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Titolo:
Randomized trial of interferon-alpha plus ursodeoxycholic acid versus interferon plus placebo in patients with chronic hepatitis C resistant to interferon
Autore:
Poupon, RE; Bonnand, AM; Queneau, PE; Trepo, C; Zarski, JP; Vetter, D; Raabe, JJ; Thieffin, G; Larrey, D; Grange, JD; Capron, JP; Serfaty, L; Chretien, Y; Girardin, MFS; Mathiex-Fortunet, H; Zafrani, ES; Guechot, J; Beuers, U; Paumgartner, G; Poupon, R;
Indirizzi:
Fac Med Necker, INSERM U370, FR-75730 Paris 15, France Fac Med Necker Paris France 15 r, INSERM U370, FR-75730 Paris 15, France CHU Besancon, Dept Hepatol & Intens Digest Care, F-25030 Besancon, France CHU Besancon Besancon France F-25030 gest Care, F-25030 Besancon, France CHU Lyons, Dept Hepatogastroenterol, Lyon, France CHU Lyons Lyon FranceCHU Lyons, Dept Hepatogastroenterol, Lyon, France CHU Grenoble, Dept Hepatogastroenterol, F-38043 Grenoble, France CHU Grenoble Grenoble France F-38043 roenterol, F-38043 Grenoble, France CHU Strasbourg, Dept Hepatogastroenterol, F-67000 Strasbourg, France CHU Strasbourg Strasbourg France F-67000 rol, F-67000 Strasbourg, France CHU Reims, Dept Hepatogastroenterol, Reims, France CHU Reims Reims France U Reims, Dept Hepatogastroenterol, Reims, France Hop Robert Debre, Dept Hepatogastroenterol, Metz, France Hop Robert DebreMetz France re, Dept Hepatogastroenterol, Metz, France CHU Montpellier, Dept Hepatogastroenterol, Montpellier, France CHU Montpellier Montpellier France togastroenterol, Montpellier, France Tenon Hosp, Dept Hepatogastroenterol, Paris, France Tenon Hosp Paris France n Hosp, Dept Hepatogastroenterol, Paris, France CHU Amiens, Dept Hepatogastroenterol, Amiens, France CHU Amiens Amiens France iens, Dept Hepatogastroenterol, Amiens, France Hop St Antoine, A P Hosp, Dept Hepatogastroenterol, F-75571 Paris, France Hop St Antoine Paris France F-75571 gastroenterol, F-75571 Paris, France Roche Prod Ltd, Neuilly Sur Seine, France Roche Prod Ltd Neuilly Sur Seine France Ltd, Neuilly Sur Seine, France Labs Hoechst Houde, Puteaux La Def, France Labs Hoechst Houde Puteaux La Def France Houde, Puteaux La Def, France Hop Henri Mondor, Dept Pathol Anat & Cytol, F-94010 Creteil, France Hop Henri Mondor Creteil France F-94010 & Cytol, F-94010 Creteil, France Hop St Antoine, Biochem Lab A, F-75571 Paris, France Hop St Antoine Paris France F-75571 Biochem Lab A, F-75571 Paris, France Univ Munich, Klinikum Grosshadern, Med Clin 2, D-8000 Munich, Germany UnivMunich Munich Germany D-8000 rn, Med Clin 2, D-8000 Munich, Germany
Titolo Testata:
SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY
fascicolo: 6, volume: 35, anno: 2000,
pagine: 642 - 649
SICI:
0036-5521(200006)35:6<642:RTOIPU>2.0.ZU;2-K
Fonte:
ISI
Lingua:
ENG
Soggetto:
CHRONIC ACTIVE HEPATITIS; SERUM LIVER-ENZYMES; TERM FOLLOW-UP; CLINICAL-TRIAL; BILE-ACIDS; APOPTOSIS; THERAPY; UDCA;
Keywords:
bile acids; chronic hepatitis C; interferon; resistance; ursodeoxycholic acid;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
34
Recensione:
Indirizzi per estratti:
Indirizzo: Poupon, R Fac Med Necker, INSERM U370, 156 Rue de Vaugirard, FR-75730 Paris 15, France Fac Med Necker 156 Rue de Vaugirard Paris France 15 15, France
Citazione:
R.E. Poupon et al., "Randomized trial of interferon-alpha plus ursodeoxycholic acid versus interferon plus placebo in patients with chronic hepatitis C resistant to interferon", SC J GASTR, 35(6), 2000, pp. 642-649

Abstract

Background: Ursodeoxycholic acid (UDCA) could potentiate the effect of interferon (IFN) in patients with chronic hepatitis C resistant to IFN. We compared the efficacy of IFN with that of a combination of IFN and UDCA. Methods: Patients were randomized to receive UDCA (13-15 mg/kg/day) (n = 47) or placebo (n = 44) plus interferon (3 MU three times weekly) for 6 months andwere then followed up for 6 additional months. Results: At entry 30% of patients had cirrhosis, and 70% had HCV genotype i. Five and four patients withdrew from the combination and the monotherapy groups, respectively. At 6 months alanine aminotransferase (ALAT) and gamma-glutamyl transferase (GGT)activities were significantly lower (P < 0.001) in the combination group than in the monotherapy group; the differences were no longer significant at1 year. At 6 months ALAT activities normalized in 10 and 8 patients in thecombination and the monotherapy groups, respectively (P = 0.67). In 10 of them (5 in each group) HCV RNA levels became undetectable. At 1 year four versus one patient had a sustained normalization of ALAT, and in one patientthe HCV RNA became negative. There was no difference in the histologic progression. In this setting, in contrast to chronic cholestasis, UDCA administration induced an increase in total serum bile acids and did not change primary bile acids. Conclusions: An IFN plus UDCA combination is more effective than IFN alone in terms of ALAT but not in terms of the virologic response. These results favor the hypothesis that UDCA has an effect on the biochemical indices of cellular injury independent of a change in primary bile acids.

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Documento generato il 03/12/20 alle ore 16:03:56