CN100364530C - Novel levamisole formulation for chronic rhinitis - Google Patents
Novel levamisole formulation for chronic rhinitis Download PDFInfo
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- CN100364530C CN100364530C CNB2003101003780A CN200310100378A CN100364530C CN 100364530 C CN100364530 C CN 100364530C CN B2003101003780 A CNB2003101003780 A CN B2003101003780A CN 200310100378 A CN200310100378 A CN 200310100378A CN 100364530 C CN100364530 C CN 100364530C
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- 206010039083 rhinitis Diseases 0.000 title claims abstract description 61
- HLFSDGLLUJUHTE-SNVBAGLBSA-N Levamisole Chemical compound C1([C@H]2CN3CCSC3=N2)=CC=CC=C1 HLFSDGLLUJUHTE-SNVBAGLBSA-N 0.000 title claims abstract description 45
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Abstract
The present invention relates to an application of spray, aerosol, atomized powder agent and nasal drops of levamisole in curing chronic rhinitis.
Description
Technical field
The present invention relates to treat the levamisole nasal drop, levamisole nasal mist of chronic rhinitis and left-handedly narrow azoles nasal aerosol and their application.
Background technology
One, chronic rhinitis brief introduction |
Chronic rhinitis (chronic rh initis) is nasal membrane and submucosal chronic inflammatory disease.Show as the chronic congestion swelling of nasal mucosa, claim chronic simple rhinitis (chronic simple rhinitis).If develop into the hypertrophy plumpness of nasal mucosa and turbinates, claim chronic hypertrophic rhinitis (chronic hypertrophic rhinitis).
(1) cause of disease
Local disease because of
(1) acute rhinitis is shown effect repeatedly or is treated and thoroughly do not develop into chronic rhinitis.
(2) because contiguous chronic inflammatory disease long-time stimulus or deformity cause the smooth or drainage obstruction of nose generation ventilation, as chronic sinusitis, deviation of nasal septum, chronic tonsillitis or adenoid vegetation etc.
(3) nasal cavity applied medicine is improper or excessively form medicamentous rhinitis (rhinitis medicamentosa) after for a long time, is common in for a long time with after the naphazoline.
Hologathy because of
(1) long-term chronic disease as endocrine disturbance, prolonged constipation, nephropathy and cardiovascular disease etc., and causes nasal mucosa for a long time or the repeatly property sent out hyperemia or blood stasis.
(2) vitamin deficiency is as vitamin A or C.
(3) tobacco and wine excessively can influence easypro the contracting of nasal mucosa vessels and obstacle takes place.
(4) take antihypertensive drugs such as reserpine for a long time, can cause nasal cavity vasodilation and produce like symptoms of rhinitis.
3. environmental factors: the worker in environment such as cement, Nicotiana tabacum L., coal dust, flour or chemical substance are arranged, nasal mucosa is subjected to the stimulation and the infringement of physics and chemokines, can cause chronic rhinitis.This disease as steel-making, freezing, workshop workman such as baking is molten, also more easily takes place in humiture environment jumpy.
(2) Therapeutic Principle's anti-inflammation detumescence, ventilation drain and as far as possible safeguard the physiological function of nasal mucosa will be noted the processing to the cause of disease simultaneously.
Two, chronic simple rhinitis
(1) the chronic expansion of pathology mucosa deep-level blood vessel changes the most obvious with the concha nasalis inferior cavernous sinusoids especially.The mucous gland function is active, secretion increasing.Turbinate mucosa swelling, but submucous tissue does not have obvious hypertrophy and sexually revises.
(2) clinical manifestation
1. nasal obstruction: intermittent or property alternately.1. intermittent nasal obstruction: alleviate when generally showing as daytime, work or motion, night, sit quietly or increase the weight of when cold.2. replace the property nasal obstruction: the normal obstruction of nasal cavity that is positioned at downside when lying on one's side increases the weight of; After changeing the opposite side that crouches, being positioned at upside does not just now have nasal obstruction or the lighter nasal cavity of nasal obstruction, forwards down rear flank appearance nasal obstruction or nasal obstruction to and increases the weight of; And the nasal cavity nasal obstruction that was positioned at downside just now alleviates.In addition, olfactory sensation can have going down in various degree, is closed rhinolalia in a minute.Nasal vestibule and upper lip because nasal mucus is flowed through for a long time can cause dermatitis or eczema, are more common in child.Nasal mucus can flow into pharyngeal cavity backward, symptoms such as cough, excessive phlegm occur.
