Traditional Chinese medicine composition for treating pelvic masses as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating pelvic masses. The effective components of the traditional Chinese medicine composition are prepared from the following raw material medicines in parts by weight: 10-50 parts of salvia miltiorrhiza, 10-50 parts of rhizoma sparganii, 10-50 parts of curcuma zedoary, 10-50 parts of ligusticum wallichii, 10-50 parts of bighead atractylodes rhizome and 10-50 parts of turtle shell. The traditional Chinese medicine composition disclosed by the invention is administered in a local transdermal administration manner, has a remarkable treatment effect on pelvic masses, can improve clinical symptoms of patients, reduce masses and relieve pain, and is high in medication safety; the traditional Chinese medicine composition is especially suitable for treating ovarian endometriosis cyst, adenomyosis (tumor) and hysteromyoma patients with blood stasis.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating pelvic masses, a preparation method thereof, and an application thereof. Background Art

[0002] Pelvic masses refer to masses originating from the uterus, adnexa, intestine, urinary tract, and retroperitoneum. They are one of the main complaints of gynecological patients and also the most common and important physical signs in gynecological pelvic examinations. They can be divided into physiological and pathological pelvic masses, and there are many types of diseases. Clinically common pelvic masses include ovarian endometriosis cysts, adenomyosis, and uterine fibroids.

[0003] Endometriosis (EMs) is a chronic and progressive disease with a high incidence in women of childbearing age, characterized by the presence of endometrial tissue outside the uterine body. Ovarian endometriosis cysts (OMA), also known as chocolate cysts, are the main pathological type of EMs, which can cause pelvic masses, pelvic pain, dysmenorrhea, and infertility. It is reported that 30-50% of EMs patients face infertility. Compared with healthy women, the pregnancy rate of EMs women drops from 15-20% per month to 2-5% per month. The treatment of OMA mainly includes drug treatment and surgical treatment. For EMs patients with fertility requirements, with an adnexal mass diameter < 4 cm and accompanied by dysmenorrhea, drug treatment is the first choice. Commonly used drugs include, in addition to non-steroidal anti-inflammatory drugs (NSAIDs) for relieving pain, oral contraceptives, high-dose progestogens, androgen derivatives, and gonadotropin-releasing hormone agonists (GnRH-a), etc. However, when using drug treatment, it can only prevent the development of the lesions, and the volume of the cysts usually does not shrink. It is necessary to regularly review the size of the cysts. If the cysts continue to grow or severe clinical symptoms appear, surgical treatment needs to be considered. Cystectomy can be performed for those with or without fertility requirements, but it is easy to damage ovarian function; for those without fertility requirements, with severe clinical symptoms or ineffective conservative treatment after recurrence, radical resection of the whole uterus, bilateral adnexa, and all ectopic lesions in the pelvis can be performed according to different ages (> 45 years old).

[0004] Adenomyosis (or adenomyoma) refers to the invasion of endometrial glands and stroma into the myometrium, usually growing diffusely; it is common in women aged 30 - 50 years. The main clinical manifestations include uterine enlargement, prolonged menstrual cycle or heavy menstrual flow, progressive dysmenorrhea, chronic pelvic pain, anemia, infertility, decreased quality of sexual life, etc., which seriously affect the quality of life of patients. It mostly occurs in multiparous women, about 15% of them are simultaneously combined with endometriosis, and about half are combined with uterine fibroids. With the continuous increase of social competition pressure, the incidence of adenomyosis has shown an obvious upward trend in recent years, and the age of onset tends to be younger. Currently, the treatment of adenomyosis is mainly divided into surgical treatment and drug treatment. Hysterectomy is an effective treatment for adenomyosis, but it is not suitable for women of childbearing age who have a need for fertility. Drug treatments such as gestrinone and danazol have large dosages and many drug side effects when used, are not suitable for long-term use, and have a high recurrence rate after drug withdrawal. The levonorgestrel intrauterine system has a good effect in inhibiting endometrial hyperplasia and reducing menstrual volume, but it is not suitable for patients with fertility requirements, and there are also side effects of long-term irregular bleeding.

