What are bacterial lysates. What are lysates? The concept of bacterial lysates

Lysates trigger immune responses to provide effective protection from real pathogens.

When pathogens enter the body, their main goal is not only to cause a disease, but also to escape from immune system 1 .

Any bacterial cell has a certain structure, enclosed in a cell membrane. Chemical or mechanical destruction of the cell wall causes the death of the microorganism. The very process of destruction of the cell membrane is called lysis. Lysates are the product of bacterial cell lysis.

The use of bacterial lysates for the prevention of acute respiratory diseases by the mechanism of action is similar to the action of vaccines. Once in the human body, they are perceived as foreign agents and provoke the development of both specific and non-specific defense factors. Preparations based on bacterial lysates can be local and systemic. Local lysates are used in oral cavity and upper respiratory tract. The purpose topical application lysates is the activation of the immune response directly at the site of infection.

Topical bacterial lysates are suitable for treating children. It is important that these drugs restore the balance of the mucous membrane and its microflora, practically do not cause adverse reactions, combine well with other drugs: antipyretic, vasoconstrictor, antibiotics and do not interfere with the work of the general immune system. When treating uncomplicated bacterial infections, lysates can help avoid or reduce antibiotic use. Local preparations based on bacterial lysates are used at any stage of the disease 3:

• In the beginning, so as not to get sick.
• In the midst of the disease, in order to prevent complications.
• As a prophylactic agent for ARVI. The use of lysates for the prevention of ARVI also reduces the risk of developing unpleasant complications.

Lysates cannot induce an inflammatory response, because are not living microorganisms, however, they are recognized quite unambiguously by the receptors of immune cells as a threat to the development of the disease, after which protective reactions are activated.

IRS®19 preparation consists of a mixture of bacterial lysates - specially isolated parts of pest bacteria. The principle of action of IRS®19 is that lysates activate the local immunity of the nasal mucosa, directing it to fight bacteria and viruses. The drug has a high safety profile and can be prescribed for the prevention of infections in both adults and children from 3 months 4. IRS®19 is an assistant on the way to a healthy and strong immune system.

You can learn more about lysates of bacteria in our cartoon "Lysates of bacteria".

Russian name

Latin name of the substance Lysate of bacteria

Pharmacological group of the substance Lysate of bacteria

Typical clinical and pharmacological article 1

Pharmaceutical action. Stimulates specific and nonspecific local immunity (activation of the phagocytic activity of macrophages, an increase in locally formed antibodies of the secretory IgA class, which prevent the fixation and reproduction of infectious agents on the mucous membranes, an increase in the amount of lysozyme).

Indications. Seasonal prophylaxis (spring / autumn) of acute and exacerbations chronic diseases upper respiratory tract and bronchi. Acute and chronic bacterial infections of ENT organs, upper and lower respiratory tract: rhinitis, sinusitis, laryngitis, tonsillitis, pharyngitis, tracheitis, bronchitis, otitis media, complications from influenza and other viral infections. Vasomotor rhinitis. Preoperative preparation for surgical interventions on ENT organs and postoperative period.

Contraindications Hypersensitivity childhood (up to 3 months), pregnancy, lactation.

Dosing. Intranasal (keep the balloon upright). Adults and children from 3 months with acute diseases (depending on age) - 2-5 doses in each nasal passage during the day, until the symptoms of the disease disappear.

For prophylactic purposes - 2 doses per day in each nasal passage for 2 weeks.

Side effect. At the beginning of treatment: sneezing, increased rhinorrhea (if the effects are pronounced, the frequency of administration should be reduced or the drug should be canceled).

Allergic reactions (urticaria).

Special instructions. In case of occurrence clinical symptoms bacterial infections, you should consider the appointment antibacterial therapy against the background of continuing treatment with the drug.

Does not affect psychomotor reactions.

State Register of Medicines. Official edition: in 2 volumes - M .: Medical Council, 2009. - V.2, part 1 - 568 p .; Part 2 - 560 p.

Interaction with other active ingredients

Trade names

The development of the pharmaceutical industry has led to the need to develop drugs that can retain their medicinal properties... For example, preparations based on biologically active components. How are beneficial microorganisms preserved in such preparations? Storage takes place due to an innovative method of drying the biological components of the drug. This method is called lyophilization, and the substance itself, processed in this way, is called "lyophilisate". What it is, in what drugs it is used, what effect it has - you can learn more by reading this article.

What is lyophilization?

