U.D.C.: 616.24-002.5:616.98:578.828HIV 

The researched group was 1.5 times dominated by male patients (42: 68.8%), over female (19: 31.2%), while the
majority of people were aged 31 to 50 years. 9.8% (6) of patients with chemoresistant pulmonary TB were hospitalized in serious condition. The average number of bed-days in hospital was (61.7 ± 4.5). 16 (26.2%) patients with chemoresistant TB died in the hospital. Our research shows that among patients with CR-PTB/HIV, rifampicin (R) resistance was 2 times more common than resistance to combination HRZE and Pre-XDR (32.8% vs. 16.4%, P < 0.05). Resistance to combination HRZ was the least common (1.4%). In some cases, they showed resistance to new anti-TB drugs (Bdg and Dlm). Disseminated PTB was 2.4 times more often diagnosed than miliary TB, and infiltrative PTB was 4.0 times more likely among CR-PTB/HIV.
Keywords: HIV/AIDS/TB, chemoresistant pulmonary tuberculosis.

УДК 616.24-002.5:615.015.8]-022.16-085.281-039.71-053.2/.6 

Анотація. Метою роботи було встановлення ефективності лікування новими ПТП на підставі імунологічних методів дослідження.
Матеріали  і  методи.  Порівняльний  когортний  аналіз  ефективності  лікування  із  застосуванням  нових  ПТП,  таких  як  бедаквілін  (Bdq)  і  деламанід (Dlm)  (40  хворих  дитячого  віку,  основна  група)  і  без  цих  препаратів  (контрольна група ‒ 27 хворих дитячого віку,) проведений у дітей та підлітків, хворих  
МР/РИФ-ТБЛ.  Визначення  популяційного  і  субпопуляційного  складу  лімфоцитів  крові  (CD3+,  CD3+CD56+,  CD3+HLA–DR+,  CD3+CD4+,  CD4+45RA+, CD3+CD8+,  CD4+/CD8+,  CD19+,  CD16/56+,  CD16/56+CD8+)  проведено  у в медичній лабораторії «ДІЛА», шляхом прямого методу імунофлюоресценції 
з використанням анти-СD-моноклональних антитіл з подальшою ідентифікацією поверхневих структур лімфоцитів на проточному цитофлуориметрі FACScan  BD Bioscience, США.
Результати та обговорення. На етапі завершення інтенсивної фази лікування усунення порушень в системі імунного захисту протікало активніше у пацієнтів, у режимах лікування яких був Bdq і Dlm. Сумарно, нормалізацію імунологічних показників відмічали у (29,6 ± 2,8) % в контрольній групі та у (43,4 ± 4,5) % осіб 
основної групи, р<0,05. Вірогідну різницю між групами отримано з боку показників ІРІ СD3+СD4+/СD3+СD8+, ІgМ та ЦІК.
Висновки.  Позитивну  динаміку  імунологічних  зрушень  виявляли  в  1,5  разів частіше у дітей та підлітків основної групи, що вказувало на зменшення явищ туберкульозної інтоксикації та антигенного навантаження в системі імунітету й кращу результативність лікування.
Ключові слова: туберкульоз, імунологічні критерії, ефективність, нові протитуберкульозні препарати. 

