CN103768357A - Compound traditional Chinese medicinal composition for treating recurrent aphthous ulcer - Google Patents

Compound traditional Chinese medicinal composition for treating recurrent aphthous ulcer Download PDF

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CN103768357A
CN103768357A CN201410061059.1A CN201410061059A CN103768357A CN 103768357 A CN103768357 A CN 103768357A CN 201410061059 A CN201410061059 A CN 201410061059A CN 103768357 A CN103768357 A CN 103768357A
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traditional chinese
ulcer
chinese medicine
rhizoma
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CN103768357B (en
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何晓瑾
汪悦
周学平
王磊
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Nanjing University of Chinese Medicine
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Nanjing University of Chinese Medicine
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Abstract

The invention discloses a compound traditional Chinese medicinal composition for treating recurrent aphthous ulcer. The composition is prepared from the following raw materials in parts by weight: 5-10 parts of coptidis rhizoma, 10-20 parts of scutellaria baicalensis, 10-20 parts of pinellia ternata, 15-25 parts of poria, 15-25 parts of dandelion, 15-25 parts of rhizoma anemarrhenae, 5-10 parts of rattletop, and 3-6 parts of liquorice. According to the compound traditional Chinese medicinal composition for treating recurrent aphthous ulcer, the raw material prescription is selected according to the traditional chinese medicine theory and the pathogenesis of recurrent aphthous ulcer, the components are scientific and reasonable in compatibility, and can be synergetic and promoted with each other to play the effect of synergism, so that the compound traditional Chinese medicinal composition has good effects of clearing accumulated heat, nourishing yin and dryness, and astringing and promoting granulation, can remarkably reduce local pains caused by RAU (recurrent aphthous ulcer), has the functions of promoting ulcer healing, prolonging diapause and controlling ulcer relapse, has the advantages of high safety and no adverse response, and is expected to be developed into a novel medicine for treating recurrent aphthous ulcer.

Description

A kind of Traditional Chinese medicine compound composition with treatment recurrent aphtha
Technical field
The present invention relates to a kind of Chinese medicine compound, be specifically related to a kind of Traditional Chinese medicine compound composition with treatment recurrent aphtha, belong to Chinese medicine preparation technical field.
Background technology
Recurrent aphtha (recurrent aphthous ulcer, RAU) claim again recurrent oral ulceration, it is modal stomatocace class disease, investigation finds that at least 10%~25% crowd suffers from this disease, in specific crowd, the prevalence of RAU can be up to 50%, and women's prevalence is generally higher than male.The age of sending out well of RAU is 10-30 year, and ulcer pain is obvious, and outbreak repeatedly, affect patient's feed, speech, emotion, has caused larger puzzlement to patient's live and work.RAU etiology unknown, studies confirm that in a large number in recent years immune factor, especially cellullar immunologic response plays an important role in the pathogenesis of RAU, and other inducements comprise heredity, local wound, food, medicine, stress, endocrine, systemic disease, infection, vitamin or trace element deficiency etc.
Due to the cause of disease of RAU and pathogenesis not yet completely clear and definite, also do not effect a radical cure at present the effect method of RAU both at home and abroad, therefore the treatment of RAU is mainly take symptomatic treatment as main, and will ease the pain, promote ulcer healing, extends the object of intermission as treatment.
