CN105147792A - Traditional Chinese medicine composition for moxibustion medicine cake and preparation method thereof - Google Patents

Traditional Chinese medicine composition for moxibustion medicine cake and preparation method thereof Download PDF

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CN105147792A
CN105147792A CN201510599057.2A CN201510599057A CN105147792A CN 105147792 A CN105147792 A CN 105147792A CN 201510599057 A CN201510599057 A CN 201510599057A CN 105147792 A CN105147792 A CN 105147792A
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moxibustion
chinese medicine
moxa
medicine composition
mild
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吴焕淦
王晓梅
赵继梦
吴璐一
马喆
黄任佳
刘慧荣
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SHANGHAI ACUPUNCTURE CHANNEL INST
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SHANGHAI ACUPUNCTURE CHANNEL INST
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Abstract

The invention provides a traditional Chinese medicine composition for a moxibustion medicine cake. The traditional Chinese medicine composition for the moxibustion medicine cake is mainly prepared from, by weight, 0.2-2 parts of angelica sinensis, 0.5-5 parts of radix aconiti carmichaeli, 0.5-5 parts of cortex cinnamomi, 0.2-2 parts of safflower, 0.2-2 parts of radix salviae miltiorrhizae, 0.2-2 parts of radix aucklandiae and 0.2-2 parts of borneol. The invention further provides a preparation method of the traditional Chinese medicine composition for the moxibustion medicine cake. The traditional Chinese medicine composition for the moxibustion medicine cake can be used by being combined with moxa floss, the double therapeutic effect of the moxa floss and the traditional Chinese medicines is achieved, and the clinical curative effect of moxibustion is greatly improved; the traditional Chinese medicine composition has the effects of warming and nourishing the spleens and the stomach, promoting blood circulation, removing blood stasis, promoting qi circulation and relieving pain; the traditional Chinese medicine composition is suitable for the cold syndromes, the deficiency syndromes, the pain syndromes and the stasis syndromes which are caused by deficiency cold of the spleens and the stomach, spleen-kidney yang deficiency, qi stagnancy, blood stasis and the like and is particularly suitable for difficult miscellaneous diseases such as chronic gastritis, refractory chronic enteritis and the like; carrying is convenient, and operation is easy; the substantial economical benefits can be brought.

Description

A kind of moxa-moxibustion medicine cake Chinese medicine composition and preparation method thereof
Technical field
The invention belongs to medical treatment and healthcare field, relate to a kind of moxa-moxibustion medicine cake Chinese medicine composition and preparation method thereof, be specifically related to a kind of moxa-moxibustion medicine cake Chinese medicine composition for the treatment of traditional Chinese medical science water seperation pillar and preparation method thereof.
Background technology
" moxibustion " is exactly the meaning of burning.To be the Ancient Times in China people to wage a struggle middle summary a kind of Therapeutic Method out with disease in moxibustion.Our people, when time immemorial, has grasped by fiery method, and people, in cooking food and heating, accidentally may be burnt by baked wheaten cake once in a while, and alleviate some slight illness; Or the roasting abdominal part that burns, alleviate the symptoms such as the cold pain of abdominal part and distension, so everybody initiatively uses the more disease of fiery burn treatment, this creates the terminal moxibustion.Have in " Ling Shu Miraculous Pivot or Divine Axis official energy " " less than pin, the institute of moxibustion is suitable ", just describe the curative effect effect of moxibustion.In the ancient times of China, due to the remarkable effect of moxibustion in disease therapy, and easily seek by the convenience of moxibustion material, moxibustion is being very prevailing at that time, obtains very large development by the material of moxibustion and treatment technology.The development for the treatment of technology: monograph " Cao Shi moxibustion side " (lost) that just occurred moxibustion as far back as the period of Three Kingdoms, the Song dynasty village is ample " region below the heart acupuncture points on the human body moxibustion therapy ", well-known figure has " preemergency moxibustion side " over sixty years of age, west has " courtyart moxibustion warp ", have " adopting Chinese mugwort compile " in the wide blessing of Ming Dynasty's leaf, Qing Dynasty Wu is the influential moxibustion monograph in history such as ancient cooking vessel " refreshing moxibustion is through opinion " also.Water seperation pillar herbal mixture is decocted juice or add a small amount of excipient after grinding into powder to make little pie, and every the indirect moxibustion therapy of one of this medicine cake moxibustion or moxa stick moxibustion.Water seperation pillar rises from when examining, and carries according to Ming Dai Zhu grand " bamboo window random notes ": " closely have monk's row moxibustion therapy person, cake made by its method and medicine, puts moxa cone and fires it thereon, and kumoharu ten thousand is sick.This does not know to come from what book, pass from whom." ancient times medicine cake, take the fragrant medicine of pungent temperature more and make, to play the effect of warming spleen and stomach for dispelling cold, promoting flow of QI and blood.No matter modern times are the compositions of medicine, the scope etc. of the method for moxibustion and treatment has all had larger development.Water seperation pillar plays therapeutical effect by Folium Artemisiae Argyi, acupuncture point and medicine three are collaborative.
Chinese patent literature CN101683410A discloses a kind of preparation method of cake for warming channels and activating collaterals, Chinese medicinal components comprises Radix Aconiti Lateralis Preparata 5-50g, Radix Aconiti Preparata 5-50g, Olibanum 5-50g, Bombyx Batryticatus 1-10g, Scorpio 1-10g, Flos Carthami 5-25g, Semen Persicae 5-25g, Radix Angelicae Sinensis 5-25g, Pheretima 1-20g, add Rhizoma Zingiberis Recens juice and traditional Chinese medicinal cake made by Mel, treatment facial paralysis.Chinese patent literature CN103071139A discloses a kind of warming YANG to expel cold, promoting the flow of QI in the collateral by warming the meridian combination medicinal vesiculation medicine and preparation method thereof, be made up of Semen Sinapis Albae, Rhizoma Corydalis, Radix Kansui, Herba Asari, Rhizoma Chuanxiong, Semen Vaccariae, Rhizoma Zingiberis, Cortex Cinnamomi, Ramulus Cinnamomi, Borneolum Syntheticum, decile porphyrize powder, with mature vinegar 5ml, make patent medicine cake, for diseases such as asthma, old-slow-bronchial tube, allergic rhinitis, arthromyodynia, neck-shoulder pain, lumbago and leg pains.The most using method of prior art is limited, clinical indication is also limited, especially for difficult miscellaneous diseases often DeGrains such as chronic gastritis, intractable chronic enteritis (ulcerative colitis, Crohn disease and irritable bowel syndrome), functional dyspepsias.
Summary of the invention
The shortcoming of prior art in view of the above, the object of the present invention is to provide a kind of moxa-moxibustion medicine cake Chinese medicine composition and preparation method thereof, for solve in prior art lack therapeutic effect obviously and can with the effective partner treatment of Folium Artemisiae Argyi, easy to carry, be easy to operate, the problem of herbs-partition moxibustion medicine for treatment cake with low cost.
For achieving the above object and other relevant objects, first aspect present invention provides a kind of moxa-moxibustion medicine cake Chinese medicine composition, and its main pharmacodynamics composition comprises following component by weight:
Preferably, the main pharmacodynamics composition of described moxa-moxibustion medicine cake Chinese medicine composition also includes Rhizoma Coptidis (RhizomaCoptidis) 0.2-2 part by weight.
Preferably, described moxa-moxibustion medicine cake Chinese medicine composition, its main pharmacodynamics composition comprises following component by weight:
More preferably, the main pharmacodynamics composition of described moxa-moxibustion medicine cake Chinese medicine composition also includes Rhizoma Coptidis 0.5-1.5 part by weight.
Second aspect present invention provides a kind of preparation method of moxa-moxibustion medicine cake Chinese medicine composition, comprises the following steps:
1) get each main pharmacodynamics composition by proportioning to pulverize, sieve, medicated powder is made in mixing, for subsequent use;
Above-mentioned various active ingredient, all selects genuine medicinal materials, conveniently operation carry out processing, levigation, and note seasonal.
Preferably, the hole order of described sieve is 80-100 order.More preferably, the hole order of described sieve is 100 orders.
The processing of various active ingredient in the present invention, must be ground into superfine, and reaching noiseless is degree, and some tongue water, then sieves, if medicated powder is coarse, the medicine cake of making is in use easily broken, causes the inequality thus cause skin scald to bubble of being heated, affects the treatment.Because containing Borneolum Syntheticum aromatic odor in this medicated powder, being stored in cold preservation in sealed container, not making to lose heart, preventing fragrance to run off, reduced drug effect.The preferred special food bag of described sealed container (250 grams/bag).
