CN1282453C - Medication for treating oral disease - Google Patents
Medication for treating oral disease Download PDFInfo
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- CN1282453C CN1282453C CNB2003101040262A CN200310104026A CN1282453C CN 1282453 C CN1282453 C CN 1282453C CN B2003101040262 A CNB2003101040262 A CN B2003101040262A CN 200310104026 A CN200310104026 A CN 200310104026A CN 1282453 C CN1282453 C CN 1282453C
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- medicine
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- pericoronitis
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- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 43
- 229930003944 flavone Natural products 0.000 claims abstract description 13
- 235000011949 flavones Nutrition 0.000 claims abstract description 13
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Abstract
The present invention provides a medicine for curing oral diseases, which is characterized in that each milliliter of physic liquor contains 1 to 20 milligrams of total flavone and balance of medical alcohol. The medicine can rapidly relieve the symptoms of the common oral infected diseases of pericoronitis, parodontitis (namely, gnawing pain of the tooth) and gingival atrophy by local application; the phenomena of red and swollen gingiva, bleeding and pyorrhea of the gingiva, halitosis, tooth looseness and gnawing pain and the simultaneous symptoms, such as the edema of the face, limitation of mouth opening, swallowing pain, etc., are relieved or eliminated, and the effective rate reaches 88.8%. The medicine has an inhibition or extermination effect on usual pyogenic bacteria, such as gold staphylococcus and streptococcus, and common oral cavity pathogenic anaerobic bacteria, such as bacilli which produce melanin, etc. The medicine can decompose putrefaction, detoxify toxin and promote tissue healing by locally external application. The medicine does not have toxic, allergic or side effect on patients, and the medicine can be popularized and applied in clinic.
Description
Technical field
The present invention relates to a kind of oral disease medicine, especially a kind ofly oral mucosa is stimulated less, have antibiotic, antiinflammatory and analgesic preparation.
Background technology
The sickness rate of oral disease is very high, in case suffer from oral disease, not only will influence normal feed, but also allows the patient suffering can't bear.The medicine for the treatment of odontopathy in the market is a lot, and specific medicament is few, though use the back analgesic effect pretty good, but can not play the effect of sterilization, antiinflammatory, take anti-inflammation drugs for a long time not only to stomach, kidney, even liver is all had certain harmful effect.Therefore, for a long time, people are seeking nontoxic, harmless always, do not stimulate oral mucosa, have the medicine of antibiotic, antiinflammatory and analgesic effect, but effect are still not obvious.The propolis natural gum that to be Apis collect from plant sprout bud or trunk, sneak into Apis palate glandular secretion thing and Cera Flava after, can be processed into the resin-like solid matter, it contains great deal of bioactive substances and trace element.According to relevant, propolis has antiviral, protozoacide, and antiinflammatory, analgesia promotes tissue regeneration, effects such as enhancing human body immunity function.Clinical dermatosis, traumatic infection, otorhinolaryngology and oral inflammation and the diseases such as ulcer, gastric and duodenal ulcers, hyperlipemia and hypertension of being used for the treatment of.
Summary of the invention
The object of the present invention is to provide a kind of antibiotic, antiinflammatory and good analgesic effect, and nontoxic, harmless, oral mucosa is stimulated less oral disease pharmaceutical preparation.
The present invention realizes by following technical proposal: a kind of medicine for the treatment of oral disease, it is characterized in that every milliliter of medicinal liquid contains total flavones 1-20 milligram, and surplus is a medical alcohol.
The medicine of treatment oral disease provided by the invention makes by following method:
A, rubber powder are broken into piece, and in propolis: it is the medical ethanol of 50-94% that the ratio of ethanol=1: 1-10 adds concentration, lixiviate 48-120 hour at normal temperatures, through leave standstill, filter propolis extract, measure total flavones amount wherein after, stand-by;
B, to add an amount of concentration in above-mentioned propolis extract be the medical ethanol of 50-94%, is mixed with every milliliter of medicinal liquid that contains total flavones 1-20 milligram and gets final product.
The present invention has effects such as heat clearing away, pathogenic fire purging, detoxifcation, pain relieving, antiinflammatory, antibiotic, sterilization, the auxiliary treatment that both can be used for the fire of acute hat week due to the stomach-fire pyretic toxicity, periodontitis, can be used for other oral disease again, while it is nontoxic, harmless, less to the oral mucosa stimulation, be the oral disease medicine of a kind of ideal, practicality.
For showing the present invention's effect, bear the correlation test result of the present invention and reference substance below.
The test material
1, bacterial strain, test sees Table 1 with bacterial strain:
| Antibacterial | Bacterial strain | The source |
| Streptococcus mutans | JH (change of serum C type) | Tooth institute of West China medical university microorganism center |
| JBP (serotype C type) | The same | |
| The middle type bacteroides melanogenicus | ATCC 25261 | The same |
| Do not understand the saccharide bacillus | NCTC 9337 | The same |
| Viscosity unwrapping wire (more than be classified as Anaerobic Bacteria) | ATCC 19346 | The same |
| Staphylococcus aureus | Unnumbered | Clinical Laboratory center, Yunnan Province |
| Micrococcus catarrhalis | Unnumbered | Microorganism teaching and research room of unming Medical College |
| Beta hemolytic streptococcus | Unnumbered | The same |
| Diplococcus pneumoniae | Unnumbered | The same |
2, culture medium, test is as follows with culture medium:
Anaerobism basal medium (Shanghai Vaccine and Serum Institute's product)
Anaerobism agar culture medium (the same)
Anaerobism fluid medium (the same)
Ordinary nutrient agar culture medium (the same)
MS culture medium (by the preparation of this laboratory)
3, trial drug, test is as follows with medicine:
3.1, for reagent: provided by the invention;
3.2, positive control drug: metronidazole, Yunnan Province medicine inspecting institute preparation provides.
3.3, the solvent tester: 95% alcoholic solution.
4, instrument and other material
DY-2 type anaerobism incubator
Bacterial concentration normal concentration pipe, the 9cm plate.
Experimental result
One, oxford cup ethods
1, presses K itby-Bauer inocalation method, different test anaerobism bacterial strains is inoculated respectively on 8% the anaerobism blood agar culture-medium plate, test common bacterial strain and be inoculated in respectively on 8% the common blood agar plate.