[0005] Uterine fibroids are common in women aged 30 - 50 years, and the incidence rate in women of childbearing age reaches 25 - 30%. The pathogenesis is closely related to stem cell dysfunction, genetics, estrogen and progesterone levels, etc. Delayed childbearing, age > 40 years, body mass index ≥ 28 kg / m 2 , hormone supplementation, and a family history of fibroids may increase the risk of disease, and are also related to daily lifestyle, emotional abnormalities, etc. The clinical symptoms are mostly atypical, and patients are often not easily aware of them. Most are discovered during physical examinations. The common clinical manifestations include: increased menstrual volume, prolonged menstrual period, secondary anemia, increased vaginal discharge, infertility, lumbosacral pain, difficulty in urination and defecation, etc. Modern medicine divides the treatment of uterine fibroids into surgical treatment and non-surgical treatment according to the patient's age, clinical symptoms, whether there is a need for fertility, and the size, type, quantity, etc. of the fibroids: Surgical treatment is mainly divided into myomectomy and total hysterectomy. However, myomectomy is prone to recurrence, and total hysterectomy is not suitable for young patients and those with fertility requirements, and the surgery has certain risks and traumas; Non-surgical treatment is divided into uterine artery embolization (UAE), high-intensity focused ultrasound (HIFU), drug treatment, and expectant treatment, etc. Among them, in addition to having strict indications, UAE may affect ovarian blood supply, leading to ovarian function decline, and is only suitable for those who require to retain the uterus and have no fertility requirements. The risk of HIFU for fibroid residue is relatively high and it is prone to recurrence. Drug treatment includes gonadotropin-releasing hormone agonists and mifepristone, etc. that can both shrink the tumor and improve anemia, as well as non-steroidal anti-inflammatory drugs, contraceptives, and tranexamic acid, etc. that can only improve menorrhagia but cannot shrink the tumor. However, they are all prone to recurrence after drug withdrawal.

[0006] In summary, the clinical treatment of pelvic masses mainly focuses on drugs and surgery. Surgical treatment can effectively remove the masses, but it has large trauma and high costs, which limits its clinical application value. Drug treatment can achieve certain effects, but it has many adverse effects. Summary of the Invention

[0007] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating pelvic masses to solve at least one of the above technical problems.

[0008] Another purpose of the present invention is to provide a preparation method of the above traditional Chinese medicine composition to solve at least one of the above technical problems.

[0009] Another purpose of the present invention is to provide the application of the above traditional Chinese medicine composition to solve at least one of the above technical problems.

[0010] According to one aspect of the present invention, there is provided a traditional Chinese medicine composition for treating pelvic masses, and its active ingredients are made from the following raw materials in parts by weight: 10 - 50 parts of Salvia miltiorrhiza, 10 - 50 parts of Sparganium stoloniferum, 10 - 50 parts of Curcuma zedoaria, 10 - 50 parts of Ligusticum chuanxiong, 10 - 50 parts of Atractylodes macrocephala and 10 - 50 parts of Trionyx sinensis.

[0011] The formula of the traditional Chinese medicine composition of the present invention is an empirical formula summarized and improved by the inventor through more than 40 years of clinical practice. The inventor found in long-term clinical practice that long-term blood stasis obstruction in pelvic masses or the use of blood-activating and stasis-dispelling drugs may lead to deficiency of healthy qi and insufficiency of yin and blood. In addition, a major pathogenesis of pelvic masses is the mutual binding of dampness and stasis, and dampness is also an important pathological factor. The main effects of "Salvia miltiorrhiza, Sparganium stoloniferum, Curcuma zedoaria, Ligusticum chuanxiong" are promoting blood circulation to remove blood stasis, dissipating stasis and relieving pain, with a stronger power of expelling pathogenic factors and a lack of the effect of strengthening the healthy qi, and the effect of invigorating the spleen, promoting diuresis and resolving dampness is also insufficient. Therefore, in the process of treating pelvic masses, the present invention mainly uses Salvia miltiorrhiza, Sparganium stoloniferum, Curcuma zedoaria, Ligusticum chuanxiong to promote blood circulation to remove blood stasis, activate blood circulation and promote qi movement to relieve pain, directly targeting the essence of blood stasis obstruction in pelvic masses for treatment. Then, on this basis, Atractylodes macrocephala and Trionyx sinensis are further added.

