АНАЛІЗ ДІАГНОСТИЧНИХ ПАРАМЕТРІВ ІМУНОБЛОТИНГУ ДЛЯ ВИЗНАЧЕННЯ СЕНСИБІЛІЗАЦІЇ ДО ПИЛКОВИХ АЛЕРГЕНІВ У ПАЦІЄНТІВ З РЕСПІРАТОРНИМИ ЗАХВОРЮВАННЯМИ

The aim of the study was to compare the diagnostic parameters of different systems of serological examination by immunoblot method for the determination of sensitization to allergens of pollen group in patients with respiratory allergic diseases – allergic rhinitis and bronchial asthma. Materials and methods. In the study, 88 patients with allergic rhinitis and/or atopic asthma were examined with three different methods of specific allergic diagnosis (in vivo and in vitro). Inclusion criteria were a diagnosis of allergic rhinitis (both intermittent and persistent) and/or atopic asthma. The pre-test was conducted according to the classic test method according to the normative documents with commercial allergen extracts. Western blots for the determination of IgE levels were performed using RIDA AllergyScreen test systems (R-Biopharm AG, Darmstadt, Germany) and Euroline (Euroimmun). Results and conclusions. The results of two systems for determining specific IgE for pollen allergens by the Rida AllergyScreen and Euroline methods do not always agree very well due to the systematic divergence of indicators. The results of determining specific IgE for individual allergens are generally in good agreement with each other and the results of skin testing by the prick test, however, for pollen, birch, hazel and alder pollen allergens, the Euroline system does not always match the results of skin testing by the prick test. negative results. Further analysis of the consistency and diagnostic parameters of the methods for other allergen groups is necessary to summarize all the results of the study.Метою дослідження було порівняти діагностичні параметри різних систем дослідження методом імуноблоту для визначення сенсибілізації до алергенів пилкової групи у пацієнтів з респіраторними захворюваннями – алергічним ринітом та бронхіальною астмою. Матеріали і методи. В ході дослідження 88 пацієнтів з алергічним ринітом і/або атопічною астмою були обстежені трьома різними методами специфічної алергічної діагностики (in vivo та in vitro). Критеріями включення були діагноз алергічного риніту (як інтермітуючого, так і персистуючого) та/або атопічної астми. Прик-тест проводився за класичною методикою тестування відповідно до нормативних документів з комерційними екстрактами алергенів. Вестерн-блот для визначення рівнів IgE проводили з використанням тест-систем RIDA AllergyScreen (R-Biopharm AG, Дармштадт, Німеччина) і Euroline (Euroimmun). Результати та висновки. Результати двох систем визначення специфічного IgE до алергенів пилкової групи методами Rida AllergyScreen та Euroline не завжди добре узгоджуються між собою внаслідок систематичної розбіжності показників. Результати визначення специфічних IgE до окремих алергенів в цілому добре узгоджуються між собою та з результатами шкірного тестування методом прик-тесту, втім до пилкових алергенів полину, берези, ліщини та вільхи система Euroline не завжди узгоджується з даними шкірного тестування методом прик-тесту, даючи хибно-негативні результати. Необхідний подальший аналіз узгодженості та діагностичних параметрів методів за іншими групами алергенів для узагальнення результатів дослідження

АНАЛІЗ ДІАГНОСТИЧНИХ ПАРАМЕТРІВ ІМУНОБЛОТИНГУ РІЗНИХ ВИРОБНИКІВ ДЛЯ ВИЗНАЧЕННЯ СЕНСИБІЛІЗАЦІЇ ДО ПИЛКОВИХ АЛЕРГЕНІВ У ПАЦІЄНТІВ ІЗ РЕСПІРАТОРНИМИ АЛЕРГІЧНИМИ ЗАХВОРЮВАННЯМИ

