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DERMATOVENEREOLOGY
INVENTION
Patent of the Russian Federation RU2264815

METHOD FOR TREATMENT OF LIMITED SCLERODERMIUM

METHOD FOR TREATMENT OF LIMITED SCLERODERMIUM

The name of the inventor: Ivanov O.L. (RU); Kosheleva I.V. (RU); Kotov A.A.
The name of the patent holder: State Educational Institution of Higher Professional Education. Moscow Medical Academy. THEM. Sechenova
Address for correspondence: 119992, Moscow, ul. Trubetskoy, 8, p. 2, MMA named after. THEM. Sechenova, Intellectual Property Department
Date of commencement of the patent: 2004.01.29

The invention relates to medicine, namely, to dermatology, and can be used for the treatment of various forms of limited scleroderma: plaque, linear scleroderma, sclerotrophic lichen, idiopathic atrophodermia Pazini-Pierini. The method includes the administration of delagil, xanthinal nicotinate, claritin, the use of Elokom ointment. Against this backdrop, 8-10 procedures of intravenous injection of ozonized saline with an ozone concentration of 1.5 mg / l in a volume of 200 ml and 5-7 procedures for subcutaneous cleavage of foci of lesions with an oxygen-ozone gas mixture with an ozone concentration of 2 mg / l alternate. This mixture is introduced along the periphery of the lesion in a volume of 10-30 ml. Intravenous administration is carried out 2-3 times a week, and subcutaneous incisions - 1-2 times a week. The method makes it possible to reduce the amount of drugs and their doses, to quickly stop the manifestation of the disease by increasing the speed and usefulness of absorption of the used ointment, immunomodulating, anti-inflammatory, normalizing collagen formation and microcirculation of the effect of complex treatment, elimination of tissue hypoxia, reflexogenic stimulation of the vascular system of the body.

DESCRIPTION OF THE INVENTION

The invention relates to medicine, namely, to dermatology, and can be used for the treatment of various forms of limited scleroderma: plaque, linear scleroderma, sclerotrophic lichen, idiopathic atrophodermia Pazini-Pierini.

Limited scleroderma (OSD) is one of the topical problems of modern medicine, primarily dermatology. The OSD refers to chronic dermatoses of unclear etiology, occupying from 0.3 to 1% in the structure of dermatological pathology (incidence of scleroderma averages from 2 to 12 cases per million inhabitants, with a steady trend towards an increase in the total number of patients in recent years). OSD is characterized by a lesion of connective tissue of the skin with a predominance of fibro-sclerotic and vascular changes. The main complaints presented by patients with OSD are skin changes, a feeling of tightness, tightness, numbness. Foci of lesion can be single and multiple, have different outlines - rounded, oval, linear, irregular - and color, depending on the stage of the disease, from bright pink to bluish, to white or brownish-brown. Depending on the stage of the pathological process in the outbreaks of the OSD, phenomena of induration or atrophy of the skin can be expressed. All these phenomena, in addition to unpleasant subjective sensations, cause patients considerable moral suffering and significantly reduce the quality of their life, as they are a serious cosmetic defect, especially if they are in open areas of the body.

Traditional approaches to the treatment of OSD involve the elimination or correction of various parts of the pathogenesis of the disease.

With rapidly progressing induration, antifibrotic agents are prescribed (D-penicillamine in a dose of 600-1000 mg / day, a preparation of the vegetable origin of madecassol inside as tablets at 30 mg / day and externally in the form of ointments and powders), prednisolone 10-20 mg / day , Ketotifen 1-2 mg / day, as well as enzymes (lidase). The appointment of various vasoactive drugs (vasodilators, calcium antagonists, disaggregants and angioprotectors) is advisable at all stages of the disease ("Modern pathogenetic therapy of scleroderma" - LABolotnaya, I.Serbina / International Journal of Medicine, 1999, N3, P.56-58; "Treatment with a madecassol of systemic and focal scleroderma" - N.G.Guseva, M.N.Starovoitova, E.S.Mach / Ter.archiv, 1998, No.5, p.58-61).

However, even the most powerful anti-inflammatory drugs used in the treatment of LDO have undesirable side effects, especially with prolonged use (development of Isenko-Cushing syndrome with systemic corticosteroid therapy, gastrointestinal disorders, leukopenia, thrombocytopenia and agranulocytosis with antifibrotic agents, Arterial hypotension in the appointment of vascular drugs).