A real breakthrough in the pharmaceutical industry was the invention of the lyophilization method. Translated from Greek, this word means "dissolve", "dry". The essence of the method lies in the dehydration of medical material by freezing and further drying in a vacuum manner. The advantages of this method of preparing components for medicines are:

• minimum physical and chemical processing of biological material is carried out, which allows you to maximally preserve the useful qualities of substances;
• in the process of lyophilization, there is a minimal change in the structure and shape of the starting material;
• the shelf life of the drug is significantly increased;
• storage conditions are extended, for example, when high temperatures or high humidity.

From the history of the lyophilization method

A relatively recent lyophilisate has been invented. What it is, medical specialists learned for the first time in 1909. It was then that scientists were able to dry it for the first time in this way. A little later, dry blood plasma was prepared by lyophilization. During the same period, Russian scientists developed the first apparatus for sublimation, after which lyophilization began to develop and spread widely. This method began to produce a wide range of medical drugs: blood plasma, bacterial drugs, hormones, antibiotics and others.

Purpose of vacuum freeze drying

This method of preparation of components is the most common in the pharmaceutical industry. How is the lyophilisate formed, what is it and where is this method used? Using this drying method, a wide variety of medications... But, besides this, the method is used in the chemical and food industries. The prepared lyophilisates preserve beneficial features, do not require strict storage conditions, have a longer duration, are as safe as possible for the consumer.

Lyophilization devices

Special devices have been developed to produce the lyophilisate. Instructions for the use of such devices require special technical knowledge and skills. The systems for lyophilization of the French production "Yuzifroy", the German "Hohvakumm", the English "Edward", the American "Stoke" have proven themselves. In Russia, the most widespread device is the Czech-made "Friger" device.

The concept of bacterial lysates

For the manufacture of immunostimulating, antiviral drugs, a lyophilisate of bacterial lysates is used. Let's take a look at what such complex medical terminology actually means. First you need to find out what bacterial lysates are. These are nothing more than microscopic particles of bacteria formed under the influence of mechanical, chemical or thermal influences. And, accordingly, they become lyophilized in the process of special drying.

Use of bacterial lysates

Bacterial lysates dried by lyophilization are used as immunostimulants. The mechanism of action is similar to that of a vaccine. Once in the body, the virus triggers a response from the human immune system, producing protective antibodies. Thus, in the event of further infection of a person with a pathogenic microorganism, the immune system will respond in a completely different way than during the initial infection. The presence in the body of protective antibodies, which are developed as a result of the fact that a person has taken a lyophilisate of bacteria for prophylactic purposes, will significantly reduce the likelihood of infection or a severe course of the disease. Most often, with the help of such drugs, the prevention of respiratory viral diseases is carried out.

Forms of application of lyophilisates

Medicines - lyophilisates are produced in different forms: in the form of emulsions, dry powder and solutions. So, for example, the drug "Bifidumbacterin" is a lyophilisate in the form of a dry powder, which requires dilution before use. The correct dosage and method of administration can only be prescribed by a doctor.

Lyophilisate solution for injection

Lyophilisate is often used for injection. For intramuscular and medication it is necessary to prepare medical solution... It is better if such a procedure is carried out by a specialist, since it is extremely important to strictly observe the proportions and technology of dilution of substances. Otherwise, you can not only spoil the drug (if the connection is incorrect, such a chemical reaction as oxidation can occur), but also harm the patient's health. Each drug has its own characteristics of dilution and use.

For example, injections are carried out with drugs such as Longidaza, Chondrolone. How to dilute lyophilisate for injection? Let's consider the method using the antifungal drug Vfend as an example. This medicine is a dry powder packaged in sterile vials. The preparation of a solution for injection is carried out in 2 stages: directly dissolving, and then diluting the resulting concentrate substance. The vial of the drug must be dissolved in 20 ml of the supplied solvent. Then the required one-time volume of concentrate medicinal product diluted with sodium chloride or glucose solution.

Immunomodulating drug "Polyoxidonium"

"Polyoxidonium" is another example of a drug that is used intramuscularly and This drug is a lyophilisate. Instructions for its use indicate that it is prescribed for both children from 6 months and adults with complicated viral respiratory infections or for the purpose of their prevention.

The dosage of the drug is prescribed by the attending physician, taking into account many factors. For the manufacture of intramuscular solution 6 mg of the lyophilisate is dissolved in 2 ml of sodium chloride. And for intravenous injection, you will need 3 ml of solvent, after which the concentrate is diluted in 200 ml of hemodez or dextrose solution.

"Polyoxidonium lyophilisate" can provoke an allergic reaction and is incompatible with some other drugs, therefore, consult your doctor before using and read the instructions carefully.

