RU2300388C1 - Method for treatment and prophylaxis of foot disease - Google Patents

Abstract

FIELD: medicine, endocrinology, therapy, diabetology.

SUBSTANCE: invention relates to a method for treatment and prophylaxis of diabetic foot. Method involves using birch bark as agent showing curative properties in form of inner soles. Based on complex mechanical and pharmacological effect proposed method provides elimination or prevention of symptoms of sensory-neuromotor neuropathy and without additional treatment with drugs.

EFFECT: enhanced effectiveness of treatment and prophylaxis.

1 tbl, 2 ex

Description

The invention relates to medicine, namely to methods of treatment and prevention using drugs containing substances of plant origin.

One of the serious diseases of the feet is the so-called diabetic foot syndrome, which is manifested in patients with diabetes. This syndrome is a consequence of diabetic sensorimotor polyneuropathy and the associated decrease in the protective sensitivity of the feet and specific changes in its shape and function. Due to a decrease in sensitivity, immunosuppression, vascular disorders, an unrecognized injury in time causes a diabetic ulcer and gangrene.

Existing methods for the prevention of diabetic foot syndrome include special care aimed at preventing foot damage. At the same time, thorough hygiene of the feet, treatment with antiseptics (for example, M.S. Lyubarsky, A.I. Shevel and others. Syndrome of a diabetic foot. Pathogenetic approaches to treatment, breast cancer, T. 9, No. 24, 2001), wearing special insoles and shoes that reduce the mechanical load on the foot, prevent corns, corns, rubbing the foot (e.g. RU 2165229 C1, 2001.04.20; US 2005177085, 2005.08.11; US 2004194352, 2004.10.07; US 2005166425, 2005.08.04).

However, to effectively prevent damage to the foot, shoes and insoles, individually made taking into account the features of the foot, are required, which is not available to most patients, and sometimes it is technically impossible at all.

The complexity of the treatment of patients with diabetic foot syndrome is also associated with the fact that due to a decrease in sensitivity, it is sometimes difficult for patients to detect small violations of the skin that can cause ulcers. In addition, in patients with diabetes mellitus, the healing of ulcers is slow, therefore the treatment of the diabetic foot is quite expensive and requires a long time, and the risk of damage to ulcerated areas by pathogenic bacteria and fungi increases. Drug treatment of ulcers involves the use of drugs that promote tissue regeneration, phagocytosis, microcirculation and wound healing (for example, RU 2253427 C1, 2005.06.10). In some cases, problem areas of the foot are exposed to laser radiation (for example, RU 2049500 C1, 1995.12.10).

A known method for the prevention of diabetic foot by external exposure to the foot of drugs with anti-inflammatory, wound healing and other therapeutic properties, by applying them to an orthopedic insole made of thermoplastic material (US 2004194352, 2004.10.07).

The disadvantage of this method is that in order to effectively affect the foot, the insole must be impregnated with drugs regularly. This requires frequent change of insoles, can cause adverse and allergic reactions and, in addition, insoles made of thermoplastic material are quite expensive.

Other diseases of the feet include trophic ulcers caused by venous insufficiency, damage to the joints of the feet due to rheumatoid arthritis, increased sweating of the feet during vegetative vascular dystonia, as well as foot mycoses, including athletic foot syndrome, foot trichophytosis, epidermophytosis of the feet, diseases caused by pathogenic bacterial flora.

Known treatment and prevention of diseases of the feet by external exposure to the problem area of herbal compositions. The compositions of the herbal compositions are selected for the prevention and treatment of specific diseases, including rheumatic diseases (CN 1368024, 2002.09.11; CN 1381215, 2002.11.27), circulatory disorders (JP 2003093523, 2003.04.02), muscle fatigue of the feet, deformities of the feet ( CN 1349776, 2002.05.22), dermatitis and eczema (US 2001005509, 2001.06.28; US 2005163878, 2005.07.28), fungal diseases and diseases caused by pathogenic microflora (US 2004244224, 2004.12.09; US 2005152998, 2005.07.14; CN 1345600, 2002.04.24), excessive sweating of the feet (CN 1345600, 2002.04.24; CN 1381215, 2002.11.27).

The composition of the compositions includes herbs used in Chinese medicine, herbs from other regions, white ash bark, oak bark, tree leaves, vegetable oils (peppermint oil, safflower oil), etc. It is known to use the hapolopilus fungus hiding for the treatment of foot mycosis (RU 2072857 C1, 1997.02.10.). To enhance the effect of herbs, chemical compounds are introduced into the composition: salicylic acid, carbonic acid of benzene, formaldehyde, benzoic resins, alcohols, etc. The compositions are used in bathtubs, in compositions for external use by applying them on the skin of the foot or on a shoe insole (CN 1345600, 2002.04.24). The use of these compositions in the insoles is also known (BG 108501, 2004.06.30; CN 1368024, 2002.09.11; US 2004244224, 2004.12.09; CN 1349776, 2002.05.22; CN 1381215, 2002.11.27).