[0012] Atractylodes macrocephala has the effects of invigorating the spleen and replenishing qi, drying dampness and promoting diuresis, and reducing swelling. When treating pelvic masses, Atractylodes macrocephala not only resolves dampness and promotes diuresis for dampness pathogen, but also plays a role in strengthening the spleen and supporting healthy qi. The spleen is the foundation of acquired constitution, governing the transportation and transformation of water dampness and qi and blood. When the spleen qi functions normally, qi and blood are generated abundantly, and the healthy qi is sufficient, which helps to enhance the body's resistance and improve the body's ability to resist pathogenic factors, so as to promote the absorption and dissipation of the mass. At the same time, the dampness-drying effect of Atractylodes macrocephala can improve the situation of dampness stagnation that may exist in the pelvis, prevent the mutual binding of dampness and blood stasis, and avoid aggravating the condition.

[0013] Vinegar-fried turtle shell has the effects of nourishing yin and suppressing yang, softening hardness and dissipating binds, etc. When treating pelvic masses, the effect of softening hardness and dissipating binds of turtle shell can act on the mass itself, gradually softening and shrinking the hard mass. At the same time, the effect of nourishing yin of turtle shell can prevent the deficiency of yin and blood caused by long-term stasis of blood or the use of blood-activating and stasis-dispelling drugs, playing the role of strengthening healthy qi and eliminating pathogenic factors, treating both the principal and secondary aspects of the disease, and making the treatment more comprehensive.

[0014] In the formula of the traditional Chinese medicine composition of the present invention, salvia miltiorrhiza promotes blood circulation to remove blood stasis, reduces swelling and relieves pain, and rhizoma sparganii and rhizoma zedoariae break blood stasis, disperse binds and dissipate masses, and they are used as the monarch drugs together. The combination of the two can enhance the effect of removing blood stasis, dispersing binds and relieving pain; rhizoma curcumae has the effects of breaking blood and promoting qi movement, removing accumulation and relieving pain, and is often used in combination with rhizoma sparganii, which can enhance the effect of rhizoma sparganii in breaking blood and dissipating masses. Ligusticum wallichii is a qi drug in blood, promoting blood circulation and qi movement, and can assist salvia miltiorrhiza, rhizoma sparganii, rhizoma curcumae, etc. to strengthen the effect of promoting blood circulation to remove blood stasis and dispersing binds, and is used as the minister drug together with rhizoma curcumae; vinegar-fried turtle shell softens hardness and dissipates binds, nourishes yin and suppresses yang, and restrains the warmth of ligusticum wallichii and rhizoma sparganii. Atractylodes macrocephala invigorates the spleen and benefits qi, dries dampness and promotes diuresis, and the two play the role of strengthening healthy qi and eliminating pathogenic factors, treating both the principal and secondary aspects of the disease, and are used as the assistant drugs together. The combination of all the drugs can achieve the effects of promoting blood circulation to remove blood stasis, softening hardness and dissipating binds, strengthening the spleen and supporting healthy qi, so as to treat both the principal and secondary aspects of the disease, remove stasis and dissipate masses, and effectively treat gynecological pelvic masses.

[0015] In some embodiments, the active ingredients of the traditional Chinese medicine composition of the present invention are made from the following raw materials in parts by weight: 20 parts of salvia miltiorrhiza, 15 parts of rhizoma sparganii, 15 parts of rhizoma curcumae, 15 parts of ligusticum wallichii, 15 parts of atractylodes macrocephala and 15 parts of turtle shell.

[0016] In some embodiments, the active ingredients of the traditional Chinese medicine composition of the present invention are made from the following raw materials in parts by weight: 10 parts of salvia miltiorrhiza, 40 parts of rhizoma sparganii, 40 parts of rhizoma curcumae, 10 parts of ligusticum wallichii, 10 parts of atractylodes macrocephala and 50 parts of turtle shell.

[0017] In some embodiments, the active ingredients of the traditional Chinese medicine composition of the present invention are made from the following raw materials in parts by weight: 40 parts of salvia miltiorrhiza, 20 parts of rhizoma sparganii, 20 parts of rhizoma curcumae, 30 parts of ligusticum wallichii, 30 parts of atractylodes macrocephala and 20 parts of turtle shell.

[0018] In some embodiments, the active ingredients of the traditional Chinese medicine composition of the present invention are made from the following raw materials in parts by weight: 30 parts of salvia miltiorrhiza, 30 parts of rhizoma sparganii, 30 parts of rhizoma curcumae, 40 parts of ligusticum wallichii, 40 parts of atractylodes macrocephala and 30 parts of turtle shell.

