenia, palpitation, short breath, spasm and pain of stomach and abdomen, limb, carbuncle, swelling, and sore.
The nipple belongs to the liver meridian of jueyin and the breast belongs to the stomach meridian of foot-yang. Liver depression and qi stagnation, spleen and stomach weakness cause disorder of qi and blood circulation of the whole body, are liable to form qi stagnation, blood stasis, phlegm coagulation, damp obstruction and the like, accumulate into tangible pathogenic factors, and the pathogenic factors in the body are not dispersed for a long time, and are liable to become toxic pathogenic factors and develop into breast cancer. Compared with other molecular breast cancers, the triple negative breast cancer has more cancer toxin, the residual toxin is not clear, and the cancer toxin is deposited in the body and is a core pathogenesis of the triple negative breast cancer which is easy to relapse and transfer. Therefore, the treatment emphasizes the elimination of cancer toxin and the prevention of recurrence and metastasis, so as to achieve the purposes of preventing disease before disease and preventing disease from becoming ill. Deficiency, phlegm, blood stasis and toxicity are pathological factors of breast cancer of three yin, and are commonly used for treating the symptoms of phlegm reduction, blood stasis removal, qi regulation and detoxification of rhizoma arisaematis, gecko, fritillary bulb, unibract fritillary bulb and szechuan lovage rhizome, and codonopsis pilosula and bighead atractylodes rhizome are used for strengthening healthy qi. Fructus Schisandrae chinensis is sour and sweet, has effects of invigorating qi, promoting fluid production, invigorating kidney, and promoting radix Glycyrrhizae production. Radix Ranunculi Ternati and radix Platycodi enter lung meridian, regulate lung and resolve phlegm, and firstly, the affected area is left. On the basis, the upper-jiao part of the breast cancer is combined, and medicines such as the charred fructus gardeniae, the fermented soybean, the platycodon grandiflorum, the orange leaf, the white muscardine silkworm and the like are used for entering the upper-jiao part, so that the medicine can be used as a menstruation guiding medicine, and can also clear heat, detoxify, resolve phlegm and dissipate stagnation.
The codonopsis pilosula and the bighead atractylodes rhizome in the prescription are monarch drugs, and are used for strengthening the spleen, tonifying the stomach, supplementing qi, nourishing blood and strengthening healthy energy. The cancer toxin of the patient with triple negative breast cancer is contained in the body, so that the anti-cancer and toxicity-reducing power should be enhanced; modern pharmacological studies have shown that dangshen can act directly on the pituitary to enhance the body's immunity. The prepared rhizoma arisaematis, the thunberg fritillary bulb, the fritillaria cirrhosa, the gecko, the white muscardine silkworm and the ligusticum wallichii are used as ministerial drugs, the thunberg fritillary bulb has stronger bitter diarrhea effect, can detoxify, dissipate stagnation and eliminate carbuncle, has the effects of activating blood circulation to remove blood stasis, soothing liver and strengthening spleen, inhibits proliferation and migration of breast cancer cells, has no obvious inhibition effect on normal breast epithelial cells, and shows excellent pharmacological effects of low toxicity and targeted treatment on breast cancer; chuan Bei mu is clear but not dry, and both are combined with the actions of mainly resolving tumor, resolving masses and removing toxicity. The arisaema tuber has strong toxicity, can remove stubborn phlegm, dredge collaterals and dissipate stagnation, can prevent brain metastasis, belongs to a blood meat loving product, is an effective medicine pair for treating tumors above thoracic diaphragm, is spicy and salty, enters liver and stomach channels, eliminates phlegm and dissipates stagnation, can expel wind and break blood accumulation and package blocks, and can treat tumors, the gecko effective component gecko sulfated polysaccharide has definite effect of enhancing lymphocyte anti-tumor immunity, and the gecko is matched with stiff silkworm to ensure that qi is light and clear and floats upwards, thereby achieving the effect of promoting the digestion of breast phlegm coagulation and stagnation. Modern pharmacological researches show that ligustrazine in Ligusticum wallichii can stabilize the hydrolysate TXB2 of thromboxane A2 in tumor range, has the effect of resisting tumor metastasis, and can improve the blood rheology index by a qi-tonifying and blood-activating method; monarch, minister and minister co-operate to improve the microenvironment for tumor growth. In the recipe, the fructus gardeniae, the fermented soybean, the platycodon grandiflorum, the orange leaf, the radix ranunculi ternati and the schisandra chinensis are taken as adjuvant drugs, the flavor is light, the upper jiao is entered, the fructus gardeniae is lowered but not raised, the fire of heart and lung is relieved, the fermented soybean is raised but not lowered, the stagnation of heat dissipation evil is eliminated, the dysphoria and insomnia of patients with triple negative breast cancer can be improved, and simultaneously, the depression is relieved, the pain is relieved, and the heart and the body are congruent; radix Platycodi has effects of dispersing lung qi, clearing lung-heat, and preventing lung metastasis; orange She Shugan has effects of regulating qi, promoting blood circulation, and activating qi-flowing, avoiding stagnation of qi and blood, eliminating phlegm, removing blood stasis, and promoting toxin generation, and radix Ranunculi Ternati has effects of regulating lung, eliminating phlegm, resolving masses, preventing lung metastasis, invigorating spleen and kidney, and relieving toxicity damage caused by radiotherapy and chemotherapy. The prescription enables the medicines to be the liquorice, can clear heat and detoxify, can tonify spleen and replenish qi, and harmonize various medicines, the whole prescription aims at clearing in-vivo cancer toxin, does not hurt vital qi, really reaches local tumor inhibition and supports whole body vital qi, takes the traditional Chinese medicine thought of 'treating disease', and aims at the characteristic that triple negative breast cancer is easy to relapse and transfer, and the development of cancer toxin is prevented at first without the evil, so that the life cycle of a patient is prolonged, and the life quality of the patient is improved.
