CN105250519B - It is a kind of alleviate sequelae of pelvic inflammatory disease Chinese medicine composition and its application - Google Patents
It is a kind of alleviate sequelae of pelvic inflammatory disease Chinese medicine composition and its application Download PDFInfo
- Publication number
- CN105250519B CN105250519B CN201510675161.5A CN201510675161A CN105250519B CN 105250519 B CN105250519 B CN 105250519B CN 201510675161 A CN201510675161 A CN 201510675161A CN 105250519 B CN105250519 B CN 105250519B
- Authority
- CN
- China
- Prior art keywords
- parts
- chinese medicine
- medicine composition
- treatment
- sequelae
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
Landscapes
- Medicines Containing Plant Substances (AREA)
Abstract
The present invention relates to a kind of Chinese medicine composition for alleviating sequelae of pelvic inflammatory disease and its applications, are prepared from the following raw materials in parts by weight: 25-35 parts of viola mandshurica, 10-20 parts of dandelion, 10-20 parts of sargentodoxa cuneata, 6-12 parts of radix bupleuri, 8-12 parts of rhizoma corydalis, 10-15 parts of paniculate swallowwort, 6-12 parts of Artemisia anomala, 6-12 parts of Fructus meliae toosendan, 6-12 parts of Fructus Aurantii, 10-15 parts of rhizoma cibotii, 10-15 parts of teasel root.Chinese medicine composition of the invention can effectively improve Accumulation of Dampness Heat and Blood Stasis type sequelae of pelvic inflammatory disease patient clinical symptom, sign, reduce serum inflammatory cytokine content, inhibit pelvic inflammation, recurrence rate is reduced, there is good analgesia, anti-inflammatory effect, stabilization curative for effect, and the Chinese medicine composition flavour of a drug number is less, convenient for preparation, have no toxic side effect, securely and reliably.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition for alleviating sequelae of pelvic inflammatory disease and its applications, specifically, being
A kind of Chinese patent drug prepared using Chinese herbal medicine as raw material.
Background technique
Sequelae of pelvic inflammatory disease (Sequelae of pelvic inflammatory disease, Sequelae
Of PID), mostly because pathogen microorganism invades genital tract and its surrounding tissue in women by all means, cause pelvic tissue
Infection, causes inflammatory reaction.Pelvic organ, connective tissue, mucous membrane etc. can be involved by inflammation, cause local organization metabolism different
Often, if infection fails in time correctly treatment, contrafluxion, oedema, disorganization, extensive adhesion, fibrosis, hyperplasia be can lead to
And cicatrization.This disease is the common genital system diseases of gynaecology, in recent years in rising and rejuvenation trend, if treatment is not thorough
The serious sequelae such as infertility, ectopic pregnancy, chronic pelvic pain can finally be caused.
Complicated due to the disease onset, change of illness state is very fast, and therapeutic process is longer, therefore usually curative effect is unstable, makes
It is refractory at protracted inflammation, recurrent exerbation.Up to 40%, which leads disease incidence PID sequelae in developing country's Women of Childbearing Age
The tubal infertility disease incidence of cause is 20%~30%, and leading to the disease incidence of ectopic pregnancy is 8~10 times of normal female.It is anxious
Property PID early stage control can be used doctor trained in Western medicine antibiotic treatment, but for treatment method that PID sequelae there is no.It is used for a long time
Antibiotic is anti-infective to be also easy to produce drug resistance, and antibacterial effect is unsatisfactory, and curative effect can be stablized by actively finding, and prevents effective hand of recurrence
The treatment of Duan Weiben disease is crucial.
The etiology and pathogenesis that modern TCM sums up PID sequelae is mostly " heat ", " poison ", " wet ", " stasis of blood ", " void ".Research is close
Document discovery in several years, each doctor of Chinese medicine have compared the etiology and pathogenesis understanding of this disease unified, it is believed that " wet " " stasis of blood " " void " three leads
Cause this disease, the more simulataneous insufficiencies and excessives of characteristic of disease.
Chinese patent literature CN201210125434.5, publication date 2013.10.30 are disclosed a kind of for treating pelvic cavity
The Chinese medicine composition and application thereof of inflammatory disease sequelae, the Chinese medicine composition are made of the bulk pharmaceutical chemicals of following weight proportion:
15-40 parts of Radix Salviae Miltiorrhizae, 15-40 parts of radix paeoniae rubra, 10-30 parts of ramulus cinnamomi, animal pharmacodynamic experiment and clinical trial prove the Chinese traditional medicine composition
Object has significant therapeutic effect to sequelae of pelvic inflammatory disease.
Chinese patent literature CN201310733972.7 discloses a kind of medicine group for treating sequelae of pelvic inflammatory disease
Close object and its preparation method and application, which is prepared by following medicinal materials: Radix Astragali, dragon's blood, ramulus cinnamomi, Chinese herbaceous peony, when
Return, Sargent gloryvine, purslane, field pennycress, dandelion, prepared RADIX ET RHIZOMA RHEI, the root bark of tree peony, peach kernel, myrrh, Poria cocos, radix glycyrrhizae preparata, volatilizees by extracting
Oil, decoction, concentration, clarification, drying and other steps are prepared, which has nourishing qi and blood, temperature through stagnation resolvation, dampness removing solution
The effect of poison meets sequelae of pelvic inflammatory disease void, the stasis of blood, cold, wet disease feature, can obviously improve blood samples of patients recycle,
With raising immune function and oxidation resistant effect.
However, it is still very necessary for developing more stable PID sequelae drugs curative for effect.
Summary of the invention
The purpose of the present invention is aiming at the shortcomings in the prior art, provide in a kind of alleviation sequelae of pelvic inflammatory disease
Drug composition.