2. many tears: often be mucus or sticking purulence, idol is purulence.Purulence person occurs after more than secondary infection.
3. check: nasal mucosa swelling, smooth surface, moistening generally is kermesinus.Turbinate mucosa softness and high resilience, the light pressure of probe can now cave in, but removes the probe very fast recovery of then caving in, and is obvious at concha nasalis inferior especially.Shrink if make nasal mucosa with 1～2% ephedrine liquid, then concha nasalis dwindles rapidly.Meatus nasi communis or inferior nasal meatus have mucus or purulent secretion.
(3) the treatment Therapeutic Principle gets rid of secretions for recovering the nasal airflow function, eradicates the cause of disease.
1.1% ephedrine or nitrofural ephedrine liquid, chloromycetin ephedrine drop nose, every day 3 times,
2.0.25 ~ 0.5% procaine is done the sealing down of agger nasi blocking or concha nasalis inferior mucosa, each 1 ~ 1.5ml, the next day 1 time, or 2 times weekly, 5 times is a course of treatment.
3. ultrashort wave or infrared physiotherapy can improve local blood circulation with mitigation symptoms.
4. when above-mentioned therapy is invalid, can select for use sclerosing agent to make the concha nasalis inferior injection for curing.
5. find out the cause of disease relevant and treatment in time with disease.Take exercises the enhancing body resistance.
Three, chronic hypertrophic rhinitis
Chronic hypertrophic rhinitis (chronic hypertrophic rhinitis) for the hypertrophy plumpness of nasal mucosa, tela submucosa and turbinates sexually revises, is generally developed by chronic simple rhinitis.
(1) pathology mucous epithelium cilium comes off, and becomes stratified cuboidal epithelium, and tela submucosa then proliferation of fibrous tissue takes place by edema and makes pachymucosa, and it can be Fructus Mori shape or polypoid to become for a long time, periosteum and osseous tissue hypertrophy, and the turbinates sclerotin also can be loose and change.
(2) clinical manifestation
1. nasal obstruction is heavier, mostly is persistence, normal mouth breathing, and olfactory sensation is gone down more.
2. the nasal mucus stiff is mucus or sticking purulence more.Because postnasal drip stimulates throat to cause cough, excessive phlegm.
3. when loose middle nasal concha is oppressed nasal septum, can cause anterior ethmoidal nerve pressurized or inflammation that ophthalmic branch of trigeminal nerve is told, irregular ictal forehead pain occur, and, claim anterior ethmoidal neuralgia, claim the anterior ethmoidal nerve syndrome again to the bridge of the nose and eye socket radiation.
4. check: 1. concha nasalis inferior is obviously loose, or concha nasalis inferior is all loose with middle nasal concha, often causes the nasal cavity obstruction.Nasal cavity bottom or inferior nasal meatus have mucus or sticking purulent secretion.2. mucosa swelling, pinkiness or aubergine, air spots, or be nodositas or Fructus Mori shape, serve as obvious with concha nasalis inferior front end and free edge thereof especially.The light indentation of probe falls into not obvious, and that touches has a strong sense.3. local not obvious with mucosa contraction after the vasoconstrictor.
(3) treatment
1. the application of vasoconstrictor nasal drop is limited to light-duty case.
2. injection of sclerosing agent under the concha nasalis inferior mucosa after its mechanism of action is injection of sclerosing agent, can make the local chemical inflammatory reaction that takes place, and produces scar tissue, dwindles the concha nasalis volume, improves ventilation.50% Glucose Liquid commonly used adds 15% sodium chloride solution, 5% sodium morrhuate or 80% glycerol etc.After the concha nasalis topical anesthesia, thrust backward from concha nasalis inferior lower edge front end is parallel with 22～No. 23 elongated syringe needles, transfixation mucosa not, limit withdraw of the needle marginal not is penetrated sclerosing agent, till syringe needle is extracted.Also can divide 3 injections in concha nasalis inferior front end, middle part, rear end, every side injection 0.5ml, per 10 days 1 time is a course of treatment with 3～5 times.
