CN115581749A

CN115581749A - A Chinese medicinal composition for treating hyperplasia of mammary glands, and its preparation method

Info

Publication number: CN115581749A
Application number: CN202210466135.1A
Authority: CN
Inventors: 裴正学
Original assignee: Individual
Current assignee: Individual
Priority date: 2022-04-29
Filing date: 2022-04-29
Publication date: 2023-01-10
Anticipated expiration: 2042-04-29
Also published as: CN115581749B

Abstract

The invention discloses a traditional Chinese medicine composition for treating hyperplasia of mammary glands and a preparation method thereof. The invention relates to a traditional Chinese medicine composition for treating hyperplasia of mammary glands, which is prepared from the following raw materials in parts by mass: 10 parts of immature bitter orange, 15 parts of white paeony root, 6 parts of liquorice, 15 parts of turtle shell, 6 parts of akebia stem, 10 parts of beautiful sweetgum fruit, 10 parts of Mongolian snakegourd root, 10 parts of frankincense, 10 parts of myrrh, 6 parts of nutgrass galingale rhizome, 15 parts of common selfheal fruit-spike, 10 parts of common burreed rhizome, 10 parts of zedoary, 15 parts of dandelion, 15 parts of dahurian patrinia herb, 10 parts of Chinese thorowax root, 10 parts of Chinese angelica, 10 parts of thunberg fritillary bulb, 10 parts of desertliving cistanche, 10 parts of Chinese honeylocust spine, 10 parts of rhizoma corydalis, 30 parts of astragalus, 10 parts of leech and 3 parts of pseudo-ginseng. The traditional Chinese medicine composition has obvious effect on improving the symptoms of the mammary gland, and has high safety and no obvious adverse effect.

Description

A Chinese medicinal composition for treating hyperplasia of mammary glands, and its preparation method

Technical Field

The invention relates to a traditional Chinese medicine composition for treating hyperplasia of mammary glands and a preparation method thereof, belonging to the technical field of traditional Chinese medicine compounding.

Background

The hyperplasia of mammary glands is a general term for a group of parenchymal mammary lesions with complex tissue morphology, is the most common mammary disease of women, and has the incidence rate increasing year by year, wherein the number of female patients in the middle-aged 30-50 years is as high as 57.8-62.6%. The hyperplasia of mammary glands is the most common benign disease of mammary glands in modern women, but the canceration risk of the disease is 1 to 3 times higher than that of healthy women, and 10 to 20 percent of patients can finally develop high hyperplasia of mammary epithelium and even atypical hyperplasia. Therefore, the disease brings great physical pain and mental fear to female patients, thereby seriously affecting the physical and mental health and the quality of life of the patients, and has attracted wide attention and attention of the medical field. The disease is complicated and various in types, and the medical community has no unified understanding about the specific pathogenesis of the disease at present, and most scholars think that the disease is related to factors such as endocrine dyscrasia, spirit and the like. The primary symptom of the disease is distending pain or stabbing pain in one or both breasts, as the menstrual cycle changes. At present, western medicine has no satisfactory therapy, mainly treats the symptoms, mainly adopts sex hormone and endocrine therapy, but has unsatisfactory clinical effect, easy relapse of the disease condition, great side effect and non-optimal choice of operation.

In recent years, traditional Chinese medicine plays an increasingly important role in diagnosis and treatment of hyperplasia of mammary glands, and provides a new idea for clinical treatment and prevention. At present, the traditional Chinese patent medicine preparations which are widely applied clinically comprise breast nodule eliminating capsules, breast hyperplasia treating capsules, xiaojin capsules, cassia twig and tuckahoe capsules and the like. Many doctors of traditional Chinese medicine also add or subtract ancient prescription of radix bupleuri liver-soothing powder and the like through dialectical treatment, the clinical curative effect is limited by the level and experience of doctors, and long-term hospitalization brings great mental and economic pressure to patients. The medicine for treating mammary nodules consists of: cornu Cervi, herba Taraxaci, thallus laminariae, notoginseng radix, radix Paeoniae Rubra, sargassum, radix Rhapontici, radix aucklandiae, radix scrophulariae, herba Leonuri, caulis Spatholobi, thin Evodia, fructus forsythiae, caulis Mahoniae, rhizoma Smilacis Glabrae, etc.; has the functions of softening hardness to dissipate stagnation, promoting blood circulation to cure carbuncle and clearing away heat and toxic material, and can relieve the symptoms of partial patients with hyperplasia of mammary glands after use. However, the whole formula of nodules of breast is mainly used for eliminating pathogenic factors, clearing heat and removing toxicity, the spleen and stomach function is damaged after long-term administration, the patient dependence on administration is reduced, reports suggest that the capsule for eliminating nodules of breast has the risk of causing liver injury, and the nodules of breast is not applicable to all hyperplasia of mammary glands. The GUIZHIFULING Capsule is a blood-regulating agent, and has effects of promoting blood circulation, removing blood stasis, and eliminating abdominal mass. The formula cassia twig warms channel and dispels cold, and promotes blood circulation and removes meridian obstruction; poria has effects of invigorating qi, nourishing heart, and benefiting blood between waist and navel; cortex moutan, semen Persicae, and radix Paeoniae have the effects of promoting blood circulation and removing blood stasis, and radix Paeoniae has the effects of nourishing blood and regulating nutrient. However, during clinical use, a few patients have been reported to experience advanced menstruation with symptoms of nausea and vomiting.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for treating hyperplasia of mammary glands and a preparation method thereof.