2, on each plate, indicate test strain,, positive control medicine, metronidazole solvent ethanol.
3, be placed on labeled drug positive control drug and the contrast solvent ethanol pressurization gently with the aseptic manipulation Oxford cuvette of will sterilizing.
4, get aseptic straw and draw test medicinal liquid metronidazole and ethanol, slowly splash in the cuvette of Oxford to full.
5, anaerobe blood plate is put in 37 ℃ of anaerobism incubators and to be cultivated 48 hours, common bacterium blood plate is put and is cultivated observed result after 24 hours in 37 ℃ of incubators.
Two, tube dilution method
(1) preparation of bacterium liquid
1, Anaerobic Bacteria: with the liquid culture of each Anaerobic Bacteria, by than the turbid bacterium liquid that is made into every milliliter 300,000,000,10 times of redilution are for using.
2, staphylococcus aureus, micrococcus catarrhalis; The bacterium liquid that adopts identical method to be made into every milliliter 900,000,000, redilution supply for 1000 times to use.
3, streptococcus pneumoniae and beta hemolytic streptococcus: the bacterium liquid that adopts identical method to be made into every milliliter 300,000,000, the dilution in 1: 10 of reuse 0.5% Sanguis caprae seu ovis cell meat extract soup is for using.
(2) method and step
1, different test antibacterials is weaved into different test group, every group compares test with metronidazole, 95% ethanol.
2, get 30 of sterile test tube for every group, behind medicine stock solution positive control drug metronidazole and 95% ethanol dilution, every again pipe is inoculated a certain amount of test organisms liquid, fully mixing.
3, the anaerobe test group is put 37 ℃ of anaerobism cultivations 72 hours, and common bacterium test group is put in 37 ℃ of incubators and cultivated 24 hours, observes culture tube bacterial growth situation afterwards, and record.
4, from each culture tube of anaerobe test group, get a certain amount of cultivation and be inoculated in 8% anaerobism agar blood plate cover oxygen cultivation 72 hours, from common each culture tube of bacterium test group, get a certain amount of being inoculated on the 8% plain agar blood plate, cultivated 24 hours, observation has or not growth.The results are shown in Table 2,3.
The size of table 2 cylinder plate method inhibition zone
| Strain | Inhibition zone (mm) | Metronidazole (positive control) inhibition zone (mm) | 95% ethanol (solvent contrast) inhibition zone (mm) |
| Streptococcus mutans JH | 51 | 53 | 8 |
| Streptococcus mutans JBP | 49 | 59 | 6 |
| Middle type produces melanin cup bacterium | 37 | 41 | 8 |
| Do not understand the saccharide bacillus | 36 | 35 | 10 |
| Cling actinomycetes | 41 | 43 | 1 |
| Staphylococcus aureus | 13 | 11 | 6 |
| Micrococcus catarrhalis | 22 | 19 | 12 |
| Beta hemolytic streptococcus | 29 | 27 | 10 |
| The lung diplococcoid | 34 | 31 | 11 |
Table 3 tube dilution method
| Strain | (UL/ml) | Metronidazole (positive control) (Ug/ml) | 95% ethanol (dark matchmaker's contrast) (UL/ml) |
| Streptococcus mutans JH | 15.6 | 6 | 1000 |
| Streptococcus mutans JBP | 7.8 | 6 | 1000 |
| Middle type produces the melanin bacillus | 3.9 | 2 | 1000 |
| Do not understand the saccharide bacillus | 7.8 | 8 | 1000 |
| Cling actinomycetes | 15.6 | 8 | 1000 |
| Staphylococcus aureus | 7.8 | 16 | 250 |
| Micrococcus catarrhalis | 3.9 | 12 | 250 |
| The beta hemolysis streptococcus | 7.8 | 26 | 125 |
| Diplococcus pneumoniae | 7.8 | 26 | 125 |
Conclusion: the same with the positive control drug metronidazole, the oral cavity common disease is had better bactericidal action.
The present invention is through clinical trial, and its result is reported as follows:
One, test objective
Estimate the curative effect of common oral inflammation pericoronitis of treatment (tooth gnawing pain) and periodontitis (gingival atrophy) and examine or check its safety.
Two, physical data
469 routine oral cavity out-patients are included in this test altogether in, pericoronitis (tooth gnawing pain) 265 examples wherein, periodontitis (gingival atrophy) 204 examples.Male's 223 examples among the patient, women's 246 examples, age 18-65 people is distributed in 20-50 between year more.To include that object divides in groups at random in or 1% iodine glycerol (positive control agent, tradition is the oral cavity external used medicine effectively) group.Collect every clinical data and, promptly suffer from all blind bags of corona or periodontal pocket, dip in dried back and inject or 1% iodine glycerol with the sterile saline flushing by treating with quadrat method, once a day, continuous 2 days.Totally 432 examples are finished the predetermined treatment observation plan, all information, and other has 22 examples to withdraw from this test because of drug for diminishing inflammation and antibiosis for oral administration simultaneously, and 6 examples are lost and are visited, and 7 examples are because of 1-2 antibacterials of idol clothes in addition, and 2 examples are imperfect because of data, put down in writing indeterminate and give rejecting.The data data is handled and analyzed.Measurement data is with comparing between T check work group.Or pairing T check is done the treatment front and back relatively.The right simultaneously reaction of paying is observed, and further checks the safety of this medicine.
Three, study subject is selected
1, tcm diagnosis, debate disease standard and foundation thereof
Tooth gnawing pain (pericoronitis): the acute pericoronitis of the wisdom tooth traditional Chinese medical science is called " tooth gnawing pain ", has another name called " closing frame wind ", " toothache to the greatest extent ", " corner bracket wind ", and the common name primary disease is the tooth gnawing pain in this test.According to version " practical traditional Chinese medical science stomatology " in 1991, according to the different causes of disease, pathogenesis and disease, the tooth gnawing pain is divided into A, gastrointestinal intrinsic heat type, i.e. gastric heat disease; B, liver and gall excess fire type, i.e. liver and gall excess-fire disease.