3. the mucosal tissue of electric coagulation plumpness under the concha nasalis inferior mucosa makes to produce the cicatrix contraction.After topical anesthesia, the acusector head thrusts from the concha nasalis inferior front end, extracts after solidifying for 20～30 seconds, and electric current is 10～30 milliamperes.
4. cryosurgery is that to place the concha nasalis inferior surface to do on special freezing head freezing, each 1～2 minute, the pathological changes mucosal necrosis is come off and regenerated mucosa.
5. operative therapy, general treatment is invalid, or mucosa is significantly plump, or plump part is positioned at concha nasalis inferior rear end or lower edge, feasible partial inferior turbinectomy or partial middle turbinectomy.The concha nasalis inferior excision is too much unsuitable, is no more than 1/3 of concha nasalis inferior in principle, in order to avoid influence nasal mucosa function or secondary atrophic rhinitis.Bone hypertrophy person, the concha nasalis inferior of should going is sticking-the subperiosteum excision, both can improve the ventilation drain of nasal cavity, again without detriment to the physiological function of nasal mucosa.
6. to whole body chronic disease or contiguous focus such as deviation of nasal septum or sinusitis etc., also give suitable treatment.
Four, levamisole brief introduction
Levamisole is the wide spectrum anthelmintic of using always, and it makes Fumaric acid can not be reduced to succinic acid, thereby influence the anaerobic metabolism of polypide muscle by optionally suppressing the succinate dehydrogenase in the worm human body, makes the polypide muscular paralysis get rid of external with feces.Levamisole also has immunomodulating and immunostimulation function, can strengthen the chemotactic response of person monocytic cell or polymorphonuclear leukocyte, can also strengthen monocytic phagocytic function, it is immunomodulator, but this regulating action only is being adjusted to normal level with repressed immunologic function, and can not cause that immunity is hyperfunction.Levamisole can be used for auxiliary treatment, autoimmune disease, the chronic and recurrent infection of tumor.
Five, so far, all do not see any report or document record that levamisole is used for the treatment of chronic rhinitis both at home and abroad as yet.
Summary of the invention
The present invention is made into compound recipe with levamisole as independent effective ingredient or with other medicines, makes the dosage form of nasal-cavity administration, and these dosage forms include, but are not limited to: nasal drop, spray, aerosol and powder spray.
Indication with levamisole or the nasal drop made from the compound recipe that contains levamisole, spray, aerosol and powder spray of the present invention includes, but are not limited to following disease: chronic rhinitis, allergic rhinitis, pharyngitis, tracheitis and bronchitis.
Use of the present invention with levamisole or the nasal drop made from the compound recipe that contains levamisole, spray, aerosol and powder spray, for the chronic rhinitis patient, direct nasal-cavity administration, relief of symptoms or make transference cure effectively; For allergic rhinitis, pharyngitis, tracheitis and bronchitis, can the amelioration of inflammation symptom.
Nasal drop of the present invention, spray and aerosol all meet the definition of the Pharmacopoeia of the People's Republic of China (version was two ones in 2000) about nasal drop, spray and aerosol.
Chronic rhinitis of the present invention is that those skilled in the art is known, has it to define accurately in the modern medical book.
Allergic rhinitis of the present invention, pharyngitis, tracheitis and bronchitis also are that the ordinary artisan of this area is known, have it to define accurately in the modern medical book.
The specific embodiment
By following examples levamisole nasal drop of the present invention, spray, aerosol and powder spray treatment chronic rhinitis, allergic rhinitis, pharyngitis, tracheitis and bronchitic application are described.It should be noted that, following embodiment just is used for explanation and unrestricted the present invention well-known to those skilled in the artly is used for the treatment of allergic rhinitis, chronic rhinitis, pharyngitis, tracheitis and bronchitic technology all within the scope of the invention by other administration route with levamisole.