Another purpose of the invention is to provide the preparation method of the Chinese medicine composition.
Another purpose of the invention is to provide the purposes of the Chinese medicine composition.
To realize above-mentioned first purpose, the technical solution adopted by the present invention is that:
A kind of Chinese medicine composition for alleviating sequelae of pelvic inflammatory disease, it is prepared from the following raw materials in parts by weight: purple
Flower Chinese violet 25-35 parts, 10-20 parts of dandelion, 10-20 parts of sargentodoxa cuneata, 6-12 parts of radix bupleuri, 8-12 parts of rhizoma corydalis, paniculate swallowwort 10-15
Part, 6-12 parts of Artemisia anomala, 6-12 parts of Fructus meliae toosendan, 6-12 parts of Fructus Aurantii, 10-15 parts of rhizoma cibotii, 10-15 parts of teasel root.
Preferably, the Chinese medicine composition is prepared from the following raw materials in parts by weight: 28-32 parts of viola mandshurica, Pu Gong
13-18 parts of English, 13-18 parts of sargentodoxa cuneata, 8-10 parts of radix bupleuri, 9-11 parts of rhizoma corydalis, 11-13 parts of paniculate swallowwort, 8-10 parts of Artemisia anomala, river
8-10 parts of chinaberry, 8-10 parts of Fructus Aurantii, 11-13 parts of rhizoma cibotii, 11-13 parts of teasel root.
It is highly preferred that the Chinese medicine composition is prepared from the following raw materials in parts by weight: 30 parts of viola mandshurica, dandelion
15 parts, 15 parts of sargentodoxa cuneata, 9 parts of radix bupleuri, 10 parts of rhizoma corydalis, 12 parts of paniculate swallowwort, 9 parts of Artemisia anomala, 9 parts of Fructus meliae toosendan, 9 parts of Fructus Aurantii, dog
12 parts of ridge, 12 parts of teasel root.
Preferably, the dosage form of the Chinese medicine composition is capsule, granule, tablet or mixture.
To realize above-mentioned second purpose, the technical solution adopted by the present invention is that:
The preparation method of Chinese medicine composition as described above, the preparation method is the following steps are included: according to described
Parts by weight take each bulk pharmaceutical chemicals, and conventional method decocts after crushing.
To realize above-mentioned third purpose, the technical solution adopted by the present invention is that:
As above any Chinese medicine composition is alleviated in preparation or is treated in the drug of sequelae of pelvic inflammatory disease
Using.
As a kind of specific embodiment of the invention, the sequelae of pelvic inflammatory disease is Accumulation of Dampness Heat and Blood Stasis type.
The invention has the advantages that:
1, Chinese medicine composition of the invention can effectively improve Accumulation of Dampness Heat and Blood Stasis type PID sequelae patient clinical symptom, sign, drop
Low serum inflammatory cytokine content inhibits pelvic inflammation, reduces recurrence rate, has good analgesia, anti-inflammatory effect, and curative effect is true
Stabilization is cut, clinical expansion is worth.
2, Chinese medicine composition flavour of a drug number of the invention is less, and convenient for preparation, abundant raw materials are easy to get, at low cost.
3, Chinese medicine composition of the invention is made of pure Chinese medicine raw material, has no toxic side effect, and securely and reliably, is easy to by patient
Receive.
Specific embodiment
It elaborates below to specific embodiment provided by the invention.
The preparation (one) of 1 the traditional chinese medicine composition of the invention of embodiment
25 parts of viola mandshurica, 20 parts of dandelion, 10 parts of sargentodoxa cuneata, 12 parts of radix bupleuri, 8 parts of rhizoma corydalis, 15 parts of paniculate swallowwort (after
Under), 6 parts of Artemisia anomala, 12 parts of Fructus meliae toosendan, 6 parts of Fructus Aurantii, 15 parts of rhizoma cibotii, 10 parts of teasel root, conventional method decoct.
The preparation (two) of 2 the traditional chinese medicine composition of the invention of embodiment
35 parts of viola mandshurica, 10 parts of dandelion, 20 parts of sargentodoxa cuneata, 6 parts of radix bupleuri, 12 parts of rhizoma corydalis, 10 parts of paniculate swallowwort (after
Under), 12 parts of Artemisia anomala, 6 parts of Fructus meliae toosendan, 12 parts of Fructus Aurantii, 10 parts of rhizoma cibotii, 15 parts of teasel root, conventional method decoct.
The preparation (three) of 3 the traditional chinese medicine composition of the invention of embodiment
25 parts of viola mandshurica, 10 parts of dandelion, 20 parts of sargentodoxa cuneata, 12 parts of radix bupleuri, 8 parts of rhizoma corydalis, 10 parts of paniculate swallowwort (after
Under), 12 parts of Artemisia anomala, 12 parts of Fructus meliae toosendan, 6 parts of Fructus Aurantii, 10 parts of rhizoma cibotii, 15 parts of teasel root, conventional method decoct.
The preparation (four) of 4 the traditional chinese medicine composition of the invention of embodiment
35 parts of viola mandshurica, 20 parts of dandelion, 10 parts of sargentodoxa cuneata, 6 parts of radix bupleuri, 12 parts of rhizoma corydalis, 15 parts of paniculate swallowwort (after
Under), 6 parts of Artemisia anomala, 6 parts of Fructus meliae toosendan, 12 parts of Fructus Aurantii, 15 parts of rhizoma cibotii, 10 parts of teasel root, conventional method decoct.
