Traditional Chinese medicine composition for treating endometrial polyp as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating endometrial polyp as well as a preparation method and application thereof. The traditional Chinese medicine composition is prepared from rhizoma smilacis glabrae, platycodon grandiflorum, honeysuckle, salvia miltiorrhiza, corydalis tuber, rhizoma atractylodis, selfheal, szechwan chinaberry fruit, Chinese yam, radix scrophulariae, endothelium The traditional Chinese medicine composition disclosed by the invention has the effects of tonifying spleen and qi, and removing blood stasis and eliminating diseases. A research result shows that the traditional Chinese medicine composition has a remarkable clinical curative effect on spleen deficiency and blood stasis type endometrial polyp, and can improve the menstrual condition of a patient, reduce the traditional Chinese medicine syndrome integral, reduce relapse and improve the detection indexes of the patient including serum VEGF and IL-6.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating endometrial polyps, a preparation method and use thereof. Background Art

[0002] Endometrial polyps (EP) are common gynecological diseases caused by localized excessive proliferation of the endometrium. They are manifested as single or multiple smooth masses protruding from the uterine cavity, with pedicles of varying lengths. They can cause irregular vaginal bleeding and infertility. Women from childbearing age to postmenopausal women are at high risk of endometrial polyps. The probability of a woman developing endometrial polyps in her lifetime is about 70%. Among these patients, about 15% develop them during the childbearing age. Endometrial polyps during the childbearing age may lead to infertility.

[0003] Hysteroscopic endometrial polypectomy is the main method for clinical treatment of endometrial polyps. This method is suitable for premenopausal patients with symptoms, combined with infertility and before assisted reproductive technology treatment, patients with high risk factors for malignant transformation, polyps with a diameter greater than 1.5 cm, recurrent polyps, poor drug treatment response, and postmenopausal endometrial polyps. For endometrial polyps, drug treatment is usually not the first choice because endometrial polyps have limited response to drugs. However, for some patients, progesterone drugs or combined oral contraceptives (COCs) can be used to manage the endometrium and prevent polyp recurrence. Drug treatment is most suitable for premenopausal patients with endometrial polyps less than 20 mm in diameter, combined with abnormal uterine bleeding or endometrial thickening, and those with surgical contraindications.

[0004] In recent years, the efficacy of traditional Chinese medicine in treating various gynecological diseases has been continuously confirmed, and its position in the multidisciplinary comprehensive treatment model of gynecological diseases has become increasingly important. Various studies on the treatment of endometrial polyps with traditional Chinese medicine have also been carried out extensively and in depth, and the mechanism of the role of traditional Chinese medicine has gradually been revealed. Although there is no name for endometrial polyps in ancient Chinese medical books, similar records of this disease can be found in many ancient books and documents. Endometrial polyps can be classified into the categories of "lumps", "metrorrhagia", "prolonged menstruation", "menorrhagia", and "infertility" in traditional Chinese medicine. The pathogenesis lies in blood stasis, which is closely related to the liver, spleen, and kidney.

[0005] The inventor has developed a Chinese medicine composition particularly suitable for treating spleen deficiency and blood stasis type endometrial polyps based on many years of clinical experience and clinical observation and research results. Summary of the invention

[0006] The purpose of the present invention is to overcome the deficiencies in the prior art and to provide a Chinese medicine composition for treating lung cancer and a preparation method and use thereof.

[0007] Specifically, the present invention is realized through the following technical solutions:

[0008] In the first aspect, the present invention provides a traditional Chinese medicine composition for treating endometrial polyps, which is prepared from the following raw materials in parts by weight: 10-60 parts of Smilax glabra, 10-50 parts of Platycodon grandiflorum, 10-40 parts of Honeysuckle, 10-50 parts of Salvia miltiorrhiza, 10-60 parts of Corydalis yanhusuo, 10-50 parts of Atractylodes macrocephala, 10-60 parts of Prunella vulgaris, 10-40 parts of Toosendan fruit, 10-60 parts of Dioscorea opposita, 10-50 parts of Scrophularia ningpoensis, 10-50 parts of Chicken gizzard lining, and 10-40 parts of Arctium lappa.

