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Please use this identifier to cite or link to this item: http://repo.knmu.edu.ua/handle/123456789/7763

Название: Randomized, double-blind, controlled study of glycerol phenylbutyrate in hepatic encephalopathy
Авторы: Rockey, Don
Vierling, John
Mantry, Parvez
Ghabril, Marwan
Brown, Robert
Alexeeva, Olga
Zupanets, Igor
Grinevich, Vladimir
Baranovsky, Andrey
Dudar, Larysa
Fadieienko, Galyna
Kharchenko, Nataliya
Klaryts’ka, Iryna
Morozov, Vyacheslav
Grewal, Priya
McCashland, Timothy
Reddy, Gautham
Reddy, Rajender
Syplyviy, Vasyl
Bass, Nathan
Dickinson, Klara
Norris, Catherine
Coakley, Dion
Mokhtarani, Masoud
Scharschmidt, Bruce
Ключевые слова: liver diseases
encefalopathy
clinical trials
glycerol phenylbutyrate
Issue Date: Mar-2014
Библиографическое описание: Randomized, double-blind, controlled study of glycerol phenylbutyrate in hepatic encephalopathy / D. Rockey, J. Vierling, P. Mantry, M. Ghabril, R. S. Brown, O. Alexeeva, I. A. Zupanets, V. Grinevich, A. Baranovsky, L. Dudar, G. Fadieienko, N. Kharchenko, I. Klaryts’ka, V. Morozov, P. Grewal, T. McCashland, K. G. Reddy, K. Rajender Reddy, V. Syplyviy, N. M. Bass, K. Dickinson, C. Norris, D. Coakley, M. Mokhtarani, B. F. Scharschmidt // Hepatology. - 2014. - Vol. 54, N 3. – P. 1073–1083.
Аннотация: Glycerol phenylbutyrate (GPB) lowers ammonia by providing an alternate pathway to urea for waste nitrogen excretion in the form of phenylacetyl glutamine, which is excreted in urine. This randomized, double-blind, placebo-controlled phase II trial enrolled 178 patients with cirrhosis, including 59 already taking rifaximin, who had experienced two or more hepatic encephalopathy (HE) events in the previous 6 months. The primary endpoint was the proportion of patients with HE events. Other endpoints included the time to first event, total number of events, HE hospitalizations, symptomatic days, and safety. GPB, at 6 mL orally twice-daily, significantly reduced the proportion of patients who experienced an HE event (21% versus 36%; P=0.02), time to first event (hazard ratio [HR]=0.56; P<0.05), as well as total events (35 versus 57; P=0.04), and was associated with fewer HE hospitalizations (13 versus 25; P=0.06). Among patients not on rifaximin at enrollment, GPB reduced the proportion of patients with an HE event (10% versus 32%; P<0.01), time to first event (HR=0.29; P<0.01), and total events (7 versus 31; P<0.01). Plasma ammonia was significantly lower in patients on GPB and correlated with HE events when measured either at baseline or during the study. A similar proportion of patients in the GPB (79%) and placebo groups (76%) experienced adverse events.
URI: http://repo.knmu.edu.ua/handle/123456789/7763
Appears in Collections:Наукові праці. Кафедра загальної хірургії № 2

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