The preparation (five) of 5 the traditional chinese medicine composition of the invention of embodiment
28 parts of viola mandshurica, 18 parts of dandelion, 13 parts of sargentodoxa cuneata, 10 parts of radix bupleuri, 9 parts of rhizoma corydalis, 13 parts of paniculate swallowwort (after
Under), 8 parts of Artemisia anomala, 10 parts of Fructus meliae toosendan, 8 parts of Fructus Aurantii, 13 parts of rhizoma cibotii, 11 parts of teasel root, conventional method decoct.
The preparation (six) of 6 the traditional chinese medicine composition of the invention of embodiment
32 parts of viola mandshurica, 13 parts of dandelion, 18 parts of sargentodoxa cuneata, 8 parts of radix bupleuri, 11 parts of rhizoma corydalis, 11 parts of paniculate swallowwort (after
Under), 10 parts of Artemisia anomala, 8 parts of Fructus meliae toosendan, 10 parts of Fructus Aurantii, 11 parts of rhizoma cibotii, 13 parts of teasel root, conventional method decoct.
The preparation (seven) of 7 the traditional chinese medicine composition of the invention of embodiment
32 parts of viola mandshurica, 18 parts of dandelion, 18 parts of sargentodoxa cuneata, 8 parts of radix bupleuri, 9 parts of rhizoma corydalis, 11 parts of paniculate swallowwort (after
Under), 10 parts of Artemisia anomala, 10 parts of Fructus meliae toosendan, 10 parts of Fructus Aurantii, 11 parts of rhizoma cibotii, 13 parts of teasel root, conventional method decoct.
The preparation (eight) of 8 the traditional chinese medicine composition of the invention of embodiment
25 parts of viola mandshurica, 20 parts of dandelion, 10 parts of sargentodoxa cuneata, 12 parts of radix bupleuri, 8 parts of rhizoma corydalis, 11 parts of paniculate swallowwort (after
Under), 10 parts of Artemisia anomala, 8 parts of Fructus meliae toosendan, 10 parts of Fructus Aurantii, 11 parts of rhizoma cibotii, 13 parts of teasel root, conventional method decoct.
The preparation (nine) of 9 the traditional chinese medicine composition of the invention of embodiment
28 parts of viola mandshurica, 18 parts of dandelion, 13 parts of sargentodoxa cuneata, 10 parts of radix bupleuri, 9 parts of rhizoma corydalis, 10 parts of paniculate swallowwort (after
Under), 12 parts of Artemisia anomala, 12 parts of Fructus meliae toosendan, 6 parts of Fructus Aurantii, 10 parts of rhizoma cibotii, 15 parts of teasel root, conventional method decoct.
The preparation (ten) of 10 the traditional chinese medicine composition of the invention of embodiment
30 parts of viola mandshurica, 15 parts of dandelion, 15 parts of sargentodoxa cuneata, 9 parts of radix bupleuri, 10 parts of rhizoma corydalis, 12 parts of paniculate swallowwort (after
Under), 9 parts of Artemisia anomala, 9 parts of Fructus meliae toosendan, 9 parts of Fructus Aurantii, 12 parts of rhizoma cibotii, 12 parts of teasel root, conventional method decoct.
In above embodiments, the conventional method decoction is the production method of traditional Chinese herbal decoction routine, i.e., by the original
Material medicine adds water to cook into decoction.
The preparation of 11 the traditional chinese medicine composition of the invention tablets/capsules agent of embodiment
Bulk pharmaceutical chemicals are weighed according to any parts by weight of embodiment 1-10, adds 8-12 times to measure water, decocts 1-3 hours, filter
Decoction out.Again plus 10 times of amount water, decoction 1.5-2.5 hours filter out decoction, merge secondary decocting liquid, stand, leaching supernatant is dense
Contracting, lets cool, and adds 2.5 times of amount alcohol of concentrate, stirs precipitates overnight.Supernatant is taken, thick medicinal extract is concentrated into；Pharmaceutical aids are added,
Vacuum drying, crushes granulation, and tabletted or filling is encapsulated.
The preparation of 12 the traditional chinese medicine composition of the invention granule of embodiment
Bulk pharmaceutical chemicals are weighed according to any parts by weight of embodiment 1-10, adds 8-10 times to measure water, it is small to decoct 2.5-3.5
When, filter out decoction.Again plus 10 times of amount water, decoction 2 hours filter out decoction, merge secondary decocting liquid, stand, leaching supernatant is dense
Contracting, lets cool, and adds 2 times of amount alcohol of concentrate, stirs precipitates overnight.Supernatant is taken, thick medicinal extract is concentrated into；Add appropriate pharmaceutical aids,
Granulation, dry, whole grain obtains 20g particle, dispenses 10g/ bags.
The preparation of 13 the traditional chinese medicine composition of the invention mixture of embodiment
Bulk pharmaceutical chemicals are weighed according to any parts by weight of embodiment 1-10, adds 8-10 times to measure water, decocts 3 hours, filter out
Decoction.Again plus 8 times of amount water, decoction 2 hours filter out decoction, merge secondary decocting liquid, stand, leaching supernatant, concentration lets cool, adds
2 times of amount alcohol of concentrate stir precipitates overnight.Supernatant is taken, thick medicinal extract is concentrated into；Add appropriate pharmaceutical aids, mixture is made.
The clinical test of 14 the traditional chinese medicine composition of the invention of embodiment treatment sequelae of pelvic inflammatory disease
One, clinical data
1 case source
This research case is (wet from the sequelae of pelvic inflammatory disease that in January, 2013-2 months Out-patient Clinic of Department of Gynecology in 2015 are gone to a doctor
Hot stasis type) patient, amount to 120.