2) get step 1) in obtained medicated powder, add mixed aid, be mixed into cream pasty mixture, then use mold compresses patent medicine cake.
Preferably, the ratio of weight that described medicated powder adds with described mixed aid is 2-3:3-5.
Preferably, described mixed aid is selected from any one in Rhizoma Zingiberis Recens juice or yellow wine.
Described Rhizoma Zingiberis Recens juice is the conventional Rhizoma Zingiberis Recens juice used, and does not have particular/special requirement to its levels etc.
Described yellow wine is the conventional yellow wine as guiding drug in Chinese medicine, does not have particular/special requirement to its levels etc.
Preferably, the mould that medicine cake adopts is prepared in the pressing molding that described mould is conventional use.Specifically, can select as the medicine cake mould in ZL201420838803.X.
Preferably, the specification of described medicine cake is: thick: 0.5-0.8cm; Diameter: 2.3-3cm.Described medicine cake is cream pasty state.
Third aspect present invention provides the purposes of above-mentioned moxa-moxibustion medicine cake Chinese medicine composition, and namely this Chinese medicine composition is for the preparation of the moxa-moxibustion medicine cake every medicine cake moxibustion treatment the intestines and stomach class disease.
Show according to actual efficacy, above-mentioned the intestines and stomach class disease includes but not limited to chronic gastritis, intractable chronic enteritis.Described intractable chronic enteritis comprises ulcerative colitis, Crohn disease, irritable bowel syndrome etc.
As mentioned above, a kind of moxa-moxibustion medicine cake Chinese medicine composition of the present invention and preparation method thereof, has following beneficial effect:
(1) in the present invention for the medicine cake every medicine moxa-moxibustion, be Chinese medicine is made medicine cake to coordinate Folium Artemisiae Argyi to use, play Folium Artemisiae Argyi and the effect of Chinese medicine double treatment, greatly improve clinical efficacy.
(2) in the present invention for the medicine cake every medicine moxa-moxibustion, its Chinese medicine composition has the effect of replenishing vital QI with drugs of warm nature taste, blood circulation promoting and blood stasis dispelling, promoting the circulation of QI to relieve pain, be applicable to cold syndrome, deficiency syndrome, pain card, blood stasis syndrome that Deficiency and coldness of spleen and stomach, deficiency of spleen-YANG and kidneyYANG, qi depression to blood stasis etc. cause, be particularly useful for chronic gastritis, intractable chronic enteritis.At present, the correlational study through this medicine of Clinical practice cake finds, and the clinical efficacy of this medicine cake treatment chronic gastritis, intractable chronic enteritis is significantly better than common mild-warm moxibustion.
(3) in the present invention for the medicine cake every medicine moxa-moxibustion, easy to carry, using method is easy to operation, can use in the family, be not limited to doctor and medical space, price is far below General Clinical diagnosis and treatment price simultaneously, if obtain universal use, can alleviate the social problems such as society " Expensive and hard to visit doctors ".
(4) in the present invention for the medicine cake every medicine moxa-moxibustion, be conventional consumable goods, therefore clinical wideling popularize not only can bring glad tidings to patient with widely using of family health care, can also bring considerable economic benefit.
Detailed description of the invention
Set forth the present invention further below in conjunction with specific embodiment, should be understood that these embodiments are only not used in for illustration of the present invention and limit the scope of the invention.
Below by way of specific instantiation, embodiments of the present invention are described, those skilled in the art the content disclosed by this description can understand other advantages of the present invention and effect easily.The present invention can also be implemented or be applied by detailed description of the invention different in addition, and the every details in this description also can based on different viewpoints and application, carries out various modification or change not deviating under spirit of the present invention.
Compatibility of the present invention meets " monarch " principle of Chinese medicine, and following each Chinese medicine that the present invention adopts makes compatibility mutually, can play its collaborative effect of curing the disease, have drug effect and be interweaved, mutually promote and coordinate usefulness between each composition of raw material of Chinese medicine used.
Crude drug of the present invention (or medical material) all can be bought from common pharmacy or Chinese crude drug sales company and obtain, and its specification meets national medical standards or meets the pertinent regulations such as Chinese Pharmacopoeia.The medical material adopted unless otherwise indicated, is tcm and herbal slice, and this tcm and herbal slice also can be through processing after obtaining.
" patient " alleged by the present invention refers to suffer from the people of disease, wild animal and domestic animal.Wild animal is the animal without domestication under naturalness.Domestic animal is the animal in order to provide food source and artificial breeding, as monkey, ape, Canis familiaris L., Mus, hamster, pig, rabbit, horse, milch cow, Babalus bubalis L., bull, sheep and goat etc." patient " that give to diagnose preferably selects mammal, especially people.
Criterion of therapeutical effect of the present invention is with reference to criterion of therapeutical effect relevant in " disease of tcm judgement criterion of therapeutical effect ".Recovery from illness: clinical symptoms all disappears, and lab testing is normal.Take a turn for the better: clinical symptom relief, lab testing improvement or normal.Invalid: clinical symptoms is without being clearly better or increasing the weight of.
Compositions of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared into any conventional oral preparations, or the dosage form that the final extracting solution through extracting said composition gained can be prepared into further through common process, comprises capsule, tablet, granule, powder, oral liquid, soft capsule, pill, mixture, syrup, gel and sustained-release preparation etc.For enabling above-mentioned dosage form realize, pharmaceutically acceptable adjuvant need be added, as filler, disintegrating agent, lubricant, suspending agent, binding agent, sweeting agent, correctives, antiseptic etc. when preparing these dosage forms.
Preparation technology of the present invention uses in principle " technical requirement of new Chinese medicine Study on Preparation ", and the principle active component using Modern preparations new technique to extract medicine is used as medicine, and adds some pharmaceutically acceptable adjuvant or carriers
Embodiment 1
Divide and get Radix Angelicae Sinensis 1.0g, Radix Aconiti Lateralis Preparata 2.0g, Cortex Cinnamomi 2.0g, Flos Carthami 1.0g, Radix Salviae Miltiorrhizae 1.0g, Radix Aucklandiae 1.0g, Borneolum Syntheticum 1.0g, above-mentioned each active ingredient is chosen authentic medicinal herbs, concrete Chinese crude drug is stocked up in enormous quantities by Fengxian De Hua decoction pieces pharmaceutical factory is unified, conveniently operation is carried out processing, after levigation, cross 100 mesh sieves, medicated powder is made in mixing.Medicated powder is stored in cold preservation in the container of sealing, for subsequent use.During use, get it filled powder 2.5g, adds yellow wine 3g, is mixed into cream pasty state, puts into mold compresses patent medicine cake sample 1#.The specification of medicine cake sample 1# is thick 0.5cm, diameter 2.3cm.When this medicine cake sample 1# is used for damp-heat accumulation type patient treatment, in above-mentioned active ingredient, also need add the Rhizoma Coptidis of 1.0g again.
Embodiment 2
Divide and get Radix Angelicae Sinensis 0.5g, Radix Aconiti Lateralis Preparata 1.0g, Cortex Cinnamomi 1.0g, Flos Carthami 0.5g, Radix Salviae Miltiorrhizae 0.5g, Radix Aucklandiae 0.5g, Borneolum Syntheticum 0.5g, above-mentioned each active ingredient is chosen authentic medicinal herbs, concrete Chinese crude drug is stocked up in enormous quantities by Fengxian De Hua decoction pieces pharmaceutical factory is unified, conveniently operation is carried out processing, after levigation, cross 100 mesh sieves, medicated powder is made in mixing.Medicated powder is stored in cold preservation in the container of sealing, for subsequent use.During use, get it filled powder 2.5g, adds yellow wine 3g, is mixed into cream pasty state, puts into mold compresses patent medicine cake sample 2#.The specification of medicine cake sample 2# is diameter 2.5cm, thickness 0.7cm.When this medicine cake sample 2# is used for damp-heat accumulation type patient treatment, in above-mentioned active ingredient, also need add the Rhizoma Coptidis of 0.5g again.
Embodiment 3
Divide and get Radix Angelicae Sinensis 1.5g, Radix Aconiti Lateralis Preparata 3.0g, Cortex Cinnamomi 3.0g, Flos Carthami 1.5g, Radix Salviae Miltiorrhizae 1.5g, Radix Aucklandiae 1.5g, Borneolum Syntheticum 1.5g, above-mentioned each active ingredient is chosen authentic medicinal herbs, concrete Chinese crude drug is stocked up in enormous quantities by Fengxian De Hua decoction pieces pharmaceutical factory is unified, conveniently operation is carried out processing, after levigation, cross 100 mesh sieves, medicated powder is made in mixing.Medicated powder is stored in cold preservation in the container of sealing, for subsequent use.During use, get it filled powder 2.5g, adds Rhizoma Zingiberis Recens juice 3g, is mixed into cream pasty state, puts into mold compresses patent medicine cake sample 3#.The specification of medicine cake sample 3# is diameter 3cm, thickness 0.8cm.When this medicine cake sample 3# is used for damp-heat accumulation type patient treatment, in above-mentioned active ingredient, also need add the Rhizoma Coptidis of 1.5g again.
