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INVENTION
Russian Federation Patent RU2144837

METHOD OF TREATMENT toxic and septic conditions in newborns

METHOD OF TREATMENT toxic and septic conditions in newborns

Name of the inventor: Korenkov I.P .; Bobkov YI .; Efimov MS .; Alexandrov AI .; Belchik YF .; Ahmina NI
The name of the patentee: Russian Medical Academy of Postgraduate Education of the Russian Federation Ministry of Health
Address for correspondence: 123836, Moscow, ul.Barrikadnaya, 2, RMAPO MoH, patent and licensing work department
Starting date of the patent: 1997.06.04

The invention relates to medicine, namely to neonatology. SUMMARY OF THE INVENTION: 5% glucose solution preliminarily irradiated with X-rays at a dose of 0.2 - 0.5 Gy / ml, and administered to a newborn immediately before or after, or simultaneously with the antibacterial agents. Use of the invention allows to obtain the following results: in the first day after the transfusion unexposed 5% glucose marked decrease symptoms of infectious toxicosis: children begin to suck themselves, become more active is added in weight; normalization of the general condition occurs in an average of 2-3 days earlier than patients receiving conventional treatment, transfusion of irradiated glucose has a stimulating effect on the immune antiendotoxic with septic disease, which manifests itself in an increase in reserves of endotoxin binding of granulocytes and the growth of anti-endotoxin antibody titers on three days after infusion, the complex treatment that includes transfusion of irradiated glucose, is more pronounced correction of hemostasis disorders and acid-base state blood of patients with severe bacterial infections, using this method dramatically reduces mortality, the method avoids the introduction into the body of a newborn baby products blood, which is fraught with various complications, including the introduction of AIDS infections, hepatitis.

DESCRIPTION OF THE INVENTION

The invention relates to medicine, namely to methods of treating toxic-sepsis in newborns.

Toxic-septic conditions occupy one of leading places in the structure of morbidity and neonatal mortality.

In the neonatal period they are formed in a modified immunological reactivity of the organism under the influence of unfavorable ante, intra and postnatal factors. The originality of immunobiological protection of newborn children determines their high susceptibility to a wide range of microorganisms. Therefore, the development of modern methods of immunotherapy to facilitate the effectiveness of treatment and reduce the mortality rate of newborn babies from severe bacterial infections is very important.

In the treatment of toxic and septic conditions in newborns using different methods:

1. Antibacterial therapy.

In appointing the drug taking into account: the severity of the disease; the individual characteristics of the newborn; inferiority of elimination mechanisms of liver and kidney, weak activity of certain enzymes. Treatment is carried out parenterally. The dose of antibiotic is determined in accordance with the severity of disease, birth weight and individual characteristics. However, the use of antibiotics contributes to the development of dysbiosis, the formation of multi-drug resistant strains of Enterobacteriaceae, sensitization, toxic effect on the kidneys [ "antibiotics". Materials of the Russian National Congress "Man and Medicine", Moscow, 1997].

2. Infusion therapy. The main objective of infusion therapy is: detoxification; Correction of metabolic disorders; replenishing the physiological fluid needs of the organism; improvement of blood microcirculation. After establishing the clinical diagnosis, determining the severity of the disease to the newborn child is assigned therapy comprising administration of one or more of the infusion solution (Hartmann's solution Aminosteril, Aminosol, levulose, 5% and 10% glucose solutions, repoliglyukin) [ "Principles of newborns with respiratory distress syndrome" . Guidelines. / Edited by Professor NN Volodin. Moscow, 1997, pp. 12].

3. Immunotherapy. Given that the inflammatory process is developing against the background of a reduced immunological reactivity of the patient, the importance of acquired immunological methods of infection control: specific immunoprophylaxis and immunotherapy with vaccines, anotoksinov, hyperimmune antimicrobial plasmas [E. Ovchinnikov. "Using specific plasma for the treatment of newborn babies with surgical infection Pseudomonas etiology", 2nd MOLGMI them. NI Pirogov. M., 1989, p. 20], immunoglobulins directed action and immunomodulators [ "Prevention of septic complications in surgical hospitals." Guidelines. M., 1995, 50 pp., Pp. 19-20]. It should be noted that one of the disadvantages of the use of blood products is a sensitization of the organism, the possibility of infection.

One of the most progressive is a method of treating septic conditions by increasing the immune resistance of the organism [ "The experience of quantum therapy in pediatric infectious pathology." IP Korenkov, F. Farzaliyev, SV Tarasov. M., 1992, p. 4], including isolation transfusion of blood substitutes irradiated with X-rays in conjunction with antibiotic therapy. The method was successfully used in the treatment of severe infections in infants. In newborns it has not been applied.

