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...

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Main Authors: I. G. Bakulin, N. A. Bokhan, P. O. Bogomolov, N. I. Geyvandova, M. V. Matsiyevich, M. A. Vinnikova, V. G. Morozov, O. M. Khromtsova, G. S. Soldatova, O. Yu. Shiryayev, R. D. Ilyuk, K. V. Rybakova, A. G. Katkovskaya, S. V. Teplykh, A. A. Bagretsova, M. V. Krasnova, Ye. V. Alekseyeva, A. V. Anipchenko, Ye. V. Baskakov
Format: Article
Language:Russian
Published: Gastro LLC 2018-08-01
Series:Российский журнал гастроэнтерологии, гепатологии, колопроктологии
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Online Access:https://www.gastro-j.ru/jour/article/view/158
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author I. G. Bakulin
N. A. Bokhan
P. O. Bogomolov
N. I. Geyvandova
M. V. Matsiyevich
M. A. Vinnikova
V. G. Morozov
O. M. Khromtsova
G. S. Soldatova
O. Yu. Shiryayev
R. D. Ilyuk
K. V. Rybakova
A. G. Katkovskaya
S. V. Teplykh
A. A. Bagretsova
M. V. Krasnova
Ye. V. Alekseyeva
A. V. Anipchenko
Ye. V. Baskakov
author_facet I. G. Bakulin
N. A. Bokhan
P. O. Bogomolov
N. I. Geyvandova
M. V. Matsiyevich
M. A. Vinnikova
V. G. Morozov
O. M. Khromtsova
G. S. Soldatova
O. Yu. Shiryayev
R. D. Ilyuk
K. V. Rybakova
A. G. Katkovskaya
S. V. Teplykh
A. A. Bagretsova
M. V. Krasnova
Ye. V. Alekseyeva
A. V. Anipchenko
Ye. V. Baskakov
author_sort I. G. Bakulin
collection DOAJ
description 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% (p
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spelling doaj-art-4f495eb6776240bda9501c18da8c6da02025-02-10T16:14:28ZrusGastro LLCРоссийский журнал гастроэнтерологии, гепатологии, колопроктологии1382-43762658-66732018-08-01273576810.22416/1382-4376-2017-27-3-57-68158Efficacy 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)I. G. Bakulin0N. A. Bokhan1P. O. Bogomolov2N. I. Geyvandova3M. V. Matsiyevich4M. A. Vinnikova5V. G. Morozov6O. M. Khromtsova7G. S. Soldatova8O. Yu. Shiryayev9R. D. Ilyuk10K. V. Rybakova11A. G. Katkovskaya12S. V. Teplykh13A. A. Bagretsova14M. V. Krasnova15Ye. V. Alekseyeva16A. V. Anipchenko17Ye. V. Baskakov18Federal government-financed healthcare institution «Moscow clinical scientific and practical center»Institution of the Russian Academy of Sciences Tomsk Scientific CenterLLC «Tsentrosoyuz clinical hospital»State educational government-financed institution of higher professional education «Stavropol state medical university»State government-financed healthcare institution of the Moscow region «Vladimirsky Moscow regional research clinical institute»Federal state government-financed healthcare institution «Serbsky Federal Medical Research Center of Psychiatry and Narcology»LLC «Medical company «Gepatolog»Municipal government-financed institution «Central city hospital #7»Institution of the Russian Academy of Sciences «Central hospital of the Siberian branch of the Russian Academy of Sciences»LLC «Lion-med»Federal state institution «Bekhterev Saint-Petersburg Psychoneurological Research Institute»Federal state institution «Bekhterev Saint-Petersburg Psychoneurological Research Institute»Federal state government-financed healthcare institution «Siberian district medical center of Federal Medical-Biological Agency of Russia»LLC «Professorskaya clinic»Federal state institution «Semashko Northern medical clinical center of Federal Medical-Biological Agency of Russia»Municipal government-financed healthcare institution «Podgorbunsky City hospital #3»Municipal Autonomous healthcare institution «City hospital #40»Saint-Petersburg state healthcare institution «City narcological hospital»State government-financed healthcare institution «Yaroslavl regional clinical narcological hospital»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% (phttps://www.gastro-j.ru/jour/article/view/158фосфоглив®гепатопротекторалкогольная болезнь печенивоспалениефиброзкачество жизни
spellingShingle I. G. Bakulin
N. A. Bokhan
P. O. Bogomolov
N. I. Geyvandova
M. V. Matsiyevich
M. A. Vinnikova
V. G. Morozov
O. M. Khromtsova
G. S. Soldatova
O. Yu. Shiryayev
R. D. Ilyuk
K. V. Rybakova
A. G. Katkovskaya
S. V. Teplykh
A. A. Bagretsova
M. V. Krasnova
Ye. V. Alekseyeva
A. V. Anipchenko
Ye. V. Baskakov
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)
Российский журнал гастроэнтерологии, гепатологии, колопроктологии
фосфоглив®
гепатопротектор
алкогольная болезнь печени
воспаление
фиброз
качество жизни
title 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)
title_full 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)
title_fullStr 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)
title_full_unstemmed 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)
title_short 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)
title_sort 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
topic фосфоглив®
гепатопротектор
алкогольная болезнь печени
воспаление
фиброз
качество жизни
url https://www.gastro-j.ru/jour/article/view/158
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