Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
  • A61K35/66—Microorganisms or materials therefrom
  • A61K35/74—Bacteria
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K39/00—Medicinal preparations containing antigens or antibodies
  • A61K39/02—Bacterial antigens
  • A61K39/085—Staphylococcus
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K39/00—Medicinal preparations containing antigens or antibodies
  • A61K39/02—Bacterial antigens
  • A61K39/116—Polyvalent bacterial antigens
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
  • A61P31/04—Antibacterial agents

Definitions

• the group of inventions relates to medical microbiology, the pharmaceutical industry, in particular to vaccines, in particular, to vaccines for the treatment and prevention of staphylococcal infections, methods for their manufacture, methods of treatment and prevention, and can be used for specific immunotherapy of adults and children suffering from acute or chronic (in the acute stage) staphylococcal infection (furunculosis, hydradenitis, panaritium, phlegmon, pyoderma, osteomyelitis, mastitis, inflammatory gynecological, urological, otolaryngological diseases, laryngo-tracheitis, bronchitis, pneumonia, etc.), patients with clinical manifestations chronic staphylococcal infection as an alternative to antibiotics or as a method of additional treatment in conjunction with antibiotics in septic conditions that are life-threatening.
• acute or chronic staphylococcal infection furunculosis, hydradenitis, panaritium, phlegmon, pyoderma, osteomyelitis,
• strain Stahpylococcus aureus N ° 44 is intended for use as one of the components in the technology of manufacturing an inactivated vaccine for the specific prevention of streptococcal, enterococcal and staphylococcal infections of animals (CCIT vaccine).
• the CCIT vaccine is intended for prophylactic use in veterinary medicine and is not intended for use in clinical medicine in humans.
• Strain 44 of Staphylococcus aureus does not indicate a degree of sensitivity / resistance to antibiotics.
• the vaccine is intended for use in veterinary medicine for animals and cannot be used in clinical practice for humans.
• a vaccine is known in which only one deposited strain of Staphylococcus aureus is contained, which significantly narrows its antigenic composition and, accordingly, the immunological response to vaccination.
• the vaccine is intended for use in animals - marine mammals and is not intended for use in humans [CN 108048364 C1, 2018.
• the isolated strains did not go through the deposition procedure.
• the authors of the article studied the sensitivity of the isolated strains of staphylococci to various antibiotics in order to select those drugs for which the bacteria, the causative agents of various diseases, still remained susceptible and did not mean the creation and use of staphylococcal vaccine for therapeutic purposes.
• the vaccine contains only one staphylococcus aureus - golden, which is why it is not effective enough.
• staphylococcus vaccine - staphylococcal toxoid in which the active substance is a staphylococcus toxin (a sterile filtrate of staphylococcus aureus broth culture containing exotoxin), previously partially inactivated with formalin and thermal energy.
• Staphylococcal anatoxin is a sterile filtrate of staphylococcus aureus broth culture containing formalin-neutralized exotoxin.
• the microbial biomass and all ballast proteins which makes it more purified. 1 ml of suspension contains from 10 to 14 so-called binding units [htp: //mednarodna.com.ua/9903-anatoksin-stafilokokkovyy.html].
• Anatoxin has insufficient functionality: the age of patients who are prescribed toxoid is limited from 16 to 60 years, that is, it is not intended for children. Anatoxin can also cause allergic reactions.
• a known method of producing staphylococcal purified liquid toxoid for specific immunotherapy of patients with staphylococcal infection including the conversion of the toxin into the anaform by treatment with formaldehyde, the purification of the toxoid by treatment with dry sodium chloride, precipitation with trichloroacetic acid, separation, dissolution of the precipitate in a 0.9% sodium chloride solution , treatment with ethanol, separating the precipitate by centrifugation and dissolving in a 0.9% sodium chloride solution to 12 EC in 1 ml with residual formaldehyde of not more than 0.003% [RU 2169580 Cl, A61K 39/085, 2001].
• staphylococcal toxoid vaccine including detoxification of exo-, endo- and superenterotoxins in suspension with autoclaved staphylococci with a formalin solution, sorption on aluminum hydroxide, sterilization.
