Method for treatment and prevention immunodeficiency conditions and diseases associated with bacterial or viral aggression

FIELD: medicine and immunology, in particular treatment and prevention immunodeficiency conditions and diseases associated with bacterial or viral aggression.

SUBSTANCE: claimed method includes administration to a patient immunoglobulin drug (e.g., pharmaceutical composition containing 6-12 % of specific heterologous secreted immunoglobulin A, isolated from milk or foremilk of immunized ungulates). Administration is performed parenterally wherein single dose is at least 10 IU/kg of patient weight for treatment or at least 5 IU/kg for prophylaxis; or perorally in dose of 0.2-0.5 g and/or topically one-two times per day for 1-5 days. Method of present invention makes it possible to decrease dose of administrating immunoglobulin due to prolonged retention of its high titers in body fluids.

EFFECT: enlarged range of application and assortment of immunoglobulin drugs.

4 cl, 5 ex

 

The invention relates to medicine and immunology, in particular to the treatment and prevention of diseases associated with bacterial or viral aggression.

Preparations of immunoglobulins is a highly effective means of treatment and prevention of various infectious diseases, viral diseases and immunodeficiencies, however, to date, developed and widely used only preparations of immunoglobulin from the serum of humans and animals. This is justified in cases when the disease is severe toxaemia, viremia or bacteraemia with toxic, bacterial or viral lesions of internal organs. However, there is a wide range of diseases in which the primary localization of the infectious process associated with the mucosa, and the greatest role in the protection of the body is the state of local immunity, in particular the content in the epithelial secrets of secretory immunoglobulins.

Secretory immunoglobulin a and M are classes of immunoglobulins, thereby protecting the body against infectious agents directly at the gate of their penetration in the skin and mucous membranes [1]. In terms of infectious process a major role in protecting the body plays locally synthesized antigen-specific secretory immunol obelin. Antigen-specific secretory immunoglobulin a is able to adsorb microbial body, neutralize toxins [2], and to regulate the functional activity of immune cells in inflammation [3], preventing generalization of the infectious process and the development of systemic immune response. Specific secretory immunoglobulin a is produced as the bacteria [4]and viral [5, 6, 7] antigens. Moreover, in models of viral infections shown that secretory immunoglobulin a is not only able to interact with the virions on the surface of the mucous membranes, but also penetrate into the infected cells, there blocking virus replication.

The difference of secretory immunoglobulins from serum immunoglobulins is the ability to penetrate from the circulation through intact mucous membranes and skin in epithelial secrets and long to persist in high titers in secreted fluids. This allows you to apply preparations of specific secretory immunoglobulin for the prevention and treatment of diseases in which the primary localization of the infectious process associated with the mucosa, and to achieve greater clinical effect due to more opportunities for combining different methods and routes of administration of immunoglobulin preparations is a - parenteral and topical application that allows you to achieve higher titers of specific antibodies in the pathological focus.

There is a method of treatment of staphylococcal infections and mixed infections with Staphylococcus human serum antistaphylococcal immunoglobulin for intravenous injection with a specific activity of not less than 20 IU/ml [8], which is used for the treatment of patients with COPD in whom sputum was determined aureus with high resistantanti to antibiotics. Immunoglobulin administered intravenously every other day, 4 times in a dose of 500-1000 ME.

The disadvantage of this method is the need for immunization staphylococcal vaccine and staphylococcal toxoid healthy donors, intravenous drug and the need to use relatively high doses of immunoglobulin.

Closest to the claimed method of the prototype - is a method of treatment and prevention of smallpox by applying sheep serum gamma-globulin, in which smallpox sheep gamma globulin intramuscularly in doses of 6-12 ml several times depending on the severity and nature of the disease [9].

The disadvantages of this method are: the drug is active only in the stage of viremia and the need for intramuscular injection in the high-dose immunoglobulin preparation, what increases the risk of anaphylactoid reactions.

An object of the invention is to increase the efficiency of the method, reducing the dose of immunoglobulin, the expansion of the scope and diversification of immunoglobulin preparations.