[0019] In some embodiments, the active ingredients of the traditional Chinese medicine composition of the present invention are made from the following raw materials in parts by weight: 50 parts of salvia miltiorrhiza, 50 parts of rhizoma sparganii, 50 parts of rhizoma curcumae, 50 parts of ligusticum wallichii, 50 parts of atractylodes macrocephala and 40 parts of turtle shell.

[0020] The traditional Chinese medicine composition of the present invention is administered by the method of local transdermal administration, has a significant therapeutic effect on pelvic masses, can improve the clinical symptoms of patients, reduce the masses, relieve pain, and has high drug safety; it is particularly suitable for treating ovarian endometriosis cysts, adenomyosis (tumor) of the uterus, and uterine fibroids belonging to the blood stasis syndrome.

[0021] The traditional Chinese medicine composition of the present invention can be applied to the treatment of diseases such as ovarian endometriosis cysts, adenomyosis of the uterus, uterine fibroids, and endometriosis.

[0022] The raw material sources of the formula of the traditional Chinese medicine composition of the present invention are as follows:

[0023] Salvia miltiorrhiza: It is the dried root and rhizome of Salvia miltiorrhiza Bge., a plant of the genus Salvia in the family Labiatae. It is bitter in taste and slightly cold in nature; it belongs to the heart and liver meridians.

[0024] Sparganium stoloniferum: It is the dried tuber of Sparganium stolonierum Buch.-Ham., a plant of the genus Sparganium in the family Sparganiaceae. It is pungent and bitter in taste and neutral in nature; it belongs to the liver and spleen meridians.

[0025] Curcuma aeruginosa: It is the rhizome of Curcuma aeruginosa Roxb. [C.zedoaria nonRosc.], Curcuma kwang siensis S.G.Lee et C.F.Liang, and Curcuma wenyujin Y.H.Chen et C.Ling of the genus Curcuma in the family Zingiberaceae. It is pungent and bitter in taste and warm in nature; it belongs to the liver and spleen meridians.

[0026] Ligusticum chuanxiong: It is the dried rhizome of Ligusticum chuanxiong Hort., a plant of the genus Ligusticum in the family Umbelliferae. It is pungent in taste and warm in nature; it belongs to the liver and gallbladder meridians.

[0027] Atractylodes macrocephala: It is the rhizome of Atractylodes macrocephala, a plant of the genus Atractylodes in the family Compositae. It is bitter and sweet in taste and warm in nature; it belongs to the spleen and stomach meridians.

[0028] Trionyx sinensis shell: It is the dorsal shell of Trionyx sinensis Wiegmann, an animal of the genus Trionyx in the family Trionychidae. It is salty in taste and slightly cold in nature; it belongs to the liver and kidney meridians. Vinegar-fried Trionyx sinensis shell is a processed product of Trionyx sinensis shell obtained by the method of stir-frying with sand and quenching with vinegar. Vinegar-fried Trionyx sinensis shell can enhance the effects of softening hardness and dissipating nodules, nourishing yin, and can moderate the drug properties, mainly entering the liver meridian, and has a more precise targeting effect in the treatment of masses and accumulations caused by liver depression and blood stasis.

[0029] In some embodiments, the traditional Chinese medicine composition of the present invention further comprises one or more pharmaceutically acceptable excipients.

[0030] In some embodiments, the administration mode of the traditional Chinese medicine composition of the present invention is local transdermal administration.

[0031] In some embodiments, the dosage form of the traditional Chinese medicine composition of the present invention is patch, ointment, cream, gel, paste, film-forming agent, powder, lotion, tincture, liniment, aerosol or spray.

[0032] In some embodiments, the dosage form of the traditional Chinese medicine composition of the present invention is patch.

[0033] According to another aspect of the present invention, there is also provided a preparation method of a traditional Chinese medicine composition for treating pelvic mass, comprising the following steps: taking each raw material medicine, pulverizing and mixing, and then adding pharmaceutically acceptable excipients to make external preparations such as patch, ointment, cream, gel, paste, film-forming agent, powder, lotion, tincture, liniment, aerosol or spray.

