Composition for treatment of a dysbacteriosis secondary immunodeficiencies and mineral disorders in the allergic and method of treatment

 

(57) Abstract:

The invention relates to the field of medicine and for the treatment of a dysbacteriosis, secondary immunodeficiencies when allergic. The invention lies in the fact that the proposed composition for the treatment of allergic contains Lactobacterin, sifilis and/or nukleinat sodium and trace elements - zinc picolinate, Magne-B6, manganese gluconate. The method of treatment of allergic includes a preliminary determination of the intestinal microflora and trace element composition and introduction composition containing Lactobacterin, sifilis and/or nukleinat sodium and taking into account the revealed disorders of mineral metabolism - zinc picolinate, Magne-B6, manganese gluconate. The invention allows to obtain more persistent and pronounced therapeutic effect. 2 S. and Z. p. f-crystals, 3 tables.

The invention relates to medicine and can be used in dermatology, gastroenterology, Pediatrics and other areas of clinical medicine.

Macro-and micronutrients are an integral part of many biostructures, in particular the active centers of certain enzymes that are involved in important biochemical processes, redox reactions, free-radikalnyye their monomers. All immune processes in humans and animals under normal, physiological conditions and in the development of pathological processes, implemented with mandatory participation of macro-and microelements.

It is known that human hair is a memory trace elements, and their concentration in the hair can serve as an objective indicator of micronutrient situation in the whole body (Avtsin A. P., 1991). Also the analysis of hair gives the most accurate information about the saturation of the body of the macro element - magnesium over a long period of time (M. Laker, 1982). The imbalance of macro-micronutrients leads to the development of various diseases (STOs. Internal medicine, vol. 2. Ed. M.: Medicine, 1993, 77 main, Impaired metabolic micronutrients, pages 451-457). So, the breach of magnesium balance leads to the emergence of a number of immune disorders detected abnormal activation of the complement, the high frequency of allergic reactions and infectious processes, the most frequent among them are chronic fungal and viral infections. Selective deficiency of zinc is observed when atrophicans with impaired bowel function in humans at this pathology, as well as in experimental deficiency of qi is STN, what level of molybdenum largely depends on the activity of the microflora of the gastrointestinal tract, as a growth factor for bacteria, this element in elevated quantities causes increased reproduction in the intestine, resulting in diarrhea observed in ruminants when molybdenate (Huigingh, Matrons G. , 1976). And excess of iron is caused by deficiencies of zinc and copper and is manifested diseases of the gastrointestinal tract (gastro, reactive hepatitis, and pancreatitis), its high content in the digestive tract limits the absorption of metal - poison of lead due to competition for a common acceptor sites on the mucosa (Microelementoses person: etiology, classification, organohalogen/A. P. Avtsin, A. A. Zhavoronkov, M. A. riche, HP Struchkova: the Academy of medical Sciences of the USSR. - M.: Medicine, 1991 92, 385 pages ). Thus, in diseases of the gastrointestinal tract, allergic disturbed mineral balance, develops immunodeficiency and for the correction of immunodeficiency States use essential macro-minerals (Drannik, N., Grinevich Y. A., Dizik, M.. Immunotropic drugs. Ed. K.: "Health", 1994, ch. X. pp. 217-245).

Restoring microflora of an organism in bol is the dependence of the intensity of dysbiotic disorders of the colon from the severity of atopic dermatitis and duration of the disease (Kosyakov N. And., Romashev L. A., 1999).

There is a method of treatment of a dysbacteriosis (patent RU N 2071339 C1, bull. N 1. 10.01.97) bifilosa that allows correction of microbiocenosis of intestines by increasing the content of bifidobacteria, improves immunological reactivity due to stimulation of cellular factors of local immunity, reducing the level of sensitization, increased levels of endogenous lysozyme content in the digestive tract, the secrets of the digestive glands and serum, correction antiproteinase activity of blood plasma. However, the known method is not effective enough in some categories of patients: not fast enough regenerates reduced content of functionally complete Escherichia coli and elimination of Escherichia with hemosiderosis activity or mild enzymatic properties (SVK), does not always ensure correction of immunological parameters in patients with significant immune system disorders characterized by deficits and imbalances of different subpopulations of T-lymphocytes, impaired B-cell component of humoral immunity.