2 case selection standards
2.1 diagnostic criteria
2.1.1 Western medicine diagnostic criteria: referring to " new Chinese medicine guideline of clinical investigations ", (Zheng Xiao cornel new Chinese medicine is clinical
The tentative Beijing [M] of research guideline: China Medical Science Press, 2002.5,243-253.) and China Association of Traditional Chinese Medicine
" Chinese medicine woman produces common disease practice guidelines " (China Association of Traditional Chinese Medicine issues the Beijing TCM Gynecology common disease practice guidelines [M]: in
State traditional Chinese medicine publishing house .2012.07:117-119.) it works out.
1. pelvic inflammatory disease medical history, lower abdominal pain or waist and sacrum pain >=6 month, after tired, sexual intercourse or through row before
Normal abdominal pain aggravation afterwards.
2. pelvic inflammatory disease history of repeated attack.
3. infertile and ectopic pregnancy.
4. gynaecological examination: uterus one or both sides can contact rope strip thickening fallopian tubal and have tenderness or pelvic cavity one or both sides
Cystic lesions are touched, activity is mostly limited or uterus is often in retroversioflexion, and limitation of activity or adhesion are fixed, uterus one or both sides
There is sheet to thicken, tenderness, the normal thickening of uterosacral ligament is hardened, and has tenderness.
Auxiliary examination: 1. negative super generating show fallopian tubal thickening, hydrosalpinx, with or not companion's pelvic hydrops, oviductal oocytes
Nest lump.2. laparoscopic examinations showed organic pelvic inflammatory disease sign.
On it is 1. i.e. diagnosable in combination with its medical history, symptom, gynaecological examination and auxiliary examination etc..
2.1.2 antidiastole
This disease should mutually identify with similar disorder, especially should be swollen with endometriosis, pelvic congestion syndrome, ovary
Object, old ectopic pregnancy, chronic appendicitis and pelvic tuberculosis etc. identify.Super check of yin can help to identify.This clinical disease and
Endometriosis is most difficult to identify, and should pass through detailed history-taking and gynaecology's physical examination antidiastole.Endometriosis
Pain is often secondary, progressive aggravates, and the accessible typical tenderness tubercle of gynaecology's physical examination, yin is super and CA125 inspection can assist to examine
Disconnected, celioscopy is goldstandard.
(Li Huajun, poplar order is clean, and Lang Jing is endometriosis with equal pelvic inflammatory disease mistaken diagnosis by Li Huajun, Lang Jinghe
29 clinical analysis [J] Chinese Journal of Clinical Obstetrics and Gynecology, 2009,10 (5): 326-329.) etc. inquire into antidiastole PID after lose
When disease is with endometriosis (EM), it is believed that the higher clinical indices of specificity have chronic abdominal pain and without sacrum desmalgia knot
Section, chronic abdominal pain and without acquired dysmenorrhea, chronic abdominal pain and age of menarche >=14 year old, specificity is 88.9%, 86.1% and
83.3%.
2.1.3 tcm diagnosis standard: Accumulation of Dampness Heat and Blood Stasis type pelvic inflammatory disease sequelae is referring to " new Chinese medicine clinical research guidance
Principle " (gynecotokology branch, Chinese Medical Association infectious diseases cooperative groups inflammatory pelvic disease diagnosis and treatment specification (revised edition)
[J] China journal of obstetrics and gynecology, 2014,49 (6): 401-403.) it works out.
Primary symptom shape: 1. hypogastralgia；2. lumbus sacrum pain；3. profuse leukorrhea color is yellow, matter is sticky.
Secondary symptom: 1. tired, sexual intercourse, bellyache in menstrual period aggravates；2. the tired body weight of limb；3. low-heat rises and falls；4. irregular menstruation；5. small
Just yellow；6. being hard and dry or half congealed and deficient smooth.
Tongue vein: wiry and rolling pulse or sliding number；Red tongue body, yellow and greasy fur.
The above syndrome at least has primary symptom 2, minor symptom 3, reference tongue vein, that is, diagnosable.
2.2 are included in standard
1. there is the women of sexual behaviour at the age between 20~55 years old.
2. meeting doctor trained in Western medicine PID sequelae diagnostic criteria.
3. meeting Chinese medicine Accumulation of Dampness Heat and Blood Stasis type PID sequelae diagnostic criteria.
4. this research of voluntary participation, can follow-up.
2.3 exclusion criteria
1. not meeting the diagnosis of this disease doctor trained in Western medicine and tcm diagnosis.
2. the age<20 years old or>55 years old.
3. gravid woman, breast feeding women and preparation gestation person within half a year.
4. there are many food, drug allergy history persons to give and exclude.
5. on inspection confirm have gynaecology's innocent and malignant tumour (wherein fibroid maximum gauge be greater than 3cm or fleshy polyp
Cause symptom), nonspecific vaginitis, acute cervicitis, be difficult to antidiastole be PID sequelae or endometriosis,
Related symptoms person caused by the other illnesss such as Pelvic Tuberculosis is excluded.
6. for the approximate drug of effect is once taken before treating in a short time, the person that can not specify drug influence.
7. merging the serious primary diseases such as cardiovascular, endocrine system and hematological system, or suffer from insane.
2.4 reject standard
1. clinical trial protocol implement in because patient compliance is poor, not by provide pill taker.
2. patient voluntarily takes the drug of other treatment this disease so that curative effect of medication can not the person of judgement.
3. occurring aggravation in patient test, or there is illness (such as wound, operation of other influences experimental observation
Deng) clinical test person should not be continued.
4. occurring serious toxicity person in patient treatment procedure.
It rejects case and answers illustration, the reservation of CRF table is put on record, does not enter statistical analysis PP collection.For received it is primary or
Curer more than once can according to circumstances carry out safety judgement.
