CN115887571A - Traditional Chinese medicine composition for treating endometriosis dysmenorrhea and application thereof - Google Patents

Traditional Chinese medicine composition for treating endometriosis dysmenorrhea and application thereof Download PDF

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CN115887571A
CN115887571A CN202211509586.5A CN202211509586A CN115887571A CN 115887571 A CN115887571 A CN 115887571A CN 202211509586 A CN202211509586 A CN 202211509586A CN 115887571 A CN115887571 A CN 115887571A
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夏馨
陈旦平
许江虹
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Shanghai Jing'an Traditional Chinese Medicine Hospital
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Abstract

The invention relates to a traditional Chinese medicine composition for treating endometriosis dysmenorrhea, which is prepared from the following raw material medicines in parts by weight: 3-15g of angelica, 6-18g of salvia miltiorrhiza, 3-15g of medicinal cyathula root, 3-15g of prepared rhizoma cyperi, 2-10g of ligusticum wallichii, 3-15g of red paeony root, 3-15g of prepared myrrh, 2-10g of prepared frankincense, 6-18g of rhizoma corydalis, 14-22g of raw cattail pollen (decocted by wrapping), 3-15g of trogopterus dung, 3-7g of dragon's blood, 5-25g of poria cocos, 10-20g of prepared rehmannia root, 5-25g of rhizoma curculiginis and 5-25g of herba epimedii. The invention also provides application of the traditional Chinese medicine composition. The invention has the advantages that: the traditional Chinese medicine composition not only accords with the compatibility of monarch, minister, assistant and guide, but also has the effects of promoting blood circulation to remove blood stasis, eliminating stagnation and relieving pain, and nourishing kidney and blood by combining various medicines; can also improve the clinical curative effect, relieve the symptoms of dysmenorrheal of patients, has better analgesic effect, can effectively control the disease development, and has satisfactory long-term effect.

Description

Traditional Chinese medicine composition for treating endometriosis dysmenorrhea and application thereof
[ technical field ] A method for producing a semiconductor device
The invention relates to a Chinese medicinal composition for treating endometriosis dysmenorrhea and application thereof, in particular to a Chinese patent medicament prepared from Chinese medicinal herbs as raw materials.
[ background of the invention ]
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 the young 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 encounter with chronic pelvic pain in genital women, the internal symptoms 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 two sperms cannot be combined; stagnant blood can not be removed, and new blood can not enter meridians, so that the menstrual flow is much 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 document CN201310228695.4 discloses a traditional Chinese medicine for treating dysmenorrhea, which is prepared from the following raw materials in parts by weight: 8-15 g of salvia miltiorrhiza, 10-15g of motherwort, 10-15g of herba lycopi, 10-15g of angelica, 10-15g of medicinal cyathula root, 8-12 g of ligusticum wallichii, 6-12g of prepared rhizoma cyperi, 6-12g of peach kernel, 8-12 g of white paeony root, 5-10 g of cattail pollen, 6-10 g of combined spicebush root, 5-10 g of angelica dahurica, 5-10 g of safflower, 5-10 g of honey-fried licorice root, 3-6 g of cinnamon and 2-5 g of asarum. The results prove that the traditional Chinese medicine composition is proved to have remarkable curative effect, mild medicine property, no toxic or side effect, effective rate of 92 percent and cure rate of 87 percent through years of clinical application verification.
Chinese patent document CN202010146739.9 discloses a Chinese medicinal composition for treating chronic pelvic pain and dysmenorrhea caused by endometriosis, which is prepared from the following raw materials (by weight ratio): 6-12 parts of obscured homalomena rhizome, 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 results prove that the traditional Chinese medicine composition 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 dysmenorrheal caused by endometriosis, and has the advantages of definite curative effect and convenience in popularization and application.
Such traditional Chinese medicine compositions for treating dysmenorrhea have many defects, such as excessive medicinal flavors, difficult material acquisition and high price; the drug effect is not obvious, the treatment effect is poor, and the like. Therefore, a medicine which has obvious effect on treating endometriosis dysmenorrheal and is convenient to prepare is needed.
[ summary of the invention ]
The invention aims to provide a traditional Chinese medicine composition for treating endometriosis dysmenorrhea aiming at the defects in the prior art.
It is a further object of the present invention to provide a use of the above-mentioned medicament.
In order to achieve the purpose, the invention adopts the technical scheme that:
a traditional Chinese medicine composition for treating endometriosis dysmenorrhea is prepared from the following raw material medicines in parts by weight: 3-15g of angelica, 6-18g of salvia miltiorrhiza, 3-15g of medicinal cyathula root, 3-15g of prepared rhizoma cyperi, 2-10g of ligusticum wallichii, 3-15g of red paeony root, 3-15g of prepared myrrh, 2-10g of prepared frankincense, 6-18g of rhizoma corydalis, 14-22g of raw cattail pollen (decocted by wrapping), 3-15g of trogopterus dung, 3-7g of dragon's blood, 5-25g of poria cocos, 10-20g of prepared rehmannia root, 5-25g of rhizoma curculiginis and 5-25g of herba epimedii.
Preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 6-12g of angelica, 9-15g of salvia miltiorrhiza, 6-12g of medicinal cyathula root, 6-12g of prepared nutgrass galingale rhizome, 4-8g of szechuan lovage rhizome, 6-12g of red paeony root, 6-12g of prepared myrrh, 4-8g of prepared frankincense, 9-15g of corydalis tuber, 16-20g of raw cattail pollen (decocted by a bag), 6-12g of trogopterus dung, 3-5g of dragon blood, 10-20g of tuckahoe, 10-15g of prepared rhizome of rehmannia, 10-20g of curculigo orchioides and 10-20g of epimedium herb.
More preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 9g of angelica, 12g of salvia miltiorrhiza, 9g of medicinal cyathula root, 9g of prepared rhizoma cyperi, 6g of ligusticum wallichii, 9g of red paeony root, 9g of prepared myrrh, 6g of prepared frankincense, 12g of rhizoma corydalis, 18g of raw pollen typhae (bag decoction), 9g of trogopterus dung, 3g of dragon's blood, 15g of tuckahoe, 10g of prepared rehmannia root, 15g of rhizoma curculiginis and 15g of herba epimedii.
The medicament of the medicine is capsules, granules, tablets, oral liquid, mixture or syrup.
In order to achieve the second object, the invention adopts the technical scheme that:
the application of the medicine in preparing the medicine for treating endometriosis dysmenorrheal diseases.
The invention has the advantages that:
1. the prepared rehmannia root is sweet in nature, warm in nature, thick in taste and moist in quality, is good at tonifying kidney and nourishing blood, the Chinese angelica is pungent and fragrant in flavor and disperses, the blood is nourished and the menstruation is regulated, the prepared rhizoma cyperi and the rhizoma corydalis are monarch drugs together, the qi is regulated and the pain is relieved, the salvia miltiorrhiza is removed and the tissue regeneration is relieved, and the ministerial drugs together are ministerial drugs; radix paeoniae rubrathe, achyranthes and rhizoma ligustici wallichii are used as adjuvant drugs for removing blood stasis, promoting blood circulation and relieving pain, and guiding blood downward, removing blood stasis and breaking knots; the curculigo orchioides and the epimedium are used for regulating Chong and ren meridians; olibanum and Myrrha can regulate qi-flowing for relieving pain, promoting blood circulation, and removing blood stasis; pollen Typhae and Oletum Trogopterori for promoting blood circulation, dispelling blood stasis, and relieving pain; sanguis Draxonis has effects of removing blood stasis, promoting tissue regeneration, promoting blood circulation, and relieving pain. The traditional Chinese medicine composition not only accords with the compatibility of monarch, minister, assistant and guide, but also has the effects of tonifying kidney, promoting blood circulation, removing blood stasis, regulating menstruation and relieving pain.
2. The traditional Chinese medicine composition is clinically applied, relieves the symptoms of dysmenorrheal of a patient, improves the traditional Chinese medicine symptoms of the patient, reduces the levels of serum CA125 and PGF2 alpha, improves the clinical curative effect, has less adverse reaction, has better analgesic effect, can effectively control the disease development, and has satisfactory long-term effect.
[ detailed description ] embodiments
The following provides a detailed description of specific embodiments of the present invention.
Example 1 preparation of a Chinese medicinal composition for the treatment of endometriosis dysmenorrhea
9g of angelica, 12g of salvia miltiorrhiza, 9g of medicinal cyathula root, 9g of prepared rhizoma cyperi, 6g of ligusticum wallichii, 9g of red paeony root, 9g of prepared myrrh, 6g of prepared frankincense, 12g of rhizoma corydalis, 18g of raw cattail pollen (bag decoction), 9g of trogopterus dung, 3g of dragon's blood, 15g of tuckahoe, 10g of prepared rehmannia root, 15g of rhizoma curculiginis and 15g of herba epimedii, and the medicines are decocted by a conventional method.
Example 2 preparation of a Chinese medicinal composition for the treatment of endometriosis dysmenorrhea
9g of angelica, 9g of salvia miltiorrhiza, 12g of medicinal cyathula root, 3g of prepared rhizoma cyperi, 10g of ligusticum wallichii, 9g of red paeony root, 6g of prepared myrrh, 8g of prepared frankincense, 6g of rhizoma corydalis, 22g of raw pollen typhae (bag decoction), 9g of trogopterus dung, 3g of dragon's blood, 20g of tuckahoe, 10g of prepared rehmannia root, 25g of rhizoma curculiginis and 15g of herba epimedii, and the decoction is carried out by a conventional method.
EXAMPLE 3 preparation of a Chinese medicinal composition for treating endometriosis dysmenorrhea
6g of angelica, 15g of salvia miltiorrhiza, 3g of medicinal cyathula root, 15g of prepared rhizoma cyperi, 6g of ligusticum wallichii, 6g of red paeony root, 12g of prepared myrrh, 2g of prepared frankincense, 18g of rhizoma corydalis, 18g of raw pollen typhae (bag decoction), 6g of trogopterus dung, 5g of dragon's blood, 5g of tuckahoe, 20g of prepared rehmannia root, 15g of rhizoma curculiginis and 10g of herba epimedii, and the decoction is carried out by a conventional method.
EXAMPLE 4 preparation of a Chinese medicinal composition for treating endometriosis dysmenorrhea (IV)
12g of angelica, 6g of salvia miltiorrhiza, 15g of medicinal cyathula root, 9g of prepared rhizoma cyperi, 4g of ligusticum wallichii, 12g of red paeony root, 3g of prepared myrrh, 10g of prepared frankincense, 12g of corydalis tuber, 16g of raw cattail pollen (bag-decocted), 12g of trogopterus dung, 3g of dragon's blood, 25g of tuckahoe, 10g of prepared rehmannia root, 10g of rhizoma curculiginis and 20g of epimedium herb, and the decoction is carried out by a conventional method.
