Traditional Chinese medicine preparation for treating climacteric syndrome in breast cancer endocrine therapy

Abstract

The invention provides a traditional Chinese medicine preparation for treating climacteric syndrome in breast cancer endocrine therapy, and belongs to the technical field of traditional Chinese medicine preparations. The traditional Chinese medicine preparation comprises 9-12 g of radix bupleuri, 9-15 g of scutellaria baicalensis, 9-15 g of rhizoma pinelliae preparata, 15-30 g of codonopsis pilosula, 9-15 g of cassia twig, 9-15 g of radix paeoniae alba, 9-15 g of calcined dragon bone, 9-15 g of calcined oyster shell, 15-30 g of rhizoma acori graminei, 9-15 g of radix curcumae, 9-15 g of roasted turtle shell, 9 g of ginger and 9 g of jujube. The traditional Chinese medicine preparation can effectively relieve symptoms such as chest and hypochondrium distension and stuffiness, depression, dysphoria and other emotion regulation, hypochondrium pain and the like of patients with breast cancer endocrine therapy climacteric syndromes.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine preparations, and particularly to a traditional Chinese medicine preparation for treating climacteric syndrome in endocrine therapy for breast cancer. Background Art

[0002] Breast cancer is the most common malignant tumor among women in China, and about 60% - 70% of them are hormone-dependent. Patients diagnosed with hormone receptor-positive need adjuvant endocrine therapy for up to 5 - 10 years, which can significantly prolong the survival period. However, while reducing the recurrence (50%) and death risks, it can also lead to dysfunction of the human neuro-endocrine-immune-metabolism network, ovarian function decline, relative or absolute deficiency of estrogen and progesterone secretion in the body, and premature appearance of hot flashes, sweating, irritability, insomnia, mood instability, decreased libido, joint pain, osteoporosis and other symptoms similar to menopause. The high cost of cancer treatment and these discomforts seriously affect the quality of life and treatment compliance of patients, and premature discontinuation of endocrine therapy even affects the cancer outcome.

[0003] Currently, the best treatment methods include non-hormonal drug treatments such as serotonin reuptake inhibitors (SSRI), norepinephrine reuptake inhibitors (SNRIs), centrally active drugs, and traditional herbal medicine (black cohosh), which can relieve the climacteric symptoms of patients by reducing the occurrence frequency of hot flashes and night sweats (HFNS); cognitive behavioral therapy can be an important alternative or complementary treatment option for breast cancer patients, with additional benefits for mood, sleep and quality of life. Due to the lack of awareness and confidence in the existing treatment options, most breast cancer patients experiencing climacteric syndrome do not receive any treatment.

[0004] The menopausal syndrome-like symptoms induced by endocrine therapy for breast cancer refer to a group of symptoms similar to those of menopause that occur in breast cancer patients after receiving endocrine therapy. Mainly, endocrine therapy indirectly or directly affects estrogen secretion, causing some breast cancer patients to experience symptoms and manifestations similar to those of menopausal syndrome, such as hot flashes, night sweats, insomnia, palpitations, irritability, and emotional depression. The pathogenesis of the menopausal syndrome-like symptoms caused by endocrine therapy in Western medicine is still unclear. However, some scholars have put forward a new view, that is: due to the decrease in hormone levels in women, it leads to changes in some neurotransmitters related to hypothalamic temperature regulation, such as gonadotropin-releasing hormone, 5-hydroxytryptamine, β-endorphin, luteinizing hormone, follicle-stimulating hormone, etc. At the same time, Tang Jia et al. established a hot flash model by intragastric administration of tamoxifen to rats and measured the tail temperature. The results showed that the tail temperature of rats gradually increased from the 12th to the 28th day, and the E2 level of model rats was significantly lower than that of normal rats. Thus, it can be seen that the hot flashes caused by tamoxifen are closely related to low hormone levels. Freedman's research also found that estrogen decline is involved in the occurrence of hot flashes, but its specific mechanism is unclear. The Western medicine treatment of the menopausal syndrome-like symptoms induced by endocrine therapy for breast cancer includes non-hormonal therapy and hormonal therapy. Because hormonal therapy will increase the risk of breast cancer recurrence and metastasis, therefore, its main treatment method is non-hormonal therapy, which includes drug and non-drug therapies. Controlling weight and diet, acupuncture, yoga and relaxation training, cognitive behavioral therapy, hypnotherapy, and stellate ganglion block belong to non-drug therapies. Drug treatments include oryzanol, venlafaxine, clonidine, gabapentin, etc. Li Huiling et al. found that black cohosh preparations can relieve menopausal syndrome-like symptoms, and the incidence of adverse events such as vaginal bleeding and breast tenderness is lower. Liu Yulong found that clonidine can significantly reduce the frequency of hot flashes, but it is prone to adverse reactions such as hypotension, constipation, and a significant increase in blood pressure induced by suddenly stopping taking the drug. The literature shows that venlafaxine, paroxetine, and gabapentin seem to be able to effectively reduce the frequency and severity of hot flashes. Studies have found that SSRIs can relieve hot flashes. Carroll et al.'s research showed that paroxetine hydrochloride can relieve hot flashes in breast cancer patients taking tamoxifen, but at the same time, it will also increase the mortality rate of breast cancer and cause moderate to severe adverse reactions, the most common of which are drowsiness and nausea. Studies have shown that the effective rate of black cohosh extract in the treatment of hot flashes is 90.20%, and it can increase estrogen levels. Studies have shown that the use of Remifemin can reduce perimenopausal symptoms with hormone-like reactions. The Western medicine treatments for the menopausal syndrome-like symptoms induced by endocrine therapy for breast cancer all have varying degrees of side effects.