The goal of the project is achieved in that for the treatment and prevention of immune disorders, bacterial and viral infections of humans and animals use a preparation containing as an active substance immunoelectrophoretic pure heterologous antigen-specific secretory immunoglobulin a in an effective amount that is administered to the patient parenterally, orally and/or applied topically once or twice a day rate 1-5 days depending on the nature and severity of the disease.

Basic drug (substance) contains 6-12% of secretory immunoglobulin a has a pH of 4-8, anticomplementary activity of not less than 10 mg of protein, not activating 2 CH50protects >70% of the respective infections when the infecting microorganism in doses ≥10 EID50), is reactogenic when administered intravenously, may contain a stabilizing additive in a total concentration of not more than 4%. The drug is separated from the whey of milk and/or colostrum of immunized ungulates.

The proposed method is syshestvyut as follows

Sterile lyophilized preparation containing immunoelectrophoretic pure heterologous secretory immunoglobulin a, dissolved in sterile 0.9 percent aqueous solution of sodium chloride in accordance with the instructions for use and administered intravenously, intramuscularly, subcutaneously, intradermally, at the puncture, sensing or endoscopy various organs and cavities of the body, amazed or other pathological process, intranasal, inhalation, in the form of endotracheal and endobronchial fills, microenemas, used for irrigation of the mouth, nasopharynx, trachea, bronchi, colon, buried nose and ears. The optimal prophylactic single dose injectable form of the drug is not less than 5 IU/kg, as treatment is not less than 10 IU/kg of body weight of the patient, depending on the nature and severity of the disease.

Tableted or encapsulated form of the drug is taken orally on an empty stomach and 0.2-0.5 g twice a day for at least 3 days, prophylactic dose decreases in 2 times.

Topical form of the drug containing 6-12% of secretory immunoglobulin a, apply a thin layer to the area of the pathological process and gently RUB until completely absorbed.

Rectal and vaginal suppositories containing 0.2-1.5 g of secretory immunoglobulin a, is entered into with the matter of bodies for at least 5 days.

Introduction secretory immunoglobulin a predominantly carried out in combination (for example, parenterally and topically, orally and topically, depending on the type of pathology that allows you to achieve higher titers of specific antibodies in the pathological focus.

The defining difference of the proposed method from the prototype is that as immunoglobulin drug use immunoelectrophoretic net specific heterologous secretory immunoglobulin a in experimentally selected optimal mode that allows you to increase the effectiveness of treatment, to expand the scope of application of the method and to reduce the dose of immunoglobulin.

Due to the fact that in the known patent and scientific and technical sources of a similar method of treatment of secretory immunoglobulin a, isolated from milk and/or colostrum of immunized ungulates, not detected, it is possible to draw a conclusion on the conformity of the proposed technical solution the criteria of “novelty” and “inventive step”.

The invention is illustrated by the following specific examples of the treatment of diseases associated with bacterial or viral aggression.

Example 1.

Patient C., 37 years old, was admitted with complaints of cough with difficult to spit purulent sputum, dyspnea at rest, the NPV to 24 in a mine is, high temperature - 37,8ºc. Auscultatory - vesicular breathing, difficult phase of exhalation, multiple scattered dry rales of different timbre, a single moist rales in the interscapular area. Percutane - “box” sound.

X-ray: pulmonary pattern is reinforced, the deformed, the roots of the lungs are expanded, pulled to the diaphragm, the sinuses free. The transparency of the lung fields is strengthened. Determined by two-way peribronchiolar infiltration of the lung tissue.

Diagnosis of the underlying disease: bilateral bronchopneumonia.

Comorbidities: chronic deforming purulent obstructive bronchitis, emphysema II Art.

Laboratory data: blood - er. - 4,8×1012/l lake. - 8,8×109/l B - 0%e - 2%, P - 18%, 60%, L 15%, M - 5%.

In sputum detected Pseudomonas aeruginosa in Association with St. Aureus resistant to penicillin, gentamicin, lincomycin, tetracycline, chloramphenicol.

