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INVENTION
Patent of the Russian Federation RU2174398

METHOD OF TREATMENT AND / OR PREVENTION OF THE DISORDERS OF THE SOFT TISSUE OF THE ORGANISM

The name of the inventor: Kabisov Ruslan Kazbekovich; Pecshev Alexander Valerevich; Shekhter Anatoliy Borukhovich
The name of the patent holder: Kabisov Ruslan Kazbekovich; Pecshev Alexander Valerevich; Shekhter Anatoliy Borukhovich
Address for correspondence: 129010, Moscow, ul.B. Spasskaya, 25, p. 3, LLC "Gorodissky and Partners", EI Emelyanova
Date of commencement of the patent: 1998.04.02

The invention relates to medicine and is intended for the treatment and / or prevention of soft tissue disorders of the body. To do this, the affected tissue or tissue of the alleged lesion is exposed to nitrogen oxide. The method allows to normalize microcirculation, improve tissue metabolism and accelerate regeneration. This improves the result of treatment and prevention of soft tissue damage.

DESCRIPTION OF THE INVENTION

The invention relates to the field of medicine, and more particularly relates to methods of treating and preventing various soft tissue lesions.

It can be successfully used in the treatment of wounds, burns, trophic skin ulcers and decubitus ulcers, stomach ulcers, and other various lesions of the skin, muscles, connective tissue, mucous, serous and synovial membranes, in abdominal and pulmonary surgery and therapy, in dentistry, Urology, otolaryngology, dermatology, gynecology, rheumatology, oncology and in other fields of medicine.

In modern medicine, the most widely used methods of treating common, purulent and long-healing (chronic) wounds, burns, trophic ulcers and decubitus, chronic ulcers of the stomach and intestines, acute and chronic inflammatory diseases of the skin, mucous membranes of the mouth, larynx , Trachea and bronchi, urogenital tract, serous membranes of the abdominal and pleural cavities, synovial joints, muscular and connective tissues.

Known, for example, is a method for treating wound and inflammatory skin lesions, the oral mucosa, gastric ulcers, etc. (see, for example, Lasers in Clinical Medicine, edited by SD Pletneva, Moscow: Meditsina, 1996) , Consisting in the fact that the affected surfaces are irradiated with low-intensity radiation of helium-neon or arsenide-gallium (infrared) lasers in pulsed or continuous generation to reduce inflammatory and activation of reparative processes, to prevent suppuration, etc.

Low-intensity laser radiation is used in surgery, dentistry, dermatology, gastroenterology and other fields of medicine for the treatment and prevention of wound, destructive and inflammatory processes. The time of irradiation, the number of sessions and the method of application (directly or through light guides and endoscopic instruments) depends on the disease, the stage and form of the pathological process, the individual sensitivity of the patient to radiation and other factors.

However, the above method does not provide reliable stimulation of tissue regeneration processes, sufficient acceleration of healing of long-healing wounds, trophic ulcers and bedsores, prevention of suppuration and other complications, effective treatment of chronic inflammatory processes of the mucous membranes of internal organs, serous and synovial membranes, muscles, ulcerative lesions of the stomach and etc.

The stimulating effect of collagen-based preparations is known for their local application for healing wounds, burns, trophic ulcers, injuries of internal organs (liver, spleen), stomach ulcers, ulcerative stomatitis and gingivitis, etc. (See, for example, Sycennikov IA, Shekhter AB, etc. Collagenoplasty in medicine., M.: Medicine, 1978). Collagen preparations are used in the form of films, sponges, powders, gel and other forms. They include a number of medicinal substances - antiseptics, antibiotics, hemostatics, regeneration stimulants, etc. Drugs are applied to the damaged surface directly or through the endoscope (with stomach ulcer). The stimulating effect is based on activation of macrophages, bacteriostatic action of antiseptic and other medicinal substances that make up the preparations.

However, the use of collagen drugs is limited by the possibility of immune reactions to the use of collagen protein, and its low efficiency in the treatment of chronic inflammatory-destructive processes in the skin and mucous membranes.

Another method for the treatment of cutaneous wounds and trophic ulcers is known (see, for example, Tolstykh PI, Gostishchev VK, Arutyunyan BN Proteolytic enzymes immobilized on fibrous materials in surgery, Yerevan, 1990), consisting in That they are closed with wound dressings with immobilized proteolytic enzymes - trypsin, collitin, lysozyme, etc. These enzymes help to remove necrotic detritus.

However, a significant acceleration of the wound process in many patients, especially with chronic wounds, does not occur. Enzymes often inhibit the healing of wounds by inhibiting the maturation of granulation tissue. In addition, the use of immobilized enzymes is limited to open wounds, they can not be used to treat lesions of the mucous membranes of internal organs and other soft tissues.

The method of treating various destructive and inflammatory lesions of the skin, muscles, connective tissue, mucous membranes of internal organs, serous and synovial membranes is widely known (see, for example, Mashkovsky MD Drugs, M .: Medicine, 1993) by using Various medications, in particular, hormones, antibiotics, regeneration stimulants (eg, methyluracil) both externally (as part of ointments, emulsions, etc.) and taken internally.

