CN111298080B - Traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis - Google Patents

Traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis Download PDF

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CN111298080B
CN111298080B CN202010146739.9A CN202010146739A CN111298080B CN 111298080 B CN111298080 B CN 111298080B CN 202010146739 A CN202010146739 A CN 202010146739A CN 111298080 B CN111298080 B CN 111298080B
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endometriosis
chinese medicine
traditional chinese
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CN111298080A (en
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俞超芹
俞瑾
翟东霞
张丹英
程雯
白玲玲
姚睿嫔
孙帅
苗津东
周玲
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Shanghai Changhai Hospital
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Abstract

The invention discloses a traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis, which is prepared from the following raw material medicines in parts by weight: 6-12 parts of homalomena occulta, 6-12 parts of dutchmanspipe vine, 9-18 parts of sinkiang spurge stem, 9-30 parts of sargentgloryvine stem, 9-18 parts of garden balsam stem, 9-18 parts of lycopodium clavatum, 6-12 parts of monkshood, 3-12 parts of evodia rutaecarpa, 3-15 parts of baked ginger, 3-15 parts of fennel, 3-12 parts of pericarpium zanthoxyli, 6-15 parts of zedoary, 6-15 parts of processed rhizoma sparganii, 12-18 parts of folium artemisiae argyi, 6-12 parts of frankincense and 6-12 parts of myrrh. The traditional Chinese medicine composition disclosed by the invention has the effects of warming channels for dispelling cold, promoting blood circulation for removing blood stasis, relieving swelling and pain and the like, can obviously relieve chronic pelvic pain and dysmenorrhea caused by endometriosis, is remarkable in effect, economic and convenient, small in side effect, exact in curative effect, free of toxic and side effects, low in cost and convenient to popularize and apply.

Description

Traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis.
Background
Endometriosis (EM) is an estrogen-dependent disease in which endometrial glands and stroma are implanted outside the uterus, and the incidence of EM in genital women is 10% -20%; the incidence rate of the patients with secondary dysmenorrhea in young people is up to 50 percent. The main clinical manifestations are pelvic pain and infertility. As for the quality of life of women, pelvic pain that is difficult to cure radically for a long time may be more devastating to physical and mental health than infertility.
Pain is the main symptom of endometriosis, and 87.7% of patients with endometriosis are accompanied by dysmenorrhea, of which about 71.3% have lower abdominal pain, 57.4% have total abdominal pain, 56.2% have sexual intercourse pain, 42.6% have anal pain, and 39.5% have defecation pain. In the clinical setting of chronic pelvic pain in genital women, the internal disorder should also be considered first.
Dysmenorrhea is the most important clinical manifestation of endometriosis, secondary and progressive exacerbation are the clinical characteristics of endometriosis, and is mostly manifested as lower abdominal pain which can be radiated to the back and legs. Lower abdominal pain often worsens with the menstrual cycle, often beginning 1-2 days before menstruation, with a peak at the beginning of menstruation, with pain relief after menstruation in most patients, but in later patients, pain sustainability exists especially when extensive and significant adhesions to the pelvic cavity are present. Some patients have severe dysmenorrhea and are difficult to endure, and even need to rest in bed or use medicines to relieve pain. Endometriosis dysmenorrhea is caused by that the estrogen level is continuously increased in the follicular phase to promote the proliferation and swelling of ectopic endometrial tissues, and along with the decrease of the progestational hormone level, the ectopic endometrial tissues bleed to stimulate local tissues, so that pain is caused. In addition, in the endometriotic tissue, local inflammatory reaction is accompanied by release of a large amount of inflammatory factors, and excessive prostaglandin, kinin and other peptide substances can be generated to promote pain development.
Therefore, in clinical practice, the research on the relation between endometriosis and pain is emphasized, the treatment of pain is enhanced, and the method has important significance on the outcome of the whole disease process and has positive effects on the physical and psychological health of women.