[0005] Therefore, it has important practical significance to provide a traditional Chinese medicine preparation for preventing and treating the menopausal syndrome-like symptoms of breast cancer with fewer adverse reactions and better effects. Summary of the Invention

[0006] The object of the present invention is to provide a traditional Chinese medicine preparation for treating climacteric syndrome caused by endocrine therapy for breast cancer, aiming to solve the technical problem that in the prior art, both Western medicine and traditional Chinese medicine have varying degrees of side effects in the treatment of climacteric syndrome induced by endocrine therapy for breast cancer.

[0007] In order to achieve the above object of the invention, the present invention provides the following technical solutions:

[0008] The present invention provides a traditional Chinese medicine preparation for treating climacteric syndrome caused by endocrine therapy for breast cancer, comprising the following components:

[0009] Bupleurum chinense, Scutellaria baicalensis, Pinellia ternata, Codonopsis pilosula, Cinnamomum cassia, Paeonia lactiflora, Calcined Os Draconis, Calcined Concha Ostreae, Acorus tatarinowii, Curcuma aromatica, Steamed Carapax Trionycis, Zingiber officinale and Ziziphus jujuba.

[0010] Further, the masses of the components are as follows: 9 - 12 g of Bupleurum chinense, 9 - 15 g of Scutellaria baicalensis, 9 - 15 g of Pinellia ternata, 15 - 30 g of Codonopsis pilosula, 9 - 15 g of Cinnamomum cassia, 9 - 15 g of Paeonia lactiflora, 9 - 15 g of Calcined Os Draconis, 9 - 15 g of Calcined Concha Ostreae, 15 - 30 g of Acorus tatarinowii, 9 - 15 g of Curcuma aromatica, 9 - 15 g of Steamed Carapax Trionycis, 9 g of Zingiber officinale and 9 g of Ziziphus jujuba.

[0011] The present invention also provides a preparation method of the traditional Chinese medicine preparation for treating climacteric syndrome caused by endocrine therapy for breast cancer according to the above technical solution, comprising the following steps:

[0012] ① Select a casserole as the utensil.

[0013] ② Soak all the components in clean cold water for not less than half an hour, and the amount of water should be higher than the surface of the medicine to ensure that the medicinal materials fully absorb water;

[0014] ③ When decocting, first break the Steamed Carapax Trionycis, Calcined Os Draconis and Calcined Concha Ostreae, wrap them in a cloth bag and put them into the pot to prevent scattering, and decoct for 20 minutes first;

[0015] ④ Decoct the remaining medicine together (already soaked), bring to a boil over high heat, and then simmer for another 20 minutes to fully blend the medicinal properties;

[0016] ⑤ Repeat the steps ① - ④ once again, and the decocting time for the second decoction should be slightly shorter than that for the first decoction;

[0017] ⑥ During the whole decocting process, keep stirring to prevent the medicinal materials from sticking to the pot. After decocting is completed, filter out the medicinal residues to obtain the traditional Chinese medicine preparation for treating climacteric syndrome caused by endocrine therapy for breast cancer.