EXAMPLE 5 preparation of a Chinese medicinal composition for treating endometriosis dysmenorrhea
3g of angelica, 18g of salvia miltiorrhiza, 9g of medicinal cyathula root, 6g of prepared rhizoma cyperi, 8g of ligusticum wallichii, 3g of red paeony root, 15g of prepared myrrh, 6g of prepared frankincense, 9g of rhizoma corydalis, 20g of raw pollen typhae (bag decoction), 3g of trogopterus dung, 7g of dragon's blood, 15g of tuckahoe, 10g of prepared rehmannia root, 20g of rhizoma curculiginis and 5g of herba epimedii, and the decoction is carried out by a conventional method.
Example 6 preparation of a Chinese medicinal composition for the treatment of endometriosis dysmenorrhea (VI)
9g of angelica, 15g of salvia miltiorrhiza, 3g of medicinal cyathula root, 15g of prepared rhizoma cyperi, 6g of ligusticum wallichii, 6g of red paeony root, 12g of prepared myrrh, 2g of prepared frankincense, 18g of rhizoma corydalis, 18g of raw pollen typhae (bag decoction), 6g of trogopterus dung, 5g of dragon's blood, 5g of tuckahoe, 20g of prepared rehmannia root, 15g of rhizoma curculiginis and 10g of herba epimedii, and the decoction is carried out by a conventional method.
EXAMPLE 7 preparation of a Chinese medicinal composition for treating endometriosis dysmenorrhea
15g of angelica, 12g of salvia miltiorrhiza, 6g of medicinal cyathula root, 12g of prepared rhizoma cyperi, 2g of ligusticum wallichii, 15g of red paeony root, 9g of prepared myrrh, 4g of prepared frankincense, 15g of rhizoma corydalis, 14g of raw cattail pollen (bag decoction), 15g of trogopterus dung, 3g of dragon's blood, 10g of tuckahoe, 15g of prepared rehmannia root, 5g of rhizoma curculiginis and 25g of herba epimedii, and the decoction is carried out by a conventional method.
EXAMPLE 8 preparation of a Chinese medicinal composition for treating endometriosis dysmenorrhea (VIII)
6g of angelica, 6g of salvia miltiorrhiza, 15g of medicinal cyathula root, 9g of prepared rhizoma cyperi, 4g of ligusticum wallichii, 12g of red paeony root, 3g of prepared myrrh, 10g of prepared frankincense, 12g of rhizoma corydalis, 16g of raw cattail pollen (bag decoction), 12g of trogopterus dung, 3g of dragon's blood, 25g of tuckahoe, 10g of prepared rehmannia root, 10g of rhizoma curculiginis and 20g of herba epimedii, and the decoction is carried out by a conventional method.
Example 9 preparation of a Chinese medicinal composition for the treatment of endometriosis dysmenorrhea
12g of angelica, 18g of salvia miltiorrhiza, 9g of medicinal cyathula root, 6g of prepared rhizoma cyperi, 8g of ligusticum wallichii, 3g of red paeony root, 15g of prepared myrrh, 6g of prepared frankincense, 9g of rhizoma corydalis, 20g of raw pollen typhae (bag decoction), 3g of trogopterus dung, 7g of dragon's blood, 15g of tuckahoe, 10g of prepared rehmannia root, 20g of rhizoma curculiginis and 5g of herba epimedii, and the decoction is carried out by a conventional method.
Example 10 preparation of a Chinese medicinal composition for the treatment of endometriosis dysmenorrhea
3g of angelica, 12g of salvia miltiorrhiza, 6g of medicinal cyathula root, 12g of prepared rhizoma cyperi, 2g of ligusticum wallichii, 15g of red paeony root, 9g of prepared myrrh, 4g of prepared frankincense, 15g of rhizoma corydalis, 14g of raw cattail pollen (bag-decocted), 15g of trogopterus dung, 3g of dragon's blood, 10g of tuckahoe, 15g of prepared rehmannia root, 5g of rhizoma curculiginis and 25g of epimedium herb, and the decoction is carried out by a conventional method.
EXAMPLE 11 preparation of a Chinese medicinal composition for treating endometriosis dysmenorrhea (eleven)
15g of angelica, 9g of salvia miltiorrhiza, 12g of medicinal cyathula root, 3g of prepared rhizoma cyperi, 10g of ligusticum wallichii, 9g of red paeony root, 6g of prepared myrrh, 8g of prepared frankincense, 6g of rhizoma corydalis, 22g of raw pollen typhae (bag decoction), 9g of trogopterus dung, 3g of dragon's blood, 20g of tuckahoe, 10g of prepared rehmannia root, 25g of rhizoma curculiginis and 15g of herba epimedii, and the decoction is carried out by a conventional method.
It should be noted that the conventional method for decocting in examples 1 to 11 is a conventional method for preparing a decoction of a Chinese medicine, i.e., decocting the above-mentioned raw materials in water to obtain a decoction.