The invention provides a traditional Chinese medicine composition for treating hyperplasia of mammary glands, which is prepared from the following raw materials in parts by mass:

10 parts of immature bitter orange, 15 parts of white paeony root, 6 parts of liquorice, 15 parts of turtle shell, 6 parts of akebia stem, 10 parts of beautiful sweetgum fruit, 10 parts of Mongolian snakegourd root, 10 parts of frankincense, 10 parts of myrrh, 6 parts of nutgrass galingale rhizome, 15 parts of common selfheal fruit-spike, 10 parts of common burreed rhizome, 10 parts of zedoary, 15 parts of dandelion, 15 parts of dahurian patrinia herb, 10 parts of Chinese thorowax root, 10 parts of Chinese angelica, 10 parts of thunberg fritillary bulb, 10 parts of desertliving cistanche, 10 parts of Chinese honeylocust spine, 10 parts of rhizoma corydalis, 30 parts of astragalus, 10 parts of leech and 3 parts of pseudo-ginseng.

The preparation method of the traditional Chinese medicine composition provided by the invention is any one of the following A1) -A2):

a1 Comprises the following steps: mixing the traditional Chinese medicine decoction pieces of the raw materials, decocting with water, and collecting decoction to obtain the traditional Chinese medicine composition;

a2 Comprises the following steps: mixing the Chinese medicinal decoction pieces of the raw materials, decocting with water, and collecting decoction; concentrating the decoction, performing spray drying, and granulating by a dry method to obtain the traditional Chinese medicine composition.

The concentration can be reduced pressure concentration to relative density of 1.01-1.05 (measured at 55-60 deg.C).

The steps of water decoction in the specific examples of the present invention are as follows: mixing traditional Chinese medicine decoction pieces of 10g of immature bitter orange, 15g of white paeony root, 6g of liquorice, 15g of turtle shell, 6g of akebia stem, 10g of beautiful sweetgum fruit, 10g of Mongolian snakegourd root, 10g of frankincense (prepared), 10g of myrrh (prepared), 6g of nutgrass galingale rhizome, 15g of common selfheal fruit-spike, 10g of common burreed rhizome, 10g of zedoary, 15g of dandelion, 15g of dahurian patrinia herb, 10g of Chinese thorowax root, 10g of Chinese angelica, 10g of thunberg fritillary bulb, 10g of desertliving cistanche, 10g of Chinese honeylocust spine, 10g of rhizoma corydalis, 30g of astragalus root, 10g of leech and 3g of pseudo-ginseng, adding water, soaking for 1h when the water amount does not reach the surface of the transverse finger of the traditional Chinese medicine raw materials, boiling the mixture with strong fire, decocting the mixture with slow fire for 1 hour, filtering to obtain supernatant, continuously adding water into filter residues for about 200ml, and decocting the residues again by a first decoction method; the filtrate is mixed with the first decoction to obtain 150ml of decoction (one dose). One dose is taken every day, and the medicine is divided into two bags for 2 times every day.

In the specific embodiment of the invention, the steps of preparing the water decoction into particles are as follows: mixing traditional Chinese medicine decoction pieces of 10g of immature bitter orange, 15g of white paeony root, 6g of liquorice, 15g of turtle shell, 6g of akebia stem, 10g of beautiful sweetgum fruit, 10g of Mongolian snakegourd root, 10g of frankincense (prepared), 10g of myrrh (prepared), 6g of nutgrass galingale rhizome, 15g of common selfheal fruit-spike, 10g of common burreed rhizome, 10g of zedoary, 15g of dandelion, 15g of dahurian patrinia herb, 10g of Chinese thorowax root, 10g of Chinese angelica, 10g of thunberg fritillary bulb, 10g of desertliving cistanche, 10g of Chinese honeylocust spine, 10g of rhizoma corydalis, 30g of astragalus root, 10g of leech and 3g of pseudo-ginseng, and decocting the mixture in water for two times; adding 8 times of water for the first time, and decocting for 1h; adding 6 times of water for the second time, decocting for 1 hr, mixing the decoctions, filtering, concentrating under reduced pressure to relative density of 1.01-1.05 (measured at 55-60 deg.C), spray drying the concentrated solution, and dry granulating. The granule is administered in a dose of 10g as minimum package, 1 bag each time, and 2 times daily.

