Method for treatment of trophic ulcer and long-term open septic wound

FIELD: medicine, dermatology, in particular treatment of trophic ulcer (TU) and long-term open septic wound (LTOSW).

SUBSTANCE: claimed method includes application of wound-healthing composition onto TU and LTOSW in the first step of wound process. Said composition contains (mass %): methyluracil 0.9-1.1; pepsin 3.4-4.4; bentaine hydrochloride 3.6-4.4; sodium chloride 9.0-11.0; and balance up to 100,0: distilled water. In the second and third phases fine cut collagen preparations in form of 3-4 mm thickness layer are applied on purified TU and LTOSW surface. Then cotton carrier freely moistened with wound-healthing composition diluted with water in ratio of 1:2 is layered onto collagen layer. Multihole microirrigator and further sterile cotton carrier are sequentially applied over abovementioned cotton carrier.

EFFECT: effective treatment due to accelerated abruption of necrotic tissues, inhibition of microbial growth, decreased risk of infective, toxic and allergic affects, and improved tissue regeneration.

2 ex, 3 cl

 

The invention relates to medicine, namely to therapeutic methods of treatment, and can be used in clinical practice for local enzymatic treatment of venous ulcers (TAN) and nonhealing wounds (DNGR).

The known method (AU No. 1149977 And 61 To 37/57; 1985) involves the local application on the surface of the TAN and DNGR in the following ratio, wt%: pepsin - 15,0; ascorbic acid 30,0; glucose - 54,25; hydroponic - 0,75.

The known method (RU, patent 2174389, a 61 K 9/06, 38/43, a 61 P 17/02; 1999), lies in the local application on the surface of the TAN and DNGR composition in the following ratio, wt%: collagenase 160-200 E; gentamicin sulfate 0,08-0,1; polyethylene oxide-400 66,0-68,0; polyethyleneoxide-1500 16,5-17, 0mm; glycerin of 10.0 to 10.1.

As a prototype, most similar in essential characteristics to the proposed method of treatment is the way (RU, patent 2160135, a 61 N 5/06, a 61 K 38/43; 1998), in which the local application on the surface of the TAN and DNGR composition in the following ratio, wt.%: pepsin 2,0-4,0; ascorbic acid 4,0-8,0; hydroponic 0,1-0,2; methyluracil 4,0; poliglyukin to 50.0.

The disadvantages of all the above treatments THEE and DNGR proteolytic enzymes, active in an acidic environment, are the following:

1) due to the absence or use of weak organic acids, not sotdae the camping optimum pH for pepsin, insufficient antibacterial and nekroliticescoe activity of the applied compositions;

2) the activity of enzymes used in the compositions of these methods are limited in time because of the rapid alkalization of wound that is due to the lack of buffer additives, stabilizing pH in THEE and DGR;

3) in many cases do not apply substances that can exert a cytoprotective effect on regenerating tissue, as well as being an active stimulants regenerative processes;

4) in these ways does not use the direct feed plastic material to regenerating tissues.

The technical problem to be solved by the proposed method consists in providing effective treatment for THEE and DNGR.

The technical result is obtained when implementing the proposed method in the treatment of THEE AND DNGR, is provided through the acceleration of necrosis, enhancement of bactericidal effect, stimulate regeneration, delivery required for anabolic processes nutrients directly to the regenerating tissues, protect regenerating tissues from external influences, prevention of secondary infections.

The achievement of the technical result consists in the local application in the first phase of wound process again pre the proposed composition, conventionally named "Necrotization", in the following ratio, wt.%: methyluracil - 0,9-1,1; pepsin - 3,6-4,4; betaine hydrochloride, 3,6-4,4; sodium chloride - 9,0-11,0; distilled water to 100.0 cotton media. In the second and part of third phase of wound process this composition on cotton carriers used in conjunction with the preparations of collagen (mostly chopped medical catgut).

The most effective ratio of the medicinal components in the composition "Necrotization" was defined experimental studies and numerous clinical observations.

All included in the composition of the ingredients permitted for use MH and CF RF (Vidal - 1999 - drugs in Russia: a Handbook. M, Attraversare, 1991. - 1520 S.).

The ingredients of the composition when dissolved not ensue in the chemical relationship that proved spectrophotometric method.

Pepsin is a digestive enzyme with highest proteolytic activity among all other enzymes of the organism.