Also known is a method of treatment of a dysbacteriosis (patent RU N 2123345 C1, bull. N 35, 20.12.98) probiotics, cha is ocensa intestine; the increase in anti-infective, antiviral, antitoxic resistance; stimulation of immune reactivity and increase adaptive capacity of the organism; the normalization of the functional state of the liver tissue and cellular structure of the hepatic lobules. Also this combination of probiotics has the property of preserving the physiological asynchronous mode of functioning cells Panet - a special type of epithelial cells containing large granules Imogene and having a peculiar property of accumulation and excretion of zinc, these cells secrete lysozyme.

However, the resulting effect of treatment of a dysbacteriosis did not take into account the recovery of microbiocenosis of intestines in the deficits of essential macro-and micronutrients. So, when allergic combined with malabsorption syndrome, identified mineral deficiency of essential macro-and microelements, in particular, to reduce the level of zinc, as well as significant increase of lead (patent RU 2129426 C1, bull. N 12, 27.04.99). Lead is a poison enzymes by binding to disulfide groups of the protein, damaging the tertiary structure of intracellular proteins by denaturing them and causing cell death and ultimately the EPR. 452-454), at the same time it causes malabsorption in the intestine, as it is a physiological antagonism of zinc and zinc deficiency leads to impaired ability to induce the synthesis of metallothionein that binds the excess of lead (Bremmer, R. K. Mehra Metallothionen some aspects of its structure and function with special regard to its involvement in copper and zinc metabolism//Chem. Scripts 1983. - Vol. 21. - P. 117-121).

There is a method of treatment of patients with atopic dermatitis, including the introduction of the oral complex (Essentiale-Forte and zinc oxide) (Gushchin N. S., Chirikova So, "the Experience of treatment of patients with atopic dermatitis children drug Essentiale-Forte in combination with zinc oxide" - Current issues of dermatology and venereology: (sat, transl. ubil. Conf., ]. 5-th anniversary of the Department. the skins. and Venus. diseases a pediatrician. the FAK. RSMU, 5-6 June 1997, M. 1997, S. 137), the duration was 20 - 30 days, after preliminary acceptance of adsorbents and biologics. The authors suggest that the effectiveness of complex patients with atopic dermatitis with accompanying hepatopancreatobiliary and prone to complications secondary infection. However, this method did not take into account data on the quantitative content of zinc in the body, i.e., not conducted a pre-study of macro-and mie in 1962, 1978 A. I. Corolla has established a range of trace elements. One of them is the area of biotic action is detected with the use of trace elements in concentrations close to those in which they are contained in the body under normal environmental conditions, the two other areas are idle and toxicopharmacological actions. In this way used salt is zinc oxide, which is for the body xenobiotics, i.e. alien substance, unlike our picolinate zinc, as zinc forms in the lumen of the intestine soluble hydroxide and phosphate compounds. In this regard, it is necessary that these elements have reached the mucous membrane in combination with food ligand (for example, in connection with amino acid - zinc picolinate). Also in this case was not considered in children microbiocenosis of intestines, and application of biological preparations without control can lead to infectious complications (Tyurin, M. C. Lactic acid bacteria as potential causative agents of human infectious diseases//. Antibiotics and microecology of humans and animals. M., 1983, S. 175-178), to oppress other representatives of normalizedate (About the properties of drugs of the normal microflora of man//. Ant the ski dermatitis (Smirnova N. With. The experience of biologically active additives (BAA) in the complex treatment of atopic dermatitis and alopecia baldness in children, "Current issues of dermatology and venereology" (collection of translated ubil. Conf., ]. 5-th anniversary of the Department. the skins. and Venus. diseases a pediatrician. the FAK. RSMU), 5-6 June 1997 M. 1997, 134-136 C.), which, along with the traditional treatment used biologically active additives (BAA) is a proteolytic enzyme (Bromelain), and for the correction of microbiocenosis used eubiotic containing bifidobacteria and lactobacilli ("Floradophilus"). The authors noted the early decrease in the intensity of pruritus (on the 7th day from the date of appointment of the drug), the improvement of the General condition, the disappearance of infiltration and lichenization skin lesions, and laboratory monitoring revealed the increase of lacto - and bifidobacteria almost to normal values of the indicators. However, patients in this way were treated macro-and micronutrients, including zinc, which is part of the pancreatic juice, and atopic dermatitis in most cases detected pancreatitia. Treatment eubiotic, in which there is no lysozyme, is less effective in contrast to complex treatment with probiotics (sifilis and/or lactoba the ANSA in the body (patent RU 2129426 C1, Bull. N 12, 27.04.99), the technical purpose which was to facilitate the determination of macro - and microelement balance in the body and change their content and correlation, differential diagnostics of various diseases. However, in the present invention was not carried out dynamic monitoring before and after treatment of macro-micronutrients.

