Clinical significance of lipohypertrophy without visual and palpable changes detected by ultrasonography of subcutaneous fat.

AIM: To estimate clinical significance of lipohypertrophy (LH) without visual and palpable changes, detected by ultrasonography of subcutaneous fat. MATERIALS AND METHODS: This study included 140 diabetic patients who received insulin in basal-bolus regimen. Ultrasonography of subcutaneous fat was performed for LH diagnostics in these diabetic patients. Than clinical significance of LH without visual and palpable changes was estimated. HbA1c level, fasting and postprandial glucose, episodes of hypoglycemia, body mass index (BMI) and scheme of insulinotherapy were evaluated at the moment of LH, after 3 and 6 months in all patients. RESULTS: After changing injection sites, good results were demonstrated by measuring glucose and HbA1c level. Thus fasting glucose decreased from 9.03±1.98 mmol/l to 7.11±0.95 mmol/l (p=0.023). Postprandial glucose reduced from 10.27±2.72 mmol/l to 9.34±1.21 mmol/l (p=0.011). HbA1c level reduced from 9.27±1.75% to 7.43±1.02% (p=0.002). Also BMI decreased from 33.75±3.49 kg/m2 to 30.5±2.96 kg/m2 (p=0.018). CONCLUSION: LH without visual and palpable changes could worsen compensation of glycemic control and leads to hypoglycemia and chronic Somogyi rebound. So, LH without visual and palpable is as important and clinically significant as classic LH.

Photothermoplastic recording media and its application in the holographic method of determination of the refractive index of liquid objects.

The photothermoplastic medium based on the films of photosensitive polymeric composites with semiconductor properties is developed for application in optical information recording and storage, in holographic interferometry, as well as for medical purposes. This medium was used in the modified holographic device for determination of changes of the refractive index of homogeneous and inhomogeneous liquid objects. The technique and holographic equipment were modified by employing the specially developed and produced transparent cuvette of special shape and the phase shifting interferometry method. Experimentally demonstrated precision of the measurements is not less than 10-5.

Chemical adjustment possibilities in the physical properties of azobenzene polycomplexes with metal.

Changes in the physical properties of polymeric composites based on azobenzene by means of chemical modifications of the polycomplexes' structure and composition are investigated. The main emphasis was on the adjustment of characteristics of electro-optical effect observed in these composites. Among the methods of chemical modification for the coordination of metallic ion include changing the dipole moment of the azobenzene fragment and the "spacer" length connecting the azobenzene fragment to the main polymeric chain. Introduction of the organic dyes in the azobenzene polymeric composites are also considered. Demonstrated flexibility in the properties of the investigated media is important for their practical application as information or optically active media.

Some features of information properties of holographic recording media based on a photoconducting carbazolyl-containing oligomer doped with an organic electron acceptor.

Unusual multimodal kinetics of diffraction efficiency in the cycle of hologram recording and erasing were observed in the recording media for the holographic photothermoplastic technique. It was shown that this effect is caused by competition between the simultaneous development of regular and random "frosty" surface reliefs of the photoconducting polymer film during the hologram development. The mechanism explaining the decrease of the maximal diffraction efficiency as compared to its calculated value is discussed.

Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy.