Further, the traditional Chinese medicine composition comprises, by weight, 10-15 parts of codonopsis pilosula, 9-30 parts of bighead atractylodes rhizome, 9-15 parts of prepared rhizoma arisaematis, 9-15 parts of fructus gardeniae preparata, 9-12 parts of fermented soybean, 15-30 parts of thunberg fritillary bulb, 9-15 parts of bulbus fritillariae cirrhosae, 9-15 parts of platycodon grandiflorum, 9-20 parts of ligusticum wallichii, 9-20 parts of orange leaf, 9-20 parts of silkworm larva, 5 parts of gecko, 12-15 parts of radix ranunculi ternati, 9-15 parts of schisandra chinensis and 6-10 parts of raw liquorice.
Further, the traditional Chinese medicine composition comprises, by weight, 10-15 parts of codonopsis pilosula, 12-30 parts of bighead atractylodes rhizome, 9-12 parts of prepared rhizoma arisaematis, 9-15 parts of fructus gardeniae, 9-12 parts of fermented soybean, 15-30 parts of fritillary bulb, 9-12 parts of fritillaria cirrhosa, 9-12 parts of platycodon grandiflorum, 9-20 parts of ligusticum wallichii, 9-20 parts of orange leaf, 9-15 parts of silkworm larva, 5 parts of gecko, 12-15 parts of radix ranunculi ternati, 9-15 parts of schisandra chinensis and 6-10 parts of raw liquorice.
Further, the traditional Chinese medicine composition comprises, by weight, 10 parts of codonopsis pilosula, 15 parts of bighead atractylodes rhizome, 9 parts of prepared arisaema tuber, 9 parts of scorched gardenia, 9 parts of fermented soybean, 30 parts of fritillaria thunbergii, 9 parts of fritillaria cirrhosa, 9 parts of platycodon grandiflorum, 12 parts of ligusticum wallichii, 9 parts of orange leaf, 15 parts of silkworm larva, 5 parts of gecko, 15 parts of radix ranunculi ternati, 15 parts of schisandra chinensis and 6 parts of raw liquorice.
Further, the traditional Chinese medicine composition comprises 12 parts of codonopsis pilosula, 20 parts of bighead atractylodes rhizome, 9 parts of prepared arisaema tuber, 9 parts of fructus gardeniae preparata, 9 parts of fermented soybean, 30 parts of fritillaria thunbergii, 9 parts of fritillaria cirrhosa, 12 parts of platycodon grandiflorum, 9 parts of ligusticum wallichii, 9 parts of orange leaf, 15 parts of silkworm larva, 5 parts of gecko, 12 parts of radix ranunculi ternati, 12 parts of schisandra chinensis and 6 parts of raw liquorice.
Further, the traditional Chinese medicine composition comprises 12 parts of codonopsis pilosula, 12 parts of bighead atractylodes rhizome, 9 parts of prepared arisaema tuber, 9 parts of fructus gardeniae preparata, 9 parts of fermented soybean, 30 parts of fritillaria thunbergii, 9 parts of fritillaria cirrhosa, 9 parts of platycodon grandiflorum, 9 parts of ligusticum wallichii, 9 parts of orange leaf, 15 parts of silkworm larva, 5 parts of gecko, 12 parts of radix ranunculi ternati, 12 parts of schisandra chinensis and 6 parts of raw liquorice.
In order to achieve the second object, the present invention adopts the technical scheme that:
the invention discloses a traditional Chinese medicine preparation for treating triple negative breast cancer, which is prepared into decoction, granules, capsules, tablets, powder, pills or oral liquid.
Further, the decoction is prepared according to the following steps:
weighing the raw materials according to the parts by weight, adding water for soaking for 30-40 minutes, and decocting for two times;
wherein, after the first decoction is boiled with strong fire, the first decoction is boiled with slow fire for 30-50 minutes; and (3) boiling the second decoction with strong fire, decocting with slow fire for 20-40 minutes, and removing residues to obtain decoction. Or refining the effective components of the preparation with water or other suitable solvents, adding pharmaceutically acceptable adjuvants, and making into various dosage forms such as granule, tablet, capsule, pill, powder, and oral liquid. Experiments prove that the preparation method and the using method can realize the therapeutic effect of the medicament.