The use of known compositions can achieve a positive effect only in the treatment and prevention of specific diseases.

As a prototype, a method for the treatment and prevention of foot diseases was selected based on the external effect on the foot of medicinal herbs with properties that protect the feet from sweating feet and damage by pathogenic fungi (BG 108501, 2004.06.30). Medicinal herbs (elderberry flowers, birch leaves, primrose flowers, oak bark, juniper berries, etc.) mixed with crushed copper and tin are mounted on the outside of the insole.

The disadvantage of this method, as well as the above, is the focus on the treatment and prevention of a limited number of diseases.

The technical problem solved by the present invention is the development of a simple, accessible to most patients a comprehensive method of treatment and prevention of foot diseases, which is especially important in the treatment of patients with, in addition to the underlying disease, concomitant, leading to aggravation of the course of foot disease corresponding to the underlying disease. So, in the treatment of paresthesia, ulcerations and other manifestations of diabetic foot syndrome, as well as for the prevention of this complication of diabetes mellitus, the drugs used must have anti-inflammatory, cleansing, antiseptic, antifungal properties, reduce foot sweating, not injure the foot, not aggravate foot deformation, contribute to the removal muscle fatigue, improve blood circulation. The method, as well as the known one, is based on the external impact on the foot with a remedy with medicinal properties and is characterized in that birch bark is used as a remedy with medicinal properties. In some cases, it is advisable to use birch bark in the form of insoles. In other cases, crushed bark can be packaged in a breathable cover.

The invention is based on the chromatographic-mass spectroscopic studies of the essential oils released by birch bark into the air at different temperatures, which were carried out before the start of clinical trials. It has been established that the composition of birch bark essential oils includes betulinol, lupeol, dipentene, isocariophilen, karyofillen, β-bisabolen, bergamotol, α-bisabolol, α-bergamotene, α-farnesene, lupenon, α-caryophilene and other components that have antiseptic anti-inflammatory, wound healing and biostimulating properties. Palmitic acid, which is part of the components of birch bark, activates the protective function of the skin, prevents microorganisms from penetrating into it, and has a heat-accumulating property. The biological activity of the total complex of components secreted by birch bark helps to suppress pathogenic microflora (Staphylococcus aureus, Staphylococcus epidermidis, Enterococci, Echerichia coli, Proteus subspicious, Klebsiella pneumonia, Pseudomonas subspicious, various microorganisms that can cause mycotic lesions of the feet and others). wounds, has immunomodulatory and anti-inflammatory effects, improves microcirculation and tissue oxygenation. Birch bark reduces foot sweating, which results in a high probability of foot damage by pathogenic microflora.

The study of birch bark as a therapeutic and prophylactic agent was carried out with the participation of patients with diabetes mellitus (72 patients), patients with degenerative-dystrophic diseases of the musculoskeletal system (10 patients), professional athletes with a diagnosis of chronic calcaneus periostitis (10 people). Also, tests were carried out on the effect of birch bark on recovery processes after training loads in professional athletes (20 people) and in children involved in youth sports schools (30 people).

The study of the effect of birch bark as a therapeutic and prophylactic agent for diabetes mellitus was carried out on 72 patients aged 33 to 67 years, suffering from diabetes for more than 5 years. Patients during the study were not in the hospital and did not receive specific therapy for the prevention or treatment of diabetic foot syndrome. Before the study, patients were divided into 4 groups. The first group included 30 patients whose analysis of the lower extremities showed a high probability of ulceration due to paresthesia, foot hyperkeratosis in the projection of the heads of the metatarsal bones, I, III, and V fingers, on the heels and on the side surface of the thumbs, and other signs of the possible development of the syndrome diabetic foot; the second group includes patients (4 people) with deep cracks and reddening of the skin in callous areas; the third group included 6 people (over the age of 60 years) who had previously undergone drug treatment of extensive ulcers; the fourth group included patients (32 people) who did not have significant lesions of the skin, but experienced discomfort and heaviness in the legs, paresthesia, cramps at night, and atrophy of the muscles of the feet.

Birch bark was used in the form of a removable insole for home and outdoor shoes, made according to the technology that makes it possible to make soft insoles with a smooth velvety surface. Insoles were used as insoles in shoes and by placing them directly in the toe (stocking) for direct contact with the skin of the feet. In two cases, instead of insoles, breathable bags with shredded birch bark were used.