• Detoxification of staphylococcal toxins is carried out with two detoxifiers - first with a 0.2% formalin solution for 7-9 days at 40-45 ° C, and then with a 0.6 ⁇ 0.1% ethonium solution for 7-9 days at 40-45 ° C, while the concentration of inactivated toxins with microorganisms is doubled by decantation of 50 ⁇ 5% of the supernatant [RU N ° 2008115050 A, A61K 39/085, 2009].
• formaldehyde is used to obtain the staphylococcal toxoid vaccine, which reduces the immunogenic effect of the vaccine and the immunological and positive clinical responses after vaccination.
• a known method of manufacturing a vaccine associated against Escherichiosis, streptococcosis and staphylococcosis of cattle including obtaining antigens with their subsequent mixing, the introduction of an adjuvant, while the selection of pathological material from a patient and fallen cattle from a local epizootic focus, then from selected pathological material prepare a suspension and then make inoculation on differential diagnostic media, after which cells of pure cultures of Escherichia coli Escherichiosis causative agent are isolated, streptococcosis Streptococcus pneumoniae and staphylococcosis Staphylococcus aureus, then cells of pure cultures of causative agents of Escherichiosis, streptococcosis and staphylococcosis are separately grown in meat-peptone broth with glucose added to 0.2% concentration with a titer of 4-5 billion microbial cells in 1 cm 3 , of this, cells of pure cultures of causative agents of Escherichia
• This method is intended for use in veterinary medicine and is not used to treat people, it is not recommended for use in research and production institutions and for clinical use.
• the method produces an associated vaccine containing the causative agents of three common diseases of cattle (E. coli, streptococci and staphylococci), which reduces the antigenic load of each of them in a single dose of the vaccine and is intended for the simultaneous treatment of escherichiosis, streptococcosis and staphylococcosis.
• the causative agents used for the manufacture of this vaccine are obtained from sick and dead animals (cattle) in “local epizootic foci”, which is inappropriate for the treatment of purulent-septic diseases in children and adults.
• Formalin is used to inactivate bacterial cultures, and aluminum hydroxide, which makes up 1/5 of the vaccine volume, is used as an adjuvant, which significantly increases the allergenicity level of the finished product with the possible use of such a vaccine in humans.
• a known method of producing a staphylococcal vaccine for the treatment of purulent infections including the cultivation of six to eight strains of pyogenic staphylococcus in a liquid nutrient medium and sterilization of biomass.
• the cultivation of six to eight strains of pyogenic staphylococci identified as Staphylococcus aureus is carried out separately for 14-16 days at a temperature of 37 ° C, then cultivated separately at a temperature of 3-5 ° C for 6-8 days, after which the resulting material is mixed and immediately autoclave at a temperature of 115-125 ° C for 15-40 minutes. [RU 2421240 C1, A61K 39/085, 2011].
• the staphylococcal vaccine obtained in this way can be used to prevent and treat purulent infections in animals and humans, the description of the use of this vaccine in humans is completely absent in the description. Namely:
• Closest to the claimed method of manufacturing a vaccine is a method of obtaining a staphylococcal vaccine for the treatment of purulent infections, including growing cultures of staphylococci in a liquid nutrient medium and sterilization of biomass.
• the cultivation of six to eight strains of pyogenic staphylococci identified as Staphylococcus aureus is carried out separately for 14-16 days at a temperature of 37 ° C, then cultivated separately at a temperature of 3-5 ° C for 6-8 days, after which the resulting material is mixed and immediately autoclave at a temperature of 115-125 ° C for 15-40 minutes. [RU ° 2009 136 113 A, A61K 39/085, 2011].
• staphylococcus aureus which contains 6-8 strains, narrows the spectrum of action and clinical efficacy of the vaccine obtained. In addition, they receive such a staphylococcal vaccine for a sufficiently long time - 24 days.
• Closest to the claimed method of treatment is a method of treatment by introducing the staphylococcal purified toxoid liquid subcutaneously into the region of the lower angle of the scapula, alternately to the right and left sides with each subsequent injection.
• the full course of treatment includes 7 injections of the drug, carried out after 2 days, in the following increasing doses: 0.1 - 0.3 - 0.5 - 0.7 - 0.9 - 1.2 - 1.5 ml.