However, the effectiveness of these drugs in chronic processes remains low, which forces us to constantly develop new methods of treatment.

Thus, none of the known methods of treating destructive and inflammatory skin lesions, mucous membranes of internal organs and serous membranes is not sufficiently effective and does not solve the problem of treating the diseases that cause these lesions.

There are also no effective ways to prevent postoperative complications, including suppuration, seam divisions, fistula formation, etc. , And prevention of skin lesions, such as radiation dermatitis, radiation ulcers in radiation therapy of cancer patients.

It is an object of the present invention to provide a method of treating and preventing soft tissue disorders of an organism that would ensure maximum normalization of microcirculatory disorders, vascular and nervous trophism, stimulation of repair processes in the affected tissue, and prevention of purulent and radiation complications.

This problem is solved by the fact that the method of treating soft tissue lesions of the body is that the affected tissue is exposed to nitrogen oxide.

This ensures maximum inhibition of inflammatory processes and acceleration of regeneration processes, normalization of microcirculatory disorders, improvement of tissue hemodynamics and tissue metabolism, nerve trophism, treatment and prevention of fibrotic processes, prevention of purulent, radiation and necrotic complications in pathological processes in soft tissues, and ultimately - The fastest and complete cure of the patient, preventing the recurrence of the disease.

It is advisable to directly affect the affected tissue with nitric oxide.

This makes it possible to most effectively influence the treatment of destructive (wound), inflammatory and fibrotic lesions of the skin, muscles, connective tissue, joints, oral mucosa, digestive, respiratory and genitourinary tracts, serous membranes of the abdominal and pleural cavities and internal organs.

The affected tissue can be influenced by a gas stream containing nitrogen oxide, obtained, for example, by passing air through an electric discharge or obtained by chemical reactions.

The affected tissue is exposed to nitrogen-containing drugs that generate nitric oxide in the most affected tissue.

Nitric oxide is advisable to affect both the affected tissue and the unaffected tissue located along the course of the main vessel, through which the blood supply to the affected tissue occurs. This allows improving hemodynamics and nerve trophism of both affected and surrounding tissues, which enhances the regeneration processes and accelerates the healing of wound and trophic lesions.

When transplanting a flap of your own tissue with nitric oxide, you can first act on the donor site and the area of ​​the future transplant, and then on the transplant flap.

This provides stimulation of microcirculation and metabolism in the donor site of the skin or musculocutaneous flap, acceleration of the development of granulations at the site of injury, as well as acceleration of engraftment of the flap and prevention of its rejection.

On affected tissue of the mucosa of internal organs, serous and synovial membranes, it is advisable to use nitric oxide through endoscopic devices.

This makes possible the effect of nitric oxide directly on various inflammatory, ulcerative or erosive lesions of the mucosa of the digestive tract, for example, the esophagus, stomach, intestines; Respiratory tract, for example, larynx, trachea, bronchi; Urinary tract, such as the bladder, etc .; But also the pleura, the peritoneum and the synovial membrane of the joints.

This task is also solved by the fact that the method of preventing soft tissue lesions is that the soft tissue in the area of ​​the alleged lesion is affected by nitrogen oxide.

This allows to prevent soft tissue damage in those cases when there is a significant risk of their occurrence, namely, in elderly or weakened patients, in extreme conditions, with radiation or chemotherapeutic treatment of cancer patients.

To prevent postoperative complications with nitric oxide, it is possible to influence the operative intervention zone in the preoperative, and / or intraoperative, and / or postoperative periods.

This makes it possible to enhance microcirculation and metabolism in soft tissues in the operation area and in this way to prevent various complications of the wound process: wound suppuration, seam divisions, fistula formation, etc.

When radiation therapy with nitric oxide, it is advisable to work on soft tissues in the irradiation zone before and / or after each radiotherapy session.

This ensures the prevention of skin lesions and underlying tissues during radiation therapy in cancer patients: radiation dermatitis, radiation trophic ulcers, radiation fibrosis of soft tissues.

For the prevention of posttraumatic complications in extreme conditions with nitrogen oxide, it is advisable to work on the affected tissue before applying a medical bandage. This allows for military operations, medicine of accidents, accidents, etc. Prevent purulent and necrotic complications in gunshot, bruised, chopped-cut and other wounds, burns and other traumatic pathology.

One of the significant achievements of biology and medicine of the last decade was the discovery of the properties of a molecule of nitric oxide (NO) formed in the body from the amino acid L-arginine with the help of the NO synthase enzyme. The most important role of endogenous NO is known as a polyfunctional regulator ("new signal molecule", "secondary messenger"). Regulating guanylate cyclase and other cellular and tissue mechanisms, NO normally and especially under pathological conditions exerts a significant influence on vasodilation, prevents intravascular platelet aggregation and blood clotting (antiplatelet effect), affects the regulation of respiration, the immune status of the organism, the activity of macrophages, the expression of genes, Conductivity of nerve impulses, etc.

