CN110354227A - Application containing soil material in the drug or health care product of preparation prevention and/or treatment immune system disorder disease - Google Patents
Application containing soil material in the drug or health care product of preparation prevention and/or treatment immune system disorder disease Download PDFInfo
- Publication number
- CN110354227A CN110354227A CN201910694668.3A CN201910694668A CN110354227A CN 110354227 A CN110354227 A CN 110354227A CN 201910694668 A CN201910694668 A CN 201910694668A CN 110354227 A CN110354227 A CN 110354227A
- Authority
- CN
- China
- Prior art keywords
- soil
- treatment
- mud
- disease
- stir
- 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.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/02—Medicinal preparations containing materials or reaction products thereof with undetermined constitution from inanimate materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/63—Arthropods
- A61K35/64—Insects, e.g. bees, wasps or fleas
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/284—Atractylodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/84—Valerianaceae (Valerian family), e.g. valerian
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/888—Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
- A61K36/8884—Arisaema, e.g. Jack in the pulpit
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/894—Dioscoreaceae (Yam family)
- A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
- A61K36/8994—Coix (Job's tears)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9062—Alpinia, e.g. red ginger or galangal
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Botany (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Biotechnology (AREA)
- Alternative & Traditional Medicine (AREA)
- Insects & Arthropods (AREA)
- Animal Husbandry (AREA)
- Zoology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Immunology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The present invention relates to the applications containing soil material in the drug or health care product of preparation prevention and/or treatment immune system disorder disease, the present invention is had found by lot of experiments, substance containing soil particle or single medicinal material containing soil or food can be improved the diversity of enteric microorganism and promote a variety of growth of probiotics, improve immunity of organisms；And have effects that prevent and/or treat immunity disease, it is highly-safe.
Description
Technical field
The present invention relates to the new applications containing soil material, and in particular to exempts from containing soil material in preparation prevention and/or treatment
The drug of epidemic disease system disorders disease or the application in health care product.
Background technique
In recent years, the disease incidence of anaphylactia increases year by year, such as infantile eczema disease incidence Tianjin Dagang District women and children
Health care institute shows that disease incidence is 75.6% to neonatal investigation in 2007；The investigation of one hospital, Chongqing City in 2013
It as a result is 64.8%；The investigation 42 age in days childhood eczema disease incidence of discovery of Beijing's outpatient service in 2011 are up to 57.3%.At present
There are about 300,000,000 asthmatic patients in the whole world, wherein every year there are about 1,005 million peoples because of the disease and disability, China it is current oneself
There is 20,000,000 asthmatic patient.The disease incidence of China big city resident's allergic rhinitis has had increased to 10-19%.Other mistakes
The disease incidence of quick property disease (such as allergic dermatitis, food irritability) also increases year by year.Therefore, heavy warp is brought to society
Ji is born and causes huge economic loss, and serious public health problem is had become.
The treatment of anaphylactia mainly uses Loratadine and hormone medicine, and Loratadine such as flutters you
Quick, Astemizole, quick gram, Clarityne etc..Antihistamine drug has side effect, and long-time service can make one drowsiness, tired, mental slow
It is blunt.Hormone medicine such as mainly has cortex hormone of aadrenaline, such as prednisone, dexamethasone and cyclophosphamide, imuran
Deng, conventional Hormone can the internals such as serious liver injury, kidney, also will affect the growth and development of children.
Summary of the invention
Goal of the invention: the purpose of the present invention is by many experiments screen, further investigation mineral containing soil particle, Chinese medicine or
The effect of food, develops its new clinical efficacy.
In order to solve the above technical problems, the technical solution adopted by the present invention is that:
Containing soil material answering in the drug or health care product of preparation prevention and/or treatment immune system disorder disease
With.
Immunity of organisms is improved, the diversity of enteric microorganism is improved and promotes a variety of probiotics in preparation containing soil material
The drug of growth or the application in health care product.
Preferably, the above-described soil material that contains includes: that soil stir-fries and eats product, soil fries Chinese medicine, Dong Bitu, forging stove ash, Hu
Golden-rumped swallow nest mud, scoliid nest, dung beetle turn ball, ant little molehill soil, termite mud, earthworm mud, Liang Shangchen, black father's mud, sun-dried mud brick, black ancient tile, ancient brick, cigarette
Glue, door-hinge pit dirt, Tian Zhongni, eaves slide down mud, manure pit bed mud, urine hole mud, dog urine mud, white eel mud, sun soil, thousand step peaks, burn corpse field
Upper soil, spiral shell mud, casserole or old wall soil.
Preferably, above-described application, the soil stir-fries and eats product or soil fry Chinese medicine include: native stir-fried kidney beans, soil fry it is grey
Art, soil fry Patrinia scaniosaefolia, soil fries Southern Star, soil fries galanga, stir-baked RHIZOMA ATRACTYLODIS MACROCEPHALAE with soil, native stir-baked RADIX PAEONIAE ALBA, stir-baked RHIZOMA DIOSCOREAE with soil, stir-baked RADIX ANGELICAE SINENSIS with soil, soil fry semen coicis.
Preferably, above-described application, the immune system disorder disease includes allergic dermatitis, anaphylaxis
Enteropathy, allergic rhinitis, allergic asthma, anaphylactoid purpura, anaphylactic shock, rheumatoid arthritis, Combination connective group
Knit disease, systemic loupus erythematosus, polymyositis, chorionitis, IgA positive ephritis, ankylosing spondylitis, Sjogren syndrome, white
It is purplish or white patches on the skin wind, linear moss, rheumatic arthritis, interstitial cystitis, interstitial pneumonia, primary trigeminal neuralgia, multiple hard
Change disease, alopecia areata, psoriasis.
Preferably, above-described application, the allergic dermatitis includes drug rash, contact dermatitis, eczema, nettle
Rash, dermographism, food hypersenstivity and environmental factor cause allergy dermatitis；Irritable bowel disorder includes allergic colitis, ulcer
Property colitis and Crohn disease.
Preferably, above-described application, will contain soil material and pharmaceutically acceptable carrier is prepared into oral system
Agent or external preparation.
Preferably, above-described application, increases the type and quantity of actinomyces door bacterium containing soil material in preparation
Drug or health care product in application.
Preferably, above-described application, which is characterized in that reduce antibiotic for enteron aisle in preparation containing soil material
The influence of Tiny ecosystem promotes the application in the drug or health care product that restore balance as early as possible after the used antibiotic of intestinal microecology.
As an improvement of the present invention, mineral containing soil particle provided by the invention, Chinese medicine or food can individually take
With and can also mixing and take without antergic Chinese medicine or Western medicine with any food and integration of drinking and medicinal herbs food.
The present invention compared with the prior art, has the advantage that as follows:
1) oxide provided by the invention contained containing soil material and a variety of inorganic ions have and adjust intestinal microecology
Structure and anabolic action；A variety of probiotics play trophism in contained oxide and the micro- state of inorganic ion-pair enteron aisle.
2) provided by the invention pass through containing soil material adjusts intestinal microecology, and having further stimulates panimmunity cell to send out
The effect educated；Required nutrients of many oxide and ion contained containing soil material as a variety of probiotics is supported prebiotic
The growth of bacterium, probiotics can further stimulate the development of immunocyte, further maintain immunologic balance, reach prevention and treatment
The effect of anaphylactia.
