SU1754113A1 - Method for treatment of acute enteric infections in children - Google Patents

Abstract

This invention relates to medicine and can be used to treat acute intestinal infections in children. The purpose of the invention: reduction of treatment time due to the increased antibacterial activity of immunoglobulin preparations. This goal is achieved by the fact that a complex immunoglobulin preparation (CIP) is orally administered as a therapeutic drug, containing immunoglobulins of classes G, M and A 50–70%, 15–15% and 15–25%, respectively. The CIP contains elevated antibody titers against a number of enterobacteria (shigella, salmonella, Escherichia, etc.) compared with commercial gamma globulin. Orally administered in a dose of 300-600 mg or rectally 400 mg. The proposed method allows to obtain high therapeutic efficacy in children with acute intestinal infections. 2 tab. cl

Description

This invention relates to medicine, in particular to the treatment of infectious diseases and pediatrics.

The goal is to shorten the treatment time by increasing the antibacterial activity.

This goal is achieved by using the complex immunoglobulin preparation KIP containing the immunoglobulins of classes G. M and A.

Unlike commercial preparations of normal human gamma globulin, the used KIP preparation contains elevated antibody titers against shigella, salmonella, Escherichia, pneumo monads and e meningococci. The content of immunoglobulins G, M and A in it is, respectively,%: 50-70.15-25 and 15-25, whereas

normal human gamma globulin levels of Ig M do not exceed 4% of the total protein. Such a ratio of components in a complex immunoglobulin preparation determines its advantages in antibacterial activity and, first of all, against pathogens of acute intestinal infections (AII) - Shigella, Salmonella, Enteropathogenic E.CoP, the antibody titers to which in the TRC are 1: 640- 1: 2560.

State trials for efficacy in clinics were conducted, and human donor immunoglobulin, also dried in ampoules, was used as a placebo.

During the tests of the instrumentation received 94 children, human immunoglobulin - 85 children. Control group (82 people) consistency |

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with

la from patients receiving the usual course of antibiotic therapy (antibiotics, sulfonamides, etc.). Patients were selected by randomization. By age, children of the first 3 years of life prevailed. In the observations, the average form of the disease was more common.

Patients received the drug at a dose of 300 mg of protein once for 5 days 30 minutes before meals. For this, 5 ml of distilled water was added to the vial and rocked until dissolved. No other etiotropic agents have been used in the appointment of the TRC. The drug was administered to patients on the 1st day of their stay in the hospital, i.e. most children received the drug during the first 3 days of illness.

The evaluation of the effectiveness of treatment was carried out taking into account the dynamics of the main symptoms of intestinal disease for 5 days and included three degrees. The effect was considered to be positive, if during the 2-3 days after the administration of the drug, intoxication had decreased, stool multiplicity decreased and its consistency improved, pathological impurities disappeared, and by the end of treatment (5th day) the stool was completely normalized. The effect was considered negative if there was no distinct positive dynamics of the disease and patients were required to use other drugs to normalize the stool. A satisfactory effect implied a partial improvement in stool (reduction in the frequency and disappearance of impurities) without the subsequent use of other pharmacological preparations.

EXAMPLE 1: Patient R. Andrei, 7 months old, was admitted to the hospital on the 3rd day of his illness with a diagnosis of acute gastroenteritis of unspecified etiology, and an average body temperature of 38.5 ° C. On examination, there was a slight enlargement of the liver, bloating, vomiting, and loose stools up to 2 times a day.

Treatment was carried out by instrumentation, 1 dose 1 time per day for 5 days. Normalization of fever and stools began by the 4th day of treatment. On the 5th day, the child was discharged from the hospital.

PRI mme R 2. Patient G. Sasha, 11 months, was admitted to the hospital on the 1st day of illness. Diagnosis: intestinal infection of unequal etiology (KINE), gastroenteritis of moderate form, temperature 38.6 ° C, in anxiety, anxiety, pain, weakness, vomiting, water stool up to 11 times a day. On examination, abdominal distention was observed, skin irritation in the area of the anus, the tongue and pharynx were clean, the liver and spleen were enlarged.

The treatment was carried out by instrumentation, 1 dose 1 time per day. The drug was given for 5 days. Normal temperature was established on the 3rd day. Normalization of the chair stepped on

5th day. The child was discharged from the hospital.

Example 3: Patient L. Alyosha, 1 year, 3 months, diagnosis: acute gastroenteritis, tons of form. Was admitted to the clinic on the 1st day

0 disease with a temperature of 39 ° C. On examination, weight loss was observed in the cavity, vomiting 7 times a day, bloating and rumbling in the abdomen.

Treatment was carried out by instrumentation for 5 days - 1 dose per day. Vomiting stopped at

5 The 3rd day, the watery stool was two days, and then the improvement began. Normalization of temperature and stools occurred on the 4th day. On the 5th day, the child was discharged from the hospital.

0 Summarizing the results (see Tables 1 and 2) of the tests, the clinicians came to the following conclusions.

The clinical efficacy in the groups receiving the complex immunoglobuli5 new drug (KIP), human immunoglobulin and in the control was 92.6, 72.9 and 71.5%, respectively, while the effectiveness was absent 3 times more often in patients in the control group (28, 5%) and in a group

0 received immunoglobulin (27%), while the TRC was not effective in only 7% (see Table 1).

A good sanitizing effect (93%) was determined in relation to the elimination of pathogens when prescribing instrumentation in patients with salmonellosis, shigellosis, escherichiosis, and in an immunoglobulin sanitizing effect of 33% (see Table 2).

Depending on the etiology of intestinal

0 infections (salmonellosis, shigellosis, escherichiosis), clinical efficacy was higher with the appointment of instrumentation 86, 100 and 100%, respectively (with the prescription of immunoglobulin -40%, 25% and a complete lack of efficacy in escherichiosis).

In patients receiving KIP, a greater number of children (70.2%) normalized stools by the end of treatment (by the 5th day). When using immunoglobulin for intramuscular administration, by the same period, 54%, in control, 50% of patients.

Taking into account the high efficiency of instrumentation in the absence of adverse reactions and good tolerability, the drug can be

5 is recommended for the treatment of children with OCI of established and unidentified etiology.

Claims (1)

DETAILED DESCRIPTION A method for treating acute intestinal infections in children, including immunotherapy, characterized in that complex immunoglobulin is used to shorten the treatment time by enhancing antibacterial activity. preparation containing immunoglobulins of class G 50-70%. M 15-25% and A 15-25%. which is administered orally at a dose of 300-600 mg or rectally at a dose of 400 mg. Table 1 Comparative results of the treatment of patients with AOID drugs KIP, human immunoglobulin and antibacterial agents table 2 Comparative effectiveness of complex immunoglobulin preparation (TRC) and human immunoglobulin in relation to the elimination of pathogens in oral application Note. In the numerator, the total number of bacteriologically confirmed carriers, in the denominator, the number of sanitized carriers.