3 standards of grading
Referring to " new Chinese medicine guideline of clinical investigations ", (Zheng Xiao cornel new Chinese medicine guideline of clinical investigations is tentative
The Beijing [M]: China Medical Science Press, 2002.5,243-253.) it works out.
3.1 syndrome score standards
Primary symptom:
Hypogastralgia: 0 point: nothing；2 points: when make, do not influence frequent breaking-out of living；4 points: influencing work, life, but can bear
By；6 points: persistently existing, seriously affect work, live.
Lumbus sacrum pain: 0 point: nothing；2 points: waist sacrum is uncomfortable, does not influence work, lives；4 points: the obvious pain of waist sacrum influences work
Make, life；6 points: lumbus sacrum pain unbearably, seriously affects work, and life need to lie up.
Band is more, and color is yellow: 0 point: normal；2 points: leukorrhagia is on the high side, and leukorrhagia amount more normally increases within 1/2 times；4 points: color is yellowish-white
Mutually and, leukorrhagia is on the high side, is normal 1/2-1 times；6 points: color is yellow, and amount is on the high side, is usually 1 times or more.
Minor symptom:
The tired body weight of limb: 0 point: nothing；1 point: when make, do not influence work；2 points: Chang You influences work；3 points: it is obvious, it is disinclined to live
It is dynamic.
Fatigue, sexual intercourse, bellyache in menstrual period aggravate: 0 point: nothing；1 point: when have exacerbation；2 points: Chang Jiachong；3 points: aggravating every time.
Urine is yellow: 0 point: nothing；1 point: micro- Huang；2 points: yellow；3 points: deep yellow.
It is hard and dry: 0 point: nothing；1 point: day is primary, dry；2 points: 2-3 days primary, dry and hard；3 points: 3 days with the last time,
Constipation is difficult to resolve.
Big loose stool is without refreshing: 0 point: nothing；1 point: day is primary, shapeless；2 points: day 2-3 times, loose stool；3 points: day 3 times with
On, loose stool is thin.
Irregular menstruation: 0 point: nothing；1 point: amount is more or menostaxis；2 points: amount is mostly with menostaxis；3 points: vagina is irregular
It bleeds.
3.2 local sign standards of grading
Sign: uterine activity is limited, tenderness 5 is divided；Fallopian tubal divides in streak, tenderness 5；Uterus one or both sides sheet,
It thickens, tenderness 5 is divided.
Symptom: lower abdomen, flank pain 3 divide；Profuse leukorrhea 1 divides；Low-heat plays shape 1 and divides；Premenstrual bellyache in menstrual period 1 divides；The course of disease is every
Increase by 1 year plus 0.5 point.
Grade scale: sign, symptom integral >=20 point are severe；Sign, 12~19 points of symptom integral be moderate；Sign,
5~11 points of symptom integral are slight.
3.3 Pain Grading standards
Pain intensity (PI): according to digitlization assessment scaling method (NRS).
0 indicate it is painless, 10 indicate most have an intense pain, 1~3 be it is slight, 4~6 be moderate, 7~10 be severe.
Two, research method
1 test grouping and medication
1.1 test groupings
Follow at random with compare principle, according to random digits table, research object is randomly divided into treatment group 60 and right
According to group 60.
1.2 treatment method
Treatment group:, taking the decoction prepared according to 10 method of embodiment by 60, decocts to 0.25g/mL containing crude drug amount, early
Evening is each 1 dose oral, and 1 dose is 200mL.Continuous medication 8 weeks, the menstrual period is not discontinued.It fully recovers case one month, follow-up in three months.
Control group: 60, each bulk pharmaceutical chemicals: 30 parts of viola mandshurica, 30 parts of dandelion, sargentodoxa cuneata are weighed according to following parts by weight
30 parts, 12 parts of rhizoma corydalis, 12 parts of Artemisia anomala, 12 parts of teasel root, conventional method is decocted to 0.25g/mL containing crude drug amount, sooner or later each oral
1 dose, 1 dose is 200mL.Continuous medication 8 weeks, the menstrual period is not discontinued.It fully recovers case one month, follow-up in three months.
2 observation index
2.1 general data
Including the age, medical history, vital sign, clinical sign scoring, TCM syndrome evaluation and local pain scoring etc. projects,
By detailed medical history-taking and fill in the acquisition of CRF table.
2.2 ultrasonic examination
(course for the treatment of terminates within 3 months) checked that postmenopause is without this limitation in 3-5 days after net before treatment and after treatment.
2.3 leukorrhea, mycoplasma inspection
(course for the treatment of terminates within 3 months) checked that postmenopause is without this limitation in 3-5 days after net before treatment and after treatment.It checks
Patient is advised within first 24 hours to prohibit sexual life, vagina administration and vagina operation.2 sterile cotton swabs are taken when collect specimen, in cervical canal
Rotate 3 weeks and stop 30 seconds at interior 1-2cm or more, pay attention to not touching vaginal wall when acquisition.
2.4 cytokines measurement
The pathomechanism of sequelae of pelvic inflammatory disease is that immune response, various inflammatory factors occurs in body after pelvic infection
Release large effect is generated to the treatment and prognosis of this disease, and Pro-inflammatory mediator, anti-inflammatory cytokine, inflammatory are situated between
The abnormal change and the occurrence of this disease of the factors such as matter, free radical and Apoptosis are closely related.This research observe inflammatory cell because
Sub- IL-2, IL-6, TNF-α variation, three is Pro-inflammatory mediator, can clear reaction sequelae of pelvic inflammatory disease inflammation
Progress extent.
Patient's (course for the treatment of terminated in 3 months) morning blood drawing on an empty stomach before treatment and after treatment, detects serum inflammatory cytokine
IL-2, IL-6, TNF-α are horizontal.