On the background of antibiotic therapy, funds aimed at restoration of function of external respiration, detoxification and symptomatic therapy were treated with a specific drug bullish secretory immunoglobulin a against Pseudomonas aeruginosa. Lyophilized drug was dissolved in 0.9% sterile solution of sodium chloride and was introduced to 3-fold at a dose of 500 ME Transline within 3 days as well as 1-fold dose of 250 ME endotracheal bronchoscopy. On the 4th day of intoxication symptoms were controlled, the temperature is normalized. Restoration of function of external respiration on day 9. Discharged 21 days to cure.

Example 2.

Child And., 5 years old, was admitted with complaints of increasing temperature up to 39.5°, lethargy, loss of appetite, pain when swallowing, shortness of breath. When viewed pale skin, damp, acrocyanosis, increased sublingual, submandibular lymph nodes, dense to the touch, painful. Nasal breathing is difficult, oropharynx hyperemic, edematous, the rear wall of the pharynx and tonsils covered with dense, poorly strippable coating, wounded while trying to remove plaque was found bleeding of mucous.

In the lungs breathing hard, no wheezing, heart sounds, rhythmic, single extrasystoles, 1st tone at the top impaired, deaf, BP 90/60 mm Hg, pulse rate was 110 beats./min Abdomen is soft, painless. No edema.

ECG - rare irregular supraventricular extrasystoles, av block first degree

The diagnosis of diphtheria, toxic form of the III degree. Toxic myocarditis.

On the background of standard therapy were treated antidiphtheria bullish secretory immunoglobulin for intravenous administration at a dose of 500 ME intravenously once and for 20 ME intranasal and inhaled with the use of the group of metering aerosol container three times with an interval of 12 hours.

Fever was stopped by the end of 1 day, the symptoms of intoxication on the second, after 2 days started off plaque from the mucous membrane of the throat, after 3 days disappeared changes of lymph nodes. On the 7th - normalization of the ECG pattern. Discharged after 14 days of recovery.

Example 3.

Patient Z., 24 years old, was admitted with complaints of itching in the vulva, scanty mucous discharge, pain during urination, feeling of sand in the eyes, excessive tearing, eye pain.

At survey: conjunctiva of the eye is swollen, hyperemic, single erosion at the edges of the eyelids bubble rash, injection of the sclera.

External genitals hypermonogenic, swollen, labia lips bubble rash, single erosion, vaginal mucosa is hyperemic, the outer opening of the urethra swollen.

In smears and tears pathogenic flora not found. PCR diagnosis - HSV-1, HSV-2.

The diagnosis of herpes simplex, herpes keratoconjunctivitis, genital herpes

On the background of traditional therapy treatment Antiherpes virus effect of horse secretory immunoglobulin. Eyes laid eye ointment containing 6% Antiherpes virus effect of secretory immunoglobulin daily for 5 days. External genitals smeared with an ointment containing 12% Antiherpes virus effect of secretory immunoglobulin for the same scheme. The same pattern was introduced to the vagina vaginal suppositories containing 0.5 g Antiherpes virus effect of secretory immunoglobulin. Discharged after 10 days of recovery.

Example 4.

Child D., 1.5 years, was admitted with complaints of lethargy, shortness of breath, nausea, single vomiting, lack of appetite, watery stool with a pungent smell in the stools whitish flakes.

On examination, the child is listless, lethargic, pale skin temperature 37,1°C. Chair - 5 times per day.

When sowing in the chair pathogenic flora not found. Blood leukocytosis - 10×109/l In urine protein 0.5 g/l, leached erythrocytes and leukocytes.

PCR diagnosis - rotavirus infection.

Diagnosis of rotavirus gastroenteritis, exsicosis II degree

On the background of the hydrating therapy treatment tablets drug bullish specific secretory immunoglobulin 0.5 g 2 times a day for 3 days. On the second day were stopped diarrhoeal syndrome, gone are the symptoms of intoxication. Discharged on the 7th day of recovery.

Example 5.

