Integrated therapy of community-acquired pneumonia

FIELD: medicine.

SUBSTANCE: invention concerns medicine, namely pulmonology, and can be used for treating community-acquired pneumonia in the patients with mid-severe and severe clinical course involving immunogram abnormalities. That is ensured by antibacterial therapy. In addition, for 3-4 day of treatment, the treatment regimen is supplemented with Polyoxidonium in a dose 6 mg daily intramuscularly within 5 days.

EFFECT: early positive dynamics of the main clinical symptoms of disease and normalisation of immunological indicators which allow reducing treatment time and preventing complications.

1 tbl, 1 ex, 1 dwg

 

The invention relates to medicine, namely to therapy, and can be used for the treatment of community-acquired pneumonia (EP).

EAP is one of the most common acute infectious diseases. The problem EAP is still relevant due to the high morbidity, with a tendency to increase. So, in the Russian Federation over the last 30 years increased by 3 times (from 5 to 15 per 1000 population per year) (Mukhina M.A., Galeeva ZH.A. Principles of antibiotic therapy of community-acquired pneumonia // Farmateka. - 2006. No. 16. - P.60-65).

Despite good results in the study of pathogenesis of infectious process, the effectiveness of chemotherapy and antibiotic therapy, the number of patients with severe, prolonged illness, and death is not only not reduced, but increased (Community-acquired pneumonia in adults: practical recommendations for diagnosis, treatment and prevention. Manual for doctors / Aguchi, Aiginsurance.com, Yakovlev S.V. [and others]. - M., 2003. 53). However, not well developed questions pathogenetic therapy of the EAP.

Many patients EAP are clinical manifestations of secondary immunodeficiency, namely: low-intensity inflammation, susceptibility to colds, minor and short-term effect of antibiotic therapy (Mukhina M is., Galeev ZH.A. Principles of antibiotic therapy of community-acquired pneumonia // Farmateka. - 2006. No. 16. - P.60-65).

Strategy for the use of drugs for infectious diseases traditionally focused on the use of a wide range of modern chemotherapeutic drugs as a means of etiotropic therapy, at the same time, the widespread use of various antibiotics has resulted in a substantial transformation of the etiology of the EAP, the formation of resistant to antibiotics of strains of pathogens. Attempts to overcome the problems identified by optimizing the only causal therapy do not lead to unambiguous results, so one of the actively ongoing areas include the impact on the reactivity of the organism, with the aim of increasing its resistance to etiopathogeny, immunotropic drugs. Currently, however, many of immunomodulatory drugs not proven clinical efficacy in the treatment of community-acquired pneumonia, and there are conflicting data about the appointment of immunotropic therapy in this disease (Mukhina M.A., Galeeva ZH.A. Principles of antibiotic therapy of community-acquired pneumonia // Farmateka. - 2006. No. 16. - P.60-65).

However, there is an opinion about whether the use of immunomodulators in this INF is ecchi from the first day of etiotropic therapy. According to some authors, already in the early stages of pneumonia observed dysfunction syndrome phagocytosis of alveolar macrophages, perhaps the use of immunomodulators that can adjust nonspecific protective factors, mainly by acting on cells of the monocyte-macrophage system. When activated, this system is driven by a whole set of specific and nonspecific factors of protection of the organism against infection.

The prototype of the present invention is a method of treatment of community-acquired pneumonia by use of licopid (Zavoruev A.I Clinical and immunological assessment of the effectiveness of immunotropic therapy of community-acquired pneumonia in young adults. Dis. Kida. the honey. Sciences. - Vladivostok, 2006. P.47).

The objective of the invention is to design (rationale) method pathogenetically oriented treatment EAP, providing positive dynamics of the main clinical symptoms and immunological parameters.

The technical result when using the invention, the positive dynamics of the main clinical symptoms: normalization temperature, reducing weakness, cough, headaches, tachycardia, dyspnea, rales in the lungs; immunological indicators: phagocytic number, phagocytic index, CD3, CD4, CD19, CD56, CRP, Ig G, Ig M, g A.

The proposed combined method of treatment of the EAP as follows: carry out standard antibacterial therapy EP (aminopenicillins, macrolides, fluoroquinolones). If deviations in the immunological patients with RR on 3-4 day hospital treatment intramuscularly polyoxidonium in a dose of 6 mg for 5 days. Polyoxidonium is physiologically active compound with a molecular mass of 100 kD and has a pronounced immunomodulatory activity. According to its chemical structure, it is a copolymer of N-oxide 1,4-ethyleneimine and (N-carboxyethyl) 1,4-ethyleneimine bromide with a molecular mass of 80 kD. Immunostimulating effect of polyoxidonium is associated with the ability to activate cells of the monocyte-macrophage system, resulting in increase of the functional activity of natural resistance factors (neutrophils, monocytes, macrophages, NK-cells) and factors of acquired immunity (humoral and cellular).

Polyoxidonium interacts well with antibacterial, antifungal and antiviral drugs, as well as interferons and inducers of interferons.

Disorders in the immune response of patients EAP proven by many researchers, the action spectrum of polyoxidonium suggests its effectiveness in complex Leche is the research Institute of the EAP.

The proposed method is illustrated in the drawing, which shows quantitative indicators lymphocyte subpopulations in patients with community-acquired pneumonia 10 days in 2 groups (group polyoxidonium and control].

We studied 60 patients EAP with moderate and severe course. The diagnosis of pneumonia and its degree of severity was determined in accordance with the recommendations of the all-Russian scientific society of pulmonologists. Depending on therapy all patients of the EP with moderate and severe severity were divided into 2 groups:

I-I group - 25 people treated in treatment immunomodulator polyoxidonium;

II-I group - 45 people, sick of the EAP who received standard therapy (control group).

