Composition for the treatment of burns

 

(57) Abstract:

The invention relates to medicine, namely to create medications for the treatment of burns. Composition for the treatment of burns in children includes a biologically active component of the drug Actovegin and gel Tizol in the following ratio, wt.%: the solution aktovegin for injection in terms of the content of the active component of 0.2-0.3, TESOL to 100. The drug has a high efficacy, good tolerability and reduces the treatment time.

The invention relates to the field of medicine, particularly surgery and treatment of burns II-III AB degree in children in hospital with comprehensive therapy, and application of the composition containing the biologically active substances of animal origin on the burnt areas.

Local inflammatory process in thermal injury in children differs from that in adult patients with malignant course. More severe burns in children is determined by the generalized response of the child's body to trauma, which results in the disturbance of peripheral circulation, depletion of local blood flow and local hypoxia. In reprograming burns. Currently, however, not to develop drugs that help minimize the pathological effects of depletion of blood flow in the affected segment.

Known ointment for the treatment of burns I and II degree and skin diseases "Halterm" based on lanolin (10-30%), including vegetable oil 10-50%, stabilizer and aggregates of proteoglycans of cartilage farm animals in an amount of from 0.01 to 2.0 wt.% (see RF Patent 2118155, a 61 K 9/06, published 27.08.1998. Bulletin 24).

Good quality treatment to the shortcomings of the ointment should be attributed to the high content of fatty basis that it is not always beneficial in the treatment of burns and that the active substance ointment - aggregates of proteoglycans from cartilage farm animals (PGA) - are produced in limited quantities, which inhibits the production of ointment.

It is also known the use of the drug Actovegin (Actovegin) production Austria in the treatment of burns (see Reference Vidal 1999. Drugs in Russia. Edition of 5. M. the company "Astra Pharm Tools. B-17). Active substance homogenized derivative of calf's blood with low molecular weight peptides and derivatives of nucleic acids. Form release: jelly (gel) 20% ointment 5% solution for injec applied on the affected skin in a thin layer. Changing bandages 1 times a week, heavy exuding wounds several times a day. Good quality treatment, including of children, poor enforcement of aktovegin a 20% gel is a significant flow, high concentration and, consequently, the high cost of the drug, manufactured abroad and imported in limited quantities.

Object of the invention is to provide a composition for the treatment of burns based on aktovegin as biologically active substances of animal origin that reduce its consumption and total cost of treatment, particularly in children, while the remaining components of the composition must be a Russian production, have pharmacopoeial article to be produced.

The task is solved in that, using as biologically active substances of animal origin Actovegin in the form of solution for injection in ampoules, prepare the composition of the drug substance Tizol in the form of a gel. The composition is prepared by mechanical mixing of microdoses aktovegin (of 0.2-0.3 wt.%) with Etizolam and get gel drug used in the treatment of burns in children. Actovegin is used in the form of solution for injection in AVO treatment of burns II-III AB degree is not inferior to treatment with 20% jelly aktovegin, this reduces the treatment time and total cost of treatment, and the composition does not contain the fatty components and easy to use.

When cooking stock use: Actovegin - solution for injection in vials manufactured by NYCOMED AUSTRIA GmbH, Austria and TESOL - Xiamen happy valley water Park of glitzerofosfata titanium.

Tizol substance - FS 42-3414-97 (instead of VFS 42-2188-93), developed and produced (company "OLYMPUS", , Yekaterinburg, has a high transcutaneous conductivity, non-toxic, easily mixed with medicinal additives.

Form Title - gel white. Tizol not the accumulation of fluid in the tissues, at the same time prevents tissue from drying and swelling, increases their oxygenation. Tizol allowed for medical use in Russia by the Ministry of health and medical industry of the Russian Federation 192 from 16.08.1993, as agent for external use (see "Farmacia" 2, 1994 , pages 9-10) and registered for 93/192/1. This product can be used as the primary (by weight) of the component composition for the treatment of burns, and have the additional therapeutic properties and the possibility of mixing with Actovegin, to form with him a homogeneous composition.

Socially, prepare the base composition - Tisol substance and add to it Actovegin in the form of solution for injection in vials of calculating obtain a given concentration Actovegin from 0.2 to 0.3% by weight. The resulting mixture is thoroughly mixed until a homogeneous environment, conduct quality control of the mixture and Packed in glass containers (dark glass) 10-50 grams, cover and paste labels. Then the composition is ready for use.

The ratio of components in the composition in an amount of aktovegin from 0.2 to 0.3 wt.% chosen empirically and tested in numerous experiments.

When the treatment composition is applied a uniform thin layer on the treated surface of the burn, the wound closed with sterile towels.

After conducting laboratory research and testing of the proposed composition aktovegin with Etizolam have been tested in children's burn ward DGKB 9, Yekaterinburg. The composition for testing and clinical trials were prepared in the hospital pharmacy of the substance Tizol production LLC "OLYMPUS" and aktovegin in the form of solution for injection in ampoules.

Indications for use of the proposed structure are set when posted is to compensate developing local hypoxia, to avoid thrombosis in the field of thermal destruction and thereby stop the development of necrobiotic processes in the affected segment, and to preserve the viability of the tissue, and accelerate their healing.

The problem solved by the invention is to reduce the period of vascular disorders in the affected segment and the prevention of infection of the wound surface.

Treatment of burns with the application of the proposed structure is as follows. Upon admission of the child to the Department of pre-determined size and depth of lesion. When the depth of the lesion II-III AB article and the total area of lesions more than 10% in children under 5 years, more than 20% in children older than 5 years are the indications for preventive vascular therapy.