In the children's infectious diseases ward under observation were 42 patients with intestinal infections in age from 3 to 12 years. At the time of observation, the Department was in quarantine about the flu epidemic. With the aim of passive prophylaxis 20 children without signs manifest the th intranasal influenza infection was introduced polyvalent equine influenza secretory immunoglobulin at a dose of 5 IU/kg of body weight once a day, 1 with an interval of 3 days. As a control group used 20 children of the same Department, which also at the time of observation no signs of influenza.

After 3 weeks of observation in the experimental group ill 1 child in the control and 4, the diagnosis of influenza in all patients was verified virologically and serologically by the dynamics of growth titer of specific serum antibodies.

It was also noted that in the control group disease proceeded heavier, have a sick child in the experimental group there was virtually no symptoms of intoxication and catarrhal phenomena in the throat were less pronounced, febrile period lasted 2 days, and body temperature did not rise above low-grade values.

The use of the present invention will improve the efficiency of treatment of diseases associated with bacterial and viral aggression, to expand the scope to reduce dose and to expand the range used immunoglobulin preparations.

SOURCES of INFORMATION

1. Kerr MA. The structure and function of human IgA. Biochem.J., 1990, 271, 1553-1559.

2. Jarvis G.A., Griffis J.M., Human IgA1 blockade of IgG-initiated lysis of Neisseria meningitides is a function of the antigen-binding fragment binding to polessaccharide capsule. J.Immunol., 1991, 147, 1962-1967.

3. Kaetzel C.S., Robinson J.K., Chintalacharuvu K.R. et al. The polymeric immunoglobulin receptor (secretory component) mediates transport of immune complexe across epithelial cells: a local defense function for IgA. Proc. Natl. Acad. Sci, USA, 1991, 88, 8796-8800.

4. Glas RI, Svennerholm A-M, Stoll BJ, et al. Protection against cholera in breast-fed children by antibodies in breast milk. N. Engl. J. Med., 1983, 108, 1389-1392.

5. Mazanec MB, Nedrud JG, Lamm ME. Immunoglobulin A monoclonal antibodies protect against Sendai Virus. J.Virol., 1987, 61, 2624-2626.

6. Turner RB, Kelsey DK. Passive immunization for prevention of rotavirus illness in healthy infants. J. Infect Dis., 1987, 156, 158-166.

7. Renegar KB, Small PA. Immunoglobulin A mediation of murine nasal anti-influenza virus immunity. J.Virol., 1991, 65, 2146-2146.

8. Sharygin S.L., Sinitsyna G.M., Kardovsky A.G. and other Application immunoglobulin antistafilokokkovh for intravenous injection in complex therapy of bronchopulmonary diseases// in : “Clinical use of intravenous immunoglobulins” edited Tea, issue 2 (EXT), Nizhny Novgorod: C, 1999, s-95.

9. Guidelines for the use of gamma globulin for the prevention and treatment of infectious diseases. - Tomsk research Institute of vaccines and sera, the USSR Ministry of health. Issue 23. - Ed. Tomsk state University, 1964.

.1. Method for the treatment and prevention of immune disorders and diseases associated with bacterial or viral aggression, including the introduction of patient immunoglobulin preparation, characterized in that as immunoglobulin drug use drug containing 6-12% specific heterologous secretory immunoglobulin a, isolated from the milk or colostrum of immunized ungulates, while the introduction is carried out PA is enterline dose of at least 10 IU/kg of body weight of the patient for therapeutic purposes and in a dose of less than 5 IU/kg of body weight for the prevention, or oral dose of 0.2-0.5 g and/or locally, one to two times per day, a rate of 1-5 days.

2. The method according to claim 1, characterized in that the drug is used in liquid, tablet, capsule or ointment form.

3. The method according to claim 1, characterized in that the preparation containing specific heterologous secretory immunoglobulin a, is used topically for the treatment of the mucous membranes in the form of drops, spray, inhalation, microenemas and irrigation dose of 20-500 ME, in the form of rectal and vaginal suppositories containing 0.2 to 1.5 g of active substance, as well as for skin treatment in the form of ointments containing 6-12% of the active substance.

4. The method according to claim 1, characterized in that the specific heterologous secretory immunoglobulin a use combined by simultaneous parenteral and local injection or oral or local administration.



 

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