The invention further provides application of the traditional Chinese medicine composition in preparing a medicine for treating hyperplasia of mammary glands.

Further, the treatment of hyperplasia of mammary glands is specifically embodied in at least one of the following B1) to B5):

b1 For relief of breast pain;

b2 Reducing lump stiffness;

b3 ) reducing the mass extent and/or mass size;

b4 Improving at least one of mood changes, menstrual disorder, soreness and weakness of the waist and knees, fullness in the hypochondrium, and blood stasis;

b5 Reduce the BI-RADS rating.

The invention also provides a medicament for treating hyperplasia of mammary glands, which comprises the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials.

The invention has the following beneficial effects:

(1) The traditional Chinese medicine composition is prepared by adopting a prescription of people by the inventor, is accurate and dialectical, and is repeatedly verified in the clinical application process to form the formula, wherein 30g of astragalus membranaceus and 10g of radix bupleuri are monarch drugs, 15g of turtle shell, 10g of rhizoma sparganii, 10g of curcuma zedoary, 3g of pseudo-ginseng (panax notoginseng), 10g of leech and 10g of spina gleditsiae are ministerial drugs, 10g of immature bitter orange, 15g of white paeony root, 10g of angelica sinensis, 10g of trichosanthes root, 6g of rhizoma cyperi, 15g of selfheal, 15g of dandelion, 15g of dahurian patrinia herb, 10g of frankincense (prepared), 10g of myrrh (prepared), 10g of thunberg fritillary bulb, 10g of cistanche deserticola, 10g of rhizoma corydalis (prepared), 6g of akebia stem, 10g of fructus liquidambaris and 6g of liquorice are conductant drugs. The clinical research finds that: the traditional Chinese medicine composition disclosed by the invention can well relieve breast pain and reduce breast lumps, has a remarkable effect on improving breast symptoms, is high in safety, and has no obvious adverse effect. The total curative effect, the main symptoms and the accompanying symptoms are obviously higher than those of the breast nodule eliminating tablets in a control group.

(2) In addition, the traditional Chinese medicine composition can be prepared into a granular preparation by concentrating, drying and granulating active ingredients of the medicine on the premise of ensuring the effectiveness of the medicine, is convenient for batch production and quality control, and has the advantages of simple preparation process, high yield, stable content and stable and feasible determined process; the capsule has the advantages of realizing batch production and processing, effectively controlling production cost, saving social resources, being clean and sanitary after being made into independent packages, being convenient to take and bringing good news to patients.

Detailed Description

The present invention is described in further detail below with reference to specific embodiments, which are given for the purpose of illustration only and are not intended to limit the scope of the invention. The examples provided below serve as a guide for further modifications by a person skilled in the art and do not constitute a limitation of the invention in any way.

The experimental procedures in the following examples, unless otherwise indicated, are conventional and are carried out according to the techniques or conditions described in the literature in the field or according to the instructions of the products. Materials, reagents and the like used in the following examples are commercially available unless otherwise specified.

Immature bitter orange, white paeony root, liquoric root, turtle shell, akebia stem, beautiful sweetgum fruit, mongolian snakegourd root, frankincense (prepared), myrrh (prepared), nutgrass galingale rhizome, common selfheal fruit-spike, common burreed rhizome, zedoary, dandelion, chinese thorowax root, chinese angelica, thunberg fritillary bulb, desertliving cistanche (cloudy), chinese honeylocust spine, corydalis tuber (rhizoma corydalis), membranous milkvetch root, leech and sanchi in the following embodiments are all medicinal materials collected in 2015 edition of Chinese pharmacopoeia, and all indexes of the medicinal materials are in accordance with the regulations through identification. Herba patriniae (herba patriniae) is a medicinal material collected in 2009 edition of processing specifications of Gansu province, and all indexes of the herba patriniae are identified to meet the regulations. The specific sources and standard provenance of the medicinal materials are shown in the following table 1.