Embodiment 4
Divide and get Radix Angelicae Sinensis 0.2g, Radix Aconiti Lateralis Preparata 0.5g, Cortex Cinnamomi 0.5g, Flos Carthami 0.2g, Radix Salviae Miltiorrhizae 0.2g, Radix Aucklandiae 0.2g, Borneolum Syntheticum 0.2g, above-mentioned each active ingredient is chosen authentic medicinal herbs, concrete Chinese crude drug is stocked up in enormous quantities by Fengxian De Hua decoction pieces pharmaceutical factory is unified, conveniently operation is carried out processing, after levigation, cross 80 mesh sieves, medicated powder is made in mixing.Medicated powder is stored in cold preservation in the container of sealing, for subsequent use.During use, get it filled powder 2.0g, adds Rhizoma Zingiberis Recens juice 3g, is mixed into cream pasty state, puts into mold compresses patent medicine cake sample 4#.The specification of medicine cake sample 4# is diameter 2.6cm, thickness 0.6cm.When this medicine cake sample 4# is used for damp-heat accumulation type patient treatment, in above-mentioned active ingredient, also need add the Rhizoma Coptidis of 0.2g again.
Embodiment 5
Divide and get Radix Angelicae Sinensis 2g, Radix Aconiti Lateralis Preparata 5g, Cortex Cinnamomi 5g, Flos Carthami 2g, Radix Salviae Miltiorrhizae 2g, Radix Aucklandiae 2g, Borneolum Syntheticum 2g, above-mentioned each active ingredient is chosen authentic medicinal herbs, concrete Chinese crude drug is stocked up in enormous quantities by Fengxian De Hua decoction pieces pharmaceutical factory is unified, conveniently operation is carried out processing, after levigation, cross 100 mesh sieves, medicated powder is made in mixing.Medicated powder is stored in cold preservation in the container of sealing, for subsequent use.During use, get it filled powder 3.0g, adds Rhizoma Zingiberis Recens juice 3g, is mixed into cream pasty state, puts into mold compresses patent medicine cake sample 5#.The specification of medicine cake sample 5# is diameter 2.9cm, thickness 0.8cm.When this medicine cake sample 5# is used for damp-heat accumulation type patient treatment, in above-mentioned active ingredient, also need add the Rhizoma Coptidis of 2g again.
Embodiment 6
Drug efficacy study: the clinical trial of chronic gastritis
The water seperation pillar medicine cake sample 1# of preparation in embodiment 1 is carried out water seperation pillar treatment by the present invention, and the mild-warm moxibustion carried out with routine treat and compared, and in evaluation the present invention, the medicine cake prepared is for after water seperation pillar, to the clinical efficacy of chronic gastritis.
1, patient criteria:
1.1 patient persons
As if collect spleen-stomach deficiency-cold Patients with Chronic Gastritis in Shanghai Acupuncture Channel Inst.'s outpatient service and flat hospital outpatient year April from June, 2009 ~ 2011, water seperation pillar group accepts 37 examples for medical treatment, and come off 7 examples; Mild-warm moxibustion group accepts 33 examples for medical treatment, and come off 5 examples.In water seperation pillar group 30 example, male 13 example, women 17 example, 30 ~ 75 years old age; In mild-warm moxibustion group 28 example, male 11 example, women 17 example, 30 ~ 75 years old age.Before two groups of patient treatments, age, sex have comparability.
1.2 patient diagnosis standards
1.2.1 Western medicine diagnose standard
The patient selected in the present embodiment is with reference to the Western medicine diagnose standard of national chronic gastritis consensus conference (Shanghai) of in JIUYUE, 2006:
A. medical history, health check-up: 1. assess gastritis to the influence degree of human body: the presence or absence of indigestion symptom, the order of severity.2. the possible cause of disease or inducement is found out: medicine, ethanol, gastroduodenal reflux.
B. the performance under gastroscope:
1. gastric mucosa congestion, color and luster are redder, congested edge blurry, and being often limitation, is dispersivity sometimes;
2. gastric mucosa edema, has swelling, moist feeling, and reflectance strengthens, and congested district and edema area can coexist, and are formed red and white;
3. mucosa surface adheres to the canescence of thickness or faint yellow mucus speckle;
4. gastric mucosa has petechia, and gastroscope touching mucosa easily causes bleeding;
5. mucosa has little rotten to the corn stove sometimes, and bottom covers lark tongue, margin hyperemia.
1.2.2 Syndrome Differentiation of Traditional Chinese Medicine
The patient selected in the present embodiment carries out Chinese medical discrimination with reference to " the disease of tcm Standardization of diagnosis and curative effect " of State Administration of Traditional Chinese Medicine's Nanjing University's publication in 1994.
Specific as follows: all possess following primary symptom 3, and tongue arteries and veins meets substantially, or possess primary symptom two and time disease 1, tongue arteries and veins meets the Patients with Chronic Gastritis that can be defined as spleen-stomach deficiency-cold substantially.
Primary symptom: (1) gastral cavilty distension or dull pain; (2) happiness of stomach pain relieved by pressing is warm; (3) loose stool; (4) weak; (5) pale tongue; (6) there is indentation on limit.Secondary disease: (1) lack of appetite; (2) breathe hard; (3) lazy speech; (4) clear water is vomitted; (5) tastelessness; (6) thready and weak pulse.
When finding damp-heat accumulation type patient, need to add the Rhizoma Coptidis with the effect such as heat clearing and damp drying, eliminating fire and detoxication, for effectively improving clinical efficacy.
1.2.3 inclusive criteria
1. the patient of Chinese medical discrimination spleen-stomach deficiency-cold chronic gastritis diagnostic criteria is met;
2. include in test in first 3 months and confirm diagnosis through gastroscopy;
3. 18 ~ 75 years old age, male or female;
4. add this test voluntarily and fill in Informed Consent Form.
1.2.4 exclusion standard
1. diagnostic criteria and inclusive criteria person is not met;
2. gestation or prepare gravid woman, women breast-feeding their children;
3. allergic constitution and to multi-medicament allergy sufferers;
4. merge peptic ulcer, gastric mucosa has severe dysplasia or pathological diagnosis is suspected to have the person of cancerating;
5. severe primary disease, the psychotics such as the heart, brain, liver, kidney and hemopoietic system is merged.
2, therapeutic scheme
2.1 Therapeutic Method
Carry out location, acupuncture point according to reference to National Standard of the People's Republic of China " acupuncture points on the human body title and location " (GB12346-2006), select the cave middle part of gastric cavity, Tianshu (two), Qihai.According to 1.1, water seperation pillar group selection 30 routine patient treat, and mild-warm moxibustion group selection 28 routine patient treat.
Wherein, medicine cake sample 1# in water seperation pillar group selection embodiment 1, moxa roll is adopted to select refining pure moxa roll (" receive fine jade you board ", upper Haitai becomes development in science and technology company limited to produce, specification: 18mm × 200mm), be cut into high 17mm, heavily about 1.8g carries out water seperation pillar, and each every cave one is strengthened, 3 times weekly, within 2 weeks, be 1 course for the treatment of, treat 1 course for the treatment of altogether.
The common clear moxa roll that mild-warm moxibustion group adopts Nanyang Chinese medicine Folium Artemisiae Argyi factory to produce, apart from acupuncture point 2-3cm just moxibustion, each every cave 20min, 3 times weekly 2 weeks is 1 course for the treatment of, treats 1 course for the treatment of altogether.
2.2 evaluation method
After moxibustion, observe the change of moxibustion treatment main clinic symptoms of patient after 14 days, clinical cardinal symptom comparitive study adopts Syndrome in TCM marquis's improvement rate (nimodipine method) to evaluate, and concrete formula is as follows:
Syndrome in TCM marquis improvement rate (nimodipine method) is: [before (before treatment the rear integration of integration-treatment) ÷ treatment integration] × 100%
The principle that " new Chinese medicine guideline of clinical investigations (trying) " that above-mentioned formula is published with reference to Ministry of Health of the People's Republic of China for 2002 formulates is marked, wherein, treatment foreset is divided into the summation of the front all symptom integral for the treatment of, and after treatment, integration is the summation of all symptom integral after treatment.The methods of marking of concrete clinical symptoms refer to " gastrointestinal disease TCM syndrome evaluation table " (the danger North Sea, Chen Zhishui, Zhang Wandai. gastrointestinal disease TCM syndrome grade form. world Chinese digests magazine, 2004,12 (11): 2701-2703).