[0009] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 20-50 parts of Smilax glabra, 15-30 parts of Platycodon grandiflorum, 10-20 parts of Honeysuckle, 15-30 parts of Salvia miltiorrhiza, 20-50 parts of Corydalis yanhusuo, 15-30 parts of Atractylodes macrocephala, 20-50 parts of Prunella vulgaris, 10-20 parts of Toosendan fruit, 20-50 parts of Dioscorea opposita, 15-30 parts of Scrophularia ningpoensis, 15-30 parts of Chicken gizzard lining, and 10-20 parts of Arctium lappa.

[0010] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 30 parts of Smilax glabra, 20 parts of Platycodon grandiflorum, 15 parts of Honeysuckle, 20 parts of Salvia miltiorrhiza, 25 parts of Corydalis yanhusuo, 20 parts of Atractylodes macrocephala, 30 parts of Prunella vulgaris, 15 parts of Toosendan fruit, 30 parts of Dioscorea opposita, 20 parts of Scrophularia ningpoensis, 20 parts of Chicken gizzard lining, and 15 parts of Arctium lappa.

[0011] As an optional manner, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition has the effects of tonifying the spleen and replenishing qi, and removing blood stasis and eliminating symptoms.

[0012] In the second aspect, the present invention provides a method for preparing the traditional Chinese medicine composition described in the first aspect, the preparation method comprising the following steps: crushing Smilax glabra, Platycodon grandiflorum, Honeysuckle, Salvia miltiorrhiza, Corydalis yanhusuo, Atractylodes macrocephala, Prunella vulgaris, Toosendan fruit, Dioscorea opposita, Scrophularia ningpoensis, Gallus gallus domesticus, and Arctium lappa, boiling with water, mixing the filtrate, and concentrating to obtain a concentrated solution.

[0013] As an optional manner, in the above preparation method, the decoction is performed twice, and after the first decoction for 1-3 hours, a primary filtrate is obtained by filtering, the filter residue is further decocted with water for 1-3 hours, and a secondary filtrate is obtained by filtering, and the primary filtrate and the secondary filtrate are combined.

[0014] As an optional manner, in the above preparation method, the material-liquid ratio of the first decoction and the second decoction is 1:4, the decoction time of the first decoction and the second decoction is 1.5 hours, and the water used for the first decoction and the second decoction is distilled water.

[0015] Preferably, the concentration is concentration under reduced pressure.

[0016] In a third aspect, the present invention provides use of the Chinese medicine composition described in the first aspect or the Chinese medicine composition prepared by the preparation method described in the second aspect in preparing a drug for treating endometrial polyps.

[0017] As an optional mode, in the above-mentioned use, the endometrial polyp is an endometrial polyp of spleen deficiency and blood stasis type.

[0018] As an optional mode, in the above-mentioned use, the dosage form of the drug is granules, tablets, oral liquid or capsules.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] (1) The Chinese medicine composition of the present invention has the effects of tonifying the spleen and replenishing qi, removing blood stasis and eliminating symptoms, and is particularly suitable for treating endometrial polyps of spleen deficiency and blood stasis type.

[0021] (2) The results of the study showed that the Chinese medicine composition of the present invention has significant clinical efficacy in treating endometrial polyps of spleen deficiency and blood stasis type. It can improve the patient's menstrual condition, reduce the TCM syndrome score, reduce recurrence, and improve the patient's test indicators including serum VEGF and IL-6.

[0022] (3) The Chinese medicine composition of the present invention is based on the traditional Chinese medicine formula, uses modern preparation technology and is deeply optimized. The preparation method is simple, and the Chinese medicine composition of the present invention can be made into various dosage forms such as granules, tablets, oral liquids or capsules. DETAILED DESCRIPTION

[0023] The efficacy and main treatment of each medicinal ingredient in the Chinese medicine composition of the present invention are as follows:

[0024] "Tuylum" is the dried tuber of Smilax glabra Roxb., a plant of the genus Smilax in the Liliaceae family. It has the effects of detoxification, dehumidification, and joint unblocking. It is mainly used to treat waxberry poison sores, limb cramps, stranguria, leukorrhea, eczema and itching, carbuncle and sore.