The treatment of doctor trained in Western medicine at present is mainly divided into Drug therapy (local application and systemic administration), naturopathy and psychotherapy.Advocate the preferential topical therapeutic of selecting, and the glucocorticoid of topical application is classified as to the first-line drug for the treatment of RAU, comprise triamcinolone acetonide oral cavity paste and Dexamethasone ointment, gargarism etc.But long-term topical application glucocorticoid may cause oral cavity monilial infection.Promote healing medicine and other topical formulations, as coming cluck promise paste, mouth paster, the fragrant hyaluronic acid gels of two chlorine etc., recombinant human epidermal growth factor gel, bFGF bovine basic fibroblast growth factor gel, ammonia can ease the pain, promote ulcer healing, but without controlling ulcer recurrence effect; And carbenoxolone sodium gargarism, the side effect of ciclosporin gargarism is more.It is only also that short-term is effective that systemic administration is selected glucocorticoid, and Control in recurring is undesirable, and side effect is large, therefore can not use for a long time, more can not rely on, otherwise drug withdrawal knock-on.Immunosuppressant, as azathioprine, cyclophosphamide, methotrexate, ciclosporin etc. all have certain therapeutical effect to RAU, but untoward reaction is more, can occur anorexia, feel sick etc. symptom, long-term taking can cause bone marrow depression,, even there is aplastic anemia in granulocytopenia, also can cause toxic hepatitis, pancreatitis etc.Immunostimulant, as transfer factor, thymosin etc. have certain curative effect to RAU, and side effect is little, but late result is not still certainly.Other,, as Thalidomide mitigation symptoms rapidly, obviously shorten stage of attack, the oral ulcer damage of this medicinal medicine treatment AIDS of U.S. FDA approved, but should be noted the side effect such as its teratogenesis, and anemia of pregnant woman's forbidding, the women of child-bearing age are cautious use of.RAU belongs to Chinese medicine " erosion of the oral mucosa, aphtha, aphtha " category, Chinese medicine is based upon on macroscopic view understanding basis the understanding of RAU pathogenic factor, think that it is a kind of topical manifestations of systemic disease, the generation that propose that flaming up of heart-fire, taste are hot and suffocating, excessive heat of liver and gallbladder, stagnation of dampness due to deficiency of the spleen, deficiency of YIN of the spleen and stomach, the hyperactivity of fire of suffering from a deficiency of the kidney etc. all can cause primary disease, giving consideration to both the incidental and fundamental in treatment, obtain certain curative effect, and there is the advantages such as side effect is little, cheap, day by day obtain the approval of extensive patients.But do not have yet the specific medicament for the treatment of RAU, many to have the promote the production of body fluid curative effect of alternative medicine treatment primary disease of effect of Chinese Medicine still imprecise.
Summary of the invention
Goal of the invention: technical problem to be solved by this invention is to overcome the deficiencies in the prior art, take Chinese medical theory as basis, adopt determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, according to the pathogenesis of recurrent aphtha, science is carried out composition of prescription, provide one effectively to treat recurrent aphtha, curative effect is clear and definite, and side effect is little, the Traditional Chinese medicine compound composition of taking convenience.
Technical scheme: in order to realize above object, the technical solution used in the present invention is:
A Traditional Chinese medicine compound composition with treatment recurrent aphtha, it is to be made up of the raw material of following parts by weight:
5~10 parts of Rhizoma Coptidis, 10~20 parts of Radix Scutellariaes, 10~20 parts of the Rhizoma Pinelliaes, 15~25 parts, Poria, 15~25 parts of Pollen Typhaes, 15~25 parts of the Rhizoma Anemarrhenaes, 5~10 parts of Rhizoma Cimicifugaes, 3~6 parts, Radix Glycyrrhizae.
As preferred version, the above-described Traditional Chinese medicine compound composition with treatment recurrent aphtha, it is to be made up of the raw material of following parts by weight:
5~8 parts of Rhizoma Coptidis, 10~15 parts of Radix Scutellariaes, 10~15 parts of the Rhizoma Pinelliaes, 15~20 parts, Poria, 15~20 parts of Pollen Typhaes, 15~20 parts of the Rhizoma Anemarrhenaes, 5~8 parts of Rhizoma Cimicifugaes, 3~4 parts, Radix Glycyrrhizae.