[0034] Specifically, the preparation method of the traditional Chinese medicine composition in the form of patch for treating pelvic mass may include the following steps:

[0035] (1) Medicinal material preparation: Taking each raw material medicine in proportion for cleaning and selection, removing impurities and non-medicinal parts, and then pulverizing the medicinal materials into powder for standby;

[0036] (2) Matrix preparation: Heating the vegetable oil to a certain temperature, adding beeswax, stirring until the beeswax is completely melted, and then continuing to stir until cooled to make the matrix have appropriate consistency;

[0037] (3) Mixing and blending: Slowly adding the medicinal material powder into the melted matrix, and continuously stirring at the same time to ensure that the medicinal materials and the matrix are fully mixed and uniform; adding 1-10% of glycerol based on the total mass of the matrix, continuing to stir evenly to form a viscous paste, pouring the ointment into a mold, and waiting for it to cool naturally to a solid state.

[0038] In some embodiments, the vegetable oil can be selected from at least one of sesame oil and peanut oil, and the heating temperature can be 40-60°C.

[0039] In some embodiments, the mass ratio of the vegetable oil to the beeswax can be 2:1-3:1.

[0040] In some embodiments, the penetration value (a common index for measuring consistency) of the matrix is usually controlled at 100-300 mm / 10 g.

[0041] In some embodiments, the mass ratio of the medicinal material powder to the matrix can be 1:2-1:4. Specific embodiments

[0042] The present invention will be further described in detail below in conjunction with the embodiments. The embodiments are only for explanation and do not limit the present invention in any way. Unless otherwise specified, the raw materials and reagents used in the embodiments are conventional products that can be obtained commercially; the experimental methods without specific conditions noted in the embodiments are usually carried out according to the conventional conditions in the art or according to the conditions recommended by the manufacturers.

[0043] Example 1 Patch for Treating Pelvic Mass

[0044] Weigh the raw materials according to the following ratio (unit: parts by weight):

[0045] Salvia miltiorrhiza 20 parts, Sparganium stoloniferum 15 parts, Curcuma zedoaria 15 parts, Ligusticum chuanxiong 15 parts, Atractylodes macrocephala 15 parts, and vinegar-fried Trionyx sinensis carapace 15 parts.

[0046] Preparation method:

[0047] (1) Preparation of medicinal materials: Select each raw material according to the ratio, remove impurities and non-medicinal parts, and then crush and grind the medicinal materials into powder for standby;

[0048] (2) Preparation of matrix: Heat sesame oil to 60 °C, add beeswax accounting for 30% of the total mass of the matrix, stir until the beeswax is completely melted, and then continue to stir until cooled to make the matrix have appropriate consistency (penetration is 100 - 200 mm / 10 g);

[0049] (3) Mixing and blending: Slowly add the medicinal powder to the melted matrix (the mass ratio of the medicinal powder to the matrix is 1:2), and continuously stir to ensure that the medicinal materials and the matrix are fully mixed evenly; add glycerin accounting for 5% of the total mass of the matrix, continue to stir evenly to form a viscous paste, pour the paste into a mold, and wait for it to cool naturally to a solid state to finally obtain the patch, and each patch contains 60 g of crude drug.

[0050] Example 2 Patch for Treating Pelvic Mass

[0051] Weigh the raw materials according to the following ratio (unit: parts by weight):

[0052] Salvia miltiorrhiza 10 parts, Sparganium stoloniferum 40 parts, Curcuma zedoaria 40 parts, Ligusticum chuanxiong 10 parts, Atractylodes macrocephala 10 parts, and Trionyx sinensis carapace 50 parts.

[0053] Preparation method:

[0054] Select each raw material according to the ratio, remove impurities and non-medicinal parts, and then crush and grind the medicinal materials into powder. After mixing, add excipients and prepare into corresponding dosage forms such as patches, ointments, creams, gels, pastes, film-forming agents, powders, lotions, tinctures, liniments, aerosols or sprays according to the conventional preparation processes of traditional Chinese medicines.

[0055] Example 3 Patch for Treating Pelvic Mass

[0056] Weigh the raw medicinal materials according to the following ratios (unit: parts by weight):

[0057] Salvia miltiorrhiza 40 parts, Sparganium stoloniferum 20 parts, Curcuma zedoaria 20 parts, Ligusticum chuanxiong 30 parts, Atractylodes macrocephala 30 parts, and Trionyx sinensis 20 parts.