BACKGROUND: Biosimilars of filgrastim are in widespread clinical use in Europe. This phase III study compares biosimilar filgrastim (EP2006), with the US-licensed reference product, Neupogen(®), in breast cancer patients receiving (neo)adjuvant myelosuppressive chemotherapy (TAC). PATIENTS AND METHODS: A total of 218 patients receiving 5 µg/kg/day filgrastim over six chemotherapy cycles were randomized 1:1:1:1 into four arms. Two arms received only one product (nonalternating), biosimilar or reference, and two arms (alternating) received alternating treatments during each cycle (biosimilar then reference or vice versa). The primary end point was duration of severe neutropenia (DSN) during cycle 1. RESULTS: The baseline characteristics were balanced between the four treatment arms. Noninferiority of biosimilar versus the reference was demonstrated: DSN (days) in cycle 1 was 1.17 ± 1.11 (biosimilar, N = 101) and 1.20 ± 1.02 (reference, N = 103), 97.5% confidence interval lower boundary for the difference was -0.26 days (above the predefined limit of -1 day). No clinically meaningful differences were observed regarding any other efficacy parameter: incidence of febrile neutropenia (FN); hospitalization due to FN; incidence of infections; depth and time of absolute neutrophil count (ANC) nadir and time to ANC recovery during cycle 1 and across all cycles. The pattern and frequency of adverse events were similar across all treatments. CONCLUSION: This study demonstrates that biosimilar and the reference filgrastim are similar with no clinically meaningful differences regarding efficacy and safety in prevention of severe neutropenia. Biosimilar filgrastim could represent an important alternative to the reference product, potentially benefiting public health by increasing access to filgrastim treatment. STUDY NUMBER: NCT01519700.

Medium for polarization-sensitive diffraction gratings.

New polymers applicable for optoelectronics are developed and investigated. The ability to form photoinduced anisotropy in the media based on the films of these polymers is demonstrated. The media can be used for recording of polarization-sensitive diffraction gratings.

Information media based on electron donor oligomers with different structures.

Information properties of recording media for photothermoplastic techniques were investigated. The films consisted of oligomer composites based on carbazole containing co-oligomers of linear and radial structures with branching centers on silicon and germanium atoms. It was ascertained that the media based on the radial oligomers possessed high holographic sensitivity because of the high plasticity and its ability to accumulate volume electric charge during the exposure. Examples of practical applications of the investigated recording media are presented.

Phase II, randomized, biomarker identification trial (MARK) for erlotinib in patients with advanced pancreatic carcinoma.

BACKGROUND: A prospective, randomized phase II study, with mandatory tumor sampling at current disease stage, aimed to identify biomarkers predictive of improved progression-free survival (PFS) in patients with pancreatic cancer treated with erlotinib. PATIENTS AND METHODS: Patients with histologically/cytologically confirmed, unresectable, locally advanced/metastatic pancreatic cancer, who had failed on or were unsuitable for first-line chemotherapy, underwent a tumor biopsy and were then randomized to receive once-daily erlotinib 150 mg or placebo. The primary end point was identification of biomarkers predicting improved PFS with erlotinib. Secondary end points included PFS, overall survival, response and toxicity. RESULTS: At data cut-off, 207 patients were enrolled and analyzed. Prespecified biomarker analyses of EGFR protein expression, EGFR gene copy number/mutations/polymorphisms and KRAS mutations did not identify any subgroups with a detrimental effect or a strong benefit for PFS with erlotinib. In the primary analysis, the median PFS was 6.1 versus 5.9 weeks in the erlotinib and placebo arms, respectively [hazard ratio (HR) 0.83; 95% confidence interval (CI) 0.63-1.10; P = 0.1909]. However, observed baseline imbalances indicated worse prognosis in the erlotinib arm. After adjustment for baseline characteristics, a significant PFS benefit for erlotinib was observed (HR 0.68; 95% CI 0.50-0.91; P = 0.0102). Exploratory biomarker analyses showed patients with high baseline serum amphiregulin levels might benefit from erlotinib. CONCLUSION: This study in patients with inoperable pancreatic cancer did not identify any prespecified biomarkers predictive of PFS benefit with erlotinib. Exploratory analyses suggested high amphiregulin might predict PFS benefit from erlotinib. CLINICALTRIALSGOV NUMBER: NCT00674973.

[Combination of taxotere and doxorubicin in chemotherapy of disseminated breast cancer]. / Kombinatsiia taksotera i doksorubitsina v khimioterapii disseminirovannogo raka molochnoi zhelezy.