This enzyme is one of the most numerous groups of enzymes proteolytic enzymes (proteases). They belong to the class of hydrolases, division of peptideatlas and catalyse the breakdown of proteins and polypeptides hydrolyzes peptide bonds and decomposes almost all natural proteins.

Proteolytic activity is very high - one gram of pure porcine pepsin can split 50 grams of chicken protein (Silaev WAS the Study of proteolytic and himani activity food pepsin // Food technology. - 1975. No. 5. - C.3). There are various forms of release of pepsin: swine pepsin of the gastric mucosa of calves and lambs milk age (abomin), chicken pepsin (pepsin), crystalline pepsin (IP) 1:3000, crystalline pepsin (IP) 1:10000. The latest figures suggest that 1 mg of pepsin can decompose 10000 mg chicken protein.

The optimum pH for its validity pH 2 (Andreeva NS why pepsin active and stable at pH 2? // Molecular biology. - 1994. - V.28, issue 6. - S-1406). The breadth of activity of porcine pepsin (abomina) in the range of pH from 1.0 to 3.0; and chicken (pepsin) from 1 to 4.0 (Haritonin V.V., Chernenko G.T., Sdobnov E.A., great A.G. Enzymatic activity and therapeutic effect of pepsin To chronic gastritis with secretory insufficiency // Clinical medicine. - 2003. No. 8. - P.35).

As an ingredient proposed composition was used the most affordable and cheap pork pepsin.

In the literature we have not received data on the possibility of overdose of pepsin.

Betaine (N-trimethylglycine, Okinawan, licin, betafin) is a natural nitrogenous libotr the Phnom substance of vegetable origin, derivative of the natural amino acid glycine. It is a readily water-soluble powder. Molecular formula betaine C5H11NO2the chemical formula - (CH3)3N+-CH2COO-(drug Importeren).

In the molecule of betaine has active metal group (CH3-), which are necessary for normal metabolism. Attaching methyl groups (methylation) is a mandatory stage of the most important biochemical reactions.

The human body cannot synthesize methyl group, and retrieves them from food. Thanks to its direct participation in the reaction of methylation betaine has a big impact, particularly on lipid metabolism, having a lipotropic effect, as its composition is close to choline and lecithin. Betaine is involved in the metabolism of methionine.

In addition, betaine acts as osmoprotective, i.e. helps to maintain water balance in cells and tissues (Wettstein M, Haussinger D. Cytoprotection by the osmolytes betaine and taurine in ischemia-reoxygenation injury in the perfused rat liver // Hepatology. - 1997. - Vol.26, No.6. - P.1560-1566).

Taking betaine reduces platelet aggregation. Betaine is used in pharmacology for the treatment of liver disease, treatment of alcoholism in toxic poisoning in the form of dietary supplements as part nutritition drugs in doses up to 12 grams per suck is.

Betaine hydrochloride or hydrochloride) is chemically, 1-carboxy-N,N,N-trimethylmethanaminium chloride. Net 5% solution of betaine hydrochloride has a pH of 1.

Betaine hydrochloride dissociate in solution to free betaine and diluted hydrochloric acid with a pH of 2-2,5, is used in tablets "acidin-pepsin together with pepsin for oral administration for the treatment of low acidity gastritis.

In the literature we have not received data on the possibility of overdose of betaine and betaine hydrochloride (Israile LI, Slinko NR. To the question about the toxicity of betaine hydrochloride (aldina medical), used as a medical drug // Hygiene and occupational diseases. - 1974. - Issue 1. - P.41-44).

In the treatment of THEE and DNGR betaine and betaine hydrochloride in the form of a 4% solution (the optimal pH for pepsin) used by us for the first time.

Meteorical (2,4-Dioxy-6-methyl-1,2,3,4-tetrahydropyrimidin). White crystalline powder, odorless, little soluble in water (up 0.9% at a temperature of 20° (C) and alcohol. Plastic surgery refers to Abdelmonim stimulants, has anabolic and anti-catabolic activity. These drugs speed up the processes of cell regeneration and reproduction; accelerate wound healing, stimulate cellular and humoral defense factors. The total regenerative mechanism of action involves increasing biosynthesis of p is rinevich and pyrimidine bases, RNA, functional and enzymatic cellular elements, including phospholipids membranes, as well as the stimulation reduplication of DNA and cell division. It should be noted that the process of biosynthesis during both physiological and reparative regeneration needs in the substrate providing essential amino and fatty acids, minerals, vitamins). Plastic surgery has anti-inflammatory action. In broad clinical practice methyluracil is taken internally in doses from 1 to 6 grams per day, and as part of various ointments for topical application.