[0025] Platycodon grandiflorus (Jacq.) A.DC. is a plant of the Campanulaceae family. It has the effects of clearing the lungs, removing phlegm, relieving sore throat, and draining pus. It is mainly used to treat cough with phlegm, chest tightness, sore throat, aphonia, and lung abscess with pus.

[0026] "Honeysuckle" is the dried buds or flowers with just opened of Lonicera japonica Thunb., Lonicera hypoglauca Miq., Lonicera confuca DC. or Lonicera dasystyla Rehd. of the genus Lonicera in the family Caprifoliaceae. It has the effects of clearing away heat and detoxifying, and evacuating wind-heat. It is mainly used to treat carbuncle, furuncle, exogenous wind-heat, early stage of febrile disease, and heat-toxic bloody diarrhea.

[0027] "Danshen" is the dried root and rhizome of Salvia miltiorrhiza Bge., a plant of the genus Salvia in the family Lamiaceae. It has the effects of promoting blood circulation and regulating menstruation, removing blood stasis and relieving pain, cooling blood and eliminating carbuncle, and relieving restlessness and calming the mind. It is mainly used to treat irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to postpartum stasis, heart pain due to blood stasis, abdominal pain, accumulation of lumps and masses, injuries from falls, rheumatic arthralgia, sores, carbuncle, swelling and poison, irritability and coma due to fever, palpitations and insomnia.

[0028] "Yanhusuo" is the dried tuber of Corydalis yanhusuo WTWW, a plant of the genus Corydalis in the family Papaveraceae. It has the effects of promoting blood circulation, promoting qi circulation, and relieving pain. It is mainly used for various pain syndromes caused by qi and blood stasis. Such as chest pain, heart pain, liver and stomach qi pain, dysmenorrhea, irregular menstruation, abdominal pain due to postpartum stasis, abdominal pain due to cold hernia, traumatic injury, pain caused by bruises and swelling, rheumatic pain, etc.

[0029] "Atractylodes" is the dried rhizome of Atractylodes lancea (Thunb.) DC. or Atractylodes chinensis (DC.) Koidz. of the Asteraceae family. It has the effects of drying dampness and strengthening the spleen, dispelling wind and dispersing cold. It is mainly used to treat dampness blocking the middle jiao, rheumatic arthralgia, wind-cold dampness with dampness on the surface, night blindness and blurred vision.

[0030] "Prunella vulgaris" is the dried fruit spike of Prunella vulgaris L., a plant of the genus Prunella in the Lamiaceae family. It has the effects of clearing away heat and purging fire, improving eyesight, dispersing stagnation and reducing swelling. It is mainly used to treat red and swollen eyes, headache and dizziness, night pain in the eyes, scrofula, goiter, and swelling and pain in breast abscess.

[0031] "Tosendan seeds" are the dried mature fruits of the plant Toosendan Sieb.et Zucc. of the Meliaceae family. It has the effects of soothing the liver and relieving heat, promoting qi and relieving pain, and killing insects. It is mainly used to treat pain in the abdomen and flanks, hernia pain, abdominal pain caused by worms, and tinea capitis.

[0032] "Yam" is the rhizome of Dioscorea opposita Thunb., a plant of the Dioscorea family. It has the effects of nourishing qi and yin, tonifying the spleen, lungs and kidneys, and consolidating essence and stopping leukorrhea. It is mainly used to treat spleen deficiency, poor appetite, fatigue, loose stools and diarrhea, lung deficiency, wheezing and coughing, kidney deficiency, spermatorrhea, leukorrhea and frequent urination, internal heat and thirst, etc.