Meanwhile, the efficacy assessment standard of above-mentioned formula is as follows:
(1) clinical recovery: symptom, sign disappear or substantially disappear, syndrome integral reduces >=95%.
(2) effective: symptom, sign are obviously improved, syndrome integral reduces >=70%.
(3) effective: symptom, sign all take a favorable turn, syndrome integral reduces >=30%.
(4) invalid: symptom, sign are all not improved, even increase the weight of, syndrome integral reduces < 30%.
The data acquisition SPSS13.0 statistical software that above-mentioned formula obtains as calculated afterwards carries out statistical disposition.The comparison of normal distribution measurement data adopts t inspection and one factor analysis of variance, use (mean ± standard deviation) ( ) represent; The measurement data of partial velocities compares employing rank test, with median (interquartile range) [M (Q l~ Q u)] represent.The comparison of enumeration data adopts X 2 test.
3, therapeutic outcome evaluation
3.1 water seperation pillar groups and mild-warm moxibustion group two groups of total effective rates compare
The treatment total effective rate of above-mentioned water seperation pillar group and mild-warm moxibustion group, in table 1.
Table 1 water seperation pillar group compares with mild-warm moxibustion group total effective rate
Group Number of cases Cure Effective Effectively Invalid Total effective rate %
Mild-warm moxibustion group 28 7 7 6 8 71.43%
Water seperation pillar group 30 0 2 24 4 80.00%
P>0.05
From table 1, effective 2 examples (6.66%) of water seperation pillar group, effective 24 examples (80.00%), invalid 2 examples (6.66%), total effective rate is 80.00%; Cure 7 examples (25.00%) in mild-warm moxibustion group, effective 7 examples (25.00%), effective 6 examples (21.42%), invalid 8 examples (28.57%), total effective rate is 71.43%.The total effective rate of two groups is without showing sex differernce P>0.05.Wherein, P value is statistics term, calculate according to statistical method, if P>0.05 represents do not have significant difference between two groups comparing, if P<0.05 represents have significant difference between two groups comparing.
3.2 water seperation pillar groups and mild-warm moxibustion group treat front and back cardinal symptom integral contrast
Cardinal symptom integration before and after the treatment of above-mentioned water seperation pillar group and mild-warm moxibustion group, in Table 2-1,2-2.
Table 2-1 water seperation pillar group and mild-warm moxibustion group treat front and back cardinal symptom integration
Compare with before treatment, #P<0.05, ##P<0.05; Compare with mild-warm moxibustion group, * P<0.01
Table 2-2 water seperation pillar group and mild-warm moxibustion group treat front and back cardinal symptom integration
Compare with before treatment, #P<0.05, ##P<0.05; Compare with mild-warm moxibustion group, ☆ P<0.05
From table 2-1,2-2, water seperation pillar group and mild-warm moxibustion group treat front cardinal symptom integral contrast, statistical procedures, without showing sex differernce (P>0.05), have comparability; After treatment, the score value of two groups of cardinal symptoms, compared with before treatment, through statistical analysis, has and shows sex differernce (P<0.05).
Compare between two groups, through statistical analysis, water seperation pillar group after the treatment patient's " happiness warm ", " loose stool " cardinal symptom is improved, and curative effect has and shows sex differernce (P<0.01, P<0.05).
Illustrate that the clinical efficacy of this medicine cake treatment chronic gastritis is significantly better than common mild-warm moxibustion.
Obvious adverse events is there is not in two groups of patients at treatments period.There is not obvious hepatic and renal function injure, serious disease in the blood system and cardiovascular and cerebrovascular vessel thunder bolt.Moxibustion treatment is described to patient without obvious harmful effect.
When finding that medicine typing is damp-heat accumulation type patient, by adding the Rhizoma Coptidis composition with the effect such as heat clearing and damp drying, eliminating fire and detoxication on formula basis, thus effectively treat damp-heat accumulation type patient, clinical efficacy is obvious.
Embodiment 7
Drug efficacy study: the clinical trial of ulcerative colitis
The water seperation pillar medicine cake sample 2# of preparation in embodiment 2 is carried out water seperation pillar treatment by the present invention, and the mild-warm moxibustion carried out with routine treat and compared, and in evaluation the present invention, the medicine cake prepared is for after water seperation pillar, to the clinical efficacy of ulcerative colitis.
1, patient criteria:
1.1 patient persons
Collect year March in March, 2012 to 2013, meet the UC 65 Cases of Patients of Low Potassium of this research standard from Shanghai Acupuncture Channel Inst.'s ulcerative colitis training and Zhongshan Hospital Attached to Fudan Univ's endoscope center, wherein women 40 example, male 25 example, come off and reject 5 examples.Wherein, herbs-partition moxibustion group 30 example, man 13 example, female 17 example, age 26-65 year, 57 ± 8 years old mean age, the course of disease 0.5 year-10 years; Mild-warm moxibustion group 30 example, man 14 example, female 16 example, 18-65 year, 53 ± 10 years old mean age, the course of disease 0.5 year-10 years.
1.2 patient diagnosis standards
1.2.1 Western medicine diagnose standard
Patient is selected in the UC diagnostic criteria that the patient selected in the present embodiment revises according to national inflammatory bowel scientific seminar (Jinan) in 2007.
1. clinical manifestation: have continue or the diarrhoea of recurrent exerbation, mucus bloody purulent stool companion stomachache, tenesmus and General Symptoms in various degree.The course of disease is many more than 4 to 6 weeks, and joint, skin, eye, mouth and the intestinal such as liver, gallbladder can be had outward to show.
2. colonoscopy: pathological changes is many from rectum, in seriality, diffusivity distribution, shows as: a mucosa vascular lake is fuzzy, disorderly, congested, edema, easily crisp, hemorrhage and purulent secretion are adhered to, and also common mucosa is coarse, in fine particulate; B pathological changes obviously locates the multiple erosion of visible diffusivity or ulcer; C catabasis visible colon bag shoals, rust or disappearance, pseudopolyp and bridge shape mucosa etc.
3. x-ray barium enema checks: main manifestations: the thick unrest of mucosa and (or) granular change; Intestinal tube edge is sawtooth sample or burr sample, and intestinal wall has multiple little filling defect; Intestinal tube cripetura, bag disappears in lead pipe sample.
4. mucous membrane tissue checks: have active stage and paracmastic different manifestations.Active stage: diffusivity, chronic inflammation cell and neutrophilic granulocyte, eosinophils in a lamina propria; B crypts acute inflammation cellular infiltration, especially neutrophil infiltration, cryptitis between epithelial cell, even form crypt abscess, and abscess can be had to burst into lamina propria; C crypts epithelial proliferation, goblet cell reduces; The visible mucosa top layer of d is rotten to the corn, ulcer, granulation tissue hyperplasia; Catabasis: a neutrophilic granulocyte disappears, chronic inflammatory cells reduces; B crypts size, form are irregular, arrangement disorder; The gap of c glandular epithelium and muscularis mucosae is broadening, Paneth cell metaplasia.
On the basis getting rid of the diseases such as infectious colitis and colon C D, ischemic colitis, radiation colitis such as bacillary dysentery, amebic dysentery, chronic schistosomiasis, tuberculosis of intestine, can by following standard diagnostics:
1. there is typical clinical manifestations, and have and (or) the diagnosable primary disease of mucosa biopsy in scope three characteristics changes at least.
2. typical clinical manifestations is had, and one of have at least x-ray barium enema characteristic to change in three item, diagnosable primary disease.
3. atypical symptoms, but have typical scope or x-ray barium enema finding person, also clinical plan can examine primary disease and observe outbreak situation.
A complete diagnosis should comprise its Clinical types, the order of severity, extent of disease, the state of an illness by stages.
(1) Clinical types
Chronic relapsing: extent of disease is little, symptom is comparatively light, often has the catabasis.
Chronic sustained type: extent of disease is comparatively wide, more than Symptoms last half a year.
Acute fulminant form: onset is hurried, serious symptom, the complication such as companion's systemic toxicity profiles symptom septicemia.
First hair style: the First episode without history of past illness.
(2) order of severity
Slight: patient suffers from diarrhoea and is less than 3 every day.
Moderate: between slight and severe.
Severe: suffer from diarrhoea every day more than 6 times, accompany obvious mucus hemafecia, body temperature >37.5 DEG C, pulse >90 time/min, hemoglobin (Hb) <100g/L, erythrocyte sedimentation rate >30mm/h.
(3) extent of disease
Proctitis, proctosigmoiditis, left hemicolon inflammation, pancolitis can be divided into.