2.5 follow-up
To sequelae of pelvic inflammatory disease patient is included in, terminates one month, follow-up in three months in the course for the treatment of, record patient symptom
Recurrence, pregnancy situation.
3 curative effect determinate standards
3.1 therapeutic effect of syndrome evaluation criterions
According to " new Chinese medicine guideline of clinical investigations ", (Zheng Xiao cornel new Chinese medicine guideline of clinical investigations is tentative
The Beijing [M]: China Medical Science Press, 2002.5,243-253.) it formulates.
Therapeutic index N is that pre-treatment score subtracts post treatment integral, and result is divided by pre-treatment score.
1. recovery from illness: each symptom disappears after treatment, and syndrome integral value reduces >=95%.
2. effective: each symptom is substantially reduced after treatment, and syndrome integral value reduces >=70%, < 95%.
3. effectively: each symptom is mitigated after treatment, and syndrome integral value reduces >=30%, < 70%.
4. invalid: for each symptom without mitigating or having exacerbation, syndrome integral value reduces < 30% after treatment.
3.2 local sign situation evaluation criterions
1. recovery from illness: sign disappears after treatment, and integrated value reduces >=95%, or reduces by 2 ranks.
2. effective: sign is substantially reduced after treatment, and integrated value reduces >=70%, < 95%, or reduces by 1 rank.
3. effectively: sign is mitigated after treatment, and integrated value reduces >=30%, < 70%, or reduces less than 1 rank.
4. invalid: for sign without mitigating or having exacerbation, syndrome integral value reduces < 30% after treatment.
3.3 pain the standard of curative effect evaluation
By NRS methods of marking and the evaluation of WHO pain criterion of therapeutical effect, (the pain caused by cancer tincture externally-applied liniment such as Gai Guitang, Lu Haili closes three
Step analgesia treats the Hebei clinical research [J] the traditional Chinese medicine journal of pain caused by cancer, 2007,22 (1): 10-11.).
1. complete incidence graph (CR): pain disappears, and NRS scoring is 0.
2. (PR) is alleviated in part: pain is substantially reduced, and NRS scoring reduces 1/2 or more compared with pre-treatment.
3. minor responses (MP): pain slightly mitigates, and alleviation is unobvious, and NRS scoring is reduced compared with pre-treatment less than 1/2.
Invalid 4. (NP): than no mitigation before pain and administration, NRD scores without significant change.
4 safety indexes
4.1 blood routines, routine urinalysis
4.2 hepatic and renal function
5 statistical methods
This test data uses PP analytic set, and statistical software is SPSS 18.0, enumeration data Chi-square Test (X2), clothes
From normal distribution and variance neat measurement data F or t is examined, and change of variable is carried out if disobeying or is examined using t ',
Repeated Measurement Data uses Repeated Measurements variance analysis, ranked data rank sum test, and each group of data uses mean ± mark
It is quasi- poorCarry out statistics description.P < 0.05 is that difference is statistically significant.
Three, result of study
1, general information compares
This research is included in case 120 altogether, completes 120, no rejecting case.Totally 120 cases enter PP analytic set.It controls
Treatment group and control group each 60, are diagnosed as PID sequelae, and Chinese medical discrimination is Accumulation of Dampness Heat and Blood Stasis type.
Treat preceding two groups of patient ages, the course of disease, abortion times, severity extent there are no significant difference.Two groups of severity extents
Through rank sum test, there was no significant difference, is comparable.
2 curative effect index compare
2.1 two groups of pretherapy and post-treatment TCM syndrome evaluations and curative effect
Two groups of tcm syndrome curative effects are shown in Table 1 after treatment, statistically significant (P < 0.05) through rank sum test, show the present invention
Chinese medicine composition improves tcm syndrome and is better than control group Chinese medicine composition.
Tcm syndrome curative effect after 1 two groups of treatments of table
Two groups of pretherapy and post-treatment TCM syndrome evaluations are shown in Table 2, before two groups of treatments in TCM syndrome evaluation group, the equal nothing of comparison among groups
Statistical significance illustrates that two groups of tcm syndromes are comparable.Two groups of tcm syndromes have improvement, but Chinese medicine after treatment after treatment
Syndrome overall score is more statistically significant (P < 0.05), shows that the traditional chinese medicine composition of the invention improves better than control tcm syndrome
Group Chinese medicine composition.
2 two groups of pretherapy and post-treatment TCM syndrome evaluations of table
2.2 two groups of pretherapy and post-treatment sign scorings and curative effect
Sign curative effect is shown in Table 3 after two groups of treatments, statistically significant (P < 0.05) through rank sum test, shows Chinese medicine of the present invention
Composition improves sign and is better than control group Chinese medicine composition.
Sign curative effect after 3 two groups of treatments of table
Two groups of pretherapy and post-treatment signs scorings are shown in Table 4, examine through t, and before two groups of treatments in sign group, comparison among groups are without statistics
Meaning is learned, illustrates that two groups of signs are comparable.Two groups of signs have improvement after treatment, but relatively there is sign overall score after treatment
Statistical significance (P < 0.05) shows that the traditional chinese medicine composition of the invention improves better than control group Chinese medicine composition sign.
4 two groups of table pretherapy and post-treatment sign scorings
Pain scores and curative effect after 2.3 two groups of treatments
Pain relief degree is shown in Table 5 after two groups of treatments, and two groups of pain relief degree, which compare, after treatment has system through rank sum test
Meter learns meaning, shows that the traditional chinese medicine composition of the invention improves better than control group Chinese medicine composition pain relief.