[0018] Compared with the prior art, the technical solution of the present invention has the following beneficial effects:

[0019] In the traditional Chinese medicine preparation of the present invention, Bupleurum chinense and Scutellaria baicalensis are added. The combination of Bupleurum chinense and Scutellaria baicalensis can relieve symptoms such as chest and hypochondrium distension and oppression, depression, irritability and other mood regulation, and hypochondrium pain in perimenopausal syndrome-like; the present invention also adds Pinellia ternata and ginger, and the combination of the two has the effects of regulating the spleen and stomach and promoting the qi movement downward; in addition, Codonopsis pilosula is commonly used to replace Ginseng in clinical medicine. Codonopsis pilosula, ginger and jujube are also added in the present invention. The combination of Codonopsis pilosula, ginger and jujube can regulate the spleen and stomach, make the qi and blood of the whole body smooth, and has a good therapeutic effect on symptoms such as fatigue, insomnia due to deficiency of vital energy, loss of appetite, sweating in perimenopausal syndrome-like; Dragon's Bone, Oyster Shell and Acorus tatarinowii can calm the mind and soothe the nerves, and can effectively relieve symptoms such as hot flashes and sweating, irritability, palpitations, difficulty in falling asleep, frequent waking up from dreams, nightmares during sleep, timidity and easy startle, nervousness, dizziness in perimenopausal syndrome-like; the compatibility of Cinnamon Twig and White Peony Root can regulate qi and blood, warm and dredge the meridians, make the body more flexible, and is beneficial to relieve symptoms such as chest distension and dysphoria in patients with perimenopausal syndrome-like. Curcuma aromatica Salisb. can coordinate with Cinnamon Twig and White Peony Root, soothe the liver and purge fire, calm the mind, and relieve the irritability and other emotions of patients; Curcuma aromatica Salisb. can promote qi and blood circulation, and when combined with Steamed Turtle Shell, it can enter the yin aspect to clear heat and remove steaming, and reduce the drug side effects such as hot flashes and sweating in patients. Detailed implementation mode

[0020] The pathogenesis of the climacteric syndrome caused by endocrine therapy in Western medicine is still unclear. However, some scholars have put forward a new view, that is, due to the decrease in hormone content in women's bodies, some neurotransmitter changes related to hypothalamic temperature regulation have occurred, such as gonadotropin-releasing hormone, 5-hydroxytryptamine, β-endorphin, luteinizing hormone, follicle-stimulating hormone, etc. At the same time, Tang Jia et al. established a hot flash model by intragastric administration of tamoxifen to rats and measured the tail temperature. The results showed that the tail temperature of rats gradually increased from the 12th to the 28th day, and the E2 level of the model rats was significantly lower than that of normal rats. It can be seen that the hot flashes caused by tamoxifen are closely related to low hormone levels. Freedman's research also found that estrogen decline is involved in the occurrence of hot flashes, but its specific mechanism is unclear. The Western medicine treatment of the climacteric syndrome induced by breast cancer endocrine therapy includes non-hormonal therapy and hormonal therapy. Because hormonal therapy will increase the risk of breast cancer recurrence and metastasis, so its main treatment method is non-hormonal therapy, which includes drug and non-drug therapies. Controlling weight and diet, acupuncture, yoga and relaxation training, cognitive behavioral therapy, hypnotherapy and stellate ganglion block belong to non-drug therapies. Drug treatments include oryzanol, venlafaxine, clonidine, gabapentin, etc. Li Huiling et al. found that black cohosh preparations can relieve climacteric symptoms, and the incidence of adverse events such as vaginal bleeding and breast distension pain is lower. Liu Yulong found that clonidine can significantly reduce the frequency of hot flashes, but it is prone to adverse reactions such as hypotension, constipation and a significant increase in blood pressure induced by suddenly stopping taking the drug. The literature shows that venlafaxine, paroxetine and gabapentin seem to be able to effectively reduce the frequency and severity of hot flashes. Research has found that SSRIs can relieve hot flashes. Carroll et al.'s research showed that paroxetine hydrochloride can relieve the hot flashes of breast cancer patients taking tamoxifen, but at the same time, it will also increase the mortality of breast cancer and cause moderate to severe adverse reactions, the most common of which are drowsiness and nausea. Research shows that the effective rate of black cohosh extract in the treatment of hot flashes is 90.20%, and it can increase estrogen levels. Research shows that the hormone-like reaction of using Remifemin can relieve perimenopausal symptoms. The Western medicine treatments for the climacteric syndrome induced by breast cancer endocrine therapy all have varying degrees of side effects.

