RU2564905C1 - Method of treating patients with localised scleroderma - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: as a novel method of increasing the efficiency of treating localised scleroderma claimed is a method of treatment with deoxynate, which is characterised by high efficiency with the shorter treatment course duration in comparison with other therapeutic methods. The method of treating localised scleroderma consists in the additional application of deoxynate at the background of standard therapy in the form of a 0.5% injection solution with an active component of sodium deoxyribonucleate - sodium salt of partly depolymerised deoxyribonucleic acid, isolated from milts of the sturgeon, 0.005 g in a dose of 5 ml intramuscularly every second day with the course up to 10 days.

EFFECT: method of treating patients with localised scleroderma makes it possible to obtain noticeable immunomodulating and therapeutic effect, favourable impact on the disease course, prolongation of remission, does not cause side effects and allergic reactions, results in the normalisation of the clinical pattern of the disease.

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Description

The invention relates to medicine, namely to dermatology, and can be used in the treatment of patients with limited scleroderma.

The applicant has carried out an analysis of the prior art and identified a number of treatment methods for limited scleroderma.

The known "Method of treating limited scleroderma" (RF patent No. 2264815), which is the introduction of delagil, xanthinol nicotinate, clarithin, the use of ointment "Elokom". Against this background, 8-10 procedures of intravenous administration of ozonized physiological solution with an ozone concentration of 1.5 mg / l in a volume of 200 ml and 5-7 procedures of subcutaneous chipping of lesions with an oxygen-ozone gas mixture with an ozone concentration of 2 mg / l alternate. This mixture is administered at the periphery of the lesion in a volume of 10-30 ml. Intravenous administration is carried out 2-3 times a week, and subcutaneous chipping - 1-2 times a week.

The disadvantage of this method is its limited use due to the presence of restrictions and contraindications for the use of delagil, which can lead to side effects of such treatment. For the use of delagil there is an impressive list of contraindications, namely: hypersensitivity; liver failure; renal failure, inhibition of bone marrow hematopoiesis; severe rhythm disturbances, psoriatic arthritis; neutropenia; porphyrinuria; pregnancy; lactation. Especially delagil is contraindicated in renal, liver failure. During treatment, systematic examinations of an ophthalmologist and monitoring of a general blood test (determination of the number of red blood cells, white blood cells, platelets, total hemoglobin level), a general analysis of urine, and liver, kidney, and heart functions are necessary. With the discontinuation of the drug, relapses usually occur. To achieve a clinical effect, 3 courses of delagil therapy are necessary.

A known method of treatment of limited scleroderma (RF patent No. 2147896), which is the irradiation of lesions with ultraviolet light with a wavelength of 320-400 nm, starting with a dose of 0.05-0.3 J / cm ² and increasing it to a maximum value of 2.0- 3.5 J / cm ² . Single doses are increased every 3-6 sessions by 0.07-0.02 J / cm ² . The first 15 sessions are carried out every other day, the remaining 2 times a week. In total, there are 35-100 sessions per course. Before irradiation, ammifurin photosensitizer in the form of a 0.3% alcohol solution is applied to the foci. Additionally, ammifurin tablets can be used orally 2 hours before irradiation.

The disadvantage of this method is its limited use due to the presence of restrictions and contraindications for the use of ammifurin, which can lead to side effects of such treatment. There is an impressive list of contraindications for the use of amifurin, namely: hypersensitivity, acute gastritis, peptic ulcer, pancreatitis, hepatitis, cirrhosis of the liver, nephritis, cachexia, arterial hypertension, decompensated endocrine diseases, thyrotoxicosis, heart disease, tuberculosis failure, malignant and benign tumors, pregnancy, lactation, cataracts, multiple pigmented nevi. With caution, it can be used in children (up to 5 years) and in old age (over 60 years).

A known method of the combined treatment of limited scleroderma using local transdermal enzymatic electrostatic effects (RF patent No. 2403921), which is a treatment by intramuscular injection of penicillin, lidase, unitiol. Penicillin is administered at 400 thousand units, 3 times a day, for a course of 14-18 million units. Lidase is administered in a dose of 64 units daily, for a course of 15-20 injections. A 5% unitiol solution is administered in an amount of 2 ml, every other day, for a course of 10 injections. Additionally, plaques are exposed by applying electrostatic films to them. The application of the films is carried out through pads soaked in a solution of ronidase, at a dose of 0.5 g per 30 ml of acetate buffer solution. Films are left for 3-4 days. After that, replace them with new ones. The total duration of exposure to applications is 12-14 days. After 1.5-2 months, similar applications with a 0.5% trypsin or chymotrypsin solution are carried out on an outpatient basis.