Specific embodiment
The preferred embodiments of the present invention will be described in detail below so that advantages and features of the invention can be easier to by
It will be appreciated by those skilled in the art that so as to make a clearer definition of the protection scope of the present invention.
1 Hu golden-rumped swallow nest mud of embodiment treats allergic asthma and merges allergic rhinitis
(1) prepared by preparation: Hu golden-rumped swallow nest mud being crushed, high pressure sterilization is spare.Auxiliary material is high-quality dry pearling cone meal and wheat flour, Hu
Golden-rumped swallow nest mud powder, pearling cone meal and wheat flour mixed proportion are Hu golden-rumped swallow nest mud powder: pearling cone meal: wheat flour is 6:3:1 (mass ratio), is made
Capsule makes rear spare 0.5-0.55 grams of drug containing in each capsule.
(2) allergic asthma merges allergic rhinitis subject selection: 30 sensitive asthmatics merge Allergic Rhinitis with
Machine is divided into treatment group and control group.Treatment group 15, male 8 are female 7, the age 5~51 years old, 22.1 ± 8.3 years old average.The course of disease
0.5~10 year, average (5 ± 3.5) year；Control group 15, male 8, female 7, the age 5~50 years old, average (23.2 ± 7.5)
Year；The course of disease 0.5~11 year, average (6 ± 4.5) year.Two groups of subject Genders, age, course of disease no difference of science of statistics.Selected disease
Example meets allergic asthma and allergia nose's inflammation diagnostic criteria (allergic asthma diagnostic criteria: is breathed with reference to Chinese Medical Association
" prevention and control of bronchial asthma guide (2008) " that sick credit meeting asthma group is formulated).
(3) treatment method: step (1) Hu golden-rumped swallow nest mud capsule is taken by treatment group, 3 times a day, 12 tablets/time of dosage, can be with food
Object, which is mixed, to be taken.Therapeutic effect evaluation and test is carried out after medication 3 months.Control group uses same dose mass ratio for the big of 3:1
It is identical as Hu golden-rumped swallow nest mud preparation that placebo, instructions of taking and dosage is made in flour and wheat flour.High-flux sequence instrument is used simultaneously
Carry out the detection of enteric microorganism variation.
(4) treatment effectiveness evaluation: after treatment 3 months, therapeutic effect is observed.
1. Asthma control standards of grading: it is 25 points that asthma, which fully controls scoring, and it is 20~24 points that Asthma control, which well scores,
It is that < 20 divides that asthma, which does not control scoring,.
2. Rhinitis Symptoms standards of grading: A. is commented referring to the allergic rhinitis in " allergic rhinitis processing is pocket to refer to 2009 "
The symptom of minute mark quasi- evaluation patient.Pretherapy and post-treatment Rhinitis Symptoms scoring is completed by the same veteran doctor.
B.RQLQ marking scales: it scores before and after treatment.
3. serum total Ig E detects: limosis vein blood, kit detect IgE content.
4. allergic rhinitis index of assessment of curative effect: improvement rate is by [(total score after total score-treatment before treating)/treatment is preceding total
Point] * 100% calculating, wherein Xian Xiao≤51%；,≤21% of You Xiao≤50%；Wu Xiao≤20%.
5. total effective rate: effectively: asthma scoring is 25 points, meanwhile, allergic rhinitis therapeutic evaluation Zhi Biao≤51%；It is good
Turn: asthma scoring is 20~24 points, while allergic rhinitis therapeutic evaluation Zhi ,≤21% of Biao≤50%；It is invalid: asthma < 20
Point, while allergic rhinitis therapeutic evaluation Zhi Biao≤20%.
(5) result: the data of acquisition are for statistical analysis using 18.0 software of SPSS.The results show that humus flava usta capsule system
The effective percentage of agent treatment is significantly higher than control (16.67%), the results are shown in Table 1 and table 2 up to 96.67%.
(6) variation of enteric microorganism: high-flux sequence instrument sequencing analysis 16s rRNA is used, as the result is shown treatment group's intestines
The diversity of road microorganism dramatically increases (P ﹤ 0.01), and random forest (Random Forests) is analysis shows that (table 3), actinomyces
Door bacterial species and quantity dramatically increase (P ﹤ 0.01).
1. pretherapy and post-treatment two groups of patient view's Indexes Comparisons of table (point,)
2. two groups of patients of table treat total effect and compare (example)
| Group | Number of cases | Effectively | It improves | In vain | Total effective rate |
| Treatment group | 15 | 13 | 1 | 1 | 93.3% |
| Control group | 15 | 2 | 1 | 12 | 20.0% |
| P value | <0.001 |
Note: through Chi-square Test: df=1, X2=16.425, P < 0.001.It is thin that 3. random forest of table analyzes treatment group's enteron aisle
The type that bacterial content dramatically increases
The research of 2 scoliid nest of embodiment treatment eczema
(1) prepared by preparation: scoliid nest being crushed, high pressure sterilization is spare.Auxiliary material is high-quality dry corn flour and wheat bran, scoliid nest
Traditional Chinese medicine powder, corn flour and wheat bran mixed proportion are scoliid nest powder: corn flour: wheatfeed is 2:1:1 (mass ratio), and piece is made in tabletting
Agent, each tablet weight are 0.5 gram, are made rear spare.
(2) adult eczema subject selection: 40 patients are randomly divided into treatment group and control group.Treatment group 20, male 10,
Female 10, the age 14~60 years old, average (40.1 ± 10.1) year.The course of disease 1~20 year, average (5.5 ± 4.4) year；Control group 20
Example, male 10, female 10, the age 13~60 years old, average (40.9 ± 8.8) year；The course of disease 1~20 year, average (5.2 ± 4.9)
Year.Two groups of subject Genders, age, course of disease no difference of science of statistics.Selected case meets eczema diagnostic criteria.
(3) treatment method: treatment group's above-mentioned scoliid nest tablet orally three times a day, 3 times a day, 6 tablets once.With identical dose
Amount mass ratio is that placebo is made in the corn flour of 1:1 and wheatfeed, and instructions of taking is identical as scoliid nest preparation.After medication 3 months
Carry out therapeutic effect evaluation and test.
(4) treatment effectiveness evaluation: after treatment 3 months, 1 month after drug withdrawal, therapeutic effect is observed.Criterion of therapeutical effect is cured: skin
Rash all subsides, and pruritis disappears；Effective: 80% or more deflorescence, pruritis is substantially reduced；Improve: skin subsides
50%, pruritis does not mitigate；Invalid: deflorescence is unobvious, and pruritis does not mitigate or in vain.With healing, effective case
Number is total to calculate effective percentage.
(5) result: treated effect as the result is shown is shown in Table 4.According to statistical analysis, treatment group and the clinical of control group are treated
There were significant differences (P < 0.001) for effect.It has no adverse reaction.
(6) enteric microorganism changes: using high-flux sequence instrument sequencing analysis 16s rRNA, as the result is shown treatment group's enteron aisle
The diversity of microorganism dramatically increases (P ﹤ 0.01), and random forest (Random Forests) is analysis shows that (table 5), actinomyces door
Bacterial species and quantity dramatically increase (P ﹤ 0.01).
4 two groups of patients of table treat total effect and compare (example)
| Group | N | It cures | It is effective | It improves | In vain | Effective number of cases | It is efficient |
| Treatment group | 20 | 16 | 1 | 1 | 1 | 18 | 90.0% |
| Control group | 20 | 2 | 1 | 0 | 17 | 3 | 15.0% |
| P value | P < 0.001 |
Note: through Chi-square Test: df=1, X2=22.556, P < 0.001.
