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V. I. Ivanova-Radkevich ¹, E. V. Filonenko ², E. K. Slovokhodov ³, I. P. Smirnova ⁴, O. M. Kuznetsova ⁴, T. A. Lobaeva ⁴, Yu. Sh. Gushchina ⁴, Z. S. Khadasheva ⁵

Affiliations
1 State Scientific Center Scientific Research Institute Organic Intermediates and Dyes, Moscow, RU
2 P. A. Herzen Moscow Research Oncology Institute (Branch of FSBI “NMRRC” of the Ministry of Health of the Russian Federation), Moscow, RU
3 City Clinical Hospital No. 40, Moscow, RU
4 Peoples Friendship University of Russia, Moscow, RU
5 Federal State Educational Institution of Higher Professional Education, The Chechen State University, Grozny, RU

Abstract

Background: This paper deals with the statistical and methodological study conducted in order to assess the possibility of combining in one study, Phase 2 and 3 clinical trials of the Russian drug Hexasense based on 5-aminolevulinic acid hexyl ester. Methods: Hexasense drug is intended for fluorescence diagnosis of bladder cancer (the route of administration - intravesical instillation of solution). The clinical trial involved a comparative study of the effectiveness of diagnostic fluorescence depending on the exposure time of the drug solution in the bladder (1 and 2 hours). This is due to the fact that the time interval of 2 hours checked on the research Phase 1 used to cause inconvenience to patients. Results: After selecting the optimal diagnostic mode (a task of Phase 2) it is necessary to evaluate the effectiveness of the selected mode as compared to standard white-light cystoscopy (a task of Phase 3). Comparison of the effectiveness of two diagnostic fluorescence diagnostic modes with different exposure time of solution of 1 and 2 hours has been planned. At the second stage, the selected fluorescence diagnosis mode will be compared with the results of a standard white-light cystoscopy obtained in the same group of patients. A difference of 10% will be taken for significant differences in values of sensitivity and specificity. The statistical analysis showed that the required number of patients at a significance level of 2.5%, power of 80%, and for minimum difference in proportions of 10% subject to the correction of 10% for the dropout and unassessed patients would be 134 people (two groups of 67 patients). In this case, the same sample of patients allows comparing reliably the effectiveness of two diagnoses with the correction for multiplicity of comparison. Application: This will help to minimize the number of patients involved in the study and not reduce the accuracy of the results at the same time. The Ministry of Health of the Russian Federation authorized the clinical trial of the drug Hexasense with Phases 2 and 3 combined.

Keywords

5-Aminolevulinic Acid Hexyl Ester, Bladder Cancer, Clinical Trials, Organization of Clinical Trials.

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I. P. Smirnova ¹, S. P. Syatkin ², T. A. Lobaeva ¹, A. S. Skorik ¹, S. M. Chibisov ³, M. L. Blagonravov ³, G. I. Myandina ⁴, V. I. Kuznetsov ⁴

Affiliations
1 1T. T. Berezov Department of Biochemistry of PFUR. Moscow, RU
2 Peoples’ Friendship University of Russia (PFUR), Miklukho-Maklaya str., 8, Moscow, RU
3 Department of Pathological Physiology of PFUR, Moscow, RU
4 Department of Biology and General Genetics of PFUR, Moscow, RU

Abstract

We studied the immunomodulatory activity of L-lysine-α-oxidase (LO) from Trichoderma harzianum Rifai F- 180 to model endogenous colony-forming cells surface of the spleen of the mice of line F/SVA С157В1. LO shows immunomodulatory activity on models in vivo and in vitro.

Keywords

L-lysine-α-Oxidase, x-Ray, Immunomodulatory Activity.

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O. M. Yuldashova ¹, S. M. Chibisov ², R. O. Karybekova ³, M. V. Abramova ², S. P. Syatkin ², E. V. Neborak ², I. P. Smirnova ², G. I. Myandina ², M. L. Blagonravov ², V. I. Kuznetsov ²

Affiliations
1 Osh State University, RU
2 RUDN University, RU
3 Osh Interregional Children's Hospital, RU

Abstract

The size of chest circumference of 1578 Kyrgyz male born at different altitudes were estimated during the observation period from 2003 to 2011. The study found the following correlation: the higher altitude at which the neonates were born, the lower was their chest circumference.

Keywords

Chest Circumference, Newborn, Altitude.