TABLE 1 sources and standards of specific drugs

Example 1 preparation of a Chinese medicinal composition (decoction) for the treatment of hyperplasia of mammary glands

1. Raw material formula

The traditional Chinese medicine composition for treating hyperplasia of mammary glands is prepared from the following raw materials in parts by mass:

10 parts of immature bitter orange, 15 parts of white paeony root, 6 parts of liquorice, 15 parts of turtle shell, 6 parts of akebia stem, 10 parts of beautiful sweetgum fruit, 10 parts of mongolian snakegourd root, 10 parts of frankincense (prepared), 10 parts of myrrh (prepared), 6 parts of nutgrass galingale rhizome, 15 parts of common selfheal fruit-spike, 10 parts of common burreed rhizome, 10 parts of zedoary, 15 parts of dandelion, 15 parts of dahurian patrinia herb, 10 parts of Chinese thorowax root, 10 parts of Chinese angelica, 10 parts of thunberg fritillary bulb, 10 parts of desertliving cistanche (cistanche), 10 parts of Chinese honeylocust spine, 10 parts of rhizoma corydalis, 30 parts of astragalus root, 10 parts of leech and 3 parts of pseudo-ginseng (sanchi).

2. Preparation method

The preparation method of the traditional Chinese medicine composition (decoction) for treating the hyperplasia of mammary glands comprises the following specific steps:

according to the formula: 10g of immature bitter orange, 15g of white paeony root, 6g of liquorice, 15g of turtle shell, 6g of akebia stem, 10g of beautiful sweetgum fruit, 10g of Mongolian snakegourd root, 10g of frankincense (prepared), 10g of myrrh (prepared), 6g of nutgrass galingale rhizome, 15g of common selfheal fruit-spike, 10g of common burreed rhizome, 10g of zedoary, 15g of dandelion, 15g of dahurian patrinia herb, 10g of Chinese thorowax root, 10g of Chinese angelica, 10g of thunberg fritillary bulb, 10g of desertliving cistanche (cistanche), 10g of spina gleditsiae, 10g of rhizoma corydalis, 30g of astragalus root, 10g of leech and 3g of pseudo-ginseng (sanchi). Taking the crude drug decoction pieces according to the formula, adding drinking water, soaking for 1 hr (water amount can only be added to submerge one finger on the surface of the traditional Chinese medicine), boiling with strong fire, decocting with slow fire for 1 hr, filtering to obtain the upper liquid, filtering to obtain the residue, adding about 200ml of water, and decocting again by the first decoction method. Filtering, mixing the filtrate with the first decoction to obtain 150ml decoction (one dose), one dose per day, and divided into two bags for warm administration after half an hour of lunch and dinner.

Example 2 preparation of a Chinese medicinal composition (granule) for the treatment of hyperplasia of mammary glands

1. Raw material formula

2. Preparation method

According to the formula, 10g of immature bitter orange, 15g of white paeony root, 6g of liquorice, 15g of turtle shell, 6g of akebia stem, 10g of beautiful sweetgum fruit, 10g of Mongolian snakegourd root, 10g of frankincense (prepared), 10g of myrrh (prepared), 6g of nutgrass galingale rhizome, 15g of common selfheal fruit-spike, 10g of common burreed rhizome, 10g of zedoary, 15g of dandelion, 15g of dahurian patrinia herb, 10g of Chinese thorowax root, 10g of Chinese angelica, 10g of thunberg fritillary bulb, 10g of desertliving cistanche (cistanche), 10g of Chinese honeylocust spine, 10g of corydalis tuber, 30g of membranous milkvetch root, 10g of leech and 3g of sanchi (sanchi). Decocting the formula medicinal materials with water twice. Adding 8 times of water for the first time, and decocting for 1h; adding 6 times of water for the second time, decocting for 1 hr, mixing the two decoctions, filtering, concentrating under reduced pressure to relative density of 1.01-1.05 (measured at 55-60 deg.C), spray drying, and dry granulating. The granule for treating mammary gland diseases is administered at a dose of 10-12g for 2 times per day, and the granule for treating mammary gland diseases is administered at a dose of 10g as minimum package amount, 1 bag per time, and 2 times per day.

Example 3 clinical efficacy study of a Chinese medicinal composition for treating hyperplasia of mammary glands

1. Data and method

1.1 sources of cases

80 cases of mammary gland hyperplasia patients meeting the Chinese and western medicine diagnosis and inclusion standards from the outpatient service of the department of Chinese medicine research in Ministry of Gansu province in 2017-2019 in 12 are selected as study objects, the study objects adopt a random-control clinical study and are randomly divided into two groups, and all the patients sign informed consent books to voluntarily participate in the study.

1.2 inclusion criteria

1.2.1 Western diagnostic standards

Diagnosis standard of hyperplasia of mammary glands: refer to "diagnostic criteria for hyperplasia of mammary glands" discussed and revised by the committee for the professional for mastopathy of the surgical society of Chinese medical science in 2002: (1) The breast has different degrees of vague pain, distending pain and stabbing pain. It can be radiated to armpit, shoulder and back, and has correlation with menstruation and mood change. (2) One or more masses of different sizes and shapes are generated in one or both breasts, which are not well-defined with the surrounding tissues, and which do not adhere to the skin or deep tissues and can be pushed. (3) auxiliary inspection: color Doppler ultrasound of mammary gland.