[0021] Therefore, it has important practical significance to provide a traditional Chinese medicine preparation for preventing and treating the climacteric syndrome of breast cancer with fewer adverse reactions and better effects.

[0022] The present invention provides a traditional Chinese medicine preparation for the climacteric syndrome caused by breast cancer endocrine therapy, comprising the following components:

[0023] Bupleurum chinense, Scutellaria baicalensis, Pinellia ternata, Codonopsis pilosula, Cinnamomum cassia, Paeonia lactiflora, calcined dragon bone, calcined oyster, Acorus tatarinowii, Curcuma aromatica, roasted turtle shell, ginger and jujube.

[0024] In the present invention, the masses of the components are preferably: 9-12g of bupleurum, 9-15g of scutellaria, 9-15g of pinellia, 15-30g of codonopsis, 9-15g of cinnamon twig, 9-15g of white peony root, 9-15g of calcined dragon bone, 9-15g of calcined oyster shell, 15-30g of calamus, 9-15g of curcuma, 9-15g of roasted turtle shell, 9g of ginger and 9g of jujube.

[0025] The Chinese medicine preparation of the present invention contains bupleurum and scutellaria, which can be used together to relieve symptoms such as chest and rib distension, depression, irritability, and other emotional regulation, as well as rib pain in menopausal syndrome.

[0026] The present invention also adds pinellia tuber and ginger, which together have the effects of regulating the spleen and stomach, and promoting the flow of qi.

[0027] In addition, in clinical practice, Codonopsis pilosula is often used as a substitute for ginseng. The present invention also adds Codonopsis pilosula, ginger and jujube. The combination of Codonopsis pilosula, ginger and jujube can regulate the spleen and stomach, make the whole body's qi and blood flow smoothly, and has a good therapeutic effect on fatigue, insomnia due to insufficient vital energy, loss of appetite, sweating and other symptoms in menopausal syndrome.

[0028] The dragon bone, oyster and calamus in the present invention can calm the mind and effectively relieve the symptoms of menopausal syndrome such as hot flashes, sweating, irritability, palpitations, difficulty falling asleep, frequent dreams and easy awakening, nightmares during sleep, timidity, nervousness, dizziness, etc.

[0029] The cinnamon twig and white peony root used in the present invention can regulate qi and blood, warm and dredge meridians, make the body more flexible, and help relieve the symptoms of chest distension and depression in patients with menopausal syndrome. Curcuma can coordinate with cinnamon twig and white peony root to soothe the liver and purge fire, calm the mind, and relieve the patient's irritability. Curcuma can move and disperse, promote blood circulation and qi, and can be used together with roasted turtle shell to enter the yin part to reduce fever and eliminate steaming, and reduce the patient's drug side effects such as hot flashes and sweating.

[0030] The present invention also provides a method for preparing the Chinese medicine preparation, comprising the following steps:

[0031] ①Use a casserole as the container.

[0032] ② Soak all components in clean cold water for no less than half an hour, with the amount of water being higher than the surface of the medicine to ensure that the medicine fully absorbs water;

[0033] ③ When decocting, first break up the roasted turtle shell, calcined dragon bone, and calcined oyster, wrap them in a cloth bag and put them into the pot to prevent them from falling apart, and decoct for 20 minutes;

[0034] ④Decoction the remaining herbs (which have been soaked in advance), bring to a boil over high heat, then simmer over low heat for another 20 minutes to allow the medicinal properties to fully blend;

[0035] ⑤ Repeat steps ① - ④ once again. The decocting time for the second decoction should be slightly shorter than that of the first decoction.

[0036] ⑥ During the entire decocting process, continuous stirring is required to prevent the medicinal materials from sticking to the pot. After the decocting is completed, filter out the medicinal residues to obtain the traditional Chinese medicine preparation for treating climacteric syndrome in breast cancer endocrine therapy.