The traditional Chinese medicine considers that the main reason for the disease is 'blood stasis', unsmooth running and blood stasis stagnation are caused by liver depression and qi stagnation, cold-damp stagnation or spleen and kidney qi deficiency of a body and blood circulation weakness or heat stagnation, the blood stasis is blocked in thoroughfare and conception cell vessels, and the stagnation leads to pain. Infertility can occur if the two essences cannot be combined; stagnant blood can not be removed, and new blood can not enter meridians, so that the menstrual flow is large, and the menstrual period is prolonged; long-term retention of blood stasis can lead to accumulation of blood stasis and mass, which results in clinically common excess syndrome or deficiency-excess with mixed syndromes, but less pure deficiency syndrome. The traditional Chinese medicine for treating endometriosis mainly adopts the traditional Chinese medicine method of regulating qi, activating blood, removing stasis and resolving masses. According to different ages, constitutions and mild or urgent conditions of patients, the traditional Chinese medicine composition is supplemented with qi-tonifying, blood-nourishing, kidney-tonifying and the like on the basis of qi-regulating, blood-activating, stasis-removing and stasis-dissipating. Chinese patent application CN1843491A discloses a pharmaceutical composition for treating endometriosis, which is an externally applied heat application ointment prepared from the following traditional Chinese medicine raw materials in parts by weight (each traditional Chinese medicine dose): 5-100 g of 10 medicines of aconitum szechenyianum, folium artemisiae argyi, caulis spatholobi, radix sileris, root bark of Chinese quince, safflower, ligusticum wallichii, radix angelicae, notopterygium root and radix angelicae pubescentis and radix clematidis respectively; or the external cold compress ointment is prepared by adopting the following traditional Chinese medicine raw materials in parts by weight (each dose of traditional Chinese medicine): 20-100 g of raw rhubarb powder and 40-500 g of mirabilite, and the external hot compress and cold compress ointment can be used for treating endometriosis and has obvious curative effect on endometriosis and infertility patients caused by endometriosis.
The external traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrheal caused by endometriosis, which has the advantages of low raw material cost, simple and convenient preparation and convenient use, is not reported at present.
Disclosure of Invention
The first purpose of the invention is to provide a traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis.
The second purpose of the invention is to provide the application of the traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis in the preparation of medicines or health-care products for treating chronic pelvic pain and dysmenorrhea caused by endometriosis.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows:
the invention provides a traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis, which is prepared from the following raw material medicines in parts by weight: 6-12 parts of homalomena occulta, 6-12 parts of dutchmanspipe vine, 9-18 parts of sinkiang spurge stem, 9-30 parts of sargentgloryvine stem, 9-18 parts of garden balsam stem, 9-18 parts of lycopodium clavatum, 6-12 parts of monkshood, 3-12 parts of evodia rutaecarpa, 3-15 parts of baked ginger, 3-15 parts of fennel, 3-12 parts of pericarpium zanthoxyli, 6-15 parts of zedoary, 6-15 parts of processed rhizoma sparganii, 12-18 parts of folium artemisiae argyi, 6-12 parts of frankincense and 6-12 parts of myrrh.
The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 9 parts of homalomena occulta, 9 parts of herba aristolochiae, 9 parts of lijin vine, 15 parts of sargentgloryvine stem, 15 parts of garden balsam stem, 15 parts of lycopodium clavatum, 9 parts of monkshood, 6 parts of fructus evodiae, 9 parts of baked ginger, 9 parts of fennel, 6 parts of pericarpium zanthoxyli, 9 parts of zedoary, 9 parts of processed rhizoma sparganii, 15 parts of folium artemisiae argyi, 9 parts of frankincense and 9 parts of myrrh.
The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 12 parts of homalomena occulta, 12 parts of herba aristolochiae, 12 parts of sinkiang arnebia root, 30 parts of sargentgloryvine stem, 18 parts of garden balsam stem, 18 parts of lycopodium clavatum, 6 parts of monkshood, 6 parts of evodia rutaecarpa, 3 parts of baked ginger, 3 parts of fennel, 3 parts of pericarpium zanthoxyli, 15 parts of zedoary, 15 parts of processed rhizoma sparganii, 18 parts of folium artemisiae argyi, 12 parts of frankincense and 12 parts of myrrh.
The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 6 parts of homalomena occulta, 6 parts of herba aristolochiae, 12 parts of sinkiang arnebia stem, 15 parts of sargentgloryvine stem, 15 parts of garden balsam stem, 15 parts of lycopodium clavatum, 12 parts of monkshood, 3 parts of evodia rutaecarpa, 6 parts of baked ginger, 6 parts of fennel, 6 parts of pericarpium zanthoxyli, 12 parts of zedoary, 12 parts of processed rhizoma sparganii, 15 parts of folium artemisiae argyi, 9 parts of frankincense and 9 parts of myrrh.
The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 10 parts of homalomena occulta, 10 parts of herba aristolochiae, 10 parts of lijin vine, 20 parts of sargentgloryvine stem, 10 parts of garden balsam stem, 10 parts of lycopodium clavatum, 10 parts of monkshood, 9 parts of fructus evodiae, 9 parts of baked ginger, 9 parts of fennel, 9 parts of pericarpium zanthoxyli, 10 parts of zedoary, 10 parts of processed rhizoma sparganii, 15 parts of folium artemisiae argyi, 10 parts of frankincense and 10 parts of myrrh.