1.2.2 Chinese medicine diagnostic standards

The traditional Chinese medicine diagnosis refers to the diagnosis standard of ' rupi ' in ' traditional Chinese medicine disease diagnosis curative effect standard ' of ' 2016 edition. And making dialectical type of 'twelve five' national planning and teaching material 'TCM surgery'. The main symptoms are: 1) Lump in breast, tough and not firm, distending pain or stabbing pain, with symptoms of irritability and growth; 2) Premenstrual exacerbation and postmenstrual remission; the secondary symptoms are as follows: 1) Chest oppression, hypochondriac distention, restlessness and irritability; 2) Depression, oliguria, insomnia and dreaminess; tongue pulse condition: a pale and dark tongue with teeth marks on the sides and a slightly greasy coating, and a wiry, thready or wiry and slippery pulse. The major symptoms are essential, the minor symptoms are 1-2 items, and the diagnosis can be made by combining the tongue pulse.

1.2.3 inclusion criteria

(1) The patients who accord with the above Chinese and western medicine diagnosis standards of the hyperplasia of mammary glands and sign informed consent;

(2) The traditional Chinese medicine syndrome differentiation belongs to the syndrome of liver depression and phlegm coagulation;

(3) The age is 20-50 years (the menstrual cycle is not stopped);

(4) The disease course is more than or equal to 3 months.

(5) The medicine which has an effect on the functions of the liver and the kidney is not used within three months;

(6) Live in or near Lanzhou city and can be diagnosed on time or with time;

1.2.4 exclusion criteria

(1) The traditional Chinese medicine dialectical is not a patient with liver depression and phlegm coagulation;

(2) Patients with mastitis and breast tumor, irregular menstrual cycle, endless dripping, and menopause; (3) The age is less than 20 years old or more than 50 years old, and the pregnant or lactating women are prepared, and the people with allergic constitution or allergy to the medicine are prepared; those who do not follow the medical advice and take indiscriminate medicines; (4) In nearly three months, patients with hyperplasia of mammary glands are treated by other medicines; (5) Patients with serious primary diseases such as cardiovascular diseases, cerebrovascular diseases, liver diseases, kidney diseases, hemopoietic systems and the like are combined; (6) Subjects were very mobile, or lived too far, or had heavy work and failed collaborators.

1.2.5 shedding and rejection criteria

(1) Those who cannot adhere to the treatment;

(2) Those with severe adverse reactions;

(3) Those with severe complications;

the reason for self-withdrawal and termination of the test in the study was carefully recorded and analyzed for its relationship to the test.

1.2.6 ethical requirements

The study should strictly follow the declaration of helsinki and the chinese regulations on clinical laboratory studies, and each subject should carefully read and sign an informed consent.

2 protocol of the test

2.1 grouping method

80 outpatients from the research institute of Ministry of Gansu province are in accordance with the Western diagnosis standard of hyperplasia of mammary glands and the cases of liver depression and phlegm coagulation type mammary lump in traditional Chinese medicine are randomly divided into two groups, namely 40 cases in a treatment group (a traditional Chinese medicine composition decoction) and 40 cases in a control group (a mammary lump removing tablet). Two groups of patients were treated with the following drugs:

the Chinese medicinal decoction of the embodiment 1 is administered in a treatment group, and is prepared from 10g of immature bitter orange, 15g of white paeony root, 6g of liquorice, 15g of turtle shell, 6g of akebia stem, 10g of beautiful sweetgum fruit, 10g of mongolian snakegourd root, 10g of prepared myrrh, 6g of nutgrass galingale rhizome, 15g of common selfheal fruit-spike, 10g of common burreed rhizome, 10g of zedoary, 15g of dandelion, 15g of dahurian patrinia herb, 10g of Chinese thorowax root, 10g of Chinese angelica, 10g of thunberg fritillary bulb, 10g of cloudby bulb, 10g of Chinese honeylocust spine, 10g of rhizoma corydalis, 30g of astragalus root, 10g of leech and 3g of sanchi, and each dose of Chinese medicinal composition is decocted into 150ml. Is orally administered at a dose of 75ml 2 times a day for 1 month.

The control group was given nodules of breast: the medicine comprises the following components: cornu Cervi, herba Taraxaci, thallus laminariae, trichosanthis radix, caulis Spatholobi, notoginseng radix, radix Paeoniae Rubra, sargassum, radix Rhapontici, radix aucklandiae, radix scrophulariae, cortex moutan, prunellae Spica, fructus forsythiae, carthami flos, etc. The efficacy is as follows: softening and resolving hard mass, promoting blood circulation, removing carbuncle, clearing away heat and toxic materials. Liaoning good nurse pharmaceutical (group) Co., ltd, batch number: the national standard of medicine character Z21021822, specification: 0.67g × 12 pieces × 6 plates/box. It is administered orally 3 tablets at a time, 3 times a day, for 1 month.

