Biopharmaceutical drug on the basis of the living culture of bacillus and treatment of diseases of infectious nature

 

(57) Abstract:

The invention relates to the field of medicine. The essence of it is that created the drug on the basis of the living culture of Bacillus, which contains recombinant strain of B. subtilis, penicillinase-2-interferon person and vibrant culture Century licheniformis in their specific content, and the usual filler. The drug allows to treat viral infections such as hepatitis, herpes, encephalitis, etc., and bacterial, such as enteritis, colitis, chlamydia, BV, etc., and immunodeficiency States. The invention expands the Arsenal of remedies against bacterial, viral infections and immunodeficiency States non-invasive methods. 2 s and 5 C.p. f-crystals, 4 PL.

The invention relates to medicine, namely to create a drug that has antibacterial and antiviral activity, and is able to treat immunodeficiency States.

One of the major contemporary approaches to therapy of various diseases is the use of recombinant interferons person. In medical practice, have found wide application such genetically engineered drugs, such as IFN, Roferon, berfor, intron-a and other Accumulated C is ended. However, this group of drugs are not without a number of disadvantages: the result of their action depends on the form of infection, body condition, individual tolerance of the drug; injections of interferon often cause undesirable side reactions (pyrexia, headache, muscle pain, nausea, vomiting); in some cases, antibodies are formed, neutralizing interferon, which dramatically reduces therapeutic efficacy and may cause allergic reactions; the use of an injectable associated with increased risk of transmission of hepatitis viruses and BEACH; injectable form of interferon relatively expensive, so in real clinical practice, these drugs have limited use.

In addition, none of the drugs interferon not antibacterial for the treatment of concomitant bacterial infection (enterocolitis, dysbacteriosis, pneumonia).

Alternative delivery of interferon to the target organ - its production in the gastrointestinal tract (GIT) saprophytic strains of bacteria (RU N 2084233). Such strains-producers can become the basis of therapeutic drugs oral administration. In our opinion, the most attention as the e aerobic bacteria producers of biologically active substances. Kiev, "Naukova Dumka", 1982, 280 C. ). This organism is widespread in the environment, has a number of valuable properties: it is an antagonist of pathogenic and conditionally pathogenic flora (Staphylococcus, Streptococcus, Salmonella, Proteus, yeast); produces enzymes that removes the products of putrefactive decomposition in the intestine; synthesize certain amino acids, vitamins and immunomodulators; promotes regeneration of epithelium; the spores of B. subtilis resistant to enzymatic proteolysis and the acidic environment in the stomach and may enter the intestine in the intact condition, where the form of the vegetative form.

A wide range of biological activity, along with the complete harmlessness make possible the application of the living culture of B. subtilis as the basis of therapeutic and preventive drugs in medicine. Registered and successfully applied a number of such drugs: baktisubtil (Croatia), flanigin-BS (Yugoslavia), bioperin (Ukraine), SL-bacterin, sporobacterin (Russia). These drugs are used for treatment of dysbacteriosis, diarrhea, enteritis, colitis, wounds, tonsillitis, diathesis, eczema, allergic diseases. Abiotically therapy efficacy is the drug "Subalign". The drug is a composition based on the living culture of the recombinant strain B. subtilis, capable of producing alpha-2-interferon (RU N 2035185, publ. 20.05.92 year). Known biological product works on the basis of biomass of B. subtilis in the amount of 1109CFU in 1 g of the drug and is intended for use in the veterinary field.

The present invention is the creation of a biopharmaceutical product on the basis of the living culture of the genus Bacillus, which had both antibacterial and antiviral activity, this could also be used in the fight with immunodeficiency. The goal is solved in that the biological product containing recombinant strain of Bacillus subtilis that produce alpha-2-interferon person, additionally contains a live culture of Bacillus licheniformis in the following ratio of components:

B. subtilis 1106- 1107CFU/g

B. licheniformis 1105- 1106CFU/g

filler - the rest is up to 1 g

To create the drug can be used in different recombinant strains of B. subtilis are capable of producing alpha-2-interferon person, including registered in the all-Russian Collection of Industrial Microorganisms, strain the formation of the tablets, such as glucose, starch, aluminum hydroxide, calcium stearate, etc. in common in such cases, the ratios (for oral administration). Agar and other gels - for outdoor use.