(3) state of an illness by stages
Be divided into active stage and catabasis, evaluate Southedand disease activity index (DAI), also claim Mayor index.
Active stage: have manifest symptom and sign or accompany the quickening of toxic colonic dilatation pulse or anemia etc., colonoscope is viewed as the performance of course inflammatory activity phase, and histopathologic examination shows activity.
Catabasis: non-evident sympton sign, colonoscope is viewed as inflammation and alleviates performance resting stage, and histopathologic examination shows that resting stage changes.
1.2.2 Syndrome Differentiation of Traditional Chinese Medicine
" the ulcerative colitis Chinese traditional medical diagnose National Consensus " issued according to the 21st, 2010 the spleen-stomach disease branch of China Association of Traditional Chinese Medicine national the spleen-stomach disease academic conference discussion is selected insufficiency of the spleenly wetly to accumulate, observation included in by stagnation of liver-QI with deficiency of the spleen and deficiency of spleen-YANG and kidneyYANG three type, and standard is as follows:
(1) insufficiency of the spleen wetting accumulates card: primary symptom: 1. large loose stool is thin, mucus white dortch less, or for freeze in vain; 2. body of the tongue is light red, while there is indentation, tongue is greasy in vain.Secondary disease: 1. stomachache indistinctly; 2. distension and fullness in the abdomen, lack of appetite poor appetite; 3. limbs asthenia, spiritlessness and sparing of words; 4. thready and weak pulse or fine and smooth.
(2) liver-depression and spleen-insufficiency type: primary symptom: 1. suffer from abdominal pain and namely rush down, rushes down rear alleviation of pain; 2. often to increase because feelings will or dietary factor bring out times of defecation.Secondary disease: 1. loose stool, or mucus is just; 2. to be in a very depressed state or anxious; 3. belch is not well, lack of appetite abdominal distention; 4. body of the tongue is light red, white and thin fur; 5. stringy pulse or stringy and thready pulse.
(3) syndrome of yang deficiency of spleen and kidney: primary symptom: 1. incessant chronic diarrhea, accompany white freezing, very then aqueous-grainy diarrhea, slippage be can't help; 2. coldness of the body with chills.Secondary disease: the 1. warm pain relieved by pressing of stomachache happiness; 2. abdominal distention, lack of appetite poor appetite; 3. soreness of waist and knee; 4. pale tongue is fat, or has indentation, and thin fur is white and moist; 5. deep-thready pulse.
Above pattern of syndrome is determined: possess primary symptom 2 (the 1. item indispensable), secondary disease 2, or primary symptom the 1. item, secondary disease 3.
When finding damp-heat accumulation type patient, need to add the Rhizoma Coptidis with the effect such as heat clearing and damp drying, eliminating fire and detoxication, for effectively improving clinical efficacy.
1.2.3 inclusive criteria
1. UC diagnostic criteria is met;
2. chronic sustained type and chronic relapsing UC is met;
3. 18 ~ 65 years old age;
4. Syndrome Differentiation of Traditional Chinese Medicine is insufficiency of the spleen type of latent damp or liver-depression and spleen-insufficiency type or yang deficiency of spleen and stomache;
5. add this test voluntarily, and sign " Informed Consent Form " person.
1.2.4 exclusion standard
1. the UC patient of other TCM Syndrome Type;
2. acute fulminant or just hair style UC patient;
3. apply glucocorticoids etc. simultaneously and may affect result judgement medicine person;
4. infectious colitis or ischemic colitis or radiation colitis patient;
5. with the heart, brain, liver, kidney and hemopoietic system serious disease person or psychotic;
6. because a variety of causes stops treatment probability greatly, person's course for the treatment of can not be completed.
1.2.5 case abort criterion
1. the selected rear continuous worsening person of the state of an illness;
2. the patient of compliance difference;
3. there is serious adverse events person;
4. bolter is required.
2, therapeutic scheme
2.1 random packet
The UC patient meeting inclusive criteria is divided into water seperation pillar group and ginger moxibustion group at random.Random packet method: utilize SPSS15.0 Software Create random digit to carry out random packet.Make random assortment card, be sealed in envelope, envelope numbers (identical with the card sequence number included), by special messenger's keeping, when Eligible subjects enters research, enter order by it and take the identical envelope of sequence number apart, treat according to card scheme.According to 1.1, water seperation pillar group selection 32 routine patient treat, and come off and reject 2 examples, mild-warm moxibustion group selection 33 routine patient treat, and comes off and reject 3 examples.
2.2 Therapeutic Method
Carry out location, acupuncture point according to reference to National Standard of the People's Republic of China " acupuncture points on the human body title and location " (GB12346-2006), select cave: TIANSHU acupoint (ST25) (two), the Large Intestine Shu (two).Wherein, TIANSHU acupoint (ST25): in the middle part of abdomen, flat Qizhong is other opens 2 cun, left and right each.The Large Intestine Shu: at waist, when under the 4th spinous process of lumbar vertebra, side opens 1.5 cun, left and right each.
Wherein, the medicine cake sample 2# in water seperation pillar group selection embodiment 2, adopts moxa cone to refine Folium Artemisiae Argyi (Suzhou product) with Huatuo's board and makes, and become diameter 1.8cm, height 1.5cm by mold compresses, weight is about 1.5g.Every cave moxibustion 1 is strengthened, and every day 1 time was for 12 times 1 course for the treatment of, interval rest course for the treatment of 3d, altogether 6 courses for the treatment of of moxibustion.
The common clear moxa roll that mild-warm moxibustion group adopts Nanyang Chinese medicine Folium Artemisiae Argyi factory to produce, apart from acupuncture point 2-3cm just moxibustion, each every cave 20min, every day 1 time was for 12 times 1 course for the treatment of, interval rest course for the treatment of 3d, altogether 6 courses for the treatment of of moxibustion.
2.3 evaluation method
After moxibustion, observe the change of the main clinic symptoms of patient after 6 courses for the treatment of of moxibustion treatment, clinical cardinal symptom comparitive study adopts therapeutic index (nimodipine method) to evaluate, and concrete formula is as follows:
Therapeutic index=[before (before treatment the rear integration of integration-treatment) ÷ treatment integration] × 100%
The principle that " new Chinese medicine guideline of clinical investigations (trying) " that above-mentioned formula is published with reference to Ministry of Health of the People's Republic of China for 2002 formulates is marked, wherein, treatment foreset is divided into the summation of the front all symptom integral for the treatment of, and after treatment, integration is the summation of all symptom integral after treatment.The methods of marking of concrete clinical symptoms refer to " gastrointestinal disease TCM syndrome evaluation table " (the danger North Sea, Chen Zhishui, Zhang Wandai. gastrointestinal disease TCM syndrome grade form. world Chinese digests magazine, 2004,12 (11): 2701-2703).
Wherein, different moxibustion therapy, to patients of ulcerative colitis clinical observation on the therapeutic effect, is carried out from the following aspect: (1) disease curative effect.(2) cardinal symptom curative effect: integration of 1. suffering from abdominal pain improves average evaluation; 2. integration of suffering from diarrhoea improves situation; 3. mucus bloody purulent stool integration improves situation.
Meanwhile, the ulcerative colitis criterion of therapeutical effect that the national the spleen-stomach disease academic conference discussion of efficacy assessment standard reference the 21st, 2010 the spleen-stomach disease branch of China Association of Traditional Chinese Medicine of above-mentioned formula is issued " ulcerative colitis Chinese traditional medical diagnose National Consensus " is revised.Specific standards is as follows:
(1) fully recover: tcm clinical practice symptom, sign disappear or substantially disappear, syndrome integral reduces >=95%.
(2) effective: tcm clinical practice symptom, sign are obviously improved, syndrome integral reduces >=70%.
(3) effective: tcm clinical practice symptom, sign all take a favorable turn, syndrome integral reduces >=30%.
(4) invalid: tcm clinical practice symptom, sign are all not improved, even increase the weight of, syndrome integral reduces < 30%.
The data SPSS15.0 software kit that above-mentioned formula obtains as calculated afterwards carries out statistical analysis to data, and measurement data meets the use of normal distribution represent, do not meet describing with Median (min, max) of normal distribution; Meet normal distribution and the neat measurement data of variance, compare between group with independent samples t test (Two-samplet-test), compare with paired-sample t test (Pairedt-test) in group; Do not meet the measurement data of normal distribution, compare the Wilcoxon rank test (Wilcoxonrandsumtest) of comparing with two independent samples between group, in group, compare the Wilcoxon signed rank sum test (Wilcoxonsigned-ranktest) compared with paired sample.Enumeration data adopts χ 2the signed rank sum test of inspection or ranked data.Inspection level α=0.05, P < 0.05 is for there being statistical significance.