3 Observation index

3.1 the therapeutic index of syndrome

Refer to the evaluation standard of curative effect of hyperplasia of mammary glands in 'the eighth conference of the mastopathy professional committee of the Chinese medical science and surgery society in 2002'. Wherein the grading and scoring of the lump is performed according to the color Doppler ultrasound result of the mammary gland. The scoring standards of the main symptoms and the general accompanying symptoms of the hyperplasia of mammary glands are as follows:

TABLE 2 score criteria for major symptoms of mammary gland hyperplasia

TABLE 3 Total associated symptom score criteria

3.2 laboratory indices

Two groups of patients were observed for luteinizing hormone before and after treatment: LH, estradiol: e2, pituitary prolactin: PRL, progesterone: p change situation. The above indexes are all detected by the inspection center of the Ministry of TCM of Gansu Zhengchong. The laboratory index reference level standards are as follows in table 4:

TABLE 4 reference level standards for laboratory indices

3.3 ultrasonic examination

The BI-RADS classification, breast thickness, internal echo, boundary, mass size, nature, blood flow (CDFI) under B-ultrasound examination before and after treatment were observed for both groups of patients. Collected on the day of initial visit and 2 days after 3 months of medication. The instrument adopts a color Doppler ultrasonic diagnostic apparatus, and has the following types: PHILIPS-IU22, which adopts a high-frequency probe with the frequency of 3.5MHZ and is collected by ultrasound science assistance of the institute of Chinese medicine in Gansu university. Color doppler imaging scoring methods are shown in table 5 below.

TABLE 5 color Doppler imaging scoring method

3.4 criteria for judging curative effects of breast pain and tumor

(1) And (3) healing: the breast pain disappears, and the lump disappears;

(2) The effect is shown: the maximum diameter of the tumor is reduced by more than 1/2;

(3) The method has the following advantages: the maximum diameter of the tumor is reduced by more than 1/3;

(4) And (4) invalidation: the tumor mass has no obvious change or the reduction is less than 1/3.

3.5 Standard of the efficacy of the syndrome in TCM

The clinical effectiveness evaluation and standard refer to the judgment standard of comprehensive curative effect in the eighth conference of the mastopathy professional committee of the Chinese medical science and surgery society in 2002. The traditional Chinese medicine syndrome curative effect index (n) = [ (a-b)/a ] multiplied by 100%, a is the integral of symptoms before treatment, b is the integral of symptoms after treatment

(1) And (3) healing: symptoms and physical signs are obviously improved or disappeared, and n is more than or equal to 90 percent;

(2) The effect is shown: part of symptoms and physical signs are obviously improved, and n is more than 90% and more than or equal to 70%;

(3) The method has the following advantages: symptoms and physical signs are improved, and n is more than 70% and is more than or equal to 30%;

(4) And (4) invalidation: the symptoms and signs are not obviously improved or aggravated, and n is less than 30 percent.

3.6 Standard of treatment Effect of Single symptom of traditional Chinese medicine

(1) And (3) healing: disappearance of symptoms;

(2) The effect is shown: the symptom is obviously improved, which is divided from 3 to 1;

(3) The method has the following advantages: the symptom is improved from 3 points → 2 points or from 2 points → 1 point;

(4) And (4) invalidation: no change or no significant reduction in symptoms was noted.

3.7 safety Observation indicators

The blood, urine and feces of all tested patients are detected before and after the test to evaluate the liver and kidney functions (the test of the clinical laboratory of the Ministry of traditional Chinese medicine in Gansu university), and adverse reactions (dizziness, headache, nausea, vomit, allergy and the like) and general conditions of the whole body during the two groups of administration are observed and recorded.

4 statistical methods

All collected data are analyzed by using SPSS22.0 statistical software, the metering data conforming to normal distribution is expressed by (X + S), and independent sample t test is used for comparison among groups; in-group comparisons using paired sample t-test; chi square (x) for counting data ² ) Checking; and comparing the grade counting data by adopting a rank sum test. P is less than 0.05, the difference is significant, and the statistical significance is achieved.

5 results

5.1 general data

5.1.1 by t-test, the difference between the two groups of patients in age and disease course is not statistically significant (P > 0.05), and the two groups of patients have comparability. The age (years) and the course (years) of the patients were compared in two groups (see Table 6).

