Terapevticheskii arkhivTerapevticheskii arkhivТерапевтический архив0040-36602309-5342LLC Obyedinennaya Redaktsiya3361410.26442/00403660.2019.08.000354Editorial articleПередовая статьяResearch ArticleGlucocorticosteroids for people with alcoholic hepatitis (Cochrane review)Глюкокортикостероиды в лечении алкогольного гепатита (Кокрейновский метаанализ)PavlovChavdar SПавловЧавдар Савович

д.м.н., проф., директор центра доказательной медицины технопарка биомедицины, проф. каф. пропедевтики внутренних болезней ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова»; ORCID: 0000-0001-5031-9798

chpavlov@mail.ruVarganovaDaria LВаргановаДарья Леонидовна

м.н.с. центра доказательной медицины технопарка биомедицины ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова», врач-гастроэнтеролог ГУЗ «Ульяновская ОКБ»; ORCID: 0000-0002-5745-7605

CasazzaGiovanniКасацаДжовани

проф., отд. биомедицинской статистики, Клиника Л. Сакко; ORCID: 0000-0003-3718-1784

TsochatzisEmmanuelТсочатисИммануил

д.м.н., проф., Гепатологический центр Шейлы Шерлок; ORCID: 0000-0001-5069-2461

NikolovaDimitrinkaНиколоваДимитринка

правляющий редактор, Гепатобилиарная группа Кокрейна, Университетский госпиталь Копенгагена; ORCID: 0000-0001-5976-6762

GluudChristianГлудКристиан

рук. Гепатобилиарной группы Кокрейна, Университетский госпиталь Копенгагена; ORCID: 0000-0002-8861-0799

The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University HospitalФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет)Center for Evidence Based Medicine, Sechenov First Moscow State Medical UniversityУниверситетский госпиталь КопенгагенаCenter for Evidence Based Medicine, Sechenov First Moscow State Medical UniversityФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет)Department of Gastroenterology, Ulyanovsk Regional Clinical HospitalГУЗ «Ульяновская областная клиническая больница»Dipartimento di Scienze Biomediche e Cliniche "L. Sacco", Università degli Studi di MilanoКлиника «Л. Сакко»Миланский университетSheila Sherlock Liver Centre, Royal Free Hospital and the UCL Institute of Liver and Digestive HealthУниверситетский госпиталь КопенгагенаThe Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University HospitalКоролевский госпитальThe Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University HospitalИнститут изучения печени и пищеварительного трактаУниверситетский госпиталь Копенгагена15082019918VOL 91, NO8 (2019)ТОМ 91, №8 (2019)526616042020Copyright ©; 2019, Consilium MedicumCopyright ©; 2019, ООО "Консилиум Медикум"2019Consilium MedicumООО "Консилиум Медикум"https://creativecommons.org/licenses/by-nc-sa/4.0https://ter-arkhiv.ru/0040-3660/article/view/33614

Alcoholic hepatitis (AH) is a form of alcoholic liver disease. Glucocorticosteroids (GCS) are used as anti - inflammatory drugs for people with alcoholic hepatitis. Aim. To assess the benefits and harms of GCS in people with AH. Material and methods. We identified trials through electronic searches in Cochrane Hepato-Biliary's (CHB) Controlled Trials Register, CENTRAL, MEDLINE, Embase, LILACS, and Science Citation Index Expanded. We considered for inclusion randomised clinical trials (RCTs) assessing GCS versus placebo/no intervention in adult participants with AH. We allowed co - interventions in the trial groups if they were similar. We followed Cochrane methodology, CHB Group methodology using Review Manager 5 and Trial Sequential Analysis(TSA) to perform meta - analysis (M-A), assessed bias risk of the trials, certainty of evidence using GRADE. Results and discussion. Sixteen trials fulfilled the inclusion criteria. Fifteen trials provided data for analysis (927 participants received GCS, 934 - placebo/no intervention). The GCS were administered to adult participants at different stages of AH orally or parenterally for a median of 28 days. There was no evidence of effect of GCCs on our primary outcomes all - cause mortality up to 3 months following randomisation (RR 0.90, 95% CI 0.70-1.15; n=1861), on health - related quality of life (MD - 0.04 points; 95% CI -0.11-0.03; n=377; trial = 1) (EQ-5D-3L scale), on the occurrence of serious adverse events during treatment (RR 1.05, 95% CI 0.85-1.29; n=1861). We found no evidence of a difference between the intervention groups. The risk of bias was high in all the trials except one. The certainty of evidence was very low or low. One of the trials seems to be not industry - funded. Conclusion. We found no evidence of a difference between GCS and placebo or no intervention on all - cause mortality, health - related quality of life, and serious adverse events during treatment. We cannot exclude increases in adverse events and cannot rule out significant benefits and harms of GCSs. Future trials ought to report depersonalised individual participant data.

Рост заболеваемости алкогольной болезнью печени и смертности от нее остается актуальной международной проблемой. В настоящее время среди многообразия лекарственных препаратов, применяющихся для терапии алкогольного гепатита, препаратами первой линии являются глюкокортикостероиды (ГКС). Цель исследования. Оценить эффективность и безопасность ГКС в терапии алкогольного гепатита. Материалы и методы. Поиск рандомизированных клинических исследований (РКИ) проводился в международных электронных базах данных. Отбирались РКИ со взрослыми участниками, сравнивающие терапию ГКС и плацебо (контрольную группу), допускалась идентичная сопутствующая терапия в обеих группах. Мы использовали методологию Кокрейна, Кокрейновской гепатобилиарной группы. Метаанализы выполнены с использованием программного обеспечения Review Manager 5 и последовательного экспертного анализа. Результаты и обсуждение. Критериям включения соответствовали 16 РКИ, в метаанализ включены результаты 15 РКИ (927 участников получали ГКС, 934 - плацебо). ГКС назначались внутрь или парентерально в среднем на 28 дней. Мы не получили убедительных данных о влиянии ГКС на показатели смертности в течение 3 мес после рандомизации (ОР 0,90; 95% ДИ 0,70-1,15; n=1861), на качество жизни (MD - 0,04 балла; 95% ДИ от -0,11 до 0,03; n=377; РКИ = 1) (шкала EQ-5D-3L), частоту возникновения серьезных нежелательных явлений во время лечения (ОР 1,05; 95% ДИ 0,85-1,29; n=1861) по результатам метаанализа. Качество доказательств оказалось очень низким или низким при оценке по шкале GRADE, а уровень ошибки - высоким во всех РКИ, кроме одного. Одно РКИ не спонсировалось фармацевтическими фирмами. Заключение. Мы не нашли убедительной разницы между группами терапии ГКС и плацебо в отношении показателей смертности, качества жизни и серьезных нежелательных явлений во время лечения. Мы не можем достоверно исключить увеличение числа нежелательных явлений, преимуществ и вреда терапии ГКС. Необходимы клинические исследования с предоставлением индивидуальных обезличенных данных участников.

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