[0033] "Scrophularia" is the dried root of Scrophularia ningpoensis Hemsl. and Scrophularia buergeriana Miq. [S.oldhami Oliv.] of the Scrophulariaceae family. It has the effects of clearing heat and cooling blood, purging fire and detoxifying, and nourishing yin. It is mainly used to treat warm pathogens entering the Ying, pericardium, warm toxicity causing spots, febrile disease damaging yin, body fluid damage causing constipation, bone steaming and fatigue cough, red eyes and sore throat, scrofula, diphtheria, carbuncle, swelling and ulcer.

[0034] "Chicken's gizzard lining" is the inner wall of the gizzard of Gallus gallus domesticus Brisson, a domesticated chicken of the genus Phasianidae. It has the effects of helping digestion and strengthening the stomach, astringing sperm and stopping nocturnal emission. It is mainly used to treat food stagnation, infantile malnutrition, spermatorrhea and enuresis due to kidney deficiency, sandstone stranguria, and gallstones.

[0035] "Burdock seeds" are the dried mature fruits of Arctium lappa L., a plant of the genus Arctium in the Asteraceae family. It has the effects of dispersing wind-heat, clearing the lungs and removing phlegm, relieving sore throat and clearing rashes, and detoxifying and reducing swelling. It is mainly used to treat wind-heat colds, early onset of febrile diseases, measles that does not clear up, urticaria itching, carbuncle, ulcer, erysipelas, mumps and throat paralysis.

[0036] The treatment principle of the Chinese medicine composition of the present invention is to tonify the spleen and replenish qi, remove blood stasis and eliminate symptoms. The formulation principle of the Chinese medicine composition of the present invention is as follows: Smilax glabra is the main medicine, clearing away heat, detoxifying and removing dampness; Herba Prunellae clears heat, detoxifies and disperses nodules; the two are used in conjunction with each other, removing dampness and clearing heat at the same time, one to remove spleen dampness, the other to clear liver fire, clear heat and dry dampness, disperse nodules and resolve blood stasis, and clear Chong and Ren meridians to stop leukorrhea; Honeysuckle is light in nature and enters the upper part of the body, and has better effects of dispersing wind and dissipating heat. It takes its effect of clearing heat, detoxifying and removing dampness, and achieves heat clearing together with Smilax glabra and Herba Prunellae. It has detoxifying, anti-inflammatory and analgesic effects; Salvia miltiorrhiza is good at circulating blood, can remove blood stasis and promote new blood circulation, and regulate the meridians; Platycodon grandiflorum can clear away heat, promote dampness and discharge pus, and can both strengthen the spleen and eliminate dampness, and promote qi circulation to prevent blood stasis; Corydalis yanhusuo can promote blood circulation and remove blood stasis, promote menstruation and relieve pain; Toosendan fruit combined with Corydalis yanhusuo can soothe the liver and release heat, promote blood circulation and relieve pain; Chinese yam can nourish the spleen and replenish qi; Atractylodes lancea can strengthen the spleen and dry dampness; Chicken gizzard lining can strengthen the spleen and nourish the stomach; Scrophularia ningpoensis can clear away heat and cool blood, detoxify and disperse nodules; Arctium lappa can detoxify and reduce swelling.

[0037] The present invention will be further described with reference to specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the scope of the present invention.

[0038] If no specific techniques or conditions are specified in the examples, the techniques or conditions described in the literature in the field or the product instructions are used. If no manufacturer is specified for the reagents or instruments used, they are all conventional products that can be purchased through regular channels.

[0039] The experimental methods in the following examples are conventional methods unless otherwise specified. The experimental materials used in the following examples are commercially available products unless otherwise specified.

[0040] Preparation Example:

[0041] Embodiment 1:

[0042] A traditional Chinese medicine composition for treating endometrial polyps is prepared from the following raw materials: 30g of Smilax glabra, 20g of Platycodon grandiflorum, 15g of Honeysuckle, 20g of Salvia miltiorrhiza, 25g of Corydalis yanhusuo, 20g of Atractylodes macrocephala, 30g of Prunella vulgaris, 15g of Toosendan fruit, 30g of Dioscorea opposita, 20g of Scrophularia ningpoensis, 20g of Gallus gallus domesticus, and 15g of Arctium lappa.