Gastric heat disease type: gastrointestinal damp-heat accumulation or affection due to external wind and heat priming stomach-fire, positive naked light is contained, and follows through fighting and gathers in tooth interlock place to the greatest extent, suppurates pain.Primary symptom: 1, interlock place of molar habit end gum is swollen and ache; 2, halitosis, thirst and liking cold drink; 3, rapid digestion of food and polyorexia.Inferior disease: 1 constipation; 2. rolling pulse (it is fluent to walk the pearl contact as dish) is counted (exhales a suction more than four times) 3, red tongue, and tongue is white or yellow greasy; 4, fever with aversion to cold.Possess the 1st of primary symptom, and have other each primary symptoms or inferior disease person to include in.
The liver and gall excess fire type: wind heat is attacked in few sun, and the fire of liver and gall follows through the stifling tooth of superinverse and stings the place, and coagulation of QI-blood causes and suppurates pain.Primary symptom: 1, molarly hold gum interlock place to swell and ache to the greatest extent; 2, dehisce unfavorable or contracture; 3, bitter taste, dry pharynx.Inferior disease: 1, stringy pulse (as touching string) number; 2, constipation; 3, red tongue, yellow fur; 4, fever with aversion to cold or alternate attack of chill and fever.Possess the 1st of primary symptom, and have other each primary symptoms or inferior disease person to include in.This is organized in analyzable 232 examples, belongs to gastric heat type person's 148 examples (63.8%), liver and gall excess fire type 84 examples (36.2%).
Gingival atrophy (periodontitis): the periodontitis of Western medicine diagnose and the gingival atrophy of tcm diagnosis, bleeding from the gum, tooth are treated, tooth is moving, tooth leakages, tooth fire etc. quite, being generally called periodontitis in this test is gingival atrophy.According to " practical traditional Chinese medical science stomatology ", the cause of disease, pathogenesis and disease that this experimental evidence is different are divided into two kinds on gastric heat disease type and kidney deficiency type with gingival atrophy.
Gastric heat disease type: the gastric intrinsic heat, hold under the arm on the exopathogen fire-transformation and steam in mouth, it is up in tooth to follow the positive cloudy stomach warp of foot or the large intesting channel of Hand-Yangming, and stagnation of QI-blood causes that gum swells and ache, true heat symptom-complex.Primary symptom: 1, gingival swelling and pain; 2, bitter taste, halitosis; 3, thirst and liking cold drink; 4, rapid digestion of food and polyorexia.Inferior disease: 1, constipation; 2, slippery and rapid pulse; 3, red tongue, yellowish fur; Or tongue hold light, white and greasy fur.Possess the 1st of primary symptom, and have other each primary symptoms or inferior disease positive person to include in.
The kidney deficiency type: deficiency of the kidney yin companion gastric heat, the damage of essence marrow is few, hyperactivity of deficient fire, loose compact, halitosis, pyorrhea but pus is few, weak pulse, soreness of the waist and knees.Primary symptom: 1, gingival swelling and pain; 2, soreness of the waist and knees; 3, bitter taste, halitosis; 4 product thirst and desire for cold drink; 5 rapid digestion of food and polyorexia.Inferior disease: 1, constipation; 2, slippery and rapid pulse; 3 red tongue, the tongue fur BOHUANG; Or pale tongue, tongue fur is white.Possess primary symptom the 1st, the 2nd, and have other each primary symptoms or inferior disease positive person to include in.In 200 examples of analyzing in this group, belong to gastric heat type person's 156 examples (78.0%), renal deficiency type person 44 examples (22.0%).
2, Western medicine diagnose standard and foundation thereof:
Pericoronitis: all because of lower tooth third molar impaction, cause that all gums of hat are organized acute redness, pain, all blind bag pyorrheas of hat are diagnosable is pericoronitis.(oral and maxillofacial surgery is coated with outward, second edition,, Beijing in 1989)
Periodontitis: periodontal pocket overflows dense or alveolus infects with corresponding site gingiva and periodontal tissue's redness, pain, periodontal pocket more than 4mm, but periodontitis.Comprise that periodontitis simplex, plyability test end does further Differential Diagnosis, various periodontitis companion acute symptom person all can include in.(oral medicine, second edition,, Beijing in 1989)
3, case inclusion criteria
Pericoronitis and periodontitis are included standard in
Debate in the disease standard primary symptom item 1-2 3.1 meet tcm diagnosis, accompany other each primary symptoms and time disease positive person to include in.
Debate in the disease standard primary symptom 1-2 3.2 meet tcm diagnosis, accompany other each primary symptoms and time disease positive person to include in.
Meeting doctor trained in Western medicine first visit patient all can be used as and includes object in.
4, case exclusion standard
The osteomyelitis of the maxillary bone (rotten osteogenesis is arranged) or the tooth of suffering from a deficiency of the kidney slit and the disease person of the bright gastric heat of depletion of YANG less than 18 years old or greater than 65 years old; Gestation and women breast-feeding their children; With serious systemic infection; The Halfway Stopping treatment can't be judged curative effect; Use antibiotics quasi drugs person in two weeks; To the propolis allergy sufferers.
Four, test method
1, trial drug
Trial drug: (tincture), lot number 931125, cloud honeybee pharmaceutical factory provides.
Control drug: the contrast medicine is 1% iodine glycerol, lot number 930703, and the May 4th pharmaceutical factory in Shanghai produces.
More than two kinds of medicament appearances, the color and luster basically identical.
2, therapeutic regimen
: medication every day is once, and is dried by through attending doctor local periodontal or hat week bag being dipped in after with normal saline flushing, with blunt nosed looper from the bag end slow injection medicine, till the visible medicine of bag mouth, totally 3 days.Matched group: medication every day once, method is the same, totally 3 days.
3, random packet
Single blind method is adopted in this test, and promptly which kind of trial drug study subject does not know to use.
This test plan is selected in test group 300 examples, and matched group 100 examples for the observer provides the dosage regimen of determining with the random table method, and are pressed the such scheme medication.The case that will meet the standard of including in is randomized in treatment group or the matched group.
4, observational technique and index
When patient's first visit and check, all inquire, check and give record by the format medical history sheet.