EXAMPLE 12 preparation of a Chinese medicinal composition tablet/Capsule for the treatment of endometriosis dysmenorrhea
The medicine of any one of the embodiments 1-11 is taken, 9-11 times of water is added, the decoction is carried out for 2-3.5 hours, and the medicine juice is filtered out. Adding 9 times of water, decocting for 2.5 hours, filtering out the decoction, mixing the two decoctions, standing, filtering to obtain the supernatant, concentrating, cooling, adding 3 times of alcohol, stirring and precipitating overnight. Taking supernatant, and concentrating to obtain thick extract; adding pharmaceutical adjuvants, vacuum drying, pulverizing, granulating, and making into tablet or capsule.
EXAMPLE 13 preparation of a Chinese medicinal composition granule for the treatment of endometriosis dysmenorrhea
The medicine of any one of the embodiments 1 to 11 is taken, 8 to 10 times of water is added, the decoction is decocted for 3 hours, and the medicine juice is filtered. Adding 10 times of water, decocting for 2.5 hr, filtering to obtain decoction, mixing the decoctions, standing, filtering to obtain supernatant, concentrating, cooling, adding 2 times of ethanol, stirring, and precipitating overnight. Taking the supernatant, and concentrating to obtain a thick extract; adding appropriate pharmaceutical adjuvants, granulating, drying, grading to obtain 20g granule, and packaging into 10 g/bag.
Example 14 preparation of a Chinese medicinal composition mixture/oral liquid/syrup for the treatment of endometriosis dysmenorrhea
The medicine of any one of the embodiments 1 to 11 is taken, 8 to 11 times of water is added, the decoction is decocted for 3 hours, and the medicine juice is filtered. Adding 8 times of water, decocting for 3 hours, filtering out the decoction, mixing the two decoctions, standing, filtering to obtain the supernatant, concentrating, cooling, adding 3.5 times of alcohol, stirring and precipitating overnight. Taking the supernatant, and concentrating to obtain a thick extract; adding appropriate pharmaceutical adjuvants, and making into mixture, oral liquid or syrup.
Example 15 animal experiments
1. Experimental materials
1.1 animals
Healthy adult, unmated, clean grade female SD rats, of quality 200 + -20g, supplied by Shanghai Semlr-Bikay laboratory animals Co., ltd. Feeding the animals according to the requirement of clean grade, freely taking water, keeping the room temperature at 25 +/-2 ℃, keeping the relative humidity at 40 +/-5%, and keeping the animals in darkness for 12h respectively, and adaptively feeding for 1 week.
1.2 preparation of the drug
The first Chinese medicine treatment group: 9g of angelica, 12g of salvia miltiorrhiza, 9g of medicinal cyathula root, 9g of prepared rhizoma cyperi, 6g of ligusticum wallichii, 9g of red paeony root, 9g of prepared myrrh, 6g of prepared frankincense, 12g of rhizoma corydalis, 18g of raw cattail pollen (bag decoction), 9g of trogopterus dung, 3g of dragon's blood, 15g of tuckahoe, 10g of prepared rhizome of rehmannia, 15g of rhizoma curculiginis and 15g of epimedium which are decocted by a conventional method and prepared by a traditional Chinese medical hospital in the quiet and quiet district of Shanghai city, and contain 1g/ml of traditional Chinese medicine;
and B, chinese medicine treatment group II: 12g of angelica, 18g of salvia miltiorrhiza, 9g of medicinal cyathula root, 6g of prepared rhizoma cyperi, 8g of ligusticum wallichii, 3g of red paeony root, 15g of prepared myrrh, 6g of prepared frankincense, 9g of rhizoma corydalis, 20g of raw cattail pollen (bag decoction), 3g of trogopterus dung, 7g of dragon's blood, 15g of tuckahoe, 10g of prepared rehmannia root, 20g of rhizoma curculiginis and 5g of herba epimedii;
control group one: 12g of angelica, 18g of safflower, 9g of medicinal cyathula root, 6g of prepared rhizoma cyperi, 8g of ligusticum wallichii, 3g of red paeony root, 15g of prepared myrrh, 6g of prepared frankincense, 9g of rhizoma corydalis, 20g of raw cattail pollen (bag decoction), 3g of trogopterus dung, 7g of dragon's blood, 15g of rhizoma alismatis, 10g of prepared rehmannia root, 20g of teasel root and 5g of epimedium herb, are decocted by a conventional method and prepared by a traditional Chinese medicine hospital in the quiet and quiet area of Shanghai city, and contain 1g/ml of traditional Chinese medicine;
control group two: 9g of angelica, 12g of salvia miltiorrhiza, 9g of medicinal cyathula root, 9g of prepared rhizoma cyperi, 6g of ligusticum wallichii, 9g of radix scrophulariae, 9g of prepared myrrh, 6g of prepared frankincense, 12g of radix curcumae, 18g of raw pollen typhae (bag decoction), 9g of trogopterus dung, 3g of dragon's blood, 15g of poria cocos, 10g of prepared rehmannia root, 15g of rhizoma curculiginis and 15g of morinda officinalis;
blank group: physiological saline;
model group: physiological saline.
1.3 reagents and instruments
VEDF immunohistochemistry and Western blotting kit, TNF-alpha detection kit (Shanghai Weiao Biotechnology, inc.).
A centrifuge: (H2050R, hunan instrument centrifuge instruments Ltd.).