[0043] The preparation method of the traditional Chinese medicine composition comprises the following steps: crushing Smilax glabra, Platycodon grandiflorum, honeysuckle, Salvia miltiorrhiza, Corydalis yanhusuo, Atractylodes lancea, Prunella vulgaris, Toosendan fruit, Dioscorea opposita, Scrophularia ningpoensis, Gallus gallus domesticus and Arctium lappa, adding water for decoction, decoction twice, the material-liquid ratio of the first decoction and the second decoction is 1:4, the decoction time of the first decoction and the second decoction is 1.5 hours, the water used for the first decoction and the second decoction is distilled water, and after decoction, the filtrate is mixed and concentrated under reduced pressure to obtain 200 mL of concentrated solution.

[0044] Comparative Example 1:

[0045] A traditional Chinese medicine composition is prepared from the following raw materials: 30g of Smilax glabra, 20g of Platycodon grandiflorum, 15g of Forsythia suspensa, 20g of Salvia miltiorrhiza, 25g of Corydalis yanhusuo, 20g of Atractylodes macrocephala, 30g of Prunella vulgaris, 15g of Toosendan fruit, 30g of Dioscorea opposita, 20g of Scrophularia ningpoensis, 20g of Gallus gallus domesticus, and 15g of Arctium lappa.

[0046] The preparation method of the Chinese medicine composition is the same as that of Example 1.

[0047] Comparative Example 2:

[0048] A traditional Chinese medicine composition for treating endometrial polyps is prepared from the following raw materials: 45g of Smilax glabra, 20g of Platycodon grandiflorum, 15g of Honeysuckle, 20g of Salvia miltiorrhiza, 25g of Corydalis yanhusuo, 20g of Atractylodes macrocephala, 45g of Prunella vulgaris, 15g of Toosendan fruit, 20g of Scrophularia ningpoensis, 20g of Gallus gallus domesticus, and 15g of Arctium lappa.

[0049] The preparation method of the Chinese medicine composition is the same as that of Example 1.

[0050] Effect Example: Preliminary clinical study on the treatment of endometrial polyps with the Chinese medicine composition of the present invention 1. Case source:

[0051] Patients who visited the outpatient clinic or ward of the Third Department of Gynecology of the First Affiliated Hospital of Heilongjiang University of Chinese Medicine and were diagnosed with endometrial polyps and met the diagnosis of spleen deficiency and blood stasis syndrome were selected.

[0052] 2. Western medicine diagnostic criteria:

[0053] It was formulated with reference to the "Chinese Expert Consensus on the Diagnosis and Treatment of Endometrial Polyps (2022 Edition)", "Gynecological Endoscopy", and "Diagnostic Pathology of Obstetrics and Gynecology (2021 Edition)".

[0054] (1) Clinical manifestations include prolonged menstruation, increased menstrual volume, abnormal uterine bleeding or infertility. A small number of patients may experience abdominal pain, vaginal discharge, etc., while some patients have no obvious clinical symptoms;

[0055] (2) Ultrasound shows single or multiple high-echo masses in the uterine cavity; the endometrium is unevenly thickened;

[0056] (3) Under hysteroscopy, vegetation of varying sizes and numbers can be seen protruding from the surface of the endometrium. Most of them are oval in shape, with slender pedicles and smooth surfaces.

[0057] (4) Surgical pathology confirmed the diagnosis of endometrial polyps.

[0058] The above can be considered a clinical diagnosis if any one of (1), (2), (3) and (4) are met.

[0059] 3. TCM diagnostic criteria:

[0060] The diagnostic criteria for spleen deficiency and blood stasis type endometrial polyps were formulated with reference to the "Guidelines for Clinical Research of New Chinese Medicines" and "Guidelines for Diagnosis and Treatment of Common Gynecological Diseases in Traditional Chinese Medicine":

[0061] Main symptoms: heavy menstrual flow, or prolonged menstrual period, or irregular menstrual flow, intermittent menstrual flow, or spotting; purple or black menstrual flow with clots, or irregular menstrual flow, light blood color and thin texture, or dark menstrual blood, or scanty menstrual flow with blood clots.