In the context of the large amount of sometimes unfair information, the physician is not always able to understand the advantages and disadvantages of each method and correctly evaluate the parameters of their diagnostic value. The aim of the study – to compare the diagnostic parameters of different systems of serological examination by immunoblot method for the determination of sensitization to allergens of pollen group in patients with respiratory allergic diseases – allergic rhinitis and bronchial asthma. Materials and Methods. In the study, 88 patients with allergic rhinitis and/or atopic asthma were examined with three different methods of specific allergic diagnosis (in vivo and in vitro). Inclusion criteria were a diagnosis of allergic rhinitis (both intermittent and persistent) and/or atopic asthma. The prick test was conducted according to the classic test method according to the normative documents with commercial allergen extracts.  Western blots for the determination of IgE levels were performed using RIDA AllergyScreen test systems (R-Biopharm AG, Darmstadt, Germany) and Euroline (Euroimmun). Results. The results of two systems for determining specific IgE for pollen allergens by the Rida AllergyScreen and Euroline methods do not always agree very well due to the systematic divergence of indicators. The results of determining specific IgE for individual allergens are generally in good agreement with each other and the results of skin testing by the prick test, however, for wormwood, birch, hazel and alder pollen allergens, the Euroline system does not always match the results of skin testing by the prick test negative results. Conclusions. Further analysis of the consistency and diagnostic parameters of the methods for other allergen groups is necessary to summarize all the results of the study.В умовах великого обсягу іноді заангажованої інформації лікар не завжди здатний зрозуміти переваги та недоліки кожного з методів та правильно оцінити параметри їх діагностичної цінності. Мета дослідження – порівняти діагностичні параметри різних систем серологічного дослідження методом імуноблоту для визначення сенсибілізації до алергенів пилкової групи у пацієнтів із респіраторними алергічними захворюваннями – алергічним ринітом та бронхіальною астмою. Матеріали і методи. У ході дослідження обстежено 88 пацієнтів з алергічним ринітом та/або атопічною астмою за допомогою трьох різних методів специфічної алергічної діагностики (in vivo та in vitro). Критеріями включення були діагноз алергічного риніту (як інтермітуючого, так і персистуючого) та/або атопічної астми. Прик-тест проводили за класичною методикою тестування відповідно до нормативних документів із комерційними екстрактами алергенів. Вестерн-блот для визначення рівнів IgE виконували з використанням тест-систем RIDA AllergyScreen (R-Biopharm AG, Дармштадт, Німеччина) і Euroline (Euroimmun). Результати. Результати двох систем визначення специфічного IgE до алергенів пилкової групи методами Rida AllergyScreen та Euroline не завжди дуже добре узгоджуються між собою унаслідок систематичного розходження показників. Результати визначення специфічних IgE до окремих алергенів у цілому добре узгоджуються між собою та результатами шкірного тестування методом прик-тесту, втім до пилкових алергенів полину, берези, ліщини та вільхи система Euroline не завджи узгоджується з результатами шкірного тестування методом прик-тесту, даючи хибно-негативні результати. Висновки. Подальший аналіз узгодження та діагностичних параметрів методів в інших групах алергенів є необхідним для узагальнення усіх результатів дослідження

The nature of the basement in the Archaean Dharwar craton of southern India and the age of the Peninsular Gneiss

The Archaean Peninsular Gneiss of southern India is considered by a number of workers to be the basement upon which the Dharwar supracrustal rocks were deposited. However, the Peninsular Gneiss in its present state is a composite gneiss formed by synkinematic migmatization during successive episodes of folding (DhF1, DhF1a and DhF2) that affected the Dharwar supracrustal rocks. An even earlier phase of migmatization and deformation (DhF∗ ) is evident from relict fabrics in small enclaves of gneissic tonalites and amphibolites within the Peninsular Gneiss. We consider these enclaves to represent the original basement for the Dharwar supracrustal rocks. Tonalitic pebbles in conglomerates of the Dharwar Supergroup confirm the inference that the supracrustal rocks were deposited on a gneissic basement. Whole rock Rb-Sr ages of gneisses showing only the DhF1 structures fall in the range of 3100-3200 Ma. Where the later deformation (DhF2) has been associated with considerable recrystallization, the Rb-Sr ages are between 2500 Ma and 2700 Ma. Significantly, a new Rb-Sr analysis of tonalitic gneiss pebbles in the Kaldurga conglomerate of the Dharwar sequence is consistent with an age of ~2500 Ma and not that of 3300 Ma reported earlier by Venkatasubramanian and Narayanaswamy (1974). Pb-Pb ages based on direct evaporation of detrital zircon grains from the metasedimentary rocks of the Dharwar sequence fall into two groups, 3300-3100 Ma, and 2800-3000 Ma. Stratigraphic, structural, textural and geochronologic data, therefore, indicate that the Peninsular Gneiss of the Dharwar craton evolved over a protracted period of time ranging from > 3300 Ma to 2500 Ma