The present invention is under the guidance of Chinese medical theory, determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, in conjunction with pathogeny and the disease symptom of recurrent aphtha, according to the pathogenesis emphasis of recurrent aphtha (RAU) " accumulation of heat in the heart and spleen ", " insufficiency of the spleen heat-dissipating ", choose raw material science compatibility according to Chinese medical theory, Chinese medicine compound of the present invention has that spleen invigorating is purged heat, effect of detumescence and promoting granulation, take treating both the principal and the secondary aspects of a disease at the same time as therapeutic goal, selecting Rhizoma Coptidis, Radix Scutellariae, the Rhizoma Pinelliae, Poria, Pollen Typhae, the Rhizoma Anemarrhenae, Rhizoma Cimicifugae, Radix Glycyrrhizae is that raw material prepares the Chinese medicine compound with treatment RAU effect.
The selected raw material of the present invention according to being: in component, Rhizoma Coptidis bitter cold is fallen clearly, and letting out clearly heart stomach accumulated heat is monarch drug.Radix Scutellariae clearing interior heat, eliminating fire and detoxication; Rhizoma Anemarrhenae clearing away heat-fire, promotes the production of body fluid and moisturizes, and both are ministerial drug altogether, both can strengthen the effect of monarch drug clearing away heat-fire, again can YIN nourishing with clearind deficient heat, promote the production of body fluid to moisturize.Pollen Typhae blood circulation promoting and blood stasis dispelling, convergence granulation promoting; Rhizoma Pinelliae toil warm-dryness syndrome, is good at eliminating stagnation dampness; The Poria spleen invigorating detumescence of purging heat; Three is adjuvant drug altogether, both can spleen invigorating to rush down YIN-fire, again can too impairment of YIN of anti-monarch drug bitter cold.The loose fire removing toxic substances of Rhizoma Cimicifugae, priming is up; Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, altogether for making medicine.Rest on a scientific basis and choose raw material and scientific matching raw material by above Chinese medicine, between each component, can mutually coordinate, mutually promote, play the effect of Synergistic, have and well let out clearly accumulated heat, nourshing Yin and drynsessmoistening prescription, effect of convergence granulation promoting, can obviously alleviate the local pain that RAU causes, and can promote ulcer healing, prolongation intermission, control ulcer recurrence.
The Traditional Chinese medicine compound composition with treatment recurrent aphtha provided by the invention can be used for preparation treatment recurrent aphtha medicine.
The preparation method of the Traditional Chinese medicine compound composition extract with treatment recurrent aphtha provided by the invention comprises the following steps, and gets Rhizoma Coptidis, Radix Scutellariae, the Rhizoma Pinelliae, Poria, Pollen Typhae, the Rhizoma Anemarrhenae, Rhizoma Cimicifugae and Radix Glycyrrhizae, add the water soaking 20~60min of 8~12 times of total medical material weight, then decoct and extract 1 to 3 time, each 1 to 3 hour, merge extractive liquid,, concentrates to obtain extractum.
The application of the Traditional Chinese medicine compound composition with treatment recurrent aphtha of the present invention in preparation treatment recurrent aphtha medicine, makes the extract of Traditional Chinese medicine compound composition and pharmaceutically acceptable carrier the medicine of capsule, microcapsule, tablet, granule or oral liquid formulation.
When the Traditional Chinese medicine compound composition with treatment recurrent aphtha provided by the invention is made tablet, the extract of Chinese medicine compound and carrier lactose or corn starch, while needs, add magnesium stearate lubricant, mix homogeneously, then tabletting is made tablet.
The Traditional Chinese medicine compound composition with treatment recurrent aphtha provided by the invention while making capsule the extract of Traditional Chinese medicine compound composition and carrier lactose or corn starch mix homogeneously, granulate, the then encapsulated capsule of making.
When the Traditional Chinese medicine compound composition granulation agent with treatment recurrent aphtha provided by the invention, the extract of Traditional Chinese medicine compound composition and diluent lactose or corn starch mix homogeneously, granulate, dry, granulation agent.
When the Traditional Chinese medicine compound composition with treatment recurrent aphtha provided by the invention is made oral liquid, add water and cosolvent to dissolve the extract of Traditional Chinese medicine compound composition, add syrup to prepare oral liquid.