The disadvantages of this method of treatment are the long course of treatment, the use of local methods of physiotherapy, which complicates the treatment in the presence of several foci of scleroderma. Limited use of unithiol due to contraindications for use (liver failure; arterial hypertension), which can lead to side effects of such treatment. Side effects such as nausea, dizziness, tachycardia, pallor of the skin, allergic reactions are possible. Especially contraindicated in liver failure. Penicillin treatment may be accompanied by side effects such as contact dermatitis and reactions from the skin and mucous membranes. On the part of the respiratory system, rhinitis, pharyngitis, laryngopharyngitis, asthmatic bronchitis, bronchial asthma are noted. From the gastrointestinal tract, allergic reactions are expressed in stomatitis, nausea, vomiting, and diarrhea. The occurrence of anaphylactic shock during the use of penicillin is a very serious complication, which can develop regardless of the dose and route of administration of penicillin and in severe cases result in death within a short time (5-30-60 minutes), so anamnestic should be collected before injection of penicillin and its preparations data on the use of penicillin preparations in the past and reactions to it. In the treatment with penicillin, like other antibiotics, the occurrence of pathological conditions may be associated with the development of dysbiosis. There are complications associated with the activation and reproduction of yeast-like (especially in weakened patients) saprophytes, which are present in the microbial flora of the mucous membranes of the oral cavity and genitals, trachea, and intestines. Penicillin, suppressing fungal antagonist bacteria, can create favorable conditions for the development of yeast-like flora. Clinically, candidiasis can occur in acute and chronic form with pathological manifestations of the skin and mucous membranes (thrush of the mouth, genitals, etc.); from the internal organs (visceral candidiasis) in the form of damage to the lungs and upper respiratory tract; in the form of septic syndrome.

The closest, essentially prototype, method of treating patients with limited scleroderma, according to a combination of matching signs and the achieved technical result, is the use of diuciphon (Butov Yu.S. Skin diseases and infections transmitted sexually / Yu.S. Butov. - M., 2002 . - S. 177). Its therapeutic effect is mainly due to the manifestation of immunomodulatory activity. Long-term observations have shown that along with a positive therapeutic effect when using this method, in a significant percentage of cases, the development of undesirable side effects is observed. The course of treatment consists in prescribing the drug at 0.1-0.2 g per day in 5-day cycles with one-day breaks for a course of 4-6 cycles (Butov Yu.S. Skin diseases and sexually transmitted infections / Yu.S. Butov. - M., 2002 .-- S. 177).

The disadvantage of the closest prototype is the presence of limitations and contraindications associated with the use of diucifon, which can lead to side effects of such treatment. List of contraindications when using diuciphone:

- persistent severe impairment of liver and kidney function,

- diseases of the blood forming organs,

- decompensation of the cardiovascular system,

- acute diseases of the gastrointestinal tract,

- organic diseases of the nervous system.

When using ducifon, amidopyrine and barbiturates are contraindicated. During treatment with ducifon, side effects are possible:

general weakness

- decreased appetite,

- dyspeptic symptoms (digestive disorders),

- dizziness,

- headache,

- heartbeat

- pain in the heart.

- In some cases:

- cyanosis (blue skin and mucous membranes),

- toxic hepatitis (inflammation of the liver tissue caused by ducifon),

- hypochromic anemia (decrease in hemoglobin in the blood due to inhibition of hematopoietic function of the bone marrow).

In addition, there are drawbacks in relation to the closest analogue, such as its insufficient effectiveness, long treatment period, long stay of patients in the hospital until their condition improves.

The objective of the invention is to obtain a more pronounced therapeutic effect compared to traditionally accepted methods of treating patients with limited scleroderma, improving the clinical dermatological status of these patients, reducing the duration of therapy, increasing the period of remission and thereby improving the quality of life of patients.

The solution to this problem and the technical result is achieved in a method of treating limited scleroderma, which, as in the prototype, is based on the immunomodulating activity of the drug, by improving the patient’s immune status by treating according to the following scheme: a 0.5% solution of 5 ml is administered intramuscularly ( in ampoules corresponds to the dosage of the active substance 0.005 g) every other day with a course of 10 days.

The claimed method is as follows. Patients on the background of standard therapy (hyaluronidase 64 UE once a day intramuscularly, externally: applications with 55% aqueous solution of demethyl sulfoxite) were prescribed deoxinate in the form of a 0.5% solution for injection with the active component sodium deoxyribonucleate (sodium salt of partially depolymerized deoxyribonucleic acid isolated from sturgeon milk) 0.005 g of 5 ml, which activates cellular and humoral immunity, metabolism in tissues, improves trophism and stimulates the regeneration process. Before the introduction of deoxinate, the solution was heated to body temperature. Deoxinate was administered intramuscularly, slowly every other day with a course of up to 10 days.