The traditional Chinese medical science is observed: tooth gnawing pain and gingival atrophy are all debated primary symptom and time disease that disease includes standard in by the traditional Chinese medical science and are inquired, check pulse condition, tongue body and tongue coating item by item.
Doctor trained in Western medicine is observed: subjective symptom, inquire following index: pericoronitis: be preced with all red swelling of gingiva, pain, facial swelling, difficulty in opening mouth, fever and feed difficulty etc.Periodontitis: red swelling of gingiva, pain, gingival hemorrhage, halitosis, odontoseisis and trouble tooth interlock discomfort etc.
Objective determination: pericoronitis: comprise all swelling and aching of gum scopes of hat, the blind bag pyorrhea and the facial swelling patient's condition are measured mouth opening.Periodontitis: comprise bleeding index (BI, Mazza, 1981:0=gingiva NIP, visit after examining not hemorrhage: 1=gingiva mild inflammation, visit after examining not hemorrhage; The 2=gingiva has inflammation, visits and examines the back petechial hemorrhage; 3=has streak-like hemorrhage after visiting and examining; 4=visits and examines hemorrhage the overflowing outside the gingival sulcus in back; 5=is hemorrhage automatically.) suffer from tooth depth of pocket, periodontal pyorrhea, odontoseisis degree and tooth and kowtow pain etc.
Record is all should give in the untoward reaction that the patient tells.Pay special attention to observe and have or not anaphylaxis.
Five, result of the test
1, efficacy assessment standard and foundation
The traditional Chinese medical science: tooth gnawing pain criterion of therapeutical effect.Recovery from illness: male primary symptom has inferior disease all to disappear.Produce effects: most of male primary symptom and time disease are significantly taken a turn for the better.Progressive: male primary symptom and time improvement.Invalid: primary symptom or inferior disease do not have improvement more or increase the weight of on the contrary.
Doctor trained in Western medicine: pericoronitis curative effect evaluation index.Recovery from illness: transference cure, objective determination are preced with all gingivas does not have redness, and facial swelling disappears, and blind bag does not have pyorrhea, and it is normal that mouth opening recovers.Produce effects: symptom is clearly better, and swelling, pain etc. alleviates more than 1/2.Local redness of objective determination and facial swelling obviously alleviate, and blind bag does not have pyorrhea, and mouth opening is near normal.Progressive: symptom slightly alleviates, or public partial symptoms obviously alleviates, and the objective determination red swelling of gingiva slightly alleviates, and the blind bag purulent secretion reduces, and the mouth opening sedan-chair has improvement.Invalid: symptom, sign do not have improvement or increase the weight of on the contrary.
The traditional Chinese medical science: gingival atrophy criterion of therapeutical effect.Produce effects: most of male primary symptom and time disease are significantly taken a turn for the better.Progressive: male primary symptom of part and time disease are taken a turn for the better.Invalid: primary symptom and time disease do not have improvement or increase the weight of on the contrary.
Doctor trained in Western medicine: periodontitis efficacy evaluation index.Produce effects: the transference cure that exists during first visit or alleviate more than 1/2; Objective determination gingival hemorrhage index reduces, and redness obviously alleviates, and periodontal pocket does not have pyorrhea, and tooth is kowtowed pain and obviously alleviated.Progressive: most symptoms alleviate to some extent, and purulent discharge of pocket improves, and it is light that tooth is kowtowed alleviation of pain.Invalid: symptom, sign all do not have improvement.
2, the efficacy evaluation time: evaluate curative effect behind the continuous use 3 times
3, efficacy analysis
3.1 analysis of comparable baseline
Sex, age: study subject is issued and the age average in the sex of, placebo group, does not all have marked difference in two kinds of pericoronitis and periodontitis.(seeing Table 4)
Table 4 study subject sex, age distribution
| Pericoronitis | Periodontitis | |||||||
| N | The man | The woman | Mean age ± SD | N | The man | The woman | Mean age ± SD | |
| The present invention | 187 | 86 | 101 | 28.3±6.4 | 153 | 74 | 79 | 45.54±13.1 |
| Placebo | 45 | 24 | 21 | 26.4±7.4 | 47 | 24 | 23 | 45.54±13.1 |
| The P value | ＞0.05 | ＞0.05 | ＞0.05 | ＞0.05 | ＞0.05 | |||
Pericoronitis cardinal symptom, sign: in group and placebo group, do not show significant difference between the group that hot cardinal symptom of pericoronitis and sign distribute.(seeing table 5 for details)
Table 5
| N | Swelling and aching of gum | Be preced with all pain | Difficulty in opening mouth | With mouth opening | Blind bag overflows dense | |||||
| n | ％ | n | ％ | n | ％ | Mm+SD | n | ％ | ||
| The present invention | 187 | 187 | 100.0 | 186 | 99.5 | 123 | 65.8 | 31.5+9.5 | 136 | 72.7 |
| Placebo | 45 | 45 | 100.0 | 45 | 100.0 | 28 | 62.6 | 34.3+9.9 | 29 | 64.4 |
| p | ＞0.05 | ＞0.05 | ＞0.05 | ＞0.05 | ＞0.05 | |||||
The pericoronitis degree that is in a bad way: according to hat all local inflammation situations, part and the whole body simultaneous phenomenon can be divided into pericoronitis gently, in, weigh three kinds of different state of an illness situations.Slightly refer to the red and swollen pain of all 1-2 sides of hat, no pyorrhea, mouth opening＞30mm, other symptoms are slight; Moderate refers to be preced with all red swelling of gingiva, pain, and pyorrhea can be arranged, and mouth opening 20-29mm often accompanies odynophagia, slight facial swelling, feveret; It is heavier that severe refers to be preced with all red swelling of gingiva pain, mouth opening＜20mm, facial swelling, fever aversion to cold.Table 6 shows that severe case proportion is bigger in the propolis tooth group, and state of an illness the lighter proportion circle is bigger in the matched group, and the group state of an illness overweights matched group, and statistically-significant difference is arranged.
