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INVENTION
Patent of the Russian Federation RU2198654
METHOD OF TREATMENT OF ONYCHOMICOSES
The name of the inventor: Raznatovsky KI; Sotnikova NV; Barinova A.N.
The name of the patent holder: St. Petersburg Medical Academy of Postgraduate Education
Address for correspondence: 193015, St. Petersburg, ul. Kirochnaya, 41, Medical Academy of Postgraduate Education, Patent IGKonovalova
Date of commencement of the patent: 2000.04.12
The invention relates to medicine, to mycology and dermatology, to methods of treating onychomycosis. As an antimycotic agent, a solution is used to prepare 14 tablets of lamilicil to a powdered state, pour 100 ml of a 1% solution of dimexide, the mixture is insisted for 24 hours in a sealed container of dark glass, then 100 ml of 70% Acetic acid and 100 ml of 5% iodine solution, after which the resulting solution is applied to the nail plates and nail rolls once a day, and to the skin of the foot 2 times a week for 6 months. This method leads to an increase in the effectiveness of treatment due to an increase in the percentage of clinical and laboratory cure for onychomycosis and prevents the development of recurrences of the disease.
DESCRIPTION OF THE INVENTION
The invention relates to medicine, in particular to dermatology, and concerns one of its most urgent problems - the treatment of fungal lesions of nail plates.
Onychomycosis is a very common disease that occurs in 40% of the population [1]. Onychomycosis almost never affects children [4]. The incidence increases with age and is highest in elderly people [4]. As is known, elderly people not only often other age groups suffer from severe somatic pathology, which is a contraindication for the appointment of highly effective systemic antimycotics, but they often do not have the opportunity to use these funds because of their high cost. Therefore, this category of patients is forced to receive only local therapy, which is less effective than the systemic one, and can not provide a cure for common and long-term fungal nail infections [4].
Local antifungal agents (bifonazole - cream, solution, isoconazole - cream, ketoconazole - cream, clotrimazole - ointment, cream, solution, miconazole - cream, econazole - cream, solution, nafttifin - cream, solution, terbinafine - cream, natamycin - cream; Chloronitrophenol - solution) contain very high concentrations of active substances, active against fungi - pathogens of onychomycosis. However, these high concentrations are created only on the surface of the nail plate, and deep into the nail bed, where the most viable fungi are located, antimycotics do not always penetrate into effective concentrations [4]. Traditionally, this problem was solved as follows: before the appointment of local antimycotics surgical removal of the affected nail plates was performed. However, firstly, this operation is very painful, secondly, along with the plate, the matrix is also removed - the nasal growth zone, the nail bed is injured, which sometimes leads to the growth of the deformed nails [4]. It should be noted that surgical removal of nails is acceptable for young patients who do not have general diseases and vascular disease of the extremities [4]. In this regard, for the treatment of onychomycosis, nail varnishes have been proposed, the main advantage of which is that they can be applied to the nail plate without removing it. The remaining drugs can not penetrate the nail plate, which requires its prior removal [4].
The method closest to the proposed method is a method for treating onychomycosis using local antimycotics in the form of nail polish (loceril, batrafen).
Lac batrafen (8% cyclopyrox) is applied every other day during the first month of treatment, twice a week for the second month, and then once a week. Lacer loceril (5% amorolfin) is applied once a week.
Before beginning treatment with any lacquer, remove as much of the affected nail plate as possible (mechanically or with keratolytic patches). The rest of the nail plate, on which the varnish will be applied, needs to be sawed with the attached file to create an uneven surface. The varnish is applied with a brush or spatula. Before each application of the varnish, the previous layer is removed with a solvent or alcohol swab and the nail plate is treated with a saw blade. Layer of varnish and can be removed by placing the nail in warm water, scraping the varnish of the scissors. The duration of treatment depends on the rate of regrowth of a healthy nail plate. For treatment of onychomycosis, 6 months are enough for the hands, 9-12 months on the legs [4].
Essential disadvantages of this method are:
1) insufficient effectiveness of the method: clinico-laboratory treatment is achieved in 46% of patients [5];
2) a high rate of recurrence of the disease;
3) high cost of treatment.
The object of the present invention is to increase the effectiveness of treatment by increasing the percentage of clinical and laboratory cure for onychomycosis and preventing the recurrence of the disease, a significant increase in the availability of the method (lower cost of treatment).
The goal is achieved using the original penetrating solution with pre-cleaning of the affected parts of the nail (mechanically or with keratolytic patches).
The penetrating solution consists of:
1) lamizil tablets of 250 mg - a fungicidal broad-spectrum antifungal drug from the class of allylamines, effective against dermatophytes, yeasts and molds [4]. Lamisyl acts at the level of the squalene epoxidase cycle, suppressing the enzyme squalene epoxidase of fungi [5]. It has the highest activity among systemic antimycotics against dermatophytes, causing a majority (up to 94%) of cases of dermatomycosis [4];
2) solutions of 5% iodine and 70% acetic acid with fungistatic properties;
3) 1% dimexide solution - an anti-inflammatory drug with antiseptic effect, which has the ability to enhance the penetration of a number of medicinal substances through the skin [2], in particular lamizil, iodine and acetic acid.
The ingredients used in the proposed anti-mycotic solution, in this combination, enhance the effect of each other and give the method a new property that provides a super-medical effect.