In order to achieve the third object, the present invention adopts the technical scheme that:
the invention discloses an application of a traditional Chinese medicine composition or a traditional Chinese medicine preparation in preparing a medicine for treating triple negative breast cancer.
Further, the application is the application in preparing a medicine for inhibiting proliferation of triple negative breast cancer tumor cells.
Further, the application is the application in preparing a medicine for inhibiting the migration of triple negative breast cancer tumor cells.
Further, the application is the application in preparing a medicament for inhibiting the invasion capacity of triple negative breast cancer tumor cells.
Further, the triple negative breast cancer tumor cells are triple negative breast cancer cell line MDA-MB-231 cells.
The invention has the beneficial effects that:
the invention discloses a traditional Chinese medicine composition for treating triple negative breast cancer, which has the following advantages compared with the formula disclosed in the prior art:
1. the traditional Chinese medicine composition disclosed by the invention can inhibit the proliferation of tumor cells for a patient with breast cancer with syndrome differentiation of qi deficiency and toxin excess in traditional Chinese medicine, can strengthen the root and banking up primordial qi in the consolidation treatment stage after operation or radiotherapy and chemotherapy, prevent recurrence and metastasis, prolong the life cycle of the patient and improve the life quality of the patient. The traditional Chinese medicine composition has the advantages of small side effect, simple preparation, convenient administration, simple material acquisition and low price, and is suitable for long-term administration of patients. For the consolidation treatment stage after triple negative breast cancer operation, or patients who cannot tolerate chemotherapy or cannot operate due to poor physical condition and large tumor load, the medicine can be used for treatment.
2. Compared with the traditional prescription, the traditional Chinese medicine composition for treating the triple negative breast cancer has the advantages that medicines such as the fructus gardeniae preparata, the fermented soybean, the platycodon grandiflorum, the orange leaves and the silkworm larva contained in the traditional Chinese medicine composition are added into upper-jiao, so that the traditional Chinese medicine composition can be used as a menstruation guiding medicine, can clear heat, detoxify and resolve phlegm and dissipate stagnation, and clinical observation shows that the traditional Chinese medicine composition for treating the triple negative breast cancer is high in safety and low in toxic and side effect.
3. The traditional Chinese medicine composition for treating triple negative breast cancer provided by the invention can be conveniently prepared into various dosage forms with pharmaceutical carriers, and is convenient to clinically take.
Detailed Description
In order to more clearly illustrate the present invention, the present invention will be further described with reference to preferred embodiments. It should be understood that the described embodiments are merely some, but not all, embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Example 1
The traditional Chinese medicine composition comprises the following components in parts by weight:
10 parts of codonopsis pilosula, 15 parts of bighead atractylodes rhizome, 9 parts of prepared arisaema tuber, 9 parts of fructus gardeniae preparata, 9 parts of fermented soybean, 30 parts of fritillaria thunbergii, 9 parts of fritillaria cirrhosa, 9 parts of platycodon grandiflorum, 12 parts of ligusticum wallichii, 9 parts of folium citri reticulatae, 15 parts of silkworm larva, 5 parts of gecko, 15 parts of radix ranunculi ternati, 15 parts of schisandra chinensis and 6 parts of raw liquorice.
Weighing the raw materials according to the prescription, adding water for soaking for 30-40 minutes, and decocting twice; wherein, after the first decoction is boiled with strong fire, the first decoction is boiled with slow fire for 40 minutes; and (3) boiling the second decoction with strong fire, decocting with slow fire for 30 minutes, and removing residues to obtain decoction.
Example 2
The traditional Chinese medicine composition comprises the following components in parts by weight:
12 parts of codonopsis pilosula, 20 parts of bighead atractylodes rhizome, 9 parts of prepared arisaema tuber, 9 parts of fructus gardeniae preparata, 9 parts of fermented soybean, 30 parts of fritillaria thunbergii, 9 parts of fritillaria cirrhosa, 12 parts of platycodon grandiflorum, 9 parts of ligusticum wallichii, 9 parts of folium citri reticulatae, 15 parts of silkworm larva, 5 parts of gecko, 12 parts of radix ranunculi ternati, 12 parts of schisandra chinensis and 6 parts of raw liquorice.
Weighing the raw materials according to the prescription, adding water for soaking for 30-40 minutes, and decocting twice; wherein, after the first decoction is boiled with strong fire, the first decoction is boiled with slow fire for 40 minutes; and (3) boiling the second decoction with strong fire, decocting with slow fire for 30 minutes, and removing residues to obtain decoction.