The be in a bad way distribution of grading of table 6 pericoronitis
| Slightly | Moderate | Severe | Add up to | |||||
| N | ％ | N | ％ | N | ％ | N | ％ | |
| The present invention | 91 | 48.7 | 64 | 34.2 | 32 | 17.1 | 187 | 100.0 |
| Placebo | 29 | 64.4 | 12 | 26.7 | 4 | 8.8 | 45 | 100.0 |
| Add up to | 120 | 76 | 36 | 232 | ||||
*X
2＝0.26，df＝1，p＞0.05
Table 7, periodontitis case cardinal symptom sign distribute
| N | Gingival swelling and pain | Gingiva is bled | Halitosis | Bleeding index | Depth of pocket | ||||
| n | ％ | n | ％ | n | ％ | GI | mm±SD | ||
| The present invention | 153 | 150 | 98.0 | 133 | 86.9 | 101 | 66.0 | 3.27±1.11 | 4.97±1.14 |
| Placebo | 47 | 45 | 95.7 | 38 | 84.4 | 24 | 53.3 | 3.19±1.10 | 4.96±0.88 |
| P | ＞0.05 | ＞0.05 | ＞0.05 | ＞0.05 | ＞0.05 | ||||
Periodontitis cardinal symptom, sign: the distribution of periodontitis cardinal symptom, sign in group and the matched group, bleeding index and week the bag degree of depth more all do not have a statistically-significant difference.(seeing table 7 for details)
Table 8 shows that gingival atrophy debates disease typing situation, also is that gastric heat disease type is in the majority in two groups, compares no significant difference for two groups.
3.2 curative effect comparative result
3.2.1 pericoronitis (tooth gnawing pain) curative effect
Show in the cardinal symptom sign with the 9-12. table 9 of relatively seeing of contrast medicine the pericoronitis therapeutic effect
Table 8, gingival atrophy traditional Chinese medical science disease type distribute
| Group | Gastric heat disease type | The gastric heat of suffering from a deficiency of the kidney disease type | Add up to | |||
| N | ％ | N | ％ | N | ％ | |
| The present invention | 119 | 77.8 | 34 | 22.2 | 153 | 100.0 |
| Placebo | 37 | 78.7 | 10 | 21.3 | 47 | 100.0 |
| Add up to | 156 | 44 | 200 | |||
X
2＝0.02，df＝1，p＞0.05
Compare before and after the treatment of table 9. pericoronitis case cardinal symptom sign
| Symptom | Group | The example number | Transference cure | Significantly alleviate | Improvement is arranged | Do not have progressive | ||||
| N | ％ | N | ％ | N | ％ | N | ％ | |||
| Swelling and aching of gum | 1 | 187 | 117 | 62.6 | 62 | 33.2 | 3 | 1.6 | 5 | 2.7 |
| 2 | 45 | 17 | 37.8 | 27 | 60.0 | 1 | 2.2 | 0 | - | |
| The transference cure rate compares: (p＜0.01) | Effective percentage compares: (p＞0.05) | |||||||||
| Be preced with all pain | 1 | 1 86 | 116 | 62.4 | 60 | 32.3 | 8 | 4.3 | 2 | 1.1 |
| 2 | 45 | 17 | 33.8 | 26 | 57.8 | 2 | 4.4 | 0 | - | |
| The transference cure rate compares: (p＜0.01) | Effective percentage compares: (p＞0.05) | |||||||||
| Facial swelling | 1 | 120 | 78 | 65.0 | 33 | 27.5 | 7 | 5.8 | 2 | 1.7 |
| 2 | 30 | 12 | 40.0 | 17 | 56.7 | 1 | 3.3 | 0 | - | |
| The transference cure rate compares: (p＜0.01) | Effective percentage compares: (p＞0.05) | |||||||||
| The blind bag pyorrhea | 1 | 136 | 79 | 58.1 | 51 | 37.5 | 5 | 3.7 | 1 | 0.7 |
| 2 | 29 | 11 | 37.9 | 16 | 55.2 | 2 | 6.9 | 0 | - | |
| The transference cure rate compares: (p＜0.01) | Effective percentage compares: (p＜0.05) | |||||||||
Annotate: group 1=, 2=placebo
Except that all blind bag pyorrheas of hat, the transference cure rate all has remarkable group difference.Promptly group significantly is better than matched group, but between organizing with effective percentage (transference cure+significantly alleviate) during comparison, two groups of each indexs of curative effect all do not have significant difference.
Table 10 demonstration treatment group and matched group mouth opening average relatively do not have significant difference.But dehisce to improve 6.5 ± 6.5mm after organizing treatment, matched group is 4.7 ±=5.2, and the two has compared statistically-significant difference (u=1.98, p＜0.05), i.e. the mouth opening improvement of group treatment back is better than matched group.
Table 10. pericoronitis case mouth opening measurement result (means standard deviation)
| Group | Before the treatment | After the treatment | P | Difference | |
| mm±SD | mm±SD | mm±SD | |||
| The present invention | N＝18 7 | 31.5±9.5 | 38.0±6.2 | ＜0.01(u＝5.62) | 6.5±6.5 |
| Placebo | N＝45 | 34.3±9.9 | 39.0±8.5 | ＜0.01(u＝2.42) | 4.7±5.2 |
| P | 0.05 | ＞0.05 | ＜0.05 | ||
Table 11 shows that by the curative effect determinate standard of design regulation, the group therapeutic outcome is better than matched group.The group cure rate, the result of effective percentage and the comparison of orderly contingency table method all shows same trend.