Biopharmaceutical drug based on the selection of strains of the genus Bacillus (vegetative and spore form) was used as compounds having antiviral and antibacterial activity in the practical clinical setting, the drug was called "Debrecen A".

The drug showed high clinical efficacy in the treatment of various infectious diseases and reinfections nature:

viral hepatitis A, B, C;

infections caused by Herpes zoster and N. simplex;

viral encephalitis;

infections caused by human papilloma virus;

acute respiratory viral infections.

serous meningitis;

slow viral infections (including multiple sclerosis);

enteritis, colitis;

acute intestinal infections, including young children;

of chlamydia;

bacterial vaginosis;

interfacedefinition syndrome.

"Debrecen-A - abiotically the new generation product, based on iunie bacteria in the intestines, where is their transient reproduction and the production of interferon. Interferon, proceeding through the epithelium of the Peyer's plaques, systems, portal vein, reaches the liver parenchyma affected hepatotropic virus. This creates a fundamentally different, not injecting the path of delivery of active drug to the organs-targets.

Clinical trials conducted on patients with viral hepatitis A, B and C, showed the following:

1. There is a decrease in the level of total bilirubin blood 3-5 times;

2. Is the disappearance of viral antigens from the blood and seroconversion occurs;

3. Significantly improves the clinical condition of patients, disappears common symptoms characteristic of viral hepatitis.

In any case, is not received manifestations of toxic, allergic or other adverse effects (fever, headache, muscle aches, abdomen, vomiting, diarrhea, and so on)

For the treatment of acute hepatitis it is recommended that the following diagram application "Debrecen-A: 4 times a day 2.5 g in between meals for 5 days. After a week break, the course can be repeated (if indicated).

The invention is explained in sleduyuschih-volunteers patients with viral hepatitis With varying degrees of severity. The results obtained after 5 days of drug use, are presented in table. 1. From the table there is a visible positive dynamics of hepatitis Depeconom And biochemical parameters (bilirubin, alanine aminotransferase (Alat), etc.

Example 2. Treatment of hepatitis B after transplantation of a kidney in the recipient K. Depeconom also gave A positive result. Dynamics of blood markers and the underlying biochemical parameters are shown in table. 2.

Example 3. Treatment of recipient HP after kidney transplantation affected by hepatitis B and C, yielded positive results with a dose of Debrecina-A. Dynamics of blood markers and the underlying biochemical parameters are shown in table. 3.

Example 4. Treatment of recipient M affected by hepatitis B and C, underwent kidney transplantation, has also led to positive results for a number of biochemical parameters.

Dynamics of blood markers and basic biochemical parameters are given in table. 4.

In addition to viral hepatitis, Debrecen-And can successfully be used in the treatment of infections caused by viruses is, entendeu viral infections (including multiple sclerosis), serous meningitis.

It should be noted that bacteria of the genus Bacillus are highly resistant to the digestive enzymes of the gastrointestinal tract and the ability to rapid colonization of the intestine and ugnettemu effect on pathogenic and conditionally pathogenic flora. The ingestion of the bacteria multiply in the digestive tract within 2 days. Two days later they are completely eliminated from the body without causing negative effects even in overdose. Therefore, the "Debrecen-And successfully applied for the treatment of not only the primary, but secondary bacterial intestinal infections.

