Bacterial lysates drugs list. Bacteria lysates: how enemies turn into friends

The development of the pharmaceutical industry has led to the need to develop drugs that can retain their medicinal properties under various external conditions. For example, preparations based on biologically active components. How are beneficial microorganisms preserved in such preparations? Storage occurs due to the 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 "lyophilizate". What it is, in what preparations it is used, what effect it has - you can find out 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 way. The advantages of this method of preparation of components for medical preparations are:

• minimal physical and chemical processing of biological material is carried out, which allows to preserve the useful qualities of substances as much as possible;
• in the process of lyophilization, there is a minimal change in the structure and shape of the starting material;
• significantly increases the shelf life of the drug;
• storage conditions are expanding, for example at high temperatures or high humidity.

From the history of the lyophilization method

Invented relatively recently lyophilisate. What it is, medical experts learned for the first time in 1909. It was then that scientists first managed to dry it in this way. A little later, dry blood plasma was harvested by lyophilization. In 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 preparations, hormones, antibiotics and others.

Purpose of vacuum freeze drying

This method of preparation of components is most common in the pharmaceutical industry. How is the lyophilizate formed, what is it and where is this method used? With the help of this drying method, a variety of medical preparations are made. But, besides this, the method is used in the chemical and food industries. The manufactured lyophilizates retain useful properties, do not require strict storage conditions, have a longer shelf life and are as safe as possible for the consumer.

Lyophilization devices

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

The concept of bacterial lysates

For the manufacture of immunostimulating, antiviral drugs, a lyophilisate of bacterial lysates is used. Let's see what such complex medical terminology actually means. First you need to find out what bacterial lysates are. This is nothing but microscopic particles of bacteria formed under the action of mechanical, chemical or thermal influences. And, accordingly, they become lyophilizates in the process of special drying.

Application 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 causes a response of 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 that have been 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, respiratory viral diseases are prevented.

Forms of application of lyophilizates

Medical preparations - lyophilizates are produced in various 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.

Solution of lyophilizates for injections

Often used lyophilisate for injection. For intramuscular and medication, it is necessary to prepare a 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, a chemical reaction such as oxidation can occur), but also harm the patient's health. Each drug has its own characteristics of cultivation and use.

For example, injections are carried out with drugs such as Longidaza, Chondrolon. How to dilute the lyophilisate intended for injection? Consider the method using the example of the antifungal drug Vfend. 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 the drug concentrate is diluted with a solution of sodium chloride or glucose.

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 old 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 an intramuscular solution, 6 mg of the lyophilizate is dissolved in 2 ml of sodium chloride. And for intravenous injection, 3 ml of solvent will be needed, after which the concentrate is diluted in 200 ml of gemodez or dextrose solution.

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

The drug "Bifidumbacterin lyophilisate": instructions for use

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

It is used for example after prolonged use of antibiotics or in childhood dysbacteriosis. It is prescribed for diseases such as:

• intestinal infections;
• stomach and duodenal ulcer;
• pancreatitis;
• poisoning and other disorders of the digestive system.

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

Vaginally used in violation of the microflora of the vagina, rectally in the postoperative period.

The drug is prescribed even for newborns, it can also be used by nursing mothers. During pregnancy, before using the drug, you should consult your doctor.

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 can not dilute Bifidumbacterin in a hot liquid, take it in parallel with antibacterial drugs, and also store the diluted powder.

Lyophilisate "Interferon"

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

The drug is used nasally, i.e. 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 vial and add distilled warm water to it up 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 an inhalation procedure is carried out using special devices.

In no case should you administer intravenously or intramuscularly, as well as lyophilisate! The instruction to the drug mentions only the nasal method of use.

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

What beautiful summer days! Water and air, permeated with sunlight, simply breathe health. But along with autumn rains and cold, the season of colds comes into our lives. People “arm themselves” with handkerchiefs, coughing or sneezing in unison. Are there really no pills that can protect a person from a cold? Experts say that bacterial preparations will help resist respiratory infections. What are bacterial lysates and how to use them correctly?

Bacteria are the oldest living organisms. Microbiologists have already described about ten thousand species of these invisible creatures. But, according to scientists, there are more than a million of them on Earth.

Bacterial microorganisms can be both friends and enemies of a person. Many of them, getting inside the human body, become a source of severe diseases. In particular, bacterial infections of the respiratory tract. Children aged 1 to 5 years are targeted. According to medical statistics, child mortality from acute respiratory diseases is in third place in the countries of the European Union.

The main task of all doctors and pharmacists in the world has become the creation of tablets that not only make the condition of a sick person as easy as possible, but also help to directly prevent infection.