The drug "Bifidumbacterin lyophilisate": instructions for use

The medical product "Bifidumbacterin" is a lyophilisate of live bacteria. Available in dry powder form for oral solutions.

It is used for example, after prolonged use of antibiotics or in children with dysbiosis. It is prescribed for diseases such as:

• intestinal infections;
• ulcers of the stomach and duodenum;
• pancreatitis;
• poisoning and other disorders of the digestive system.

Also used externally "Bifidumbacterin lyophilisate". Instructions for use indicate that for purulent wounds, you can apply an application made of gauze soaked in a solution of the drug.

Intravaginally used in violation of the vaginal microflora, rectally in the postoperative period.

The drug is prescribed even for newborns; it can also be used for nursing mothers. During pregnancy, consult your doctor before using this medicine.

The powder of the drug is dissolved in a small amount of warm liquid: breast milk, fermented milk products, juice, boiled water. The dosage depends on the age and disease of the patient.

It is very important to remember that you cannot dilute "Bifidumbacterin" in hot liquid, take it in parallel with antibacterial drugs, and store the diluted powder.

Lyophilisate "Interferon"

The Russian-made medicinal product "Interferon lyophilisate" is produced in the form of a powder, packaged in vials. Its components are natural alpha interferon and leukocytes donated blood... "Interferon" is an antiviral agent, and also increases the body's resistance to various kinds of infection.

The drug is used nasally, that is, it is instilled or sprayed with special devices into the nasal passages. In order to carry out such a procedure, it is first necessary to dissolve the lyophilisate. To do this, open one bottle and add distilled warm water to it to the highlighted mark of 2 ml. Then you need to shake the bottle until the dry particles dissolve.

The solution is instilled into the nose, 5 drops several times a day, or the inhalation procedure is carried out using special devices.

In no case should it be administered intravenously or intramuscularly, as well as lyophilisate! The instructions for the drug only mention the nasal method of use.

The invention of lyophilisates has contributed to the emergence of many modern pharmaceuticals. This form of drug release significantly reduces their cost and increases and the use does not cause any particular difficulties even at home. But, like any other medicine, the lyophilisate preparation requires prior consultation with a specialist. What it is, in which cases it becomes necessary to take such a drug, only the attending physician will explain in detail.

Preferanskaya Nina Germanovna
Associate Professor, Department of Pharmacology, Faculty of Pharmacy, First Moscow State Medical University. THEM. Sechenov, Ph.D.

Under unfavorable conditions, the "entrance gate" of the macroorganism begins to pass various pathogens. Pathogenic microorganisms enter the body and face various physical and mechanical obstacles. The macroorganism, in response to the penetration of microorganisms and their pathogenic effect, mobilizes all initially nonspecific and then specific defense factors inherent in it.

Due to the growth of microflora resistance, a new approach in pharmacotherapy for the most common infectious diseases is the use of a new class of drugs based on bacterial lysates. Bacterial lysates are highly effective and safe. In most cases, with the topical application of these drugs, complete release from microorganisms dangerous to the body occurs. The action of drugs based on bacterial lysates is aimed not only at destroying microorganisms and toxic products of their vital activity, but also at restoring and activating a powerful immune response. The action of bacterial lysates is carried out through polymorphonuclear lymphocytes, which have a valuable ability to recognize foreign material; through B-lymphocytes involved in the production of antibodies; through dendritic cells that predominantly produce cytokines and perform important immunoregulatory functions, as well as natural killer cells and mononuclear phagocytes that destroy most pathogenic agents that have entered the body.

Bacterial lysate preparations are most often referred to as immunocorrectors of microbial origin, which are a pathogen-associated molecular agent that leads to a cascade of local immune responses and stimulates the immune response through recognition receptors. Bacterial lysates contain crushed, killed bacteria. When used in the patient's body, the production of immunomodulators is summed up, and a qualitatively new stable immunity is formed. After two weeks of application to the lysates of the main strains of pathogens, the immunological memory is fixed up to six months, therefore the drugs are used in courses 2 times a year. Bacterial lysates are most often classified according to the pharmacotherapeutic principle into drugs used:

• in otolaryngology and dentistry - IRS19, Imudon, Ismizhen;
• in pulmonology - Broncho-munal, Broncho-Vaxom, Ribomunil;
• in urology - Uro-Vax;
• in gynecology - Floragin;
• in proctology - Pasteurisan, Pasteurisan forte;
• in dermatology - Actinolizate.