[0062] Secondary symptoms: ① Poor appetite; ② Dull and sallow complexion, fatigue, shortness of breath; ③ Infertility or abdominal pain during menstruation; ④ Stabbing pain in the lower abdomen, pain in a specific area; ⑤ Skin and nails become discolored.

[0063] Tongue and pulse: The tongue is dull with teeth marks on the edges, or with scattered ecchymosis and petechiae, with a thin white coating or little coating, and a deep and sluggish pulse.

[0064] If the above main symptoms are present and 2 or more secondary symptoms are present, the diagnosis can be made in combination with tongue and pulse.

[0065] 4. Inclusion criteria:

[0066] (1) Patients who meet the above-mentioned Western medicine diagnostic criteria and TCM syndrome differentiation criteria;

[0067] (2) Premenopausal women aged 20-50 years;

[0068] (3) had not received hormone treatment for 3 months;

[0069] (4) ECG and liver and kidney function are basically normal;

[0070] (5) normal speech and behavior ability and the ability to read and write;

[0071] (6) Voluntarily participate in this study and sign the informed consent.

[0072] 5. Exclusion criteria:

[0073] (1) received hormone treatment within 3 months;

[0074] (2) Patients with severe reproductive system inflammation or cancer;

[0075] (3) Patients with serious diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system;

[0076] (4) Patients with uterine fibroids, adenomyosis, or endometriosis;

[0077] (5) People with allergic constitution or multiple drug allergies;

[0078] (6) Patients with mental illness;

[0079] (7) Pregnant and lactating women;

[0080] 6. Elimination criteria:

[0081] (1) Patients who are pregnant during the study;

[0082] (2) receiving other treatment options during treatment;

[0083] (3) Failure to use the medication as prescribed, inability to judge efficacy, or incomplete data that affect efficacy and safety judgment;

[0084] (4) Those who voluntarily withdraw from the medication due to other diseases;

[0085] (5) Those lost to follow-up.

[0086] 7. Grouping:

[0087] The patients who met the inclusion criteria were randomly divided into Example 1 group, Comparative Example 1 group, Comparative Example 2 group and a control group using a random number table method.

[0088] (1) 30 cases in group 1 of Example 1 were first given hysteroscopic diagnostic curettage and then orally taken for three months (without taking during menstruation) the Chinese medicine decoction prepared by the method of Example 1;

[0089] (2) Comparative Example 1 group of 30 cases, first given hysteroscopic diagnostic curettage, and then orally taking for three months (stop taking during menstruation) the Chinese medicine decoction prepared by the method of Comparative Example 1;

[0090] (3) Comparative Example 2 group of 30 cases, first given hysteroscopic diagnostic curettage, and then orally taking for three months (stop taking during menstruation) the Chinese medicine decoction prepared by the method of Comparative Example 2;

[0091] (4) The control group of 30 cases was first given hysteroscopic diagnostic curettage, and then dydrogesterone (Duphaston, Abbott Biologicals BV, specification 10 mg × 20 tablets) was taken orally for three months. One tablet each time, twice a day, for 21 days, and then repeated on the 5th day of the next menstrual cycle, for 21 days, and the treatment was continued for 3 menstrual cycles.

[0092] 8. Testing indicators:

[0093] 8.1 Therapeutic effect of TCM syndromes:

[0094] The same attending physician quantified the scores of the main and secondary symptoms before treatment (the day before surgery) and 3-7 days after the end of menstruation after 3 menstrual cycles of treatment. The main symptoms were scored as 0, 2, 4, and 6 points according to 4 levels, and the secondary symptoms were scored as 0, 1, 2, and 3 points according to 4 levels to calculate the total score.

