Nikolay Nikolenko

Dr. Nikolay Nikolenko

orcid

Research Focus & Metrics

Academic Career Length

6Years (2021-Present)

(Calculated once Scilit publication data is synced: current year − year of first publication + 1)

Representative Publications

View All Publications
27 July 2021 in FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology
Verified
Journal Article
Open access
PDF file
NNNikolay Nikolenko
Nikolay Nikolenko
DKDmitry Kudlay
Dmitry Kudlay
NDNatalia Doktorova
Natalia Doktorova
Treatment of multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB) is a current problem worldwide. Currently, special attention is paid to the possibility of using new high-cost chemotherapy regimens in the treatment of MDR/XDR-TB. Numerous studies have shown that, from a clinical point of view, the effectiveness of MDR/XDR-TB therapy increases with the inclusion of bedaquiline, delamanid, linezolid, fluoroquinolones (moxifloxacin, levofloxacin), and pretomanid. At the same time, there is an assumption that the use of new and repurposed anti-tuberculosis drugs (ATDs) may be associated with an increase in overall costs. This paper demonstrates the potential of pharmacoepidemiology and pharmacoeconomics to evaluate the widespread introduction of new anti-tuberculosis drugs (ATDs), taking into account all the typical features of MDR/XDR-TB therapy. The authors analyzed studies of pharmacoeconomic feasibility of using expensive drugs in treatment regimens of pulmonary tuberculosis patients with MDR/XDR pathogen. It was shown that the use of chemotherapy regimens containing new high-cost and highly effective drugs (moxifloxacin, linizolid, and bedaquiline) in rational combinations with other drugs of the basic and reserve series, selected concerning drug resistance of the pathogen, is associated with a significant economic effect. From the applicability of pharmacoeconomic analysis point of view, the introduction of short-term MDR-TB treatment regimens is also a promising direction in phthisiology. The key link to achieve effective MDR/XDR-TB treatment is the use of new drugs. Considering the specificity of pharmacoeconomic analysis in phthisiology and results of existing clinical and economic studies, the authors have formed recommendations aimed at a more complete realization of pharmacoeconomic analysis potential in MDR- and XDR-TB treatment.

20 October 2021 in Journal of Medical Microbiology
Verified
Journal Article
Open access
VLVitaly Litvinov
Vitaly Litvinov
MMMarina Makarova
Marina Makarova
DKDmitry Kudlay
Dmitry Kudlay
NNNikolay Nikolenko
Nikolay Nikolenko
JMJulia Mikhailova
Julia Mikhailova
Introduction. Nontuberculous mycobacteria (NTM) are widespread in the environment and can cause various diseases in humans, especially immunocompromised patients. Hypothesis. Treatment of diseases caused by NTM is a complicated issue, mainly due to the resistance of the pathogen to most antimicrobial agents. Bedaquiline (Bdq) is now widely used for the treatment of multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB). Aim. The main goal of our study was to evaluate the activity of Bdq against Mycobacterium avium complex (MAC), the most common species among NTM. Methodology. A total of 166 MAC cultures (124 Mycobacterium avium and 42 Mycobacterium intracellulare ) were studied. The minimum inhibitory concentrations (MICs) of Bdq for M. avium and M. intracellulare were obtained by twofold serial dilutions in the Middlebrook 7H9 medium. MIC ranges were determined and the MIC50, MIC90 and ECOFF values were obtained. Results. The MICs in respect of M. avium ranged from 0.003 to 1.0 µg ml−1; those for M. intracellulare ranged from 0.003 to 0.5 µg ml−1. The Bdq MIC50 and MIC90 values were found to be 0.015 and 0.12 µg ml−1 , respectively, for M. avium and 0.007 and 0.06 µg ml−1, respectively, for M. intracellulare . The tentative ECOFF values for M. avium and M. intracellulare were 0.12 and 0.06 µg ml−1, respectively. Conclusion. The main bedaquiline susceptibility parameters for MAC strains isolated in the Moscow region were determined.