Current trends in the reduction of the volume of drug therapy contribute to the introduction of physiotherapeutic methods of treatment, combining several therapeutic effects. One of the newest non-medicamentous ways of treatment of SDS is the contact effect on the skin of extremely high-frequency electromagnetic radiation of millimeter range (EHF-therapy) for 10 minutes daily, the total exposure for a session of 40 minutes, for 15-20 days ("EHF-therapy in the treatment of limited Scleroderma "- A.V. Smirnov, G.Yu. Kurnikov, V.S. Perastoronina / Millimeter waves in biology and medicine, 2000, №2 (18), p. 34-35).

However, EHF-therapy is undesirable to conduct with the concomitant pathology of the thyroid gland, which is often observed in patients with OSD, and in the presence of pustular rashes on the skin.

Low-intensity laser irradiation of ODD centers is performed in a sparing mode - locally, defocused by a beam of a helium-neon laser (red light of a wavelength of 0.63 μm) with an output power at the end of the fiber 3-5 mW, spot diameter 4 mm (power density 0.4 -0.6 mW / cm 2 ) and exposure for each affected area is 3 minutes. Irradiation is carried out according to the field-by-field method, in one session no more than 3 skin fields per day, 8-10 procedures per course of treatment against the background of traditional external treatment including Dimexide and Unna cream ("Clinical and immunological features and modification of complex treatment in focal Scleroderma of external genitalia in girls with the help of course low-intensity laser therapy "- VFKokolina, EI Kharybina, ILUkolova, ESKireeva / Pediatrics, 2001, №3, p.106-108) . In the presence of multiple rashes it is necessary to conduct several courses of treatment for 2-3 weeks each.

While laser therapy, however, one must take into account a number of pathologies frequently encountered in patients with scleroderma, which are contraindications to this method of treatment: diseases of the cardiovascular system, diabetes mellitus, thyroid diseases.

A method for treating OSD with various stages of the skin process (early inflammation and later sclerosing and atrophy) is known by applying low doses of ultraviolet irradiation with wavelength "A" of the spectrum - a single dose of 20 J / cm 2 4 times a week for 6 weeks , And then once a week for a further 6 weeks (Gruss, -CJ, Von-A, and Von-Steen, "Effects of low dose of ultraviolet A-1 phototherapy on morphea" (Effects of low doses of ultraviolet irradiation with wavelength of the A spectrum on limited scleroderma) Kobyletzki, -G; Behrens-Williams, -SC et al. / Photodermatol-Photoimmunol-Photomed 2001 Aug; 17 (4): 149-55).

It is proposed to combine ultraviolet irradiation of "A" spectrum (340-400 nm) with deposition on lesions twice a day of ointment containing calcipotriol (0.005%). At the same time, irradiation at a dose of 20 J / cm 2 is carried out 4 times a week for 10 weeks - until a cumulative dose of 800 J / cm 2 ("Combined treatment with calcipotriol ointment and low-dose ultraviolet A1 phototherapy in childhood morphea" Treatment with the use of an ointment containing calcipotriol and low doses of ultraviolet irradiation with wavelength of the A-spectrum for limited scleroderma in children ") Kreuter, -A; Gambichler, -T; Avermaete, A. et al., Pediatr-Dermatol. 2001 May-Jun; 18 (3): 241-5).

The disadvantage of treatment with long-wave ultraviolet radiation is its long duration, and the fact that it is due to side effects is largely limited to the presence of impaired functions of the parenchymal organs - the liver and kidneys. In addition, as can be seen from the above example, an obvious drawback is that for the success of treatment it is necessary to combine phototherapy with other medications, which aggravates the possibility of side effects.

For the treatment of OSD, the method of interval hypoxic therapy is applied. The method consists in intermittent (5-20 inclusions) inhalation of hypoxygenated (10-15%) gas mixture with oxygen partial pressure up to 76 mm Hg. The main factors of the action on the body of hypoxia is the inclusion of all the transport systems of the body (increased pulmonary ventilation, increased minute circulation, increased regional blood flow, increased capillarization of body tissues), and simultaneously increases the activity of oxidative phosphorylation ("The experience of interval hypoxic therapy in dermatological practice" - VI Kulagin, IV Khamaganova, AG Shekrota and others / Russian Journal of Skin and Venereal Diseases, Moscow, 1998, N3, p.29-31).