The above examples, reflecting the results of the study and the clinical evaluation of the use of deoxinate in comparison with conventional methods of treatment, reveal the essence of the invention and demonstrate the effectiveness of the proposed method.

Example 1. Patient X., 48 years old, complained of itching, soreness, tingling and tightness of the skin, changes in volume and tissue deformation in the affected areas of the body. The effectiveness of standard treatment is not noted.

Objectively: upon examination, the skin process was localized in the abdomen, chest, thighs on both sides of the foci of thickening and thickening of ivory skin with a smooth surface and a characteristic waxy gloss. At the periphery of the foci, an inflammatory nimbus of pinkish-violet color is observed, which is an indicator of the activity of the process. At the lesion sites, the skin did not fold well, perspiration was reduced, the skin count was 9, the activity index was 3 points, the fibrosis index was 3 points, and the sclerodermic process depth was 2 points. Subjective: itching of various intensities, soreness, tingling sensation and tightness of the skin.

Dz: Scleroderma limited.

Past diseases: chronic gastroduodenitis, otitis media, hypertension, frequent SARS.

The patient received standard treatment: 64 UE hyaluronidase once a day intramuscularly, externally: applications of 55% aqueous solution of demethyl sulfoxite. Additionally, 5 ml of intramuscular deoxinate was added every other day for 10 days. On the 11th day after treatment, the cessation of disease progression was observed, the manifestations of itching, soreness, tingling sensation and tightness of the skin disappeared, blanching of the corolla of peripheral growth was observed, foci were less bright in color. On day 19, the skin count was 6, the activity index was 1 point, the fibrosis index was 1 point, the scleroderma process depth was 1 point, skin tightening decreased, pale color was observed, and there were no clear boundaries in the focus. After treatment, there was a significant improvement, expressed in the cessation of disease progression, blanching and significant softening of the skin density of the foci of scleroderma. Over the next 8 months, recurrence of scleroderma was not observed.

Before and after therapy with the inclusion of deoxinate, studies of the immune status were conducted. Before treatment, dysfunction of a non-specific immunity link, T-lymphocytes and B-lymphocytes was revealed. After therapy with the inclusion of deoxinate, the studied parameters of the immunity units and the clinical picture were normalized.

Example 2. Patient F., 47 years old, complained of rashes on the skin of the body, limbs, itching, and a feeling of tightness of the skin. Over the past year, I applied for medical help about a skin disease 5 times, a complete resolution of the skin process was not observed. There was no effect against standard therapy methods.

Objectively: upon examination, the skin process is localized in the area of the lateral surfaces of the trunk, forearms on both sides against the background of the inflammatory nimbus of the lilac color, foci of compaction of ivory skin with a smooth surface were visualized. At the lesion sites, the skin did not fold well, the skin count was 12, the activity index was 3 points, the fibrosis index was 2 points, and the depth of the scleroderma process was 2 points. Subjective: itching, a feeling of tightness of the skin.

Dz: Scleroderma limited.

Past diseases: ischemic heart disease, chronic bronchitis, pyelonephritis, goiter of the II degree, hepatitis A, frequent acute respiratory viral infections.

The patient received treatment: hyaluronidase, externally: applications of 55% aqueous solution of demethyl sulfoxite. Additionally, the patient received treatment for 10 days according to the above method. On the 12th day after treatment, the itching, the feeling of tightness of the skin disappeared, there was a blanching of the corolla of peripheral growth, foci of less bright color, and skin tightening decreased. On day 18, the skin count was 7, the activity index was 1 point, the fibrosis index was 1 point, the scleroderma process depth was 1 point, pale color was observed, the absence of clear boundaries in the focus, hypopigmentation, and no subjective complaints. As a result of the course of treatment, a significant clinical improvement was noted in the form of a softening of skin induction in the lesion foci, restoration of normal skin color. Within 7 months of observation of new lesions, no persistent clinical remission was observed.

Before and after therapy with the inclusion of deoxinate, studies of the immune status were conducted. Before treatment, dysfunction of a nonspecific immunity link, T-lymphocytes and B-lymphocytes, was revealed, in comparison with healthy individuals. After therapy with the inclusion of deoxinate, the parameters of the immunity units and the clinical picture of the disease in the patient were normalized.

Example 3. Patient Z., 49 years old, complained of changes in the trunk and lower extremities. Despite the therapy, relapses occurred at a frequency of 4-5 times a year. Standard methods without positive dynamics.

Objectively: upon examination, the skin process was localized in the chest, navel, buttocks, and thighs on both sides, foci with a smooth surface, inflammatory pink-violet nimbus, densification in the central part were visualized, the skin was poorly folded at the lesion sites, the skin count was equal to 15, activity index 3 points, fibrosis index 2 points, sclerodermic process depth 2 points. Subjective: a feeling of tightness of the skin.