The type that 5 random forest of table analysis treatment group enteric bacteria content dramatically increases
The research of 3 ant little molehill soil prevention and treatment IgA positive ephritis of embodiment
(1) prepared by preparation: ant little molehill soil being crushed, high pressure sterilization is spare.Auxiliary material is high-quality dry corn flour and wheat bran, ant little molehill soil
Powder, corn flour and wheat bran mixed proportion are ant little molehill soil powder: corn flour: wheatfeed is 2:1:1 (mass ratio), and tablet is made in tabletting,
Each tablet weight is 0.5-0.55 grams, is made rear spare.
(2) IgA ephritis Western medicine diagnostic criteria: according to national higher education national planning teaching material " clinical practice " and " ear nose pharynx
Larynx section common disease diagnostic criteria ":
1. pathology of the renal biopsies diagnosis meets Ig A nephrosis；2. antiadoncus, congestion and edema is simultaneously shown in pharynx rear wall lymph follicle
Hyperplasia or crypts opening can have purulent secretion or cheesy secretion, and secretion is excessive when extruding or lateral pharyngeal band, soft palate are red
Swell or be dispersed in pus point or submandibular lymph nodes enlargement；3. with albuminuria, blood urine；4. fever is not hot, blood picture such as white blood cell count(WBC) increases
Height or c reactive protein increase；5. eyelid or edema of pair of lower extremities, or accumulation whole body；6. it is checked according to clinical manifestation and laboratory,
Exclude secondary ephritis etc..When diagnosis, wherein 1. 2. 3. 6. item be diagnosis necessary condition, companion or not with 4. 5..
(4) subject selection, totally 50, random to be grouped, treatment group 25, male 12, female 13, the age 38.23 ± 10.85
Year, the course of disease 19.33 ± 8.24 months；Control group 25, male 11, female 14, the age 36.23 ± 9.82 years old, the course of disease 18.63 ±
10.33 months.Statistical analysis, P > are carried out to general information such as the age of two groups of patients, the course of disease, gender, Oxford pathologicals
0.05, two groups of patient's general information no difference of science of statistics are prompted, are comparable.To every observation index before two groups of patient's treatments
Statistical analysis is carried out, P > 0.05 prompts no difference of science of statistics, and two groups of data are comparable.
(5) treatment method: treatment group takes orally ant little molehill soil preparation 2 times of step (1) daily, each taking 10g.Control group with
The corn flour and wheatfeed of 1:1 is placebo, the same treatment group of taking dose (2 times a day, each taking 10g).After taking 2 months
Observe therapeutic effect.
(6) therapeutic effect compares
TCM syndrome Quantitative marking therapeutic evaluation
1. symptom disappears after clinical recovery treatment, i.e., tcm symptom Quantitative marking is 0 point；
2. symptom degree classification drop two-stage after effective treatment has severe to slightly, performance primary symptom scoring is from 6 points → 2 points
Or minor symptom scoring is from 3 points → 1 point；
3. symptom degree classification drop level-one effectively after treatment, that is, have severe to moderate, or shows primary symptom to slightly by moderate
Scoring is from 6 points → 4 points, 4 points → 2 points or minor symptom scoring from 3 points → 2 points, 2 points → 1 point；
4. unchanged before and after futile treatment
(7) treatment results are analyzed: the therapeutic effect of two groups of patients compares, and difference has statistical significance (P < 0.001), controls
The treated effect for the treatment of group is significantly higher than control group.See Table 6 for details.
(8) enteric microorganism changes: using high-flux sequence instrument sequencing analysis 16s rRNA, as the result is shown treatment group's enteron aisle
The diversity of microorganism dramatically increases (P ﹤ 0.01), and random forest (Random Forests) is analysis shows that (table 7), actinomyces door
Bacterial species and quantity dramatically increase (P ﹤ 0.01).
6 two groups of therapeutic effects of table compare
| Group | Number of cases | It is effective | Effectively | In vain | Total effective rate |
| Control group | 25 | 7 | 2 | 16 | 36% |
| Treatment group | 25 | 14 | 9 | 2 | 92% |
Note: χ2=17.014, df=1, p < 0.001..
The type that 7 random forest of table analysis treatment group enteric bacteria content dramatically increases
The research of 4 earthworm mud prevention and treatment rheumatoid arthritis pain of embodiment
(1) prepared by preparation: earthworm mud being crushed, high pressure sterilization is spare.Auxiliary material is high-quality dry wheat flour and soy meal, earthworm
Mud powder, wheat flour and soy meal mixed proportion are earthworm mud powder: wheat flour: soy meal is 2:1:0.5 (mass ratio), and tabletting is made
Tablet, each tablet weight are 0.5-0.55 grams, are made rear spare.
(2) rheumatoid arthritis pain diagnostic criteria: referring to the new classification diagnosis mark of the revision of ACR/EULAR in 2010
Standard, research object meet classification standard, can be included in.
(3) active stage diagnostic criteria
The RA disease activity scores system DAS28 standard recommended using EULAR.Specific formula for calculation are as follows: DAS28 (3)
=[0.56 × sqrt (t28)+0.28 × sqrt (sw28)+0.70Ln (ESR)] × 1.08+0.16
Note: sqrt: sqrt；Ln: natural logrithm is taken；Tender joint number in t28:28 joint；Sw28:28
Swollen joint number in joint；ESR: erythrocyte sedimentation rate；
Referring to DAS28 scoring classification standard:
DAS28 value > 5.1 indicates disease high activity；5.1 >=DAS28 value >=3.2 indicate disease moderate activity；3.2 >
DAS28 value >=2.6 indicate that disease activity is low；DAS28 value < 2.6 indicates remission.
DAS28 scoring >=2.6 can be diagnosed as active stage RA.
(4) disease activity curative effect determinate standard
Referring to the RA Disease Activity DAS28 standards of grading that EULAR recommends, the DAS28 integral of pretherapy and post-treatment patient is calculated
Value situation of change assesses state of an illness improvement, is as a result divided into effective, effective and invalid:
1) effective: DAS28 reduces > 1.2；
2) effectively: DAS28 reduces by 0.6 DAS28≤1.2 <；
3) invalid: DAS28 reduces≤0.6.
(5) subject selection: in 25 treatment groups, 6 male patients, 19 female patients；Age is 19 years old minimum, maximum 62
It is year, 49.77 ± 10.23 years old average；Average course of disease 3.9 ± 2.88 years.In 25 control groups, 9 male patients, 16 women
Patient；Age minimum 18, it is 60 years old maximum, it is 47.32 ± 10.11 years old average；Average course of disease 3.76 ± 1.83 years.Two groups sexual
Not, through examining, difference does not have statistical significance (P > 0.05) for age, the course of disease.
(6) treatment method: treatment group takes orally clay dose of earthworm 3 times of step (1) daily, each taking 8g；With identical dose
Amount mass ratio is that placebo is made in the wheat flour of 1:0.5 and soy meal, and instructions of taking is identical as clay dose of earthworm.After taking January
Observe curative effect.
(7) therapeutic effect compares
The therapeutic effect of two groups of patients compares, and difference has statistical significance (P < 0.05), the treated effect for the treatment of group
It is significantly higher than control group.See Table 8 for details and table 9.
