Глюкокортикостероиды в лечении алкогольного гепатита (Кокрейновский метаанализ)
- Авторы: Павлов Ч.С.1,2, Варганова Д.Л.1,3, Касаца Д.4,5,2, Тсочатис И.6,7, Николова Д.2, Глуд К.2
-
Учреждения:
- ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет)
- Университетский госпиталь Копенгагена
- ГУЗ «Ульяновская областная клиническая больница»
- Клиника «Л. Сакко»
- Миланский университет
- Королевский госпиталь
- Институт изучения печени и пищеварительного тракта
- Выпуск: Том 91, № 8 (2019)
- Страницы: 52-66
- Раздел: Передовая статья
- URL: https://journals.rcsi.science/0040-3660/article/view/33614
- DOI: https://doi.org/10.26442/00403660.2019.08.000354
- ID: 33614
Цитировать
Полный текст
Аннотация
Полный текст
Открыть статью на сайте журналаОб авторах
Чавдар Савович Павлов
ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет); Университетский госпиталь Копенгагена
Email: chpavlov@mail.ru
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 Россия
Дарья Леонидовна Варганова
ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет); ГУЗ «Ульяновская областная клиническая больница»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 Россия
Джовани Касаца
Клиника «Л. Сакко»; Миланский университет; Университетский госпиталь Копенгагенапроф., отд. биомедицинской статистики, Клиника Л. Сакко; ORCID: 0000-0003-3718-1784 Италия
Иммануил Тсочатис
Королевский госпиталь; Институт изучения печени и пищеварительного трактад.м.н., проф., Гепатологический центр Шейлы Шерлок; ORCID: 0000-0001-5069-2461 Великобритания
Димитринка Николова
Университетский госпиталь Копенгагенаправляющий редактор, Гепатобилиарная группа Кокрейна, Университетский госпиталь Копенгагена; ORCID: 0000-0001-5976-6762 Дания
Кристиан Глуд
Университетский госпиталь Копенгагенарук. Гепатобилиарной группы Кокрейна, Университетский госпиталь Копенгагена; ORCID: 0000-0002-8861-0799 Дания
Список литературы
- WHO. Global status report: Alcohol and health, 2018. Available from: https://www.who.int/substance_abuse/publications/global_alcohol_report/gsr_2018/en/ (Ссылка активна на 19.04.2019).
- EASL Clinical Practice Guidelines: Management of alcohol - related liver disease. J Hepatol. 2018;69:154-81. doi: 10.1016/j.jhep.2018.03.018
- WHO. Global status report: Alcohol and health, 2014. Available from: http://www.who.int/substance_abuse/publications/ global_alcohol_report/en/ (Ссылка активна на 21.03.2019).
- Ellis E.L, Mann D.A. Clinical evidence for the regression of liver fibrosis. J Hepatol. 2012;56(5):1171-80. doi: 10.1016/j.jhep.2011.09.024
- Maddrey W.C, Boitnott J.K, Bedine M.S, Weber F.L. Jr, Mezey E, White R.I. Jr. Corticosteroid therapy of alcoholic hepatitis. Gastroenterology. 1978;75(2):193-9.