The penetrating solution is prepared as follows. 14 tablets of lamilic acid are triturated to a powdery mass and poured into 100 ml of a 1% solution of dimethoxide. This mixture is insisted in a sealed container of dark glass for a day. Then 100 ml of 70% acetic acid and 100 ml of a 5% iodine solution are added to it. This solution is applied to the nail plates and nail rolls for 6 months (1 time per day). On the skin of the foot, the same solution is applied 2 times a week for 6 months.
The proposed method was tested on the clinical basis of the Scientific Research Institute of Medical Mycology of St. Petersburg MAPO together with the department of dermatovenerology of St. Petersburg MAPO.
Examples of application of the method
Example 1 . Patient V. 42 years old suffers from onychomycosis of hands and feet for 15 years. Before applying to the clinic of the Scientific Research Institute of Medical Mycology, St. Petersburg MAPO applied varnish loceril to the affected nail plates for 6 months without significant effect. On examination: all the nail plates of the toes and the first, third fingers of the right hand of the normal configuration, dull, with a yellow tinge from the free edge to the middle of the nail plate, with thickening in the corners of the nail plate due to the accumulation of horny masses, on the skin of the hands and feet - peeling. At laboratory research: a mycelium of a fungus, cultural - growth Trichophyton rubrum is microscopically found out in scrapings of dermal and nail flakes.
Diagnosis: palpebral fistula and stop of squamous dry type with onychomycosis of distal-lateral subungual form (normotrophic type of lesion of all nail plates of toes, first and third fingers of right hand).
After preliminary cleaning of the affected parts of the nail plates, the patient applied daily the nail plates on the nail plates twice a week twice a week to the original penetrating solution, which was prepared as follows: 14 tablets of lamilicum were triturated to a powdery mass, 100 ml of a 1% solution of dimexide , This mixture was infused for 24 hours in a sealed container of dark glass, then 100 ml of 70% acetic acid and 100 ml of a 5% iodine solution were added to it.
After the end of treatment, the nail plates had a clinically healthy appearance. One month after the completion of the treatment, microscopic examination of the mycelium of the fungus was not detected, culture - Trichophyton rubrum was not detected.
Example 2 . The patient M. for 84 years suffers from onychomycosis of the feet for 20 years. Before applying to the clinic of the Scientific Research Institute of Medical Mycology, St. Petersburg MAPO used various external antifungal agents without effect. When examined: all the nail plates of the fingers of the feet are yellow in color, thickened all over due to corneous masses (moderate subungual hyperkeratosis), at the free edge the nail plates are dirty gray, loosened, on the skin - lamellar peeling. At laboratory research microscopically in scrapings of dermal and nail scales the mycelium of a mushroom, cultural - growth Trichophyton rubrum is found out.
Diagnosis: rubophytosis of stop squamous dry type with opiochomycosis of total dystrophic form (hypertrophic type of lesion of all nail plates of toes).
After preliminary cleaning of the affected parts of the nail plates, the patient applied daily the nail plates twice a week to the skin of the foot twice a week, which was prepared as follows: 14 tablets of lamilicum were triturated to a powdery mass, 100 ml of a 1% solution of dimexide , This mixture was infused for 24 hours in a sealed container of dark glass, then 100 ml of 70% acetic acid and 100 ml of a 5% iodine solution were added to it.
After the end of treatment, apparently unchanged nail plates grew to half of the nail bed. One month after the completion of the treatment, microscopic examination of the mycelium of the fungus was not detected, culture - Trichophyton rubrum was not detected.
This method was used to treat 95 patients with onychomycosis at the age of 18 to 84 years old, they suffered from onychomycosis of the hands - 4, onychomycosis of the feet - 91. T. rubrum was sowed in 82 people, C. albicans - in 8 people, mold fungi - in 5 human.
Relapses of the disease were not observed within two years after the end of treatment. Side effects and complications were not observed.
Comparison of the results of treatment with the proposed method with the prototype showed:
1) the percentage of clinical and laboratory cure of onychomycosis in patients treated with the original penetrating solution was 86.4, which is significantly higher than the similar indicator (46%) in the treatment with varnishes (loceril, batrafen);
2) no recurrence of the disease;
3) the average cost of treatment with the original penetrating solution is 3.5 times cheaper than varnishes (loceril, batrafen).
USED BOOKS
1. Lamisil in the treatment of patients with onychomycosis. A manual for doctors. M., 1999. - 3 p.
2. Mashkovskiy MD Drugs. M .: Medicine, 1993, - 1 t. 222 p.
3. Rukavishnikova M.V. Modern methods of treatment of mycosis patients with feet. Journal "The attending physician" 10.
4. Sergeev Yu.V., Sergeev A.Yu. Onychomycosis. Fungal infections of the nails. M.: Geotard medicine, 1998. - 33 p., 100-108 p.
5. Stepanova Zh.V. Fungal diseases. М .: Kron-press, 1996. - 48 with.
6. Stepanova Zh.V. Onychomycosis. Russian Medical Journal 14, 1999.
CLAIM
The method of treatment of onychomycosis by local action of antimycotic agents, characterized in that an antimycotic solution is used to prepare 14 tablets of lamilicol to a pulverulent mass, they are filled with 100 ml of 1% dimexide solution, this mixture is insisted for 24 hours in a sealed container of Dark glass, then 100 ml of 70% acetic acid and 100 ml of 5% iodine solution are added to it, then the solution is applied to the nail plates and nail rolls for 6 months once a day, the skin is applied to the foot 2 times Per week for 6 months.
print version
Date of publication 01.04.2007гг
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