(8) enteric microorganism changes: using high-flux sequence instrument sequencing analysis 16s rRNA, as the result is shown treatment group's enteron aisle
The diversity of microorganism dramatically increases (P ﹤ 0.01), and random forest (Random Forests) is analysis shows that (table 10), actinomyces
Door bacterial species and quantity dramatically increase (P ﹤ 0.01).
8 curative effect of disease Indexes Comparison of table
9 two groups of rheumatoid arthritis pain patient outcomes of table compare
| Group | Number of cases | It is effective | Effectively | In vain | Total effective rate |
| Control group | 25 | 3 | 2 | 20 | 20% |
| Treatment group | 25 | 18 | 3 | 4 | 84% |
Note: χ2=20.513, df=1, p < 0.001.
The type that 10 random forest of table analysis treatment group enteric bacteria content dramatically increases
The research of 5 Liang Shangchen prevention and treatment primary Sjogren's syndrome of embodiment
(1) prepared by preparation: dirt powder on beam is broken, and high pressure sterilization is spare.Auxiliary material is high-quality dry wheat bran, dirt powder and wheat bran on beam
Mixed proportion is dirt powder on beam: wheatfeed is 2:1 (mass ratio), and tablet is made in tabletting, and each tablet weight is 0.5-055 grams,
It makes rear spare.
(2) subject selection: primary Sjogren's syndrome is diagnosed as simultaneously with the adult patients of hyper immunoglobulinemia
50, the course of disease 8-50 month, wherein women 45, male 5, average age be (42.8 ± 11.3) year.All patients meet
The Sjogren syndrome international classification standard that European wind resistance diseases caused by dampness alliance in 2002 establishes.
(3) clinical evaluation index collection
A. exocrine glandular function: patient's eyes Schirmer test and saliva flow rate detection；
B.ESSDAI scoring: the Sjogren syndrome condition assessment index that European wind resistance diseases caused by dampness alliance (EULAR) formulates
(ESSDAI) scoring is used as objective evaluation index, which is completed by specialist；
C.ESSPRI scoring: European wind resistance diseases caused by dampness alliance patient index (ESSPRI) scoring refers to as patient's subjective evaluation
Mark, the scoring are completed by patient；
D. serological index: acquisition patient's leucocyte, serum I g, blood platelet, erythrocyte sedimentation rate, c reactive protein, complement, class on an empty stomach
The clinical indices data such as the rheumatism factor, glutamic-pyruvic transaminase, glutamic-oxalacetic transaminease
(4) treatment method: treatment group takes orally Liang Shangchen tablet 3 times of step (1) daily, each taking 8g；Control group with
Wheat bran is placebo, taking dose and the same treatment group of method.Curative effect is observed after taking 2 months.
(5) research object is periodically distinguished before administration (O weeks), pays a return visit after 4 weeks after administration, tests its relevant index variation
Situation, the sign of disease, have have no adverse reaction, the situation of change of clinical symptom remission degree etc..Above-mentioned clinic is commented in this research
Whole improvement situation < 30% are invalid before the relatively treatment such as valence index, and improving situation >=30% is effective, improvement situation >=50%
It is significant effective.
(6) therapeutic effect compares: the therapeutic effect of two groups of patients compares, and difference has statistical significance (P < 0.05), controls
The treated effect for the treatment of group is significantly higher than control group.See Table 1 for details 1 and table 12.
(7) enteric microorganism changes: using high-flux sequence instrument sequencing analysis 16s rRNA, as the result is shown treatment group's enteron aisle
The diversity of microorganism dramatically increases (P ﹤ 0.01), and random forest (Random Forests) is analysis shows that (table 13), actinomyces
Door bacterial species and quantity dramatically increase (P ﹤ 0.01).
11 two groups of patient ESSDAI scorings of table and ESSPRI scoring variation are compared
12 two groups of patient outcomes of table compare
| Group | Number of cases | It is effective | Effectively | In vain | Total effective rate |
| Control group | 25 | 1 | 4 | 20 | 20% |
| Treatment group | 25 | 13 | 9 | 3 | 88% |
Note: χ2=23.269, df=1, p < 0.001.
The type that 13 random forest of table analysis treatment group enteric bacteria content dramatically increases
The research of 6 door-hinge pit dirt prevention and treatment leucoderma of embodiment
(1) prepared by preparation: door-hinge pit dirt powder is broken, and high pressure sterilization is spare.Auxiliary material is high-quality dry corn flour, door-hinge pit dirt powder and jade
Rice flour mixed proportion is door-hinge pit dirt powder: corn flour 2:1 (mass ratio), and tablet is made in tabletting, and each tablet weight is 0.5-055
Gram, it makes rear spare.
(2) subject selection: subject selection, totally 50, random to be grouped, treatment group 25, male 11, female 14, the age 32.56
± 10.13 years old, the course of disease 24.11 ± 10.83 months；Control group 25, male 13, female 12, the age 33.52 ± 10.88 years old, the course of disease
23.83 ± 10.33 months.Statistics credit is carried out to general information such as the age of two groups of patients, the course of disease, gender, Oxford pathologicals
Analysis, P > 0.05 prompt two groups of patient's general information no difference of science of statistics, are comparable.It is seen to every before two groups of patient's treatments
It examines index and carries out statistical analysis, P > 0.05 prompts no difference of science of statistics, and two groups of data are comparable.
(3) Western medicine diagnostic criteria
According to " Chinese Association of Chinese and Western Medicine Dermatology Professional Committee pigment disease group, chloasma and leucoderma
Diagnosis and treatment standard " (version in 2010) formulation.
1) the different decolourising property hickie of size and shape, ambient color is normal or has pigment increase；
2) skin lesion is apt to occur in face, neck, the back of the hand and trunk；Accent mucous membrane and surrounding skin；Also it is common in trauma site；
The hair at hickie position generally also bleaches；
3) depigmentation macule, piebaldism, idiopathic depigmentation macule, pityriasis alba, amelanotic nevus and poor after inflammation are excluded
The skin diseases such as vascular nevus；
4) brilliant white fluorescent is seen in Wood Deng Xia hickie area.
(4) leucoderma area Scoring Index (Vitiligo area scoring index, VASI): referring to " Chinese Chinese and Western
Doctor combines association's Dermatology Professional Committee pigment disease group, chloasma and leucoderma diagnosis and treatment standard " (version in 2010) draft.
It uses rule of Nine: body surface area 1% is accounted for as standard with palm area.Body is divided into 6 positions: neck surface, hand,
Upper limb, trunk, lower limb, foot.For each above-mentioned position, hickie in the palm units and skin lesion of each skin lesion area is estimated
Percentage shared by area, white spot area percentage presses 7 grade classifications in skin lesion, it may be assumed that
(1) 0%: non-pigment depigmentation
(2) 10%: only dotted depigmentation
(3) 25%: the non-depigmentation area of pigment is more than depigmentation area
(4) 50%: depigmentation area is equal to non-depigmentation area
(5) 75%: depigmentation area is more than non-depigmentation area
(6) 90%: the dotted pigment of remaining
(7) 100%: non-pigment
Leucoderma area Scoring Index (VASI)=∑ (the palm units of each skin lesion area) × region pigment is de-
It becomes homeless the percentage accounted for
(5) treatment method: treatment group takes orally door-hinge pit dirt preparation 3 times of step (1) daily, each taking 10g.Control group with
Corn flour is placebo, the same treatment group of taking dose (3 times a day, each taking 10g).Therapeutic effect is observed after taking June.