BACTERIAL LYSATES FOR INFECTIONS IN OTORINOLARYNGOLOGY AND DENTISTRY

IRS 19- immunostimulating respiratory spray based on 19 bacterial lysates ( Streptococcus pneumoniae type I, Streptococcus pneumoniae type II, Streptococcus pneumoniae type III, Streptococcus pneumoniae type V, Streptococcus pneumoniae type VIII, Streptococcus pneumoniae type XII, Haemophilus influenzae type B, Klebsiella pneumoniae ss pneumoniae, Stapretoxalis , Neisseria subflava, Neisseria perflava, Streptococcus pyogenes group A, Streptococcus dysgalactiae group C, Streptococcus group G, Enterococcus faecium, Enterococcus faecalis).

When using various types of streptococcus, staphylococcus, enterococcus, klebsiella, moraxella, haemophilus influenzae contained in IRS 19, nonspecific and specific immunity increases. Nonspecific immunoprotection is manifested in an increase in the phagocytic activity of macrophages, an increase in the content of lysozyme. The proteolytic enzyme lysozyme is synthesized by macrophages, neutrophils and other phagocytic cells and constantly enters the body fluids and tissues (blood, lymph, mucous membranes). Lysozyme destroys glycoproteins (muramyl dipeptide) of the bacterial cell wall, this leads to lysis and phagocytosis of damaged cells is activated. Specific protection is due to locally produced antibodies of the immunoglobulin class A (IgA). The formation of antibodies activates lysozyme.

About 60% of all IgA is contained in the secretions of the mucous membranes and exists in two forms - serum and secretory. Serum IgA has a high affinity, provides neutralization, opsonization and labeling of antigen, triggers antibody-dependent cell-mediated cytotoxicity. Serum IgA does not bind complement.

The secretory form of IgA is not detected in blood serum and is the main factor of local specific humoral immunity. Secretory IgA prevents the adhesion (adhesion) of microorganisms to epithelial cells, their multiplication and generalization (spread throughout the entire microorganism) of infection within the mucosa.

IRS 19 contains strains of causative agents of the most common diseases in otolaryngology and dentistry. The use of the drug increases the locally produced secreted antibodies of class A (IgA), stimulates the phagocytic activity of macrophages, increases the release of lysozyme, increases the level of opsonins, properdin and activates the induction of endogenous interferon. A protective film forms on the surface of the mucous membrane.

IRS 19 is used for the treatment and prevention of acute and chronic diseases of the upper respiratory tract and bronchi, such as rhinitis, sinusitis, laryngitis, pharyngitis, tonsillitis, tracheitis, bronchitis, etc .; to restore local immunity after suffering from influenza or other viral infections; in preparation for the planned surgical intervention on ENT organs and in the postoperative period.

For the treatment of acute and chronic diseases of the upper respiratory tract and bronchi used in adults and children over 3 years old - 1 dose of the drug in each nasal passage 2-5 times a day; children aged 3 months to 3 years (after preliminary release from mucous discharge) - 1 dose of the drug in each nasal passage 2 times a day. Treatment is carried out until the symptoms of infection disappear. For prophylaxis for adults and children from 3 months of age, 2-3 weeks before the expected rise in incidence - 1 dose of the drug in each nasal passage 2 times a day for 2 weeks.

The drug is used exclusively locally, injected intranasally, by aerosol administration of 1 dose (1 dose \u003d 1 short press of the spray bottle). When spraying, keep the bottle in an upright position and do not tilt your head back. When sprayed with IRS 19, a fine aerosol is formed, which covers the nasal mucosa, which leads to the rapid development of a local immune response.

The pharmacological effect occurs one hour after spraying the drug, the duration of action is 3-4 months. The use of the drug IRS 19 allows to reduce the incidence rate by up to five times, the occurrence of exacerbations and relapses of the disease, its chronicity, which leads to normal life, increases efficiency and significantly improves the quality of life of patients. A good preventive effect occurs when using the drug several times a year, depending on the frequency of the epidemic [Greek. epidemia - widespread disease / epi - on, among; demos - people].

Important! At the beginning of treatment, reactions such as sneezing and increased nasal discharge may occur. As a rule, they are short-term. If these reactions become severe, the frequency of administration of the drug should be reduced or canceled.

When applied, there may be allergic reactions: rarely - urticaria, angioedema, at the beginning of treatment - rhinopharyngitis, sinusitis, laryngitis, bronchitis, nausea, vomiting, abdominal pain, diarrhea, rarely - asthma attacks and cough, fever (\u003e 39 ° C) without apparent reasons... If clinical symptoms appear bacterial infection systemic antibiotics should be considered.

If intranasal spray has not been used long time, a blockage of the drug tip may occur. In this case, it is necessary to make several presses in a row so that the liquid can pass under the influence of excess pressure, and if there is no effect, the nozzle should be immersed in warm water for several minutes.