Example 3
The traditional Chinese medicine composition comprises the following components in parts by weight:
12 parts of codonopsis pilosula, 12 parts of bighead atractylodes rhizome, 9 parts of prepared arisaema tuber, 9 parts of fructus gardeniae preparata, 9 parts of fermented soybean, 30 parts of fritillaria thunbergii, 9 parts of fritillaria cirrhosa, 9 parts of platycodon grandiflorum, 9 parts of ligusticum wallichii, 9 parts of folium citri reticulatae, 15 parts of silkworm larva, 5 parts of gecko, 12 parts of radix ranunculi ternati, 12 parts of schisandra chinensis and 6 parts of raw liquorice.
Weighing the raw materials according to the prescription, adding water for soaking for 30-40 minutes, and decocting twice; wherein, after the first decoction is boiled with strong fire, the first decoction is boiled with slow fire for 40 minutes; and (3) boiling the second decoction with strong fire, decocting with slow fire for 30 minutes, and removing residues to obtain decoction.
Clinical trial
1 subject of study
1.1 case Source
The cases originate from the clinic of oncology department in Guangan-Can Hospital in 2 months 2019 to 8 months 2020, and accord with the Western diagnosis standard, the diagnosis is three-negative breast cancer, and the differentiation of the Chinese traditional medicine is the patient with qi deficiency and toxin exuberance. The study was included in 60 patients with triple negative breast cancer, 30 patients with treatment group and 30 patients with control group, the random numbers and the corresponding intervention schemes were placed in sealed, opaque envelopes with numbers attached to the envelopes, and the investigator opened the envelopes in the order of numbers to randomly divide the patients into treatment group and control group.
1.2 diagnostic criteria
1.2.1 Western diagnostic criteria:
the pathological diagnosis standard of the triple negative breast cancer is diagnosed according to the breast cancer diagnosis standard set by the national integrated cancer network National Comprehensive Cancer Network, NCCN (Chinese edition 2020), and the diagnosis standard of Immunohistochemistry (IHC) is referred to the breast cancer female and progestogen receptor immunohistochemical detection guidelines (2015 edition) and the human epidermal growth factor receptor 2 positive breast cancer clinical diagnosis and treatment expert consensus (2016): ER/PR negative: in the case of good staining of the positive and negative controls, tumor nuclei with different degrees of staining or no staining at all <1%; her-2 negative: IHC (+) or IHC (-); IHC (++) and HER-2/CEP17 ratio <2.0 and mean HER-2 copies/cell <4.0. And the patient is determined to be a triple negative breast cancer patient according to the medical history, physical symptoms, tumor markers and imaging examination (such as X-ray, breast ultrasound, molybdenum target, nuclear magnetic resonance and the like) of the patient.
1.2.2 diagnostic criteria for Chinese medical science symptoms:
the diagnosis and treatment standard of the relevant content of the traditional Chinese medicine diagnosis and treatment guide of the tumor traditional Chinese medicine, the traditional Chinese medicine publishing society, the traditional Chinese medicine science, the new traditional Chinese medicine clinical research guiding principle is referred to by the traditional Chinese medicine differentiation, and the diagnosis and treatment standard of qi deficiency and toxin excess syndrome is formulated according to the four diagnosis results of patients under the guidance of doctors of the traditional Chinese medicine, and the clinical manifestations are as follows:
main symptoms are as follows: shortness of breath and weakness; spontaneous perspiration; pale or sallow complexion; breast contact or a bag block; numbness of limbs; skin nail error; tarnish complexion; distending and disintegrating the spleen and stomach or chest; and (5) anorexia.
Secondary symptoms: pale, fat and tender, with teeth marks on the pale edges and dark; weak or thready pulse, wiry and thready pulse.
Has at least 2 main symptoms or 1 main symptom and 2 secondary symptoms, and meets the diagnosis standard.
1.3 inclusion criteria
(1) The age is between 18-80 years old;
(2) the primary triple negative breast cancer patient is diagnosed by surgical pathology examination, and the traditional Chinese medicine syndrome is qi deficiency and toxin exuberance;
(3) through standardized western medicine treatment;
(4) the time for completing radiotherapy and chemotherapy is not more than 6 months when the group is put in;
(5) and signing an informed consent form.
1.4 exclusion criteria
(1) Has bilateral breast cancer or inflammatory breast cancer;
(2) other tumor medical history exists in the past;
(3) those suffering from infectious diseases or immune system diseases which are not yet controlled;
(4) patients with severe heart, liver, kidney and hematopoietic diseases, and uncontrolled;
(5) patients with mental diseases, serious neurological impairment (such as aphasia and aphasia) or other reasons can not be matched with the examination;
(6) other medications are being received.
(7) Allergic to the recipe.
1.5ECOG scoring criteria
Scoring was performed according to Zubrod-ECOG-WHO (ZPS, 5 score method) physical condition ECOG scoring criteria.
1.6 termination or Exit criteria
(1) The patient actively applies for withdrawal from the trial at any time;
(2) the patient dies or the disease progresses. Disease progression is defined by reference to a solid tumor efficacy evaluation criterion (RECIST): for measurable lesions, disease progression is defined as a 20% increase in the sum of the primary target lesion length and its absolute value increased by 5mm, and the appearance of new lesions; for non-measurable lesions, if any new lesions appear, or have a lesion estimation increase of more than 25%, or tumor markers continue to rise in combination with clinical manifestations, can also be assessed as disease progression.