• Treatment with staphylococcal purified liquid toxoid can be carried out in parallel with general and local therapy, except for serum antistaphylococcal drugs, such as antistaphylococcal immunoglobulin and antistaphylococcal plasma [https://tabletki.ua/ Anatoxin-staphylococcal /].
• serum antistaphylococcal drugs such as antistaphylococcal immunoglobulin and antistaphylococcal plasma [https://tabletki.ua/ Anatoxin-staphylococcal /].
• Staphylococcal toxoid Since in staphylococcal toxoid there is only a weakened staphylococcal toxin, the vaccine is not effective enough. Staphylococcal toxoid vaccination is done only for adults. In addition, with such vaccination, allergic reactions are possible.
• the basis of the invention is the task of creating an inactivated liquid staphylococcal vaccine, which would have wide functionality, effectively treat purulent-inflammatory diseases of staphylococcal etiology without allergic reactions.
• the second task which is the basis of the invention, is the creation of a method for producing inactivated staphylococcal liquid vaccine, which would expand the spectrum of action and clinical efficacy of the vaccine, as well as reduce the time for its receipt.
• the third task which is the basis of the invention, is the creation of a method for the treatment of staphylococcal infection by introducing an inactivated staphylococcal liquid vaccine to expand the functionality, effective treatment of purulent-inflammatory diseases of staphylococcal etiology without allergic reactions.
• the inactivated staphylococcal liquid vaccine including Staphylococcus aureus (Staphylococcus aureus), according to the invention, contains at least 21 strains of 3 types of staphylococci, namely at least 15 strains of Staphylococcus aureus (Staphylococcus aureus), 3 strains of hemolytic staphylococcus (Staphylococcus haemolyticus) and 3 strains of epidermal staphylococcus (Staphylococcus epidermidis), including bacterial strains with varying degrees of antibiotic resistance, deposited in the Depository of the Institute of Microbiology and Virology of the National Academy of Sciences of Ukraine:
• staphylococcal toxoid where only weakened staphylococcal toxin
• the claimed vaccine there is an antigenic complex of whole non-viable cells of thermally inactivated bacteria, corpuscular thermolabile and thermostable protein-polysaccharide antigens of the staphylococcal cell wall and unrefined staphylococcal toxins (mainly endotoxins), which increases the immunogenic immunological vaccine effect and the vaccine .
• the vaccine can be used both for adults and children, starting from infancy, which expands its functionality.
• the vaccine has a hypoallergenic effect with a significant reduction in the levels of IgE that are elevated before treatment.
• the vaccine is prepared from at least 21 different types of staphylococci from a clinical clinical strain, isolated from bacteriological examination of biological substrates from smears from the skin and mucous membranes: Staphylococcus aureus - 15 strains, Staphylococcus haemolyticus - 3 strains, Staphylococcus epidermidis - 3 strains of a certain location, isolated from various acute and chronic inflammatory diseases of the bacterial etiology, wash off the agar from the surface of the solid nutrient medium with pyrogen-free distilled water and placed in sterile containers, and to eliminate impurities of the nutrient medium, bacterial strains are washed with distilled water by centrifugation at 1500-3000 rpm pouring
• a container with inactivated bacteria add an equal amount of a preparation of embryonic origin, or physiological saline, or water for injection and receive a suspension of microbial cells, to control sterility, vaccine samples are plated on nutrient broth, seeded incubated in a thermostat at a temperature of 35-40 ° C for 24-48 hours, and in the absence of growth, a preservative is added and poured the vaccine in sterile ampoules.
• the method uses a 24-hour agar culture.
• Erbisol or inflamafertin are used as a preparation of embryonic origin.
• Bacterial strains are washed with distilled water by centrifugation three times.
• the pellet is standardized according to the MAK Farland (McF) standard with an optical density of 1.0, which corresponds to 3 billion (3.0 * 10 L 9) microbial cells in 1 ml.
• McF MAK Farland
• the vaccine is poured into ampoules of 1 ml.
• Spilled and sealed ampoules are checked for leaks, labeled and packaged in 10 ampoules for vaccination, leaving 2 ampoules of each series for control.
• the vaccine is received within 24 hours, and in the prototype - 24 days.