Hypertonic saline has long been applied in the 5% and 10% concentration for local treatment of purulent wounds due to its osmotic effect, contributing to the separation of wound exudate. Hypertonic sodium chloride solutions have local bacteriostatic action. Applied topically, hypertonic solution of sodium chloride does not have obscherezorbtivnymi toxic or irritant action.

To apply the composition "Necrotization" in clinical practice, we have obtained the permission of farmkomiteta the USSR №211-7032/24 from 12.03.90,

In the second and part of third phase of wound process to the composition is added to the preparations of collagen.

Collagen is the most abundant protein in the human body. About 70% in the CA dry skin is collagen.

Collagen composite materials are not toxic, irritating, antigenic, carcinogenic action; easily lyse tissue and bacterial proteases slow release contained in these drugs. Decomposing on the surface of the TAN and DNGR into simpler compounds, metabolites of collagen take an active part in metabolism at the cellular level and stimulates reparative processes (Magomedov A.G. and other Trophic ulcers of the lower extremities. - Makhachkala, 2000. - 160 S.).

Treatment method this method was developed, and its effectiveness is confirmed by numerous clinical observations.

For immediate treatment composition "Necrotization" prepared ex tempore by mixing batches of ingredients in the flask followed by the addition of distilled water under normal conditions, and does not require sterilization, as itself has a pronounced bactericidal activity.

The proposed method in the 1st phase of wound process in the first 3-5 days after the toilet surface THEE and DNGR in aseptic conditions imposed 6-10 ply gauze napkins, liberally soaked in the composition "Necrotization in the preferred implementation: methyluracil 1,0; pepsin 4,0; betaine hydrochloride 4,0; sodium chloride 10,0; water distill is consistent - to 100.0 (pH 2.0). The frequency of changing dressings is 2 times daily.

Subsequently, after cleansing THEE and DNGR from necrotic detachable under aseptic conditions at its surface is covered with chopped collagen (catgut) or other official collagen dressings with a layer thickness of 3-4 mm On collagen layer overlaps the first layer of gauze bandages (cut according to the contours of TAN or DNGR) from 8-10 layers, liberally soaked in the composition "Necrotization", diluted 1:2 with distilled water. On top of napkins koltseobrazno superimposed megacity microirrigation under the guise of another 8-10 ply dry with a sterile cloth.

The portion of a limb with TAN or DNGR sabitovakamila to prevent displacement of the dressing. Through microirrigation in a bandage with a frequency of 1-2 times per day served a small amount of composition "Necrotization"diluted in a ratio of 1:2. Change bandages are made with an interval of 7 days (for control surface THEE and DNGR and determine their readiness to autodermoplasty).

If YOU or DNGR heal without the use of autodermoplastiki, regular transparent after soaking layers of bandages in 3% hydrogen peroxide, if necessary, can be added on its surface is chopped in aseptic conditions collagen (catgut) and the other offitsialnye collagen dressings, without completely removing the remaining on the surface of the granulations of the collagen film.

Examples of specific applications of this method.

Example 1.

Sick paperna TO-HZ, 67 years old, IB. No. 735/35, was admitted to the hospital 14.01.96, with a diagnosis of Primary varicose saphenous veins of both lower extremities. Complications: chronic venous insufficiency of the left leg 2 degrees, right - 3 degrees, circular dermatosclerosis and hyperpigmentation in the lower third of the right tibia, trophic ulcer in the lower third of the right tibia on the anteromedial surface size 114 cm2. Comorbidities - recurrent diffuse goiter, thyrotoxicosis moderate; koronarokardioskleroze, atrial fibrillation, cardiovascular insufficiency 2A degree; chronic obstructive bronchitis with asthmatic component; prolapse of the vaginal wall prolapse of the uterus; status post right mastectomy for breast cancer in March of 1995.

The patient initially received conventional therapy for 20 days using himopsina 150 mg for dressing. 6.02.97 were plastic skin surface ulcers. The flaps first took root, the patient was discharged from the hospital because she refused the surgery on the venous system of the lower extremities.