(6) evaluation of clinical curative effect standard
Referring to " Chinese Association of Chinese and Western Medicine Dermatology Professional Committee pigment disease group, chloasma are examined with leucoderma
Treatment standard " (version in 2010) draft, it regard pretherapy and post-treatment leucoderma area Scoring Index (VASI) variation as main indicator,
Carry out efficacy determination.
Recovery from illness: hickie all subsides, and restores normal skin tone；
Effective: hickie partial remission or diminution restore the 50% of the area > original skin lesion area of normal skin tone；
Effective: hickie partial remission or diminution, 50% > of former skin lesion area restore the area > original skin lesion of normal skin tone
The 10% of area；
It is invalid: hickie it is unchanged or expand, or restore normal skin tone area < original skin lesion area 10%.
Efficient=(recovery from illness number of cases+effective number of cases+effective number of cases) total case load × 100% of/this group
(7) treatment results are analyzed: the therapeutic effect of two groups of patients compares, and difference has statistical significance (P < 0.001), controls
The treated effect for the treatment of group is significantly higher than control group.See Table 1 for details 4 and table 15.
(8) enteric microorganism changes: using high-flux sequence instrument sequencing analysis 16s rRNA, as the result is shown treatment group's enteron aisle
The diversity of microorganism dramatically increases (P ﹤ 0.01), and random forest (Random Forests) is analysis shows that (table 16), actinomyces
Door bacterial species and quantity dramatically increase (P ﹤ 0.01)
14 two groups of patient's VASI index tables of table
| Group | Number of cases | Before treatment | After treatment | It compares before and after treatment |
| Treatment group | 25 | 2.87±1.33 | 0.82±0.64 | p<0.001 |
| Control group | 25 | 2.35±1.22 | 2.39±1.33 | P=0.912 |
| Two groups are compared | P=0.156 | p<0.001 |
15 two groups of Clinical efficacy comparisons of table
| Group | Number of cases | It cures | It is effective | Effectively | In vain | It is efficient |
| Control group | 25 | 1 | 1 | 3 | 20 | 20.0% |
| Treatment group | 25 | 12 | 8 | 3 | 2 | 92.0% |
Note: χ2=26.299, df=1, p < 0.001.
The type that 16 random forest of table analysis treatment group enteric bacteria content dramatically increases
The research of 7 Tanaka's mud prevention and treatment rheumatic arthritis of embodiment
(1) prepared by preparation: Tanaka's mud being crushed, high pressure sterilization is spare.Auxiliary material is high-quality dry wheat flour, Tanaka's mud powder and small
Flour mixed proportion is Tanaka's mud powder: wheat flour is 2:1 (mass ratio), and tablet is made in tabletting, and each tablet weight is 0.5-
It 0.55 gram, makes rear spare.
(2) subject selection: it is academic to meet national combination of Chinese tradiational and Western medicine rheumatism for selection rheumatoid arthritis patients 50
The rheumatism joint inflammation diagnostic criteria of meeting revision, tcm diagnosis is referring to Standards for Diagnosis and Curative Effect of Chinese Medical Symptom.Patient age 18
~66 years old, other drugs treatment was not used at nearly 2 weeks.It excludes serious former with cardiovascular and cerebrovascular, liver, kidney and hemopoietic system etc.
Hair property disease patient, and exclude with the poor person that is unable to partner treatment of mental disease and compliance.Patient is according to table of random number
Method is divided into 2 groups: treatment group 25, male 15, female 10；Year at age 20~65 (42.3 ± 5.6).Control group 25, male 14
Example, female 11；Year at age 19~65 (41.1 ± 4.3).Two groups of genders, age and indices comparing difference are not statistically significant
(P > 0.05)
(3) treatment method: treatment group takes orally clay dose of Tanaka 2 times of step (1) daily, each taking 12g.Control group with
Wheat flour is placebo, the same treatment group of taking dose (2 times a day, each taking 12g).Therapeutic effect is observed after taking 2 months.
(4) observation index
1. comprehensive therapeutic effect: being drafted referring to " new Chinese medicine guideline of clinical investigations ".
Cure: patient's affected joints pain symptom all disappears, and joint function recovery is normal, and erythrocyte sedimentation rate is normal, resists " O " high person
Drop to normal level；
It is effective: patient's affected joints pain symptom be improved significantly, erythrocyte sedimentation rate is normal, and anti-" O " Gao Zhejun drops to normally
It is horizontal；
Improve: patient's affected joints pain symptom is alleviated, and laboratory testing index of correlation obtains part improvement；
Invalid: patient clinical symptom sign is without any improvement, and the state of an illness even deteriorates.
It is effectively total effective for curing+effective+.
2. Clinical symptom and sign improves situation: referring to standard related in " new Chinese medicine guideline of clinical investigations ", statistics
Analyze two groups of pretherapy and post-treatment articular pain numbers, arthroncus number and TCM syndrome integral.
3. blood biochemistry index: two groups of erythrocyte sedimentation rate (ESR)s (ESR) of detection, c reactive protein (CRP) and anti-hammer before and after treatment
Rhzomorph O (ASO) is horizontal.
4. drug safety: a situation arises for adverse reaction during two groups of treatments of statistics.
(5) treatment results are analyzed: the therapeutic effect of two groups of patients compares, and difference has statistical significance (P < 0.001), controls
The treated effect for the treatment of group is significantly higher than control group.See Table 1 for details 7 to 19.
(6) enteric microorganism changes: using high-flux sequence instrument sequencing analysis 16s rRNA, as the result is shown treatment group's enteron aisle
The diversity of microorganism dramatically increases (P ﹤ 0.01), and random forest (Random Forests) is analysis shows that (table 20), actinomyces
Door bacterial species and quantity dramatically increase (P ﹤ 0.01)
17 two groups of table pretherapy and post-treatment Clinical symptom and sign situations of change compare
18 two groups of table pretherapy and post-treatment blood parameters levels compare
Comprehensive therapeutic effect compares after 19 two groups of treatments of table
| Group | Number of cases | It cures | It is effective | Effectively | In vain | Total effective rate |
| Control group | 25 | 1 | 2 | 1 | 21 | 16% |
| Treatment group | 25 | 9 | 11 | 2 | 3 | 88% |
Note: χ2=25.962, df=1, p < 0.001.
The type that 20 random forest of table analysis treatment group enteric bacteria content dramatically increases
8 eaves of embodiment slides down the research of mud prevention and treatment interstitial cystitis
(1) prepared by preparation: eaves being slid down mud and is crushed, high pressure sterilization is spare.Auxiliary material is high-quality dry corn flour, and eaves slides down mud powder
Be that eaves slides down mud powder with corn flour mixed proportion: corn flour is 2:1 (mass ratio), and tablet is made in tabletting, and each tablet weight is
It 0.5-0.55 grams, makes rear spare.
(2) interstitial cystitis research object: selecting 50 patients as experimental subjects, and age range is 23~81 years old,
Average age 48.3 ± 13.9 years old, wherein male patient 20, female patients 30.Patient's course of disease 10~70 months, course of disease area
Between 31.1 ± 10.7 months.Wherein first visit 13, further consultation 37.