The second aspect of the invention provides a pharmaceutical preparation, which adopts the traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrheal caused by endometriosis as an active ingredient, and is prepared into a pharmaceutic common external preparation by adopting a conventional preparation method in the field.
The medicinal preparation is external powder, emplastrum or cataplasm.
The pharmaceutical preparation can be prepared by the following method: (A) weighing the medicinal material components, and mixing to obtain a mixture; (B) adding pharmaceutically acceptable carrier into the mixture, and preparing by conventional preparation method in the field.
The cataplasm is prepared from the following raw material medicinal powder in proportion: 5-20g (preferably 13g) of raw material medicinal powder of the traditional Chinese medicine composition, 1-5g (preferably 3g) of sodium polyacrylate, 1-5g (preferably 3g) of carbomer, 0.5-2g (preferably 1g) of CM sodium cellulose, 5-50ml (preferably 30ml) of glycerol, 1-10ml (preferably 5ml) of antifoaming agent (mineral oil DF879), 0.1-1g (preferably 0.6g) of tartaric acid, 0.1-1g (preferably 0.3g) of aluminum glycinate, 1-3g (preferably 2g) of kaolin, 0.1-0.5ml (preferably 0.3ml) of 1-methyl-2 pyrrolidone and 0.1-0.5ml (preferably 0.3ml) of azone.
The traditional Chinese medicine composition raw material powder is prepared by grinding the traditional Chinese medicine composition into powder according to the formula amount.
The third aspect of the invention provides application of the traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis in preparation of medicines or health-care foods for treating chronic pelvic pain and dysmenorrhea caused by endometriosis.
The fourth aspect of the invention provides an application of the medicinal preparation in preparing medicaments or health-care foods for treating chronic pelvic pain and dysmenorrheal caused by endometriosis.
The use method of the pharmaceutical preparation of the invention comprises the following steps: the prepared traditional Chinese medicine preparation is applied to the lower abdomen (below the navel and above the pubic symphysis) or the area with the most obvious pain is selected, and the traditional Chinese medicine preparation is taken once before sleeping every night, and each time lasts for at least 30 minutes.
The traditional Chinese medicine has no name of endometriosis, but can belong to the categories of dysmenorrheal, infertility and the like according to different symptoms. The disease is located in the lower energizer, in the middle of the lower abdomen, and the stagnation of the uterus collaterals is obstructed. The pathogenesis is that the patients are weak, or after the proper menstrual period, the blood chamber is open, the regulation is not performed, and the patients feel damp-heat exogenous evil; or the operation injures the thoroughfare and conception vessels, so that the malignant blood is not clean and remained without removing, and the disease is accumulated. Also, the disease is located in the lower energizer, and the dampness is heavy and turbid and is easy to attack, so that long-term retention of blood stasis and dampness will cause the blood stasis and dampness to be mixed with each other and become mass, which affects the qi movement of the lower energizer and leads to disorder of qi and blood movement.
The traditional Chinese medicine composition disclosed by the invention has the effects of dispelling cold and relieving pain by taking monkshood, fructus evodiae, baked ginger, fennel, pericarpium zanthoxyli and folium artemisiae argyi as monarch drugs, and is used for treating cold accumulation stomachache and dysmenorrhea, wherein the monkshood is pungent in taste, sweet in flavor, large in nature and hot in nature, is yang in yang, is good in tonifying fire and supporting yang, and is used for dispelling cold and relieving pain, and is mainly used for treating stomachache and dysmenorrhea caused by yin-cold, such as impotence and cold uterus, yin-cold edema, cold-damp arthralgia and the like; evodia rutaecarpa, pungent in flavor and bitter in flavor and purging heat and cold in property, excels in dispelling cold and relieving pain, and is mainly used for treating abdominal pain such as hernia of cold, abdominal pain during menstruation, abdominal distension and pain; pao Jiang is special in smell, slightly pungent and spicy in flavor, and is good at warming the middle energizer to relieve pain and warming meridians to stop bleeding; the fennel has pungent taste, warm property and fragrant smell, can warm kidney and dispel cold, and is mainly used for treating cold hernia and abdominal pain, testicle falling, abdominal cold pain, hypochondriac pain, lumbago due to kidney deficiency, dysmenorrhea and the like; the pericarpium zanthoxyli is homologous in medicine and food, warms middle energizer, relieves pain, eliminates dampness and kills parasites; folium Artemisiae Argyi is pungent and bitter in flavor, warm in nature, pungent and fragrant in flavor, bitter in flavor and dry in nature, warm in nature, and has the functions of dispelling cold and dampness, warming uterus and relieving pain. Rhizoma zedoariae and rhizoma sparganii preparata are used for breaking blood and eliminating mass, and frankincense and myrrh are used for activating blood and dissolving stasis, and the four drugs are used as ministerial drugs for removing blood stasis and relieving pain, and the monarch drugs are used for treating dysmenorrhea caused by cold coagulation and blood stasis; rhizoma homalomenae, herba Aristolochiae, herba seu radix Tetrastigmatis Oblongifoliae, caulis Sargentodoxae, and caulis Sargentodoxae are used as adjuvants for dispelling pathogenic wind and removing dampness, promoting blood circulation and dredging collaterals; in addition, herba Lycopodii and herba speranskiae tuberculatae are used as guiding drugs and are used together to warm channel, dispel cold, dredge collaterals and relieve pain. Therefore, the traditional Chinese medicine composition is designed for chronic pelvic pain and dysmenorrheal caused by endometriosis, and is particularly suitable for pelvic endometriosis caused by blood stasis and damp obstruction and cold coagulation.