A real revolutionary breakthrough in the fight against respiratory diseases was the creation of bacterial Lysates. Preparations are made on the basis of strains of pathogenic bacteria. Under normal conditions, these microorganisms cause diseases:

• respiratory tract;
• oral cavity;
• urinary system.

Thanks to the lysis technology, dangerous bacteria are inactivated. They are no longer the source of the disease, but they retain their entire constitution. Getting into the composition of the drug on the mucous membranes, Lysates bring the human immune system into "full combat readiness". When attacked by viable microbes Enterococcus faecalis, the body will be ready to give them a worthy rebuff.

Know the heroes by sight

It is worth getting acquainted with our little defenders, if they provide such an invaluable service to humanity in the fight against serious ailments. In the production of Lysates involved:

• Enterococcus faecium;
• Enterococcus faecalis;
• Escherichia coli.

These microorganisms play a dual role in human life. On the one hand, Enterococcus faecium, Enterococcus faecalis can cause severe diseases. They have become resistant to antibiotics, so it can be difficult to deal with them.

On the other hand, they are an integral element of medicines with probiotics. For example, a non-pathogenic strain of Enterococcus faecium is used in the production of Hilak Forte and Linex preparations.

Release forms

The pharmaceutical industry produces Lysates in the form of:

• capsules;
• lozenges;
• ampoules for injection;
• creams, ointments;
• rectal suppositories.

For respiratory infections, doctors most often prescribe to their patients "Bacteria lysates mixture", nasal spray and lozenges. Lysates cover the mucous membrane of the throat with a thin protective layer that serves as a barrier to pathogenic bacteria. In addition, the content of immunocompetent cells, which create the effect of vaccination, sharply increases at the site of the drug.

The resorption of tablets activates the body's defenses almost instantly. A layer of lyophilized bacteria prevents evil microbes from gaining a foothold on the mucous membrane. This means that they do not get the opportunity to actively live and multiply, poisoning a person with the products of their vital activity.

In the instructions for preparations, manufacturers focus consumers' attention on the local action of Lysates. Indeed, lozenges have a therapeutic effect directly at the site of infection. At the same time, their use minimizes side effects.

But if we are talking about undesirable consequences, we should list the symptoms that are rare, but are found in medical practice:

• stool disorder;
• nausea;
• stomachache;
• allergic rashes;
• temperature increase.

In case of pronounced symptoms, you should stop taking the tablets and be sure to contact your doctor, who will select a drug analogue that is more suitable for the patient.

In the instructions, manufacturers focus on the fact that it is possible to use tablets in combination with antibiotics, that in this case, bacterial lysates do not leave the disease a chance for progression and significantly speed up recovery.

Target point - urinary system

Unfortunately, patients with complaints of bladder and ureter infections quite often go to the doctor. According to statistics, 25% of the female population of the planet is familiar with diseases such as cystitis and urethritis. The culprits of suffering are the bacteria Escherichia coli and Enterococcus faecalis.

It is dangerous to ignore even minor symptoms of the disease. Lack of proper treatment provokes serious disorders in the urinary system. The infection can spread to the kidneys, and then treatment can be delayed for a long time.

Lizaty will help get rid of an unpleasant disease and return to a normal lifestyle. Pharmacists have figured out how the causative agent of Escherichia coli infection itself can defeat the disease. With the help of lysis technology, a lyophilized lysate of Escherichia coli bacteria is obtained for the treatment and prevention of cystitis.

The drug is produced mainly in the form of capsules. But for patients who, for objective reasons, cannot take them, the attending physician can choose an analogue in the form of tablets, injections, suppositories or drops.

Before using the medicine, be sure to read the instructions. Taking capsules is rarely accompanied by disturbances in the functioning of the body. But you should consult a doctor for a consultation with negative symptoms:

• headache;
• eczema;
• chills.

It is worth remembering that taking Lysate of Escherichia coli bacteria favors a speedy recovery. But without the help and assistance of the patient himself, invisible helpers will not be able to cope with the insidious disease. Patients must observe personal hygiene, drinking regimen, adhere to the doctor's recommendations.

Connoisseurs of female beauty

Bacteria became crowded in the world of drugs, and they decided to master a new area - the cosmetic industry. A probiotic cream with bacterial lysates for the eyelids has appeared on sale.

The cream contains only natural ingredients:

• Lysate of the bacterium Micrococcus Luteus;
• bifido- and lactobacilli;
• vitamins;
• amino acids;
• cosmetic oils.