Safety and efficacy of telaprevir in treatment of a chronic hepatitis C in patients of the Russian population included in early access program study

Aim of investigation. HEP3002 is the international early access program of efficacy and safety estimation of telaprevir in combination to peginterferon alpha and ribavirin for patients with severe fibrosis or liver cirrhosis caused by hepatitis C virus (HCV) genotype 1. Efficacy and safety of this therapeutic mode were evaluated in intermediate analysis on 16-th week of treatment in 153 patients from Russia who have already reached the 16-th week of treatment or potentially can do so.Material and methods. The study has prospectively included 153 HCV infected patients (genotype 1), with bridging fibrosis or compensated liver cirrhosis who received treatment by telaprevir in combination to peginterferon-alpha and ribavirin for 12 wks with subsequent 12-or 36-week rate of antiviral therapy (AVT) by peginterferon alpha and ribavirin in relation to virologic response and fibrosis severity. Analysis has been carried out for intention to treat (ITT) populations with application of 16-th week AVT data.Results. Total of 153 patients have completed 12-week course of triple therapy and 4-week course of peginterferon-alpha and ribavirin treatment (48% cirrhotic patients, 97% – HCV-1b). The level of HCV RNA was undetectable both at the 4-th week, and at the 12-th week (extended rapid virologic response) in 42 (75%) of 56 previously untreated patients, in 34 (89%) of 38 with relapses after previous treatment, in 4 (57%) of 7 with previous incomplete response, in 22 (52%) of 42 with the previous zero response and in 7 (70%) of 10 with previous virologic breakthrough. Sustained virologic response was achieved in 73 (80%) of patients available for analysis (n=91). Most frequent adverse events of the 2-4 degrees, related to telaprevir, were anemia (63 patients, 41%), thrombocytopenia (15 patients, 10%) and skin rash (7 patients, 5%). For anemia treatment in 50 (33%) patients the doze of ribavirin has been reduced, erythropoietin was prescribed to 12 (8%) to patients and no blood transfusion was required; 10 (7%) patients have ahead of schedule stopped course of treatment by telaprevir in connection with development of anemia (6), thrombocytopenia (2) and occurrence of skin rash (2).Conclusion. In 153 patients with severe liver fibrosis caused by hepatitis C virus (genotype 1), on background of triple AVT with telaprevir high level of immediate virologic response and low level of the preterm treatment discontinuation was marked

Efficacy and safety of 3D-therapy at HCV-related subcompensated liver cirrhosis (genotype 1b)

Aim of the study. To estimate efficacy and safety of 3D mode of interferon­free therapy in patients with subcompensated liver cirrhosis (LC) of HCV etiology (genotype 1b). Material and methods. Original study included the data of 66 patients (26 men and 40 women) with subcompensated LC of HCV etiology (genotype 1b) who underwent interferon­free therapy by ombitasvir/paritaprevir/ritonavir, dasabuvir and ribavirin for 12 weeks (the latter was cancelled at receiving the new data on treatment efficacy after 4 weeks of therapy) in September, 2015, before the drug instruction was updated. Mean age of patients was 56.4±10.0 years. At onset of etiological therapy 21 patients (31.8%) had Child­Pugh score of 9, eleven patients (16.7%) had Child­Pugh 8, 34 patients (51.5%) had Child­Pugh 7. The causes of inefficacy of previous modes of combined antiviral therapy (CAT) included absence of virologic response in 43.9% of the cases, recurrence of HCV replication - in 30.3%, virological breakthrough - in 16.7%, development of serious adverse effects - in 9.1%. Taking into account the change of the group quantity during the course of therapy because of treatment cancellation for safety reasons and the subsequent assessment of its efficacy in patients with early treatment cancellation, the modified «intent­to­treat» (ITT) analysis was the basic method of results evaluation. Along with that «per protocol» (PP) analysis was carried out as well. Results. During the treatment course aviremia in 14 days was achieved in 53.8% of patients (in 35 patients of 65), prompt virologic response - at 79.7% (in 51 of 64 patients). All patients underwent complete 12 week course of CAT (n=60) and those for whom treatment was canceled for safety reasons (n=3) - in terms from 14 to 30 days - sustained virologic response (SVR) in 12 weeks and SVR in 24 weeks was registered. The assessment of liver function compensation degree in 6 months after CAT termination demonstrated 3 to 4 points reduction of the Child-Pugh Score in 21 patients (33.9 %), 1 to 2 points in 35 patients (56.5 %). According to the MELD score the clinical improvement was achieved in 66.1% of patients. The early treatment termination was caused by progression of hepatic encephalopathy symptoms and/or jaundice development (4 cases). Most cases of the progression­related treatment termination due to liver failure were reversible after CAT interruption. Three lethal outcomes after the early treatment termination and 1 patients death in follow­up period were registered. Conclusion. Antiviral therapy in 3D mode for subcompensated LC is highly effective not only in those patients who received complete treatment course, but also in those with early treatment secession. Profiling of 3D therapy safety demonstrated that development of serious adverse effects during the treatment is comparable to outcomes at natural course of subcompensated LC in the absence of etiological therapy

