[Erratum in "Point-of-Care Blood Glucose Testing: Post-Market Performance Assessment of the Accu-Chek Inform II Hospital-Use Glucose Meter" (DOI: 10.26442/00403660.2023.12.202522)].

In the article "Point-of-care blood glucose testing: post-market performance assessment of the Accu-Chek Inform II hospital-use glucose meter," published in the Terapevticheskii Arkhiv journal, Vol. 95, No.12, 2023 (DOI: 10.26442/00403660.2023.12.202522), errors were made: the term "measurements at the place of treatment" was changed, as well as the section "Conflict of interest." At the request of the authors' team, errors in the conflict of interest and the wording of the term have been corrected, and the section "Information about the authors" has been updated. The publisher replaced the original version of the published article with the corrected one; the information on the website was also corrected. Correct text of the section "Conflict of interest": Conflict of interest. All authors are not employees or consultants of Roche Diagnostics and have not received any compensation from Roche Diagnostics. Correct wording of the term in Russian: "измерения по месту лечения". Changes were made to the title of the article in Russian: "Измерения глюкозы по месту лечения: пострегистрационное испытание госпитального глюкометра Акку-Чек Информ II", the text of the abstract, keywords, citation, in the text of the article, and abbreviations. Information of the place of work has been updated: Center for Laboratory Diagnostics of the Russian Children Clinical Hospital, a Branch of the Pirogov Russian National Research Medical University. The publisher apologizes to readers and authors for the errors and is confident that the correction of errors will ensure the correct perception and interpretation of the results of the study described in the text.

[Point-of-Care Blood Glucose Testing: Post-Market Performance Assessment of the Accu-Chek Inform II Hospital-Use Glucose Meter].

BACKGROUND: A point-of-care glucose testing (POCT) is an essential component of care in patients with hyperglycemia and hypoglycemia in inpatient and outpatient settings. In Russian medical facilities (MFs), conventional glucose meters designed for self-monitoring by patients with diabetes are commonly used for POCT. These home-use meters have two serious disadvantages: the first is large measurement bias and the second - they can't be integrated into laboratory information systems, so measurement data have to be recorded into patient charts manually. Both factors may lead to medical errors. It is reasonable to use in the MFs specialized POCT glucose meters, as they are superior to conventional ones in accuracy and may be easily connected to laboratory information systems. With this in mind, physicians at the Russian Children's Clinical Hospital decided to substitute conventional meters with the Accu-Chek Inform II POCT meter, however, after preliminary performance assessment of the model. AIM: To test the Accu-Chek Inform II performance characteristics: accuracy, linearity, repeatability, and mean absolute relative difference (MARD). MATERIALS AND METHODS: Performance of the Accu-Chek Inform II was tested by comparing the results of parallel CGL measurements with the meter and reference laboratory analyzer in capillary blood samples. Overall, 99 parallel CGL measurements were made in 45 samples. Accuracy was evaluated according to the ISO 15197-2013 and POCT12-A3 criteria. RESULTS: The Accu-Chek Inform II meter met the requirements of ISO 15197-2013 and POCT12-A3 and demonstrated high linearity (correlation coefficient, r=1,0), good repeatability (mean coefficient of variation, CV=1,38%) and acceptable MARD (4,9%). CONCLUSION: The Accu-Chek Inform II POCT glucose meter may be efficiently and safely used in inpatient and outpatient MFs and particularly in pediatric clinics.

Self-sustained non-equilibrium co-existence of fluid and solid states in a strongly coupled complex plasma system.

A complex (dusty) plasma system is well known as a paradigmatic model for studying the kinetics of solid-liquid phase transitions in inactive condensed matter. At the same time, under certain conditions a complex plasma system can also display characteristics of an active medium with the micron-sized particles converting energy of the ambient environment into motility and thereby becoming active. We present a detailed analysis of the experimental complex plasmas system that shows evidence of a non-equilibrium stationary coexistence between a cold crystalline and a hot fluid state in the structure due to the conversion of plasma energy into the motion energy of microparticles in the central region of the system. The plasma mediated non-reciprocal interaction between the dust particles is the underlying mechanism for the enormous heating of the central subsystem, and it acts as a micro-scale energy source that keeps the central subsystem in the molten state. Accurate multiscale simulations of the system based on combined molecular dynamics and particle-in-cell approaches show that strong structural nonuniformity of the system under the action of electostatic trap makes development of instabilities a local process. We present both experimental tests conducted with a complex plasmas system in a DC glow discharge plasma and a detailed theoretical analysis.

