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 w...
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| Language: | Russian |
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Gastro LLC
2018-08-01
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| Series: | Российский журнал гастроэнтерологии, гепатологии, колопроктологии |
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| Online Access: | https://www.gastro-j.ru/jour/article/view/133 |
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| author | V. T. Ivashkin I. G. Bakulin P. O. Bogomolov M. V. Matsiyevich N. I. Geyvandova P. V. Koroy S. V. Nedogoda O. A. Sablin L. G. Lenskaya Ye. V. Beloborodova A. A. Bagretsova R. A. Abdulkhakov M. F. Osipenko I. V. Osipova D. A. Pocheptsov Ye. V. Chumachek O. M. Khromtsova Ye. V. Kuzmicheva |
| author_facet | V. T. Ivashkin I. G. Bakulin P. O. Bogomolov M. V. Matsiyevich N. I. Geyvandova P. V. Koroy S. V. Nedogoda O. A. Sablin L. G. Lenskaya Ye. V. Beloborodova A. A. Bagretsova R. A. Abdulkhakov M. F. Osipenko I. V. Osipova D. A. Pocheptsov Ye. V. Chumachek O. M. Khromtsova Ye. V. Kuzmicheva |
| author_sort | V. T. Ivashkin |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-4131ff0071c74aa1ac7482e20794c338 |
| institution | Kabale University |
| issn | 1382-4376 2658-6673 |
| language | Russian |
| publishDate | 2018-08-01 |
| publisher | Gastro LLC |
| record_format | Article |
| series | Российский журнал гастроэнтерологии, гепатологии, колопроктологии |
| spelling | doaj-art-4131ff0071c74aa1ac7482e20794c3382025-02-10T16:14:29ZrusGastro LLCРоссийский журнал гастроэнтерологии, гепатологии, колопроктологии1382-43762658-66732018-08-01272344310.22416/1382-4376-2017-27-2-34-43133Efficacy 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)V. T. Ivashkin0I. G. Bakulin1P. O. Bogomolov2M. V. Matsiyevich3N. I. Geyvandova4P. V. Koroy5S. V. Nedogoda6O. A. Sablin7L. G. Lenskaya8Ye. V. Beloborodova9A. A. Bagretsova10R. A. Abdulkhakov11M. F. Osipenko12I. V. Osipova13D. A. Pocheptsov14Ye. V. Chumachek15O. M. Khromtsova16Ye. V. Kuzmicheva17The State Education Institution of Higher Professional Training The First Sechenov Moscow State Medical UniversityFederal government-financed healthcare institution «Moscow clinical scientific and practical center (MCSPC)»LLC «Tsentrosoyuz clinical hospital»LLC «Tsentrosoyuz clinical hospital»State educational government-financed institution of higher professional education «Stavropol state medical university»State educational government-financed institution of higher professional education «Stavropol state medical university»The State educational institution of higher education «Volgograd state medical university»; Federal government-financed healthcare institution «Volgograd regional hospital #3»The Federal state institute of public health «The Nikiforov Russian Center of Emergency and Radiation Medicine»Tomsk region State autonomous healthcare institution «Tomsk regional hospital»The State educational institution of higher education «Siberian State Medical University»State educational government-financed healthcare institution «Semashko Northern medical clinical center»The State educational institution of higher education «Kazan State Medical University»The State educational institution of higher education «Novosibirsk state medical university»Non-governmental healthcare institution «Barnaul station sectional hospital»Federal government-financed healthcare institution «Volgograd regional hospital #3»The State educational institution of higher education «Volgograd state medical university»The State educational institution of higher education «Ural state medical university»Municipal government-financed healthcare institution «Central municipal hospital #7»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.https://www.gastro-j.ru/jour/article/view/133фосфогливгепатопротекторнеалкогольная жировая болезнь печенивоспалениефиброзкачество жизни |
| spellingShingle | V. T. Ivashkin I. G. Bakulin P. O. Bogomolov M. V. Matsiyevich N. I. Geyvandova P. V. Koroy S. V. Nedogoda O. A. Sablin L. G. Lenskaya Ye. V. Beloborodova A. A. Bagretsova R. A. Abdulkhakov M. F. Osipenko I. V. Osipova D. A. Pocheptsov Ye. V. Chumachek O. M. Khromtsova Ye. V. Kuzmicheva 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) Российский журнал гастроэнтерологии, гепатологии, колопроктологии фосфоглив гепатопротектор неалкогольная жировая болезнь печени воспаление фиброз качество жизни |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | фосфоглив гепатопротектор неалкогольная жировая болезнь печени воспаление фиброз качество жизни |
| url | https://www.gastro-j.ru/jour/article/view/133 |
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