The tests showed:

- in the first group, after 3 months of wearing insoles, not a single patient showed any cracks or ulcers, most patients noted a pleasant sensation of warmth in the legs, a decrease in leg fatigue;

- in the second group, in 3 patients in the area of cracks, redness of the skin disappeared after 4 days, in one patient (age 67 years), swelling appeared on the site of the crack 1 day after wearing the insoles, the crack healed after 17 days;

- in the third group, after 14 weeks of wearing insoles, no patient showed a recurrence of ulceration;

- in the fourth group, only 8 people experienced night cramps and numbness after 6 weeks of wearing insoles.

A paraclinical study of patients of all groups who used insoles from birch bark showed that such therapy leads to the restoration of the functional activity of the nervous tissue. In particular, this position is confirmed by the results of thermography. So, before treatment, most patients had a pronounced focal spotting of the thermographic pattern with its asymmetry, which is characteristic of venous insufficiency - one of the signs of neuropathy. After treatment, there was a positive trend with a clear reduction in spotting and asymmetry, and in some cases the thermographic pattern looked like that of a normal foot.

Rheovasography, in turn, revealed an improvement in venous outflow with almost unchanged other parameters - pulse blood filling, resistance of postcapillaries and arterioles. The effect of using the insoles is quite brightly manifested in the improvement of all types of sensitivity of the feet (see table):

Kinds Before treatment After treatment Tactile 40/60 25/75 Vibrating 100/0 15/85 Temperature 50/50 20/80

Example 1

Patient K. (37 years old), was diagnosed with diabetes mellitus with insulin dependence 8 years ago, and the patient receives traditional antidiabetic treatment. Clinic: lack of sensitivity of the feet with pressure, insensitivity to temperature changes, hyperkeratosis in both feet, deformation of both feet and nails, night cramps, numbness at rest, cracks and inflammatory process were not detected.

Wearing birch bark insoles for 2 months reduced the frequency of seizures and paresthesia (observed only 3 times, earlier - almost every night), keratinization of the soles (subjectively, according to the patient) decreased, foot deformation did not change.

Example 2

Patient J. (57 years old), diagnosed with diabetes mellitus 12 years ago, stage of incomplete compensation, taking oral antidiabetic drugs irregularly. Clinic: pronounced diabetic foot syndrome with a tendency to ulceration (almost monthly), 2 weeks before the insoles were started in stationary conditions, a course of complex pathogenetic therapy was carried out with the treatment of ulcers with a diameter of 2 and 1.5 cm.

Wearing birch bark insoles for 3 months improved the appearance of the feet, the number of paresthesia decreased, and there was no recurrence of ulceration.

The use of birch bark as a therapeutic and prophylactic agent for patients with degenerative-dystrophic diseases of the musculoskeletal system (10 patients) was carried out as part of complex therapy.

In all patients undergoing outpatient treatment with osteoarthritis of the feet, the pain syndrome decreased during the first week, and movement improved. In 2 patients, a decrease in venous stasis was noted. All patients noted a pronounced warming effect. Adverse reactions have not been identified.

When studying the effect of birch bark on the condition of professional athletes, two groups were formed. The research objective in the first group (6 men and 4 women, athletics) was to assess the effect of birch bark on the condition of the feet of athletes with a diagnosis of chronic calcaneus periostitis. The research task in the second group (12 men and 8 women, table tennis) was to assess the effect of birch bark on recovery processes after training loads.

The test period in the first group averaged 15 days. Athletes used birch bark insoles before and after treatment procedures during the entire treatment period. During the tests, it was revealed: a weakening of the pain syndrome when walking before the start of physiotherapeutic treatment, a weakening of pain during palpation after the first 1-3 procedures, an unexpressed pain reaction to the action of ultrasound and SMV (a pain reaction is observed during the first procedures of physiotherapeutic treatment), a decrease in the feeling of tension of the leg muscles decreased sweating of the legs. The general therapeutic effect usually began to appear after 5-7 days (average - 12 days).

During tests of the influence of birch bark on recovery processes after training loads in professional athletes, it was noted: a decrease in the individual muscle tone of the leg muscles in a state of operative rest (dynamic myography data), a decrease in the feeling of “clogged” leg muscles in all athletes (subjectively), an increase in tolerance time volume of physical activity until the first signs of fatigue (special ergometric functional tests), quick relaxation of post-workout muscle pain and high loads, decreased sweating feet. The test period was 21 days of sports gathering.

Subjectively assessed the beneficial effects of birch bark insoles after training, all children involved in sports (gymnasts and hockey players aged 15-16 years).

The inventive method is the most cost-effective method of treatment and prevention of various diseases of the feet due to the large reserves of birch bark in Russia and the proven technology for the production of birch bark insoles that meets high operational requirements.

Claims (1)

A method for the treatment and prophylaxis of a diabetic foot, based on the external action of the foot on a remedy with medicinal properties, characterized in that birch bark in the form of insoles is used as a remedy with therapeutic properties.