Impact of discontinuation of antithrombotic therapy after surgery for chronic subdural hematoma.

INTRODUCTION: The management of antithrombotic therapy (AT) after surgery for chronic subdural hematoma (cSDH) requires taking account of the balance of risk between hemorrhage recurrence (HR) and the prophylactic thromboembolic effect (TE). The goal of the present study was to evaluate the prevalence of vascular events (VE: TE and/or HR) in the first 3 postoperative months after cSDH evacuation in patients previously treated by AT. The impact of AT resumption was also evaluated. PATIENTS AND METHODS: This observational prospective multicenter collaborative study (14 French neurosurgery centers) included patients with cSDH treated by AT and operated on between May 2017 and March 2018. Data collection used an e-CRF, and was principally based on an admission questionnaire and outcome/progression at 3 months. RESULTS: In this cohort of 211 patients, VE occurred in 58 patients (27.5%): HR in 47 (22.3%), TE in 17 (8%), with mixed event in 6 cases (2%). Median overall time to onset of complications 26 days±31.5, and specifically 43.5 days±29.25 for HR. Non-resumption of AT significantly increased the relative risk of VE [OR: 4.14; 95% CI: 2.08 - 8.56; P <0.001] and especially of TE [OR: 7.5; 95% CI: 1.2 - 42; P<0.001]. The relative risk of HR was significantly increased when AT was resumed at less than 30 days (P=0.015). CONCLUSION: The occurrence of VE in patients operated on for cSDH and previously treated by AT was statistically significant (27.5%). HR was the most common event (22.3%), whereas TE accounted for only the 8%, although with shorter time to onset. In order to prevent TE risk, AT should be restarted after 30 days, as HR risk is greatly decreased beyond this time.

A Simplified Streptozotocin-Induced Diabetes Model in Nude Mice.

Preclinical studies of human cellular and tissue-based products (HCT/Ps) for transplantation therapy of type 1 diabetes mellitus (T1DM) necessarily involve animal models, particularly mouse models of diabetes induced by streptozotocin (STZ). These models should mimic the clinical and metabolic manifestations of T1DM in humans (face validity) and be similar to T1DM in terms of the pathogenetic mechanism (construct validity). Furthermore, since HCT/Ps contain human cells, modeling of diabetes in immune-deficient animals is obligatory. Here we describe the most simplified diabetes model in Nude mice. Diabetes was induced in 31 males by a single intraperitoneal injection of STZ in normal saline at a medium-to-high dose of 150 mg/kg body weight. Fourteen control animals received only saline. Non-fasting plasma glucose (PG) levels were measured periodically for 50 days. All STZ-treated mice survived beyond 50 days. By day 15 after STZ administration, 22 of 31 (71%) mice developed stable diabetes based on the following criteria: (1) non-fasting PG ≥ 15 mmol/L on consecutive measurements up until day 50; (2) no diabetes remission. The mean non-fasting PG in mice with stable diabetes over the period of 35 days was equal to 25.7 mmol/L. On day 50, mean plasma insulin concentration, mean pancreatic insulin content, and the average number of ß-cells in pancreatic islets were 2.6, 8.4, and 50 times lower, respectively, than in the control animals. We consider that our Nude mouse model of diabetes meets face validity and construct validity criteria and can be used in preclinical studies of HCT/Ps.

Efficacy and safety in frameless robot-assisted stereo-electroencephalography (SEEG) for drug-resistant epilepsy.