• the third task is solved by the fact that in the method of treating staphylococcal infection with an inactivated staphylococcal liquid vaccine, comprising administering the vaccine subcutaneously in the region of the lower angle of the scapula, alternately in the right and left sides with each subsequent injection in appropriate increasing doses, according to the invention, the course of treatment is 10- 12 injections, with 6-7 injections being carried out first, and after an interval of 3 weeks, another 4-5 injections are given taking into account the age and body weight of the patients.
• immunization with a staphylococcal vaccine is carried out according to the scheme: 0.1 - 0.2 - 0.3 - 0.4 - 0.5 - 0.5 - 0.5 ml in the 1st, 3rd, 5th, 7th, 9th, 14th and 19th days of treatment, and 3 weeks after the seventh injection - every other day according to the scheme: 0.1 - 0.2 - 0.3 - 0.4 - 0.5 ml.
• immunization with a staphylococcal vaccine is carried out according to the scheme: 0.1 - 0.3 - 0.5 - 0.6 - 0.7 - 0.7 - 0.7 ml in the 1st, 3rd , 5th, 7th, 9th, 14th and 19th days of treatment, and 3 weeks after the seventh injection - every other day according to the scheme: 0.2 - 0.4 - 0, 5 - 0, 6 - 0.8 ml.
• immunization with a staphylococcal vaccine is carried out according to the scheme: 0.1 - 0.3 - 0.5 - 0.7 - 0.9 - 0.9 - 0.9 ml in the 1st, 3rd , 5th, 7th, 9th, 14th and 19th days of treatment, and 3 weeks after the seventh injection - every other day according to the scheme: 0.2 - 0.4 - 0, 6 - 0, 8 - 1.0 ml.
• immunization with a staphylococcal vaccine is carried out according to the scheme: 0.1 - 0.3 - 0.5 - 0.7 - 0.9 - 1.0 - 1.0 ml in the 1st, 3rd , 5th, 7th, 9th, 14th and 19th days of treatment, and 3 weeks after the seventh injection - every other day according to the scheme: 0.3 - 0.5 - 0, 7 - 0, 9 - 1.0 ml.
• immunization with a staphylococcal vaccine is carried out according to the scheme: 0.1 - 0.5 - 0.7 - 0.9 - 1.0 - 1.0 - 1.0 ml in the 1st, 3rd , 5th, 7th, 9th, 14th and 19th days of treatment, and 3 weeks after the seventh injection - every other day according to the scheme: 0.3 - 0.7
• immunization with a staphylococcal vaccine is carried out according to the scheme: 0.1 - 0.5 - 0.7 - 0.9 - 1.0 - 1.0 - 1.5 ml in the 1st, 3rd , 5th, 7th, 9th, 14th and 19th days of treatment, and 3 weeks after the seventh injection - every other day according to the scheme: 0.3 - 0.7
• immunization with a staphylococcal vaccine is carried out according to the scheme: 0.1 - 0.5 - 1.0 - 1.0 - 1.5 - 1.5 - 2.0 ml in the 1st, 3rd, 5th, 7th, 9th, 14th and 19th days of treatment, and 3 weeks after the seventh injection - every other day according to the scheme: 0.3 - 0.7
• the claimed vaccine is used for acute or chronic staphylococcal infection (furunculosis, hydradenitis, panaritium, phlegmon, pyoderma, osteomyelitis, mastitis, inflammatory gynecological, urological, otolaryngological diseases, laryngo-tracheitis, bronchitis, pneumonia and bronchitis. n.), in patients with clinical manifestations of chronic staphylococcal infection as an alternative to antibiotics or as a method of additional treatment in conjunction with antibiotics in septic conditions that are life-threatening.
• staphylococcal infection furunculosis, hydradenitis, panaritium, phlegmon, pyoderma, osteomyelitis, mastitis, inflammatory gynecological, urological, otolaryngological diseases, laryngo-tracheitis, bronchitis, pneumonia and bronchitis. n.
• the claimed method of treatment contains whole cells of inactivated non-viable bacteria, corpuscular thermolabile and thermostable protein-polysaccharide antigens of staphylococcal cell wall and unrefined staphylococcal effect, which enhances the immunological effect and enhances the toxic effect of and positive clinical effect after vaccination.