Embodiment 1 levamisole spray treatment chronic rhinitis
Levamisole treatment chronic rhinitis 105 examples have obtained significant clinical effectiveness.
Physical data clinic case 217 examples, wherein male 142 examples, women 75 examples; 16～44 years old age, average 27 years old.Patient's course of disease 13 months is to 12a.Chronic simple rhinitis 63 examples, chronic hypertrophic rhinitis 154 examples.All cases were all once accepted Drug therapy, and 11 examples were once accepted cold therapy, and 23 examples were once accepted laser therapy, and 17 examples were once accepted the injection of concha nasalis inferior medicine, and medicine is not quite clear.
The Therapeutic Method patient is divided into levamisole treatment group (105 examples, chronic simple rhinitis 36 examples wherein, chronic hypertrophic rhinitis 69 examples) and matched group (112 examples, chronic simple rhinitis 27 examples wherein, chronic hypertrophic rhinitis 85 examples) at random.Levamisole treatment group adopts the treatment of levamisole spray, nasal-cavity administration spray every day secondary, and dosage is the every spray of 100ug/0.14ml.Matched group is with 0.25% chloromycetin ephedrine liquid, collunarium or spray into nasal cavity, every day three times, each 3～5.Be for 1 week two groups of courses of treatment, during the nasal drop of forbidding other anti-inflammatory drugs and other types.
The inspection situation was a standard when therapeutic evaluation standard was followed up a case by regular visits to last.Recovery from illness: the complete obiteration of nasal obstruction symptom, nasal cavity recovers ventilation fully, and nasal discharge and olfactory sensation also have improvement, and concha nasalis inferior obviously dwindles.Take a turn for the better: nasal obstruction is obviously improved, and slight nasal obstruction phenomenon is only arranged in upper respiratory tract infection or when lying on one's side, and concha nasalis inferior has in various degree before the treatment and dwindles.Invalid: follow up a case by regular visits to nasal obstruction nothing improvement in the time, concha nasalis inferior does not have change.
Two groups of results treatment, 1 week of back, follow up a case by regular visits to respectively 4 times 2 weeks, 1 month and 3 months, irregularly follow up a case by regular visits to later on.Followed up a case by regular visits to the time elder 9 months, the shortest person 1 month on average followed up a case by regular visits to 4 months.
The levamisole treatment is organized among the 105 routine patients, and chronic simple rhinitis 36 examples (29 examples of fully recovering, 7 examples that take a turn for the better, invalid 0 example, total effective rate 100%) are arranged; Chronic hypertrophic rhinitis 69 examples (51 examples of fully recovering, 13 examples that take a turn for the better, invalid 5 examples, total effective rate 92.8%) are arranged.
Among the 0.25% chloromycetin ephedrine liquid matched group 112 routine patients, chronic simple rhinitis 27 examples (7 examples of fully recovering, 10 examples that take a turn for the better, invalid 10 examples, total effective rate 63%) are arranged; Chronic hypertrophic rhinitis 85 examples (2 examples of fully recovering, 56 examples that take a turn for the better, invalid 27 examples, total effective rate 68.3%) are arranged.
Therefore, the effective percentage height of levamisole treatment chronic rhinitis, curative effect is higher than 0.25% chloromycetin ephedrine liquid.
Embodiment 2 levamisole treatment by aerosol chronic rhinitiss
Repeat " embodiment 1 " described experiment, what adopt except that curative is that patient's state of an illness of levamisole aerosol (dosage is the every spray of 70ug/0.14ml) and observation is with quantity is different, patient goes into group standard, therapeutic scheme, curative effect judging standard all with " embodiment 1 ", experimental result is similar with " embodiment 1 ", promptly adopt levamisole treatment by aerosol chronic rhinitis, its curative effect is better than 0.25% chloromycetin ephedrine liquid.