[0095] Clinical recovery: menstrual period, menstrual volume and quality return to normal, other symptoms disappear, and the total score of TCM syndrome decreases by >95%;

[0096] Markedly effective: menstrual period, menstrual volume, and menstrual quality are normal or significantly improved, other symptoms are significantly alleviated, and the total score of TCM syndromes is reduced by >70%-95%;

[0097] Effective: Menstrual period, menstrual volume and quality are improved, other symptoms are alleviated, and the total score of TCM syndrome is reduced by ≥30%-70%;

[0098] Ineffective: There is no improvement in menstruation and other symptoms, and the total score of TCM syndromes decreases by <30%.

[0099] The total effectiveness is clinical cure + marked effect + effectiveness.

[0100] 8.2 Menstrual status:

[0101] The menstrual status of the four groups of patients before treatment and after 3 menstrual cycles of treatment was compared. The same physician guided the patients to record their menstrual cycles and menstrual periods; the menstrual volume was evaluated according to the menstrual blood loss chart, and the number of sanitary napkins or tampons changed each time, the degree of menstrual blood infiltration (mild, moderate, and severe), and the size of blood clots were recorded in a table. The degree of tampon infiltration was scored as 1 point, 5 points, and 10 points, the degree of blood staining of sanitary napkins was scored as 1 point, 5 points, and 20 points, and the size of blood clots was scored as 5 points and 1 point. The number of sanitary products with different degrees of blood staining and the number of blood clots of different sizes were multiplied by the corresponding weight value. A score greater than 100 points represented abnormal uterine bleeding.

[0102] 8.3 Serum indicators:

[0103] Peripheral blood was collected from patients before treatment (the day before surgery) and 3-7 days after menstruation ended 3 menstrual cycles after treatment, and VEGF and IL-6 levels were determined using ELISA.

[0104] 8.4 Postoperative recurrence:

[0105] All the patients in the four groups were admitted to the hospital for follow-up examination regularly within 6 months after surgery. Ultrasound examination showed abnormal thickening of the endometrium, high echo masses and uneven echoes. Combined with hysteroscopic surgical pathological examination, it was confirmed as endometrial polyp and postoperative recurrence. The recurrence rate of the four groups of patients was calculated.

[0106] 9. Statistical analysis methods:

[0107] SPSS 27.0 statistical software was used to analyze the data, and count data were analyzed by χ 2 The measurement data were compared by paired t test and independent t test. P<0.05 was considered statistically significant.

[0108] 10. Research results: 10.1 Therapeutic effect of TCM syndrome:

[0109] The research results are shown in Table 1. The total effective rate of the TCM syndrome efficacy score of the Example 1 group is 90%, which is statistically significantly different from that of the control group (p<0.05). However, the efficacy of the comparative example 1 group and the comparative example 2 group is significantly lower than that of the Example 1 group, which indicates that there is a very close relationship between the medicinal flavor composition of the Chinese medicine composition of the present invention and its efficacy.

[0110] Table 1: Comparison of TCM syndrome efficacy in patients with endometrial polyps after treatment

[0111]

[0112] Note: Compared with the control group, * p<0.05.

[0113] 10.2 Menstrual status:

[0114] The research results are shown in Table 2. After treatment, the menstrual cycle and menstrual period of the patients in Example 1 group were significantly shortened compared with those before treatment (p<0.01; p<0.05), and the menstrual volume score was also significantly reduced compared with that before treatment (p<0.01). In addition, the effect of Example 1 group on the above evaluation indicators was significantly better than that of the control group (p<0.05).

[0115] However, the therapeutic effects on menstruation in Comparative Example 1 and Comparative Example 2 were significantly inferior to that in Example 1, which indicates that there is a very close relationship between the medicinal composition of the Chinese medicine composition of the present invention and its therapeutic effect.

[0116] Table 2: Comparison of menstrual status in patients with endometrial polyps after treatment

[0117]

[0118]

[0119] Note: Compared with before treatment, * p<0.05, ** p<0.05; compared with the control group, # p<0.05.

[0120] 10.3 Serum Indicators:

[0121] The research results are shown in Table 3. After treatment, the serum VEGF and IL-6 of the patients in Example 1 group were significantly reduced compared with those before treatment (p<0.01), and the effect of Example 1 group on the above evaluation indicators was slightly better than that of the control group, but the difference between the two groups was not statistically significant.