1.7 drop criteria
(1) Violating the requirement of research scheme, and not according to the prescription, the dosage is less than 80% or more than 120%;
(2) poor data recording quality, incomplete data and inaccuracy;
(3) cases in the group due to adverse reactions were not evaluated for efficacy, but their adverse drug reactions should be included in statistics.
1.8 study termination criteria
(1) More than 25% of patients experience more serious adverse events, which are likely to be associated with the intervention drug tested;
(2) external information proves that the intervention scheme is invalid or effective, and the current clinical test is unnecessary to go on;
(3) differences in the expected efficacy are achieved by the planned phase analysis, as has been observed when the intervention regimen for the test group is significantly better than for the control group.
2 treatment regimen
2.1 dosing regimen
The treatment group takes the decoction of the example 2 on the basis of receiving routine nursing, 300ml of the decoction is decocted in water, each time is 1 time in the morning and evening, warm taking is carried out after meal, two months are 1 treatment course, at least 12 months of taking or stopping taking is carried out, and the decoction pieces are provided by Guangan-Men hospital pharmacy of Chinese medical college; the control group is subjected to routine care, and if patients with diseases such as hypertension, diabetes and the like can be subjected to routine treatment according to treatment guidelines such as hypertension, diabetes and the like.
2.2 observations index
2.2.1 main study endpoint:
progression free survival for 3 years (progress free survival, PFS): follow-up observations of patients were made from the onset of randomization to the time of disease progression or death.
2.2.2 secondary study endpoint:
2.2.2.1 quality of life
The quality of life of the two groups of patients was assessed using Karonofsky (karsons, KPS, percent) functional status scoring criteria and the scores before and after treatment were compared. The percentage is increased by more than 10 minutes than the last time, which shows that the quality of life is improved; the living quality is reduced by more than 10 minutes compared with the previous reduction, and the living quality is stable between the two.
Using the breast cancer patient quality of life assay table FACT-B, the quality of life of two groups of patients was evaluated from the following five aspects: physiological conditions, social conditions, emotional conditions, functional conditions, and other items of interest, and comparing the scores of the two sets before and after treatment. Each entry uses 5 rank scoring: "neither" is level 0, "one" is level 1, "normal" is level 2, "quite" is level 3, and "quite" is level 4. Class 0 counts 0 points, class 1 counts 1 points, and so on, the higher the score, the poorer the quality of life.
2.2.2.2 integration of the syndrome in TCM
The evaluation criteria of the breast cancer traditional Chinese medicine symptoms grading quantification are respectively evaluated at the time of group entry and the time of follow-up by referring to the related content of the Chinese medicine new medicine clinical research guidelines. A total score was 4 criteria, each of which was: the treatment effect was evaluated using a treatment effect criterion formula without score 0, with a mild score of 1, a moderate score of 2, and a severe score of 3: syndrome accumulation ratio= [ (pre-treatment integral-post-treatment integral)/pre-treatment integral ] x100%, set: the method has the advantages that: more than or equal to 70 percent, and partially improves: the integral ratio of the syndrome is less than 70% and is not effective: the syndrome accumulation ratio is less than 30%.
2.4 follow-up plans
The follow-up was calculated from the first day of treatment and the final follow-up date was 2022, 8 months and 10 days, and subjects were followed up one time 3-6 months after the group. The follow-up content is as follows: (1) inquiring about clinical symptoms; (2) collecting review laboratory inspection and image data; (3) inquiring the medication condition; (4) collecting and scoring life quality information by using a KPS scoring scale and a breast cancer patient life quality measuring scale FACT-B; (5) recording the existence, type, occurrence time, duration, degree and alleviation mode of the adverse event.
2.5 statistical methods
Clinical data of 60 patients taken in are analyzed and sorted by SPSS26.0 data statistics software, and all data are analyzed by descriptive statistics, including demographics, baselines, efficacy evaluation indexes and the like. For metering data, normal distribution inspection is carried out, data conforming to normal distribution is inspected by an independent sample t, the average value, standard deviation, median, maximum value and minimum value of the data are described, and a 95% credible interval of the average value is calculated; data that do not fit the normal distribution uses a non-parametric rank sum test. Aiming at counting data, adopting chi-square test to describe the frequency and percentage of the counting data, and not meeting the Fisher accurate test method; and calculates the 95% confidence interval for that percentage. Aiming at the basic clinical data of patients and the correlation study of curative effect indexes before and after group treatment and three-year progression-free survival rate, a Logistic regression model is adopted to analyze single factors and multiple factors, and independent prognosis factors affecting PFS are calculated, wherein P < 0.05 is statistically significant difference.