Beneficial effect: compared to the prior art the Traditional Chinese medicine compound composition with treatment recurrent aphtha provided by the invention has the following advantages:
The Traditional Chinese medicine compound composition with treatment recurrent aphtha provided by the invention, choose material combination prescription according to the pathogenesis of Chinese medical theory and recurrent aphtha, each component proportioning is scientific and reasonable, between each component, can mutually coordinate, mutually promote, play the effect of Synergistic, have and well let out clearly accumulated heat, nourshing Yin and drynsessmoistening prescription, effect of convergence granulation promoting, can obviously alleviate the local pain that RAU causes, and can promote ulcer healing, extend the intermission, control ulcer recurrence, there is effect of good treatment recurrent aphtha, and experimental result shows, Traditional Chinese medicine compound composition provided by the invention, safe, have no adverse reaction.
And the Traditional Chinese medicine compound composition with treatment recurrent aphtha provided by the invention can be prepared into the medicine of various dosage forms easily with pharmaceutically acceptable carrier, facilitate clinical taking.
The specific embodiment
According to following embodiment, the present invention may be better understood.But, those skilled in the art will readily understand, the described concrete material proportion of embodiment, process conditions and result thereof be only for the present invention is described, and should also can not limit the present invention described in detail in claims.
Embodiment 1
A Traditional Chinese medicine compound composition with treatment recurrent aphtha, it is to be made up of the raw material of following parts by weight:
5 parts of Rhizoma Coptidis, 10 parts of Radix Scutellariaes, 10 parts of the Rhizoma Pinelliaes, 15 parts, Poria, 15 parts of Pollen Typhaes, 15 parts of the Rhizoma Anemarrhenaes, 5 parts of Rhizoma Cimicifugaes, 3 parts, Radix Glycyrrhizae.
Embodiment 2
A Traditional Chinese medicine compound composition with treatment recurrent aphtha, it is to be made up of the raw material of following parts by weight:
10 parts of Rhizoma Coptidis, 20 parts of Radix Scutellariaes, 20 parts of the Rhizoma Pinelliaes, 25 parts, Poria, 25 parts of Pollen Typhaes, 25 parts of the Rhizoma Anemarrhenaes, 10 parts of Rhizoma Cimicifugaes, 6 parts, Radix Glycyrrhizae.
Embodiment 3
A Traditional Chinese medicine compound composition with treatment recurrent aphtha, it is to be made up of the raw material of following parts by weight:
8 parts of Rhizoma Coptidis, 15 parts of Radix Scutellariaes, 15 parts of the Rhizoma Pinelliaes, 20 parts, Poria, 20 parts of Pollen Typhaes, 20 parts of the Rhizoma Anemarrhenaes, 8 parts of Rhizoma Cimicifugaes, 4 parts, Radix Glycyrrhizae.
Embodiment 4 clinical research datas
1 case selection
1.1 physical data
In JIUYUE, 2011 to 2013 year August rheumatism immunity section of Jiangsu TCM Hospital and general internal clinic medical meet Chinese stomatology can oral mucosal disease Professional Committee, RAU patient's 106 examples of making a definite diagnosis of the dialectical standard of " RAU practice guidelines (trying) " the Chinese and western medicine diagnostic criteria of can combination of Chinese and Western medicine Professional Committee formulating of Chinese stomatology and the traditional Chinese medical science " accumulation of heat in the heart and spleen ", " insufficiency of the spleen accumulated heat " pattern of syndrome, wherein male's 46 examples, women's 60 examples; 18~62 years old age, average (38.5 ± 1.2) year; The course of disease 1 to 15 year, average (3.1 ± 1.0) year.Case adopts digital watch method to select at random, treatment group 54 examples, matched group 52 examples.
1.2 diagnostic criteria
1.2.1 Western medicine diagnose standard
Because RAU does not have specific laboratory parameters, therefore the diagnosis of RAU mainly as foundation, does not generally need special lab testing take medical history feature (recurrent, periodically, self limiting) and Clinical symptoms (yellow, red, recessed, bitterly).According to Clinical symptoms, that RAU can be divided into is light-duty, 3 types of heavy type and herpesvirus types.