[0058] Preparation method:

[0059] Take each raw medicinal material in proportion for purification, remove impurities and non-medicinal parts, then crush the medicinal materials into powder, add excipients after mixing, and prepare into corresponding dosage forms such as patches, ointments, creams, gels, pastes, film-forming agents, powders, lotions, tinctures, liniments, aerosols or sprays according to the conventional preparation process of traditional Chinese medicines.

[0060] Example 4 Patch for treating pelvic mass

[0061] Weigh the raw medicinal materials according to the following ratios (unit: parts by weight):

[0062] Salvia miltiorrhiza 30 parts, Sparganium stoloniferum 30 parts, Curcuma zedoaria 30 parts, Ligusticum chuanxiong 40 parts, Atractylodes macrocephala 40 parts, and Trionyx sinensis stir-fried with vinegar 30 parts.

[0063] Preparation method:

[0064] Take each raw medicinal material in proportion for purification, remove impurities and non-medicinal parts, then crush the medicinal materials into powder, add excipients after mixing, and prepare into corresponding dosage forms such as patches, ointments, creams, gels, pastes, film-forming agents, powders, lotions, tinctures, liniments, aerosols or sprays according to the conventional preparation process of traditional Chinese medicines.

[0065] Example 5 Patch for treating pelvic mass

[0066] Weigh the raw medicinal materials according to the following ratios (unit: parts by weight):

[0067] Salvia miltiorrhiza 50 parts, Sparganium stoloniferum 50 parts, Curcuma zedoaria 50 parts, Ligusticum chuanxiong 50 parts, Atractylodes macrocephala 50 parts, and Trionyx sinensis stir-fried with vinegar 40 parts.

[0068] Preparation method:

[0069] Take each raw medicinal material in proportion for purification, remove impurities and non-medicinal parts, then crush the medicinal materials into powder, add excipients after mixing, and prepare into corresponding dosage forms such as patches, ointments, creams, gels, pastes, film-forming agents, powders, lotions, tinctures, liniments, aerosols or sprays according to the conventional preparation process of traditional Chinese medicines.

[0070] In order to verify the effect of the traditional Chinese medicine composition of the present invention in treating pelvic mass, the patch for treating pelvic mass prepared in Example 1 of the present invention was used as the test drug to carry out a clinical study. The research process and results are as follows:

[0071] 1 Data and methods

[0072] 1.1 General information

[0073] A total of 150 patients with pelvic masses who visited Guangdong Provincial Hospital of Traditional Chinese Medicine from June 2022 to June 2024 were selected (including 45 cases of ovarian endometriosis cysts, 55 cases of adenomyosis (tumor) of the uterus, and 50 cases of uterine fibroids). The age range was 25 - 60 years old, with an average age of (34.97 ± 6.73) years; the course of disease was 3 - 12 months, with an average course of (5.21 ± 1.20) months; the minimum diameter of the mass was 15 mm, and the maximum was 40 mm. TCM syndrome differentiation types: blood stasis type (including 70 cases of qi stagnation and blood stasis type, 25 cases of cold coagulation and blood stasis type, 20 cases of kidney deficiency and blood stasis type, and 35 cases of damp - heat stasis type).

[0074] 1.2 Diagnostic criteria

[0075] Meet the relevant diagnostic criteria for uterine fibroids, adenomyosis of the uterus, and ovarian endometriosis cysts in "Obstetrics and Gynecology (Tenth Edition)" published by People's Medical Publishing House;

[0076] TCM syndrome criteria: Refer to the pelvic mass blood stasis syndrome formulated for uterine fibroids, adenomyosis of the uterus, and ovarian cysts in the "Clinical Diagnosis and Treatment Guidelines for TCM Gynecology" issued by the Chinese Association of Chinese Medicine in 2020.

[0077] Main symptom: Pelvic mass.

[0078] Sub - symptoms: Dark - colored menstruation or blood clots; dull complexion or dark spots; dry and rough skin; abdominal pain; dark tongue or ecchymosis, petechiae, or varicose veins under the tongue.

[0079] With the above main symptom and at least 1 sub - symptom, the diagnosis can be made.

[0080] 1.3 Inclusion and exclusion criteria

[0081] Inclusion criteria: ① Those who meet the above Chinese and Western medicine diagnostic criteria; ② With complete clinical data and continuous treatment for at least 3 months; ③ Having imaging examinations before and after treatment.