2. Experimental methods
2.1 Molding and grouping
Rats were randomly divided into a blank group, a model group, a first Chinese medicine treatment group, a second Chinese medicine treatment group, a first control group and a second control group, and 6 rats were each group. The rats in the model group, control group and treatment group were modeled. After 3% pentobarbital sodium solution (30 mg/kg) is injected into the abdominal cavity of a rat for anesthesia, the abdominal cavity is cut open under the aseptic condition, the incision is about 2cm long, the left uterus is taken out, blood vessels at two ends of the uterus are ligated, a section of the uterus is cut off, the uterus section is longitudinally cut in normal saline, the endometrium and the muscle layer are separated, 2 pieces of endometrium blocks with the size of about 5mm multiplied by 5mm are sutured at the rich part of the blood vessel at the inner wall of the right abdominal cavity, and the muscle layer and the skin are sutured. After 3 weeks of operation, the abdominal cavity is opened again to check the molding condition, the ectopic intima is enlarged in volume and is in a transparent vesicular shape, yellowish clear effusion can be seen in the vesicular, and blood vessels around the ectopic intima are formed into a film.
2.2 administration and drawing of materials
Blank and model groups: the normal saline is given for per stomach irrigation with 0.2 ml; control group one and control group two: administering the above Chinese medicinal materials 0.2 ml/intragastric; the first traditional Chinese medicine treatment group and the second traditional Chinese medicine treatment group are as follows: the Chinese medicine is administered at a dose of 0.2 ml/intragastric administration for 4 weeks. After the dosing was completed, the abdominal cavity was opened under anesthesia, and the abdominal aorta was bled and the rats were sacrificed. A small amount of abdominal cavity liquid of the ectopic focus is sucked and respectively placed in a marked sterile centrifuge tube. Setting the rotation number of a centrifuge to 3000r/min, centrifuging for 20min, taking supernatant in a tube after centrifugation, and quickly freezing and storing at-20 ℃ to prepare for subsequent experiments.
2.3 detection of indicators
Detecting the concentration of VEGF and TNF-alpha
2.4 statistical methods
All statistical analyses were performed using SPSS 21.0 software, and the results are expressed as means ± standard deviation. Paired and unpaired data were evaluated using Student-t test. Multiple sets of comparisons were evaluated using one-way AONVA. P <0.05 is statistically significant for the differences.
3. Results of the experiment
3.1 comparison of peritoneal fluid VECF and TNF- α concentrations
The concentration comparison of the peritoneal fluid VECF and TNF-alpha shows that the concentration of the peritoneal fluid VEGF and TNF-alpha of ectopic focus of the model group is obviously higher than that of the blank group, and the difference has statistical significance (P is less than 0.05); the concentrations of the VEGF and TNF-alpha of the ectopic focus abdominal cavity fluid of the control group and the treatment group are compared with the model group, and the difference has statistical significance (P < 0.05); the concentration of VEGF and TNF-alpha in the abdominal fluid of ectopic foci in the treatment group was lower than that in the control group, and the difference was statistically significant (P <0.05, see Table 1).
TABLE 1 comparison of peritoneal fluid VECF and TNF-alpha concentrations
Figure BDA0003970193130000071
Note: in comparison to the set of models, # P<0.05; compared with the control group, the compound of the formula, * P<0.05。
EXAMPLE 16 clinical trial
1. Standard of study
1.1 sources of cases
The traditional Chinese medicine diagnosis is endometriosis by the doctor Western medicine diagnosis of the gynecologic outpatient service of the traditional Chinese medicine hospital from 7 months to 2021 months in 2019 to 6 months in the quiet region, and the traditional Chinese medicine syndrome is a patient with kidney deficiency and blood stasis syndrome, and the age is in accordance with 20-48 years old.
1.2 diagnostic criteria
1.2.1 Western diagnostic standards
The Western diagnosis standard refers to the eighth edition of gynecological science and 2019 diagnosis standard of "diagnosis and treatment guide for endometriosis combined with Western medicine" specified by the Heterozygosis in the Special Committee of gynecology and obstetrics of the Chinese and Western medicine Union.
Clinical symptoms:
a. progressive, aggravated dysmenorrhea, chronic pelvic pain, dyspareunia;
b. the progressive exacerbation of rectum stimulation symptoms such as discomfort of lower abdomen and lumbosacral part in menstrual period, periodic anus bulge and the like;
c. infertility and menstrual abnormalities;
d. pelvic cavity mass packing: can be found by B-ultrasonic examination or gynecological examination, and has obvious size change along with menstrual cycle (without anti-inflammatory treatment);
e. gynecological examination: the double-joint examination can be performed with poor uterine activity, and the fornix posterior has a tender node; the attachment area can be used for holding a cystic mass and can be adhered to the periphery. Laboratory examination: the level of CA125 (carbohydrate antigen 125) in serum is mostly slightly and moderately increased (35-200U/ml); anti-endometrial antibodies (endometerial antibodies) are mostly positive.
Imaging examination:
(1) b, ultrasonic wave: a non-echogenic cystic mass with fuzzy boundaries and thick walls is detected beside the uterine horn or at the uterine rectum fossa, the lump is generally fixed and has an obvious boundary with the uterus, the cyst is round or semicircular, a little echo is generated in the cyst, the center is attenuated, and the size of the cyst changes along with the menstrual cycle.
(2) CT: endometriotic cysts are mainly characterized by cystic lesions closely connected with the uterus and adjacent organ tissues, CT is 30-50Hu, the intensity of the tumor wall is strengthened slightly and moderately, the focus in the cyst is high-density, and the symptom of the "satellite cyst" is the specific expression of the endometriosis.