Embodiment 3 levamisole nasal drop treatment chronic rhinitis
Repeat " embodiment 1 " described experiment, what adopt except that curative is levamisole nasal drop (concentration is 350ug/ml), administrated method patient's state of an illness of changing each collunarium and observation for the every spray with spray into quantity is different, patient goes into group standard, therapeutic scheme, curative effect judging standard all with " embodiment 1 ", experimental result is similar with " embodiment 1 ", promptly adopt levamisole nasal drop treatment chronic rhinitis, its curative effect is better than 0.25% chloromycetin ephedrine liquid.
Embodiment 4 levamisole powder sprays treatment chronic rhinitis
Repeat " embodiment 1 " described experiment, patient's state of an illness that what adopt except that curative is levamisole powder spray (dosage is every spray 70ug), observe is with quantity is different, patient goes into group standard, therapeutic scheme, curative effect judging standard all with " embodiment 1 ", experimental result is similar with " embodiment 1 ", promptly adopt levamisole powder spray treatment chronic rhinitis, its curative effect is better than 0.25% chloromycetin ephedrine liquid.
Embodiment 5 levamisole sprays treatment chronic rhinitis case
Certain man, 42 years old, suffered from chronic rhinitis more than 20 year, headache, dizzy, nasal obstruction, symptom is more serious during flu, uses local treatment, the transference cure after eight days of sucking of the capable nose of " embodiment 1 " described levamisole spray May calendar year 2001.Follow-up observation 10,20 30 days, is not seen recurrence.There is not the rhinitis symptom when removing flu later on again.
Embodiment 6 levamisole treatment by aerosol chronic rhinitis cases
Certain woman, 35 years old, Xuanhua, Hebei province city a surname steel engineer of subsidiary factory was because of the untimely chronic rhinitis that causes of treatment of catching a cold, nasal obstruction, rhinorrhea, can not use nasal respiration night, can only use mouth breathing, causes dry mouth and tougue, dizzy headache will be suppressed and wake up for several times for one evening, directly has influence on the working and learning of oneself.Suck treatment with the capable nose of " embodiment 2 " described levamisole aerosol is local in November, 2002, once a day, continues 5 days, and the symptom of nasal obstruction all disappears, treated for 2 weeks after, the chronic rhinitis symptom all disappears.
Embodiment 7 levamisole nasal drop treatment chronic rhinitis case
Certain man, nineteen sixty-eight gives birth to, and just suffers from rhinitis in 1984, and the state of an illness increased the weight of in 99 years, nasal obstruction, dizziness headache, hypomnesis uses the capable nose dropping treatment of the several different methods treatment described levamisole nasal drop of all undesirable usefulness " embodiment 3 ", once a day, continue 5 days, from medication the 2nd day, symptom alleviated day by day.Continuation is used the levamisole nasal drop with method, check after 10 days, symptom complete obiteration.
Claims (6)
1. the application of levamisole in the medicine of preparation treatment chronic rhinitis.
2. according to the application of claim 1, it is characterized in that described chronic rhinitis is chronic simple rhinitis or chronic hypertrophic rhinitis.
3. the application of levamisole in the nasal drop of preparation treatment chronic rhinitis.
4. the application of levamisole in the spray of preparation treatment chronic rhinitis.
5. the application of levamisole in the powder spray of preparation treatment chronic rhinitis.
6. the application of levamisole in the aerosol of preparation treatment chronic rhinitis.
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| CN1375291A (en) * | 2001-03-16 | 2002-10-23 | 王玉万 | Veterinary mixed injection containing levamisole or its salts |
| CN1439369A (en) * | 2002-02-22 | 2003-09-03 | 王鹤尧 | Levoimidazole for treating nasal polyp |
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| US4287176A (en) * | 1980-10-09 | 1981-09-01 | American Cyanamid Co. | Anthelmintic levamisole and tetramisole gel compositions |
| US4439439A (en) * | 1981-03-24 | 1984-03-27 | Janssen Pharmaceutica N.V. | Non-irritating tetramisole- or levamisole pour-on conpositions |
| CN1375291A (en) * | 2001-03-16 | 2002-10-23 | 王玉万 | Veterinary mixed injection containing levamisole or its salts |
| CN1439369A (en) * | 2002-02-22 | 2003-09-03 | 王鹤尧 | Levoimidazole for treating nasal polyp |
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