The application of this technique requires special equipment and special safety precautions. It should be borne in mind that the inhalation of a gas mixture with a reduced oxygen content may not be of concern to patients with concomitant pathology of the respiratory tract. The course of treatment lasts 30 days; Repeated courses of 10-15 sessions are held after 2-3 months (only 3-4 courses).

The method closest to the proposed method of treatment of LDO is the appointment of hyperbaric oxygenation (HBO) procedures performed against a background of complex therapy including penicillin, lidaz, andecalin, angioprotectors, vitamins, topical lotions with 10-30% dimexide solution (Hyperbaric Oxygenation in the complex therapy of plaque scleroderma. "- SS Kryazheva, TI Sapronova, LM Bullokhova / The Russian Journal of Skin and Venereal Diseases, Moscow, 1998, N4, p.39-41 ).

However, it should be borne in mind that the HBO method requires complex special equipment and extensive facilities, in addition, the procedure of HBO in a number of patients causes emotional discomfort (claustrophobia). In addition, HBO is recommended to combine with active medication (penicillin, lidase, trental, Aevit, compresses with 30% dimexide solution) and start on the 5th-7th day from the beginning. The total duration of treatment is 22-28 days.

The object of the present invention is to develop a simpler method of treating limited scleroderma that is not associated with the use of special equipment, which allows to reduce side effects by eliminating antifibrotic agents from the therapeutic complex and reducing the number of vascular preparations and their dose.

In practice, the solution of the task is accomplished in the following way: prescribe delagil to 0.25 g per day, xanthinal nicotinate 0.15 g 2 times a day, claritin 0.001 g per night, externally on the lesion ointment "Elokom" once a day, For 3 weeks and, against this background, alternate (every other day) 8-10 procedures of intravenous infusion of physiological solution enriched with oxygen-ozone mixture and 5-7 procedures of hypodermic injections of the oxygen-ozone mixture into the scleroderma foci.

To obtain the oxygen-ozone mixture, the automatic ozone therapy unit UOTA-60-01 "MedOzon" was used. Saturation of the physiological solution with medical ozone (ozonization) was carried out in standard vials until the ozone concentration in the solution was 1.5 mg / l; Ozonized saline (OPF) was injected intravenously into the patient with standard 200 ml single-use systems, at a rate of 60 to 80 drops per minute. In the subcutaneous incision of the oxygen-ozone gas foci, a disposable 20-ml plastic syringe was filled with an oxygen-ozone gaseous mixture with an ozone concentration of 2 mg / l, which was then administered subcutaneously to the patient on the periphery of the lesion in the amount of 10-30 ml Depending on the size of the source). The procedures were prescribed from the first day of taking medications (intravenous infusions alternated every other day with subcutaneous incisions). Intravenous injections of OPF were performed 2-3 times a week, subcutaneous injections of the gas mixture 1-2 times a week.

Clinical examples

1) Patient K., 65 years old, retired. She complained about the presence of multiple rashes on the skin of the trunk and limbs, accompanied by a feeling of tightening the skin. She is sick for 3 years, repeatedly received outpatient and inpatient treatment with various corticosteroid ointments, vitamins of groups A and E, antihistamines, twice - courses of penicillin therapy. The treatment gave a short-term positive effect in the form of regression of hyperemia and puffiness of the skin, but after 6 months after the end of the last course of treatment progression of the skin process was observed in the form of the appearance of fresh rashes on the skin of the thighs and the phenomena of skin atrophy in the foci on the skin of the chest and abdomen. Local status: on the skin of the abdomen, anterior, external and internal surfaces of the thighs foci of whitish-cyanotic color of rounded and irregular contours, up to 5-7 cm in diameter; There is a slight wrinkling of the skin in the lesions, resembling a crumpled tissue paper.

Clinical diagnosis: Limited scleroderma, proceeding according to the type of sclerotrophic lichen.