INTRODUCTION: Stereo-electroencephalography (SEEG) is an invasive procedure, used to identify the epileptogenic zone that can be surgically removed in order to treat drug-resistant epilepsy. Frameless robot-assisted positioning of depth electrodes permits a 3D approach with different obliquities and trajectories. The objective of the present study was to evaluate the morbidity and the accuracy related to this frameless procedure. PATIENTS AND METHODS: Sixty-six patients were managed wherein 901 electrodes were implanted during a 6-year-period. All patients had a postoperative CT-scan that was fused with preoperative MRI planning. In order to assess the accuracy of the procedure, the Euclidian distance was calculated between the coordinates of the planned trajectory and the actual position of the electrode at the entry point and at the target point for 857 electrodes. RESULTS: Among the 66 patients, one (1.5%) experienced a symptomatic brain haematoma and one (1.5%) a stroke-like migraine after radiation therapy (SMART) syndrome. There was no permanent morbidity or mortality. Compared to the classical SEEG approach, a higher rate of asymptomatic postoperative bleeding was found on the CT-scan in 8 patients (12.1%). Any infectious events were recorded. The median accuracy of frameless robotic SEEG procedure was equivalent to a 1.1mm error deviation (0.15-2.48) at the entry point and 2.09mm (1.06-3.72) at the target point respectively, with no differences for double obliquity trajectories. CONCLUSION: Frameless robot-assisted SEEG appears to be a safe procedure, providing sufficient accuracy in order to delineate the epileptogenic zone and represents a helpful tool in the pre-surgical management of refractory epilepsy.

Pure endoscopic management of epileptogenic hypothalamic hamartomas.

Hypothalamic hamartomas (HH) are rare congenital malformations located in the region of the tuber cinereum and third ventricle. Their usual clinical presentation is characterized by gelastic/dacrystic seizures which often become pharmaco-resistant and progress to secondary focal/generalized intractable epilepsy causing mostly in children cognitive and behavioral problems (particularly in cases of progressive epileptic encephalopathy) and precocious puberty. Whereas gelastic seizures can be surgically controlled either by resection of the lesion or disconnection (tissue-destructive) procedures, aimed at functionally prevent the spreading of the epileptic burst; generalized seizures tend to respond better to HH excision rather than isolated neocortical resections, which generally fail to control them. Prospective analysis of 14 consecutive patients harboring HH treated in an 8-year period; 12 patients had unilateral and two bilateral HH. All patients were managed by pure endoscopic excision of the HH. The mean operative time was 48 min and mean hospital stay was 2 days; perioperative blood loss was negligible in all cases. Two patients showed a transient diabetes insipidus (DI); no transient or permanent postoperative neurological deficit or memory impairment was recorded. Complete HH excision was achieved in 10/14 patients. At a mean follow-up of 48 months, no wound infection, meningitis, postoperative hydrocephalus, and/or mortality were recorded in this series of patients. Eight patients became seizure free (Engel class I), 2 other experienced worthwhile improvement of disabling seizures (Engel class II); 2 patients were cured from gelastic attacks while still experiencing focal dyscognitive seizures; and 2, having bilateral HH (both undergoing unilateral HH excision), did not experience significant improvement and required later on a temporal lobectomy coupled to amygdalohyppocampectomy. Overall, the followings resulted to be predictive factors for better outcomes in terms of seizure control: (1) cases of unilateral, Delalande class B, HH, (2) shorter history of epilepsy. Endoscopic resection of HH proved, in our series, to be effective in achieving complete control or in reducing the frequency of seizures. Furthermore, this approach has confirmed its minimally invasive nature with a very low morbidity rate: of note, it allowed to better preserve short-term memory and hypothalamic function.

[THE VERIFICATION OF ANALYTICAL CHARACTERISTICS OF THREE MODELS OF GLUCOMETERS].

The individual portable systems of control of glucose level in blood commonly known as glucometers permit to patients with diabetes mellitus to independently correct pharmaceutical therapy. The effectiveness of this correction depends on accuracy of control of glucose level. The evaluation was implemented concerning minimal admissible accuracy and clinical accuracy of control of glucose level of devices Contour TC, Satellite Express and One Touch Select according standards expounded in GOST 15197-2011 and international standard ISO 15197-2013. It is demonstrated that Contour TC and One Touch Select meet the requirements of these standards in part of accuracy while Satellite Express does not.

[Nonstructural protein 1 of tick-borne encephalitis virus activates the expression of immunoproteasome subunits].

The interaction of viral proteins with host cell components plays an important role in antiviral immune response. One of the key steps of antiviral defense is the formation of immunoproteasomes. The effect of nonstructural protein 1 (NS1) of tick-borne encephalitis virus on the immunoproteasome formation was studied. It was shown that cell expression of NS1 does not reduce the efficacy of the immunoproteasome generation in response to interferon-γ stimulation and even increases the content of the immunoproteasome subunits without the interferon-γ treatment. Thus, NS1 of tick-borne encephalitis virus activates, rather than blocks the mechanisms of immune defense in the cell.