The patented method of treatment and prevention of destructive, inflammatory and sclerotic lesions of soft tissues is that for the first time in medical practice, the affected skin, muscle or connective tissues, as well as the diseased mucosa, serosa or synovial membranes, are exogenous, that is, coming from the outside, Nitric oxide. It is advisable to use nitric oxide directly for the direct delivery of gaseous NO to the affected tissues of the body.

To the affected tissues, in the treatment of wounds, burns, trophic skin ulcers and decubitus, erosive and ulcerative lesions of the oral mucosa, inflammatory and fibrous skin diseases, muscle tissue, joints, inflammatory-erosive processes in the mucous membrane of the vagina and cervix can be influenced by gas flow Containing nitrogen oxide, obtained, for example, by passing air through an electrical discharge.

With the passage of the atmospheric air flow through virtually any electrical discharge in it, due to the high temperature, NO is formed from nitrogen and oxygen in accordance with a reversible chemical reaction accompanied by the absorption of a large amount of heat:

N ₂ + O ₂ <------> 2NO - 43.2 kcal

The displacement of the equilibrium of this reaction to the right is ensured by the rapid cooling of the gas mixture after the passage of the electric discharge region, so that the equilibrium does not have time to immediately shift to the left and then is not shifted because of the extremely low reaction rate at low temperature , And, thus, almost the same amount of NO that was formed at a high temperature remains in the mixture.

The classical way to produce NO is a method of passing air through an electric arc (electric arc) of direct current, realized in two- or three-electrode plasma devices, called plasmatrons (thermally equilibrium plasma-chemical technology).

Exhaust gas flow from the device, which is in a state of low-temperature plasma at a temperature of 3000-4000 K, can contain up to 5% NO in the immediate vicinity of the outlet. The therapeutic effect is carried out by the peripheral region of the gas flow, sufficiently remote (by 10 to 20 cm) from the exit opening of the device, at a temperature of 20 to 45 ^° C, and due to the expansion of the flow in the environment, the nitrogen oxide content in it is 0.03-0.0, 15% (concentration - 400-2000 mg / m ³ ).

An alternative way to produce nitric oxide from atmospheric air is a thermally nonequilibrium plasma-chemical technology, in which an air stream is passed through an electric discharge excited by a high-frequency current. An example of such a method can be a one-electrode flare discharge realized at frequencies of the electric field of 0.1-100 MHz in the so-called high-frequency plasmatron.

Because of the thermal disequilibrium, the temperature of the gas stream (~ 100 ^° C) and the concentration of nitric oxide (~ 50 mg / m ³ ) in the outlet of the device is much lower than these values ​​with a thermally equilibrium technology, then the therapeutic effect is carried out at distances of ~ 10 Mm from the exit aperture of the plasma torch.

The described devices are essentially air-plasma generators of nitric oxide.

An experimental study of the effect of an air stream containing NO obtained using an equilibrium plasma chemical technology carried out on 80 white rats with models of conditionally aseptic and infected skin purulent wounds yielded the following results.

In the first series of experiments, rings closed on top of the film were inserted into the edges of the skin wound with a size of 300 mm ² to prevent the formation of a scab. 1, 3 and 4 days after the operation, the wounds were exposed to a cooled air-plasma flow at a distance of 20 cm from the exit aperture of the plasma torch (temperature 42 ^° C, NO concentration 400 mg / m ³ ). In the control group, the effect was carried out by the flow of air heated by the fan heater with a similar temperature and dynamic pressure of the gas, but not containing NO. After 4 days, the rings were removed, and further the wounds healed under the scab. After 4, 10, 14 and 21 days, a part of the animals was taken out of the experiment for morphological examination of wound tissues.

In experimental animals macroscopically much faster were removed inflammatory phenomena, the quantity of wound exudate decreased, the wound was reduced in size; In 40% of the animals in the control group there was infection and suppuration, in the experimental group there was no suppuration. The sizes of wounds in the experimental group (excluding the festering wounds in the control group) were 95.2 ± 6.1 mm ² (in the control 158.8 ± 10.6) on the 10th day, 56.9 ± 3.42 on the 14th day Mm ² (in the control 97,4 ± 7,2), on the 18th day - 34,6 ± 1,82 mm ² (in the control 60,6 ± 5,7), for 21 days - 21,8 ± 2,6 Mm ² (in the control 34.9 ± 1.6), on the 24th day - 5.7 ± 0.6 mm ² (in the control 18.5 ± 1.6). The final healing in experimental rats was accelerated in comparison with control rats by 24.8% without taking into account festering wounds.

Morphological study using histochemical methods showed that under the influence of NO in the wound there was no microflora, fibrin exudation decreased, edema, neutrophil infiltration and other manifestations of impaired vascular permeability. Significantly shortened the inflammatory phase of the wound process and accelerated the reparative phase: proliferation of fibroblasts, neoplasm of vessels, growth and maturation of granulation tissue. NO and stimulated the macrophage reaction, enhanced the phagocytosis of microbes and necrotic detritus. As a result, in experimental animals, wound reduction was significantly faster due to the development of mature fibrous tissue (contraction) and due to the marginal regeneration of the epithelium.