Pain relief degree after 5 two groups of treatments of table
Two groups of pretherapy and post-treatment pain scores are shown in Table 6, examine through t, and pain scores are more not statistically significant before two groups of treatments,
Illustrate that two groups of pain scores are comparable.Pain scores are statistically significant (P < 0.05) after treatment, show after treatment two groups
Improving comparison to pain has significant difference, and the traditional chinese medicine composition of the invention improves better than control Chinese medicine composition pain.
6 two groups of pretherapy and post-treatment pain scores of table
2.4 two groups of pretherapy and post-treatment inflammatory cytokine variations
Two groups of pretherapy and post-treatment serum IL-2s, IL-6, TNF-α situation of change are shown in Table 7-9.It is examined through t, IL- before two groups of treatments
2, IL-6, TNF-α comparison among groups are not statistically significant, show that two groups are comparable.In being organized after treatment relatively, treatment group patient
Serum IL-2, IL-6, TNF-α change statistically significant, P < 0.05, show that trouble can be effectively reduced in the traditional chinese medicine composition of the invention
Person's serum inflammatory cytokine IL-2, IL-6, TNF-α are horizontal.Control group patients serum IL-6 variation is not statistically significant, and P >
0.05, it is not significant to show that control Chinese medicine composition reduces IL-6 content.
7 two groups of table pretherapy and post-treatment serum IL-2 situations of change
8 two groups of table pretherapy and post-treatment blood serum IL-6 situations of change
9 two groups of table pretherapy and post-treatment Serum TNF-α situations of change
2.5 two groups of pretherapy and post-treatment yin are super to check situation
Two groups of pretherapy and post-treatment yin are super to check that situation is shown in Table 10, and treatment group and control group are to patient's pelvic hydrops, inflammatory mass
There is improvement, but there was no significant difference for comparison, P > 0.05.
Yin surpasses inspection situation to 10 two groups of table before and after treatment
The pretherapy and post-treatment mycoplasma of 2.6 two groups of patients checks situation
Two groups of pretherapy and post-treatment mycoplasmas check that situation is shown in Table 11, and mycoplasma turns after treatment group and the treatment of control group some patientss
Yin, two groups are compared that there was no significant difference, P > 0.05.
11 two groups of table pretherapy and post-treatment mycoplasmas check situation
The observation of 3 safety indexes
Two groups of vital sign patients, blood routine, liver kidney function, routine urinalysis etc. are showed no anomalous variation and face during treatment
The case of bed meaning, all patients do not have found related reactions over the course for the treatment of, show two kinds of Chinese medicine compositions have compared with
High safety.
4 recent follow-up relapse assessments
To two groups of patients after treatment, follow-up is carried out after being discontinued 1 month, 3 months.Wherein in treatment group 60 recovery from illness and
Effective patient symptom is showed no repeatedly, and being discontinued 1 month in effective patient has 1 symptom recurrence occur, be discontinued 3 months 1 go out
Existing symptom is repeatedly.Recovery from illness and effective patient symptom are showed no repeatedly in control group 60, and being discontinued 1 month in effective patient has 3
There is symptom recurrence in example, be discontinued 3 months 4 there is symptom repeatedly.
Recurrence after 12 two groups of treatments of table
In summary it is found that Chinese medicine composition of the invention can effectively improve Accumulation of Dampness Heat and Blood Stasis type PID sequelae patient clinical
Symptom, sign, reduction serum inflammatory cytokine content, inhibit pelvic inflammation, reduce recurrence rate, have good analgesia, resist
Inflammation effect, effect are worth clinical expansion better than control Chinese medicine composition.
The above is only a preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art
Member, under the premise of not departing from the method for the present invention, can also make several improvement and supplement, these are improved and supplement also should be regarded as
Protection scope of the present invention.
Claims (6)
1. a kind of Chinese medicine composition for alleviating Accumulation of Dampness Heat and Blood Stasis type sequelae of pelvic inflammatory disease, which is characterized in that it is by following heavy
The bulk pharmaceutical chemicals of amount part are made: 25-35 parts of viola mandshurica, 10-20 parts of sargentodoxa cuneata, 6-12 parts of radix bupleuri, prolongs recklessly at 10-20 parts of dandelion
8-12 parts of rope, 10-15 parts of paniculate swallowwort, 6-12 parts of Artemisia anomala, 6-12 parts of Fructus meliae toosendan, 6-12 parts of Fructus Aurantii, 10-15 parts of rhizoma cibotii, teasel root
10-15 parts.
2. Chinese medicine composition according to claim 1, which is characterized in that it is prepared from the following raw materials in parts by weight: purple
Flower Chinese violet 28-32 parts, 13-18 parts of dandelion, 13-18 parts of sargentodoxa cuneata, 8-10 parts of radix bupleuri, 9-11 parts of rhizoma corydalis, paniculate swallowwort 11-13
Part, 8-10 parts of Artemisia anomala, 8-10 parts of Fructus meliae toosendan, 8-10 parts of Fructus Aurantii, 11-13 parts of rhizoma cibotii, 11-13 parts of teasel root.
3. Chinese medicine composition according to claim 2, which is characterized in that it is prepared from the following raw materials in parts by weight: purple
Flower 30 parts of Chinese violet, 15 parts of dandelion, 15 parts of sargentodoxa cuneata, 9 parts of radix bupleuri, 10 parts of rhizoma corydalis, 12 parts of paniculate swallowwort, 9 parts of Artemisia anomala, melia toosendan
Sub 9 parts, 9 parts of Fructus Aurantii, 12 parts of rhizoma cibotii, 12 parts of teasel root.
4. Chinese medicine composition according to claim 1, which is characterized in that the dosage form of the Chinese medicine composition is capsule
Agent, granule, tablet or mixture.