[0082] Exclusion criteria: ① Those with missing clinical data, including those with less than 3 months of treatment or non - continuous treatment for 3 months, and those with missing imaging examinations before and after treatment; ② Those with combined other malignant tumors; ③ Those with severe internal medical diseases such as hypertension, diabetes, heart disease, etc.; ④ Those with a history of using hormones or drugs with similar functional efficacy within 3 months; ⑤ Those with skin rashes or allergies.

[0083] 1.4 Treatment methods

[0084] The patch prepared in the embodiment of the present invention, one patch each time, once a day, applied externally to the lower abdomen for 5 - 6 hours. Continuously treat for 3 months.

[0085] 1.5 Observation indicators and efficacy evaluation

[0086] 1.5.1 Traditional Chinese Medicine Syndrome Score

[0087] The evaluation indicators include 5 items such as stabbing pain in the lower abdomen, menstrual blood clots, changes in the mass, dull complexion or rough skin, and dark tongue or ecchymosis. A four - level scoring method of 0 - 4 points is used for evaluation. The higher the score, the more severe the symptoms.

[0088] ① Recovery: The syndrome score is 0 points;

[0089] ② Marked effect: The syndrome score is reduced by more than 50%;

[0090] ③ Effective: The syndrome score is reduced by 25 - 50%;

[0091] ④ Ineffective: The syndrome score is reduced by less than 25% or shows no change or increase.

[0092] 1.5.2 Size of the Mass

[0093] Evaluation is carried out 3 months after treatment:

[0094] ① Recovery: B - ultrasound or MR examination shows that the pelvic mass has completely disappeared;

[0095] ② Marked effect: The degree of reduction in the volume of the pelvic mass is more than 50%;

[0096] ③ Effective: The volume of the pelvic mass is reduced by 25 - 50%;

[0097] ④ Ineffective: The volume of the pelvic mass is reduced by less than 25% or shows no change or increase.

[0098] Total effective rate = (number of cases of recovery + marked effect + effective) / total number of cases × 100%.

[0099] 1.5.3 Pain

[0100] The VAS pain scale is used for scoring. The degree of pain is represented by 1 - 10 points. The larger the number, the more obvious the pain.

[0101] ① Recovery: The pain has completely disappeared and the pain score is 0;

[0102] ② Marked effect: The pain score is reduced by more than 50%;

[0103] ③ Effective: The pain score is reduced by 25 - 50%;

[0104] ④ Ineffective: The pain score is reduced by less than 25% or shows no change or increase.

[0105] Total effective rate = (number of cases of recovery + marked effect + effective) / total number of cases × 100%.

[0106] 1.5.4 Adverse Reactions

[0107] Record the occurrence of adverse reactions such as skin itching, nausea or vomiting, and fatigue in patients.

[0108] 1.6 Statistical methods

[0109] Analysis was performed using SPSS 20.0 software. Measurement data were described using and the t-test was used; count data were expressed as rates (%) and the chi-square 2 test was used. P < 0.05 was considered statistically significant.

[0110] 2 Results

[0111] 2.1 Changes in the size of the mass

[0112] 2.1.1 Efficacy of changes in the size of the mass before and after treatment

[0113] After treatment, the mass could be effectively reduced. Among them, 58 cases had complete recovery plus marked effect, 51 cases had effective results, and 41 cases had ineffective results. The total clinical effective rate reached 73%.

[0114] 2.1.2 Changes in the size of the mass before and after treatment.

[0115] Before treatment, the average diameter of 150 patients was 30.66 ± 0.56 mm. After treatment, the average diameter was 26.06 ± 0.35 mm, with an average reduction of 4.6 mm. The difference in the average diameter before and after treatment was statistically significant (P < 0.001), as shown in Table 1.

[0116] Table 1 Comparison of the size of the mass before and after treatment ( mm)

[0117]

[0118] 2.2 VAS pain scale

[0119] 2.2.1 Efficacy of VAS pain scale scores before and after treatment

[0120] Among 150 patients, 120 had lower abdominal pain. After treatment, 50 cases had complete recovery, 50 cases had marked effect, 15 cases had effective results, and 5 cases had ineffective results. The total effective rate was 95.8%.