Imudon - an immunostimulating drug of bacterial origin, tablets for topical resorption in otorhinolaryngology, dentistry.

It is a polyvalent antigenic complex, which includes lysates of bacteria that most often cause inflammatory processes in the oral cavity and pharynx. Bacterial lysate mixture - Lactobacillus acidophilus, Lactobacillus delbrueckii ss lactis, Lactobacillus helveticus, Lactobacillus fermentum, Streptococcus pyogenes groupe A, Streptococcus sangius groupe H, Staphylococcus aureus, Enterococcus faecium, Enterococcus faecalis, Klebsiella pneumoniae ss pneumoniae, Fusobacterium nucleatum ss fusiforme, Corynebacterium pseudodiphtheriticum, Candida albicans+ excipients.

The drug activates phagocytosis, increases the number of immunocompetent cells, increases the production of lysozyme and interferon, immunoglobulin A in saliva.

It is used for the treatment and prevention of superficial and deep periodontal disease, periodontitis, stomatitis, aphthous stomatitis, glossitis, erythematous and ulcerative gingivitis, infection after tooth extraction, implantation of artificial dental roots, ulceration caused by dentures, as well as in inflammatory and infectious diseases of the oral cavity and pharynx, pharyngitis, tonsillitis, chronic tonsillitis, preoperative preparation and in the postoperative period after tonsillectomy, oral dysbiosis.

In case of acute inflammatory diseases of the oral cavity and pharynx, in case of exacerbation of chronic diseases - 8 tablets per day. The tablets dissolve (without chewing) in the oral cavity with an interval of 1-2 hours. The average duration of the course of treatment is 10 days. For the prevention of chronic inflammatory diseases oral cavity and pharynx - 6 tablets per day. The duration of the course is 20 days.

For children aged 3 to 14 years, in the treatment of acute and exacerbation of chronic inflammatory diseases of the oral cavity and pharynx, the drug is prescribed in a dose of 6 tablets per day. Children aged 3 to 6 years should be supervised to dissolve tablets. It is recommended to carry out preventive courses 3-4 times a year. You should not take food and water, as well as rinse your mouth within 1 hour after using Imudon, so as not to reduce the therapeutic efficacy of the drug.

Important! When applied, allergic reactions may occur: skin rash, urticaria, angioedema; dyspeptic disorders: nausea, vomiting, abdominal pain; rarely - exacerbation of bronchial asthma, cough, hemorrhagic vasculitis, fever.

Ismizhen- lyophilized bacterial lysate - Streptococcus viridans, Streptococcus pneumoniae, Streptococcus pyogenes, Staphylococcus aureus, Klebsiella ozaenae, Klebsiella pneumoniae, Neisseria catarrhalis, Haemophilus influenzae... The drug is available in the form of lozenges. The medicine is an immunostimulant that increases the body's resistance to specific and nonspecific infections, increasing the amount of secretory and serum antibodies. The drug stimulates the activity of humoral and cellular immunity; as well as the production of neutrophils, macrophages, T-lymphocytes, B-lymphocytes, specific serum IgM, IgG, IgA, adhesion of macrophages on bacteria. As a result, the risk of contracting respiratory infections is significantly reduced, and the course of the disease is facilitated. In patients taking Ismizhen, complications develop less often. When combined with chemotherapy, the need for antibiotics is reduced. Active substance well absorbed in the oral cavity. Prescribed for the treatment of influenza, rhinitis, pharyngitis, laryngitis, bronchitis and other respiratory diseases.

The tablet must be kept in the mouth until it is completely absorbed. You can not drink, rinse your mouth and throat within half an hour after taking the pill. For treatment and prevention, take 1 tablet once a day. The course dosage is set by the doctor, as a rule, until all symptoms disappear, but no more than 10 days.

Important! The drug is contraindicated for use in children under one year old.

Acute respiratory diseases (ARI) prevail in the structure of the general morbidity in children and account for 50-60%. The main cause of most acute respiratory infections is respiratory viruses and the influenza virus, however, antibiotics are prescribed for more than half of children due to fear of activation of the bacterial flora against the background of a viral disease. Viral infection is often complicated by the development of bacterial superinfection of exogenous or endogenous origin. The urgency of irrational use antibacterial drugs in acute respiratory viral infections (ARVI) is associated with the possibility side effects antibiotics, the spread of resistant strains of pneumotropic bacteria and, in addition, unnecessary treatment costs.