5. the preparation method of Chinese medicine composition described in claim 1, which is characterized in that the preparation method includes following step
Rapid: parts by weight described in accordance with the claim 1 take each bulk pharmaceutical chemicals, and conventional method decocts after crushing.
6. any Chinese medicine composition of claim 1-4 is after preparation is alleviated or treats Accumulation of Dampness Heat and Blood Stasis type pelvic inflammatory disease
Lose the application in the drug of disease.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510675161.5A CN105250519B (en) | 2015-10-19 | 2015-10-19 | It is a kind of alleviate sequelae of pelvic inflammatory disease Chinese medicine composition and its application |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510675161.5A CN105250519B (en) | 2015-10-19 | 2015-10-19 | It is a kind of alleviate sequelae of pelvic inflammatory disease Chinese medicine composition and its application |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN105250519A CN105250519A (en) | 2016-01-20 |
| CN105250519B true CN105250519B (en) | 2019-09-03 |
Family
ID=55090649
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510675161.5A Expired - Fee Related CN105250519B (en) | 2015-10-19 | 2015-10-19 | It is a kind of alleviate sequelae of pelvic inflammatory disease Chinese medicine composition and its application |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN105250519B (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109893557B (en) * | 2019-03-29 | 2022-01-25 | 上海市浦东新区公利医院(第二军医大学附属公利医院) | Traditional Chinese medicine composition for treating sequelae of pelvic inflammatory disease |
| CN111905002B (en) * | 2020-08-29 | 2021-12-14 | 南京中医药大学 | Traditional Chinese medicine preparation for treating sequelae of pelvic inflammatory disease and preparation method and application thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101380434A (en) * | 2008-10-21 | 2009-03-11 | 沈阳药科大学 | Yisheng granules and preparation method thereof |
| CN101810737A (en) * | 2009-11-09 | 2010-08-25 | 景玲 | Chinese medicinal preparation for treating pelvic inflammation |
-
2015
- 2015-10-19 CN CN201510675161.5A patent/CN105250519B/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101380434A (en) * | 2008-10-21 | 2009-03-11 | 沈阳药科大学 | Yisheng granules and preparation method thereof |
| CN101810737A (en) * | 2009-11-09 | 2010-08-25 | 景玲 | Chinese medicinal preparation for treating pelvic inflammation |
Non-Patent Citations (1)
| Title |
|---|
| 南孙教授治疗慢性盆腔炎;陈瑞银等;《吉林中医药》;20130915;第33卷(第9期);第881页左边栏第4段-第882页右边栏第2段 |
Also Published As
| Publication number | Publication date |
|---|---|
| CN105250519A (en) | 2016-01-20 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN102370725A (en) | Traditional Chinese medicine compound preparation for treating chronic pelvic inflammation and preparation method thereof | |
| CN110478452A (en) | A kind of Chinese medicine composition and preparation method thereof for treating gout | |
| CN105250519B (en) | It is a kind of alleviate sequelae of pelvic inflammatory disease Chinese medicine composition and its application | |
| CN103736030A (en) | Traditional Chinese medicine compound formulation for treating dysmenorrhea as well as preparation method and use of formulation | |
| CN101069726A (en) | Chinese medicine preparation of expelling toxin by cooling and eliminating damp and removing stasis, preparing method and use | |
| CN102309651B (en) | New use of compound traditional Chinese medicine | |
| CN101019981B (en) | Chinese medicine preparation and its preparing process | |
| CN103705664B (en) | One treats psoriatic pharmaceutical composition and preparation method thereof | |
| CN102488825B (en) | Traditional Chinese medicine composition for treating beriberoid pyretic arthralgia and application of traditional Chinese medicine composition | |
| CN107007652B (en) | Application of new rehabilitation liquid combined with traditional Chinese medicine in preparation of medicine for treating infertility | |
| CN116637160B (en) | Spleen-invigorating kidney-tonifying dampness-eliminating pill and application thereof in treating spleen deficiency and damp-excess syndrome of sequelae of pelvic inflammatory disease | |
| CN101322771A (en) | Capsules for treating gynecology inflammation | |
| Li et al. | Overview of contraindicated Chinese medicines for pregnancy | |
| CN111905002B (en) | Traditional Chinese medicine preparation for treating sequelae of pelvic inflammatory disease and preparation method and application thereof | |
| CN107213426A (en) | Treat Chinese patent drug of mammary gland disease and preparation method thereof | |
| CN101601832A (en) | A kind of medicine for the treatment of chronic pelvic inflammatory disease and preparation method thereof | |
| CN115282249B (en) | Traditional Chinese medicine composition for treating leukorrhagia and preparation method thereof | |
| CN109045162B (en) | Traditional Chinese medicine composition for treating endometriosis and application thereof | |
| CN102091263B (en) | Application of Chinese medicine composition in preparation of medicament for treating overhigh level of urine cell factor or receptor thereof and Escherichia coli infection | |
| CN101181599A (en) | Chinese medicine composition for curing chronic pelvic inflammatory disease as well as application thereof | |
| CN105560668A (en) | Pharmaceutical composition for curing immune infertility | |
| CN105944033B (en) | Traditional Chinese medicine composition containing radix curcumae | |
| CN103623237B (en) | A kind ofly treat Chinese medicine preparation of deficiency-heat type metrorrhagia and preparation method thereof | |
| CN104398972A (en) | Traditional Chinese medicine treating qi-stagnation blood-stasis type hysteromyoma and preparation method | |
| CN100490884C (en) | Chinese medicine for treating urdithiasis and its preparation method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| CF01 | Termination of patent right due to non-payment of annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20190903 Termination date: 20201019 |