Patient meets Canadian Urology Surgery association (CUA) diagnostic criteria in 2016.It is included in standard: 1) medical history 6 week or more,
Without urinary tract infections, the discovery without exception of ultrasonic kidney, ureter, bladder；2) there are frequent micturition, lower abdomen discomfort or distending pain, urination when suppressing urine
Lower abdomen is uncomfortable afterwards or distending pain alleviates symptom；3) after anaesthetizing, under 80cmH2O (1cm H2O=0.098kPa) pressure, bladder persistently expands
After opening 5min, cystoscope finds Hunner ulcer or diffusivity mucous membrane of urinary bladder bleeding, it may be assumed that 10 and the above bleeding occurs in every visual field
Point, and have 3 visuals field or more.
Exclusion criteria: 1) patient's maximum bladder function capacity > 350ml under waking state；2) 150ml liquid filling bladder
When without urgency urinate feel；3) 6 weeks symptom duration <；4) using remission after antibiotic or antispasmodic；5) daily
Awake frequent micturition number on situation lower daytime < 8 times, enuresis nocturna < 2 times.6) occur together urethra or vagina infection, bacterial cystitis, tuberculosis
Property cystitis, radiocystitis, chemical cystitis, inflammatory pelvic disease, endometriosis, sexually transmitted disease,
Stone in urinary system, tumor of bladder etc..
(3) research contents: 1. age, gender, the course of disease, medical cardinal symptom etc.；2. urinate diary (Urinary
Diary)；3. O ' Leary Sant grade form, including symptom index (ICSI) and problem index (ICPI) two parts；4. pelvic cavity aches
Pain and frequent micturition/symptoms of urgency grade form (PUF)；5. visual analogue scale (Visual Analogue Scale/Score, VAS)；
6. Athens insomnia scale (Athens insomnia scale, AIS)；7. Analysisof Self-rating Anxiety Scale (Self-ratingAnxiety
Scale, SAS), depression self-rating scale (Self-rating Depression scale, SDS).All IC/ before record is treated
Follow-up situation when March, June after BPS patient's initial situation and treatment, all questionnaires (except urination diary) are on the scene by investigator
It fills in and withdraws, urination is withdrawn after diary 2~3 days.
(3) treatment method: the eaves that treatment group takes orally step (1) slides down clay dose, and 2 times a day, dosage 10g/ times can be with food
Object, which is mixed, to be taken.Therapeutic effect evaluation and test is carried out after medication 1 month.Therapeutic evaluation is carried out after taking three months.
(4) treatment effectiveness evaluation: the data of acquisition are for statistical analysis using 18.0 software of SPSS.With IC symptom score
Decline > 5 divides or > 25% is effective.
(5) result: according to statistical analysis, there were significant differences before and after treatment for treatment group (P ﹤ 0.001).It has no adverse reaction.Such as
Table 21 and table 22.
(6) enteric microorganism changes: using high-flux sequence instrument sequencing analysis 16s rRNA, as the result is shown treatment group's enteron aisle
The diversity of microorganism dramatically increases (P ﹤ 0.01), and random forest (Random Forests) is analysis shows that (table 23), actinomyces
Door bacterial species and quantity dramatically increase (P ﹤ 0.01).
The pretherapy and post-treatment patient of table 21. for 24 hours compare by number of micturitions, ICSI, ICPI, PUF, VAS scoring
| Time | N | Number of micturitions for 24 hours | ICSI | ICPI | PUF | VAS |
| Before treatment | 50 | 21.33±12.35 | 13.53±4.97 | 8.76±2.16 | 13.24±3.76 | 5.93±2.17 |
| After treatment | 50 | 13.7±2.93 | 3.35±1.32 | 1.57±0.43 | 2.31±1.33 | 1.07±0.46 |
| Variance analysis | P<0.001 | P < 0.001 | P < 0.001 | P < 0.001 | P < 0.001 |
Table 22.IC patient anxiety, depression scores
| N | SAS | SDS | AIS | |
| Before IC patient's treatment | 40 | 40.37±7.09 | 50.11±10.46 | 4.93±2.93 |
| After IC patient's treatment | 40 | 31.37±5.73 | 41.39±8.31 | 2.64±1.07 |
| Chinese norm | 1628/1158 | 27.31±9.12 | 40.33±9.53 |
Note: comparing before and after treatment, P < 0.001
The type that 23 random forest of table analysis treatment group enteric bacteria content dramatically increases
The research of 9 stir-baked RHIZOMA DIOSCOREAE with soil prevention and treatment primary trigeminal neuralgia of embodiment
(1) prepared by preparation: stir-baked RHIZOMA DIOSCOREAE with soil being crushed, high pressure sterilization is spare.Auxiliary material be high-quality dry wheat bran, stir-baked RHIZOMA DIOSCOREAE with soil powder and
Wheat bran mixed proportion is stir-baked RHIZOMA DIOSCOREAE with soil powder: corn flour is 10:1 (mass ratio), and tablet is made in tabletting, and each tablet weight is 0.5-
It 0.55 gram, makes rear spare.
(2) primary trigeminal neuralgia subject selection: 50 patients are randomly divided into treatment group and control group.Treatment group 25
Example, male 10, female 15, the age 16-76 year old, be averaged (49.6 ± 13.7) year.The course of disease 7 days~14 years, average (3.2 ± 2.1)
Year；Control group 25, male 9, female 16, the age 15~79 years old, average (54.3 ± 13.2) year；It is the course of disease 5 days~18 years, average
(3.82 ± 1.3) year.Two groups of subject Genders, age, course of disease no difference of science of statistics.Selected case meets primary trident
Neuralgia diagnostic criteria.
Diagnostic criteria was referring to the classification of International Headache association the committee " international classification (second edition) of headache " middle pass in 2004
In the diagnostic criteria of primary trigeminal neuralgia.1) pain of breaking out property of face, the duration is general less than 2 minutes,
One or several for invading trigeminal neuralgia distributed area；2) pain, which at least has, following holds one of sign: violent, needle pricked, burn
Sample even cut sample；It can be induced and be broken out by trigger point or related trigger factor；3) the clinically no positive body of nervous system
Sign；4) other diseases and disorder cannot be attributed to.
It is included in standard: 1) meeting related traditional Chinese and western medicine diagnostic criteria；2) age is greater than or equal to 15 years old, the male less than 80 years old
Or women, two groups of observation objects have no apparent after being statistically analyzed in the course of disease, age and pretherapy and post-treatment indices
Difference is comparable；3) observation the last week need to withdraw in various, western drug and stop other treatment methods；4) state of an illness
Stablize, Clear consciousness；5) day seizure frequency is more than or equal to 1 person.6) patient understands experiment process and voluntary participation, and signature is known
Letter of consent；
Exclusion criteria: 1) above-mentioned diagnostic criteria person is not met；2) secondary trigeminal neuralgia patient；3) lactation, the gestational period
Women；4) merge the primary diseases persons such as other serious cardiovascular and cerebrovasculars, blood coagulation disorders；5) other medical experimenters are being participated in；
6) serious neurological damage and cognitive disorder influence pain Assessment person.
Grouping: processing group 25 are randomly divided into, conventional therapy group 25, two groups of Genders, age, courses of disease are without statistics
Difference.
(3) treatment method: the stir-baked RHIZOMA DIOSCOREAE with soil powder preparation of step (1) is taken by treatment group, and 3 times a day, dosage 50g/ times can be with
Food, which is mixed, to be taken.Placebo, the same treatment group of taking dose is made using corn flour in control group.It is carried out after medication 1 month
Therapeutic effect evaluation and test.