(3) MRI: for recurrent uterine endometriotic cyst hemorrhage, high signals are presented on T1W1 and T2W 2; for those with long bleeding time and blood clots, low signals are shown on TIWI and T2W 2; the TIWI and T2W2 may be different in signal due to the change of bleeding time and different examination postures of patients. Clinical symptoms were consistent with one diagnosis combined with the aid of examination, CA125> 35U/ml.
1.2.2 Chinese medicine diagnostic standards
The traditional Chinese medicine diagnosis standard refers to the kidney deficiency and blood stasis syndrome type of dysmenorrhea in the guiding principles of traditional Chinese medicine clinical research: has one of (1), (2) and one of (3), (4), both of which are diagnostically compatible.
(1) The distending pain and tenderness of the lower abdomen before and during menstruation gradually worsen;
(2) unsmooth menstruation, dark color, lumps, pain reduction and immobility under the lumps;
(3) infertility, low libido;
(4) dark tongue with petechiae and wiry and unsmooth pulse.
1.3 inclusion criteria
(1) The diagnostic standard is met;
(2) the clinical pathological type belongs to endometriosis;
(3) the usage history of related medicaments such as contraceptive, powerful analgesic and the like is not available within 2 months before selection;
(4) no serious primary diseases or mental diseases such as malignant tumor, cardiovascular disease, liver disease, kidney disease, etc.
1.4 exclusion criteria
(1) Pelvic pain due to adnexitis; ovarian cyst and ovarian malignant tumor; tuberculosis of the internal genital tract;
(2) patients with serious diseases such as cardiovascular and cerebrovascular diseases, liver, kidney and hemopoietic system;
(3) the ovarian cyst is more than 5cm through B ultrasonic examination, and the patient needs operation treatment or has other operation indications;
(4) is participating in clinical drug experiment patients.
1.5 rejection Standard
(1) Misdiagnosis and mistaking;
(2) the judgment of curative effect is not affected by treatment record or data insufficiency;
(3) other medicines for treating dysmenorrhea are taken during the treatment period;
(4) serious adverse reactions appear in the course of treatment, and patients can not continue to be treated.
1.6 criteria for shedding
(1) Patients quit or lost visitors by themselves;
(2) poor compliance, the appearance of other conditions affecting therapy, serious adverse events, etc.
2. Study protocol
2.1 grouping and administration
Control group: drospirenone ethinylestradiol (yosmine), manufacturer: bayer weimar GmbH & co.kg; registration certificate number of imported drugs: h20170316; approval document No.: national drug standard J20171071). The use method comprises the following steps: 1 tablet is orally taken every night on day 1 of the menstrual period, the medicine is stopped after 21 days of continuous administration, the medicine is stopped for 7 days, the next course of treatment is applied, 3 months of administration are taken as one course of treatment, and the follow-up is carried out 3 months after the course of treatment is finished.
Treatment groups: the formula for promoting blood circulation (9 g of angelica sinensis, 12g of salvia miltiorrhiza, 9g of medicinal cyathula root, 9g of prepared rhizoma cyperi, 6g of ligusticum wallichii, 9g of red paeony root, 6g of prepared myrrh, 6g of prepared frankincense, 12g of rhizoma corydalis, 18g of raw cattail pollen (bag decoction), 9g of trogopterus dung and 3g of dragon blood) is orally taken to be cleaned on the day 1 in the menstrual period and taken twice a day in the morning and at night; the kidney regulating formula (15 g of poria cocos, 6g of flos caryophyllata, 10g of prepared rehmannia root, 10g of radix rehmanniae, 15g of rhizoma curculiginis, 15g of herba epimedii, 30g of glossy privet fruit, 15g of photinia leaf, 10g of salvia miltiorrhiza, 10g of moutan bark, 10g of prepared turtle shell, 10g of prepared rhizoma cyperi and 10g of angelica sinensis) is that the medicine is taken after being cleaned, and the medicine is continuously taken for 14 days and is taken twice a day in the morning and evening; the medicines are decocted by a unified decoction machine of the quiet traditional Chinese medicine hospital, each package contains 150ml, 3 months of medicine taking is a treatment course, and 3 months follow-up visits are carried out after the treatment course is finished.
2.2 Observation index
2.2.1 dysmenorrhea symptom score: according to the guiding principle of clinical research of new traditional Chinese medicines: pain in the lower abdomen during and before and after menstruation was divided into 5 points (basal points); the abdominal pain is obvious, the face is pale, the pain is relieved by common pain relieving measures, the waist is sore, the nausea and vomiting are accompanied, the fever is accompanied, and each item with the pain within 1d is counted for 1 point; abdominal pain, restlessness in sitting and lying, cold sweat, cold limbs, sickbed rest, influence on work and study, general pain relieving measures for not relieving, headache, dizziness, anal pendant expansion, and diarrhea, each item is recorded for 1 minute; 2 points of shock is recorded; pain times were recorded at 0.5x (days-1) and the total number of points was accumulated. Before treatment, after the treatment course, and at follow-up visit points, scoring is carried out.
2.2.2 visual analogue Scale for dysmenorrhea (VAS): in clinic, a 1-10cm ruler is usually used as a tool, the back surface of the ruler faces a patient without scales, the patient is marked on the ruler according to the first response of the menstrual pain degree of the patient, and finally, a doctor compares the first response to obtain a score. Scoring is performed before treatment and after treatment course.