The bacterial etiology of acute respiratory infections in children, as in adults, is relatively rare, but it is this that poses the greatest threat to the development of serious complications. Bacterial acute respiratory infections are caused by a relatively small number of pathogens, mainly vegetating in the upper respiratory tract (Table 1). These are pneumococci hemolytic streptococcus group A, capsule-free Haemophilus influenzae ( H. influenzae) and etc. .

Children early age have a high susceptibility to pathogens of acute respiratory infections, which is due to the immaturity of the child's immune system, a small number of previous contacts with viruses, a low level of formation and activity of interferons, an imperfect nature of phagocytosis, insufficient barrier function of the skin and mucous membranes of the respiratory tract, a low level of secretory IgA. In this connection, the antiviral protection is weakened, the adhesion and penetration of the pathogen is facilitated. Despite the frequency respiratory infections in children, it is important that they proceed easily and are not accompanied by the development of complications.

Maturation of specific immune defense, T- and B-lymphocytes occurs in a child for a long time, up to puberty. The immunological protection received from the mother (Ig mainly of class G) is completely eliminated by 6-9 months of the child's life, while the synthesis of its own immunoglobulins G will reach the adult level only by 6-8 years, immunoglobulins A - by 10-12 years. Therefore, the risk of developing ARVI in children is increased by such factors as the unfavorable course of pregnancy, prematurity, intrauterine infection, artificial feeding and others. Carriage of opportunistic bacterial flora can also serve as a reservoir of infection.

Thus, transient changes in the child's immune system lead to frequent acute respiratory infections, but are not a sign of immunodeficiency, but are most often associated with a high level of contacts with sources of infection. In the conditions of the children's collective, group immunity to a number of pathogens is formed, as indicated by the high percentage of carriage in the absence of diseases.

In children with frequent recurrent diseases of the respiratory tract, signs of immune imbalance and insufficient reserve immunity are often revealed. The consequences of frequent respiratory diseases can be violations of the functional activity of the immune system and the formation of chronic inflammatory processes in the respiratory organs. Considering the above, the prevention of recurrent respiratory diseases in children who are often and for a long time ill is relevant. An individualized approach to vaccine prophylaxis, hardening is required, and it is possible to prescribe preventive courses of immunomodulatory drugs.

The most effective and targeted method of preventing respiratory infections is vaccination against the main pathogens, such as pneumococcus, Haemophilus influenzae, influenza virus. Unfortunately, however, there are many more respiratory pathogens than existing vaccines. In addition, respiratory pathogens are characterized by rapid variability, and specific immunity against them is short-lived. Therefore, drugs that affect the creation of specific immunity against a specific infectious agent? respiratory tract are of great importance.

In recent years, immunocorrectors of bacterial origin have been actively used for the treatment and prevention of respiratory diseases, primarily bacterial lysates, which cause the formation of a selective immune response against the most common bacterial pathogens, and also activate nonspecific mechanisms of innate immunity that help fight both bacteria and viruses. Bacterial lysates were developed in order to prevent infectious diseases of the upper and lower respiratory tract and are a mixture of antigens obtained from various inactivated bacteria, which is a pathogen-associated molecular agent that leads to a cascade of local immune responses and stimulates the immune response through recognition receptors. Bacterial lysates have a dual purpose: specific (vaccinating) and non-specific (immunostimulating).

There are various drugs of systemic (Broncho-munal, Broncho-Vaxom) and local (IRS 19, Imudon) action based on bacterial lysates.

The mechanisms of action and the effectiveness of systemic and topical immunotropic agents are different. Insufficient effect of local immunomodulators may be associated with a short contact time and insufficient uptake of the drug with mucous membranes due to constant flushing of the oropharyngeal segment with saliva.

Bacterial lysates have a number of specific properties at all stages of the immune response, due to which the effectiveness of their use is much higher. The mechanism of action is to stimulate the processes of phagocytosis and antigen presentation, increase the production of anti-inflammatory cytokines (IL-4, IL-10, TRF), and develop an adjuvant effect. In this case, this mechanism turns out to be the most physiological, since bacterial lysates stimulate the body's own reactions to antigen exposure and do not cause unnecessary additional effects. Along with the production of specific antibodies to the pathogens included in the preparations, they also stimulate nonspecific immunity - the production of secretory IgA, interleukin-1 and α-interferon, cytokines, NK cells, cells of the macrophage-phagocytic system, etc., increases.

Numerous clinical studies have shown that the use of immunotherapy with bacterial lysates leads to a decrease in the incidence of acute respiratory viral infections and their complications, and a decrease in the severity of their course.