1.2.1 Standards of Chinese Medical Syndrome Differentiation (with reference in Zheng Xiao cornel in 2002 chief editor " new Chinese medicine guideline of clinical investigations (try) " about " new Chinese medicine is treated the guideline of clinical investigations of recurrent aphtha ")
(1) accumulation of heat in the heart and spleen card
Primary symptom: ulcer differs in size, round or oval, can be by small rice grain to Semen phaseoli radiati or Semen Glycines size, ulcer number is more, around can be red and swollen raised, concavity.Local scorching hot pain, thirst with desire to drink.
Inferior disease: flushing mouth and nose burn and do and hot, dysphoria with smothery sensation, are hard and dry, and yellowish urine is red.
Tongue fur: the tip of the tongue is partially red and dry, yellow fur or greasy.
Pulse condition: stringy,thready and rapid pulse.
(2) insufficiency of the spleen heat-dissipating card
Primary symptom: ulcer is dark greatly and, the rubescent edema in edge is raised, has greyish white or lark to ooze out, indolence, easily outbreak repeatedly, is hard and dry or not smooth, and abdominal distention is mouthful sticky or thirsty.
Inferior disease: shallow complexion, lassitude and weak, urine is clear long or yellow red.
Tongue fur: light red tongue tongue is white greasy or yellow greasy.
Pulse condition: soft and thready pulse or heavy thin.
1.3 include in and exclusion standard (" tentative standard of RAU therapeutic evaluation " that the Chinese stomatology meeting of reference diseases of oral mucosa Professional Committee formulates)
1.3.1 inclusive criteria: 1. have RAU morbidity history at least 2 times, and medical history is more than 1 year; 2. ulcer is shown effect more than 1 time every month.
1.3.2 exclusion standard: 1. heavy RAU, Behcet disease; 2. systemic disease background: anemia, peptic ulcer, crohn, acute infectious diseases, autoimmune disease etc.; 3. in 24h, use analgesic, use antibiotic, antibiotic medicine in 1 month, in 3 months, whole body uses corticosteroid, immunosuppressant; 4. tumor patient; 5. gravid woman.
2, Therapeutic Method
Treatment group: adopt that the embodiment of the present invention 1 provides Traditional Chinese medicine compound composition, decocting boils, every day, potion, point sooner or later took for twice 1 hour after meal.Matched group: the peace that swells and ache capsule, each 3, every day 2 times, warm water is swallowed.
All taking for two groups 1 month is 1 course for the treatment of, and treatment finishes to follow up a case by regular visits to 1 year observation oral cavity ulcer recurrence situation.
3 observation index
3.1 cardinal symptoms, sign Index:
3.1.1 total intermittent time (day) (interval, I): the evaluation period is without ulcer temporal summation.
3.1.2 total ulcer number (individual) (number, N): evaluate period ulcer recurrence number summation.
3.1.3 average ulcerative stage (day) (duration, D): evaluation summation of each ulcer persistent period of period is divided by ulcer sum.
3.1.4 pain index (dividing) (pain, P): adopt Visual analogue scale (visual analog scale, VAS) to record the ulcerative stage pain scores of every day.The implication of VAS is the straight line that adopts 10cm, and 0 end of straight line represents " painless ", and 10cm end represents " the most violent pain ", and patient, according to the level of sensitivity difference of pain, keeps a record in the corresponding scale of straight line, every day 1 time.
3.2 main tcm syndrome indexs:
Comprise clinical modal part and General Symptoms (ulcer surface pain has congestion and edema to ooze out, and there is burn feeling part, and xerostomia is thirsty or mouthful sticky, and constipation with dry stool or stool are not smooth, tongue partially red and Enteromorpha clathrata (Roth) Grev. Emend bliding Huang or light red tongue greasy fur).
With reference to Zheng Xiao cornel chief editor in 2002 " new Chinese medicine guideline of clinical investigations (trying) ", record one by one the score value of each symptom by following scalar quantization standard.