11 February 2026 in Diseases
Verified
Journal Article
Open access
PDF file
Dmitry KudlayDmitry Kudlay
Dmitry Kudlay
ASAdilya Sabirova
Adilya Sabirova
OKOlesya Koroteeva
Olesya Koroteeva
Igor KudryavtsevIgor Kudryavtsev
Igor Kudryavtsev
ARArtem Rubinstein
Artem Rubinstein
DKDmitry Kudlay
Dmitry Kudlay
Background/Objectives: Latent tuberculosis infection (LTBI) represents a critical reservoir for subsequent development of active tuberculosis (ATB) and poses significant challenges for early diagnosis and disease prevention. Traditional immunological assays, such as interferon-gamma release assays (IGRAs), are limited in their ability to reliably distinguish LTBI from ATB. Recent advances in high-throughput omics technologies and machine learning (ML) approaches offer new opportunities for precise, biomarker-based differential diagnostics. Methods: Transcriptomic and proteomic profiling of host immune responses has revealed reproducible gene and protein signatures associated with LTBI and ATB. The integration of ML techniques—including feature selection, dimensionality reduction, multimodal learning, and explainable AI—facilitates the construction of robust diagnostic models. Single-modality signatures, derived from RNA-seq, microarrays, or proteomic assays, are complemented by multimodal approaches that incorporate soluble mediators, immunological readouts, and imaging-derived features. Deep learning frameworks, such as convolutional neural networks and transformer-based architectures, enhance the extraction of complex molecular and structural patterns from high-dimensional datasets. Results: ML-driven analyses of transcriptomic and proteomic data consistently outperform conventional immunological tests in terms of sensitivity, specificity, and clinical applicability. Multimodal integration further improves diagnostic accuracy and robustness. These advances support the translational development of concise, quantitative reverse transcription PCR (qRT-PCR)-based biomarker panels suitable for routine clinical application, enabling early and reliable differentiation between LTBI and ATB. Overall, the combination of high-throughput omics and AI-based analytical frameworks provides a promising pathway for enhancing global tuberculosis diagnostics. Conclusions: This review provides a structured and critical synthesis of transcriptomic and proteomic biomarker research for LTBI and ATB discrimination, with a particular emphasis on machine learning–based analytical frameworks. Unlike previous narrative reviews, we systematically compare data-generating platforms, modelling strategies, validation approaches, and sources of heterogeneity across studies. We further identify key translational barriers, including cohort homogeneity, platform dependency, and limited external validation, and propose directions for future research aimed at improving clinical applicability.

6 April 2022 in Meditsinskiy sovet = Medical Council
Verified
Journal Article
Open access
PDF file
TMT. I. Morozova
T. I. Morozova
NDNatalia Doktorova
Natalia Doktorova
OOO. N. Otpushchennikova
O. N. Otpushchennikova
NNNikolay Nikolenko
Nikolay Nikolenko
Introduction. Extensive drug resistance (XDR) M. Tuberculosis (MBT) is considered the main factor that reduces the effectiveness of the treatment of TB patients around the world, including Russia. A significant role in improving the effectiveness of chemotherapy (CT) in people with resistant TB belongs to the introduction of new anti-TB drugs, the first of which was bedaquiline (LP-002281).Objective. To assess the profile of an XDR-TB patient receiving bedaquiline and the efficacy of chemotherapy regimens including bedaquiline in patients with XDR pulmonary tuberculosis.Materials and methods. The study is retrospective, non-comparative, descriptive. The data of 88 patients who received bedaquiline in the XDR-TB treatment regimen in anti-tuberculosis institutions of the Saratov region in 2017–2018.Results. Patients with chronic TB prevailed – 50/88 [56.8%, 95% CI 46.3–67.4], every fourth patient had a history of surgery. The cessation of bacterial excretion, confirmed by bacterioscopy, was achieved in 51/67 [76.1%, 95% CI 65.7–86.5] patients; by cultural method – in 47/67 [70,1%, 95% CI 59.0–81.3]. Negative sputum smear in a significant proportion of patients 43/51 [84.3%, 95% CI 52.4–75.9] was observed after 12 weeks of therapy, negative cultures in 36/47 [76.6%, 95% CI 41.6–65.9] – after 16 weeks.Discussion. Compared to individual patient analyzes – 43% success rate in the treatment of XDR-TB, in our cohort of XDR-TB patients treated with bedaquiline, the success rate was 53.4%, which is consistent with data from a large study describing the safety in 2017, tolerability and efficacy of bedaquiline and could be higher in the absence of “discontinuations from treatment”.Conclusion. The regimens of treatment of patients with XDR-tuberculosis with the inclusion of bedaquiline are effective in terms of the termination of bacterial excretion, confirmed by bacterioscopy and culture in patients with a complex course of a specific process with previous ineffective therapy.