• the vaccine can be used both for adults and children, which expands its functionality.
• the vaccine Stafilo Primavak has no side effects. Only local (hyperemia, swelling and pain at the injection site) and general (fever, skin rash, as a manifestation of bacterial toxicoderma) reactions to the vaccine are possible. Such reactions are of a natural physiological nature and are due to the activation of local immunity (at the injection site) and a general immune response with the release of toxins from the bacteria against which a specific Stafilo Primavak vaccine is directed, due to the rapid destruction of bacteria after their immune recognition by a tuned immune system.
• the vaccine When using the Stafilo Primavak vaccine, there is no development of allergic reactions, moreover, the vaccine has a hypoallergenic effect with a significant decrease in the levels of IgE elevated before treatment.
• the claimed inactivated staphylococcal liquid vaccine StafiloPrimavak includes at least 21 strains of staphylococci 3 different species, namely: Staphylococcus aureus (Staphylococcus aureus) - 15 strains, hemolytic staphylococcus (Staphylococcus haemolyticus) - 3 strains, and epidermal epidermal 3 strain of a certain location, isolated in various acute and chronic inflammatory diseases of bacterial etiology in children and adults.
• Stafilo Primavak receive as follows.
• the vaccine is prepared from industrial clinical strains of staphylococci, not less than from the 21st strain of 3 different types of different locations previously isolated during bacteriological examination of biological substrates (sputum, mucus from the nose, urine, tears, prostate juice, vaginal discharge, etc.
• swabs smears from the mucous membranes, purulent foci and from the skin of patients with various acute and chronic inflammatory diseases of bacterial etiology in children and adults, namely: Staphylococcus aureus - 15 strains, Staphylococcus haemolyticus - 3 strains, Staphylococcus epidermidis - 3 strains , including bacterial strains with varying degrees of antibiotic resistance deposited in the Depository of the Institute of Microbiology and Virology of the National Academy of Sciences of Ukraine:
• Staphylococcus aureus strain 776, isolated from the pharynx of a patient with lacunar angina, November 1, 2017, deposited on January 17, 2018 under registration number IIB B-7684, antibiotic resistance - 10%;
• Staphylococcus aureus strain 627 isolated from sputum of a patient bronchial asthma 04/18/2018, deposited on 05/07/2018 under the registration number IIW ⁇ -7756, resistance - 0%;
• Staphylococcus aureus strain 681, isolated from an abscess on 09/27/2017, deposited on 10/26/2018 under registration number IIV ⁇ -7665, resistance - 10%;
• Staphylococcus aureus strain 308, isolated from the urine of a patient with chronic pyelonephritis September 27, 2017, deposited October 26, 2017 under registration number IIV B-7666, resistance - 0%;
• Staphylococcus aureus strain 834, isolated from the sputum of a patient with chronic bronchitis on September 26, 2018, deposited on October 31, 2018 under registration number IIV B-7782, resistance - 10%;
• Staphylococcus aureus strain 487, isolated from the sputum of a child with cystic fibrosis on 03/10/2018, deposited on 10/31/2018 under registration number IIV B-7786, resistance - 20%;
• Staphylococcus haemolyticus strain 908, isolated from the urethra and prostate juice of a patient with chronic urethroprostatitis December 13, 2017, deposited on March 23, 2018 under registration number IIV B-7712, resistance - 20%;
• Staphylococcus haemolyticus strain 502, isolated from the urine of a patient with chronic cystitis on 02/20/2018, deposited on 03/23/2018 under registration number IIV B-7731, resistance - 0%;
• Staphylococcus haemolyticus strain 579, isolated from the nose of a patient with chronic sinusitis 05/23/2018, deposited on 10/31/2018 under registration number IIV B-7766, resistance - 0%;
• Staphylococcus epidermidis strain 116, isolated from the skin of a patient with pyoderma and furunculosis on 04/25/2018, deposited on 05/14/2018 under registration number IIV B-7763, resistance - 0%.
• At least 21 clinical pathogenic strains of staphylococci of 3 types of a specific location are used, which were isolated during bacteriological examination of patients with localized bacterial diseases of various organs and systems: nose, pharynx, oral mucosa, tongue, gums, teeth, eyes , trachea, bronchi, lungs, genitourinary system, skin, etc.