3.2.1 ulcer surface pain has congestion and edema to ooze out
0=without.
2=ulcer diameter is less than 3mm, and ulcer surface is micro-wet, and color is micro-red, and edema is confined to ulcer place, hypodynia.
4=ulcer diameter is greater than 3mm, is less than 5mm, and ulcer surface has greyish white (Huang) to ooze out on a small quantity, and color depth is red, and the light white edge edge of local color is micro-raised, and pain is slightly obvious, but does not affect feed.
6=ulcer diameter is more than 5mm, and ulcer surface exudate is many and have pseudomembrane, and color is purplish red, and the high improvement of the obvious edema of whole disease damage is white, and pain obviously and impact feed.
3.2.2 there is burn feeling part
0=without.
2=is micro-burn feeling.
4=scalded sense like hot water
6=need contain cold water
3.2.3 xerostomia is thirsty or mouthful sticky
0=without.
The slightly dry nothing of 1=mouth is felt yearningly, or even feel mouthful is glued.
2=xerostomia is thought drink, or sometimes feels sticky in mouth.
3=xerostomia drink does not quench one's thirst, or continues in mouth sticky.
3.2.4 constipation with dry stool or stool are not smooth
0=without.
1=has but dry stool every day, or it is shapeless to defecate, and every day 1-2 time, slightly feels not well just time.
2=a few days a line, dry stool, or loose stool, every day 3-4 time, not well just time.
3=needs relieving constipation just to separate, or diarrhea with loose stool, and every day is more than 4 times, not well just time.
3.2.5 lassitude and weak
0=without.
1=random thoughts are tired, and degree is slight, and the power of not enduring hardships can be adhered to light physical labor.
It is weak that 2=general activity is felt, and intermittently occurs, supports reluctantly daily routines.
3=has a rest and also feels fatigue and weak, continues to occur, can not adhere to daily.
3.2.6 partially red and Enteromorpha clathrata (Roth) Grev. Emend bliding Huang or light red tongue greasy fur of tongue
0=is without extremely.
1=tongue is partially red and Enteromorpha clathrata (Roth) Grev. Emend bliding Huang or light red tongue greasy fur are not obvious.
2=tongue is partially red and Enteromorpha clathrata (Roth) Grev. Emend bliding Huang or light red tongue greasy fur are more obvious.
3=tongue is partially red and Enteromorpha clathrata (Roth) Grev. Emend bliding Huang or light red tongue greasy fur are obvious.
4 the standard of curative effect evaluations (in " tentative standard of RAU therapeutic evaluation " can diseases of oral mucosa Professional Committee formulated with reference to Chinese stomatology and Zheng Xiao cornel chief editor's in 2002 " new Chinese medicine guideline of clinical investigations (trying) " about " new Chinese medicine is treated the guideline of clinical investigations of recurrent aphtha ")
4.1 short-term evaluation standards: after medicine 7 days, carry out the curative effect comparison for the treatment of group and matched group.
4.1.1DP staging: effective: average ulcerative stage shortens, pain index reduces (t check, P<0.05);
Effective: average ulcerative stage shortens (t check, P<0.05), pain index is without changing (t check, P>0.05) or average ulcerative stage without changing (t check, P>0.05), pain index reduces (t check, P<0.05); Invalid: average ulcerative stage without changing, pain index is without changing (t check, P>0.05).
4.1.2 tcm syndrome integration changes: clinical recovery: tcm clinical practice symptom, sign disappear or substantially disappear, and syndrome integration reduces >=95%; Effective: tcm clinical practice symptom, sign are obviously improved, syndrome integration reduces >=70%; Effective: tcm clinical practice symptom, sign all take a favorable turn, syndrome integration reduces >=30%; Invalid: tcm clinical practice symptom, sign are all not improved, even increase the weight of, syndrome integration reduces less than 30%.
Note: computing formula (nimodipine method) is: [integration before (the rear integration of integration-treatment before treatment) ÷ treatment] × 100%.