In pediatric practice, bacterial lysate of systemic action OM-85 ( tradename Broncho-munal, Broncho-Vaxom), which has been proven to be effective and safe in numerous clinical studies with a high level of evidence. OM-85 contains lyophilized lysate of the most common causative agents of acute respiratory diseases: Streptococcus pneumoniae, Klebsiella pneumoniae, Staphylococcus aureus, Streptococcus pyogenes, Branchamella catarralis, Haemophilus influenzae, Klebsiella ozaenae, Streptococcus viridans and can be used in children from 6 months of age (pediatric forms of release with a dosage of bacterial lysate 3.5 mg).

When using lysates of systemic action (OM-85), the development of a specific immune response occurs with the cooperation of T- and B-lymphocytes, macrophages or dendritic cells, after the antigen-stimulated cells with surface immunoglobulin A enter the lymphoid organs. Subsequently, specific immunoglobulin A is again transported to the surface of the mucous membranes, preventing the invasion of infectious agents, their adsorption, phagocytosis, and the formation of immune complexes. At the same time, the activation of cytotoxic T-lymphocytes leads to the destruction of infected cells.

By modern ideas the pharyngeal and palatine tonsils are not only an independent anatomical unit, but also a part of the MALT-system (Mucosa-associated lymphoid tissue). The antigens of bacterial lysates, in contact with the macrophages of the MALT system of the tonsils, respiratory and gastrointestinal tracts, are subsequently presented by lymphocytes, as a result of which clones of B-lymphocytes appear, producing specific antibodies to pathogens, the antigens of which are contained in the preparation. The migration of B-lymphocytes to other lymphoid formations of the MALT system and their subsequent differentiation into plasma cells lead to the production of specific secretory IgA and the development of effective local immune defense against the main causative agents of acute respiratory diseases. These mechanisms contribute to a decrease in the frequency of carriage of pathogenic and opportunistic flora and the degree of contamination of the tonsils with it by more than 50% when using OM-85.

Immunological studies indicate that the obvious anti-infectious effect of the OM-85 bacterial lysate is, in addition to an increase in the level of specific antibodies, an increase in IgA levels both in the blood serum and in the secretions of the respiratory tract. IgA is fixed on mucous membranes, supports their barrier function, interacts with specific antigens bacteria. The drug improves the parameters of humoral and cellular immunity through Peyer's patches in the intestinal mucosa, stimulates peritoneal macrophages. When it is used in the blood serum, the number of T-lymphocytes, IgA, IgG, IgM increases.

The studies also demonstrated the effect of OM-85 on the activation of CD16 + cells, an increase in the functional activity of macrophages, the production of a number of cytokines and mediators (IL-6, IL-8, IL-2, γ-IFN). At the same time, there is an increase in the production of α-interferon, a decrease in the levels of IL-4, TNF-α, and an increase in the level of IgG enhances the intercellular interactions of macrophages, natural killers. These shifts can be interpreted as a switch of the Th2-type immune response to the Th1-type (Fig. 1).

By stimulating a specific and nonspecific immune response, the use of OM-85 in children with recurrent respiratory diseases helps to reduce the incidence of acute respiratory infections, and reduces the likelihood of bacterial complications. Several studies have shown a decrease in the number of exacerbations chronic pharyngitis and otitis media 2 times when using OM-85.

Also, in children with allergic diseases, when OM-85 is included in complex therapy, there is not only a decrease in the frequency of episodes of respiratory infections, but also manifestations of bronchial obstruction, which can be useful for the prevention of exacerbations in patients with bronchial asthma... OM-85, in addition, increases the functional activity of alveolar macrophages against infectious and tumor antigens, NK cells "natural, natural killers", reduces the production of IgE. In children with bronchial asthma and frequent intercurrent acute respiratory diseases, the use of OM-85 promotes clinical improvement in 68% of cases. The incidence of acute respiratory infections with symptoms of bronchial obstruction during the year is reduced by more than 2 times. The number of severe attacks choking and the child's annual need for bronchodilators. At the same time, there is an increase in the level of interferon gamma, a decrease in total immunoglobulin E and circulating immune complexes in the blood.

Activation of a nonspecific immune response when using bacterial lysates allows them to be successfully used in complex therapy acute respiratory infections. Studies have shown that the use of OM-85 reduces the percentage of intracranial complications from the paranasal sinuses and ear in young children.

Prescription of OM-85 for relapse prevention chronic bronchitis reduces the frequency and severity of relapses, reduces hospitalizations by 1.43 times, and its duration by 1.8 times. Children with chronic rhinosinusitis showed a decrease in the frequency of relapses and in the severity of symptoms. In children with frequent and long-term illnesses, when OM-85 is prescribed, the frequency of acute respiratory infections, pharyngitis, and bronchitis decreases 2-3 times.