2.2.3 Pain Rating Index (PRI) contains 11 sensory words and 4 emotional events including jumping pain, stabbing pain, knife cutting pain, angina, persistent fixed pain, spasm pain, tenderness, weakness, boredom, fear, conviction punishment, etc. are counted as 0, 1, 2, 3 points on 4 grades of none, mild, moderate and severe, and the scores are cumulatively added. Before treatment, the treatment course is scored after cleaning.
2.2.4 Current pain intensity score (PPI) scores were obtained according to the scale shown no pain 0 score, mild pain 1 score, discomfort causing pain 2 score, distress pain 3 score, severe pain 4 score, intolerable pain 5 score. Scoring is performed before treatment and after treatment course.
2.2.5 traditional Chinese medicine syndrome score: with reference to the clinical research guidelines (trial) of new Chinese medicines, the main symptoms include menstrual period, menstrual color, menstrual volume, pain in lower abdomen during menstruation, soreness and weakness of waist and knees, blood clots in menstrual blood, fatigue and hypodynamia, and the like, and the symptoms are respectively 0, 2, 4 and 6 according to no, mild, moderate and severe 4 grades. The secondary symptoms comprise infertility, sexual desire change, clear and abundant urine, dizziness, tinnitus, insomnia, amnesia, etc., which are respectively counted into 0, 1, 2, and 3 according to 4 grades of none, mild, moderate, and severe, and are added up to score. Before treatment, after the treatment course, and at follow-up visit points, scoring is carried out.
2.2.6 laboratory blood indices: including CA125, PGF2 α. Collecting index before treatment and after cleaning course, collecting forearm venous blood 5ml, separating serum, storing in refrigerator at-80 deg.C, and determining CA125 and PGF2 alpha by enzyme-linked immunosorbent assay (ELISA).
2.3 evaluation of therapeutic Effect
(1) And (3) healing: the score is restored to 0 point after the medicine is taken, the abdominal pain and other symptoms disappear, and the patient does not relapse after the medicine is stopped for 3 months;
(2) the effect is shown: the score after treatment is reduced to be less than 1/2 of the score before treatment, the abdominal pain is obviously relieved, other symptoms are improved, and the patient can stay working without taking analgesic;
(3) the method has the following advantages: the score is reduced to 1/2-3/4 of the score before treatment, the abdominal pain is relieved, other symptoms are improved, and the taking of the analgesic can keep working;
(4) and (4) invalidation: abdominal pain and other symptoms unchanged.
2.4 statistical methods
Statistical analysis will be calculated using SPSS 21.0 statistical analysis software. All statistical tests used a two-sided test, and differences less than 0.05 in P would be considered statistically significant. Comparing the counting data components by using chi-square test; for the measurement data, the data which obeys normal distribution is expressed by mean +/-standard deviation; if the data meet the normal distribution requirement, the difference among the groups is tested by an independent sample t, and the difference in each group is tested by a matched sample t; if the data do not meet the normal distribution requirement, representing by using a median and a quartile interval (M, Q), and performing statistical analysis by using a non-parametric test of rank conversion.
3. Results of the study
3.1 comparison of clinical efficacy before and after treatment of two groups of patients
Compared with the clinical effects before and after treatment of the 2 groups, the curative rate of the treatment group is 78.8 percent (26/33), the curative rate of the control group is 46.9 percent (15/32), and the curative effect of the treatment group is better than that of the control group (P < 0.01) (see table 2).
TABLE 2 comparison of Pre-and post-treatment clinical efficacy of two groups of patients [ n (%) ]
Figure BDA0003970193130000111
Note: compared with the control group, the compound of the formula, ** P<0.01
3.2 comparison of Long-term clinical efficacy between two groups
The long-term clinical effects of the 2 groups are compared, after 3 months of follow-up visit, the curative rate of the treatment group is 51.5 percent (17/33), the curative rate of the control group is 3.0 percent (1/32), and the long-term curative effect of the treatment group is better than that of the control group (P < 0.01) (see table 3).
TABLE 3 comparison of Long-term clinical efficacy of two groups of patients [ n (%) ]
Figure BDA0003970193130000112
Figure BDA0003970193130000121
Note: compared with the control group, the compound of the formula, ** P<0.01
3.3 comparison of dysmenorrhea before and after treatment scores in two groups of patients
Compared with the scores of dysmenorrhea before and after treatment of the 2 patients, the scores of dysmenorrhea after treatment of the 2 patients are obviously reduced (P < 0.05), and the scores of the treated group are obviously lower than those of the control group (P < 0.05) (see table 4).
TABLE 4 comparison of dysmenorrhea scores before and after treatment in two groups of patients: (
Figure BDA0003970193130000122
Minute)
Figure BDA0003970193130000123
3.4 comparison of Long-term dysmenorrhea scores of two groups of patients
Compared with the long-term dysmenorrhea score of the patients in the group 2, after the follow-up visit for 3 months, the dysmenorrhea score of the patients in the treatment group is continuously reduced (P > 0.05) compared with that before the follow-up visit, the dysmenorrhea score of the control group is obviously improved (P < 0.05) compared with that before the follow-up visit, and the reducing effect of the traditional Chinese medicine group on the dysmenorrhea score is obviously better than that of the control group (P < 0.01) (see table 5).