A course of drug therapy was prescribed: delagil 0.25 g once a day, xanthinal nicotinate 0.15 g 2 times a day, claritin 0.001 g once a night, externally: Elokom ointment once a day. In parallel, the course of oxygen-ozone therapy was carried out in the form of intravenous injections of OBS with ozone concentration in a solution of 1.5 mg / l No. 10 and subcutaneous cutting of foci of peripheral lesions with an oxygen-ozone gas mixture with ozone concentration in a mixture of 2 mg / l No. 5. Treatment tolerated without side effects. As a result of the course of treatment conducted during the 21st day, a significant clinical improvement was noted in the form of cessation of the appearance of fresh foci, changes in the color of the rashes to a warmer shade closer to the color of normal skin, smoothing of the skin, and the disappearance of the feeling of tightening the skin. Persistent clinical remission for 8 months.

2) Patient K., 58 years old, electrician. Has addressed with complaints to rashes on a skin of a breast and a stomach, consolidation of a skin in the centers of defeat. He was sick for 11 years, repeatedly received outpatient and inpatient treatment: repeated courses of penicillin therapy, vitamins of group B, intramuscular injections of lidaz, external corticosteroid and softening ointments and creams. As a result of previous treatment, the progression of the process is suspended (fresh rashes at the time of treatment did not appear for 5 years already), but in the foci on the skin of the chest and abdomen there are phenomena of skin induration. Local status: on the skin of the chest and anterior abdominal wall, the lesions of the skin are brownish-cyanotic in color with irregular contours up to 10 cm in diameter; The skin in some lesions on the abdomen is shiny, compacted; The remaining foci are hyperpigmented (brownish-brown), the skin in them is atrophic.

Clinical diagnosis: Plaque (inducible-atrophic) scleroderma.

The following treatment was performed: Delagil 0.25 g once a day, xanthinal nicotinate 0.15 g 2 times a day, claritin 0.001 g once a night, externally: Elokom ointment once a day; Intravenous fluids of OBS with a concentration of ozone in a solution of 1.5 mg / l No. 8 and subcutaneous cleavage of the lesions of the oxygen-ozone gas mixture with ozone concentration in a mixture of 2 mg / l No. 7. The treatment was tolerated without side effects. As a result of the course of treatment conducted during the 21st day, a significant clinical improvement was observed in the form of softening of the skin induration in the lesions, repigmentation (restoration of normal color) of the skin. During 7 months of observation, the positive effect of treatment remained.

51 patients were treated with the proposed method, while in 92% of cases a positive clinical effect (significant clinical improvement or complete regression of the rash) was achieved in the form of cessation of signs of progression of the skin process, softening of induration, restoration of normal color and smoothing of the skin, and a loss of feeling of tightness. No side effects were observed. To complete the course of treatment by our proposed method, it takes 3 weeks, while to achieve a clinical effect using only traditional medicinal preparations it takes from 1-2 months or more.

High clinical effectiveness of the proposed method of treatment is provided by combining oxygen-ozone therapy with selected medications. The anti-inflammatory effect of the proposed therapeutic complex is due to the activation of cellular metabolism and the work of the antioxidant system, realized with systemic administration of therapeutic doses of ozone to the body, and by external application to the lesions of the corticosteroid ointment "Elokom". In this case, the possibility of developing side effects from steroid therapy is minimized due to the fact that, firstly, they are applied locally, and secondly, the selected external drug is applied only once a day. The normalizing collagen formation and moderately pronounced immunosuppressive effect of the aminoquinoline preparation delagil is supplemented by the immunomodulating effect of systemic administration of the ozone mixture into the body, which consists in activation of phagocytosis, and modulating influence on humoral immunity. In addition to the known biological properties of the ozone mixture, it is possible, when combined with its systemic and local administration together with the drugs prescribed in the therapeutic complex, it has a pronounced effect on the improvement of microcirculation processes at the level of the dermis and hypodermis vessels, on the improvement of oxygen supply of tissues, and the elimination of tissue hypoxia.

CLAIM

The method of treatment of limited scleroderma, characterized by the introduction of Delagil, Xanthinal nicotinate, Claritin, use the "Elokom" ointment and against this background, alternate 8-10 procedures for intravenous injection of ozonized saline with an ozone concentration of 1.5 mg / l in a volume of 200 ml and 5-7 procedures for subcutaneous cleavage of lesions with an oxygen-ozone gas mixture with an ozone concentration of 2 mg / l, introducing this mixture around the periphery of the lesion in a volume of 10-30 ml, with intravenous injections 2-3 times a week, and subcutaneous cleavage 1 -2 times a week.

print version
Date of publication 01.04.2007гг