- Dunn W, Jamil L.H, Brown L.S, Wiesner R.H, Kim W.R, Menon K.V.N, et al. MELD accurately predicts mortality in patients with alcoholic hepatitis. Hepatology (Baltimore, Md.). 2005;41:353-8. doi: 10.1002/hep.20503
- Forrest E.H, Evans C.D, Stewart S, Phillips M, Oo Y.H, Mc Avoy N.C, et al. Analysis of factors predictive of mortality in alcoholic hepatitis and derivation and validation of the Glasgow alcoholic hepatitis score. Gut. 2005;54:1174-9. doi: 10.1136/gut.2004.050781
- Dominguez M, Rincon D, Abraldes J.G, Miquel R, Colmenero J, Bellot P, et al. A new scoring system for prognostic stratification of patients with alcoholic hepatitis. Am J Gastroenterol. 2008;103:2747-56. doi: 10.1111/j.1572-0241.2008.02104.x
- Carithers R.L. Jr, Herlong H.F, Diehl A.M, Shaw E.W, Combes B, Fallon H.J, et al. Methylprednisolone therapy in patients with severe alcoholic hepatitis. A randomized multicenter trial. Ann Intern Med.1989;110:685-90. doi: 10.7326/0003-4819-110-9-685
- Phillips M, Curtis H, Portmann B, Donaldson N, Bomford A, O’Grady J. Antioxidants versus corticosteroids in the treatment of severe alcoholic hepatitis - a randomised clinical trial. J Hepatol. 2006;44:784-90. doi: 10.1016/j.jhep.2005.11.039
- O'Shea R.S, Dasarathy S, Mc Cullough A.J. Alcoholic liver disease. Hepatology (Baltimore, Md.). 2010;51:307-28. doi: 10.1002/hep.23258
- Ивашкин В.Т., Маевская М.В., Павлов Ч.С., Сиволап Ю.П., Луньков В.Д., Жаркова М.С., Масленников Р.В. Клинические рекомендации Российского общества по изучению печени по ведению взрослых пациентов с алкогольной болезнью печени. Российский журнал гастроэнтерологии, гепатологии, колопроктологии. 2017;27(6):20-40. doi: 10.22416/1382-4376-2017-27-6-20-40
- www.lillemodel.com
- Louvet A, Naveau S, Abdelnour M, Ramond M.J, Diaz E, Fartoux L. The Lille model: a new tool for therapeutic strategy in patients with severe alcoholic hepatitis treated with steroids. Hepatology (Baltimore, Md.). 2007;45(6):1348-54. doi: 10.1002/hep.21607
- Lefkowitch J.H. Morphology of alcoholic liver disease. Clin Liv Dis. 2005;9(1):37-53. doi: 10.1016/j.cld.2004.11.001
- Christensen E, Gluud C. Glucocorticoids are ineffective in alcoholic hepatitis: a meta - analysis adjusting for confounding variables [see comments]. Gut. 1995;37(1):113-8. doi: 10.1136/gut.37.1.113
- Rambaldi A, Saconato H.H, Christensen E, Thorlund K, Wetterslev J, Gluud C. Systematic review: glucocorticosteroids for alcoholic hepatitis - a Cochrane Hepato-Biliary Group systematic review with meta - analyses and trial sequential analyses of randomized clinical trials. Aliment Pharmacol Ther. 2008;27(12):1167-78. doi: 10.1111/j.1365-2036.2008.03685.x
- Reynolds T.B, Benhamou J.P, Blake J, Naccarato R, Orrego H. Treatment of acute alcoholic hepatitis. Gastroenterol Int. 1989;2(4):208-16.
- Imperiale T.F, Mc Cullough A.J. Do corticosteroids reduce mortality from alcoholic hepatitis? A meta - analysis of the randomized trials. Ann Intern Med. 1990;113(4):299-307. doi: 10.7326/0003-4819-113-4-299
- Daures J-P, Peray P, Bories P, Blanc P, Yousfi A, Michel H, et al. Steroid therapy in acute alcoholic hepatitis: a pooled estimate based on published randomized controlled trials [Place de la corticotherapie dans le traitement des hépatites alcooliques aiguës. Résultants d'une méta - analyse]. Gastroenterologie Clinique et Biologique. 1991;51:223-8.
- Christensen E, Gluud C. Glucocorticosteroids are not effective in alcoholic hepatitis. Am J Gastroenterol. 1999;94(10)(3065):66.
- Mathurin P, O'Grady J, Carithers R.L, Phillips M, Louvet A, Mendenhall C.L, et al. Corticosteroids improve short - term survival in patients with severe alcoholic hepatitis: meta - analysis of individual patient data. Gut. 2011;60(2):255-60. doi: 10.1136/gut.2010.224097
- Louvet A, Thursz M, Kim D.J, Labreuche J, Atkinson S.R, Sidhu S.S, et al. Corticosteroids reduce risk of death within 28 days for patients with severe alcoholic hepatitis, compared with pentoxifylline or placebo - a meta - analysis of individual data from controlled trials. Gastroenterology. 2018;155:458-68. doi: 10.1053/j.gastro.2018.05.011
- Pavlov C.S, Varganova D.L, Casazza G, Tsochatzis E, Nikolova D, Gluud C. Glucocorticosteroids for people with alcoholic hepatitis. Cochrane Database Syst Rev. 2017;(11):Art. No.: CD001511. doi: 10.1002/14651858.CD001511.pub3
- Pavlov C.S, Tsochatzis E, Casazza G, Nikolova D, Volcek E, Gluud C. Glucocorticosteroids for people with alcoholic hepatitis [Protocol]. Cochrane Database Syst Rev. 2016;(6). doi: 10.1002/14651858
- International Conference on Harmonisation Expert Working Group. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH harmonised tripartite guideline. Guideline for good clinical practice CFR & ICH Guidelines. Vol. 1. Philadelphia (PA): Barnett International/PAREXEL, 1997.