UDC 616.24-002.5-036.22-085.28.015.8-085.37-039.71-053.2

Aim – to study the feasibility of using the natural immunomodulator BIVEL (BI-V) as a non-specific immunoprevention of tuberculosis (TB) among contact children from focies of multidrug-resistant tuberculosis infection (FsMDR-TBI) on the basis of clinical and immunological studies.
Materials and methods. The object of study: 120 contacted from FsMDR-TBI (75 children and 45 adolescents). The Group 1 – 95 children/adolescents who did not receive BI-V and the Group 2 – 25 patients who received BI-V. The state of phagocytic reactivity of immunity; cellular and humoral immunity; interleukins and specific immunity were determined. Statistical analysis of the obtained results was performed based on a software package Excel.
Results. In infected children/adolescents with FsMDR-TBI, insignificant functional disorders of the cellular response were revealed (decrease by 1.3 times IRI CD3+CD4+/CD3+CD8+), a shift in the balance in the regulatory system towards pro-inflammatory cytokines (increase by 2.0 times TNF-α/IL-10). The existing deviations in the regulatory and cellular response systems disappeared after the completion of the autumn-spring BI-V course. Preventive administration of immunomodulator BI-V to infected children/adolescents with FsMDR-TBI reduced the frequency of acute respiratory viral infections and exacerbations of bronchopulmonary diseases by 2.0 times, the development of latent tuberculosis infection into an active process by 2.6 times. Among children of the Group 2 – 8% of people fell ill with various forms of primary pulmonary TB, among children of the Group 1 – 22.1%. In both groups, the maximum level of TB occurred in the first two years of observation.
Conclusions. The introduction of the algorithm of preventive measures with appointment of BI-V confirmed feasibility of using this immunomodulator for contact children/adolescents with FsMDR-TBI.
The study was carried out in accordance with the principles of the Declaration of Helsinki. The study protocol was approved by the Local Ethical 
Committee of the participating institution. The informed consent of patient was obtained for conducting the studies.
No conflict of interests was declared by the authors.
Keywords: immunoprevention, contact children and adolescents, focies of multidrug-resistant tuberculosis.

УДК: 616.24-002.5:615.015.8]-085.281-078.73-036.8-053.2/6

BACKGROUND. The feasibility of combining antimycobacterial therapy (AMBT) with bedaquiline (Bdq) and delamanid 
(Dlm) with non-specific immunomodulator BI-V in children and adolescents with multidrug-resistant and rifampicin-resistant pulmonary tuberculosis (MDR/Rif-TBP) needs to be studied.
OBJECTIVE. To find out the effectiveness of the use of complex AMBT with Bdq and Dlm with non-specific immunomodulator BI-V in children and adolescents with MDR/Rif-TBP.
MATERIALS AND METHODS. Children and adolescents with MDR/Rif-TBP at the initial stage of AMBT were given BI-V 
(BIVEL, Slovenia) as a non-specific immunomodulator. The patients were divided into two groups: 1st – 20 patients who received Bdq + Dlm + levofloxacin (Lfx) + linezolid (Lzd) + clofazimine (Cfz); 2nd ‒ 28 patients whose complex treatment included BI-V (Вdq + Dlm + Lfx + Lzd + Cfz + BI-V). BI-V was prescribed from the age of 3 years at 5 ml suspension once a day during 24 days.
RESULTS. The use of BI-V against the background of individualized regimens of AMBT in children and adolescents with  MDR/Rif-TBP increased the effectiveness of treatment, contributed to the disappearance of symptoms of intoxication, the resolution of infiltration foci and the healing of decay cavities in system of immune protection, which contributed to the shortening of the inpatient stage of treatment, while maintaining a high therapeutic effectiveness (“cured” ‒ 92.8 %)  and the formation of small residual changes in the lungs in the majority (89.3 %).
CONCLUSIONS. When using combined complex AMBT with Bdq, Dlm and BI-V, high therapeutic efficiency was observed  in most patients (92.8 %).
KEY WORDS: multiple drug-resistant pulmonary tuberculosis, treatment, bedaquiline, delamanid, BI-V, children, adolescents

UDC: 616.24-002.5:615.015.8]-022.16-085.281-039.71-053.2/.

Summary. 
120 exposed children/adolescents (75 children and 45 adolescents) from the multi-drug resistant tuberculosis sites underwent the complex clinical radiological and immunological examination. Insignificant functional disorders of cellular response (immunoregulatory processes) caused by the prevalence of suppressor and cytotoxic reactions by 1.3 times and by the prevalence of pro-inflammatory cytokines in the regulatory 
system (2.0 times above the norm, TNF-α/IL 10.0. р<0.01) were revealed in the infected children/adolescents from the multi-drug resistant tuberculosis sites, while their СD3+. СD3+СD4+. СD3+СD8+ were within norm. The evident disorders of the regulatory system and cell immune system were eliminated after the completion of the autumn-spring BI-V course. The non-specific immune regulator BI-V is efficient for the prevention of multi-drug resistant tuberculosis for the exposed children/adolescents from the multi-drug tuberculosis sites. Consequently, the latent TB infection grew into the active form by 2.8 times less often in the children that took BI-V as compared to the infected children who did not take the drug.
Key words: BIVEL immunomodulator, pulmonary tuberculosis in children, cellular immunity, tuberculosis.