3, therapeutic outcome evaluation
3.1 Clinical Global comparitive study
The Clinical Global curative effect of above-mentioned water seperation pillar group and mild-warm moxibustion group, in table 3.
Table 3 liang group patients of ulcerative colitis Clinical Global comparitive study [n (%)]
Group n Recovery from illness Effective Effectively Invalid Total effective rate %
Water seperation pillar group 30 0 10(33.3) 18(60.00) 2(6.7) 93.3
Mild-warm moxibustion group 30 0 6(20.0) 17(56.67) 7(23.33) 76.7
From upper table 3, effective 10 examples (33.3%) of herbs-partition moxibustion group, effective 18 examples (60%), invalid 2 examples (6.7%), total effective rate 93.3%; Effective 6 examples (20.0%) of mild-warm moxibustion group, effective 17 examples (66.7%), invalid 7 examples (13.3%), total effective rate 76.7%.Two groups of comparitive study have statistical significance (P<0.05), and prompting water seperation pillar treatment ulcerative colitis general curative effect is better than mild-warm moxibustion.
3.2 TCM symptom scores improve situation
Symptom total mark situation before and after the treatment of above-mentioned water seperation pillar group and mild-warm moxibustion group, in table 4, wherein, M is meansigma methods, min and max is minima and maximum respectively.
Before and after table 4 liang group treatment, symptom total mark compares [M (min, max)]
Group n Before treatment After treatment Difference
Herbs-partition moxibustion group 30 18.0(12,36) 7.0(1,20) 10.0(4,24)
Mild-warm moxibustion group 30 14.0(5,32) 6.0(2,16) 12.5(3,17)
Note: compared with mild-warm moxibustion, P < 0.05
From upper table 4, before two groups of treatments, symptom total mark is through Mann-WhitneyU non parametric tests, difference has statistical significance (P < 0.05), and prompting water seperation pillar significantly can improve patients of ulcerative colitis tcm symptom total mark, is better than mild-warm moxibustion.
In sum, water seperation pillar treatment ulcerative colitis has good clinical efficacy, is obviously better than mild-warm moxibustion.
Obvious adverse events is there is not in two groups of patients at treatments period.There is not obvious hepatic and renal function injure, serious disease in the blood system and cardiovascular and cerebrovascular vessel thunder bolt.Moxibustion treatment is described to patient without obvious harmful effect.
When finding that medicine typing is damp-heat accumulation type patient, by adding the Rhizoma Coptidis composition with the effect such as heat clearing and damp drying, eliminating fire and detoxication on formula basis, thus effectively treat damp-heat accumulation type patient, clinical efficacy is obvious.
Embodiment 8
Drug efficacy study: the clinical trial of irritable bowel syndrome
The water seperation pillar medicine cake sample 3# of preparation in embodiment 3 is carried out water seperation pillar treatment by the present invention, and the mild-warm moxibustion carried out with routine treat and compared, and in evaluation the present invention, the medicine cake prepared is for after water seperation pillar, to the clinical efficacy of irritable bowel syndrome.
1, patient criteria:
1.1 patient persons
With random, contrast, single blind method, therapeutic evaluation is carried out to 227 routine irritable bowel syndrome (IBS) patients and technical specificationization is studied.From the IBS patient that year February in November, 2004 to 2007 goes to a doctor in out-patient department of Shanghai Acupuncture Channel Inst., Maple Street, Shanghai City road Health Center and Shanghai Qigong Inst, collect 227 cases altogether.Carry out clinical grouping randomized controlled treatment, after two courses for the treatment of, collect case mild-warm moxibustion group 115 example of completed treatment, water seperation pillar group 112 example.
1.2 patient diagnosis standards
1.2.1 Western medicine diagnose standard
The patient selected in the present embodiment chooses Patients with Diarrhea Irritable Bowel Syndrome according to the classification of Rome functional gastrointestinal disease and diagnostic criteria.Rome diagnostic criteria for irritable bowel syndrome is as follows:
(1) past 12 months at least accumulatively had 12 weeks (needing not to be continuous print) to suffer from abdominal pain or abdominal discomfort, and with 2 of following 3 symptoms:
1. stomachache or abdominal discomfort are alleviated after defecation.
2. there is the change with defecation frequency in stomachache or abdominal discomfort.
3. there is the change with feces character in stomachache or abdominal discomfort.
(2) following symptom is not that diagnosis institute is indispensable, but belong to IBS common sympton, these symptoms more support the diagnosis of IBS more at most: 1. stool abnormal (every day defecation >3 time or weekly defecation <3 time), 2. feces character abnormal (block/hard just or rare/watery stool), 3. feces discharge process abnormal (effort, sense of urgency, defecation are not felt only), 4. mucus just, 5. flatulence or abdominal distension sense.
(3) morphological change and the biochemistry that lack soluble symptom are abnormal
Clinical typing:
According to clinical symptoms, IBS can be divided into diarrhoea for principal mode, constipation be principal mode and alternating diarrhea and constipation type 3 hypotypes.The symptom of typing foundation: 1. defecation <3 time weekly, 2. every day defecation >3 time, 3. block or hard just, 4. just completely mashed or watery stool, 5. defecation effort, 6. defecation urgency sense.
1.2.2 Syndrome Differentiation of Traditional Chinese Medicine
The patient selected in the present embodiment carries out Chinese medical discrimination for following symptom.
(1) incoordination between the liver and spleen type: often because depression is angry or psychentonia and fall ill or increase the weight of, gas is vowed in borborygmus, and namely stomachache rush down, and rushes down seldom lower, rushes down rear pain to delay, companion's cramp and pain in the lower abdomen, and fullness and distention in the chest and hypochondrium, belch is eaten less, just descends mucus, light red tongue, white and thin fur, stringy and thready pulse.
(2) due to weakness of spleen and stomach: disease sees the slightly improper i.e. loose stool of diet, often or aqueous-grainy diarrhea, and accompanies white slimy.Abdominal part dull pain, oppression sensation over the epigastrium, shallow complexion, tired, pale tongue with white fur, thready and weak pulse.
When finding damp-heat accumulation type patient, need to add the Rhizoma Coptidis with the effect such as heat clearing and damp drying, eliminating fire and detoxication, for effectively improving clinical efficacy.
1.2.3 inclusive criteria
1. diagnostic criteria is met;
2. the IBS of diarrhea-type is met;
3. 18 ~ 65 years old age, male or female;
4. Syndrome Differentiation of Traditional Chinese Medicine is due to weakness of spleen and stomach, incoordination between the liver and spleen type;
5. do not apply the medicine of other treatment such as pinaverium bromide, octreotide or Chinese medicine IBS simultaneously;
6. without serious condition and the mental disease of other systems such as the heart, brain, liver, kidney.
1.2.4 exclusion standard
1. above-mentioned diagnostic criteria is not met;
2. meet diagnostic criteria but be constipation type or constipation and diarrhoea alternate type;
3. the patient of functional abdominal pain and functional diarrhea is belonged to;
4. apply cisapride, Ao get Tai Long, other Chinese medicines etc. may affect result and judge to obtain medicine person simultaneously;
5. the patient of less than 17 years old or over-65s;
6. gestation or age of sucking patient;
7. with the heart, brain, liver, kidney and hemopoietic system serious disease, psychosis and other serious diseases patient.
2, therapeutic scheme
2.1 random packet
Each center adopts simple randomization grouping, and group technology is: make random assortment card, be sealed in envelope, and envelope numbers (identical with the card sequence number included), by special messenger's keeping.When Eligible subjects enters research, by its entering order associated envelope sequence number, carry out dividing into groups and treating according to the random number in card.Random digit odd number is treatment group, and random number is even number is matched group.According to 1.1, water seperation pillar group selection 112 routine patient treat, and mild-warm moxibustion group selection 115 routine patient treat.
2.2 Therapeutic Method
Carry out location, acupuncture point according to reference to National Standard of the People's Republic of China " acupuncture points on the human body title and location " (GB12346-2006), acupuncture points on the human body prescription selects cave: Tianshu, Shangjuxu.Dialectical adjunct acupuncture points: 1. due to weakness of spleen and stomach adds Pishu; 2. incoordination between the liver and spleen type adds bl.
Wherein, the medicine cake sample 3# in water seperation pillar group selection embodiment 3, adopts moxa cone, carries out water seperation pillar, and each moxibustion 2 in each every cave is strengthened, the next day 1 time, be for 10 times 1 course for the treatment of, the course for the treatment of, interval had three days off, altogether 2 courses for the treatment of of moxibustion.