The drug is taken for 1-4 tablet 3-5 times a day at intervals of 4-12 hours during the entire course of therapy (3-5 days in the treatment of dysbacteriosis up to 6-12 months in the treatment of chronic hepatitis). In order to more effectively settling disputes throat and mouth medication, it is advisable not to drink and kept in the mouth until dissolved. For the prevention of immunodeficiency States, the drug given in tablet 1-2 times per day for 5 consecutive days. The drug is not recommended concurrently with oral antibiotics and sulfonamides, which inhibit the injectable forms of antibiotics.

Serous meningitis

Example 5. Patient K., 49 years old, was admitted to the infectious Department with a diagnosis of acute CNS infection of unknown etiology. Meningeal syndrome. CSF bacterial flora is not detected. PCR in the CSF and peripheral blood lymphocytes identified by the DNA virus Herpes simplex 1. Initiated comprehensive treatment of aciclovir and "Depeconom-A (table 2. 4 times a day). On the 4th day from the start of treatment is not detected viral DNA in blood lymphocytes, but in the cerebrospinal fluid viral DNA was determined. On the 7th day PCR analysis of samples of CSF were negative. Positive clinical dynamics.

Acute respiratory viral infections

Example 6. We observed 25 outpatients aged 18 to 55 years (11 men and 14 women) with a diagnosis of SARS in the early stages of the disease. All patients underwent a course Debrecen "And" in table 2. 4 times a day for 7 days. On the 3rd day from the beginning of reception in 23 cases with a positive clinical dynamics: the temperature was decreased to low or normal values, decreased symptoms of tracheitis or tracheobronchitis, fatigue, congestion in the throat. The recovery took place on 5-6 day. In 2 cases of acute period nakanune very sick (headache, chills, fever up to 38oC). Took "Debrecen" for 6 days. Acute effects disappeared for day 2. Temperature normalized on day 3.

Example 8. Patient O., 50 years. Dry cough, nasal congestion, low-grade fever. Took "Debrecen" within 7 days. The main manifestations of the infection cropped to 6 days. Asthenic condition remained until 7-8 days.

Urogenital chlamydia

Example 9. In the studied group consisted of 15 ambulatory patients aged from 25 to 40 years (10 men and 5 women) with urogenital dysfunction. Diagnosis of urogenital chlamydia trachomatis was performed by direct immunofluorescence or by polymerase chain reaction (PCR). In the history of all patients is ineffective antibiotic treatment of chlamydia. After the start of treatment "Depeconom " And" 5 patients with chronic infection followed acute chlamydia, followed by effective elimination of chlamydia during antibiotic therapy. In 9 patients with acute chlamydia use of Debrecina-A" followed by antibiotic therapy has been completed clinical response, which was confirmed by the negative results of PCR analysis for chlamydial DNA. In one case the use of "Debrecina-the giving of the clinical condition of the patient.

Example 10. Patient P., aged 26, was seen by a urologist in connection with chlamydial urethritis. Antibiotics (azithromycin) is ineffective. Upon completion of the course re-identified Chlamydia trachomatis. Was held on 10-day course "Depeconom", and then conducted therapy ruledom. Elimination of chlamydia confirmed negative by PCR analysis.

Example 11. Patient O., 31, has addressed to the urologist for infertility in marriage for 5 years. In a laboratory study method immunofluorescence detected chlamydia in the scraping of the urethra in the prostate secretion. The diagnosis of urogenital chlamydia, complicated by chronic prostatitis. Was carried out the treatment Sumamed, after which newly discovered chlamydia. The patient is assigned a 10-day course of Debrecina" with the subsequent course of rulide. During the control study swab from the urethra and prostate secretion by PCR chlamydia is not found.