Table 11, pericoronitis case efficacy determination situation
| Group | N | Clinical recovery | Produce effects | Progressive | Invalid | ||||
| n | ％ | n | ％ | n | ％ | n | ％ | ||
| The present invention | 187 | 99 | 52.9 | 76 | 40.9 | 9 | 4.8 | 3 | 1.6 |
| Placebo | 45 | 9 | 20.0 | 28 | 62.2 | 8 | 17.8 | 0 | - |
P＜0.001
The different disease type of table 12 tooth gnawing pain efficacy determination situation
| The disease type | Group | Clinical recovery | Produce effects | Progressive | Invalid | Add up to | |||||
| n | ％ | n | ％ | n | ％ | n | ％ | n | ％ | ||
| Gastric heat disease type | 1 | 62 | 53.0 | 48 | 41.0 | 4 | 3.4 | 3 | 2.6 | 117 | 100.0 |
| 2 | 8 | 26.7 | 18 | 60.0 | 4 | 13.3 | 0 | - | 30 | 100.0 | |
| Clinical recovery is (p＜0.01) relatively | Effective percentage compares: (p＞0.05) | ||||||||||
| The liver and gall excess fire type | 1 | 37 | 52.9 | 28 | 40.0 | 5 | 7.1 | 0 | - | 70 | 100.0 |
| 2 | 4 | 26.7 | 10 | 66.7 | 1 | 6.7 | 0 | - | 15 | 100.0 | |
| Clinical recovery is (p＜0.01) relatively | Effective percentage compares: (p＞0.05) | ||||||||||
Annotate: group 1=, 2=placebo
Table 12 shows the therapeutic outcome of the different disease types of tooth gnawing pain: relatively more visible between cure rate is organized no matter be gastric heat principal mode or liver and gall excess fire type, and all be to organize significantly to be better than matched group.
3.2.2 periodontitis curative effect
The periodontitis treatment effect relatively sees Table 13-15.
Table 13 shows treatment level cardinal symptom disappearance rate in the periodontitis case, and antihalitosis all significantly is better than 1% iodine glycerol group outward.Contingency table chi-square analysis method shows same trend in order.
Table 14 shows with iodine glycerol all can significantly reduce bleeding index, and the former declines by a big margin, but does not reach statistical significant level.Depth of pocket seemingly has attenuating trend, but does not all reach significant level.
Table 15 shows: no matter still carry out ranked data relatively by orderly contingency table method by effective percentage, all be that the periodontitis treatment effect significantly is better than 1% iodine glycerol.
Table 16 shows the different disease type of gingival atrophy therapeutic effect, and in the gastric heat disease type, the level effective percentage significantly is better than matched group, and in the gastric heat of the suffering from a deficiency of the kidney disease type, two groups of curative effects do not have significant difference.
3.2.3 pericoronitis and periodontitis curative effect overall merit.
With the recovery from illness in pericoronitis and the efficacy evaluation, produce effects case, with produce effects in the periodontitis efficacy evaluation
Compare before and after the treatment of table 13 periodontitis case cardinal symptom
| Symptom | Group | The example number | Transference cure | Significantly alleviate | Improvement is arranged | Do not have progressive | ||||
| N | N | ％ | N | ％ | N | ％ | N | ％ | ||
| Red swelling of gingiva | 1 | 150 | 94 | 62.7 | 42 | 28.0 | 9 | 6.0 | 5 | 3.3 |
| 2 | 45 | 11 | 24.4 | 25 | 55.6 | 8 | 17.8 | 1 | 2.2 | |
| The transference cure rate compares: (p＜0.01) | Orderly contingency table chi-square analysis: (p＞0.05) | |||||||||
| Gingiva pain | 1 | 146 | 107 | 73.3 | 31 | 21.2 | 6 | 4.1 | 2 | 1.4 |
| 2 | 44 | 16 | 36.4 | 23 | 52.3 | 5 | 11.4 | 0 | - | |
| The transference cure rate compares: (p＜0.01) | Orderly contingency table chi-square analysis: (p＞0.05) | |||||||||
| Dental hemorrhage | 1 | 133 | 79 | 59.4 | 37 | 27.8 | 13 | 4.8 | 4 | 3.0 |
| 2 | 38 | 9 | 23.7 | 22 | 57.9 | 6 | 15.8 | 1 | 2.6 | |
| The transference cure rate compares: (p＜0.01) | Orderly contingency table chi-square analysis: (p＜0.05) | |||||||||
| Halitosis | 1 | 101 | 46 | 45.5 | 18 | 17.8 | 13 | 12.9 | 24 | 23.8 |
| 2 | 24 | 7 | 29.2 | 4 | 16.7 | 9 | 37.5 | 4 | 16.7 | |
| The transference cure rate compares: (p＜0.01) | Orderly contingency table chi-square analysis: (p＞0.05) | |||||||||
Annotate: group 1=, 2=placebo
Change before and after the treatment of table 14 periodontal index
| Group | N | Mean value SD before the treatment | Treatment back mean value SD | p | Difference mean value SD | |
| Bleeding index | 1 | 153 | 3.47±1.11 | 1.45±0.99 | ＜0.01 | 1.82±1.25 |
| 2 | 47 | 3.19±1.10 | 1.66±0.73 | ＜0.01 | 1.53±0.93 | |
| P | ＞0.05 | ＞0.05 | ＞0.05 | |||
| Depth of pocket | 1 | 153 | 4.97±1.14 | 4.77±1.12 | ＞0.05 | 0.20±0.46 |
| 2 | 47 | 4.96±0.88 | 4.68±0.63 | ＞0.05 | 0.28±0.54 | |
| P | ＞0.05 | ＞0.05 | ＞0.05 |
Annotate: group 1=, 2=placebo
Table 15 periodontitis treatment effective evaluation
| Group | Produce effects | Progressive | Invalid | Add up to | |||
| n | ％ | n | ％ | n | ％ | N | |
| The present invention | 127 | 83.0 | 22 | 14.4 | 4 | 2.6 | 153 |
| Placebo | 20 | 42.6 | 27 | 57.4 | 0 | - | 47 |
| Effective percentage relatively | (P＜0.01) is the contingency table chi-square analysis in order: (P＞0.01) group | ||||||
The evaluation of the different disease type of table 16 gingival atrophy therapeutic effect
| The disease type | Group | Produce effects | Progressive | Invalid | Add up to | ||||
| n | ％ | n | ％ | n | ％ | n | ％ | ||
| Gastric heat disease type | 1 | 100 | 84.0 | 16 | 13.5 | 3 | 2.5 | 119 | 100.0 |
| 2 | 14 | 37.8 | 23 | 62.2 | 0 | - | 37 | 100.0 | |
| Effective percentage compares: (P＜0.01) | |||||||||
| The gastric heat of suffering from a deficiency of the kidney disease type | 1 | 27 | 79.5 | 6 | 17.6 | 1 | 2.9 | 34 | 100.0 |
| 2 | 6 | 60.0 | 4 | 40.0 | 0 | - | 10 | 100.0 | |
| Effective percentage compares: (P＞0.05) | |||||||||
Annotate group 1=, the 2=placebo
Table 17 pericoronitis and periodontitis effective percentage statistics
| Group | Effectively | Invalid | Add up to | ||
| n | ％ | n | ％ | N | |
| The present invention | 302 | 88.8 | 38 | 11.2 | 340 |