[0037] In the present invention, unless otherwise specified, the raw materials required for preparation are all commercially available products well-known to those skilled in the art.

[0038] The following provides a detailed description of the technical solutions provided by the present invention in conjunction with embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0039] Example 1

[0040] ① Select a casserole as the utensil.

[0041] ② Soak all components in clean cold water for 40 minutes. The amount of water should be higher than the surface of the medicinal materials to ensure that the medicinal materials are fully hydrated.

[0042] ③ When decocting, first break 9g of roasted turtle shell, 9g of calcined dragon bone, and 9g of calcined oyster shell, wrap them in a cloth bag and put them into the pot to prevent scattering, and decoct for 20 minutes first.

[0043] ④ Then decoct 9g of bupleurum, 9g of scutellaria baicalensis, 9g of pinellia ternata, 15g of codonopsis pilosula, 9g of cinnamon twig, 9g of white peony root, 15g of acorus tatarinowii, 9g of curcuma aromatica, 9g of ginger, and 9g of jujube together (already soaked in advance), bring to a boil over high heat, and then simmer for another 20 minutes to fully blend the medicinal properties.

[0044] ⑤ Repeat steps ① - ④ once again. The decocting time for the second decoction should be slightly shorter than that of the first decoction.

[0045] ⑥ During the entire decocting process, continuous stirring is required to prevent the medicinal materials from sticking to the pot. After the decocting is completed, filter out the medicinal residues to obtain the traditional Chinese medicine preparation for treating climacteric syndrome in breast cancer endocrine therapy.

[0046] Application Example 1

[0047] Use the traditional Chinese medicine preparation obtained in Example 1 for patients with climacteric syndrome-like symptoms during oral endocrine therapy after breast cancer surgery. Observe the curative effect after oral administration for 14 days, and record the information of all patients, as shown in Table 1;

[0048] Table 1 Patient Treatment Information Table

[0049]

[0050]

[0051]

[0052]

[0053]

[0054]

[0055]

[0056]

[0057]

[0058]

[0059]

[0060]

[0061]

[0062]

[0063]

[0064]

[0065]

[0066] Based on Table 1, it can be seen that the traditional Chinese medicine preparation obtained by the present invention can effectively treat patients with climacteric syndrome in endocrine therapy for breast cancer.

[0067] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can still be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A Chinese medicine preparation for endocrine therapy of breast cancer and menopausal syndrome, characterized in that: Includes the following components: Bupleurum, Scutellaria, Pinellia, Codonopsis, Cassia twig, White Peony Root, Calcinated Dragon Bone, Calcinated Oyster, Acorus calamus, Curcuma, Roasted Turtle Shell, Ginger and Jujube.

2. The Chinese medicine preparation for endocrine therapy of breast cancer and menopausal syndrome according to claim 1, characterized in that: The masses of the components are respectively: 9-12g of bupleurum, 9-15g of scutellaria, 9-15g of pinellia, 15-30g of codonopsis, 9-15g of cinnamon twig, 9-15g of white peony root, 9-15g of calcined dragon bone, 9-15g of calcined oyster shell, 15-30g of calamus, 9-15g of curcuma, 9-15g of roasted turtle shell, 9g of ginger and 9g of jujube.

3. The method for preparing the Chinese medicine preparation for endocrine therapy of breast cancer and menopausal syndrome according to any one of claims 1 to 2, characterized in that: The following steps are involved: ①Use a casserole as the container. ② Soak all components in clean cold water for no less than half an hour, with the amount of water being higher than the surface of the medicine to ensure that the medicine fully absorbs water; ③ When decocting, first break up the roasted turtle shell, calcined dragon bone, and calcined oyster, wrap them in a cloth bag and put them into the pot to prevent them from falling apart, and decoct for 20 minutes; ④Decoction the remaining herbs (which have been soaked in advance), bring to a boil over high heat, then simmer over low heat for another 20 minutes to allow the medicinal properties to fully blend; ⑤ Repeat steps ① to ④ once more, and the second decoction time should be slightly shorter than the first decoction time; ⑥ During the entire boiling process, stirring is required to prevent the medicinal materials from sticking to the pot. After boiling is completed, the residue is filtered out to obtain the Chinese medicine preparation for endocrine therapy of breast cancer and menopausal syndrome.

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