Interfacial Engineering of Semiconductor-Superconductor Junctions for High Performance Micro-Coolers.

The control of electronic and thermal transport through material interfaces is crucial for numerous micro and nanoelectronics applications and quantum devices. Here we report on the engineering of the electro-thermal properties of semiconductor-superconductor (Sm-S) electronic cooler junctions by a nanoscale insulating tunnel barrier introduced between the Sm and S electrodes. Unexpectedly, such an interface barrier does not increase the junction resistance but strongly reduces the detrimental sub-gap leakage current. These features are key to achieving high cooling power tunnel junction refrigerators, and we demonstrate unparalleled performance in silicon-based Sm-S electron cooler devices with orders of magnitudes improvement in the cooling power in comparison to previous works. By adapting the junctions in strain-engineered silicon coolers we also demonstrate efficient electron temperature reduction from 300 mK to below 100 mK. Investigations on junctions with different interface quality indicate that the previously unexplained sub-gap leakage current is strongly influenced by the Sm-S interface states. These states often dictate the junction electrical resistance through the well-known Fermi level pinning effect and, therefore, superconductivity could be generally used to probe and optimize metal-semiconductor contact behaviour.

[Activation of immunoproteasome subunit genes transcription in mice monocytes infected with different strains of mycobacteria].

Immunoproteasomal processing of mycobacterial antigens is necessary to control the infection and to protect the organism from development of active form of tuberculosis. Here we investigate the activation of immunoproteasome subunit genes transcription in peritoneal monocytes of C57Bl/6 mice infected with vaccine M. bovis BCG and virulent strain M. tuberculosis H37Rv. The level of transcription of LMP2, LMP7, MECL1 subunits didn't increase for one and two days after a single infection. Two rounds of infection with BCG strain M. bovis led to enhancement of the only LMP7 subunit gene transcription. However after subsequent infection of monocytes with vaccine followed by virulent strain infection the dramatic rise of all immunoproteasomal subunit genes transcription was observed. Activation of transcription of the gene coding the PA28alpha subunit of regulatory complex PA28 was observed only after a single infection of monocytes with strain M. bovis BCG. Thus, vaccination with strain M. bovis BCG promotes effective activation of immunoproteasomal genes in case of subsequent contact with virulent strain M. tuberculosis H37Rv.

[Apoptosis and neutrophils on the regulation of proliferation and differentiation ex vifo of myeloid cells with Ph-chromosome].

Human myeloid cells with Ph chromosome (Ph+ cells) from chronic myeloid leukemia (CML) in the course of proliferation and differentiation ex vivo are regulated under alternation of cell proliferation and neutrophil maturation stages by consecutive blocking and inducing apoptosis with of neutrophils participation as well bcr/abl, bax and bcl2 genes expression. Apoptosis regulation of three main Ph+ cells types from CML patients depends on alternation sequences of proliferation (1) and maturation (2) cell stages and realized by two ways. The first one is performed by consecutive blocking and inducing apoptosis under 2/1/2 stage alternation. The way is not described early. Neutrophils accumulation correlates with apoprosis blocking. Apoptosis level enhances under neutrophils exhausted. Apoptosis blockage allows cells to proliferate and, thus, to form new portion of neutrophils with consecutive regular their death as well a consequent alternation of apoptosis blocking and inducing. This way regulates proliferation efficiency indexes P/D that reflect Ph+ cells proliferating potential and performs cycle completion for proliferation and differentiation. The second way of apoptosis regulation starts from proliferation stage and performs for 1/2/1 alternations under diminished content of neutrophils and a little increase under next maturation. It leads to resistant depressed apoptosis levels that, at maximal points, are 3-8 times lower than those under alternation 2/1/2. Resistant apoptosis blocking is observed in the Ph+ cells with prolong proliferation or maturation stages, when blasts and myelosytes are accumulated under enhanced bcr/abl and bcl2 > box gene expression and remain under next maturation. Stable apoptosis blocking is accompanied by increasing amounts of blasts and myelocytes and enhancing bcr/abl and bcl 2 > bax expression. This is observed under CML progression. Ph+ cells cultivation may be useful for more distinct diagnostics of CML phases of individual CML patients and optimization of the treatment.