The invention takes the lower energizer and the mutual combination of blood stasis and damp turbidity at the position of endometriosis as the pathogenesis, and the traditional Chinese medicine composition is externally applied to the lower abdomen to promote the acceleration of local blood flow and the opening and increase of capillary vessels, thereby improving the local microcirculation, promoting the absorption of medicines, achieving the effects of warming channels, dispelling cold, promoting blood circulation, removing blood stasis, relieving swelling and relieving pain, and finally achieving the purpose of relieving and obviously improving the pelvic pain and dysmenorrheal of endometriosis.
The invention aims at the traditional Chinese medicine pathogenesis and local physiological and pathological changes of endometriosis pelvic pain and dysmenorrheal, adopts the treatment principles of warming channel and dispelling cold, activating blood and dissolving stasis, and reducing swelling and relieving pain, and prepares the traditional Chinese medicine composition into an external application for convenient use, thereby being beneficial to the effect of the medicine and the transdermal penetration.
Due to the adoption of the technical scheme, the invention has the following advantages and beneficial effects:
the traditional Chinese medicine composition has the advantages of low price of raw materials, simple and convenient preparation and convenient use, and has better curative effect on relieving pelvic pain and dysmenorrheal caused by endometriosis after years of clinical application and pharmacological research. In view of the fact that women with endometriosis pelvic pain and dysmenorrhea are more, and are mostly women in the reproductive period, and more work or study, clinical simple analgesia has no treatment effect on endometriosis diseases at present, and drug resistance and other adverse reactions exist after long-term use, the traditional Chinese medicine composition provided by the invention has a good application prospect.
The traditional Chinese medicine composition disclosed by the invention has the effects of warming channels for dispelling cold, promoting blood circulation for removing blood stasis, relieving swelling and pain and the like, and can obviously relieve chronic pelvic pain and dysmenorrhea caused by endometriosis after years of clinical application and pharmacological research, and is remarkable in effect, economic, convenient, small in side effect, exact in curative effect, free of toxic and side effects, low in cost and convenient to popularize and apply.
Detailed Description
In order to more clearly illustrate the invention, the invention is further described below in connection with preferred embodiments. It is to be understood by persons skilled in the art that the following detailed description is illustrative and not restrictive, and is not to be taken as limiting the scope of the invention.
Example 1
The traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis is prepared from the following raw material medicines in parts by weight: 9 parts of homalomena occulta, 9 parts of herba aristolochiae, 9 parts of lijin vine, 15 parts of sargentgloryvine stem, 15 parts of garden balsam stem, 15 parts of lycopodium clavatum, 9 parts of monkshood, 6 parts of fructus evodiae, 9 parts of baked ginger, 9 parts of fennel, 6 parts of pericarpium zanthoxyli, 9 parts of zedoary, 9 parts of processed rhizoma sparganii, 15 parts of folium artemisiae argyi, 9 parts of frankincense and 9 parts of myrrh.
Example 2
The traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis is prepared from the following raw material medicines in parts by weight: 12 parts of homalomena occulta, 12 parts of herba aristolochiae, 12 parts of sinkiang arnebia root, 30 parts of sargentgloryvine stem, 18 parts of garden balsam stem, 18 parts of lycopodium clavatum, 6 parts of monkshood, 6 parts of evodia rutaecarpa, 3 parts of baked ginger, 3 parts of fennel, 3 parts of pericarpium zanthoxyli, 15 parts of zedoary, 15 parts of processed rhizoma sparganii, 18 parts of folium artemisiae argyi, 12 parts of frankincense and 12 parts of myrrh.