Particularly pronounced were the processes of stimulation of wound healing in the second series of experiments, where a similar experimental model was used, but with the infection of wounds with golden staphylococcus (1 billion microbial bodies). The wound was purulent, but under the influence of NO, the purulent exudate significantly decreased and the wound was cleaned to 3-4 days (in control in some animals - by 10 days). Microbiological examination of smears from the wound surface showed that in the experimental group the severity of microbial contamination significantly decreased, which indicated bactericidal and bacteriostatic action of NO. Morphological study revealed that NO significantly normalizes the disturbed microcirculation in the tissues of the wound: the sludge phenomenon disappears (gluing of erythrocytes), intravascular aggregation of platelets and leukocytes, microthrombosis, increased permeability of microvessels, edema and inflammatory neutrophil infiltration are weakened, phagocytosis of microbes is enhanced by macrophages. On the 10th day, when purulent inflammation of the bottom of the wound was still prevalent in control and there was practically no granulation tissue, the experimental group already noted a pronounced development of the latter. Subsequently, the inflammatory processes were significantly reduced in the experiment and the reparative processes were intensified. The final healing was accelerated by 26.4%.

In the therapeutic treatment of patients, the therapeutic effect is expedient to be carried out by the peripheral region of the gas flow removed at a distance of 15-25 cm from the outlet of the device, with an appropriate temperature of 30 to 45 ^° C. The criterion for the distance of the object (skin, mucous membrane, wound surface, etc.). ) From the outlet opening of the device is the absence of pain reaction of the patient. The time of exposure to the affected tissue, i.e. The duration of the therapy session, the speed of scanning the gas flow beam (light spot on the tissue), the number of treatment sessions and their frequency are established based on the form and stage of the pathological process, the intensity and depth of the lesion, the effectiveness of the treatment and other factors.

To carry out therapeutic treatment of affected tissues by exposure to a flow of gas containing NO, for example, in wound pathology, the patient is placed in the procedural or dressing room standing, sitting or lying, depending on the location of the wound defect and the physical condition of the patient. The bandage covering the wound is removed, the treating physician switches on the source of the air-plasma flow that is in his hand, and acts on the wound surface, focusing on the patient's pain. Non-drug stimulation of reparative processes in the wound is effected by exposure to a NO-containing stream on the wound surface until a light yellowish, opalescent film appears and there is no wound exudate. The effect is carried out on the surface cleared of medicines, ointments, dressings; It is mandatory to capture surrounding, visually unchanged tissues in the zone of exposure to the gas flow; There should be no bleeding and massive necrobiotic changes in the wound. After treatment, the wound is closed with a sterile gauze dressing or left open. The number of treatment sessions and the duration of each session are determined depending on the area of ​​the wound, its phase and other conditions.

We present a clinical example of the implementation of the claimed method of treating a chronic wound by exposure to an NO-containing plasmodynamic flow.

Patient P-th AM, born in 1929, N of the case history of ZhA-428.

He entered the Moscow Cancer Research Institute. PA Gertsen 24.10.97 with the diagnosis: Malignant histiocytoma of the left scapular region of the IV stage. The condition after extensive excision of a tumor of soft tissues of the back with resection of the scapular bone, closure of the defect by displaced rags, necrosis of the flaps. Condition after postoperative radiotherapy.

At admission: on the surface of the back there is an extensive wound defect of soft tissues, covering the entire middle third of the left scapular and subscapular region, 18 x 14 cm, against the background of post-radiation and postoperative fibro-altered tissues. The bottom of the wound is unevenly covered with dull granulations, the process of epithelialization is not expressed.

The patient started a course of plasmodynamic NO-therapy by direct exposure to a gas stream containing nitric oxide on the wound surface and surrounding tissues. The effect was carried out at a distance of 17-22 cm from the outlet of the device for 2-4 minutes daily. Medication was excluded. At 4-5 sessions, the appearance of active, juicy granulation tissue over the entire surface of the wound, islet and marginal epithelialization was noted. At the same time, a decrease in pain sensitivity and a decrease in wound size were revealed. Complete closure of the extensive tissue defect was achieved in 18-20 sessions by secondary tension due to concentric narrowing of the wound defect, marginal and islet epithelization, reduction of the fibroticisation of surrounding tissues.

Given the high penetrating ability of the NO molecule, it is advisable to conduct plasmodynamic NO-therapy for the treatment of such inflammatory and sclerotic diseases of soft tissues as acute and chronic post-fibrosis, myositis, fasciitis, fibrositis, neuritis) tendovaginitis, fibromyalgia and other similar diseases of various genesis. The regime and duration of the therapy session, the frequency of sessions and the duration of the entire course of treatment depend on the form and stage of the disease, the effectiveness of treatment.

We present a clinical example of the implementation of a method for treating lesions of soft tissues of a non-venous nature.