TABLE 6 comparison of age (year) and course (year) of two groups of patients (x + S)

5.1.2 Chi meridian ² Test, no statistical significance in lesion size distribution before treatment (P) in both groups of patients>0.05 Has the possibility of use. Comparison of the extent of the lesions before treatment in two groups of patients (see Table 7)

TABLE 7 comparison of the extent of pre-treatment lesions in two groups of patients

5.1.3 through t test, the integration comparison of main symptoms such as breast pain, lump hardness, lump range, lump size and the like of the two groups of patients before treatment has no statistical significance (P is more than 0.05), and has comparability. Integral comparison of the chief symptoms before treatment in two groups of patients (see Table 8)

TABLE 8 comparison of the score of each chief complaint before treatment (X + S)

5.1.4 through t test, the symptoms of mood change, abnormal menstruation, soreness and weakness of waist and knees, hypochondrium fullness, blood stasis symptoms (tongue quality and sublingual venation condition) and the like of the patients in the former two groups of patients have no statistical significance (P is more than 0.05) in comparison of the integral of the symptoms, and the treatment is comparable. Comparison of the score of each concomitant symptom before treatment in both groups (see Table 9)

TABLE 9 comparison of the score of each concomitant symptom before treatment in two groups of patients (X + S)

5.1.5 by t-test, the comparison of the total score (chief symptoms + concomitant symptoms) between the two groups of patients before treatment was not statistically significant (P > 0.05) and was comparable. Comparison of the Total score before treatment (chief symptoms + concomitant symptoms) in both groups of patients (see Table 10)

TABLE 10 Total before treatment score (chief complaints + concomitant complaints) comparison of two groups of patients (X + S)

5.1.6 by t-test, comparison of LH, PRL, E2 and P in the two groups of patients before treatment has no statistical significance (P is more than 0.05), and the comparison is comparable. Comparison of Pre-treatment hormone levels in two groups of patients (see Table 11)

TABLE 11 comparison of the levels of each hormone before treatment (X + S)

5.1.7 through t test, the B ultrasonic imaging examination score, doppler blood flow imaging, left gland thickness (mm) and right gland thickness (mm) of the two groups of patients before treatment have no statistical significance (P is more than 0.05) and are comparable. Comparison of color Doppler imaging Scoring before treatment (see Table 12)

TABLE 12 comparison of pre-treatment color Doppler imaging scores (X + S)

5.2 clinical efficacy results

5.2.1 improvement of symptoms after treatment in two groups of patients (chief symptoms + concomitant symptoms) (see Table 13)

Through t test, the comparison P in the two groups before and after treatment is less than 0.01, and the difference has statistical significance; comparison of P between groups after treatment was less than 0.05, with statistical significance for the differences.

TABLE 13 improvement of symptoms after treatment

5.2.2 comparison of the improvement in the chief complaints after treatment in the two groups of patients (see Table 14)

The comparison of the two groups of patients before and after treatment has statistical significance, and the comparison of the treatment groups such as breast pain, lump hardness, lump range and lump size is remarkably improved (P is less than 0.01); compared with the control group, the breast pain and the lump hardness are obviously improved in the group (P is less than 0.01), and compared with the lump range and the lump size are obviously improved in the group (P is less than 0.05). Compared with the two groups of patients before treatment, the traditional Chinese medicine composition has no difference (P values are all more than 0.05) and is comparable; compared with the two groups after treatment, the breast pain and the lump size difference are obvious (P is less than 0.01), compared with the lump hardness and the lump range, the improvement is obvious (P is less than 0.05), analysis shows that the main symptoms of the two groups of patients are improved after treatment, and compared with the control group, the treatment group is obviously improved in the breast pain and the lump size.

TABLE 14 improvement of the main symptoms after treatment of the two groups of patients (X + S)

5.2.3 improvement of symptoms in each of the two groups of patients after treatment (see Table 15)

After treatment, the patients in the two groups have statistical significance in comparison, and the emotional changes, abnormal menstruation, soreness and weakness of waist and knees, fullness in hypochondrium and blood stasis symptoms in the treatment groups are remarkably improved (P is less than 0.01); the comparative improvement in the control group is obvious (P is less than 0.01), and the comparative improvement in the group with symptoms of mood change, abnormal menstruation and blood stasis is obvious (P is less than 0.05). Compared with the two groups of patients before treatment, the traditional Chinese medicine composition has no difference (P values are all more than 0.05) and is comparable; compared with the mood change and the blood stasis symptom (tongue and sublingual venation conditions) between the two groups after treatment, the comparison difference between the two groups is obvious (P is less than 0.01), the menstrual disorder, the soreness and weakness of waist and knees and the fullness and distention difference between two ribs are obvious (P is less than 0.05), analysis shows that the main symptoms of the two groups of patients are improved after treatment, and compared with a control group, the treatment group is obviously improved on the mood change and the blood stasis symptom.