In the observation on the observed, the flaps were quickly rejected, joined by infection and by March 1997, he formed ulcer surface with purulent-necrotic detachable area of 84 cm2. The edges of her gentle, the skin around hyperpigmentation and sclerotic (fibrous), ackzematization. From wound inoculated Staphylococcus aureus.

Patient newly admitted to hospital. I.B. No. 842/42. With 3.03.97, 5.03.97, the treatment composition Necrotization" according to the following recipe: methyluracil 1,0; pepsin 4,0; betaine hydrochloride 4,0; sodium chloride 10.0 g; distilled water - up to 100.0 (pH 2.0). With 6.03.97, 11.03.97, the same composition, but diluted with distilled water in the ratio 1:2 (pH 2,5).

During this period the area of the wound surface was reduced to 35 cm2. Later on THEE with change after 7 days were overlapped cathalogue bandages, in which through microirrigation twice a day was applied diluted 1:2 composition "Necrotization". To 3.04.97, THEE fully healed yourself.

Subsequently, the patient produced a combined excision of the saphenous vein, right n/limbs. Recurrence of the ulcer is not observed within 5 years of observation.

Example No. 2.

Patient M. Kurbanov, 39 years old, IB. 988/188, received 19.03.99 was diagnosed with obliterirutego endarteritis left n/extremities, gangrene of the first finger of the left foot. 27.03.99 is. transaction - left lumbar sympathectomy, exarticulation 1 toe of the left foot with resection of the metatarsal head. In the postoperative period as a result of necrosis of the edges of the wound and attach infection formed, the wound size 6×to 3.5×4 cm with purulent-necrotic detachable. Inoculated Staphylococcus aureus.

With 1.04.99, within two weeks the wound was treated with dressings with chymotrypsin and 10% solution of sodium chloride, but without much effect - purulent-necrotic discharge from the wound remained.

With 14.04.99, 16.04.99, within three days, during binding, after the toilet with 3% hydrogen peroxide to the wound surface was applied napkins, liberally soaked in the composition "Necrotization" according to the following recipe: methyluracil 1,0; pepsin 4,0; betaine hydrochloride 4,0; sodium chloride 10.0 g; distilled water - up to 100.0 (pH 2.0). After purification from purulent-necrotic tissue with the appearance of bright red granulation and epithelialization to further stimulate the regeneration over the next 9 days on DNGR was imposed kathaluwa bandage, in which through microirrigation twice a day was applied diluted 1:2 composition "Necrotization" (pH 2,5).

Complete wound healing after 12 days from the start of treatment composition "Necrocide is in conjunction with collagen dressings.

The proposed method of treatment used in the clinic in 66 patients with trophic ulcers and nonhealing purulent wounds of various etiologies (venous-venous, ischemic scar-trophic and so on).

The clinical effect is observed on the first day of starting treatment. Nonhealing purulent wounds and trophic ulcers cleansed of purulent-necrotic detachable for 3-5 days, appear active granulation and marginal epithelization. In the future, together with collagen dressings, another 7-14 days method is used to stimulate the regeneration and prevention of secondary infection.

The advantage of the proposed method is confirmed bacteriologically, cytomorphological, clinically.

Compared with the methods using pancreatic and bacterial protease, the proposed method accelerates the rejection of necrotic tissue, inhibits the growth of bacteria, including antibiotic-resistant. The danger of generalization of infection is reduced. Toxic and allergic phenomena are excluded. Tissue regeneration is significantly faster. All this leads to the reduction of treatment time in 1,5-2 times and the prevention of relapse in the long term.

In the clinical trials revealed the following positive factors of the proposed method of treatment:

1. with the spruce proteolysis in the proposed mixture used enzyme pepsin from the group of acidic geralis (optimum pH 2), because the activity of the other enzymes from the group of alkaline geralis (thermitase, papain, chymotrypsin, himopsina, turrilites etc., the pH optimum of which about 8.5) under various conditions above 2-20 times; pepsin has the strongest collagenase activity;

2. the essential difference is that instead of weak organic is used with amphoteric properties of hydrochloric acid salt of betaine - betaine hydrochloride, which, decomposing in solution, provides free 1% hydrochloric acid with a pH of 2.0 to 2.5, the optimal action of pepsin, and also by acting as a buffer, supports this pH for 8-12 hours (depending on the number of wound), which is optimal for the action of pepsin and bactericidal effect on pathogens.