3. Results of the study
3.1 patient baseline data
3.1.1 two groups of patient general data
Collecting the patients which are diagnosed as triple-negative breast cancer according with Western diagnosis standards and are treated by the department of oncology clinic of Guangdong Hospital and the department of oncology clinic from 2 months in 2019 to 8 months in 2020, and taking 60 patients according to the nano-ranking standard. The basic data of the cases included in the study can be seen in Table 1.
Table 1 triple negative breast cancer patient baseline
3.1.2. Comparison of general data for two groups of patients
3.1.2.1 age comparisons of two groups of patients
The patient ages of the treatment group and the control group were in accordance with normal distribution, and the two groups were tested for variability using independent sample t-test, and the results showed no statistical difference in the ages of the two groups (p=0.945 > 0.05), as shown in table 2.
Table 2 age comparison of two groups of patients (mean.+ -. Standard deviation)
3.1.2.2 two groups of patients were compared for tumor diameter size, pathology type, ki-67.
The differences were tested by using chi-square test for tumor diameter and Fisher exact test for pathology type for the treatment group versus control group patients, ki-67, and the results showed that the two groups were not statistically different (P > 0.05) in the above-described comparison, as shown in Table 3.
TABLE 3 comparison of tumor diameter size, pathological type, ki-67 for two groups of patients
3.1.2.3 comparison of BRCA1/2 Gene mutation status in two groups of patients
The differences between the BRCA1/2 gene mutation cases of the treatment group and the control group patients are tested by using a chi-square test, and the results show that the two BRCA1/2 gene mutation cases have no statistical difference compared with each other (P=0.184 > 0.05), and are shown in table 4.
TABLE 4 comparison of BRCA1/2 Gene mutation in two groups of patients
3.1.2.4 comparison of lymph node metastasis in two groups of patients
The differences between the lymph node metastasis of the treated group and the control group were examined by using the chi-square test, and the results showed that there was no statistical difference between the lymph node metastasis of the two groups of patients (p= 0.793 > 0.05), as shown in table 5.
Table 5 two groups of patient transfer cases
3.1.2.5 comparison of quality of life for two groups of patients
The treatment group and the control group patients have KPS scores and FACT-B scale scores which accord with normal distribution, and the two groups of differences are tested by using independent sample t test, so that the results show that the two groups of KPS scores and FACT-B scale scores have no statistical difference (P=0.915 > 0.05 and P=0.939 > 0.05), and the results are shown in table 6.
Table 6 quality of life scores for two groups of patients
3.1.2.6 Chinese medicine syndrome integral comparison of two groups of patients
The Chinese medicine syndrome integral of the treatment group and the control group of patients accords with normal distribution, the two groups of differences are checked by using independent sample t test, and the results show that the two groups of Chinese medicine syndrome integral have no statistical difference (P=0.633 > 0.05), and the results are shown in table 7.
TABLE 7 integration of TCM syndrome for two groups of patients when they were entered into group
3.2 observations of index results
3.2.1.3 Progression Free Survival (PFS)
In the study, 60 triple negative breast cancer patients are included, and no shedding occurs in the control group and the treatment group. Wherein the 3-year progression-free survival of the treatment group was 90% (27/30), and the control group was 70% (21/30). Wherein 30 patients in the treatment group have no progress survival more than or equal to 1 year, 1 patient has no progress survival (2 years > PFS more than or equal to 1 year), and 2 patient has no progress survival (3 years > PFS more than or equal to 2 years); the progression free survival of 1 patient out of 30 patients in the control group was <1 year, of 5 patients (2 years > PFS. Gtoreq.1 year), of 3 patients (3 years > PFS. Gtoreq.2 years), as shown in Table 8.
Table 8 Progression Free Survival (PFS) for two groups of patients
3.2.2. Quality of life evaluation
Two groups of patients enrolled were scored for KPS, face-B scale at month 6, 12, 21, respectively, during follow-up. The results show that:
after 6 months of the group, 30 patients were treated and 30 patients were control.
The KPS score of the treatment group was better than that of the control group with statistical differences (p=0.04 < 0.05); there was no statistical difference before and after treatment and control KPS scoring interventions.
The quality of life of the treatment group is scored better than the control group by the FACT-B scale, and has statistical difference (P=0.043 < 0.05); the treatment group FACT-B scale scoring dry prognosis is superior to that before intervention, with statistical difference (P=0.024 < 0.05), and the control group FACT-B scale scoring dry prognosis is not statistically different than that before intervention.
After 12 months of the group, 29 patients in the treatment group and 28 patients in the control group.
The KPS scores of the treatment group were better than the control group with statistical differences (p=0.000 < 0.05); the KPS scores of the patients in the treatment group had better prognosis than before the intervention, and had statistical difference (p=0.000 < 0.05), while the KPS scores of the patients in the control group had no statistical difference before and after the intervention.
The quality of life of the treatment group is scored better than the control group by the FACT-B scale, and has statistical difference (P=0.000 < 0.05); the treatment group FACT-B scale scoring dry prognosis is superior to that before intervention, and has statistical difference (P=0.001 < 0.050), and the control group FACT-B scale scoring dry prognosis has no statistical difference compared with that before intervention.