Gene Expression upon Proliferation and Differentiation of Hematopoietic Cells with Ph Chromosome ex vivo.

The genesp53, mdm2, p21, c-myc,bcr/abl, bcr, bcl2, bax, and gapdh participate in the regulation of cell proliferation and differentiation, apoptosis and cell distribution for the cell cycle ex vivo in the Ph(+)cells of chronic myeloid leukemia containing the Ph chromosome andbcr/abloncogene. Expression of these genes correlates with regulation of cell proliferation and differentiation by alternating proliferation and maturation stages for three main Ph+cell types that occur under chronic myeloid leukemia. Thep53, p21, mdm2, and gapdh genes overexpress in active proliferating myeloid cells in the cell cycle S+ G2/M phases and when the phases are coincident with the proliferation stage. Expression of these genes decreases to a considerable level under alternation of the Ph(+)cell proliferation and maturation stages and whenever the expression is greatly diminished under significant neutrophil accumulation and especially under repeated alternation of the stages. In the course of neutrophil maturation, gene expression levels decrease in the range of gapdh > actin > c-myc, bcr/abl,p21 > p53 > bcl2 > bax.The expression levels of these genes in neutrophils are lower than those in myelocytes and lower by an order of magnitude than that in the cells with a prolonged proliferation stage. TheBcr/ablexpression gene under prolonged maturation and neutrophil accumulation is inhibited; however it is enhanced by 2-3 times for the proliferation stage with myelocyte accumulation. Minimalbcr/ablexpression is observed under overexpression ofp53, mdm2, p21, c-myc,as well as under cell maximum at the S and G2/M phases. Bcr/abloverexpression is observed under low expression of thep53, p21, mdm2genes. In the Ph(+ )cells with a high P/D efficiency index (5-20), overexpression of the genes in the range ofbcr> gapdh>bcr/abl, as well as a decreased expression of thep53, bcl2, mdm2, p21<< gapdh genes is observed for Ph(+)cells from the CML blast crisis and CML acceleration phase. Low control of cell proliferation and cell cycle by gene-regulators presumably promotesbcr/abloverexpression and activаtes the production ofbcr/abl+ cells. Apoptosis in the Ph(+ )cells is induced by expression of thebax > bcl2, р53, p21, c-myc andgapdhgenes. The blocking of Ph(+)cell apoptosis, neutrophil accumulation, and decrease in the expression of the p53, mdm2 and p21, c-myc,bcr/abl genes occur at the maturation stage.

[DNA vaccine encoding alpha-fetoprotein with fused ornithine decarboxylase degradation signal significantly suppresses hepatocellular carcinoma growth in mice].

Hepatocellular carcinoma (HCC) is among the most frequent malignancies in humans. HCC therapy is not efficient and the usual outcome is poor. In this regard, novel approaches to treat and prevent HCC are urgently needed. The Alpha-fetoprotein (AFP) is a serological marker of HCC. Recently it has been shown, that the DNA vaccines expressing AFP are capable in generating immune response against AFP. However, both, the immunization procedures and DNA vaccines used before were complex and not always very effective. We have shown that DNA vaccine encoding HIV-1 reverse transcriptase (RT) with fused ornithine decarboxylase (ODC) degradation signal induced a strong Th-1 immune response against RT in mice. Using this approach we designed a set of novel DNA vaccines bearing AFP and ODC degradation signal. Results obtained on transfected cells demonstrated efficient expression and fast proteasomal degradation of the recombinant AFP. The anti-tumor immune response stimulation was shown in immunized animals and most importantly a notable retardation of tumor growth was observed as a result of protective vaccination.

Kinetic temperature of dust particle motion in gas-discharge plasma.

A system of equations describing motion of dust particles in gas discharge plasma is formulated. This system is developed for a monolayer of dust particles with an account of dust particle charge fluctuations and features of the discharge near-electrode layer. Molecular dynamics simulation of the dust particles system is performed. A mechanism of dust particle average kinetic energy increase is suggested on the basis of theoretical analysis of the simulation results. It is shown that heating of dust particles' vertical motion is initiated by forced oscillations caused by the dust particles' charge fluctuations. The process of energy transfer from vertical to horizontal motion is based on the phenomenon of the parametric resonance. The combination of parametric and forced resonances explains the abnormally high values of the dust particles' kinetic energy. Estimates of frequency, amplitude, and kinetic energy of dust particles are close to the experimental values.