Secondary immunodeficiency States, interferometrically syndrome

Example 12. We observed 19 outpatient and inpatient patients (10 men and 9 women) aged 22 to 47 years with different forms of secondary immunodeficiency States (including interference is all patients investigated immune and interferon status. The study was repeated after 14-day course of the drug (table 2. 3-4 times a day). All patients were observed positive dynamics of immunological indices, health improvement, normalization of temperature, a decrease cough. 9 out of 10 outpatients recorded relatively stable remission acute respiratory infections over the next 2 months. Laboratory studies on completion of the course "Debrecina-A demonstrated increase in the number of leukocytes in average by 22%, segmented neutrophils, 18%, lymphocytes 9%. The total number of T-lymphocytes increased by 8.1%, T-killers-suppressor 32%, T-inductors-helper cells by 15%.

Example 13. Patient E., 39 years old, was in the hospital due to chronic pneumonia caused by Streptococcus pneumoniae and secondary immunodeficiency syndrome. On the 4th day from the beginning of reception "Debrecina-A marked increase in the concentration of interferon in the serum of up to 32 IU/ml (at a rate of 4-8 IU/ml). Normalized body temperature, decreased fatigue, appetite. Sputum culture on day 10 after initiation of therapy showed a reduction in the number of Streptococcus pneumoniae 2 orders.

Example 14. Sick Hours, 26 years background secondary immunodeficiency syndrome with signs of interferon deficit and tolerance inducers of interferon. After the course "Depeconom " And" marked by persistent remission within 2 months, and I feel much better. Registered mitogenic and viral induction of interferon. The level of serum interferon was 64 IU/ml

Example 15. Patient F., 36, was observed in outpatient physician-pulmonologist due to chronic pneumonia on a background of secondary immunodeficiency syndrome. The patient identified antibody classes lgG and lgM to antigens of Mycoplasma pneumoniae. At the end of the 14-day course "Depeconom " And" normalized temperature, decreased fatigue, appetite. Analysis of serum in the next 3 months showed a significant decrease in titer Mycoplasma antibodies.

Acute intestinal infections (AII), enteritis, colitis

Example 16. The study group included 32 patients aged 16 to 45 years, of which 19 men and 13 women. The course of Debrecina "And" scheme table 1-2. 3-4 times a day lasted from 5 to 7 days. All patients underwent bacteriological examination of faeces before therapy and after 2-3 days after its completion. On the background of the application "Debrecina" noted faster (compared to patients not taking the drug) extinction spasm of the intestine, ending Bo is their General condition. On the background of the application "Debrecina-A noted decrease in the numbers of pathogenic organisms (in particular, Shigella, Salmonella) in the early period of convalescence, as well as reducing the frequency of formation of a protracted and chronic forms of dysentery. In 94% of cases occurred restore intestinal flora with III-IV degree of dysbiosis to normal.

Example 17. The studied group consisted of 10 children aged 1.5 to 3 years with a diagnosis of acute enterocolitis, staphylococcal infection with gastro-intestinal tract, the dysbacteriosis of varying severity after suffering dysentery and salmonellosis. "Debrecen" was used in a dose of 0.5-1 table. 2 times a day for 5-7 days. All observed children showed improvement in General condition, decreased the number of defecations, disappeared pathological impurities in the chair. By 10-12 days there was complete or partial restoration of normal intestinal microflora, the elimination of pathogenic microorganisms (including Shigella, Salmonella).

Example 18. Patient S., 22 years old, hospitalized with a diagnosis of acute intestinal infection bacterial etiology. Bacteriological analysis of fecal allocated to culture Salmonella enteritidis, Proteus vulgaris, Citrobacter sp. The wedge is 5 days according to scheme 2 table. 4 times a day. The signs of intoxication disappeared after 2 days. To 5 days frequency of defecation decreased to 2 times. When re-bacteriological analysis of Salmonella enteritidis and Proteus vulgaris was not detected.

Example 19. Patient Z., 39 years old, was admitted to the hospital with a diagnosis of exacerbation of chronic enterocolitis. A state of moderate severity, hyperthermia, noted tenderness and spasm of the sigmoid colon, unformed slimy stools, frequency of defecation reached 15 per day. Bacteriological analysis of fecal selected culture Shigella sonnei. The use of "Debrecina" within 7 days, according to scheme 2 table. 4 times a day, contributed to the normalization of a chair, the disappearance of signs of intoxication and the disappearance of intestinal pain. In Calais when you study Shigella sonnei is not detected, there is a restoration of normal intestinal flora.