As a prototype accepted method for the treatment of toxic and septic conditions in infants [NV Beloborodov. "Algorithms antibacterial therapy for severe infections," Wiley: publishing company F.Hoffmann-La Roche Ltd.], comprising administering an antibiotic in appropriate dosages and 5% glucose solution in amounts physiological needs of the body.

The known method has several disadvantages: so often the effectiveness of antibacterial drugs is insufficient, their repeated use leads to a sharp sensitization of the body of the newborn, the development of side effects of using strong antibiotics (toxic effects on the kidneys, etc.), the inhibition of immune reactions of the child. To increase the effect of antibiotic therapy is necessary to combine it with the infusion therapy and increased immunoresistance body.

The object of the invention is to provide a method for the treatment of toxic and septic conditions in newborns, allowing to obtain a more pronounced therapeutic effect and to prevent possible complications.

Summary of the invention consists in the fact that the pre-irradiated with X-rays at a dose of 0.2 in a method of treating toxic-sepsis in newborn infants, comprising administering to the newborn 5% glucose solution and antibacterial drugs, glucose - 0.5 Gy / ml and his administration is performed immediately before or after, or concurrently with the administration of antibacterial agents.

Use of the invention allows to obtain the following technical result.

On the first day after the transfusion unexposed 5% glucose marked decrease symptoms of infectious toxicosis: children begin to suck themselves, gain weight, become more active. Normalizing the general condition occurs on average 2-3 days earlier than patients receiving conventional treatment.

Transfusion of irradiated 5% glucose has a stimulating effect on the immune antiendotoxic with septic diseases in term newborn infants, manifesting itself in an increase in reserves of endotoxin binding of granulocytes and the growth of anti-endotoxin antibody titers on the 3rd day after the infusion.

In the complex treatment including transfusion of irradiated 5% glucose, there is a more pronounced correction of hemostasis disorders and acid-base status of the blood of patients with severe bacterial infections.

Using this method dramatically reduces mortality. So of the 25 patients who received this treatment, fatal cases were not.

The method is highly effective in the treatment of toxic and septic conditions in term newborn infants, patients with pneumonia, bronchitis, pyelonephritis, enterocolitis, sepsis, meningitis, can reduce the severity of the disease and reduce the time of treatment. The method avoids the introduction into the body of a newborn baby blood products, which is fraught with various complications, including the introduction of AIDS infections, hepatitis.

Endotoxin is a general pathological factor in the development of many syndromes [ "The successes of theoretical and clinical medicine. Materials 1 Scientific Session of the Russian Medical Academy of Postgraduate Education." MY Yakovlev, M., 1995, p. 10-11], in particular, endotoxin shock, disseminated intravascular coagulation, infectious toxicosis observed during severe bacterial infections, determine the level of antibodies to endotoxin in the dynamics of the flow of toxic and septic conditions were used to assess the effectiveness of the treatment, its correction and prediction of disease outcome.

Clinical efficacy unexposed glucose due to increased humoral and cellular protection antiendotoxin manifested in the growth of antibodies to endotoxin, granulocytes ability to bind endotoxin, decreasing its systemic effects and thereby contributing to the reduction of toxicity. Thus, the irradiated glucose combines two functions: the infusion solution and an immunostimulant.

One of the main conditions of exposure of the isolated 5% glucose solution is the right choice of physical and technical parameters of exposure. With the physical and technical point of view, the task of selecting the optimal conditions is to create a uniform dose distribution in the irradiated volume and integration time infusion of irradiated solution.

Method is as follows

After establishing the clinical diagnosis and determine the severity of the disease and the child is prescribed antibiotics, making it an adjustment taking into account the sensitivity of the isolated microorganisms to the designated media.

The bottle of 5% glucose 500ml daily transfusions or transfusion day before irradiated via radiotherapeutic apparatus RUM-17. The radiation dose is 0.2 - 0.5 Gy / ml.

Isolated X-ray irradiation is performed glucose commercially available domestic industry radiotherapeutic devices such as RUM. These devices allow the most rapidly and simply produce radiation, providing accurate observance of the selected dose.

exposure mode 5% glucose solution for transfusion newborn is:. voltage - 200 kV, current - 15 mA, distance from the source to the object irradiation - 10 cm Filter is missing. Exposure dose rate of 7 Gy / min. The radiation dose is regulated by time X-ray tube and is dependent on the time of transfusion.

Transfusion previously irradiated by X-rays corresponding to 5% glucose solution dosage readings performed at a rate of 20-30 drops per minute.

The amount of glucose solution is calculated according to the physiological needs of newborn and infusion day according to the therapeutic indications [Reference neonatology. Ed. VA Tabalina and NP Shabalova. L .: Medicine, 1984, p. 291].