In addition to clinical, laboratory and instrumental methods of research conducted complex immunological studies. Dynamic observations showed that in patients with EAP treated in complex therapy of polyoxidonium, after 2-3 injections was a decrease of symptoms such as weakness (85% of patients against 75,7%), cough (75% of patients vs. 69%), normalization temperature (73% vs. 68.9%)and headaches (61% compared to 58.2%), tachycardia (86% vs. 80%), dyspnea (55% vs. 35.9 percent), rales in the lungs (55% vs. 35.9 per cent). Immunological status in all patients with severe EAP to undertake the surveillance immunocorrective therapy decreased phagocytic number (p< 0,001), phagocytic index (p<0,001), CD3 (p<0,01), CD4 (p<0,01), CD 19 (p<0.01), and the decrease in CD56 (p<0.01), and increased CRP (p<0,001).

The results of immunological evaluation of patients treated in the adjuvant therapy of polyoxidonium, compared with the group receiving standard therapy, revealed a pronounced positive dynamics from the indices of cellular immunity and phagocytic activity of neutrophils. In the group of patients (treated with polyoxidonium) in the analysis of indicators of cellular immunity, we found a significant increase in the relative content of CD3+lymphocyte - 78,3±1,4%, CD4+-helpers of 45.3±1.3 per cent, compared with patients who received only standard therapy - 53,9±41,9% (p<0,01) and 30.4±1,6% (p<0,05), respectively; increased immunoregulatory index, which was 1.52±0.06, which was significantly higher values in patients of the control group - 1,27±0,05 (p<0,01) (see drawing).

Indicators of humoral immunity also reacted to immunocorrective therapy polyoxidonium: there was a trend toward normalization of Ig G patients treated in the adjuvant therapy of polyoxidonium, while in the control group, significant dynamics of indicators of humoral immunity was not observed after 10-14 days of treatment.

In parallel with the research of the immune status of us who studied the dynamics of cytokines in the serum of both groups tended to normalize levels of TNF-α and IL-6, however, their values remained significantly higher than the healthy group (table).

On the background of therapy with polyoxidonium is an increase in the total number of T-lymphocytes, T-helpers, immunoregulatory index, phagocytic index and phagocytic number.

Example

Patient S., aged 40, arrived on the 4th day of illness. Upon receipt complained of weakness, sweating, increased body temperature up to 40°C, cough yellow-green color, pain in the right half of the chest. Objectively: a serious condition. The pale skin, acrocyanosis. Percutere dullness of the lung sound right in the lower divisions, in the same breath weakened vesicular, wet fine basal rales, crepitation.

Radiography OGK: right inferior pneumonia, midlevel pleurisy.

In the General analysis of blood leukocytes to 11.7·109/l, stab neutrophils 22, segmented 53, lymphocytes 15, monocytes 6, eosinophils 4, ESR 61 mm/h

The immunological: Ig M 0,60 g/l; Ig G 4,7 g/l; Ig A 3,14 g/l; CD19 6,7%, CD3 55,9%, CD4 49,5%, CD8 32,4%.

The content of substances in serum: IL-4 to 29.8 PG/ml; IL-6 72,5 PG/ml; TNF-α 8 PG/ml

Clinical diagnosis of community-acquired bacterial driver proximal pneumonia, severe.

The GSP. DN 1-2. Encysted midlevel pleurisy on the right.

Patients received treatment proposed method is m The complex treatment included antibiotics (amoxicillin, macropen), detoxification therapy, mucolytics, 3-day treatment - polyoxidonium intramuscularly at a dose of 6 mg for 5 days.

On the background of the treatment, the patient noted improvement in health as reducing weakness, cough, temperature normalization, reduction, and then the disappearance of dyspnea, rales in the lungs on the 7-8th day of inpatient treatment.

Immunological status in the dynamics: the increase in relative and absolute number of CD3+lymphocyte - 78,3%, CD4+-helpers of 45.3%, CD56+lymphocytes 15.3%, and normalization of immunoregulatory index of 1.9, the reduction of CRP to 0.6 ng/ml, Ig M 1.55 g/l; Ig G 11.3 g/l; Ig A 3,14 g/l (results not significantly differ greatly from those of healthy). The content of substances in serum: TL-4 of 14.3 PG/ml; IL-6 to 45.5 PG/ml; TNF-α was 4.02 PG/ml (the tendency to normalization of the levels of TNF-α, IL-4 and IL-6, but their values remain significantly higher than the healthy group).

Thus, the complex therapy of the EAP with the inclusion of immunomodulator polyoxidonium, in comparison with standard therapy, leads to a more rapid normalization of the clinical condition, immunological parameters, providing a positive immunocorrective effect on the disease and a positive outcome of community-acquired pneumonia.

Table
Indicators of TNF-α, IL-6 (PG/ml) in patients with community-acquired pneumonia 10 days in 2 groups
IndicatorsI-I groupII-I groupThe healthy group
TNF-α, PG/ml4.09 to±2,62**6,54±2,11**1,50±0,35
IL-6, PG/ml14,3±8,2**59,16±30,8***5,50±2,30
Note - the statistical significance of the differences:
* - p<0,05; ** - p<0,01; *** p<0,001.

Method for the treatment of community-acquired pneumonia in patients with moderate and severe disease with variations in the immunological, including antibacterial therapy and the introduction of the immunomodulator on the 3-4th day of treatment, characterized in that as an immunomodulator is administered polyoxidonium in a dose of 6 mg / day intramuscularly for 5 days.



 

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