Example 3
The traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis is prepared from the following raw material medicines in parts by weight: 6 parts of homalomena occulta, 6 parts of herba aristolochiae, 12 parts of sinkiang arnebia stem, 15 parts of sargentgloryvine stem, 15 parts of garden balsam stem, 15 parts of lycopodium clavatum, 12 parts of monkshood, 3 parts of evodia rutaecarpa, 6 parts of baked ginger, 6 parts of fennel, 6 parts of pericarpium zanthoxyli, 12 parts of zedoary, 12 parts of processed rhizoma sparganii, 15 parts of folium artemisiae argyi, 9 parts of frankincense and 9 parts of myrrh.
Example 4
The traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis is prepared from the following raw material medicines in parts by weight: 10 parts of homalomena occulta, 10 parts of herba aristolochiae, 10 parts of lijin vine, 20 parts of sargentgloryvine stem, 10 parts of garden balsam stem, 10 parts of lycopodium clavatum, 10 parts of monkshood, 9 parts of fructus evodiae, 9 parts of baked ginger, 9 parts of fennel, 9 parts of pericarpium zanthoxyli, 10 parts of zedoary, 10 parts of processed rhizoma sparganii, 15 parts of folium artemisiae argyi, 10 parts of frankincense and 10 parts of myrrh.
Example 5
Preparation of cataplasm:
the cataplasm is prepared by adopting a conventional method in the field and mixing the raw material powder and a specific reagent according to the following proportion: 13g of the raw material powder, 3g of sodium polyacrylate, 3g of carbomer, 1g of CM cellulose sodium salt, 30ml of glycerol, 5ml of defoamer (mineral oil DF879), 0.6g of tartaric acid, 0.3g of aluminum glycinate, 2g of kaolin, 0.3ml of 1-methyl-2-pyrrolidone and 0.3ml of azone according to the proportion of any one of examples 1 to 4 are taken.
Example 6
Preparation of emplastrum
The plaster is prepared by adopting a conventional method in the field, the raw material medicinal powder in the proportion according to any one of the embodiments 1 to 4 is ground into fine powder, the fine powder is mixed with auxiliary materials such as water, maltose or honey to form paste for later use, the prepared plaster is spread on kraft paper when in use, the surface of the plaster is covered by the tissue paper, and the plaster is applied to the lower abdomen (below the navel and above the pubic symphysis) or the area with the most obvious pain is selected when in use.
Example 7
Pharmacodynamic experiments of the traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis
(one) the source of the cases: the cases were collected from 2018 between 1 month and 2019 between 12 months, and 30 cases of endometriosis patients who were outpatient in department of medicine in Changhai Hospital, second military medical university were treated with chronic pelvic pain, dysmenorrhea, etc., with informed consent.
(II) inclusion criteria: the patients are both in accordance with the Western diagnosis standard and the Chinese medicine syndrome diagnosis standard.
1. Western diagnostic criteria (disease): dysmenorrhea refers to the condition of pain and distention of the lower abdomen before and after menstruation or during menstruation, accompanied by soreness of the waist or other discomfort, and the symptoms seriously affect the quality of life. Dysmenorrhea is divided into primary dysmenorrhea and secondary dysmenorrhea, wherein the primary dysmenorrhea refers to dysmenorrhea caused by genital organ anergy, and the secondary dysmenorrhea refers to dysmenorrhea caused by pelvic organ diseases.
2. Diagnostic criteria of traditional Chinese medicine (dialectics): type of congealing cold with blood stasis: the principal syndrome is that the cold pain of the lower abdomen before or during the menstrual period is tendered, and the pain is relieved by heat; the secondary symptoms can be menstruation or after tui, with little amount, dark menstrual color and blood stasis; in the case of combined symptoms, the patients may be accompanied by pale complexion, cold limbs and aversion to cold; tongue pulse: the tongue has a white coating and a deep and wiry pulse.
(III) exclusion criteria:
1. patients with serious primary diseases such as cardiovascular diseases, liver diseases, kidney diseases, hemopoietic system diseases and the like are combined.
2. The skin has infection, ulceration, scar, etc., or severe allergic skin disease.
3. The dysmenorrhea is not taken as the main symptom or does not meet the diagnosis standard of Chinese and Western medicine, and the curative effect judgment is influenced by the failure of judging the curative effect or incomplete data and the like without taking the medicine according to the regulation.