Dz: Scleroderma limited.

Past diseases: endometriosis, adnexitis, osteochondrosis, radiculopathy, chronic tonsillitis, dyscirculatory encephalopathy.

The treatment was carried out according to the method described above. On the 11th day after treatment, there was no feeling of tightness of the skin, overall health improved, new elements did not appear, blanching of the corolla of peripheral growth was observed, foci of less bright color. On day 18, the skin count was 8, activity index 1 point, fibrosis index 1 point, scleroderma process depth 1 point, observed, skin tightening, lack of clear boundaries in the focus, hypopigmentation, no subjective complaints. After the end of treatment, a significant clinical improvement was observed, expressed in the cessation of the appearance of fresh foci, discoloration of rashes close to the color of normal skin, smoothing of the skin, and the disappearance of a feeling of skin tightening. Persistent clinical remission for 8 months.

Before and after therapy with the inclusion of deoxinate, studies of the immune status were conducted. Before treatment, dysfunction of a non-specific immunity link, T-lymphocytes and B-lymphocytes was revealed. After therapy with the inclusion of deoxinate, the studied parameters of the immunity units and the clinical picture were normalized.

The proposed method of influencing the body’s immune system with limited scleroderma, manifested by a decrease in immunological parameters, has been tested on an outpatient basis at outpatient department No. 2 of the State Autonomous Educational Institution "RKKVD" of the Republic of Tatarstan. The treatment results were evaluated by the clinical method and laboratory diagnostic method.

The examples of the proposed method for the treatment of limited scleroderma with the use of deoxinate showed a significantly more pronounced therapeutic effect compared to traditionally accepted methods of treatment and a beneficial effect on the course of the disease.

The drug does not have a toxic effect, does not cause side effects, allergic reactions, positively affects intracellular and cellular regeneration, stimulates protective mechanisms, in addition, deoxinate has a noticeable immunomodulating effect, affecting specific and non-specific protective mechanisms.

The application of the claimed method by the end of deoxinate therapy against the background of standard treatment contributed to an improvement in the following indicators, which turned out to be the most informative.

Compared with the control group of standard treatment of patients, it was noted:

- faster transition from the acute stage to the stabilization stage;

- earlier periods of resorption of foci, the cessation of the appearance of new elements, the disappearance of itching, tightness of the skin, a decrease in skin tightening;

- a positive clinical result, all patients tolerated the prescribed treatment well, in no case were exacerbations of the skin process;

- normalization of the main immunological parameters took place: the signs of violations of the nonspecific and humoral parts of the immune system were eliminated, which underlies the therapeutic effect.

After the indicated course of treatment, the course of the disease was significantly facilitated and the remission was prolonged. In some cases, after the first injections of deoxinate, a significant effect was observed, the well-being of all patients improved, and the symptoms of the disease decreased.

The proposed method for the treatment of patients with limited scleroderma with the use of deoxinate meets the criteria of novelty, since when determining the level of technology, no agent has been found that has features that are consistent with the use in a complex therapy of a drug that has a regenerating effect with the active component sodium deoxyribonucleate, which has immunomodulating with antimicrobial, antiviral and antifungal activity was prescribed to patients with limited scleroderma to standard therapy by intramuscular injection of 5 ml every other day for 10 days. The use of deoxinate showed that the drug accelerates tissue regeneration processes, reduces treatment time, and helps to normalize the immune system.

The method of treating patients with limited scleroderma using deoxinate has an inventive step, since technical solutions have not been identified that have signs that match the distinguishing features of this invention, and the influence of distinctive signs on the specified technical result is not known.

Deoxinate treatment can be used in patients of various age groups with concomitant pathology, regardless of the seasonality of dermatosis. Possible long-term use of immunocorrection and repeated courses.

A method of treating patients with limited scleroderma with the use of deoxinate has shown its high effectiveness, the absence of side effects, stable remission, accompanied by normalization of the immune system and a reduction in treatment time. Therefore, the claimed technical solution can be implemented in the activities of healthcare organizations through the use of deoxinate in the complex therapy of patients with limited scleroderma, which meets the criteria for inventions. The invention provides high efficiency in the treatment of patients with limited scleroderma.

Claims (1)

A method for treating patients with limited scleroderma, including complex drug therapy, characterized in that deoxinate is additionally prescribed as a medicine in the form of a 0.5% solution for injection with the active component sodium deoxyribonucleate - the sodium salt of partially depolymerized deoxyribonucleic acid isolated from sturgeon milk, 0.005 g 5 ml intramuscularly, slowly every other day with a course of up to 10 days.