As the closest analogue is adopted a method of treatment of a dysbacteriosis (patent RU 2123345 C1, bull. N 35, 20.12.98) providing for the treatment of a dysbacteriosis, and immunodeficiency, as in this way there is stimulation of the immunobiological reactivity of the organism (stimulation of phagocytes, the increase is reduced lysozyme activity and antitoksicescuu resistance), the correction mechanisms of regulation of proteolysis - reduce the original high functional activity of the major plasma protease - granulocyte elastase and correction activity of its main inhibitor, protein acute phase of inflammation - and-1-proteinase inhibitor (a-1-PI) involved in the control mechanisms of adaptation and implementation of the inflammatory process. The authors have established new mechanisms of action of a combination of lysozyme hydrochloride with bifidobacteria and nuclein the total effect of split application of individual components. However, the known method of treatment of a dysbacteriosis was not taken into account the imbalance of macro-minerals, occur when immune deficiency.

An object of the invention is the creation of a more effective method of treatment of a dysbacteriosis, secondary immunodeficiency disorders of mineral metabolism in the allergic, to reduce the treatment time, to get more persistent and pronounced therapeutic effect.

To solve this problem is proposed group of inventions, joint General inventive composition and method of treatment of a dysbacteriosis, secondary immunodeficiencies and mineral disorders and allergic dermatitis.

Composition for the treatment of these conditions contains one dose Lactobacterin, sifilis and/or nukleinat sodium and macro-and microelements in the following ratio of ingredients per dose:

Lactobacterin - 105- 108< / BR>
Sifilis - 105- 108SOME

Nukleinat sodium - 5 - 1000 mg

At the same time as the trace elements it contains zinc picolinate 11 - 66 mg: Magne B-6 (200 - 400 mg of magnesium lactate; magnesium gluconate 2 - 10 mg One bottle of bifilosa contains 5 doses of Bifidumbacterin and 50 mg do what matzah carried out taking into account the intestinal flora and macro - and microelement balance in the body. While imposing a single dose of the composition containing Lactobacterin, sifilis and/or nukleinat sodium and appropriate trace elements based on identified violations mineral balance. The course of treatment to normalize microbiocenosis bowel and mineral metabolism. When zinc deficiency is injected zinc picolinate in the number 11-66 mg per dose; in violation of magnesium balance enter Magne B-6 (200 - 400 mg of magnesium lactate per day) and manganese balance - manganese gluconate in an amount of 2 to 10 mg.

Conducted a comparative study of the elemental composition of hair (Al, Cd, Co, Cu, Fe, Mg, Mn, Mo, P, Pb, Zn, S) by atomic-emission spectral analysis on spectrochemical system G. B. C (AUSTRIA) and feces on a dysbacteriosis before and after treatment of macro-micronutrients and probiotics in patients with allergic.

Sample preparation was carried out using acid digestion (Black M. S. and all, 1981). Patients (aged 3 to 14 years) were divided into 2 groups: 1st (control) - 6 patients treated only macro-and microelements (zinc picolinate at a dose of from 11 to 66 mg per day, Magne-B6 at a dose of 200 to 400 mg of magnesium lactate per day and manganese gluconate at a dose of from 2 to 10 mg) and 2-nd group of 6 patients receiving complex was teeplechase basic therapy, including antigistaminny drugs. In table. 1 presents the General clinical characteristics of the examined patients.

All children were found to decrease magnesium (1 patient-level limit of normal), zinc - 9, manganese - in 4 cases; increased iron in 10 cases, molybdenum - 2; the increase of toxic metals - aluminium - all patients, lead - in 9.

In the 1st group after treatment, we noted a positive trend in the balance of toxic metals, but in a comparative perspective the efficiency of elimination of toxic metals in group 2 was higher: in this group the level of aluminum was reduced by 70%, lead by 75%, and in group 1 in 49% and 40%, respectively. In group 1 there was a reliable increase in zinc (p<0.05) and insignificant change in manganese, magnesium, iron, molybdenum. These patients were identified dysbacteriosis II and III (table. 3), all patients were found a fungal infection of the intestine, after the treatment only minerals level of anaerobic and aerobic component of the intestinal microflora has not recovered enough now was the elimination of conditionally pathogenic microorganisms, survived a fungal infection Kish is stepped.