Women who have tested the products on themselves speak enthusiastically about the effect of the cosmetic product. It can be assumed that probiotic creams will take their rightful place on the dressing table of the beautiful half of humanity.

What attracted fragile ladies to the use of cosmetics based on Lysates?

1. The skin becomes smooth and soft to the touch.
2. Dark circles under the eyes disappear.
3. Decreased swelling of the lower eyelid.
4. The cream is quickly absorbed.
5. Yoghurt delicate aroma of cosmetics.

Store cosmetics containing Bacteria Lysates preferably in the refrigerator. Then the cream will take care of the beauty of the skin of its mistress around the clock.

Bacterial lysates (BL) for the treatment and prevention of respiratory tract infections are a set of inactive bacteria that cannot harm themselves, but cause an immune response. If we simplify with a more understandable example, then in principle it is similar to vaccination in order to stimulate the body's natural protective functions at the cellular level.

Most often, a mixture of antigens (pathogens) from lysates of various bacteria is used immediately: staphylococci, streptococci, Klebsiella and other species that provoke tonsillitis, sinusitis and other ENT diseases. These mixtures are called lyophilized, because they are made using a special method of drying at low temperature or using chemical reactions. This method of drying allows you to save the protein part of the bacteria, so that the cells of the immune system determine their foreignness and activate their defense mechanisms.

Pros of BL and arguments of supporters

The use of bacterial lysates dates back to the late nineteenth century and is now widely used in many countries. Over the past few decades, BL has been used in both adults and children, mainly for the prevention and treatment of bacterial infections of the respiratory tract. Modern lyophilized bacterial lysate is both specific and non-specific immunostimulating agent. It can be prescribed for the prevention and treatment of ENT diseases, including the effects of colds and flu. The main advantages include:

• a small number of side effects (except for allergic reactions);
• good results in the complex therapy of recurrent respiratory infections (acute and chronic bronchitis, tonsillitis, tonsillitis, pharyngitis, laryngitis, rhinitis, sinusitis and otitis media);
• effectiveness in treating or at least reducing the number of relapses (exacerbations) of chronic infections compared with antibiotics, which are advisable to use only in the acute period of the disease.

Equally important is the convenience of outpatient reception. Lysates of bacteria for resorption are used according to two schemes:

1. In acute conditions, one tablet per day under the tongue (minimum ten days) until symptoms disappear.
2. Prevention of exacerbations - one tablet per day to dissolve under the tongue for 10 consecutive days followed by a 20-day break. The cycle is repeated for three consecutive months.

Proponents cite data from analyzes of medical publications in pediatric and adult studies, where the use of bacterial lysate preparations helped to reduce hospitalization time and the number of episodes of exacerbations, time of disability. The mixture of bacterial lysates appears to be able to recruit specific immunocompetent cells through activation of the pathogen recognition receptor to increase the production of certain cytokines and immunoglobulins.

Cons and arguments of skeptics

The main complaint of skeptics is the unsatisfactory quality of the available research. The analysis of almost 170 PubMED articles, including data on positive results of treatment with baclisates, does not sufficiently meet the criteria of evidence.

Otolaryngologists point out the potential risks for the consumer in case of refusal of antibiotic treatment in favor of BL. In acute tonsillitis and sinusitis, the use of antibiotics is necessary to prevent serious complications. There is a substitution of concepts when the effectiveness of bacterial lysates is declared in the acute period because they should be used only in addition (at the same time), but not in place of. Keep in mind that lysates of bacteria for the throat are differently effective against different pathogens. For example, immunity modulation with BL helped well against Haemophilus influenzae, but not enough against beta-hemolytic streptococcus.

With regard to immunostimulation with the help of BL for chronic infections during remission, it is important to carry out an individual approach:

• take into account the person's tendency to allergic reactions;
• check for a history of autoimmune diseases or a hereditary predisposition to them.

Many aspects of BL (including the mechanism of action) are still poorly understood, which proponents acknowledge. Therefore, large clinical trials are required before BL can be confidently introduced into the public health arena.

What preparations of bacterial lysates are available in our pharmacies?