(IV) research method:
1. grading the degree of dysmenorrhea (refer to "guiding principles of clinical research on treating dysmenorrhea and endometriosis due to new Chinese medicine", or "guiding principles of clinical research on new Chinese medicine" (first edition))
Grading standard: the pain of the lower abdomen during and before the menstrual period is counted by 5 points (basic points); 1 point of abdominal pain; the abdominal pain is obviously counted for 0.5 point; 1 point of Sichuanning meter; 2 minutes of shock meter; the face color is 0.5 minutes; counting for 1 minute; measuring the cold limbs for 1 minute; the rest of the patient needing to be bedridden is counted for 1 minute; influence the study work to count 1 point; the pain can not be relieved by common pain relieving measures for 1 point, and the pain can be temporarily relieved by common pain relieving measures for 0.5 point; the meter is 0.5 minutes accompanied by waist soreness, 0.5 minutes accompanied by nausea and vomiting and 1 minute accompanied by anus plumpness; pain was counted at 0.5 point per day (0.5 point per day of increase).
Grading standard: and (3) severe degree: more than 14 minutes; medium: 8-13.5 min; mild: 8 min or less.
2. Method of treatment
Traditional Chinese medicine external application group: the traditional Chinese medicine composition (the formula of the embodiment 1 comprises 9 parts of obscured homalomena rhizome, 9 parts of dutchmanspipe vine, 9 parts of sinkiang gloryvine stem, 15 parts of sargentgloryvine stem, 15 parts of garden balsam stem, 15 parts of lycopodium clavatum, 9 parts of monkshood, 6 parts of evodia rutaecarpa, 9 parts of baked ginger, 9 parts of common fennel fruit, 6 parts of pericarpium zanthoxyli, 9 parts of zedoary, 9 parts of prepared common burreed rhizome, 15 parts of Chinese mugwort leaf, 9 parts of frankincense and 9 parts of myrrh) is put into a cloth bag, steamed for 30 minutes in a waterproof mode, and the cloth bag is taken out and wrapped by a towel to be applied to the lower abdomen (with the umbilical point as the central point). It is administered once a day for about 30 min before sleep, and 2 times per bag. All patients were treated for a 3 month menstrual period, before 1-2 days and during the menstrual period.
Western medicine (fenpride) group: fenbide (ibuprofen sustained release capsule, approved by Zhongmei Tianjin Shike pharmaceutical Co., Ltd., No. H10900089) is orally administered 1-2 days before menstruation, 0.3g, 1 tablet/time, 1 time/day, and 3 months menstruation period is continuously taken.
(V) observation of curative effect:
1. the clinical observation indexes are as follows: observing the change of the degree of dysmenorrhea before and after the treatment of the patient.
2. Laboratory detection indexes are as follows: serum prostaglandin detection, wherein anterior venous blood is extracted from a patient within 48 hours before menstruation, serum is separated, and the content of PGF2a in the serum is determined by adopting an enzyme-linked immunosorbent double antibody sandwich method (ELISA).
3. The therapeutic effect judgment standard is as follows: referring to the clinical research guiding principle of treating dysmenorrhea and pelvic endometriosis with new Chinese medicine, nimodi group method is adopted, i.e. the ratio of the integral difference of symptoms before and after treatment to the integral value before treatment is used as the curative effect judgment value.
And (3) healing: the judgment value is equal to 1, the dysmenorrheal and other symptoms disappear, the medicine is stopped for three menstrual cycles without relapse, and the corresponding level is recovered by physicochemical examination results.
The effect is shown: the decision value is more than 2/3, the abdominal pain is obviously relieved, other symptoms are improved, the patient can insist on working without taking the analgesic, and the physicochemical inspection result basically recovers the corresponding level.
The method has the following advantages: the decision value is 1/3-2/3, the abdominal pain is relieved, other symptoms are improved, the taking of the analgesic can keep working, and the physicochemical inspection result is improved.
And (4) invalidation: the decision value is less than 1/3, the abdominal pain and the symptoms thereof are not improved, and the results of physical and chemical examination are basically not changed.
(VI) results of the experiment
1. Clinical observations
(1) Comparison of pain level scores before and after treatment
And (3) displaying a statistical result: the dysmenorrheal scores of the two groups of patients after treatment are obviously reduced compared with those before treatment, and the difference has statistical significance (P is less than 0.05); in addition, the scores of the western medicine control group after treatment are lower than those of the traditional Chinese medicine external application group, but the differences are not obvious, and the statistical significance (P >0.05) is not achieved (see table 1).
TABLE 1 comparison of dysmenorrhea degree scores before and after treatment
Figure BDA0002401019790000071
Note: p <0.05 compared to pre-treatment.