| Placebo | 57 | 62.0 | 35 | 38.0 | 92 |
| Add up to | 359 | 73 | 432 | ||
P＜0.001
The evaluation of the different disease type of table 18 tooth gnawing pain therapeutic effect with gingival atrophy
| The disease type | Group | Effectively | Invalid | Add up to | |||
| n | ％ | n | ％ | n | ％ | ||
| Gastric heat disease type | 1 | 210 | 89.0 | 26 | 11.0 | 236 | 100.0 |
| 2 | 40 | 59.7 | 27 | 40.3 | 67 | 100.0 | |
| Effective percentage compares: (P＜0.01) | |||||||
| The liver and gall excess fire type | 1 | 65 | 92.9 | 5 | 7.1 | 70 | 100.0 |
| 2 | 14 | 93.3 | 1 | 6.7 | 15 | 100.0 | |
| Effective percentage compares: (P＞0.05) | |||||||
| The gastric heat of suffering from a deficiency of the kidney disease type | 1 | 27 | 79.4 | 7 | 20.6 | 34 | 100.0 |
| 2 | 6 | 60.0 | 4 | 40.0 | 10 | 100.0 | |
| Effective percentage compares: (P＞0.05) | |||||||
Annotate: group 1=, 2=placebo
Case merges statistics, makes effectively meter, will improve and invalid meter is made in invalid merging, and group effective percentage 88.8%, placebo effective percentage 62%, the two is compared, and there were significant differences, i.e. evident in efficacy in traditional thing 1% iodine glycerol to pericoronitis, periodontitis.(seeing Table 17)
With the recovery from illness in the tooth gnawing pain efficacy evaluation, produce effects case, merge statistics with produce effects case in the gingival atrophy efficacy evaluation, make effectively meter, will improve and invalidly close invalid meter, make chromatographic analysis by different disease types.To gastric heat disease type effective percentage 89.0%, placebo effective percentage 59.7%, the two is compared, and there were significant differences: to the liver and gall excess fire type and the then two groups of therapeutic equivalences of gastric heat type of suffering from a deficiency of the kidney.(seeing table 18 for details)
4, analysis of adverse reactions
Routine blood test, urine routine examination have been done before and after the 15 example treatments of this group.30 examples have been done electrocardiogram, hepatic and renal function inspection, other has 18 routine volunteers (comprising because of he sick prescription on individual diagnosis patient) to do routine blood test, urine routine examination before and after using, 27 routine volunteers (comprising because of he sick prescription on individual diagnosis patient) did the hepatic and renal function inspection before and after using, all in normal range.This medicine external is described, hemopoietic system, conscience and renal function are had no adverse effects.
Record all has no adverse reaction in the 432 routine case notes.Quick reaction was met at the end.
(1) withdraws from, loses visit, easily removes the case situation analysis
Amount to 37 examples and include object in because of withdrawing from, lose 7.9 % that eliminatings such as visit account for object of observation sum 469 examples, details is shown in table 19:
Table 19 is included object in and is got rid of situation
| Reason | Pericoronitis | Periodontitis | Add up to | ||
| The propolis group | Matched group | The propolis group | Matched group | ||
| Withdraw from | 14 | 4 | 2 | 2 | 22 |
| Lose and visit | 5 | 1 | - | - | 6 |
| Easily remove | 8 | 1 | - | - | 9 |
| Add up to | 27 | 6 | 2 | 2 | 37 |
Withdraw from case and be the person that takes antibiotics simultaneously, the treatment group is totally 16 examples, iodine glycerol group 6 examples mostly are the heavier person of the state of an illness, as are preced with week, facial swelling, serious limitation of mouth opening, accompanying heavier General Symptoms, is the safety meter through attending doctor, uses antibiotics simultaneously, but the case that also has oneself adds and uses antibacterial therapy for not complying with doctor's advice.
Losing and visiting case is person out of touch for only going to a doctor 1-2 time, totally 6 examples.
9 cases rejecting are for taking the antibacterial-anti-inflammatory drug person simultaneously 1-2 time, and only 2 examples are the incomplete or indeterminate person of data.
Count 8 invalid, that the iodine glycerol group is got rid of cases for effectively counting curative effect situation such as table 20 after the correction as organizing 29 cases getting rid of:
Table 20, with placebo curative effect correction analysis
| Group | Effectively | Invalid | Add up to | |||
| n | ％ | n | ％ | n | ％ | |
| The present invention | 302 | 81.8 | [38+29] | 18.2 | 369 | 100.0 |
| Placebo | [57+8] | 65.0 | 35 | 35.0 | 100 | 100.0 |
*P＜0.05
Six, discuss
Single blind random contrast clinical trial scheme is adopted in this test, and curative effect and traditional oral cavity medicine for external use 1% iodine glycerol for the treatment of common oral cavity infection pericoronitis, periodontitis is compared observation.Its result is as follows:
1, harmonious analysis result shows: preceding group of test and iodine glycerol matched group are in a bad way except that pericoronitis the degree, the principal element that all the other may affect the treatment, sex, age distribution as study subject, the cardinal symptom sign distributes, the traditional Chinese medical science is debated disease typing etc., compares for two groups not have significant difference.The pericoronitis state of an illness relatively in, matched group is light-duty in the majority, and organizes medium and heavy in the majorityly, in fact increased the difficulty of treatment.
2, efficacy analysis shows: after treatment, pericoronitis (tooth gnawing pain) case cardinal symptom disappearance rate all is to be better than the iodine glycerol group except that blind bag pus, and mouth opening obviously increases.During the curative effect Comprehensive Assessment, clinical recovery rate, effective percentage all are groups (52.9%, 93.5%), are better than matched group (20.0%, 822%).