[Critical amino acids of ornitin decarboxylase degron: the presence and C-terminal arrangement is insufficient for alfa-fetoprotein degradation].

Mouse ornithine decarboxylase (ODC) degrades in proteasome in an ubiquitin-independent manner with an averagehalf-life of 2 h. The 37 amino acid long C-terminal fragment known as a degradation signal (degron) is responsible for the effective degradation of ODC. Recently, amino acids being critical for degradation in the ODC-degron have been mapped. Mutations of Cys441 and Ala442 led to protein stabilization, while a substitution of other amino acids composing ODC-degron had almost no effect on the protein turnover; whereas insertions or deletions in region between Ala442 and ODC C-terminus diminished greatly rate of protein degradation, e.g. positioning of the key amino acids from the C-terminus was shown to be crucial. Using these data we introduced both key amino acids into the alfa-fetoprotein with truncated exportation signal (deltaAFP), at the same distance from the C-terminus as they being in the ODC (deltaAFPCAG and deltaAFPLCAG). Removal of N-terminal exportation signal prevented secretion of modified proteins. Using in silico approach we demonstrated no significant difference in hydrophobicity or secondary structure between C-terminus of deltaAFP and mutated proteins. The degradation kinetics of deltaAFP, deltaAFPCAG, deltaAFPLCAG in cyloheximide-chase and proteasome inhibition assay (using MG132) was identical. Obtained results suggest that introduced substitutions are insufficient for effective recognition of mutated deltaAFP by26S proteasome. We assume thatadditional amino aci ds composing ODC-degron or their combine action could also affect degradation. Besides that, one cannot exclude that conformation of the mutated deltaAFP limits its C-terminus accessibility to proteasome.

[The level of cytokines in the ex vivo infection of murine macrophages with Mycobacterium tuberculosis complex].

To study whether the genotype of a mycobacterial strain might affect the ability of macrophages (MP) to produce the key cytokines, we determined the synthesis of interferon-gamma (IFN-gamma), tumor necrosis factor-gamma (TNF-gamma), and interleukin-6 (IL-6) in the infection of murine MP with M. tuberculosis H37Rv and M. bovis BCG, the strains that belong to the same genetic group (M. tuberculosis complex) but are opposite in virulent properties. MP infection with a virulent and attenuated M. tuberculosis complex strain was shown to differently affect the synthesis of IFN-gamma, TNFaalpha-, and IL-6. MP infection with M. tuberculosis H37Rv activated the generation of IFN-gamma and that with M. bovis BCG substantially increased the levels of TFN-alpha and IL-6. The findings suggest that this model may be used to investigate the specific features of mycobacterial strains of various genotypic clusters with eukaryotic cells.

Recombination-limited energy relaxation in a Bardeen-Cooper-Schrieffer superconductor.

We study quasiparticle energy relaxation at subkelvin temperatures by injecting hot electrons into an Al island and measuring the energy flux from quasiparticles into phonons both in the superconducting and in the normal state. The data show strong reduction of the flux at low temperatures in the superconducting state, in qualitative agreement with the theory for clean superconductors. However, quantitatively the energy flux exceeds the theoretical predictions both in the superconducting and in the normal state, suggesting an enhanced or additional relaxation process.

[Research and comparative characteristic of the factors determining elasticity of the human skin].

Changes in skin elasticity have been analyzed under different conditions (upon skin stretching, at different thickness of the skin, at different contents of collagen, intercellular and endocellular liquids, upon changes of venous pressure, and during contraction and relaxation of smooth muscles in skin vessels - vasomotions). Elasticity was defined by the acoustic method from the speed of diffusion of a superficial sheared acoustic wave in the skin, by the autoresonant method from the mechanical resonance frequency of skin, and from the vacuum pressure needed for skin site deformation of constant volume. It was shown that the major factors determining the elasticity of skin are it stretching, thickness, and the contents of collagen and liquids in it. The influence on elasticity of venous pressure and the contraction activity of smooth muscles in vessels is not essential. This suggests that the parameters of skin elasticity can be used as indicators of systemic and local lesions of the connective tissue.