- Higgins J.P.T, Altman D.G, Sterne J.A.C (eds). Chapter 8: Assessing risk of bias in included studies. In: Higgins J.P.T, Green S (eds). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from: handbook.cochrane.org
- Gluud C, Nikolova D, Klingenberg S.L. Cochrane Hepato-Biliary Group. About Cochrane (Cochrane Review Groups (CRGs)) 2017, Issue 2. Art. No.: LIVER 2017.
- Jakobsen J, Wetterslev J, Winkel P, Lange T, Gluud C. Thresholds for statistical and clinical significance in systematic reviews with meta - analytic methods. BMC Med Res Methodol. 2014;14:120. doi: 10.1186/1471-2288-14-120
- Higgins J.P.T, Thompson S.G. Quantifying heterogeneity in a meta - analysis. Stat Med. 2002;21(11):1539-58. doi: 10.1002/sim.1186
- GRADE [Computer program]. Available from: http://www.gradeworkinggroup.org/
- Review Manager (RevMan) [Computer program]. Version 5.3. Copenhagen: The Nordic Cochrane Centre, the Cochrane Collaboration; 2014. Available from: https://community.cochrane.org/help/tools-and-software/revman-5. Accessed Sep 9, 2018.
- TSA - Trial Sequential Analysis [Computer program]. Version 0.9 Beta. Copenhagen: Copenhagen Trial Unit, 2011. Available from: www.ctu.dk/tsa/downloads.aspx
- Wetterslev J, Jakobsen J.C, Gluud C. Trial Sequential Analysis in systematic reviews with meta - analysis. BMC Med Res Methodol. 2017;17(1):39. doi: 10.1186/s12874-017-0315-7
- Thorlund K, Engstrøm J, Wetterslev J, Brok J, Imberger G, Gluud C. User manual for Trial Sequential Analysis (TSA). Available from: ctu.dk/tsa/files/tsa_manual.pdf
- Brok J, Thorlund K, Gluud C, Wetterslev J. Trial Sequential Analysis reveals insufficient information size and potentially false positive results in many meta - analyses. J Clin Epidemiol. 2008;61:763-9. doi: 10.1016/j.jclinepi.2007.10.007
- Brok J, Thorlund K, Wetterslev J, Gluud C. Apparently conclusive meta - analyses may be inconclusive - Trial Sequential Analysis adjustment of random error risk due to repetitive testing of accumulating data in apparently conclusive neonatal meta - analyses. Int J Epidemiol. 2009;38(1):287-98. doi: 10.1093/ije/dyn188
- Thorlund K, Devereaux P.J, Wetterslev J, Guyatt G, Ioannidis J.P, Thabane L, et al. Can trial sequential monitoring boundaries reduce spurious inferences from meta - analyses. Int J Epidemiol. 2009;38(1):276-86. doi: 10.1093/ije/dyn179
- Thorlund K, Anema A, Mills E. Interpreting meta - analysis according to the adequacy of sample size. An example using isoniazid chemoprophylaxis for tuberculosis in purified protein derivative negative HIV-infected individuals. Clin Epidemiol. 2010;2:57-66. doi: 10.2147/СLEP.S9242
- Helman R.A, Temko M.H, Nye S.W, Fallon H.J. Alcoholic hepatitis. Natural history and evaluation of prednisolone therapy. Ann Intern Med. 1971;74(3):311-21. doi: 10.7326/0003-4819-74-3-311
- Porter H.P, Simon F.R, Pope C.E. II, Volwiler W, Fenster L.F. Corticosteroid therapy in severe alcoholic hepatitis. A double - blind drug trial. N Engl J Med. 1971;284(24):1350-5. doi: 10.1056/NEJM197106172842404
- Blitzer B.L, Mutchnick M.G, Joshi P.H, Phillips M.M, Fessel J.M, Conn H.O. Adrenocorticosteroid therapy in alcoholic hepatitis. A prospective, double - blind randomized study. Dig Dis. 1977;22(6):477-84.