(4) treatment effectiveness evaluation: after treatment 2 months, observation therapeutic effect refers to " the Chinese medicine Drugs in Therapy promulgated in 2002
The clinical guidance principle of trigeminal neuralgia " determined criterion of therapeutical effect, and cooperate clinical treatment experience, carry out efficacy evaluation.
1. follow-up is fully recovered: from treating day, pain symptom is completely disappeared in December；
2. follow-up is effective: from treating day, pain largely disappears in December；
3. follow-up is effective: from treating day, pain is mitigated in December；
4. follow-up is invalid: from treating day, pain is without substantially reduced in December.
Efficient=(recovery from illness number+effective number+significant figure) 100%/total quantity of X
(5) result: according to statistical analysis, there were significant differences (P ﹤ 0.001) for the clinical efficacy for the treatment of group and control group.Invariably
Good reaction.It is shown in Table 24 and table 25.
(6) enteric microorganism changes: using high-flux sequence instrument sequencing analysis 16s rRNA, as the result is shown treatment group's enteron aisle
The diversity of microorganism dramatically increases (P ﹤ 0.01), and random forest (Random Forests) is analysis shows that (table 26), actinomyces
Door bacterial species and quantity dramatically increase (P ﹤ 0.01).
It is integrated before 24 two groups of treatments of table with pain after treatment
| Group | N | Before treatment | After treatment | Difference |
| Control group | 25 | 17.31±4.03 | 14.42±3.74 | 2.89±3.68 |
| Treatment group | 25 | 17.14±4.48 | 3.42±1.99 | 13.72±5.39 |
Note: two groups of pretherapy and post-treatment differences of patient meet normal distribution, through paired t-test, control group t=2.46, P <
0.017, treatment group t=13.99, P < 0.001
25 two groups of pretherapy and post-treatment curative effects of table compare
| Curative effect | N | Recovery from illness | It is effective | Effectively | In vain | It is efficient |
| Control group | 25 | 2 | 1 | 2 | 20 | 20% |
| Treatment group | 25 | 7 | 8 | 4 | 6 | 76% |
Note: df=3, X2=15.705, P < 0.001.
The type that 26 random forest of table analysis treatment group enteric bacteria content dramatically increases
The research of 10 sun soil prevention and treatment multiple sclerosis of embodiment
(1) prepared by preparation: sun soil being crushed, high pressure sterilization is spare.Auxiliary material is high-quality dry corn flour, sun soil powder and jade
Rice flour mixed proportion is sun soil powder: corn flour is 2:1 (mass ratio), and tablet is made in tabletting, and each tablet weight is 0.5-
It 0.55 gram, makes rear spare.
(2) subject selection: in 25 treatment groups, 9 male patients, 16 female patients；Age is 20 years old minimum, maximum 65
It is year, 43.53 ± 11.14 years old average；Average course of disease 2.7 ± 4.8 months.In 25 control groups, 11 male patients, 14 women
Patient；Age minimum 19, it is 66 years old maximum, it is 42.35 ± 12.35 years old average；Average course of disease 2.4 ± 5.3 months.Two groups of clinic
It shows no difference of science of statistics (P > 0.05).
(3) treatment method: sun soil preparation is taken by treatment group, 2 times a day, 15g/ times each, can be mixed with food
It takes.Control group is using the corn flour of same dose as placebo, the same treatment group of taking dose.Treatment effect is carried out after medication 3 months
Fruit evaluation and test.
(4) two groups of EDSS scorings are compared after treating
After treating March, the EDSS for the treatment of group and control group scores, and has statistics with the variation feelings after treatment before the treatment
Significant difference (P < 0.05) on.And after treating, the reduction for the treatment of group EDSS scoring is significantly more than control group, there is statistics meaning
Adopted (P=0.000), specific value situation are shown in Table 27.
(5) two groups of EDSS scorings in 1 year and recurrent number compare after treating
1 year after the treatment, treatment group compared with control group, and the situation of change of pretherapy and post-treatment EDSS scoring has significance difference
The amplitude of different (P < 0.05), treatment group EDSS scoring decline has statistical difference compared with control group, (P < 0.05).In addition, two groups of trouble
Recurrent number after person 1 year, 1 person-time for the treatment of group, 2 person-times of control group, no difference of science of statistics (P > 0.05), specific value situation is shown in Table
28。
(6) therapeutic effect compares
According to statistical analysis, there were significant differences (P ﹤ 0.001) for the clinical efficacy for the treatment of group and control group.It has no adverse reaction.
See Table 2 for details 9.
(7) enteric microorganism changes: using high-flux sequence instrument sequencing analysis 16s rRNA, as the result is shown treatment group's enteron aisle
The diversity of microorganism dramatically increases (P ﹤ 0.01), and random forest (Random Forests) is analysis shows that (table 30), actinomyces
Door bacterial species and quantity dramatically increase (P ﹤ 0.01)
EDSS scoring is compared after 27 two groups of patients with multiple sclerosis of table treat March
EDSS scoring in 1 year and recurrent number compare after 28 two groups of patient's treatments of table
| Group | Before treatment | 1 year after treatment | T value | P value |
| Treatment group n=20 | 5.27±1.11 | 2.07±1.31 | 8.142 | <0.001 |
| Control group n=20 | 5.13±2.43 | 4.72±1.63 | 0.175 | 0.862 |
| P value | <0.001 |
29 two groups of patients with multiple sclerosis therapeutic effects of table compare
| Group | Number of cases | It is effective | Effectively | In vain | Total effective rate |
| Control group | 25 | 1 | 6 | 18 | 28% |
| Treatment group | 25 | 12 | 10 | 3 | 88% |
Note: through Chi-square Test: df=1, X2=18.473, P < 0.001
The type that 30 random forest of table analysis treatment group enteric bacteria content dramatically increases
Above-described embodiment is only the preferred technical solution of the present invention, and is not construed as limitation of the invention, the present invention
Protection scope should with claim record technical solution, including claim record technical solution in technical characteristic etc.
It is protection scope with alternative, i.e., equivalent replacement within this range is improved, also within protection scope of the present invention.
Claims (9)
1. the application containing soil material in the drug or health care product of preparation prevention and/or treatment immune system disorder disease.
2. improving immunity of organisms in preparation containing soil material, improving the diversity of enteric microorganism and promoting a variety of probiotics raw
Application in long drug or health care product.
3. application according to claim 1, which is characterized in that the soil material that contains includes: during soil stir-fries and eats product, soil is fried
Medicine, Dong Bitu, forging stove ash, Hu golden-rumped swallow nest mud, scoliid nest, dung beetle turn ball, ant little molehill soil, termite mud, earthworm mud, Liang Shangchen, crow father mud,
Sun-dried mud brick, black ancient tile, ancient brick, smoked sheet, door-hinge pit dirt, Tian Zhongni, eaves slide down mud, manure pit bed mud, urine hole mud, dog urine mud, white eel mud, too
Positive soil, thousand step peaks burn soil on corpse field, spiral shell mud, casserole or old wall soil.
