13 research outputs found

    ЭФФЕКТИВНОСТЬ И БЕЗОПАСНОСТЬ НОВОГО РОССИЙСКОГО НЕНУКЛЕОЗИДНОГО ИНГИБИТОРА ОБРАТНОЙ ТРАНСКРИПТАЗЫ ЭЛСУЛЬФАВИРИНА В ПЕРВОЙ ЛИНИИ ЛЕЧЕНИЯ ВИЧ-ИНФЕКЦИИ В КОМБИНАЦИИ С ДВУМЯ НУКЛЕОЗИДНЫМИ/НУКЛЕОТИДНЫМИ ИНГИБИТОРАМИ ОБРАТНОЙ ТРАНСКРИПТАЗЫ – ИССЛЕДОВАНИЕ 96 НЕДЕЛЬ

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    A randomized multicenter 96-week study of an elsulfavirine (ESV),  non-nucleoside reverse transcriptase inhibitor (NNRTI) of novel  generation, in combination with 2 nucleoside/ nucleotide reverse  transcriptase inhibitors (NRTIs) was conducted in naive HIV adult  patients, divided by 2 parts: 1) partially blind comparative to  efavirenz (EFV) 48-week study, 2) open-label observational study  during additional 48 weeks. High virological and immunological  effectiveness maintained during the study: proportion of patients  with HIV RNA <50 copies/ml in 48 weeks achieved 81,6%, in 96  weeks – 83,9% (MITT-analysis) and 91% (if patients withdrawn from the study due to other reasons not related to treatment were excluded). No resistance mutations were found in patients with viral  replication blips (HIV RNA 50-1300 copies/ml). CD4+-lymphocytes  count was increased by 187,5 at week 48 and 251,0 cells/mcl at  week 96. Good tolerability and safety were confirmed during second year of treatment: no additional safety data which could influence  benefit/risk ratio were recorded as well as withdrawal from the  treatment due to adverse events. Serious adverse events, connected with treatment, allergic reactions were not registered during the whole 96-week study. Conclusion. Results of the 96-week study confirm earlier data from  48-week study on high efficacy and safety of ESV. Based on these  data ESV was included into “National recommendations on  dispensary follow-up and treatment of patients with HIV-infection” as the first-line ART regime in combination with 2 NRTIs.Проведено многоцентровое рандомизированное исследование элсульфавирина (ESV) –  ненуклеозидного ингибитора обратной транскриптазы (ННИОТ) нового поколения в  комбинации с 2 нуклеотидными/нуклеозидными ингибиторами обратной транскриптазы  (НИОТ) у взрослых пациентов с ВИЧ-инфекцией, ранее не получавших АРТ, длительностью  96 недель, состоявшее из 2 этапов: 1) частично слепое, сравнительное с эфавирензом (EFV) исследование – 48 недель, 2) открытое наблюдательное исследование – дополнительные 48 недель. Наблюдалась высокая вирусологическая и иммунологическая эффективность  лечения, устойчивая в течение 96 недель: доля пациентов с неопределяемым уровнем РНК  ВИЧ <50 копий/мл через 48 недель составила 81,6%, через 96 недель – 83,9% (MITT- анализ) и 91% (без учета пациентов, выбывших по не связанным с лечением причинам). Ни  в одном случае всплесков репликации вируса (РНК ВИЧ от 50 до 1300 копий/мл) не  выявлено мутаций резистентности ВИЧ к препаратам. Прирост медианы количества CD4+- лимфоцитов через 48 недель составил 187,5 клеток/мкл, через 96 недель – 251,0 клетку/ мкл. Подтверждена хорошая переносимость и безопасность лечения в течение второго года  исследования: не выявлено каких-либо новых значимых данных в отношении безопасности,  негативно влияющих на соотношение польза/риск, не зарегистрировано  случаев отмены лечения из-за нежелательных явлений. На протяжении 96 недель не  зарегистрированы серьезные нежелательные явления, связанные с приемом препарата,  аллергические реакции. Заключение. Результаты 96-недельного исследования подтверждают полученные ранее  (по итогам 48 недель применения) данные о высокой эффективности и безопасности  элсульфавирина. На основании полученных результатов элсульфавирин включен в «Национальные рекомендации по диспансерному наблюдению и лечению больных ВИЧ- инфекцией» в качестве режима первой линии АРТ в комбинации с 2 препаратами группы НИОТ

    Informatisation intraschool control as a factor in increasing its efficiency

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    The article deals with the actual positions of the requirements of the present day problem of the use of information technology in intra-school supervision. The necessity of informatization control and diagnostic activities in the modern school. Focuses on the importance of transfer of school inspection and diagnostic procedures on the basis of information and communication

    Aggregation Features of Monodisperse Palladium Nanoparticles Supported on g-Al2O3

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    The production of supported on γ-A1&lt;sub&gt;2&lt;/sub&gt;O&lt;sub&gt;3&lt;/sub&gt; palladium catalysts by colloidal solution deposition method have been improved. Influence of temperature on the structure and dispersion characteristics of supported nanosized palladium particles during catalyst preparation and activation was investigated. It has been shown that at temperatures below 300&lt;sup&gt;o&lt;/sup&gt;C monodisperse particles palladium catalysts are stable. Further temperature increase leads to aggregation of monodisperse metal nanoparticles by the mechanism of reaction-limited aggregation (RLA) to form polydisperse system.Key words: palladium nanoparticles, catalyst preparation, aggregation, catalyst thermal stability.</p

    Efficacy and safety of novel russian non-nucleoside reverse transcriptase inhibitor elsulfavirine in combination with 2 nucleoside/nucleotide reverse transcriptase inhibitors in first-line HIV treatment – 96-week study

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    A randomized multicenter 96-week study of an elsulfavirine (ESV),  non-nucleoside reverse transcriptase inhibitor (NNRTI) of novel  generation, in combination with 2 nucleoside/ nucleotide reverse  transcriptase inhibitors (NRTIs) was conducted in naive HIV adult  patients, divided by 2 parts: 1) partially blind comparative to  efavirenz (EFV) 48-week study, 2) open-label observational study  during additional 48 weeks. High virological and immunological  effectiveness maintained during the study: proportion of patients  with HIV RNA &lt;50 copies/ml in 48 weeks achieved 81,6%, in 96  weeks – 83,9% (MITT-analysis) and 91% (if patients withdrawn from the study due to other reasons not related to treatment were excluded). No resistance mutations were found in patients with viral  replication blips (HIV RNA 50-1300 copies/ml). CD4+-lymphocytes  count was increased by 187,5 at week 48 and 251,0 cells/mcl at  week 96. Good tolerability and safety were confirmed during second year of treatment: no additional safety data which could influence  benefit/risk ratio were recorded as well as withdrawal from the  treatment due to adverse events. Serious adverse events, connected with treatment, allergic reactions were not registered during the whole 96-week study. Conclusion. Results of the 96-week study confirm earlier data from  48-week study on high efficacy and safety of ESV. Based on these  data ESV was included into “National recommendations on  dispensary follow-up and treatment of patients with HIV-infection” as the first-line ART regime in combination with 2 NRTIs
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