Introduction is performed immediately before or after, or simultaneously with the introduction of antibacterial drugs. The frequency of infusion is determined individually according to the patient's condition.

Example 1. A child H. girl. Transferred to the intensive care unit of the CST N 6 of the surgical department of TCS N 13 at the age of 28 days to 13 days of illness. DS: umbilical sepsis, omphalitis, erysipelas of the anterior abdominal wall, enterocolitis. When a condition is severe: swelling of the anterior abdominal wall, labia, bloating, sucks sluggish. Diffuse redness in the form of flames there. Chair green, with mucus. From urine, feces, navel isolated beta - hemolytic streptococcus. In the analysis of blood leucocytes of 15.9 x 10 9 / l, shift to the left, ESR - 2 mm / h. Hepatosplenomegaly stayed 4 days, occasionally fever. On the 4th day condition worsened due to the rise of infectious toxicosis, joining catarrhal symptoms, regurgitation, weight curve is flat. Antibiotic therapy was administered for 7 days at therapeutic dosages. In accordance with physiological need calculated once been transfused with 80 ml of 5% glucose solution was irradiated with X-ray irradiation dose - 0.2 Gy / ml simultaneously with lincomycin intravenous administration at a dose of 90 mg. The following day, the state has improved: sucks, do not burp, pink, no fever, catarrhal symptoms decreased. I began to gain weight. The patient was discharged in good condition on the 15th day. DS: postnatal umbilical streptococcal sepsis, st.septikopiemii (erysipelas anterior abdominal wall, arteritis, enterocolitis) during lightning.

Example 2. L. Child boy. He enrolled in the Department of Pathology neonatal CST N 6 in state of moderate severity at the age of 24 days, restless, painful cry, light manifestations of SARS. In urinalysis - l-all you n / s, protein and 0.99 g / l, leukocytosis - 22.2 × 10 9 l, ESR - 42 mm / h. Renal ultrasound - pronounced immaturity, renal lobed form, poor differentiation. The following day, the condition worsened due to infectious toxicosis, neurologic symptoms: pulls his head back, reflexes are not persistent, marbling of the skin, vomits, he does not suck, hepatosplenomegaly. Once introduced irradiated 5% glucose solution in a volume of 70 ml, calculated on the physiological needs for the day of transfusion, dose - 0.4 Gy / ml. Immediately after the infusion klaforan administered in a dose of 100 mg. The next day morning sickness decreased, eats itself, not regurgitation, weight gained, no fever, liver and spleen of normal size. Antibiotic therapy with claforan conducted for 3 days. The patient was discharged home in satisfactory condition on the 10th day. DS: toxic-septic condition, pyelonephritis newborns, postnatal malnutrition Article 2, AED, muscular dystonia syndrome..

Example 3. A child N. boy. Enrolled in the Department of Pathology neonatal CST N 6 at the age of 18 days from the somatic department Khimki CRH in serious condition due to infectious toxicosis, exsicosis 1-2 tbsp. I do not suck, restless, marbling of the skin. The blood tests: white blood cells - 16.1 x 10 9 / l, the shift to myelocytes, ESR - 8 mm / hr. L / P: 421/3 cell count, protein - 10 g / l, neutrophils - 25%. NSG: meanders smoothed, severe ventriculomegaly due to increase in the anterior horn (P-26, H-6) and occipital horns of the lateral ventricles. The third ventricle increased to 8 ml, hemorrhagic hydrocephalus occlusion (occlusion at the level of the 4th ventricle - bleeding in the cerebellum). On the first day, prior to administration of antimicrobials is transferred irradiated 5% glucose solution in an amount of 100 ml, calculated on the physiological need for the day dose - 0.5 Gy / ml. Antibiotics were administered in dosages meningitis 4 times a day - Claforan 300 mg / day, and gentamicin 30 mg / day. The following day, the state has improved: sucks itself, not burp, but the fever. In connection with the long-lasting infectious toxicosis received seven transfusions of glucose, irradiated at doses of 0.5; 0.4; 0.4; 0.3; 0.3; 0.2; 0.2 Gy / ml, respectively, in quantities of 100, 100, 90, 90, 80, 70, 60 ml. Condition improved: infectious toxicosis was stopped, became more active, putting on weight, sanitize liquor on the 20th day. Subsequently, during the treatment, the condition has stabilized. Discharged in satisfactory condition at the 25 th day. DS: purulent meningitis, hydrocephalus occlusion in / cerebellar hemorrhage.

CLAIM

A method for treating toxic and sepsis in newborn infants comprising administering antibacterial drugs and a 5% glucose solution, wherein the glucose solution preliminarily irradiated with X-rays at a dose of 0.2 - 0.5 Gy / ml, and its administration is directly before or after, or simultaneously with the introduction of antibacterial drugs.

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Publication date 09.01.2007gg