In the 2nd group after the combined treatment, the levels of aluminum and lead significantly decreased (p<0,05), (PL. 2).

Example 1. Sick, So , 6 years. Diagnosis: Atopic dermatitis erythematosquamous form lehenetsia, Subtotal alopecia areata.

Dysbacteriosis III Art.

Complaints about skin irritation, scratching, itching, abdominal pain, not associated with eating, flatulence, poor appetite, poor weight gain, constipation.

The child suffers from food allergies. The first signs of disease appeared to 1 year of birth, areas of alopecia have been identified in 3 years. The child also show signs of minimal brain dysfunction: hyperactivity, irritability sensitive and motor nerve cells. History of - artificial feeding, frequent colds. The present exacerbation occurred after use of antibiotics.

Spectral analysis of hair revealed a deficiency of zinc, magnesium, manganese, increased levels of iron, molybdenum, and toxic accumulation of lead and aluminum. The analysis of a feces on a dysbacteriosis has revealed a sharp decline in normal E. coli to 40 million/year, an increase of Escherichia coli with weakly expressed enzymatic its is clear to 106 degrees and a fungal infection of the intestine.

Conducted comprehensive treatment, which included zinc picolinate 22 mg, manganese gluconate 5 mg, Magne - B6 (200 mg magnesium lactate) per day (for 4 months) and treatment with probiotics. Biotherapy conducted by a combination of bifilosa (5 doses), Lactobacterin (5 doses) and nucleinate sodium (500 mg), 2 times a day for 2 months. Control the spectral analysis of hair was performed after 4 months, feces analysis on disbacteriosis was measured after 2 weeks of starting treatment. Clinical improvement occurred by the end of 2 weeks from the start of treatment and was characterized by a decrease in the intensity of itching, improving overall health, the disappearance of infiltration and lichenization skin lesions, normalization and frequency of stools, decrease flatulence and stomach, improve appetite. Clinical manifestations of bowel dysfunction were controlled completely by the 30th day from the start of treatment. Bacteriologically after treatment in the intestinal microflora normalized content of bifidobacteria, lactic acid bacteria, has increased the total number of E. coli to 305 million/year, reduced the number of E. coli SVK up to 30%, hemolytic E. coli and yeast is not found.

After the combined treatment by the end of the 2nd throwing areas of hair loss and permanent cure, also completely passed phenomena of hyperactivity and emotional lability. In the spectral analysis of hair normalization of the metabolism of essential macro-and micronutrients and elimination of toxic.

Example 2. Patient T., aged 14. Diagnosis: Atopic dermatitis, erythematous form. Duodenitis, pancreatopathy. Dysbacteriosis II Art.

Complaints of skin rashes, itching, pain in the stomach after intake of sour, spicy, flatulence, unstable chair. History of - artificial feeding, food Allergy. The present exacerbation occurred after ingestion of rich and fatty foods.

Spectral analysis of hair revealed a pronounced deficiency of zinc, magnesium, increased iron levels, as well as toxic nakoplenie lead and aluminum. The analysis of a feces on a dysbacteriosis showed a reduction in normal E. coli up to 140 m/g, the increase of E. coli with weakly expressed enzymatic properties up to 60%, we also observed a decrease in bifidobacteria lactobacilli to 106 degrees and a fungal infection of the intestine.

Conducted comprehensive treatment, which included zinc picolinate 66 mg per day for 2 months, 44 mg per day to 1 month, Magne-B6 (400 mg magnesium lactate) per day (for 4 mg for 1.5 months. Control of spectral analysis of hair was performed after 4 months, feces analysis on disbacteriosis was measured after 3 weeks. from the beginning of treatment. Clinical improvement occurred by the end of the 1st week of starting treatment, and were characterized by improvement of the General condition, decrease in the intensity of itching, normalization and frequency of stools, decrease flatulence and abdominal pain. Clinical manifestations of bowel dysfunction were controlled completely by the 30th day from the start of treatment.