(2) Serum PGF2a levels
ELISA test results showed that the PGF2a content in peripheral blood after treatment was significantly decreased compared to that before treatment in both groups (P <0.05), and there was no significant difference in serum PGF2a levels after treatment between the two groups (P >0.05) (see Table 2).
TABLE 2 serum PGF2a levels in patients before and after treatment
Figure BDA0002401019790000081
Note: p <0.05 compared to pre-treatment.
(3) Comparison of therapeutic effects
The results of the clinical study showed that: compared with the western medicine control group, the clinical cure rate and the total effective rate of the external traditional Chinese medicine application group have statistical significance (see table 3).
TABLE 3 comparison of therapeutic effects
Group of Number of examples Cure rate (%) Significant efficiency (%) Effective rate (%) Inefficiency (%) Total effective rate (%)
External application set of traditional Chinese medicine 15 4(26.67%)* 4(26.67%) 5(33.33%) 2(13.33%)* 13(87.67%)*
Western medicine control group 15 2(13.33%) 3(20.00%) 4(26.67%) 6(40.00%) 9(60.00%)
Note: p <0.05 compared to western control group.
Clinical effect observation shows that the traditional Chinese medicine composition for relieving chronic pelvic pain and dysmenorrhea caused by endometriosis can improve clinical symptoms of patients, reduce the content of prostaglandin in peripheral blood of the patients, improve pelvic pain and dysmenorrhea symptoms of the patients and even achieve a healing effect; the total effective rate of the traditional Chinese medicine composition is 87.67 percent, which is obviously superior to that of the western medicine fenbibi, and the traditional Chinese medicine composition provided by the invention can permeate the medicine into the body through the body, so that the effects of warming channels, dispelling cold, regulating qi, activating stagnancy, removing blood stasis and relieving pain are exerted, and the purpose of relieving or even curing chronic pelvic pain and dysmenorrhea caused by endometriosis is achieved.
Example 8
Typical case
Lie a woman, born in 09 months 1987, supermarket staff. For the diagnosis of dysmenorrhea and the discovery of right ovarian cyst for more than 1 year, the patient begins to have menstrual abdominal pain in 6 months in 2018, and the subjective score is as follows: 8-9 min; b-ultrasonography in 8 months in 2018: right ovarian endocystic structure (23 × 20 × 18mm), intimal cyst, self-administered fenbidon therapy, no dysmenorrhea during treatment, relapse after drug withdrawal, obvious dysmenorrhea, subjective scoring: 8-9 min; review of B-mode ultrasound in 2019 in 1 month: the right annex zone was seen in the 35 × 32 × 28mm hypoechoic zone, not tested by CA 125. The patients were diagnosed in my family, and the Chinese medicinal composition (example 1) was administered for external application treatment because the patients refused to take the Chinese medicinal composition orally, and the patients were retested after 3 months, and no obvious dysmenorrhea was observed, and the subjective score was less than 3 points.
Example 9
Typical case
Tanshiji, born in 07 months in 1990, a company staff is in a doctor for more than 10 years of dysmenorrhea due to 'non-contraception and non-pregnancy for 3 years', the patient has dysmenorrhea at the beginning of the tide, the abdominal pain is usually obvious in 1-2 days of menstrual period, the subjective score is 7-8 minutes, the abdominal pain is severe and is accompanied by nausea, vomiting and migraine, the patient has been married for three years, has not been pregnant all the time, and has been treated by intermittent oral traditional Chinese medicine, and the effect is poor. Iodized oil angiography of fallopian tubes in 09 months in 2017 suggests that the fallopian tubes on both sides are obstructed and not smooth. The doctor visits the department in 5 months in 2018, and the lower abdomen is externally applied with the traditional Chinese medicine composition (example 1) of the invention, and the doctor rechecks after the traditional Chinese medicine is orally taken for 3 months, the symptoms such as obvious dysmenorrheal and migraine are not existed, the subjective score is less than 3 points, the gynecological B-mode ultrasonography in 8 months in 2018: no obvious abnormality is seen in the uterus and the double adnexal area. Natural pregnancy in 2019, month 01.
The traditional Chinese medicine composition used in the invention has good clinical curative effect in clinical practical application, and has good clinical effects on relieving pelvic pain and dysmenorrhea caused by endometriosis, promoting pelvic local microcirculation, regulating pelvic internal environment, improving the quality of life of patients with endometriosis, diminishing inflammation, regulating menstruation, assisting pregnancy and the like.
Although the present invention has been described with reference to a preferred embodiment, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims.