After 21 months into the group, 29 patients in the treatment group and 27 patients in the control group.
The KPS score of the treatment group was better than that of the control group with statistical differences (p=0.002 < 0.05); the treatment group KPS scores were better dry than before the intervention and had statistical differences (p=0.005 < 0.05), and the control group KPS scores were not statistically different.
The quality of life of the treatment group is better than that of the control group, and the treatment group has statistical difference (P=0.026 < 0.05); the treatment group FACT-B scale scoring dry prognosis is superior to that before intervention, with statistical difference (P=0.000 < 0.050), and the control group FACT-B scale scoring dry prognosis is not statistically different than that before intervention.
The KPS scoring results for two of the groups of patients are shown in table 9. The difference in KPS scores and FACT-B scale scores for the two groups of patients is shown in tables 10 and 11.
Table 9 KPS scoring results before and after two groups of patient interventions
Table 10 KPS score differences before and after two groups of patient interventions
Compared to the baseline of the present group (case of group entry):
treatment group 6 months later compared to baseline for this group: t= -0.372, p=0.712; comparison to this group baseline 12 months after group entry: t= -5.704, p=0.000; comparison to this group baseline after 21 months into group: t= -3.023, p=0.005. Control group was compared to this group baseline 6 months after group entry: t= -0.254, p=0.861; comparison to this group baseline 12 months after group entry: t=0.777, p=0.447; comparison to this group baseline after 21 months into group: t=0.450, p=0.665.
The same time point is compared with two groups:
after 6 months, the treatment group was compared with the control group: t=2.102, p=0.04; after 12 months, the treatment group was compared with the control group: t=5.273, p=0.000; after 21 months, the treatment group was compared with the control group: t=3.590, p=0.002.
Table 11 quality of life FACT-B scale scoring results before and after intervention in two groups of patients
Both groups were compared to the baseline of the present group (case at the time of group entry), respectively, and 6 months after treatment group entry was compared to the baseline of the present group: t= -2.120, p=0.024; comparison to this group baseline 12 months after group entry: t= -7.205, p=0.000; comparison to this group baseline after 21 months into group: t= -5.150, p=0.000. Control group was compared to this group baseline 6 months after group entry: t=1.306, p=0.202; comparison to this group baseline 12 months after group entry: t=0.552, p=0.588; comparison to this group baseline after 21 months into group: t= -1.210, p=0.261.
Two groups at the same time point were compared, and after 6 months, the treatment group was compared with the control group: t=2.071, p=0.043; after 12 months, the treatment group was compared with the control group: t=3.726, p=0.001; after 21 months, the treatment group was compared with the control group: t=2.382, p=0.026.
3.2.3. Integral evaluation of Chinese medicine syndrome
The evaluation of the efficacy of the traditional Chinese medicine syndrome treatment was carried out on two groups of patients who were in the group at the 6 th, 12 th and 21 th months of the follow-up period, and the results are shown in Table 12:
the improvement rate was statistically significant (p=0.001 < 0.05) after 6 months in the treatment group, statistically significant (p=0.019 < 0.05) after 12 months in the group, and statistically significant (p=0.002 < 0.05) after 21 months in the group, as compared with the control group.
Table 12 scoring results of Chinese medical Condition after two groups of patients intervene
Note that: a: x-shaped articles 2 ＝18.326，P＝0.001；b：χ 2 =14.971, p=0.019; c: fisher value=13.792, p=0.002.
3.2.4. PFS-related influence factor analysis
The two groups of patients are respectively subjected to Logistic regression analysis by taking the group-entering type, age, tumor diameter size, pathological type, ki-67, lymph node metastasis condition and BRCA1/2 gene mutation as covariates and taking the three-year survival rate as dependent variables to obtain possible influence factors related to PFS. The results show that: whether the traditional Chinese medicine is intervened, the tumor diameter and the lymph node metastasis affect the survival rate of the patient for 3 years, wherein the tumor diameter and the lymph node metastasis are dangerous factors of the progression-free survival time of the patient with triple negative breast cancer, whether the traditional Chinese medicine is intervened is a protective factor (P is less than 0.05) of the progression-free survival time of the patient with triple negative breast cancer, and as shown in table 13, the traditional Chinese medicine intervention can prolong the progression-free survival time of the patient with triple negative breast cancer.
TABLE 13 results of PFS multifactor Logistic analysis
It should be understood that the foregoing examples of the present invention are provided merely for clearly illustrating the present invention and are not intended to limit the embodiments of the present invention, and that various other changes and modifications may be made therein by one skilled in the art without departing from the spirit and scope of the present invention as defined by the appended claims.
Claims (10)
1. A traditional Chinese medicine composition for treating triple negative breast cancer is characterized by comprising radix codonopsitis, bighead atractylodes rhizome, prepared arisaema tuber, fructus gardeniae preparata, fermented soybean, fritillaria thunbergii, fritillaria cirrhosa, platycodon grandiflorum, ligusticum wallichii, folium citri reticulatae, silkworm larva, gecko, radix ranunculi ternati, schisandra chinensis and raw liquorice.