Patient A-a TM, born in 1954, N of the history of the disease ZhA-264.

She entered the Moscow Cancer Research Institute. PA Herzen on December 22, 1997 with the diagnosis: Pronounced post-fibrosis of soft tissues of the anterior abdominal wall, buttocks, inguinal region. Lymphedema of the lower extremities. Pain syndrome.

Earlier (1996-1997), the patient underwent chemoradiotherapy for cervical cancer of the fourth stage (squamous cell carcinoma).

At admission: soft tissues of the lower abdominal wall from the navel to the pubis with the transition to the lateral divisions, inguinal folds and the right gluteal region are represented by a fibrously altered conglomerate of a solid "stony" consistency, uneven in length, insensitive but painful in palpation of the skin. In occasion of the specified complications of the patient multiple courses of medicamentous therapy (compresses, ointments, etc.) without effect were carried out. Moreover, the patient noted an increase in tissue density, an increase in the size of the changes and the intensity of the pain syndrome.

The patient underwent a course of plasma-dynamic NO-therapy according to the following procedure: remote action at a distance of 15-20 cm for 10 seconds per one zone (beam diameter 3 cm), total exposure time 1.5 min. In total, two courses of treatment were conducted for 10 sessions daily with a break of 14 days.

A significant improvement was achieved: the severity of fibrosis was much reduced palpation and according to sonography, the tissues became soft, in some areas slightly different from healthy ones, skin pigmentation was normalized, sensitivity was restored, pain was practically absent. Subjective - a sharp decrease in discomfort.

The patient is examined after 2 - 3 weeks after the end of the course. At the same time, prolongation of the effect of NO-therapy in the form of reinforcement of subjective and objective positive symptoms of treatment was revealed.

A good clinical effect in this case was achieved due to the fact that NO, acting on microcirculation, tissue metabolism and nerve trophism of soft tissues, promoted, as shown by histological examination, a reduction in dense edema, reverse development of excess connective tissue in the dermis, subcutaneous tissue and muscle tissue . Similarly, it is possible to promote resorption of scar formation of soft tissues, including hypertrophic and keloid scars.

Plasmodynamic gas flow containing nitric oxide can be used for the treatment of diseases of the mucous membrane, for example periodontitis, erosive ulcer and ulcerative necrotic lesions of the oral mucosa, tongue and gums of teeth during post-radiation or herpetic stomatitis, chronic autonomic stomatitis, erosive- Ulcerative form of red lichen planus, multiforme exudative erythema, ulcerous-necrotic gingival stomatitis of Vincent and other diseases of the oral mucosa.

To do this, the mucous membrane of the mouth, gums and tongue in the affected area is exposed to a gas stream containing NO at a temperature of 38-42 ^° C for 15-20 seconds per affected area. The temperature and total duration of one exposure, the frequency and number of effects depend on the form of the disease, the prevalence of the pathological process, its stage, the effectiveness of treatment, the individual sensitivity of patients and other factors. This effect can be part of a complex of other traditional medical procedures. The effect of NO increases the effectiveness of complex therapy, reduces the duration of treatment, promotes the healing of ulcers, erosion and the removal of inflammatory phenomena, prolongs the periods of remission of chronic diseases, etc.

Similarly, a gas stream containing nitric oxide can act on the mucous membrane of the vagina and cervix with their inflammatory erosive diseases, such as for example erosive colpitis and vaginitis. The temperature of the gas stream, the duration of one exposure and the overall treatment, the frequency of exposure depends on the stage and form of the disease, the prevalence of the process, the sensitivity and age of patients and other factors.

In addition, the effect of nitric oxide contained in the plasmodynamic gas stream can be used for inflammatory skin diseases such as erysipelas, streptoderma and other pustular diseases, exudative diathesis, psoriasis, certain forms of eczema and dermatitis, and other diseases in case of intolerance Antibiotics and hormonal drugs, as well as in cases that are not amenable to conventional therapy.

The effect of NO in these cases leads to a bactericidal effect and a decrease in skin infection, a significant decrease in inflammatory manifestations and skin itching, elimination of the pathological process, and an increase in the timing of remission in chronic diseases.

On affected skin, muscle and mucous membranes, it is also possible to act with a gas stream containing nitric oxide, obtained, for example, by a chemical reaction.

There are several methods for obtaining NO from chemically pure substances. NO is conveniently obtained, for example, by the interaction of metallic copper with dilute nitric acid:

3Cu + 8HNO3 = 3Cu (NO3) ₂ + 2NO + 4H2O.

For purification from higher oxides of nitrogen (nitrogen dioxide NO ₂ , nitrogen tetroxide N ₂ O ₄ , etc.) and sprays of nitric acid, the NO produced is passed through a 5% solution of sodium hydroxide NaOH and collected above the solution. If necessary, the nitrogen oxide is dried by passing through a tube with solid potassium hydroxide KOH.