Mild-warm moxibustion group adopts moxa roll, is executing mild-warm moxibustion after being lighted by moxa roll apart from about 5cm place, above acupuncture point, can stand as degree with patient, moxibustion to erubescence, 30 minutes, each every cave, the next day 1 time, 10 times was 1 course for the treatment of, had three days off between the course for the treatment of, altogether 2 courses for the treatment of of moxibustion.
2.3 evaluation method
After moxibustion, observe the change of the main clinic symptoms of patient after 2 courses for the treatment of of moxibustion treatment, clinical cardinal symptom comparitive study adopts observation of symptoms and point system (nimodipine method) to evaluate, and concrete formula is as follows:
Integration × 100% before diagnosis and treatment index R=(before N treatment, integration-N treats rear integration)/N treats
The principle that " new Chinese medicine guideline of clinical investigations (trying) " that above-mentioned formula is published with reference to Ministry of Health of the People's Republic of China for 2002 formulates is marked, wherein, treatment foreset is divided into the summation of the front all symptom integral for the treatment of, and after treatment, integration is the summation of all symptom integral after treatment.The methods of marking of concrete clinical symptoms refer to " gastrointestinal disease TCM syndrome evaluation table " (the danger North Sea, Chen Zhishui, Zhang Wandai. gastrointestinal disease TCM syndrome grade form. world Chinese digests magazine, 2004,12 (11): 2701-2703).
Wherein, after terminating the course for the treatment of, observe the improvement situation of the symptom such as stomachache, diarrhoea, abdominal distention, borborygmus, and judge effect according to the grade difference of each observation item symptom before and after treatment.1. effective: transference cure, or symptom scales difference=2 before and after treatment; 2. effective: treatment before and after symptom scales poor=1; 3. invalid: treatment before and after symptom scales poor=0.Carry out comprehensive assessment according to result, this work is collected by the special messenger through training, records, preserves and is analyzed with being responsible for related data, and clinical treatment operator does not participate in this work.
Meanwhile, the efficacy assessment standard of above-mentioned formula is as follows:
(1) effective: stool is normal, and other symptom is alleviated substantially, R >=70%;
(2) effective: times of defecation obviously reduces, other symptom is improved, 30%≤R<70%;
(3) invalid: times of defecation has no obvious improvement, other symptom has no improvement, R<30%.
3, therapeutic outcome evaluation
Before and after 3.1 treatments, curative effect scoring is compared
Before and after the treatment of above-mentioned water seperation pillar group and mild-warm moxibustion group, curative effect is marked situation, in table 5, wherein ( ) be statistics term, represent mean plus-minus standard deviation.
The curative effect scoring of table 5 treatment front and back is compared ( )
Compare in group: * * is p<0.01
From upper table 5, respectively statistical analysis is carried out to mild-warm moxibustion and this short term effect of two groups of water seperation pillar and late result, have significant statistical significance (the equal <0.01 of P), mild-warm moxibustion and water seperation pillar all have good therapeutical effect to D-IBS.
Result after 3.2 treatments is observed
3.2.1 short term effect
The short term effect data of above-mentioned water seperation pillar group and mild-warm moxibustion group, in table 6.
Table 6 short term effect statistical table
Group Number of cases (n) Effective Effectively Invalid Obvious effective rate (%) Total effective rate (%)
Mild-warm moxibustion 115 35 63 17 35.61 85.22
Water seperation pillar 112 55 52 5 49.11 95.54
Note: compared with mild-warm moxibustion, P < 0.05
From upper table 6, collect effective case totally 227 examples, wherein mild-warm moxibustion group 115 example, effective 35 examples (30.43%), effective 63 examples (54.78%), invalid 17 examples (14.78%), obvious effective rate 35.61%, total effective rate 85.22%; Herbs-partition moxibustion group 112 example, effective 55 examples (49.11%), effective 52 examples (46.43%), invalid 5 examples (4.46%), obvious effective rate 49.11%, total effective rate 95.54%.The obvious effective rate of two groups is compared, has significant difference (P<0.05), two groups of therapeutic equivalences; The total effective rate of two groups is compared, has significant difference (P<0.05).
3.2.2 every clinical symptoms comparitive study
(1) mild-warm moxibustion and water seperation pillar are to the comparitive study of D-IBS symptom of diarrhea
Above-mentioned water seperation pillar group and mild-warm moxibustion group to the efficacy data of D-IBS symptom of diarrhea, in table 7.
Table 7 mild-warm moxibustion and water seperation pillar are to the comparitive study table (example) of D-IBS symptom of diarrhea
From upper table 7, analyze through ridit, two groups have statistical significance to difference in the improvement of times of defecation and stool, and the curative effect of water seperation pillar is better than mild-warm moxibustion (the equal <0.05 of P).In improvement diarrhoea frequency and stool, mild-warm moxibustion and water seperation pillar group curative effect no difference of science of statistics (P>0.05).
(2) mild-warm moxibustion and water seperation pillar are to the comparitive study of D-IBS colic symptoms
Above-mentioned water seperation pillar group and mild-warm moxibustion group to the efficacy data of D-IBS colic symptoms, in table 8.
Table 8 mild-warm moxibustion and water seperation pillar are to the comparitive study table (example) of D-IBS colic symptoms
From upper table 8, analyze through ridit, two groups of frequency, degree Different therapeutical effect not statistically significants (the equal >0.05 of P) in stomachache, the improvement of stomachache time has statistical significance (P<0.05), and water seperation pillar curative effect is better than mild-warm moxibustion.
(3) mild-warm moxibustion and water seperation pillar are to the comparitive study of D-IBS abdominal distention or abdominal discomfort
Above-mentioned water seperation pillar group and mild-warm moxibustion group to the efficacy data of D-IBS abdominal distention or abdominal discomfort, in table 9.
Table 9 mild-warm moxibustion and water seperation pillar are to the comparitive study table (example) of D-IBS abdominal distention or abdominal discomfort
From upper table 9, analyze through ridit, two groups of improvement no difference of science of statistics (the equal >0.05 of P) to abdominal distention or abdominal discomfort frequency, degree, two groups of curative effects are substantially suitable.Have significant difference (P<0.05) to the improvement of the time of abdominal distention or abdominal discomfort, water seperation pillar is better than mild-warm moxibustion for the improvement of symptom.
(4) mild-warm moxibustion and water seperation pillar are to the comparitive study of D-IBS borborygmus
Above-mentioned water seperation pillar group and mild-warm moxibustion group to the efficacy data of D-IBS borborygmus, in table 10.
Table 10 mild-warm moxibustion and water seperation pillar are to the comparitive study table (example) of D-IBS borborygmus
Group Effective Effectively Invalid
Mild-warm moxibustion 29 47 39
Water seperation pillar 42 38 32
From upper table 10, analyze through ridit, two groups have significant difference (P<0.05) to the improvement of borborygmus symptom, and water seperation pillar curative effect is better than mild-warm moxibustion.
(5) mild-warm moxibustion and water seperation pillar comparitive study that D-IBS defecation is felt not to the utmost
The efficacy data that above-mentioned water seperation pillar group and mild-warm moxibustion group are felt not to the utmost to D-IBS defecation, in table 11.
The comparitive study table (example) that table 11 mild-warm moxibustion and water seperation pillar are felt not to the utmost to D-IBS defecation
Group Effective Effectively Invalid
Mild-warm moxibustion 28 50 37
Water seperation pillar 33 54 25
From upper table 11, analyze through ridit, two groups of improvement felt not to the utmost defecation have significant difference (P<0.05), and water seperation pillar curative effect is better than mild-warm moxibustion.
(6) mild-warm moxibustion and water seperation pillar are to the comparitive study of D-IBS defecation urgency sense
Above-mentioned water seperation pillar group and mild-warm moxibustion group to the efficacy data of D-IBS defecation urgency sense, in table 12.
Table 12 mild-warm moxibustion and water seperation pillar are to the comparitive study table (example) of D-IBS defecation urgency sense
Group Effective Effectively Invalid
Mild-warm moxibustion 30 51 34
Water seperation pillar 36 49 27
From upper table 12, analyze through ridit, two groups of improvement no difference of science of statistics (P>0.05) to defecation urgency sense.
(7) mild-warm moxibustion and water seperation pillar are to the comparitive study of D-IBS psychological abnormality
Above-mentioned water seperation pillar group and mild-warm moxibustion group to the efficacy data of D-IBS psychological abnormality, in table 13.
Table 13 mild-warm moxibustion and water seperation pillar are to the comparitive study table (example) of D-IBS psychological abnormality
Group Effective Effectively Invalid
Mild-warm moxibustion 35 39 41
Water seperation pillar 32 42 38
From upper table 13, analyze through ridit, two groups of improvement to psychological abnormality are without notable statistics difference (P>0.05).