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S. M. Chibisov ¹, M. V. Abramova ¹, M. L. Blagonravov ¹, J. V. Voropaeva ², S. A. Meladze ², S. P. Syatkin ¹, E. V. Neborak ¹, I. P. Smirnova ¹, G. I. Myandina ¹, V. I. Kuznetsov ¹

Affiliations
1 RUDN University, RU
2 Research Clinical Pediatric Pirogov Institute GBOU VPO of the Ministry of Health of Russia, Moscow, RU

Abstract

Currently there is no consensus about the etiology and pathogenesis of the conditions, manifested by a persistent increase in the thymus gland. A retrospective long-controlled study conducted on the basis of computer monitoring clinical examination of children discrete ages to test hypothesis about the sensitivity of the thymus gland during embryogenesis to heliogeomagnetic fluctuations (magnetic storms). The results showed that children with a persistent increase in the thymus and in healthy children during ontogeny (embryogenesis) geomagnetic conditions significantly different. It is assumed that the low level of geomagnetic activity during the final formation of all areas of the thymus (emigration of T-lymphocytes, check their peripheral lymphoid organs and in the period of active growth of the parenchyma of the thymus) may be a risk factor for persistent hyperplasia of thymus. The data obtained do not contradict the idea that developing structures required a certain optimum level cosmophysical impact.

Keywords

Children, the Thymus Gland, Thymus, Timomegalia, Solar Activity, Heliogeomagnetic Activity, Heliogeomagnetic Indexes, Critical Periods of Embryogenesis, Fetal Development, Prenatal Development, Gestational Periods.

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I. V. Rakovskaya ¹, I. P. Smirnova ², S. P. Syatkin ², G. I. Myandina ², S. M. Chibisov ², M. L. Blagonravov ², A. S. Skorik ²

Affiliations
1 Federal State Budgetary Institution “Research Institute of Epidemiology and Microbiology Named after Honorable academician N. F. Gamaleya”, 16 Gamalei Str, Moscow, RU
2 Medical Department of Medical Institute of Peoples’ Friendship University of Russia, 6 Miklukho-Maklaya Str., Moscow, RU

Abstract

Concentrate of the culture liquid of Trichoderma harzianum Rifai F-180-producer of the enzyme L-lysine-α- oxidase with activity in the culture fluid 0,54-0,56 U/ml was obtained by culturing in the fermenter. For the first time we studied the influence of obtained concentrate on the growth of Mycoplasma: 2 species of the family Мycoplasmataceae: Mycoplasma hominis (Mh) and Mycoplasma fermentans (Mf) and one species representative of the family Aholeplasmataceae: Aholeplasma laidlawii (Al). It is shown that the cultural liquid of Trichoderma producer of the enzyme L-lysine-α-oxidase inhibits the growth of Mycoplasma hominis after the preliminary contact. The degree of growth inhibition depends on the sowing dose of Mycoplasma and concentration of the culture fluid of Trichoderma.

Keywords

L-lysine-α-Oxidase, Concentrate of Trichoderma, Mycoplasma.

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V. F. Larichev ¹, I. P. Smirnova ², S. P. Syatkin ², G. I. Myandina ², S. M. Chibisov ², Е. А. Ryskina ²

Affiliations
1 Federal State Budgetary Institution “Research Institute of Epidemiology and Microbiology Named after Honorable Academician N. F. Gamaleya”, 16 Gamalei Str, Moscow, RU
2 Medical Department of Medical Institute of Peoples’ Friendship University of Russia, 3 Ordzhonikidze Str., Moscow, RU

Abstract

For the first time we studied the effect of the anticancer drug L-lysine-α-oxidase, obtained from culture liquid of Trichoderma harzianum Rifai F-180.

In vitro experiments we established the high activity of L-lysine-α-oxidase in a model of tick-borne encephalitis and the lack of activity against viruses Sindbis, West Nile, Tahyna and Dhori.

Keywords

L-lysine-α-Oxidase, Arboviruses, Tick-Borne Encephalitis, Cytopathic Effect, Antiviral Activity.

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M. V. Dementyev ¹, S. M. Chibisov ², M. V. Abramova ², S. D. Beeharry ², M. L. Blagonravov ², S. P. Syatkin ², E. V. Neborak ², I. P. Smirnova ², G. I. Myandina ², V. I. Kuznetsov ²

Affiliations
1 South Ural State Hospital, Chelyabinsk, RU
2 RUDN University, RU

Abstract

To prevent disease it is not enough to eliminate only modifiable factors but it is also necessary to identify patients at a preclinical stage, when physiological parameters are still within normal limits, but there is an excess stress on the regulation systems. In this study, we aim to examine the parameters of the cardiovascular system(CVS) from their physiological limits to diagnose desynchronization at an early stage.

Keywords

Desynchronosis, Shift Work, Desynchronization, Driver, Prophylaxis.

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