The table shows 6 preparations containing a mixture of bacterial lysates and which are in the greatest demand. Let's compare them with the following criteria: the range of lyophilized strains, the form of release and methods of application, the age from which use is possible.

comparison table

Name	Number of bacterial species	The form	From what age
Broncho-Munal and Broncho-Munal P (Slovenia)	8 (mixture OM-85)	Capsules (by mouth)	from 12 years old, normal, from 6 months. - "P" (children's)
Broncho-Wachsom (Switzerland)
Ismigen (Russia)	8 (including 6 subtypes of Streptococcus pneumoniae)	Tablets (by mouth)	From 3 years old
Imudon (Russia)	12	Lozenges	From 3 years old
IRS-19 (Russia)	13 (including 6 subtypes of Streptococcus pneumoniae)	Spray (in the nose)	From 3 months
Ribomunil (France)	5	Granules or tablets (by mouth)	From 6 months
Uro-Wachsom (Switzerland) [added]	1 (18 strains of E. coli)	Capsules (by mouth)	From 3 years (you can open the capsule and pour the contents into a drink)

In addition to Ribomunil and IRS-19, all the others have the same and standard regimen for such drugs: from 10 days until the symptoms disappear, and with a preventive goal for 10 days for three months (an interval of 20 days). The differences between Broncho-Munal and Broncho-Vaksom are analyzed in detail.

Conclusion

Preparations based on bacterial lysates can take an intermediate link between other immunomodulators and antibiotics in the treatment of chronic recurrent infections. The results of existing studies on the effectiveness of BL are encouraging, but they may contain a conflict of interest or be ordered by manufacturers. Randomized trials should be carried out, with a large number of patients selected according to the disease and its severity. The presence of more convincing evidence of the beneficial effects of lysates will allow them to gain a foothold in the niche of useful and safe treatments and prevention.

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

Under unfavorable conditions, the "entrance gates" of the macroorganism begin to let in various pathogens. Pathogenic microorganisms enter the body and encounter various physical and mechanical obstacles. The macroorganism, in response to the penetration of microorganisms and their pathogenic effect, mobilizes all its initially non-specific, and then specific defense factors.

Due to the growing resistance of microflora, 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 local use 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 the destruction of microorganisms and toxic products of their vital activity, but also at the restoration and activation of 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 produce predominantly cytokines and perform important immunoregulatory functions, as well as natural killers and mononuclear phagocytes, which destroy most of the pathogenic agents that have entered the body.

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

• in otolaryngology and dentistry - IRS19, Imudon, Ismizhen;
• in pulmonology - Broncho-munal, Broncho-vaxom, Ribomunil;
• in urology - Urovaxom;
• in gynecology - Floragin;
• in proctology - Pasteurisan, Pasteurisan forte;
• in dermatology - Actinolysate.

BACTERIAL LYSATES FOR INFECTIONS IN OTORHINOLARYNGOLOGY 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 Staphylococcus aureus ss aureus , 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 body fluids and tissues (blood, lymph, mucous membranes). Lysozyme destroys glycoproteins (muramyl dipeptide) of the bacterial cell wall, which leads to lysis and phagocytosis of damaged cells is activated. Specific protection is due to locally formed antibodies of the immunoglobulin type A (IgA) class. The formation of antibodies activates lysozyme.

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

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

IRS 19 contains strains of causative agents of the most frequently occurring diseases in otolaryngology and dentistry. The use of the drug increases locally formed secreted class A antibodies (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 the flu or other viral infections; in preparation for a planned surgical intervention on the ENT organs and in the postoperative period.

For the treatment of acute and chronic diseases of the upper respiratory tract and bronchi, adults and children over 3 years old are used - 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 the 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 prevention in 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, administered intranasally, by aerosol administration of 1 dose (1 dose = 1 short press of the sprayer). When spraying, keep the bottle upright and do not throw your head back. When spraying IRS 19, a fine aerosol is formed that covers the nasal mucosa, which leads to the rapid development of a local immune response.

The pharmacological effect occurs an hour after spraying the drug, the duration of action is 3-4 months. The use of the drug IRS 19 can reduce the incidence rate 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 the drug is used several times a year, depending on the frequency of the epidemic [gr. epidemic- generalized 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 of short duration. If these reactions take a severe course, the frequency of administration of the drug should be reduced or it should be canceled.

When applied, allergic reactions may occur: rarely - urticaria, angioedema, at the beginning of treatment - rhinopharyngitis, sinusitis, laryngitis, bronchitis, nausea, vomiting, abdominal pain, diarrhea, rarely - asthma attacks and cough, fever (> 39 ° C) for no apparent reason. In case of clinical symptoms of a bacterial infection, the advisability of prescribing systemic antibiotics should be considered.

If the intranasal spray has not been used for a long time, blockage of the drug nozzle may occur. In this case, it is necessary to make several clicks 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 lowered into warm water for several minutes.

Imudon- an immunostimulating drug of bacterial origin, lozenges for local use in otorhinolaryngology, dentistry.