Bacterial lysates can be prescribed in the acute period of the disease and for prophylactic purposes. In the acute period of respiratory infections, the administration of drugs is more effective in combination with etiotropic therapy. In pediatric practice, children's forms of OM-85 are used, which contains half the adult dose of bacterial lysate (0.0035 g).

For the prevention of infectious diseases of the respiratory tract, the drug is used in three 10-day courses with 20-day intervals between them. The effect of systemic immunomodulators (OM-85) lasts for 6 months, which is important for determining the interval between courses. In children with frequent recurrent diseases during the year, two three-month courses for 10 days every month are shown.

It is possible to use the drug for treatment: in the acute period of the disease, 1 capsule / day is prescribed until the symptoms of the disease disappear, but not less than 10 days. In the next 2 months, prophylactic use of the drug in 1 caps is possible. within 10 days with a 20-day interval between courses. In young children, the contents of the capsule are dissolved in a small amount of liquid (milk, tea, juice).

Thus, OM-85 affects various links of the immune response, stimulates cellular and humoral immunity, which in children with frequent recurrent diseases leads to a decrease in the frequency and severity of infections, the need for antibiotics. OM-85 is effective in the treatment and prevention of infectious diseases of both the upper and lower respiratory tract.

Literature

1. An integrated approach to the treatment and prevention of acute respiratory infections in children: A practical guide for doctors / Ed. prof. N.A.Geppe, prof. A. B. Malakhova. M., 2012.47 p.
2. Simon H. B.Bacterial infections of the upper respiratory tract // ACP Medicine. 2010.
3. Samsygina G.A. Frequently ill children: problems of pathogenesis, diagnosis and therapy // Pediatrics. 2005, No. 1, p. 66-74.
4. Petrov R.V.Vaccination against influenza: problems and successes // Treating Doctor. 2007. No. 9, p. 20-24.
5. Ivanova N.A.Systemic bacterial lysates: mechanism of action and indications for use // Consilium Medicum. Pediatrics. 2015; 02: 29-32.
6. Malkoch A.V., Anastasevich L.A., Botkina A.S. Acute respiratory diseases and the possibilities of immunomodulatory therapy // Attending Physician. 2008. No. 5. S. 16-23.
7. Malakhov A.B., Kolosova N.G., Khabibullina E.V.Bacterial lysates in programs for the prevention of respiratory infections in children // Practical Pulmonology. 2015, No. 4, p. 16-19.
8. Del-Rio-Navarro B. E., Espinosa Rosales F., Flenady V., Sienra Monge J. J. L. Immunostimulants for preventing respiratory tract infection in children // Cochrane Database Syst Rev. 2996; 4: CD004974.
9. SteurerStey C., Lagler L., Straub D. A., Steurer J., Bachmann L. M.Oral purified bacterial extracts in acute respiratory tract infections in childhood: a systematic quantitative review // Eur. J. Pediatr. 2007. Vol. 166, No. 4. P. 365-376.
10. Cisney E. D., Fernandez S., Hall S. I., Krietz G. A., Ulrich R. G. Examining the Role of Nasopharyngealassociated Lymphoreticular Tissue (NALT) in Mouse Responses to Vaccines // J. Vis. Exp. 2012. Vol. 66. P. 39-60.
11. Bogomilskiy M.R.The value of bacterial immunocorrection in the treatment of diseases of the ear, nose and throat in children // Difficult patient. 2007.10.S. 26-32.
12. Schaad U. B. OM85 BV, an immunostimulant in pediatric recurrent respiratory tract infections: a systematic review // World J. Pediatr. 2010. Vol. 6, No. 1. P. 5-12.
13. Rozy A., Chorostowska Wynimko J. Bacterial immunostimulants - mechanism of action and clinical application in respiratory diseases // Pneumonol. Alergol. Pol. 2008. Vol. 76, No. 5. P. 353-359.
14. Razi C. H., Harmanci K., Abaci A., Özdemir O., Hizli S., Renda R., Keskin F. The immunostimulant OM85 BV prevents wheezing attacks in preschool children // J. Allergy Clin. Immunol. 2010. Vol. 126, No. 4. P. 763-769.
15. Sprenkle M. D., Niewoehner D. E., MacDonald R., Rutks I., Wilt T. J. Clinical efficacy of OM85 BV in COPD and chronic bronchitis: a systematic review // COPD. 2005. Vol. 2, No. 1. P. 167-175.

N. G. Kolosova, Candidate of Medical Sciences

GBOU VPO First MGMU them. I.M.Sechenov, Ministry of Health of the Russian Federation, Moscow