4.2 Evaluation of long-term standards: recovery from illness: oral ulcer did not recur more than 1 year; Effective: total intermittent time extends, always ulcer number reduces (t check, P<0.05); Effective: total intermittent time extends (t check, P<0.05), unchanged (the t check of total ulcer number, or unchanged (the t check of total intermittent time P>0.05), P>0.05), total ulcer number reduces (t check, P<0.05); Invalid: total unchanged, total ulcer number of intermittent time unchanged (t check, P>0.05).
5 statistical procedures methods
Before and after statistics treatment, clinical symptoms, sign and laboratory observation index, adopt the analysis of SPSSl9.0 software kit, and measurement data is added and subtracted standard deviation with mean , ask that measurement data relatively adopts t check for two groups, enumeration data adopts X2 check, and ranked data are analyzed with Ridit, test level α=0.05, two-sided test.
6 therapeutic outcomes
6.1 baseline comparisons
Therapist basic condition is as the position of case load, sex, age, the course of disease and ulcer, size, number, type, pain degree etc. and matched group no significant difference (P>0.05), illustrate that treatment group and matched group data are balanced, there is comparability.
The comparison of 6.2 liang of group short term effects
Treatment group and matched group comparison, average ulcerative stage obviously shortens (P<0.01), and pain index reduces (P<0.05), and specific experiment result is as shown in table l; Treatment group clinical efficacy is remarkable, and total effective rate is 100%, is significantly better than matched group (P<0.05), and specific experiment result is as shown in table 2; Treatment group tcm syndrome curative effect clinical recovery rate 18.5%, obvious effective rate 59.3%, total effective rate 100%, is significantly better than matched group (P<0.01), and specific experiment the results are shown in Table 3.
Table two groups of average ulcerative stages of l and pain index comparison
Group Number of cases (n) Average ulcerative stage (my god) Pain index (p)
Treatment group (embodiment 1) 54 3.81±1.2 2 1.5±0.36 1
Matched group 52 5.15±1.6 1.9±0.48
With matched group comparison: 1p<0.05, 2p<0.01
Table 2 liang group Clinical efficacy comparison (n, %)
Group Effective Effectively Invalid Total effective rate
Treatment group (embodiment 1) 46(85.2) 8(14.8) 0(0.0) 54(100.0) 1
Matched group 19(36.5) 25(48.1) 8(15.4) 44(84.6)
With matched group comparison: 1p<0.05
Table 3 liang group tcm syndrome curative effect comparison (n, %)
Group Clinical recovery Effective Effectively Invalid Total effective rate
Treatment group (embodiment 1) 10(18.5) 2 32(59.3) 2 12(22.2) 0(0.0) 54(100.0) 2
Matched group 0(0.0) 10(19.2) 27(51.9) 15(28.9) 37(71.1)
With matched group comparison: 2p < 0.01
The comparison of 6.3 liang of group late results
The cure rate that treatment group does not recur in treatment for latter 1 year is 51.9%, obvious effective rate 40.7%, and total effective rate is 100%, is significantly better than matched group (P<0.01), specific experiment result is as table 4.
A table 4 liang group is followed up a case by regular visits to curative effect comparison (n, %) after 1 year
Group Recovery from illness Effective Effectively Invalid Total effective rate
Treatment group (embodiment 1) 28(51.9) 2 22(40.7) 2 4(7.4) 0(0.0) 54(100.0) 2
Matched group 2(3.8) 7(13.5) 31(59.6) 12(23.1) 40(76.9)
With matched group comparison: 2p < 0.01
7 safety observations
In clinical experiment process, treatment group patient has no untoward reaction, and matched group has 1 example to occur Upper abdominal pain, the symptoms such as loss of appetite, but add with transference cure after protection gastric mucosa medicine.Two groups all there is not the abnormal of the index such as hepatic and renal function and blood, routine urinalysis.Safety testing result shows that Chinese medicine compound safety provided by the invention is good, and long-term taking has no adverse reaction.