It is a polyvalent antigenic complex, which includes lysates of bacteria that most often cause inflammation in the oral cavity and pharynx. A mixture of bacterial lysates - 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 inflammatory and infectious diseases of the oral cavity and pharynx, pharyngitis, tonsillitis, chronic tonsillitis, preoperative preparation and postoperative period after tonsillectomy, oral dysbacteriosis.

In acute inflammatory diseases of the oral cavity and pharynx, in case of exacerbation of chronic diseases - 8 tablets per day. 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 of the 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 at a dose of 6 tablets per day. Children aged 3 to 6 years should dissolve tablets under adult supervision. It is recommended to conduct preventive courses 3-4 times a year. You should not eat and drink, as well as rinse your mouth for 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 produced in the form of tablets for resorption. The drug is an immunostimulant that increases the body's resistance to specific and nonspecific infections by 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 to bacteria. As a result, the risk of getting respiratory infections is significantly reduced, the course of the disease is facilitated. Patients taking Ismigen are less likely to develop complications. When combined with chemotherapy, the need for antibiotics is reduced. The active substance is well absorbed in the oral cavity. Assign for the treatment of influenza, rhinitis, pharyngitis, laryngitis, bronchitis and other respiratory diseases.

The tablet must be kept in the oral cavity until completely resorbed. It is impossible to drink, rinse your mouth and throat for 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 not more than 10 days.

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

■ Clinical pharmacology and pharmaceutical news

Bacterial lysates in programs for the prevention of respiratory infections in children

A.B. Malakhov, N.G. Kolosova, E.V. Khabibullina

The use of bacterial lysates has become widespread in many countries around the world. The clinical effect of these drugs is aimed at reducing the frequency, duration and severity of infectious respiratory diseases. The article presents data on the mechanisms of action and clinical efficacy of bacterial lysates in children with respiratory infections, as well as summarizes information about a new drug of this class - Ismigen.

Key words: bacterial lysates, respiratory infections, prevention, Ismigen.

The child's immune system begins to form even before birth, and the processes of maturation and development of the body's immune functions continue until the end of puberty. To understand the functional capabilities of the immunity of a growing organism, it is important to know the physiology of its formation: it is characterized by the presence of critical periods of development that must be taken into account when assessing the state of health, developing preventive programs and prescribing treatment.

Stages of development of the immune system

By 6-9 months of a child's life, immunoglobulins (mainly class O) received from the mother are completely eliminated. The synthesis of one's own reaches the level of an adult only by 6-8 years. The level of IgA, which provides local protection of the mucous membranes, is low in newborns and young children and reaches the level of an adult only by the age of 10-12, which causes a higher susceptibility of the child to respiratory infections. When all these factors are taken into account, it becomes clear why the unfavorable

Department of Pediatric Diseases, Faculty of Medicine, SBEE HPE "First Moscow State Medical University named after I.M. Sechenov" of the Ministry of Health of the Russian Federation. Alexander Borisovich Malakhov - professor. Natalya Georgievna Kolosova - Ph.D. honey. sciences, associate professor. Ekaterina Andreevna Khabibullina - post-graduate student.

The slow course of pregnancy, prematurity, intrauterine infection, artificial feeding and other factors significantly increase the risk of developing acute respiratory viral infections (ARVI).

Acute respiratory diseases are the most common childhood pathology. The frequency of respiratory infections in children in different age periods ranges from 2-3 to 10-12 per year. Carriage of opportunistic bacterial flora of the respiratory tract serves as a reservoir of infection, especially in the inter-epidemic period.

The incidence increases sharply with the beginning of visits to preschool institutions. So, in the 1st year of the visit, half of the children suffer from 6 SARS or more, and their frequency decreases only in the 2nd-3rd years of the visit. With age, antibodies to a greater number of infectious agents appear, which is accompanied by a decrease in the incidence. In the conditions of the children's team, group immunity to a number of pathogens is formed, as indicated by a high percentage of carriers in the absence of diseases.

However, about 10% of children still have a high incidence of acute respiratory viral infections, which leads to large economic losses. In cases of frequent respiratory morbidity in a child, the development of severe complications in him, signs of immune imbalance are often revealed, which requires immunocorrection.

Application of bacterial lysates

In the arsenal of immunoprophylaxis there are vaccines against a number of pathogens of acute respiratory diseases (HIB (Haemophilus influenzae type b - vaccine against Haemophilus influenzae type B), pneumococcal, pertussis, diphtheria, influenza vaccines), but there are no specific vaccines against the main pathogens of SARS yet.