2. The traditional Chinese medicine composition according to claim 1, which is characterized by comprising, by weight, 10-15 parts of codonopsis pilosula, 9-30 parts of bighead atractylodes rhizome, 9-15 parts of prepared arisaema tuber, 9-15 parts of fructus gardeniae, 9-12 parts of fermented soybean, 15-30 parts of fritillaria thunbergii, 9-15 parts of fritillaria cirrhosa, 9-15 parts of platycodon grandiflorum, 9-20 parts of ligusticum wallichii, 9-20 parts of orange leaf, 9-20 parts of silkworm larva, 5 parts of gecko, 12-15 parts of radix ranunculi ternati, 9-15 parts of schisandra chinensis and 6-10 parts of raw liquorice.
3. The traditional Chinese medicine composition according to claim 1, which is characterized by comprising, by weight, 10-15 parts of codonopsis pilosula, 12-30 parts of bighead atractylodes rhizome, 9-12 parts of prepared arisaema tuber, 9-15 parts of scorched gardenia, 9-12 parts of fermented soybean, 15-30 parts of fritillary bulb, 9-12 parts of unibract fritillary bulb, 9-12 parts of platycodon root, 9-20 parts of szechuan lovage rhizome, 9-20 parts of orange leaf, 9-15 parts of white stiff silkworm, 5 parts of gecko, 12-15 parts of radix ranunculi ternati, 9-15 parts of shizandra berry and 6-10 parts of raw liquorice.
4. The traditional Chinese medicine composition according to claim 1, which is characterized by comprising 10 parts of codonopsis pilosula, 15 parts of bighead atractylodes rhizome, 9 parts of prepared arisaema tuber, 9 parts of fructus gardeniae preparata, 9 parts of fermented soybean, 30 parts of fritillaria thunbergii, 9 parts of fritillaria cirrhosa, 9 parts of platycodon grandiflorum, 12 parts of ligusticum wallichii, 9 parts of folium citri reticulatae, 15 parts of silkworm larva, 5 parts of gecko, 15 parts of radix ranunculi ternati, 15 parts of schisandra chinensis and 6 parts of raw liquorice.
5. The traditional Chinese medicine composition according to claim 1, which is characterized by comprising 12 parts of codonopsis pilosula, 20 parts of bighead atractylodes rhizome, 9 parts of prepared arisaema tuber, 9 parts of fructus gardeniae preparata, 9 parts of fermented soybean, 30 parts of fritillaria thunbergii, 9 parts of fritillaria cirrhosa, 12 parts of platycodon grandiflorum, 9 parts of ligusticum wallichii, 9 parts of folium citri reticulatae, 15 parts of silkworm larva, 5 parts of gecko, 12 parts of radix ranunculi ternati, 12 parts of schisandra chinensis and 6 parts of raw liquorice.
6. The traditional Chinese medicine composition according to claim 1, which is characterized by comprising 12 parts of codonopsis pilosula, 12 parts of bighead atractylodes rhizome, 9 parts of prepared arisaema tuber, 9 parts of fructus gardeniae preparata, 9 parts of fermented soybean, 30 parts of fritillaria thunbergii, 9 parts of fritillaria cirrhosa, 9 parts of platycodon grandiflorum, 9 parts of ligusticum wallichii, 9 parts of folium citri reticulatae, 15 parts of silkworm larva, 5 parts of gecko, 12 parts of radix ranunculi ternati, 12 parts of schisandra chinensis and 6 parts of raw liquorice.
7. A traditional Chinese medicine preparation for treating triple negative breast cancer, which is characterized in that the traditional Chinese medicine composition of any one of claims 1-6 is prepared into decoction, granules, capsules, tablets, powder, pills or oral liquid.
8. The Chinese medicinal preparation according to claim 7, wherein the decoction is prepared according to the following steps:
weighing the raw materials according to the parts by weight, adding water for soaking for 30-40 minutes, and decocting for two times;
wherein, after the first decoction is boiled with strong fire, the first decoction is boiled with slow fire for 30-50 minutes; and (3) boiling the second decoction with strong fire, decocting with slow fire for 20-40 minutes, and removing residues to obtain decoction.
9. Use of a traditional Chinese medicine composition according to any one of claims 1-6 or a traditional Chinese medicine preparation according to any one of claims 7-8 in the preparation of a medicament for treating triple negative breast cancer.
10. The use according to claim 9, wherein the use is in the manufacture of a medicament for inhibiting the proliferation, migration or invasive capacity of triple negative breast cancer tumor cells.
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| 刘东梅: "乳腺癌术后用疏肝解郁化痰法调治", 中国实验方剂学杂志, vol. 17, no. 06, 20 March 2011 (2011-03-20), pages 290 - 291 * |
| 张冬妮: ""三辨"论治乳腺癌", 世界中医药, vol. 15, no. 04, 31 March 2020 (2020-03-31), pages 617 - 622 * |
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