TABLE 15 improvement of symptoms (X + S) following treatment in each of the two groups of patients

5.2.4 improvement in hormone levels before and after treatment in two groups of patients (see Table 16)

The comparison in the treated groups of the two groups of patients has statistical significance, and the comparison in the treated groups of LH, P, E2, PRL and E2/P is remarkably improved (P is less than 0.01); compared with the control group LH and the control group P, the improvement is obvious (P is less than 0.01), and compared with the control group PRL and the control group E2, the improvement is not obvious (P is more than 0.05). Compared with the two groups of patients before treatment, the patients have no difference (P values are all more than 0.05) and are comparable; comparison of the LH, P, E2, PRL, E2/P differences between the two groups after treatment was not statistically significant (P values were all > 0.05), and analysis showed no improvement in sex hormone levels in the two groups of patients after treatment.

TABLE 16 Pre-and post-treatment hormonal improvements (X + S) in two groups of patients

5.2.5 improvement of color Doppler imaging after treatment in two groups of patients (see Table 17)

Compared with the treated groups of two groups of patients, the B-ultrasonic imaging examination score group of the treated group has obvious improvement (delta P is less than 0.05), the left gland thickness group and the right gland thickness group have obvious improvement (P is less than 0.01), and the CDFI score group has no statistical difference (P is more than 0.05); the comparison in the control group B ultrasonic imaging examination score group (P is more than 0.05) has no statistical difference, and the comparison in the left side gland thickness group and the right side gland thickness group is obviously improved (P is less than 0.05). Compared with the two groups of patients before treatment, the two groups of patients have no difference (P is more than 0.05) and are comparable; compared with B-ultrasonic imaging examination scores of two groups after treatment, the B-ultrasonic imaging examination scores of the two groups are obviously different (P is less than 0.05), the left gland thickness, the right gland thickness and the CDFI scores of the two groups are not different (P is more than 0.05), analysis shows that the B-ultrasonic imaging examination scores of the two groups of patients are improved after treatment, and the left gland thickness, the right gland thickness and the CDFI scores of the treatment group and the control group are not obviously improved.

TABLE 17 color Doppler imaging improvement after treatment for two groups of patients (X + S)

5.2.6 comparison of the Total score (chief complaints + secondary complaints) after treatment in both groups (see Table 18)

The total integrated curative effect of the two groups of patients after treatment shows that 4 (10%) patients, 18 (45%) patients, 15 (37.5%) patients and 3 (7.5%) patients are cured, the total effective rate is 92.5% in 40 patients in the treatment group; in 40 patients in the control group, 3 patients (5.2%) are cured, 10 patients (23.68%) are effective, 19 patients (50%) are effective, 8 patients (21.05%) are ineffective, and the total effective rate is 78.95%. The comparison difference of the total integrated curative effects of the two groups has statistical significance (Z = -2.456, P =0.014 < 0.05), and the curative effect of the treatment group is better than that of the control group.

TABLE 18 comparison of Total efficacy of two groups of patients after treatment

Conclusion 6

According to the analysis of research results, the treatment group and the control group can improve the symptoms of breast pain and breast lumps caused by the hyperplasia of mammary glands; mood changes, abnormal menstruation, soreness and weakness of waist and knees, hypochondrium fullness, blood stasis and other accompanying symptoms are improved. The traditional Chinese medicine composition disclosed by the invention can be used for well relieving breast pain and reducing breast lumps, and has a remarkable effect on improving mammary gland symptoms. During the treatment period, the blood coagulation, liver and kidney functions of the treatment group and the control group are not obviously abnormal due to routine blood and urine. The treatment group and the control group have no adverse reaction. The Chinese medicinal composition has high safety and no obvious adverse effect. The total curative effect, the main symptoms and the accompanying symptoms are obviously higher than those of the control group.

Claims

1. A traditional Chinese medicine composition for treating hyperplasia of mammary glands is prepared from the following raw materials in parts by mass:

2. The preparation method of the traditional Chinese medicine composition of claim 1 or 2, which is characterized by comprising the following steps: the method is any one of the following A1) to A2):

3. The use of the Chinese medicinal composition of claim 1 in the preparation of a medicament for the treatment of cyclomastopathy.

4. Use according to claim 3, characterized in that: the treatment of the hyperplasia of mammary glands is specifically embodied in at least one of the following B1) to B5):

b1 For relief of breast pain;

b2 Reducing lump stiffness;

b3 ) reducing the mass extent and/or mass size;

b5 Reduce the BI-RADS rating.

5. A medicament for treating hyperplasia of mammary glands, which comprises the traditional Chinese medicine composition as claimed in claim 1 and pharmaceutically acceptable auxiliary materials.