And an available way of obtaining NO is the addition of a 40% solution of sodium nitride NaNO ₂ to a 30% solution of ferric chloride FeCl ₂ (or to a 20% solution of ferrous sulfate FeSO ₄ ) mixed with an equal volume of hydrochloric acid HCl (density 1.19 g / cm ³ ):

FeCl ₂ + NaNO ₂ + 2HCl = FeCl ₃ + NaCl + NO + H ₂ O

The liberated NO is purified by passing it through a 10% solution of sodium hydroxide NaOH.

For further medical use, the NO obtained by the methods described above should be mixed with inactive, oxygen-free gases (nitrogen, inert gases-argon, helium) in a concentration of 0.1 to 1% and pumped under pressure into cylinders. To effect the therapeutic effect, the resulting mixture, through a system of reduction and flow control through flexible tubes with appropriate tips, is sent at ambient temperature to the affected tissue.

The use of nitric oxide for treatment is in a mixture with inactive gases in high pressure vessels, it is advisable to use in inpatient medical institutions.

For use in extreme conditions, for example at the stage of prehospital care with gunshot wounds, in medicine, catastrophes, etc. It is possible to use a chemical reaction to produce nitric oxide by heating a mixture of potassium nitride KNO ₂ , potassium nitrate KNO ₃ and chromium oxide Cr ₂ O ₃ :

3KNO ₂ + KNO ₃ + Cr ₂ O ₃ = 2K ₂ CrO ₄ + 4NO.

This mixture can be included in tablets containing (in weight percent) 22% KNO ₂ , 9% KNO ₃ , 27% Cr ₂ O ₃ and 42% iron oxide Fe ₂ O ₃ , which, when stored in a special container, For example, by means of a catalytic heat source, a gas containing 99.78% of nitrogen oxide is recovered, of which 1060 g of 860 to 870 ml of gas are obtained from 10 g of such tablets. The container can be filled with an inactive gas, for example nitrogen, and is equipped with a manual valve, when opened, a mixture of nitrogen oxide and nitrogen is directed to the affected tissue.

A gas stream containing nitric oxide obtained chemically is used for the same purposes and for the same diseases as the plasmodynamic gas stream containing NO produced by passing air through an electric discharge. The gas flow acts directly on the affected tissue. The method and duration of the individual exposure, the frequency of the exposure sessions, the total duration of treatment, the total duration of treatment, as in the first case, depend on the form and stage of the disease, the size and depth of the lesion, the rate of granulation tissue formation, the purification and epithelization of the defect, the reduction of the inflammatory or sclerotic process in soft tissues .

Впервые в медицинской практике для лечения долго не заживающих ран и язв, при воспалительных и воспалительно-деструктивных заболеваний кожи и слизистых оболочек на пораженные поверхности воздействуют азотосодержащими лекарственными веществами, которые при метаболизации в организме больного выделяют оксид азота: нитропруссид натрия, нитроглицерин, N-нитропиразолы, 5-нитрозоглутатион, нитрозокомплексы металлов и другие нитросоединения.

Эти лекарственные вещества могут быть использованы в виде спрея при опрыскивании раневой поверхности кожи, воспалительных поражений кожи, ингаляции при поражении слизистой оболочки ротовой полости, в виде гелей и пластырей, в виде ингаляций для лечения поражений слизистой оболочки гортани, трахей, бронхов и т.д. Азотосодержащие вещества применяются в количествах, достаточных для достижения лечебного эффекта: заживления ран и язв, купирования воспалительных процессов. Дозы, а и интервалы между введением лекарств устанавливают в зависимости от нозологической формы заболевания, объема поражения, длительности и стадии заболевания, скорости заживления и индивидуальной переносимости больным лекарственных препаратов.

Приводим клинический пример использования ингаляции нитросоединений при лечении стоматита.

Больной Ш-в Х.А., 1943 г.р., N истории болезни ЕА-827.

Поступил в МНИОИ им. П.А.Герцена 28.01.98 г. с диагнозом: Рак слизистой оболочки дна ротовой полости IV стадии (плоскоклеточный вариант), метастазы в лимфоузлы шеи.

На фоне предоперационной лучевой терапии у больного развились осложнения в виде раннего лучевого стоматита, ввиду чего была прекращена лучевая терапия и больному начат курс ингаляционной терапии нитроглицерином на слизистую ротовой полости. Воздействие осуществлялось два раза в день с расстояния 7 см от поврежденной поверхности путем разбрызгивания препарата Nitrolinqual-Pumpspray, содержащего нитроглицерин. Через 7 сеансов лечения нитроглицерином у больного значительно уменьшилась клиническая картина стоматита, что позволило возобновить и полноценно закончить курс специального - лучевого - лечения.

Thus, nitric oxide or exogenous origin in the form of a gas stream, or emerging in tissues from medicinal substances, exerts a pronounced therapeutic effect by normalizing the impaired microcirculation of blood in the affected tissues, activation of macrophages, phagocytosis of bacteria and production of cytokines regulating the growth of fibroblasts. In this case, NO enhances the proliferation of fibroblasts, the synthesis of DNA, RNA and intercellular matrix proteins, as shown in cell culture (fibroblasts).