- Mendenhall C.L, Goldberg S. Risk factors and therapy in alcoholic hepatitis (AH). Gastroenterology. 1977;72(5):1100.
- Mendenhall C.L, Anderson S, Garcia-Pont P, Goldberg S, Kiernan T, Seeff L.B, et al. Short - term and long - term survival in patients with alcoholic hepatitis treated with oxandrolone and prednisolone. N Engl J Med. 1984;311(23):1464-70. doi: 10.1053/jhep.2000.8627
- Shumaker J.B, Resnick R.H, Galambos J.T, Makopour H, Iber F.L. A controlled trial of 6-methylprednisolone in acute alcoholic hepatitis. With a note on published results in encephalopathic patients. Am J Gastroenterol. 1978;69(4):443-9.
- Depew W, Boyer T, Omata M, Redeker A, Reynolds T. Double - blind controlled trial of prednisolone therapy in patients with severe acute alcoholic hepatitis and spontaneous encephalopathy. Gastroenterology. 1980;78(3):524-9.
- Ramond M.J, Poynard T, Rueff B, Mathurin P, Theodore C, Chaput J.C, et al. A randomized trial of prednisolone in patients with severe alcoholic hepatitis. New Engl J Med. 1992;326:507-12. doi: 10.1056/NEJM199202203260802
- De B.K, Mandal S.K, Sau D, Mani S, Chatterjee S, Mondal S.S, et al. Pentoxifylline plus prednisolone versus pentoxifylline only for severe alcoholic hepatitis: a randomized controlled clinical trial. Ann Med Health Sci Res. 2014; 4(5):810-16. doi: 10.4103/2141-9248.141562
- Thursz M.R, Richardson P, Allison M, Austin A, Bowers M, Day C.P, et al. Prednisolone or pentoxifylline for alcoholic hepatitis. New Engl J Med. 2015;372(17):1619-28. doi: 10.1056/NEJMoa1412278
- Campra J.L, Hamlin E.M. Jr, Kirshbaum R.J, Olivier M, Redeker A.G, Reynolds T.B. Prednisone therapy of acute alcoholic hepatitis. Report of a controlled trial. Ann Intern Med. 1973;79(5):625-31. doi: 10.7326/0003-4819-79-5-625
- Theodossi A, Eddleston A.L, Williams R. Controlled trial of methylprednisolone therapy in severe acute alcoholic hepatitis. Gut. 1982;23(1):75-9. doi: 10.1136/gut.23.1.75
- Bories P, Guedj J.Y, Mirouze D, Yousfi A, Michel H. Prednisolone treatment of alcoholic hepatitis: forty - five patients [Traitement de l'hepatite alcoolique aigue par la prednisolone. Quarante - cinq malades]. La Presse Medicale. 1987;16:769-72.
- Richardet J.P, Dehoux M, Mal F, Roulot D, Labadie H, Pol S, et al. Influence of corticosteroids (CS) on plasma cytokines concentrations in patients with severe alcoholic hepatitis (HA): results of a randomized study. J Hepatol. 1993;18:S75.
- Lesesne H.R, Bozymski E.M, Fallon H.J. Treatment of alcoholic hepatitis with encephalopathy. Comparison of prednisolone with caloric supplements. Gastroenterology. 1978;74(2 Pt 1):169-73.
- Cabré E, Rodríguez-Iglesias P, Caballería J, Quer J.C, Sánchez-Lombraña J.L, Parés A, et al. Short - and long - term outcome of severe alcohol - induced hepatitis treated with steroids or enteral nutrition: a multicenter randomized trial. Hepatology (Baltimore, Md.). 2000;32:36-42. doi: 10.1053/jhep.2000.8627
- Harbord R.M, Egger M, Sterne J.A.C. A modified test for small - study effects in meta - analyses of controlled trials with binary endpoints. Statist Med. 2006;25(20):3443-57. doi: 10.1002/sim.2380
- Student. The probable error of a mean. Biometrika. 1908;6(1):1-25.
- Buzzetti E, Kalafateli M, Thorburn D, Davidson B.R, Thiele M, Gluud L.L, et al. Pharmacological interventions for alcoholic liver disease (alcohol - related liver disease). Cochrane Database System Rev. 2017;(3):Art. No.: CD011646. doi: 10.1002/14651858
- Chan A.W, Tetzlaff J.M, Altman D.G, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583