TABLE 5 comparison of scores for distant dysmenorrhea in two groups of patients: (
Figure BDA0003970193130000124
Branch) based on the status of the blood vessel>
Figure BDA0003970193130000125
Note: compared with the method before the follow-up visit, # P<0.05; compared with the control group, the compound had better effect, ** P<0.01。
3.5 comparison of VAS, PRI scores in two groups of patients
The VAS, PRI and PRI scores of the patients in the 2 groups are compared, after treatment, the VAS score of the patients in the control group is obviously reduced (P < 0.05), the PRI score is obviously reduced (P < 0.01), the VAS score and the PPI score of the patients in the treatment group are both obviously reduced (P < 0.01), the PRI score is obviously reduced (P < 0.05), and the reduction effect on the VAS, PPI and PRI scores of the patients in the treatment group is better than that of the patients in the control group (P < 0.01) (see tables 6-7).
TABLE 6 comparison of VAS and PRI scores for dysmenorrhea before and after treatment in two groups of patients: (
Figure BDA0003970193130000126
Minute)
Figure BDA0003970193130000127
Figure BDA0003970193130000131
TABLE 7 comparison of PPI scores for dysmenorrhea before and after treatment (Scoring) for two groups of patients
Figure BDA0003970193130000132
3.6 comparison of the scores of the syndromes of traditional Chinese medicine before and after treatment of two groups of patients
The traditional Chinese medicine syndrome scores of the patients in the treatment group are obviously reduced (P is less than 0.01) compared with the traditional Chinese medicine syndrome scores before and after treatment in the 2 groups, and the traditional Chinese medicine syndrome scores of the patients in the treatment group are obviously lower than those before the treatment group (P is less than 0.01); after 3 months of follow-up, the traditional Chinese medicine syndrome score of the patients in the treatment group is obviously reduced (P < 0.05) compared with that after treatment and is obviously reduced (P < 0.01) compared with that before treatment, and the long-term curative effect of the treatment group is better than that of the control group (P < 0.01) (see table 8).
TABLE 8 comparison of the scores of the syndromes before and after treatment of two groups of patients: (
Figure BDA0003970193130000133
Branch) based on the status of the blood vessel>
Figure BDA0003970193130000134
Note: compared with the treatment before the treatment, P<0.01; compared with the control group, the compound of the formula, * P<0.01; compared with the treatment after the treatment, # P<0.05
3.7 comparison of CA125, PGF-2 alpha levels before and after treatment in two groups of patients
Compared with the serum CA125 and PGF-2 alpha levels before and after treatment in the 2 groups, the CA125 and PGF-2 alpha levels of the patients in the treatment group are obviously reduced (P is less than 0.01) after the treatment, and the reduction effect of the treatment group on the CA125 and PGF-2 alpha levels is better than that of the control group (P is less than 0.01) (see table 9).
TABLE 9 comparison of CA125, PGF-2 alpha levels before and after treatment in two groups of patients
Figure BDA0003970193130000135
Figure BDA0003970193130000136
Figure BDA0003970193130000141
The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and additions can be made without departing from the method of the present invention, and these modifications and additions should also be regarded as the protection scope of the present invention.

Claims (5)

1. A traditional Chinese medicine composition for treating endometriosis dysmenorrhea is characterized by being prepared from the following raw material medicines in parts by weight: 3-15g of angelica, 6-18g of salvia miltiorrhiza, 3-15g of medicinal cyathula root, 3-15g of prepared rhizoma cyperi, 2-10g of ligusticum wallichii, 3-15g of red peony root, 3-15g of prepared myrrh, 2-10g of prepared frankincense, 6-18g of corydalis tuber, 14-22g of raw cattail pollen (decocted by a package), 3-15g of trogopterus dung, 3-7g of dragon's blood, 5-25g of poria cocos, 10-20g of prepared rhizome of rehmannia, 5-25g of curculigo orchioides and 5-25g of epimedium herb.
2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight: 6-12g of angelica, 9-15g of salvia miltiorrhiza, 6-12g of medicinal cyathula root, 6-12g of prepared nutgrass galingale rhizome, 4-8g of szechuan lovage rhizome, 6-12g of red paeony root, 6-12g of prepared myrrh, 4-8g of prepared frankincense, 9-15g of corydalis tuber, 16-20g of raw cattail pollen (decocted by a package), 6-12g of trogopterus dung, 3-5g of dragon's blood, 10-20g of tuckahoe, 10-15g of prepared rhizome of rehmannia, 10-20g of curculigo rhizome and 10-20g of epimedium herb.
3. The traditional Chinese medicine composition according to claim 2, which is prepared from the following raw materials in parts by weight: 9g of angelica, 12g of salvia miltiorrhiza, 9g of medicinal cyathula root, 9g of prepared rhizoma cyperi, 6g of ligusticum wallichii, 9g of red paeony root, 9g of prepared myrrh, 6g of prepared frankincense, 12g of rhizoma corydalis, 18g of raw pollen typhae (bag decoction), 9g of trogopterus dung, 3g of dragon's blood, 15g of tuckahoe, 10g of prepared rehmannia root, 15g of rhizoma curculiginis and 15g of herba epimedii.
4. The composition according to claims 1-3, wherein the pharmaceutical agent is a capsule, granule, tablet, oral liquid, mixture or syrup.
5. The use of a Chinese medicinal composition according to any one of claims 1 to 3 in the preparation of a medicament for the treatment of endometriosis dysmenorrhoea.
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Title
付金荣等: "蔡氏内异系列方治疗子宫内膜异位症的生存质量评价", 中医文献杂志, no. 04, pages 42 - 44 *

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