Bacteriologically after treatment in the intestinal microflora normalized content of bifidobacteria, lactic acid bacteria, has increased the total number of E. coli to 340 million/year, reduced the number of E. coli SVK up to 10% detected elimination of microorganisms with pathogenic potential (yeast).

After the combined treatment by the end of the 2nd month of atomic dermatitis went into remission, skin rash is completely gone. After 3 months of starting treatment, the patient noted a strong recovery (positive dynamics of laboratory and functional indicators - reduction of enzyme activity, normalization of the size of the pancreas).

In the control spectral">

Example 3. Treatment product containing only bifidobakterii or in combination with lysozyme (table. 3).

Clinical and laboratory study of drug VIGIL (sifilis) was conducted on the clinical bases of the Department of neonatology of Ramapo (40B-x) and Department of Pediatrics, Ramapo (20 b-x) in children aged 3 to 5 days to 10 months of life. The condition was most severe. In the experimental group consisted of 20 children who were given sifilis ser. E-111 and 3 to 5 doses x 2 times a day; 20 children in the control group received Bifidumbacterin (ser. 220 production "Biomed" and 14-1 production LLP "Enzyme") 5 doses 2 to 3 times a day. Duration of use bifilosa 10 days, follow - up to 1.5 months.

Examination of feces on a dysbacteriosis was performed in 10 children from the experimental group before and after 10 days of application of bifilosa and 5 children in the control group for 10 days before the end and after a course of applying bifidumbakterin (PL. 3). Thus sifilis after 10 days of application 5 doses 2 times a day (10 doses per day) provided good clinical and bacteriological effect and compensation of the deficit of lysozyme digestive tract in infants with dysbiosis and bowel dysfunction, and inhibited the development of dysbiosis in the case of massive antibiotic therapy. the in coprofilia at 6 of the 7 children of the experimental group, whereas in the control of the lysozyme was not found before and after treatment. Children from the experimental group also appeared lysozyme in the serum (0.7 to 1.0 microgram/ml). The severity of dysbacteriosis decreased during the observation period both in the experimental and control groups, but in the control group none of the children are not marked normalization of microflora.

1. Composition for treatment of a dysbacteriosis, secondary immunodeficiencies and mineral disorders in the allergic containing Lactobacterin, sifilis and/or nukleinat sodium and macro - and microelements in the following ratio of components 1 dose:

Lactobacterin - 105- 108< / BR>
Sifilis - 105- 108SOME

Nukleinat sodium - 5 - 1000 mg

Trace elements - 2 - 66 mg

2. Composition under item 1, characterized in that as trace elements it contains zinc picolinate 11 - 66 mg.

3. Composition under item 1, characterized in that as trace elements it contains Magne-B6 (100 - 400 mg of magnesium lactate per day).

4. Composition under item 1, characterized in that as trace elements it contains manganese gluconate in an amount of 2 to 10 mg.

5. The method of treatment of a dysbacteriosis, secondary immunodeficiencies and mineralglas intestine, macroeconometric balance in the body and inject 1 dose of the composition containing Lactobacterin, sifilis and/or nukleinat sodium and appropriate trace elements with identified disorders of mineral metabolism, treatment to normalize microbiocenosis bowel and mineral metabolism.

6. The method according to p. 5, characterized in that when zinc deficiency is injected zinc picolinate 11 - 66 mg per dose.

7. The method according to p. 5, characterized in that when the violation magnesium balance enter Magne-B6 (100 - 44 mg of magnesium lactate per day).

8. The method according to p. 5, characterized in that in case of infringement of manganese balance - manganese gluconate in an amount of 2 to 10 mg per dose.

 

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FIELD: biotechnology, microbiology, medicine.

SUBSTANCE: invention relates to the strain Lactobacillus paracasei CNCM I-2116 used for diarrhea prophylaxis causing by pathogenic microorganisms. Supernatant of this strain culture elicits ability to prevent colonization of intestine with pathogenic microorganisms causing diarrhea also and this strain is designated for preparing agent used for prophylaxis and/or treatment of disorders associated with diarrhea. Agent for oral administration represents therapeutically effective dose of the strain L. paracasei CNCM I-2116 or supernatant of its culture and acceptable foodstuff. Invention provides the enhanced viability of the strain in its applying and effectiveness in prophylaxis of adhesion to intestine cells and invasion to intestine cells of pathogenic microorganisms causing diarrhea.

EFFECT: valuable medicinal properties of strain.

5 cl, 8 dwg, 10 ex

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