Example 20. Patient F., 2 years old, was admitted to the infectious Department with a diagnosis of acute enterocolitis (severe). The condition was characterized by hyperthermia, acrocyanosis, pain and spasm of the sigmoid colon, multiple liquid stools with mucus. Bacteriological analysis of chairs allocated to culture Salmonella infantis. The patient is assigned to intravenous rehydration therapy who were assessed as satisfactory. 3 day frequency of defecation decreased to 2 times, recovered normal stool consistency, disappeared mucus. Re bacteriological examination of Salmonella (on the 7th day from the start of treatment) gave a negative result.

In addition to injectable interferon, widespread therapeutic forms of interferons for local application in the form of ointments, gels, aerosols, suppositories, etc. drugs Such as ointment "Agitare" (Hungary), gel "Alferon N Gel" (USA), suppository, ointment and gel "Viferon" (Russia), eye drops "Berfor" (Austria) are used in clinical practice for the prevention and treatment of a wide range of viral diseases. The disadvantage of these drugs is relatively narrow range of clinical action required is quite high concentrations, side effects such as allergic reactions and a small shelf of drugs due to inactivation of interferon. None of the drugs interferon does not have concurrent antibacterial effect for treatment of opportunistic bacterial and fungal infections (chlamydia, bacterial dermatitis, enterocolitis, dysbacteriosis, pneumonia, candidiasis, and so on).

Similarly, oral is capable of producing alpha-2-interferon person (including registered in the all-Russian Collection of Industrial Microorganisms strain N VKPM B-7289). As filler for the local form can be used lanolin, petroleum jelly, agar and other gels, water, saline solution and other pharmaceutically-acceptable bases that do not have a negative impact on bacteria and products of their biosynthesis in vegetative and spore forms. Local form may be in the form of an emulsion, suspension, lotion, oil, cream, ointment, gel, varnish, aerosol, suppository, powder, etc. Local form can be applied epidermal, intrabronchial, intranasal, intrawaginalno, rectal, etc.

We created the product in gel form for topical application having antiviral and antibacterial activity was tested in a practical clinical setting called "Debrecen-Gel".

"Debrecen-Gel probiotic preparation of new generation on the basis of the living culture of Bacillus subtilis, containing the gene for alpha-2-interferon person. The use of "Debrecen-Gel topically leads to disputes existing in the gel bacteria, transformed into vegetative forms, which secrete enzymes (proteases, transferases, hydrolases, amylase, and others), vitamins (group and other), amino acids, ¡ to pathogenic microflora, located on the treated surface, such as streptococci, staphylococci, Salmonella, various species of Shigella, Pseudomonas aeruginosa, as well as other kinds of bacteria, viruses and fungi. Specific protease cut the damaged tissue proteins and facilitate their removal. Other biologically active substances provide the additional power available healthy cells, disposal of damaged tissue and the induction of interferon. In addition, due to the synthesis of interferon is local stimulation mainly cellular immunity, resulting in acceleration of the process of elimination of pathogenic microflora and healing of the affected surfaces. The drug is readily absorbed in the tissue and forms a protective film on the surface. As mentioned above the occasion of the oral form, is implemented other than injecting the path of delivery of active drug to the organs-targets. The drug is applied in a thin layer on the affected area 1-4 times per day during the entire course of therapy.

In many cases was effective not only oral or local form of the drug individually, but their combined use, as illustrated by the examples below. Similarly oral form, n is the temperature, headache, muscle aches, stomach, skin rashes, and so on).