All this led to the creation of a large number of drugs to reduce respiratory morbidity, which include drugs from the group of bacterial lysates. The effectiveness of bacterial lysates, demonstrated in Europe in the 1980-1990s and somewhat later in Russia, underlies their recommendation as a safe means of non-specific prevention of acute respiratory viral infections in children.

The prescription of immunomodulators of bacterial origin has become widespread in many countries: to date, approximately 150 million patients worldwide have been treated with these drugs since their commercialization.

Bacterial lysates are assigned to the group of immunotropic drugs and in the modern classification they constitute a separate subgroup - immunomodulators of microbial origin (table). Currently, there are three types of drugs:

Purified bacterial lysates;

Immunostimulating membrane fractions;

Bacterial ribosomes stimulated by proteoglycans, i.e. membrane fractions.

Bacterial lysates, in turn, are divided into:

Systemic (Broncho-Vaxom, Broncho-munal, Ribomunil);

Local (Imudon, IRS-19);

Systemic and local (Ismigen - double action).

Mechanism of action

Although lysates are close to vaccines, their mechanism of action on the immune system is different. These drugs are complex PAMP-containing (PAMP - pathogen-associated molecular patterns) drugs that affect the innate immune system mainly through signal pattern-recognizing receptors. At the same time, the effectiveness of the use of this group of drugs is associated not only with the activation of innate immunity effectors, but also with the initiation of the adaptive immunity system.

Bacterial lysates stimulate the body's specific and non-specific defenses by stimulating the T-helper type 1 (Th1) immune response, which is more mature than the T2-type response with which children are born. Under the influence of microbial stimulation, the child develops a Thl-type response, the lack of which at present may be associated with the relative rarity of bacterial infections and the unreasonably widespread use of antibiotics that suppress the commensal flora, as well as the irrational use of antipyretic drugs for any increase in body temperature, which suppress production

Types of immunocorrectors of microbial origin

Drug Composition

Ismigen, Stada, Italy Lysates of bacteria Staphylococcus aureus, Streptococcus pyogenes, Streptococcus viridans, Streptococcus pneumoniae (types TY1/EQ11, TY2/EQ22, TY3/EQ14, TY5/EQ15, TY8/EQ23, TY47/EQ24), Klebsiella pneumoniae, Klebsiella ozaenae , Haemophilus influenzae type b, Neisseria catarrhalis

Immunovac-VP-4, Federal State Unitary Enterprise NPO Microgen, Russia Cell-free multicomponent vaccine - antigens and associated lipopolysaccharides of S. aureus, K. pneumoniae, Proteus vulgaris, E. coli, as well as teichoic acid

Broncho-Waxom, OM Pharma SA, Switzerland Lyophilized lysate of 8 bacteria: S.pneumoniae, H. influenzae, K.pneumoniae, K. ozaenae, S. aureus, S. viridans, S. pyogenes, M. catarrhalis

Broncho-munal, Lek d.d., Slovenia Lyophilized lysate of 8 bacteria: S.pneumoniae, H. influenzae, K.pneumoniae, K. ozaenae, S. aureus, S. viridans, S. pyogenes, M. catarrhalis

Imudon, Solvay Pharma, France Mixture of lysates of 13 bacteria: Streptococcus pyogenes group A, Enterococcus faecalis, Enterococcus faecium, Streptococcus sanguis, Staphylococcus aureus, K.pneumoniae, Corynebacterium pseudodiphtheriticum, Fusobacterium nucleatum, Lactobacillus acidophilus, L. fermentum, L. helveticus, L Delbrueckii ss lactis, Candida albicans

IRS-19, Solvay Pharma, France Lysates of 18 bacteria: S.pneumoniae (6 serotypes), S.pyogenes (groups A and C), H. influenzae, K.pneumoniae, N.perflava, N.flava, M. catarrhalis, Staphylococcus aureus, Enterococcus faecium, Enterococcus faecalis, Group G Streptococcus, Acinetobacter calcoaceticus

Ribomunil, Pierre Fabre Medication Production, France Ribosomal fractions K.pneumoniae (35 shares), S.pneumoniae (30 shares), S.pyogenes (30 shares), H. influenzae (5 shares) + Klebsiella membranous proteoglycans

cytokines that cause a Thl-type response (y-interferon (y-IFN), interleukin-1 (IL-1), IL-2, tumor necrosis factor a (TNF-a)). Suppression of the Thl-type response prevents the development of a more stable response to infection and the formation of immunological memory.