• pyrogen-free distilled water water for injection
• bacterial strains are washed with distilled water by centrifugation three times at 1500-3000 rpm. within 10-15 minutes. The supernatant is poured.
• the resulting culture residue of the bacteriological strain is suspended in pyrogen-free distilled water for injection and standardized in accordance with the MAK Farland (McF) standard with an optical density of 1.0, which corresponds to 3 billion (3.0 * 10 L 9) microbial cells in 1 cm 3 ( 1 ml).
• McF MAK Farland
• Strains of microorganisms are taken in equal quantities to obtain the same final concentration - a total of 3 billion (3.0 * 10 L 9) microbial cells in 1 ml.
• a standardized suspension of strains is inactivated in an autoclave at a temperature of 115-125 ° C and a pressure of 1 ATM. within 15-40 minutes.
• Erbisol or another preparation of embryonic origin, for example, Inflamafertin
• physiological saline or water for injection or another solvent is added in equal amounts in accordance with the production technical regulations and a suspension of microbial cells of 1.5 billion (1.5 * 10 L 9) in 1 ml of the finished vaccine.
• vaccine samples are plated on nutrient broth. Crops are incubated in a thermostat at a temperature of 37 ° C for 24-48 hours. In the absence of growth, a preservative and other ingredients are added according to the production technical regulations and the 1 ml vaccine is poured into sterile ampoules. Spilled and sealed ampoules are checked for leaks, labeled and packaged in 10 ampoules for vaccination, leaving 2 ampoules of each series for control.
• Immunization with the Stafilo Primavak vaccine is prescribed for acute staphylococcal infection in newborns, infants and children, adults with lesions of the skin and mucous membranes, organs of the rhinopharynx, eyes, respiratory tract, urinary tract and genitals, bones and joints (osteomyelitis, purulent arthritis, including including after the installation of artificial joints), as well as with other purulent-inflammatory diseases of staphylococcal etiology (paraproctitis, bartholinitis, Fournier gangrene, etc.) subcutaneously (under the shoulder blade) with a course of 12 injections (vaccination - 7 injections, after an interval of 3 weeks revaccination - another 5 injections) taking into account the age and body weight of patients according to the following schemes:
• the shelf life of the Stafilo Primavak vaccine is 24 months.
• the invention is not limited to the manufacture of a liquid vaccine.
• the vaccine can also be made in the form of sublingual sucking tablets, capsules for oral administration, drops in the nose or spray, vaginal suppository suppositories, ointments, solution for irrigation of the mucous membranes.
• the invention is illustrated by examples of treatment.
• strains of Staphylococcus aureus were identical from nasopharynx and feces and additionally from different affected areas of the skin and urine.
• the level of total IgE increased from 2 to 110 IU / ml (age norm - up to 10 IU / ml).
• 2 courses of immunization with the staphylococcal vaccine StafiloPrimavak were carried out (each - 10 injections).
• positive clinical dynamics were noted: the skin was completely cleansed of the elements of the rash until the 12th month of the child's life.
• the level of total IgE decreased to 19 IU / ml.
• Hyperimmunoglobulinemia E syndrome (or Job syndrome), the symptoms of which begin at the age of the infant, is considered a hereditary disease in which there is a combined humoral-cell immunodeficiency (T and B cells) with severe staphylococcal skin lesions (boils, abscesses, skin phlegmon, etc.) in combination with total eosinophilic dermatitis with stunning itching of the skin.
• T and B cells humoral-cell immunodeficiency
• severe staphylococcal skin lesions (boils, abscesses, skin phlegmon, etc.) in combination with total eosinophilic dermatitis with stunning itching of the skin.
• T cells were 59% or 3537.05 * 10 b / l cells (above normal), B cells - 6% or 359.7 * 10 6 / l (within normal limits) ); IgA -0.58 g / l, IgM -1.24 g / l, IgG-10.2 g / l.
• the level of total IgE was 2250 IU / ml at the start of treatment in the clinic. Over 2 years (until August 2014), 3 courses of immunization with a staphylococcal vaccine, a total of 35 injections, and 4 courses of immunization with bacterial auto- and multivalent vaccines were carried out.

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