4. application according to claim 3, which is characterized in that the soil stir-fries and eats product or soil stir-fry Chinese medicine includes: that soil stir-fry is flat
Beans, native fried atractylodes, soil fry Patrinia scaniosaefolia, soil fries Southern Star, soil fries galanga, stir-baked RHIZOMA ATRACTYLODIS MACROCEPHALAE with soil, native stir-baked RADIX PAEONIAE ALBA, stir-baked RHIZOMA DIOSCOREAE with soil, stir-baked RADIX ANGELICAE SINENSIS with soil, soil
Fry semen coicis.
5. application according to claim 1, which is characterized in that the immune system disorder disease includes anaphylaxis skin
Inflammation, irritable bowel disorder, allergic rhinitis, allergic asthma, anaphylactoid purpura, anaphylactic shock, rheumatoid arthritis, mixing
Property connective tissue disease, systemic loupus erythematosus, polymyositis, chorionitis, IgA positive ephritis, ankylosing spondylitis, drying it is comprehensive
It is simulator sickness, leucoderma, linear moss, rheumatic arthritis, interstitial cystitis, interstitial pneumonia, primary trigeminal neuralgia, more
Hair property sclerosis, alopecia areata, psoriasis.
6. application according to claim 5, which is characterized in that the allergic dermatitis include drug rash, contact dermatitis,
Eczema, nettle rash, dermographism, food hypersenstivity and environmental factor cause allergy dermatitis；Irritable bowel disorder includes anaphylaxis knot
Enteritis, ulcerative colitis and Crohn disease.
7. application according to claim 1, which is characterized in that soil material will be contained and is prepared by pharmaceutically acceptable carrier
At oral preparation or external preparation.
8. application according to claim 2, which is characterized in that increase the kind of actinomyces door bacterium in preparation containing soil material
The drug or the application in health care product of class and quantity.
9. application according to claim 2, which is characterized in that micro- for enteron aisle in preparation reduction antibiotic containing soil material
The influence of ecology promotes the application in the drug or health care product that restore balance as early as possible after the used antibiotic of intestinal microecology.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910694668.3A CN110354227A (en) | 2019-07-30 | 2019-07-30 | Application containing soil material in the drug or health care product of preparation prevention and/or treatment immune system disorder disease |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910694668.3A CN110354227A (en) | 2019-07-30 | 2019-07-30 | Application containing soil material in the drug or health care product of preparation prevention and/or treatment immune system disorder disease |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN110354227A true CN110354227A (en) | 2019-10-22 |
Family
ID=68222561
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201910694668.3A Pending CN110354227A (en) | 2019-07-30 | 2019-07-30 | Application containing soil material in the drug or health care product of preparation prevention and/or treatment immune system disorder disease |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN110354227A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2020200212A1 (en) * | 2019-04-04 | 2020-10-08 | 东南大学 | Soil preparation for preventing and treating metabolic diseases and preparation method therefor and use thereof |
| WO2021138979A1 (en) * | 2019-12-16 | 2021-07-15 | 南京大学 | Probiotic mineral material composite preparation and application of mineral materials in preparation of drugs for inhibiting malignant tumor growth |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102008016A (en) * | 2010-11-09 | 2011-04-13 | 南京农业大学 | Probiotic solid powder and preparation method thereof |
| CN106344618A (en) * | 2016-10-09 | 2017-01-25 | 东南大学 | Soil preparation for preventing and treating immune disorder, enteritis and autism |
-
2019
- 2019-07-30 CN CN201910694668.3A patent/CN110354227A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102008016A (en) * | 2010-11-09 | 2011-04-13 | 南京农业大学 | Probiotic solid powder and preparation method thereof |
| CN106344618A (en) * | 2016-10-09 | 2017-01-25 | 东南大学 | Soil preparation for preventing and treating immune disorder, enteritis and autism |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2020200212A1 (en) * | 2019-04-04 | 2020-10-08 | 东南大学 | Soil preparation for preventing and treating metabolic diseases and preparation method therefor and use thereof |
| WO2021138979A1 (en) * | 2019-12-16 | 2021-07-15 | 南京大学 | Probiotic mineral material composite preparation and application of mineral materials in preparation of drugs for inhibiting malignant tumor growth |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| Okuyan et al. | Effect of abdominal massage on constipation and quality of life in older adults: a randomized controlled trial | |
| Li et al. | Complementary effects of auricular acupressure in relieving constipation symptoms and promoting disease-specific health-related quality of life: a randomized placebo-controlled trial | |
| Yıldırım et al. | The efficacy of abdominal massage in managing opioid-induced constipation | |
| CN109157541A (en) | Application of the kaolin in preparation prevention and treatment anaphylactia, mental disorder, metabolism class disease and endocrine disturbance disease medicament | |
| CN108888630A (en) | Application of the humus flava usta in preparation prevention and treatment anaphylactia, mental disorder, metabolism class disease and endocrine disturbance disease medicament | |
| CN110354227A (en) | Application containing soil material in the drug or health care product of preparation prevention and/or treatment immune system disorder disease | |
| CN110101715A (en) | Soil preparation and the preparation method and application thereof with prevention and treatment neuroendocrine disorders related disease | |
| Gu et al. | Analysis of the efficacy of abdominal massage on functional constipation: A meta-analysis | |
| CN102188602B (en) | Traditional Chinese medicine particles for treating syndrome of insufficiency of lung and kidney qi caused by chronic obstructive disease of lung | |
| Chen et al. | Study on the therapeutic effect of floating needle therapy combined with pressing acupoint embedding for female stress urinary incontinence after childbirth: a randomized trial | |
| Lai et al. | An Apriori algorithm-based association analysis of analgesic drugs in Chinese medicine prescriptions recorded from patients with rheumatoid arthritis pain | |
| CN109157540A (en) | Application of the medical stone in preparation prevention and treatment anaphylactia, mental disorder, metabolism class disease and endocrine disturbance disease medicament | |
| Purwati | The Effectiveness of Effeurage Massage Using Lavender Aromatherapy For Menstrual Pain Relief | |
| CN110384713A (en) | Application of the red halloysite in preparation prevention and treatment anaphylactia, mental disorder, metabolism class disease and endocrine disturbance disease medicament | |
| CN109288858A (en) | Application of the ginger chunk in preparation prevention and treatment anaphylactia, mental disorder, metabolism class disease and endocrine disturbance disease medicament | |
| CN109172602A (en) | Application of the montmorillonite in preparation prevention and treatment anaphylactia, mental disorder, metabolism class disease and endocrine disturbance disease medicament | |
| CN110063966A (en) | Soil preparation and the preparation method and application thereof with prevention and treatment serum antibody exception related disease | |
| AlOtaibi et al. | Functional assessment of quality of life using EORTC QLQ-CR29 in patients with colon cancer at King Abdulaziz University Hospital | |
| CN108635555A (en) | A kind of traditional Chinese medicine acupoint emplastrum and preparation method thereof for treating depressive disorder | |
| CN102813888B (en) | Chinese herbal composition for treating epilepsy | |
| CN106310133A (en) | Traditional Chinese medicine and medicine pillow for treating depression, resisting anxiety, resisting insomnia and relieving senile dementia | |
| CN110327437B (en) | Traditional Chinese medicine for treating chronic diarrhea and preparation method thereof | |
| CN104435314B (en) | A kind of pharmaceutical composition for treating osteoarthropathy and its application | |
| CN107998144A (en) | Ozonating vitamin | |
| CN110507667A (en) | Application of the humus flava usta in the drug or health care product of preparation prevention and treatment immunity complex disease |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20191022 |
|
| RJ01 | Rejection of invention patent application after publication |