After treatment, periodontitis (gingival atrophy) case cardinal symptom disappearance rate antihalitosis all is better than matched group, and bleeding index obviously reduces, but change is seen at the depth of pocket end, and overall merit effective percentage (83.0%) significantly is better than matched group (42.6%)
3, debate the disease phenotypic analysis by the traditional Chinese medical science, no matter be that pericoronitis or periodontitis all are to be better than the iodine glycerol group in the gastric heat disease type.
4, the result who gets rid of the case correction analysis shows, is 81.8% to the effective percentage of pericoronitis, periodontitis, significantly is better than matched group (65.0%).
Pericoronitis and periodontitis are frequently-occurring diseases, mainly take antibacterial therapy clinically, and not only price is high because of there being serious abuse antibiotics phenomenon, and its toxic and side effects causes that day by day people pay attention to.As a kind of natural medicinal formulations, pericoronitis and periodontitis have been shown good curative effect, easy to use, have no side effect and anaphylaxis, exploitation motherland medical treasure-house is described, to treatment common frdquently encountered disease, minimizing antibiotics abuse, very good prospect is arranged.
Show that according to this result of the test it has following characteristics:
1, function and curing mainly: stomach, gallbladder Liver and kidney warp are put down, returned to bitter in the mouth, sweet, property, and wind-expelling pain-stopping, heat-clearing toxin-expelling functions are arranged, antibacterial, antiinflammatory, hemostasis and astriction.The common infectious disease in oral cavity such as pericoronitis, periodontitis etc. mostly are the gastric intrinsic heat, hold the exopathogen fire-transformation again under the arm and follow through up, and due to QI and blood all stagnated, local topical can be changed the decomposition poison, promote organization healing.Experiment in vitro disease is real to be had antibacterial or killing action to common pathogenic anaerobe of common suppuration bacterium such as gold-coloured staphylococci, streptococcus and oral cavity such as bacteroides melanogenicus etc.Zoopery disease still has antiinflammatory, surface anesthetic effect in fact in addition.According to this result of the test, cure mainly pericoronitis, periodontitis.
2, subject range: local topical cures mainly periodontitis, acute and chronic pericoronitis etc. and causes red swelling of gingiva, hemorrhage, pyorrhea, halitosis, odontoseisis, interlock pain, and follows, and companion symptom such as swelling of the face, limitation of mouth opening, swallows pain etc.
3, dosage regimen, the course of treatment: normal saline washing periodontal pocket or be preced with all blind bags, dip in and will splash into or inject in the bag after doing, till the visible medicinal liquid of bag mouth, once a day, each consumption is advisable to be no more than 0.5 milliliter (about 8-10 drips), one course of treatment of work on the 3rd.According to clinical experience, can increase every day access times to 2-3 time.But as personal should in time go to see a doctor when invalid.
4, curative effect: external can make 80-90% periodontitis, the remarkable mitigation symptoms of acute and chronic pericoronitis patient.Make red swelling of gingiva, hemorrhage.Pyorrhea, halitosis, odontoseisis, interlock pain goes into its simultaneous phenomenon such as swelling of the face, limitation of mouth opening, swallow pain etc. alleviates or disappears.
5, untoward reaction: when routine administration, do not have the whole body toxic and side effects.During the some cases topical application of short duration stimulation or pain can be arranged.
6, taboo: allergic constitution is arranged, particularly Apis goods and ethanol allergy sufferers are avoided usefulness.Child, anemia of pregnant woman and the careful usefulness of the old and the weak depletion person.
Seven, conclusion
This evidence, the present invention are to the common pericoronitis that catches in oral cavity, and periodontitis is tooth gnawing pain, gingival atrophy local application, mitigation symptoms rapidly, and effective percentage reaches 88.8%, significantly is better than traditional oral cavity external used medicine 1% iodine glycerol.To nontoxic pair of effect of patient, do not meet quick reaction, the suggestion clinical application.
The specific embodiment
Embodiment 1
A, get propolis 1000 gram, it is ground into fritter, add 2000 ml concns and be 94% medical ethanol, lixiviate at normal temperatures 48 hours after leaving standstill, is filtered roguing, draws supernatant, measures its general flavone content, and is stand-by;
Add 95% medical ethanol to 3000 milliliter in B, the above-mentioned propolis extract, every milliliter of spray that contains 20 milligrams of total flavones amounts.
Embodiment 2
A, take by weighing propolis 1000 gram, it is ground into fritter, add 6000 ml concns and be 50% medical ethanol, lixiviate at normal temperatures 120 hours after leaving standstill, is filtered roguing, draws supernatant, measures its general flavone content, and is stand-by;
B, in above-mentioned propolis extract, add 95% medical ethanol to 10000 milliliter, every milliliter of tincture that contains 1 milligram of total flavones amount.
Embodiment 3
A, take by weighing propolis 1000 gram, it is ground into fritter, add 3000 ml concns and be 75% medical ethanol, lixiviate at normal temperatures 80 hours after leaving standstill, is filtered roguing, draws supernatant, measures its general flavone content, and is stand-by;
B, in above-mentioned propolis extract, add 95% medical ethanol to 6500 milliliter, every milliliter of tincture that contains 10 milligrams of total flavones amounts.
Claims (2)
1, a kind of medicine for the treatment of oral disease is characterized in that every milliliter of medicinal liquid propolis-containing total flavones 1-20 milligram, and surplus is a medical alcohol.
2, the preparation method of medicine according to claim 1 is characterized in that it makes by following method:
A, rubber powder are broken into piece, and in propolis: it is the medical ethanol of 50-94% that the ratio of ethanol=1: 1-5 adds concentration, lixiviate 65-80 hour at normal temperatures, through leave standstill, filter propolis extract, measure total flavones amount wherein after, stand-by;
B, to add concentration in above-mentioned propolis extract be the medical ethanol of 50-94%, and the medicinal liquid that is mixed with every milliliter of propolis-containing total flavones 1-20 milligram gets final product.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2003101040262A CN1282453C (en) | 2003-12-13 | 2003-12-13 | Medication for treating oral disease |
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2003101040262A CN1282453C (en) | 2003-12-13 | 2003-12-13 | Medication for treating oral disease |
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| CN1282453C true CN1282453C (en) | 2006-11-01 |
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