[0121] 2.2.2 Changes in VAS pain scale scores before and after treatment

[0122] The VAS pain scale score before treatment was 7.35 ± 0.11 points, and after treatment it was 1.7 ± 0.10 points, with a decrease of 5.65 points. The difference in scores before and after treatment was statistically significant (P < 0.001), as shown in Table 2.

[0123] Table 2 Comparison of VAS scale scores before and after treatment ( points)

[0124] Number of cases Before treatment After treatment t value P value 150 7.35±0.11 1.7±0.10 1.354 <0.001

[0125] 2.3 TCM syndrome score

[0126] Therapeutic effect of TCM syndrome score: After treatment, 65 cases were cured, 70 cases were markedly effective, 15 cases were effective, and 0 cases were ineffective. The total effective rate was 100%.

[0127] After treatment, the scores of menstrual blood clots, lower abdominal pain, complexion and tongue color of the patients were all improved. The difference before and after treatment was statistically significant (P<0.01), as shown in Table 3.

[0128] Table 3 Comparison of TCM syndrome scores before and after treatment ( points)

[0129] Menstrual blood clots Lower abdominal pain Sallow complexion Dark or ecchymotic tongue Before treatment 2.45±0.31 1.66±0.45 1.67±0.35 1.67±0.43 After treatment 0.79±0.10 0.34±0.10 0.62±0.26 0.54±0.15 t value 0.443 0.866 1.254 0.399 P value <0.001 <0.001 0.004 <0.001

[0130] 2.4 Adverse reactions

[0131] No adverse reactions were observed during the treatment period, and no adverse events occurred. The clinical application is safe and reliable.

[0132] In summary, the traditional Chinese medicine composition provided by the present invention for treating pelvic masses is administered by local transdermal administration, has a significant therapeutic effect on pelvic masses, can improve the clinical symptoms of patients, reduce the masses, relieve pain, and has high drug safety.

[0133] The above are only some embodiments of the present invention. For those of ordinary skill in the art, without departing from the inventive concept of the present invention, several modifications and improvements can still be made, and these all belong to the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating pelvic masses, characterized in that, Its active ingredients are made from the following raw medicinal materials in parts by weight: 10 - 50 parts of Salvia miltiorrhiza, 10 - 50 parts of Sparganium stoloniferum, 10 - 50 parts of Curcuma zedoaria, 10 - 50 parts of Ligusticum chuanxiong, 10 - 50 parts of Atractylodes macrocephala, and 10 - 50 parts of Trionyx sinensis.

2. The traditional Chinese medicine composition for treating pelvic mass according to claim 1, wherein, Its active ingredients are made from the following raw medicinal materials in parts by weight: 20 parts of Salvia miltiorrhiza, 15 parts of Sparganium stoloniferum, 15 parts of Curcuma zedoaria, 15 parts of Ligusticum chuanxiong, 15 parts of Atractylodes macrocephala, and 15 parts of Trionyx sinensis.

3. The traditional Chinese medicine composition for treating pelvic mass according to claim 1 or 2, wherein, It further includes one or more pharmaceutically acceptable excipients.

4. The traditional Chinese medicine composition for treating pelvic mass according to claim 3, wherein, The administration method of the traditional Chinese medicine composition is local transdermal administration.

5. The traditional Chinese medicine composition for treating pelvic mass according to claim 4, wherein, The dosage form of the traditional Chinese medicine composition is patch, ointment, cream, gel, paste, film - forming agent, powder, lotion, tincture, liniment, aerosol or spray.

6. The traditional Chinese medicine composition for treating pelvic mass according to claim 5, wherein, The dosage form of the traditional Chinese medicine composition is patch.

7. The preparation method of the traditional Chinese medicine composition for treating pelvic mass according to any one of claims 1 to 6, characterized in that, The preparation method includes the following steps: taking each raw medicinal material, crushing and mixing, and then adding pharmaceutically acceptable excipients to make patch, ointment, cream, gel, paste, film - forming agent, powder, lotion, tincture, liniment, aerosol or spray.

8. Use of the traditional Chinese medicine composition for treating pelvic mass according to any one of claims 1 - 6 in the preparation of a drug for treating pelvic mass.

9. The application according to claim 8, wherein The pelvic mass is selected from at least one of ovarian endometriotic cyst, adenomyosis, and uterine fibroids.

10. Use of the traditional Chinese medicine composition for treating pelvic mass according to any one of claims 1 - 6 in the preparation of a drug for treating endometriosis.

Images