[0122] The therapeutic effects of Comparative Example 1 and Comparative Example 2 on serum VEGF and IL-6 were significantly lower than those of Example 1, which indicates that there is a very close relationship between the medicinal composition of the Chinese medicine composition of the present invention and its therapeutic effect.

[0123] Table 3: Comparison of serum indicators in patients with endometrial polyps after treatment

[0124]

[0125] 10.4 Postoperative recurrence:

[0126] Six months after surgery, there were 2 cases (6.67%) of recurrence in Example 1, 10 cases (33.33%) in Comparative Example 1, 11 cases (36.67%) in Comparative Example 2, and 7 cases (23.33%) in the control group. It can be seen that the postoperative recurrence rate in Example 1 was significantly lower than that in the other three groups.

[0127] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A Chinese medicine composition for treating endometrial polyps, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-60 parts of Smilax glabra, 10-50 parts of Platycodon grandiflorum, 10-40 parts of honeysuckle, 10-50 parts of Salvia miltiorrhiza, 10-60 parts of Corydalis yanhusuo, 10-50 parts of Atractylodes macrocephala, 10-60 parts of Prunella vulgaris, 10-40 parts of Toosendan fruit, 10-60 parts of Dioscorea opposita, 10-50 parts of Scrophularia ningpoensis, 10-50 parts of Gallus gallus domestica, and 10-40 parts of Arctium lappa.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20-50 parts of Smilax glabra, 15-30 parts of Platycodon grandiflorum, 10-20 parts of honeysuckle, 15-30 parts of Salvia miltiorrhiza, 20-50 parts of Corydalis yanhusuo, 15-30 parts of Atractylodes macrocephala, 20-50 parts of Prunella vulgaris, 10-20 parts of Toosendan fruit, 20-50 parts of Dioscorea opposita, 15-30 parts of Scrophularia ningpoensis, 15-30 parts of Gallus gallus domesticus, and 10-20 parts of Arctium lappa.

3. The Chinese medicine composition according to claim 2, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 30 parts of Smilax glabra, 20 parts of Platycodon grandiflorum, 15 parts of Honeysuckle, 20 parts of Salvia miltiorrhiza, 25 parts of Corydalis yanhusuo, 20 parts of Atractylodes macrocephala, 30 parts of Prunella vulgaris, 15 parts of Toosendan fruit, 30 parts of Dioscorea opposita, 20 parts of Scrophularia ningpoensis, 20 parts of Gallus gallus domesticus, and 15 parts of Arctium lappa.

4. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition has the effects of invigorating the spleen and replenishing qi, removing blood stasis and eliminating symptoms.

5. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The preparation method comprises the following steps: crushing smilax glabra, platycodon, honeysuckle, salvia miltiorrhiza, corydalis, atractylodes, selfheal, toosendan fruit, yam, scrophularia, chicken gizzard lining and burdock fruit, adding water for decoction, mixing filtrate and concentrating to obtain concentrated solution.

6. The preparation method according to claim 5, characterized in that: The decoction is performed twice. After the first decoction for 1-3 hours, a primary filtrate is obtained by filtering. The filter residue is then decocted with water for 1-3 hours, and a secondary filtrate is obtained by filtering. The primary filtrate and the secondary filtrate are combined.

7. The preparation method according to claim 6, characterized in that: The material-liquid ratio of the first decoction and the second decoction is 1:4, the decoction time of the first decoction and the second decoction is 1.5 hours, and the water used in the first decoction and the second decoction is distilled water; preferably, the concentration is reduced pressure concentration.

8. Use of the Chinese medicine composition according to any one of claims 1 to 4 or the Chinese medicine composition prepared by the preparation method according to any one of claims 5 to 7 in the preparation of a medicament for treating endometrial polyps.

9. The use according to claim 8, characterized in that: The endometrial polyps are spleen deficiency and blood stasis type endometrial polyps.

10. The use according to claim 8, characterized in that: The dosage form of the medicine is granules, tablets, oral liquid or capsules.

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