Bacterial lysates stimulate the production of Thl-type cytokines, increase the production of IgA, slgA (secretory IgA), lysozyme in the mucous membranes of the respiratory tract, stimulate the activity of natural killers, normalizing the level of CD4+ cells when it decreases, and also suppress the production of IgE and antibodies of this class. It is this action of lysates that is currently considered as the main one that contributes to the formation of a mature immune response and a decrease in respiratory morbidity. In addition to stimulating the formation of specific antibodies to the microorganisms included in their composition, bacterial lysates activate the humoral activity characteristic of a Thl-type response.

Clinical effect

All drugs in this group can be used to prevent recurrent acute respiratory viral infections and related respiratory diseases (rhinitis, sinusitis, pharyngitis, tonsillitis, laryngitis, acute and recurrent bronchitis), including in children with recurrent diseases and with allergic pathology. You can start using drugs both in a healthy child and with the next respiratory disease, continuing the course after recovery.

The clinical effect of bacterial immunomodulators is aimed at reducing the frequency and severity of exacerbations of respiratory infections. Specific and nonspecific mechanisms of action of bacterial immunomodulators determine their effect not only against bacteria, the lysates of which are part of the preparations, but also against other pathogens of respiratory infections, which can be traced by the frequency of acute respiratory viral infections in the group of frequently ill children.

Ismigen: features of action

In the manufacture of bacterial lysates, after in vitro cultivation of bacterial strains, antigens are isolated by either mechanical or chemical lysis, followed by lyophilization and mixing in certain proportions. Mechanical lysis is carried out by increasing pressure on the wall of an inactivated bacterium, which preserves coarse antigens, while chemical lysis is carried out using a chemical alkali to act on inactivated bacteria.

bacteria that can denature proteins and therefore antigens. The drug obtained by mechanical lysis has a stronger immunogenicity.

Ismigen is the first official mechanical bacterial lysate, the drug is recommended for use in the treatment of infections of the upper and lower respiratory tract and the prevention of relapses. 1 tablet (50 mg) contains lyophilized bacterial lysates, including bacterial lysates of Staphylococcus aureus, Streptococcus pyogenes, Streptococcus viridans, Streptococcus pneumoniae (types TY1/EQ11, TY2/EQ22, TY3/EQ14, TY5/EQ15, TY8/EQ23, TY47 /EQ24), Klebsiella pneumoniae, Klebsiella ozaenae, Haemophilus influenzae type b, Neisseria catarrhalis - 7.0 mg; excipient: glycine - 43 mg.

Ismigen contains the six most pathogenic types of pneumococci. The natural reservoir of S. pneumoniae is the human nasopharynx, the pathogen is transmitted by airborne droplets. A high frequency of pneumococcal infections is observed in children and the elderly, who are at risk for developing immunodeficiency. Most strains of H. influenzae are opportunistic pathogens. In neonates and young children, H. influenzae type b (Hib infection) causes bacteremia, pneumonia, and acute bacterial meningitis. In some cases, inflammation of the subcutaneous tissue, osteomyelitis, and infectious arthritis develop. Moraxella catarrhalis, or Neisseria catarrhalis, is a Gram-negative bacterium that causes infections of the respiratory tract, middle ear, eyes, central nervous system, and joints. M. catarrhalis is an opportunistic pathogen that poses a threat to humans and persists in the respiratory tract. M. catarrhalis in 15-20% of cases causes acute otitis media in children.

Ismigen activates phagocytosis, increases the level of lysozyme in saliva, the number of immunocompetent cells, the functional activity of macrophages (including alveolar), polymorphonuclear leukocytes. The drug activates lipid peroxidation, increases the expression of adhesion molecules on monocytes and granulocytes (LEA-1, MAC-1, p150, ICAT-1), activates CD4+-, CD8+-cells, increases the expression of receptors for IL-2, enhances T- lymphocytes and antigen-presenting cells and the destruction of infectious agents. Ismigen increases the synthesis of prostaglandin E2 by cells of the macrophage-phagocytic star

on, activates natural killers, synthesis of anti-inflammatory cytokines IL-1, IL-2, IL-6, IL-8, y-IFN, TNF-a; reduces the synthesis of IL-4, IL-12; increases the level of sIgA in saliva, serum IgA, IgG, IgM; reduces the level of serum IgE.

Studies have demonstrated the high efficiency of Ismigen in the treatment and prevention of acute and chronic diseases of the upper and lower respiratory tract.

In an open comparative randomized controlled trial, which included 114 patients, the effectiveness of Ismigen in the treatment of upper respiratory tract infections was studied by assessing the duration and severity of the disease. During the 3-month course of treatment and follow-up in patients taking Ismigen, there was a decrease in the duration of upper respiratory tract infections (the difference is statistically significant) compared with the control group and the group receiving chemical lysate, as well as a decrease in the number of absences from work during treatment by 93% and during follow-up by 87%. Ismigen was 10 times more effective than the chemical lysate.

