Results of non-interventional observational study of ursodeoxycholic acid in primary biliary cirrhosis
Aim of investigation. To estimate clinical efficacy and safety of ursodeoxycholic acid («Livodexa®») in a dose of 15 mg/kg/day for 3 months in the treatment of primary biliary cirrhosis (PBC) of the I to III stage. Material and methods. Open single center clinical trial included 30 patients with PBC...
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| Format: | Article |
| 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/82 |
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| _version_ | 1823860276627243008 |
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| author | Yelena N. Shirokova Anna F. Sheptulina |
| author_facet | Yelena N. Shirokova Anna F. Sheptulina |
| author_sort | Yelena N. Shirokova |
| collection | DOAJ |
| description | Aim of investigation. To estimate clinical efficacy and safety of ursodeoxycholic acid («Livodexa®») in a dose of 15 mg/kg/day for 3 months in the treatment of primary biliary cirrhosis (PBC) of the I to III stage. Material and methods. Open single center clinical trial included 30 patients with PBC of the I-III stage. All patients received «Livodexa®» in the daily dose of 15 mg/kg taken two times per day for 3 months. Efficacy and safety investigation of the drug was carried out at the day 30 (visit 2) and at the day 90 (visit 3) according to the laboratory tests results, quality of life assessment by SF-36 questionnaire, registration of frequency and severity of the adverse events (AE). Results. The median age (interquartile range) of PBC patients enrolled in the original study was 53 (48-61) years, the women prevailed: 29 (96,6%). The majority (43,2%) of patients had PBC of the histological grade II according to the Ludwig system. Treatment with «Livodexa®» in a dose of 15 mg/kg/day resulted in a statistically significant decrease of biochemical marker levels: alanine transaminase, aspartate aminotransferase, alkaline phosphatase, gamma-glutamyltranspeptidase, total and conjugated bilirubin at the 30th day of treatment (visit 2; p |
| format | Article |
| id | doaj-art-4a593110718d4faaafaf520023011d13 |
| 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-4a593110718d4faaafaf520023011d132025-02-10T16:14:28ZrusGastro LLCРоссийский журнал гастроэнтерологии, гепатологии, колопроктологии1382-43762658-66732018-08-01265364410.22416/1382-4376-2016-5-36-4482Results of non-interventional observational study of ursodeoxycholic acid in primary biliary cirrhosisYelena N. Shirokova0Anna F. Sheptulina1Federal state educational government-financed institution of higher education «Sechenov First Moscow state medical university»Federal state educational government-financed institution of higher education «Sechenov First Moscow state medical university»Aim of investigation. To estimate clinical efficacy and safety of ursodeoxycholic acid («Livodexa®») in a dose of 15 mg/kg/day for 3 months in the treatment of primary biliary cirrhosis (PBC) of the I to III stage. Material and methods. Open single center clinical trial included 30 patients with PBC of the I-III stage. All patients received «Livodexa®» in the daily dose of 15 mg/kg taken two times per day for 3 months. Efficacy and safety investigation of the drug was carried out at the day 30 (visit 2) and at the day 90 (visit 3) according to the laboratory tests results, quality of life assessment by SF-36 questionnaire, registration of frequency and severity of the adverse events (AE). Results. The median age (interquartile range) of PBC patients enrolled in the original study was 53 (48-61) years, the women prevailed: 29 (96,6%). The majority (43,2%) of patients had PBC of the histological grade II according to the Ludwig system. Treatment with «Livodexa®» in a dose of 15 mg/kg/day resulted in a statistically significant decrease of biochemical marker levels: alanine transaminase, aspartate aminotransferase, alkaline phosphatase, gamma-glutamyltranspeptidase, total and conjugated bilirubin at the 30th day of treatment (visit 2; phttps://www.gastro-j.ru/jour/article/view/82первичный билиарный циррозурсодезоксихолевая кислотакачество жизни |
| spellingShingle | Yelena N. Shirokova Anna F. Sheptulina Results of non-interventional observational study of ursodeoxycholic acid in primary biliary cirrhosis Российский журнал гастроэнтерологии, гепатологии, колопроктологии первичный билиарный цирроз урсодезоксихолевая кислота качество жизни |
| title | Results of non-interventional observational study of ursodeoxycholic acid in primary biliary cirrhosis |
| title_full | Results of non-interventional observational study of ursodeoxycholic acid in primary biliary cirrhosis |
| title_fullStr | Results of non-interventional observational study of ursodeoxycholic acid in primary biliary cirrhosis |
| title_full_unstemmed | Results of non-interventional observational study of ursodeoxycholic acid in primary biliary cirrhosis |
| title_short | Results of non-interventional observational study of ursodeoxycholic acid in primary biliary cirrhosis |
| title_sort | results of non interventional observational study of ursodeoxycholic acid in primary biliary cirrhosis |
| topic | первичный билиарный цирроз урсодезоксихолевая кислота качество жизни |
| url | https://www.gastro-j.ru/jour/article/view/82 |
| work_keys_str_mv | AT yelenanshirokova resultsofnoninterventionalobservationalstudyofursodeoxycholicacidinprimarybiliarycirrhosis AT annafsheptulina resultsofnoninterventionalobservationalstudyofursodeoxycholicacidinprimarybiliarycirrhosis |