The use of NO for the treatment of amazed soft tissues significantly weakens inflammatory tissue infiltration, normalizes immune responses, enhances the regeneration of connective tissue and epithelium, dramatically accelerates the healing of tissue defects (wounds, ulcers, burns, etc.) and the elimination of inflammatory and sclerotic processes in soft tissues. There is a stimulation of the conductivity of nerve impulses, i.e. Not only vascular, but also nervous trophism of tissues improves, which additionally leads to an increase in tissue regeneration, elimination of inflammation and resorption of sclerotic changes.

For the treatment of long-lasting wounds and trophic ulcers of lower extremities in diabetes, atherosclerosis, venous insufficiency, and decubitus wounds, one can apply nitric oxide obtained by one of the methods described above, not only to the wound surface, but also to the overlying intact limb regions to enhance blood flow and nervous Conductivity, i. To improve vascular and nerve trophism in the affected areas, which significantly improves the results of treatment.

Here is a clinical example

Patient VA, VA, born in 1929, N history of the disease EA-97.

Enrolled in the MNIOR them. PA Gertsen 07.01.98 with the diagnosis: Obliterating endarteritis of the vessels of the lower extremities, occlusion of the iliac-femoral arteries, condition after prosthetics of the indicated vessels, diabetes mellitus, trophic ulcer of the left tibia.

Objectively: the extremities, especially the feet, are cold to the touch, hyperpigmentation in certain areas, a positive symptom of "plantar" ischemia, a barely perceptible pulse on the rear artery of the feet. On the lateral surface of the lower third of the left tibia ulcer up to 2 cm ² . With ultrasonic dopplerography, the blood flow in the calf vessels is not determined.

A plasmodynamic NO-therapy session was performed by affecting the area of ​​the ulcer and along the course of the main vessels of the shin. Control ultrasonic Doppler ultrasonography showed a distinct pulsation of the arterial vessels of the lower leg and an improvement in the background blood filling of the limb tissues.

Taking into account the received data, the patient was treated with plasma-dynamic NO-therapy daily. As a result, after 10 days, elimination of trophic ulcers, normalization of skin pigmentation, increase in skin temperature of extremities, improvement of pulsation in the back arteries of both feet was achieved.

Similarly, it is possible to treat obliterating endarteritis and other diseases with deterioration of the arterial blood supply of the extremities and without ulcerative lesions of the latter.

The claimed method can be successfully used in transplant operations of an autologous cutaneous or musculocutaneous flap onto an extensive or non-healing wound surface formed as a result of burns, extensive operations, injuries, trophic ulcers or other causes. In this case, it is more convenient to use a gas stream containing NO produced by passing air through an electrical discharge or chemically.

The gas flow is advisable to first act on the skin of the donor site in the area of ​​skin flap or small skin areas for 4-6 days before transplanting daily for one treatment session. The time of exposure is determined by the size of the flap. The aim of the action is to stimulate microcirculation and metabolism in the donor site. At the same time, it is advisable to apply the gas flow to the wound surface of the future transplant to accelerate the development of granulations and the preparation of autodermoplasty. After autoplasty, a gas stream containing NO is applied to the transplanted flap daily for 3-6 days, depending on the size of the wound to accelerate the engraftment and prevent rejection of the transplanted flap. At the same time, it is expedient to use a gas stream containing NO to influence the donor wound, thereby accelerating its healing.

For the first time in medical practice, for the treatment of acute and chronic inflammatory, inflammatory-destructive and ulcerative processes in the mucous membranes of internal organs, a gas stream containing nitric oxide obtained by any of the above methods is operated through endoscopic devices. For example, to treat erosive gastritis or chronic gastric ulcer and 12 duodenal ulcer, the gas flow is directed to the gastric or intestinal mucosa through the gastroscope. A gas containing NO produced chemically, and can be directed through a thick probe.

In the treatment of inflammatory processes in the larynx, trachea and bronchi, a gas stream containing nitric oxide is directed to the mucosa through a laryngoscope or bronchoscope. In the treatment of inflammatory and inflammatory-destructive diseases of the urinary tract, a gas stream containing NO is directed to the mucosa of the bladder and urethra through the cystoscope. In this case, due to the high permeability of nitric oxide, it is possible to exercise a therapeutic effect on the prostate gland with such a common disease as prostatitis.

The dosage of NO, the duration and frequency of exposure sessions, the duration of treatment for all of the above diseases depends on the stage and form of the disease, the sensitivity of the patient to the effect of NO, age, the effectiveness of therapy and other nosological, topical and individual factors.

Similarly, the affected surface of the serous membrane of the abdominal cavity, for example, in peritonitis or other diseases, as well as the serous membrane of pleural cavities, for example, pleurisy for the treatment of inflammatory processes, can be influenced by a gas stream containing nitric oxide through a laparoscope, thoracoscope or drainage tubes. It is also possible that the gas stream containing NO is influenced by endoscopic instruments on the internal organs of the abdominal cavity (pancreas, gall bladder, etc.) in pancreatitis, cholecystitis and other diseases. The dose and duration of treatment is determined by the nature of the inflammation (serous, purulent), the intensity and phase of the process, as well as many other factors.