16 December 2024 in Tuberculosis and Lung Diseases
Verified
Journal Article
Open access
PDF file
LSL. V. Slogotskaya
L. V. Slogotskaya
EBE. M. Bogorodskaya
E. M. Bogorodskaya
LSL. F. Shamuratova
L. F. Shamuratova
TST. A. Sevostyanova
T. A. Sevostyanova
DKDmitry Kudlay
Dmitry Kudlay
NNNikolay Nikolenko
Nikolay Nikolenko
The objective: to assess effectiveness of mass screening for tuberculosis infection in children and adolescents in Moscow, determine infection rate and incidence in different age groups.Subjects and Methods. Screening was performed in 2023. Two different screening methods were used in different ages: all children aged 0 to 7 years were given Mantoux test with 2 TU PPD-L, and if the reaction increased versus the previous year, a test with tuberculous recombinant allergen (Diaskintest or TRA) was performed additionally. Children and adolescents aged 8-17 years were given the TRA test only. Mantoux test was used in 729,972 children from 0 to 7 years old. Positive responses were observed in 488,706 (66.9%) of them, which was due to the high rate of post-vaccination allergies at that age. When tuberculosis infection was suspected, the TRA test was performed in 21,552 people. (4.4% of all tuberculin-positive individuals). At the same time, positive reactions were noted in 201 people (0.9%). Among them, tuberculosis was detected in 7.5% (15 patients), post-tuberculosis changes (the calcification phase of the disease) were detected in 8.5% (17 people), while the proportion of positive reactions to the TRA test increased. Children of 8-17 years old were screened with the TRA test only. 1,170,461 people were examined, positive reactions were noted in 0.2%. The detection rate of tuberculosis among them was 1.6% (30 people), and the rate of the calcification phase of the disease indicating spontaneous recovery was 3.7%. The proportion of positive reactions is growing as the age of children increases, which corresponds to the higher incidence of pulmonary tuberculosis at these ages. The analysis of the incidence of various forms of tuberculosis in Moscow revealed the following. At the age of up to 7 years, tuberculosis of the lymphatic system predominates and this is the period with the highest incidence of this form. Then in the period before puberty, the lowest incidence is observed. After that, pulmonary forms of tuberculosis begin to predominate, and in adolescence, the incidence rises to maximum rates. BCG vaccination in the neonatal period resulted in the near disappearance of tuberculosis mortality, and such forms as miliary tuberculosis and meningitis. However, BCG vaccination and revaccination could not prevent pulmonary forms of tuberculosis in adolescence. The article presents age-specific mortality rates in Moscow in the pre-antibacterial era, when BCG vaccination was not available and the predominant forms of tuberculosis at different ages were the cause of death.Results: Obviously, a one-stage screening (TRA test) performed in children of 8-17 years old, is more convenient for both medical workers and patients, and it is more cost effective. However, it is currently impossible to switch to this test when examining children under 7 years, since children receive BCG revaccination if the response to Mantoux test is negative.

19 July 2023 in FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology
Verified
Journal Article
Open access
PDF file
NNNikolay Nikolenko
Nikolay Nikolenko
DKDmitry Kudlay
Dmitry Kudlay
SBS. E. Borisov
S. E. Borisov
TSTatiana E Sannikova
Tatiana E Sannikova
NDNatalia Doktorova
Natalia Doktorova
Objective: analysis of clinical and economic efficiency of various etiotropic chemotherapy regimes in patients with respiratory tuberculosis with multidrug- and extensively drug-resistant (MDR and XDR) pathogen using the pharmacoeconomic modeling method (Markov model).Material and methods. A single-centre, observational, retrospective, cohort study was performed, which included patients who received treatment in clinics and affiliated organizations of the main Moscow tuberculosis institution during 2014–2019 regarding respiratory tuberculosis with the MDR/XDR pathogen. The data of 1387 patients were analysed, of which 1093 patients received “optimized basic regimen” (OBR) in accordance with the Federal Clinical Recommendations of 2015, 294 patients received etiotropic therapy in accordance with the recommendations of the World Health Organization of 2018–2019. To evaluate economic efficiency, the pharmacoeconomic costeffectiveness analysis and pharmacoeconomic modeling were used. When assessing the economic costs of treatment, the direct costs (medical and non-medical) were taken into account.Results. The study results showed that 68.4% of patients in the group with bedaquiline-containing chemotherapy regimens reached the outcome of “treatment successfully completed” (patient was cured or transfered into the III group of dispensary follow-up) compared to 51.8% in the OBR group. The use of “new” etiotropic therapy regimens is most economically justified in patients with ХDR-tuberculosis with repeated treatment courses: incremental cost-effectiveness ratios (ICER) were 24,530.20 and 21,526.50 rubles per 1 patient. Markov model was developed, transitions from one state to another were evaluated according to the results of clinical observations during the first 2 years of research.Conclusion. The use of the dynamic model of the patient state made it possible to refine the estimates of the effectiveness of the compared etiotropic chemotherapy regimens for tuberculosis with MDR/XDR pathogen. Based on the results of modeling the dynamics of patients in the interval of 2 to 10 years of treatment, the use of “new” regimens provides a significant increase in the proportion of treatment success (by 16.1–29.8% in different groups of patients and at different times), a decrease in mortality (by 6.1–11.0%), and in the proportion of those who interrupted treatment (by 8.0–21.8%) in comparison with OBR.