Efficacy and safety of glycyrrhizic acid combined to essential phospholipids (Phosphogliv) at non-alcoholic fatty liver disease: results of multicenter double blind randomized placebo-controlled post-registration clinical study (IV phase) «Gepard» (PHG-M2/P02-12)

Aim of investigation. To estimate efficacy and safety of two pharmacological forms of «Phosphogliv» (lyophilizate for intravenous administration and capsules) for the treatment of fatty liver degeneration of non-alcoholic etiology. Material and methods. Original study included overall 180 patients with nonalcoholic fatty liver disease that were randomized to the basic and control groups in the ratio of 2:1. The basic group patients received Phosphogliv 5 mg/day as intravenous bolus injection for 2 weeks, followed by oral intake of 2 capsules t.i.d. for 10 weeks (the total treatment duration was 12 weeks), control group patients received placebo in the same mode. Serum levels of inflammatory marker adiponectin, NAFLD fibrosis score, treatment effect on quality of life and safety of patients were monitored. Results. In 12 wks in patients with more significant cytolysis (threefold and higher serum alanine transaminase activity) and the rate of adiponectin level improvement on the background of Phosphogliv was 57.9% versus only 10.0% (p=0.019) in the placebo group. The mean NAFLD fibrosis score in the basic group remained almost unchanged, while in the control group negative dynamics was revealed, that resulted in statistically significant differences between groups (2.5±1.2 units versus 2.0±1.3 units respectively; р=0.009). At Phosphogliv injection already during the first 2 wks more pronounced improvement of subjective perception of dyspeptic symptoms was observed (mean score was 5.6±1.3 versus 5.1±1.4; р=0.021). When the treatment course was completed the basic group patients had higher mean score by «level of energy» scale (5.9±1.0 versus 5.6±1.0; р=0.034). Only sporadic adverse effects were found to the background of treatment, no statistically significant differences in their rate in were recorded. Dynamics of the basic physical parameters and laboratory tests was comparable as well. Conclusions. Treatment of non-alcoholic fatty liver disease that includes Phosphogliv provides reduction of steatohepatitis activity, retardation of fibrosis progression, improvement of overall disease prognosis and high satisfaction of patients at a favorable safety profile

Efficacy and safety of glycyrrhizic acid and essential phospholipids (Phosphogliv) combination for alcoholic liver disease: results of the double-blind randomized placebo-controlled multicenter post-registration (phase IV) clinical trial «Jaguar» (PHG-M2/P03-12)

Material and methods. The original study included overall 120 patients with ALD, who were randomized in two identical groups. The patients of the main group (group A) received 2 courses of therapy: the first - Phosphogliv 5 mg/day as intravenous bolus injection for 2 wks, followed by the oral intake of 2 capsules t.i.d. for 10 wks (the total treatment duration was 24 wks). Patients of the control group (group B) received placebo in the same regimen. The dynamics of serum alanine transaminase (ALT), aspartate transaminase (AST), liver scores by noninvasive FibroMax test was applied to assess the treatment efficacy and safety, along with change in quality of life of patients. Results. In 24 wks in group A in comparison to the group B significantly lower mean ALT level was found: 35,2±29,4 U/l vs 48,4±36,1 U/l (р =0,044), AST level became normal in higher rate of patients: 69,4% vs 47,7% (р =0,034), that had more prominent decrease in gamma-glutamyltranspeptidase (GGT) level - 47,4±36,5% vs 25,1±63,9% (р =0,039), the rate of patients with Aktitest A2-A3 range decreased - 8,5% vs 21,4% (