Infection caused by the virus Herpes simplex and Herpes zoster

Example 21. Watched 26 ambulatory patients aged 19 to 50 years (16 men and 10 women) with different manifestations of herpes infections (Herpes genitalis, Herpes labialis, Herpes zoster) of moderate severity. The diagnosis was confirmed by detection of viral DNA in the contents of the vesicles (PCR-diagnostics). 9 patients had recurrent genital herpes on the background of significant immunodeficiency, 7 patients - shingles, 10 patients with Herpes labialis. All patients received therapy with acyclovir, without any significant effect. All patients on background treatment Depeconom "And" in combination with gel Debrecen-Gel" observed the reduction or disappearance of the cutaneous manifestations of herpetic infection, the positive dynamics of indicators of immune and interferon status, increasing the overall resistance of the organism.

Example 22. Patient I., 37 years old, was observed by the doctor-immunologist in connection with recurrent genital herpes. In the contents of the vesicles PCR detected DNA Herpes simplex II and scrapings from the mucous membrane of the cervical canal DNA of cytomegalovirus. Analysis of the immune status is; efficinet interferon system of the 3rd degree. Therapy with acyclovir and IFN clinical effect has not been given. The last 2 years relapses are repeated at least 2 times per month. Patient designated "Debrecen " And" in table 2. 3 times a day for 14 days and locally - gel Debrecen-Gel on the affected areas. At 2 weeks of starting treatment, the rash disappeared. Stable remission observed during the entire observation period (2 months), on the background normalization of immune status.

Example 23. Patient A., 28 years old, suffers from recurrent Herpes labialis with large lesions of the skin around the mouth and nose. The use of acyclovir was ineffective. Therapy "Debrecen " And" in combination with gel Debrecen-Gel" contributed to a significant reduction in the severity of infection and the area affected by the 4th day and cleanse the skin to 7 days of treatment. Stable remission observed during the entire observation period (6 months).

Example 24. Patient T., 43 years old, was observed at the dermatologist about Herpes zoster. Massive eruptions on the skin of the back. Persistent throughout, difficult to treat aciclovir. He was appointed "Debrecen " And" in table 2. 3 times a day in combination with gel Debrecen-Gel". On the 5th day from the start of treatment of vesicula is R> Example 25. Under the supervision of a dermatologist as outpatients were 11 patients (7 men and 4 women) aged from 23 to 45 years with a diagnosis of genital papillomatosis. In biopsies of lesions of patients determined the DNA content of human papillomavirus (HPV) by PCR and performed the typing of viruses. All observed patients papillomatosis wore a recurrent nature. Surgical removal of the papillomas were accompanied by their recurrence with different frequency. The study of the immune status in 100% of cases revealed significant deviations from the norm. Treatment "Debrecen-A (table 2. 3 times a day) in combination with applications of gel Debrecen And the Gel was carried out for 14 days, followed by 5-day intervals and repeated 14-day course. In 10 patients by the end of the course showed prolonged remission for 6 months (observation period), in one case marked relapse after 3 months.

Example 26. The patient Was, 23 years old, suffers from genital papillomatosis in the last two years with frequent relapses. Treatment Depeconom "And" began to take immediately after the removal of papillomas. In the biopsy identified DNA HPV type 6. General course "Debrecen And amounted to 28 days. The course combined with local application of gel Debrecen the orbital papillomatosis for 3 years with frequent relapses. In biopsies of lesions identified HPV DNA 8-th type. After the course "Depeconom" within 28 days in combination with gel Debrecen-Gel watched remission within 6 months (observation period).

Bacterial vaginitis

Example 28. Under the supervision of a gynecologist outpatient were 19 women aged 20 to 45 years with a diagnosis of bacterial vaginosis. In all patients the diagnosis was confirmed by microscopic identification of characteristic vaginitis microorganisms: Gardnerella vaginalis, Mobiluncus spp., anaerobic cocci. Patients underwent treatment "Depeconom-And within 5-7 days (table 2. 3 times a day) in combination with local application of gel Debrecen-A Gel in the form of applications on the mucous membranes of the vagina. In all cases, there were positive clinical dynamics (disappearance of discharge), accompanied by restoration of normal microflora of the vagina.