Chemotherapy (taxotere + doxorubicin) was given to 46 patients with disseminated breast cancer: first line--27 (group A) and second line (including treatment after anthracycline-containing combinations and taxol--19) (group B). Average effectiveness in group A was 70.4% (10/27); group B--42.1% (8/19). The highest response was shown by metastases to the lung, liver, peripheral lymph nodes and primary tumors; least response--metastases to bones and soft tissues. Remission duration ranged 3-26 months. Median remission duration in group A was significantly longer than in group B (13.3 +/- 1.0 and 7.0 +/- 1.4 months, respectively) (p(0 < 05). Remission is still on in 11 patients (more than 26 months). Toxic poisoning was moderate: neutropenia stage III-IV was reported in 82/225 cycles (36.4%) lasting more than 7 days in 4/225 cycles (1.7%), febrile neutropenia stage 1-II--10/225 cycles (4.4%); stomatitis and diarrhea stage III-IV--1/225 cycles (0.44%). Treatment was suspended because of hypertension in one patient. No other side effects stage III-IV were registered.

[Sanitary and toxicologic characteristics of anisaldehyde]. / Sanitarno-toksikologicheskaia kharakteristika anisovogo aldegida.

The threshold dose of anisealdehyde was ascertained at the level of 1,8 mg/kg, and maximum noneffective one - 0,04 mg/kg.

A rise in activity of natural cold isolymphocytotoxins after hemostimulation.

Natural cold isolymphocytotoxins (NCILCT) were studied in sera of patients with chronic renal insufficiency who had undergone 3-200 hemodialyses, in sera of healthy subjects before and after intramuscular injections of 5-9 ml of whole autologous blood, and in sera of hemophilia patients before and after a transfusion of 130-250 ml of freshly drawn donor plasma concentrate. It was noted NCILCT activity rose from 20-50% to 50-100% dead cells after injections of autologous blood and plasma transfusions in the majority of cases. In subjects who had undergone hemodialysis from 50 to 200 time NCILCT activity was considerably higher (50-80% dead cells) compared to patients with 3-10 hemodialyses (20-30% dead cells). It was suggested that the graft protection effect of blood transfusions and hemodialysis on kidney graft may be associated with an increase in NCILCT activity.

[Effect of unilateral extirpation of the superior cervical sympathetic ganglion and electric stimulation of the posterior hypothalamus on the rate of reflex conditioning in the dog]. / Vliianie odnostoronnei ékstirpatsii verkhnego sheinogo simpaticheskogo uzla i élektricheskoi stimuliatsii zadnego gipotalamusa na skorost' obrazovaniia uslovnykh refleksov u sobak.

The influence of the sympathetic nervous system and the posterior hypothalamus on the rate of conditioning and the magnitude of conditioned reflexes was studied on dogs by motor defensive method. Extirpation of the superior cervical sympathetic ganglion reduced the conditioned reflex magnitude, delayed the elaboration of positive reflexes facilitating the formation of the inhibitory process. Stimulation of the posterior hypothalamus with electrical current of medium strength (50 mcA) promoted the enhancement of positive conditioned reflexes, and while not substantially affecting the rate of their formation, facilitated elaboration of internal inhibition.

[Evaluation of the interrelations among auditory potential parameters by means of the technic of correlation-regression analysis]. / otsenka vzaimosviazi parametrov slukhovykh potentsialov s pomoshch'iu metoda korreliatsionno-regressionnogo analiza.

The characteristics (amplitude, latency) of two types of evoked potentials, action potential of the 8th nerve recorded at the cochlea round window and sonomotor evoked potential recorded from the postauricular region and the back of the guinea pigs were studied in response to sound stimulation. The degree and type of interrelation between the parameters of the auditory evoked potentials were established employing the method of correlation-regression analysis. A close linear dependence was established for amplitude values ( r = 0.93) of the action potential and the sonomotor potential irrespective of the recording site of the latter. The similar dependence (r = 0.91) was established when analysing the latency of the action potential and the evoked sonomotor potential, if the latter was in the postauricular region. The performed mathematical simulation permitted justifying the correction of disturbed functions of the auditory system.