Claims (10)

1. A traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis is characterized by being prepared from the following raw material medicines in parts by weight: 6-12 parts of homalomena occulta, 6-12 parts of dutchmanspipe vine, 9-18 parts of sinkiang spurge stem, 9-30 parts of sargentgloryvine stem, 9-18 parts of garden balsam stem, 9-18 parts of lycopodium clavatum, 6-12 parts of monkshood, 3-12 parts of evodia rutaecarpa, 3-15 parts of baked ginger, 3-15 parts of fennel, 3-12 parts of pericarpium zanthoxyli, 6-15 parts of zedoary, 6-15 parts of processed rhizoma sparganii, 12-18 parts of folium artemisiae argyi, 6-12 parts of frankincense and 6-12 parts of myrrh.
2. The traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis according to claim 1, which is prepared from the following raw material medicines in parts by weight: 9 parts of homalomena occulta, 9 parts of herba aristolochiae, 9 parts of lijin vine, 15 parts of sargentgloryvine stem, 15 parts of garden balsam stem, 15 parts of lycopodium clavatum, 9 parts of monkshood, 6 parts of fructus evodiae, 9 parts of baked ginger, 9 parts of fennel, 6 parts of pericarpium zanthoxyli, 9 parts of zedoary, 9 parts of processed rhizoma sparganii, 15 parts of folium artemisiae argyi, 9 parts of frankincense and 9 parts of myrrh.
3. The traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis according to claim 1, which is prepared from the following raw material medicines in parts by weight: 12 parts of homalomena occulta, 12 parts of herba aristolochiae, 12 parts of sinkiang arnebia root, 30 parts of sargentgloryvine stem, 18 parts of garden balsam stem, 18 parts of lycopodium clavatum, 6 parts of monkshood, 6 parts of evodia rutaecarpa, 3 parts of baked ginger, 3 parts of fennel, 3 parts of pericarpium zanthoxyli, 15 parts of zedoary, 15 parts of processed rhizoma sparganii, 18 parts of folium artemisiae argyi, 12 parts of frankincense and 12 parts of myrrh.
4. The traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis according to claim 1, which is prepared from the following raw material medicines in parts by weight: 6 parts of homalomena occulta, 6 parts of herba aristolochiae, 12 parts of sinkiang arnebia stem, 15 parts of sargentgloryvine stem, 15 parts of garden balsam stem, 15 parts of lycopodium clavatum, 12 parts of monkshood, 3 parts of evodia rutaecarpa, 6 parts of baked ginger, 6 parts of fennel, 6 parts of pericarpium zanthoxyli, 12 parts of zedoary, 12 parts of processed rhizoma sparganii, 15 parts of folium artemisiae argyi, 9 parts of frankincense and 9 parts of myrrh.
5. The traditional Chinese medicine composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis according to claim 1, which is prepared from the following raw material medicines in parts by weight: 10 parts of homalomena occulta, 10 parts of herba aristolochiae, 10 parts of lijin vine, 20 parts of sargentgloryvine stem, 10 parts of garden balsam stem, 10 parts of lycopodium clavatum, 10 parts of monkshood, 9 parts of fructus evodiae, 9 parts of baked ginger, 9 parts of fennel, 9 parts of pericarpium zanthoxyli, 10 parts of zedoary, 10 parts of processed rhizoma sparganii, 15 parts of folium artemisiae argyi, 10 parts of frankincense and 10 parts of myrrh.
6. A pharmaceutical preparation characterized in that it employs, as an active ingredient, the Chinese medicinal composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis according to any one of claims 1 to 5.
7. The pharmaceutical formulation of claim 6, wherein the pharmaceutical formulation is a cataplasm.
8. The pharmaceutical preparation as claimed in claim 7, wherein the cataplasm is prepared from the following raw medicinal powders in proportion: 5-20g of raw material medicinal powder of the traditional Chinese medicine composition, 1-5g of sodium polyacrylate, 1-5g of carbomer, 0.5-2g of CM sodium cellulose, 5-50ml of glycerol, 1-10ml of defoaming agent, 0.1-1g of tartaric acid, 0.1-1g of aluminum glycinate, 1-3g of kaolin, 0.1-0.5ml of 1-methyl-2-pyrrolidone and 0.1-0.5ml of azone.
9. Use of a Chinese medicinal composition according to any one of claims 1 to 5 for the treatment of chronic pelvic pain and dysmenorrhea caused by endometriosis in the preparation of a medicament for the treatment of chronic pelvic pain and dysmenorrhea caused by endometriosis.
10. Use of a pharmaceutical formulation according to any one of claims 6 to 8 in the manufacture of a medicament for the treatment of chronic pelvic pain and dysmenorrhea caused by endometriosis.
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