After anesthesia is the primary toilet burn wounds, including floor and emptying epidermal bubbles, debris removal of damaged epidermis, cleansing the wound with sterile gauze swab moistened with antiseptics. Ends toilet wounds by the application of the proposed composition, Title with Actovegin of 0.25%. In subsequent ligation are performed daily for the first 3-4 days, and then if necessary.

12the hemoglobin - 145 g/l, hematocrit of 41%, Leucocytes - 6,4109eosinophils - 1, band - 4, segmented 28%, The leukocyte - 12,4109, eosinophils - 3, young - 2, band - 7, segmented - 45, lymphocytes - 33, monocytes - 10. UAC at discharge: Erythrocytes - 3,61012the hemoglobin - 131 g/l, hematocrit 31%, Leucocytes - 8,6109, eosinophils - 3, band - 3, segmented - 57, lymphocytes - 30, monocytes - 7.

2. Patient Anastasia J., age 11 months, I. B. 6543, the burn area is 25% II-III AB article, burn shock of 1 degree. Delivered to the Burn center GDMB 9 ambulance after 1 hour and 10 min after injury. On admission, clinic of burn shock, expressed microcirculatory disorders, acrocyanosis, vomiting. The patient started antishock therapy adopted in the clinic technique. After the stabilization under/anesthesia underwent primary toilet burn wounds, certified by the imposition vlazhnovysyhayuschih bandages soaked Titlem with Actovegin of 0.25%. After cupping manifestations of shock continued infusion therapy with the aim of detoxification and liver support. The patient continued introduction of angioprotective to 4 days, antibiotic therapy was not carried out. Infusion therapy is discontinued for 5 days. Local treatment was carried out appliques Title with Actovegin daily at first the epithelization on the 17th day, the patient was discharged home. In the observation of the appearance of scars in the affected segments are not detected. UAC on admission: Erythrocytes - 4,61012the hemoglobin - 147 g/l, hematocrit 37%, Leucocytes - 7,7109, eosinophils - 2, band - 4, segmented - 49, lymphocytes - 36, monocytes - 9. The KLA on the third day: Erythrocytes - 3,31012the hemoglobin - 116 g/l, hematocrit of 28%, Leucocytes - 12,4109, eosinophils - 2, young - 4, stab - 8, segmented - 46, lymphocytes - 30, monocytes - 10. UAC at discharge: Erythrocytes - 3,51012the hemoglobin - 136 g/l, hematocrit 35%, Leucocytes - 7,8109, eosinophils - 4, band - 3, segmented - 59, lymphocytes - 27, monocytes - 7.

3. Patient Irina M. 11 years, I. B. 4461, the burn area is 15% of the II-III century Delivered to the burn ward of a children's burn center after 1 hour 15 min after injury, in the state of moderate severity, signs of burn shock is not detected. The wound presents naked from the affected epidermis dermis mosaic coloring in the center of the wounds of the crimson and white on the periphery of pink, pain sensitivity saved. Toilet wounds completed applique Title with Actovegin of 0.25%. Parenteral appointed cardiovascular drugs in a dosage of age day with 4 hours a day, 9 days ligation was not performed. The full healing with bandages with the proposed structure. The patient was discharged on the 15th day after the injury. In the observation within one year of the occurrence of scars is not detected. Laboratory methods: UAC on admission: Erythrocytes - 4,21012the hemoglobin - 132 /l, hematocrit 35%, Leucocytes - 6,7109, eosinophils - 3, band - 6, segmented - 52, lymphocytes - 31, monocytes - 8. OAK on the third day: Erythrocytes - 3,11012, hemoglobin 118 g/l, hematocrit 30%, Leucocytes - 11,6109, eosinophils - 4, young - 3, band - 9, segmented - 43, lymphocytes - 31, monocytes - 10. OAK at discharge: Erythrocytes - 3,81012the hemoglobin - 133 g/l, hematocrit 32%, Leucocytes - 7,4109, eosinophils - 3, band - 4, segmented - 57, lymphocytes - 30, monocytes - 6.

Clinical examination showed that the proposed composition used in the complex treatment of burns, allows to compensate developing and to prevent possible local hypoxia, prevents further development of necrobiotic processes in the affected segments in children with borderline burns, does not require massive drug, including antiaging active substances, thus accelerating the healing process. The method does not lead to polipragmazie, can be used in specialized burn centers and specialized clinics.

To determine the effectiveness of the proposed composition for the treatment of burns was made a statistical study of the results of treatment in 4 groups of patients by 30 people, matched for age, area and depth of the lesion. The first group of victims with burns III and Art., local treatment was conducted of the proposed composition, group 2 - victims with burns III and Art., treatment was carried out using aktovegin-jelly, group 3 - deep burns, the treatment proposed by the composition, group 4 - deep burns, treatment Actovegin-jelly.

Results: achieved a significant reduction of the period of epithelialization of wounds in the proposed composition in patients with burns III and article 14.3%, epithelization cell mesh grafts after operations autodermotransplantat 18.6%.

Calculation of economic efficiency of the proposed composition for the treatment of burns conducted on the basis of statistical data obtained in DGKB 9 showed that in comparison with Actovegin in the form of jelly new composition society economic effect of new members per treated patient is expressed in average 1071,5 ruble and prices of 2000. The composition is well tolerated, easy to use, does not require for the preparation of special expensive equipment and can be widely used in the treatment of burns as in specialized burn units, so in specialized clinics.

Composition for the treatment of burns in children, including biologically active component of the drug Actovegin, characterized in that it includes Actovegin in the form of a solution for injection and gel Tizol in the following ratio, wt.%:

The solution aktovegin for injection in terms of the content of the active component - 0,2 - 0,3

Tizol Up to 100 RUB

 

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