Example 29. Patient T., aged 30, has addressed to the gynecologist with complaints of vaginal discharge with strong odor. When the smear with the vaginal mucosa revealed a typical pattern promotes the almost complete absence of lactobacilli, the predominance of anaerobic cocci, key cells adhered a large number Gardnere the La "Debrecen-Gel". Upon completion of the course selection disappeared, microscopic examination of vaginal smear normalization of microflora (mucosal colonization by lactobacilli, gardnerelly and yeast is not found).

Example 30. Patient I., 41, was observed at the gynecologist in connection with recurrent bacterial vaginosis. At the last examination of smears from the mucous membrane of the vagina identified Trichomonas, key cells, the number of lactobacilli drastically reduced. Conducted a 7-day course Debrecen "And" in combination with gel Debrecen-Gel". If re-study of vaginal smears Trichomonas and Gardnerella is not detected, the number of lactobacilli increased significantly. Clinical signs of vaginitis completely disappeared.

Staphylococcal infection of the skin

Example 31. Under the supervision of a physician-immunologist outpatient were 35 patients aged from 16 to 30 years (18 men and 17 women) with a diagnosis of acne vulgaris. Lesions were localized on the face, chest, back. All patients bacteriological analysis of pus cultures of Staphylococcus aureus. In the comparison group (20 patients, 12 men and 8 women) were treated with adjuvant, tactivin, human immunoglobulin, staphylococcal vaccine based on the lesions and reduce the frequency of relapses. Patients of the studied group (15 people, 8 men and 7 women) received staphylococcal vaccine Wood 46 2 injections per week for 5 weeks, Debrecen by 1 tab. 4 times a day and topical application of the gel form of the drug ("Debrecen-Gel"). By the end of the first week of therapy noted the disappearance of papules, drying up pimples. By the end of the fifth week was complete remission in all affected areas of the skin. Recurrence was not during the whole observation period (5 months).

Example 32. Patient Z., 29 years. The diagnosis of acne vulgaris of the face and neck. By the end of the first week after the start of the comprehensive treatment "Debrecen", vaccine Wood 46 and topical gel Debrecen-Gel" has dramatically increased the effectiveness of local treatment; after 2 weeks, the affected area was significantly reduced; by the end of the fifth week observed a complete remission. Persistent no recurrence within four months.

Example 33. Patient H., 17 years. The diagnosis of acne vulgaris skin back and face. The low efficiency of tactivin and human immunoglobulin. Integrated therapy "Debrecen and vaccine Wood 46 with local application of gel Debrecen-Gel resulted in a complete remission within four weeks. Relapse was absent for three months (the observation period of the strain of Bacillus subtilis producing alpha-2-interferon man, and a filler, characterized in that it further contains a live culture of Bacillus lichemformis in the following ratio of components: Bacillus subtilis - 106- 107CFU (colony forming unit), Bacillus lichemformis - 105- 106SOME, filler up to 1000 mg, antibacterial, antiviral and immunomoduliruushimi activity.

2. The drug under item 1, characterized in that it contains recombinant strain of Bacillus subtilis VKPM-7289.

3. The drug PCP.1 and 2, characterized in that it is designed for the treatment of immunodeficiency States.

4. The drug PCP.1 to 3, characterized in that it is designed to ensure interfacedefinition syndrome.

5. The method of treatment of a disease of an infectious nature by introducing into the body of the drug on the basis of the living culture of B. subtilis, characterized in that the patient is injected biopharmaceutical drug under item 1 in an effective amount.

6. The method according to p. 5, wherein the infectious disease is selected from the group of bacterial infections: enteritis, colitis, acute intestinal infection (including young children), chlamydia, bacterial vaginosis, staphylococcal infection.


 

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