When using Ismigen in 120 children (age 4-9 years) with recurrent nasopharyngitis, and/or otitis media, and/or recurrent pharyngotonsillitis, a statistically significant decrease in the number of episodes of infections was observed over 3 months of treatment (Fig. 1, 2). In children receiving Ismigen, the need for antibiotics was significantly reduced (3 times compared with the control group and 2 times compared with the chemical lysate), antipyretic and anti-inflammatory drugs. There was a decrease in the severity and duration of episodes of infections (by 2 times compared with the control group and 1.7 times compared with chemical lysates), a decrease in the number of school absences. All children were observed and treated in the same period, which made it possible to exclude the seasonality factor.

When Ismigen was prescribed to patients with diseases of the lower respiratory tract, a decrease in the frequency of their exacerbations was noted. The efficiency of Ismigen compared to the chemical lysate was 2 times higher. The need for antibiotics in the group receiving Ismigen was 2.5 times lower.

Ismigen is allowed in adults and children from 3 years of age. In acute and subacute infections of the upper and lower respiratory tract, the drug is prescribed 1 tablet per day until the symptoms disappear.

4 oh b! m D EN O O No. d h az

Chemical lysate

The control

Rice. 1. Results of a study on the treatment and prevention of recurrent bacterial infections of the upper respiratory tract in children (rhinitis, pharyngitis, otitis media, tonsillitis, laryngitis). Here and in fig. 2: n = 120 (4-9 years) (3 groups of 40 patients); observation period of 6 months (3 months of therapy + 3 months after treatment); R< 0,016. (По Ьа МапШ. I. е! а1., 2007.)

Ismigen Chemical Control

(1 tablet 1 time per day, 10 days per month x3 months)

(1 capsule 1 time per day, 10 days per month x3 months)

Rice. 2. Average number of episodes of acute respiratory infections (ARI) with the use of antibiotics. (According to La Manja I. e! a1., 2007.)

disease (at least 10 days) under the tongue on an empty stomach. The tablet should be kept under the tongue until completely dissolved. As a prevention of recurrent infections of the upper and lower respiratory

paths, exacerbations of chronic respiratory diseases are prescribed 1 tablet per day for 10 days. The prophylactic course includes 3 cycles of 10 days with 20-day intervals between them. A preventive course should be carried out no more than 1-2 times a year.

Thus, the use of bacterial lysates, in particular Ismigen, for the treatment and prevention of acute and chronic respiratory diseases helps to reduce the frequency of respiratory infections, reduce the duration of diseases, reduce the need for antibiotics, due to their effect on systemic and local immunity, as well as high immunogenicity. and low incidence of side effects. Ismi gene is an important component of a comprehensive scheme for the treatment and prevention of respiratory infections, especially in frequently ill children.

Akhmatova N.K. Molecular and cellular mechanisms

action of immunomodulators of microbial origin

on the functional activity of effectors of innate immunity: Dis. ... doc. honey. Sciences. M., 2006. Lebedinskaya E.A. and others // Fundam. research 2010. No. 12. S. 5152.

Markova T.P. // Rus. honey. magazine 2009. No. 3. S. 2427.

Revyakina V.A. // Lech. doctor. 2015. No. 4. P. 24.

Boris V.M. et al. // Giorn. It. Mal. Tor. 2003. V. 57. P. 210.

Bouvet J.P. et al. // Trends Immunol. 2002. V. 23. P. 209.

Cazzola M.A. // Trends Med. 2006. V. 6. P. 199.

Cogo R. et al. // Acta Biomed. 2003. V. 74. P. 81.

Dagan R. et al. // J. Antimicrob. Chemother. 2001. V. 47.

Falchetti R. // American College of Chest Physicians: Italian chapter. National meeting. Naples, Italy, June 20-22, 2002.

La Mantia I. et al. // GIMMOC. 2007.V.XI. No. 3. P. 1. Macchi A., Vecchia L.D. // Arzneimittelforschung. 2005. V. 55. P. 276.

Maul J. // Respiration. 1994. V. 61. P. 15. Melioli G. // Gior. It. Mal. Tor. 2002. V. 56. P. 245. Rossi S., Tazza R. // Arzneim. Forsch. drug. 2004. V. 54. P. 55.

Ruedl C.H. et al. // clinic. Diagn. Lab. Immunol. 1994. V. 1. R. 150.

Tricarico D. et al. // Arzneim. Forsch. drug. 2004. V. 54. P. 52.