3. the tool improves the lymphatic drainage of tissues (proved that increasing the acidity of the tissues from 7.35 to 5.9 increases the volume of the exudate by 20% due to the flow of lymph, at the same time, 10% hypertonic solution of sodium chloride in the mixture outflow tissue fluid with toxic elements and microflora in the band);

4. as active promoters of regeneration and protectors in the strongly acidic conditions of the environment are used betaine produced by the decay of betaine hydrochloride, methyluracil and the very acidic environment created on the surface is rnost THEE and DNGR;

5. as nutrients and plastic material delivered directly to the regenerating tissues, used products of the enzymatic degradation of collagen (catgut);

6. as a defense regenerating tissues from external influences and prevention of secondary infection used long-term (7 days) imposed cathalogue dressings in combination with periodic feeding them the song "Necrotization".

The combined use of the components of the compositions and preparations of collagen in this way leads to a pronounced synergistic effects upon THEE, AND DNGR.

Given the low cost of the ingredients used in the composition for treatment in this way, you can expect significant economic effectiveness of its implementation in clinical practice.

1. Treatment of trophic ulcers (TAN) or nonhealing wounds (DGR), characterized in that in the 1st phase of wound healing on the surface of the TAN and DNGR impose wound healing composition with the following ratio of components, wt.%: methyluracil - 0,9-1,1; pepsin - 3,6-4,4; betaine hydrochloride, 3,6-4,4; sodium chloride - 9,0-11,0; distilled water to 100.0 cotton carriers, and the second and third phases to the cleaned surface THEE and DNGR put chopped preparations of collagen SL is eat a thickness of 3-4 mm, then on collagen layer lay the first layer of cotton carrier, liberally soaked in wound healing composition is diluted in a ratio of 1:2 with distilled water, over a cotton carrier impose megacity microirrigation under the guise of another sterile cotton carrier.

2. The method according to claim 1, characterized in that as the cotton carrier use gauze bandage in 6-10 layers.

3. The method according to claim 1, characterized in that the quality of products of collagen use chopped medical catgut or other official collagen dressings.



 

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3 cl, 4 dwg, 1 tbl, 3 ex

FIELD: medicine, biotechnology, pharmaceutical industry, veterinary science.

SUBSTANCE: method involves addition of tris-HCl buffer (pH 7.5) containing 0.1 M of lysine and 5 mM of EDTA to the Cohn's fraction followed by incubation and centrifugation. Prepared suspension is incubated with 10% PEG-3000 and after centrifugation the solution is applied onto column with lysine-Sepharose at pH 7.5 and plasminogen is eluted with buffer solution at pH 3.5 containing 0.1 M of glycine, 30 mM of lysine and 5 mM of caprylic acid. Then plasminogen is incubated with streptokinase in tris-buffer (pH 7.5) containing 15 mM of lysine, 10 mM of ε-aminocaproic acid and 50% of glycerol. Then method involves chromatography on column with benzamidine-Sepharose at pH 8.5 and elution with buffer at pH 3.5 containing 0.1 M of glycine, 30 mM of lysine, and the end product is lyophilized that comprises about 30 IU/ml of plasmin with purity above 98%, at least 10 mM of lysine and 10 mM of glycine in an aqueous solution at pH about 3.5. The prepared product shows apyrogenic property, absence of toxicity in experiments in laboratory animals and it doesn't cause allergic or other adverse response reactions in intracutaneous or intravenous administrations, and the preparation doesn't cause defects in the vision field after its an intraorbital route of administration.

EFFECT: improved preparing method, valuable medicinal properties of plasmin.

7 cl, 1 ex

Medical-cosmetic // 2242218
The invention relates to the field of cosmetology and relates to a composition for therapeutic skin care

FIELD: medicine, experimental medicine.

SUBSTANCE: one should introduce tripeptide Pro-Gly-Pro for laboratory animals as injections at the quantity of 0.09-1.0 mg/kg body weight, and, also, gelatin as fodder additive. The method suggested enables to suppress appetite, decrease the quantity of fodder intake that leads to decreased body weight as a result.

EFFECT: higher efficiency.

2 cl, 5 dwg, 5 ex

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