Above clinical observation result shows, Traditional Chinese medicine compound composition provided by the invention can obviously alleviate the local pain that recurrent aphtha (RAU) causes, and can promote ulcer healing, prolongation intermission, control ulcer recurrence, short term effect and late result are all remarkable, illustrate that Traditional Chinese medicine compound composition provided by the invention has obvious therapeutic action to RAU, and Traditional Chinese medicine compound composition life-time service provided by the invention, without obvious adverse reaction, can be developed into the new drug into the treatment RAU of a new generation.
Above embodiment is only explanation technical conceive of the present invention and feature; its object is to allow person skilled in the art understand content of the present invention and implemented; can not limit the scope of the invention with this; all equivalences that spirit is done according to the present invention change or modify, and all should be encompassed in protection scope of the present invention.

Claims (4)

1. a Traditional Chinese medicine compound composition with treatment recurrent aphtha, is characterized in that, it is to be made up of the raw material of following parts by weight:
5 ~ 10 parts of Rhizoma Coptidis, 10 ~ 20 parts of Radix Scutellariaes, 10 ~ 20 parts of the Rhizoma Pinelliaes, 15 ~ 25 parts, Poria, 15 ~ 25 parts of Pollen Typhaes, 15 ~ 25 parts of the Rhizoma Anemarrhenaes, 5 ~ 10 parts of Rhizoma Cimicifugaes, 3 ~ 6 parts, Radix Glycyrrhizae.
2. the Traditional Chinese medicine compound composition with treatment recurrent aphtha according to claim 1, is characterized in that, it is to be made up of the raw material of following parts by weight:
5 ~ 8 parts of Rhizoma Coptidis, 10 ~ 15 parts of Radix Scutellariaes, 10 ~ 15 parts of the Rhizoma Pinelliaes, 15 ~ 20 parts, Poria, 15 ~ 20 parts of Pollen Typhaes, 15 ~ 20 parts of the Rhizoma Anemarrhenaes, 5 ~ 8 parts of Rhizoma Cimicifugaes, 3 ~ 4 parts, Radix Glycyrrhizae.
3. the application of the Traditional Chinese medicine compound composition with treatment recurrent aphtha described in claim 1 or 2 in preparation treatment recurrent aphtha medicine.
4. the Traditional Chinese medicine compound composition with treatment recurrent aphtha according to claim 3 is treated the application in recurrent aphtha medicine in preparation, it is characterized in that, the extract of Traditional Chinese medicine compound composition and pharmaceutically acceptable carrier are made to the medicine of capsule, microcapsule, tablet, granule or oral liquid formulation.
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107596326A (en) * 2017-10-25 2018-01-19 周安德 A kind of Chinese medicine for treating canker sore

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CN101167900A (en) * 2007-09-20 2008-04-30 吴月 Traditional Chinese medicine for treating recurrent aphthae
CN102727817A (en) * 2012-07-02 2012-10-17 葛晓云 Oral liquid for treating oral ulcer
CN102772693A (en) * 2012-08-21 2012-11-14 孙凤梅 Medicine for treating recurrent oral ulcer and preparation method thereof
CN103071070A (en) * 2013-01-29 2013-05-01 张永雷 Traditional Chinese medicine formula for treating recurrent aphthous ulcer

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Publication number Priority date Publication date Assignee Title
CN101167900A (en) * 2007-09-20 2008-04-30 吴月 Traditional Chinese medicine for treating recurrent aphthae
CN102727817A (en) * 2012-07-02 2012-10-17 葛晓云 Oral liquid for treating oral ulcer
CN102772693A (en) * 2012-08-21 2012-11-14 孙凤梅 Medicine for treating recurrent oral ulcer and preparation method thereof
CN103071070A (en) * 2013-01-29 2013-05-01 张永雷 Traditional Chinese medicine formula for treating recurrent aphthous ulcer

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107596326A (en) * 2017-10-25 2018-01-19 周安德 A kind of Chinese medicine for treating canker sore

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