A gas stream containing nitric oxide can be used to treat acute and chronic synovitis, for example, in rheumatoid arthritis and other joint diseases. The gas flow can be directed through the arthroscope or the puncture needle into the joint cavity, and, taking into account the permeability of NO, to the skin of the affected joint.

For the first time in medical practice, in order to prevent purulent complications of the wound process, divergence of sutures, fistula formation, etc., in the preoperative period in patients with a high risk of complications (weakened, oncological, with immune disorders, etc.), the skin in the operation area is affected by gas flow, Containing NO produced by one of the above-described methods. This effect is carried out daily for 3-4 days before the operation (1 session per day) and then continues after the operation (up to 3-4 days) on the area of ​​the surgical suture.

In addition, the patented method can be used to prevent skin lesions with radiation therapy (radiation dermatitis, radiation ulcers). For this purpose, before and / or after each radiotherapy session, the skin in the irradiation region is exposed to a plasmodynamic gas stream containing nitrogen oxide or NO produced by any of the above-described methods.

As an example of the effectiveness of such therapy, we give a clinical observation.

Patient BA RV, born in 1946, N of the medical history of ZhA-2022.

She entered the MNIOR them. P.A.Gertsen 02.10.97 with the diagnosis: cancer of the right breast of III B stage. The condition after a radical mastectomy for Maden. In terms of combined treatment of a patient, a course of postoperative radiation therapy is shown. To prevent radiation reactions, a course of plasmodynamic NO-therapy has been initiated prophylactically, covering the entire surface of the skin in the irradiation zone with the capture of surrounding tissues up to 3 cm from the irradiation boundary. Plasmodynamic therapy was performed 0.5 hours after each radiotherapy session (20 exposures daily).

As a result of such combined radiotherapy and NO-therapy, a full course of radiotherapy was performed according to the prescribed schedule and the planned dose, which was achieved only due to the absence of development of radiation reactions in the irradiation zone.

Conclusion . A complete clinical effect of prevention of early radiation reactions with NO-therapy has been achieved.

In order to prevent complications (eg, suppuration, etc.) with soft tissue lesions, for example, gunshot, bruised, chopped and other types of wounds, traumatic pathology, burn diseases and other states of medicine of catastrophes and military conflicts, nitrogen oxide obtained by any of Of the methods described above, it is possible to act on the affected tissue once before applying the dressing during the prehospital care phase.

From the foregoing it follows that for the first time in the domestic and world practice a method of exogenous and endogenous NO-therapy and NO-prevention of the most diverse traumatic, destructive, inflammatory and sclerotic lesions of the soft tissues of the body has been created in numerous diseases by exposing them to nitric oxide.

Treatment according to the claimed method is easily combined with any other types of therapeutic or surgical treatment. Undoubted merits of the proposed method of treatment include its simplicity, accessibility, universality, painlessness, atraumaticity, the possibility of both inpatient and outpatient treatment, saving medicines and dressings.

CLAIM

1. A method for treating soft tissue disorders of an organism, characterized in that affected tissue is exposed to nitrogen oxide.

2. A method according to claim 1, characterized in that the affected tissue is directly exposed to nitric oxide.

3. A method according to claim 2, characterized in that the affected tissue is exposed to a gas stream containing nitrogen oxide obtained by passing air through an electric discharge.

4. A method according to claim 2, characterized in that the affected tissue is exposed to a gas stream containing nitrogen oxide obtained by chemical reactions.

5. The method of claim 1, wherein the affected tissue is exposed to nitrogen containing medicines that generate nitric oxide in the most affected tissue.

6. The method according to claims 3 to 5, characterized in that the nitrogen oxide is applied to both the affected tissue and the unaffected tissue located along the main vessel, through which the blood supply to the affected tissue occurs.

7. The method according to claim 2, characterized in that, when transplanting a flap of its own tissue with nitric oxide, it is first applied to the donor site and to the affected tissue, and then to the transplanted flap.

8. The method according to claims 3 and 4, characterized in that the affected tissue of the mucosa of the internal organs, serosa or synovial membranes is affected by nitrogen oxide through endoscopic devices.

9. A method for preventing soft tissue injuries, characterized in that the soft tissue in the area of ​​the intended lesion is affected by nitrogen oxide.

10. The method of prophylaxis according to claim 9, characterized in that for the prevention of postoperative complications, nitric oxide affects the soft tissue located in the surgical intervention zone in the preoperative and / or intraoperative and / or postoperative periods.

11. The method of prevention according to claim 9, characterized in that soft tissues in the radiation zone before and / or after each radiotherapy session are applied to prevent soft tissue lesions during radiotherapy with nitric oxide.

12. The method of prevention according to claim 9, characterized in that for the prevention of posttraumatic complications in extreme conditions, nitrogen oxide is applied to the affected tissue prior to application of the medical dressing.

print version
Date of publication 29.03.2007gg

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