(8) mild-warm moxibustion and water seperation pillar are to the comparitive study of D-IBS stomach discomfort
Above-mentioned water seperation pillar group and mild-warm moxibustion group to the efficacy data of D-IBS stomach discomfort, in table 14.From following table 14, analyze through ridit, two groups have significant difference (P<0.05) to the improvement of stomach discomfort, and mild-warm moxibustion curative effect is better than water seperation pillar.
Table 14 mild-warm moxibustion and water seperation pillar are to the comparitive study table (example) of D-IBS stomach discomfort
Group Effective Effectively Invalid
Mild-warm moxibustion 42 40 33
Water seperation pillar 33 39 40
(9) mild-warm moxibustion and the water seperation pillar comparitive study indigestion and loss of appetite to D-IBS
Above-mentioned water seperation pillar group and the mild-warm moxibustion group efficacy data indigestion and loss of appetite to D-IBS, in table 15.From following table 15, through ridit analyze, two groups to indigestion and loss of appetite improvement without notable statistics difference (P>0.05).
Table 15 mild-warm moxibustion and the water seperation pillar comparitive study table (example) indigestion and loss of appetite to D-IBS
Group Effective Effectively Invalid
Mild-warm moxibustion 36 34 45
Water seperation pillar 31 36 45
(10) mild-warm moxibustion and the water seperation pillar comparitive study weak to D-IBS
Above-mentioned water seperation pillar group and the mild-warm moxibustion group efficacy data weak to D-IBS, in table 16.From following table 16, analyze through ridit, two groups to weak improvement no difference of science of statistics (P>0.05).
Table 16 mild-warm moxibustion and the water seperation pillar comparitive study table (example) weak to D-IBS
Group Effective Effectively Invalid
Mild-warm moxibustion 37 46 32
Water seperation pillar 39 42 31
(11) mild-warm moxibustion and water seperation pillar are to D-IBS mucus comparitive study just
Above-mentioned water seperation pillar group and mild-warm moxibustion group to D-IBS mucus efficacy data just, in table 17.
Table 17 mild-warm moxibustion and water seperation pillar are to D-IBS mucus comparitive study table (example) just
Group Effective Effectively Invalid
Mild-warm moxibustion 30 29 56
Water seperation pillar 42 26 44
From upper table 17, analyze through ridit, two groups have significant difference (P<0.05) to the improvement of Mucous Stool, and herbs-partition moxibustion curative effect is better than mild-warm moxibustion.
3.2.3 (after 6 months) each clinical symptoms statistical result is followed up a case by regular visits to
Above-mentioned water seperation pillar group and mild-warm moxibustion group are treated treatment and are followed up a case by regular visits to after 6 months and obtain each clinical symptoms statistical result data, in table 18.
Each clinical symptoms statistical table followed up a case by regular visits to by table 18
*P<0.05
According to follow up a case by regular visits to treat before each grade difference of observing item symptom judge effect, namely be effective, effective and invalid according to score value size determination curative effect, wherein, 1. effective: transference cure, or symptom scales difference=2 before and after treatment, 2. effective: treatment before and after symptom scales poor=1,3. invalid: treatment front and back symptom scales poor=0.
Can be drawn by table 18, the improvement situation of 141 each symptoms of patient of following up a case by regular visits to is as follows:
1. two groups have significant difference to the improvement of stomachache, abdominal distention (P<0.05) symptom, and herbs-partition moxibustion curative effect is better than mild-warm moxibustion.
2. two groups to diarrhoea, stool not to the utmost sense, defecation urgency sense, mucus just, the improvement not statistically significant (P>0.05) of indigestion and loss of appetite, weak, stomach discomfort, at heart abnormal symptom.
In sum, moxibustion treatment irritable bowel syndrome has good clinical efficacy, and the curative effect of herbs-partition moxibustion group is better than mild-warm moxibustion group on the whole.
Obvious adverse events is there is not in two groups of patients at treatments period.There is not obvious hepatic and renal function injure, serious disease in the blood system and cardiovascular and cerebrovascular vessel thunder bolt.Moxibustion treatment is described to patient without obvious harmful effect.
When finding that medicine typing is damp-heat accumulation type patient, by adding the Rhizoma Coptidis composition with the effect such as heat clearing and damp drying, eliminating fire and detoxication on formula basis, thus effectively treat damp-heat accumulation type patient, clinical efficacy is obvious.
At present, the correlational study of this medicine of Clinical practice cake finds, and the clinical efficacy of the treatment of this medicine cake chronic gastritis, intractable chronic enteritis etc. is significantly better than common mild-warm moxibustion.So the present invention effectively overcomes various shortcoming of the prior art and tool high industrial utilization.
Above-described embodiment is illustrative principle of the present invention and effect thereof only, but not for limiting the present invention.Any person skilled in the art scholar all without prejudice under spirit of the present invention and category, can modify above-described embodiment or changes.Therefore, such as have in art usually know the knowledgeable do not depart from complete under disclosed spirit and technological thought all equivalence modify or change, must be contained by claim of the present invention.

Claims (10)

1. a moxa-moxibustion medicine cake Chinese medicine composition, is characterized in that, its main pharmacodynamics composition comprises following component by weight:
2. moxa-moxibustion medicine cake Chinese medicine composition according to claim 1, is characterized in that, the main pharmacodynamics composition of described moxa-moxibustion medicine cake Chinese medicine composition also includes Rhizoma Coptidis 0.2-2 part by weight.
3. moxa-moxibustion medicine cake Chinese medicine composition according to claim 1, it is characterized in that, its main pharmacodynamics composition comprises following component by weight:
4., according to the preparation method of the arbitrary described moxa-moxibustion medicine cake Chinese medicine composition of claim 1-3, it is characterized in that, comprise the following steps:
1) get each main pharmacodynamics composition by proportioning to pulverize, sieve, medicated powder is made in mixing, for subsequent use;
2) get step 1) in obtained medicated powder, add mixed aid, be mixed into cream pasty mixture, then use mold compresses patent medicine cake.
5. the preparation method of moxa-moxibustion medicine cake Chinese medicine composition according to claim 4, is characterized in that, step 2) in, the ratio of the weight that described medicated powder adds with described mixed aid is 2-3:3-5.
6. the preparation method of moxa-moxibustion medicine cake Chinese medicine composition according to claim 4, is characterized in that, step 2) in, described mixed aid be selected from Rhizoma Zingiberis Recens juice or yellow wine any one.
7. the preparation method of moxa-moxibustion medicine cake Chinese medicine composition according to claim 4, is characterized in that, step 2) in, the specification of described medicine cake is: thick: 0.5-0.8cm; Diameter: 2.3-3cm.
8. according to the moxa-moxibustion medicine cake of the arbitrary described moxa-moxibustion medicine cake Chinese medicine composition of claim 1-3 for the preparation for the treatment of the intestines and stomach class disease.
9. purposes according to claim 8, is characterized in that, described the intestines and stomach class disease selected from chronic gastritis, intractable chronic enteritis.
10. purposes according to claim 9, is characterized in that, described intractable chronic enteritis comprises ulcerative colitis, Crohn disease, irritable bowel syndrome.
CN201510599057.2A 2015-09-18 2015-09-18 Traditional Chinese medicine composition for moxibustion medicine cake and preparation method thereof Pending CN105147792A (en)

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CN107802489A (en) * 2017-11-28 2018-03-16 云南中医学院 Sandwiched moxibustion medicine cake and its prepare instrument and preparation method
CN108078771A (en) * 2017-01-22 2018-05-29 金华市人民医院 A kind of portable thermosensitive medicine Electric moxibustion appts. and its application method
CN113244363A (en) * 2021-05-31 2021-08-13 南方医科大学 Traditional Chinese medicine cake moxibustion for orthopedics department as well as preparation method and application thereof

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Publication number Priority date Publication date Assignee Title
CN106389557A (en) * 2016-06-29 2017-02-15 上海市针灸经络研究所 Traditional Chinese medicinal composition used for traditional Chinese medicinal moxibustion therapy as well as preparation method and applications of traditional Chinese medicinal composition
CN106389557B (en) * 2016-06-29 2019-07-09 上海市针灸经络研究所 A kind of Chinese medicine composition and its preparation method and application for Chinese medicine moxibustion
CN108078771A (en) * 2017-01-22 2018-05-29 金华市人民医院 A kind of portable thermosensitive medicine Electric moxibustion appts. and its application method
CN107802489A (en) * 2017-11-28 2018-03-16 云南中医学院 Sandwiched moxibustion medicine cake and its prepare instrument and preparation method
CN113244363A (en) * 2021-05-31 2021-08-13 南方医科大学 Traditional Chinese medicine cake moxibustion for orthopedics department as well as preparation method and application thereof

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