Catalogo Articoli (Spogli Riviste)

OPAC HELP

Titolo:
Randomized controlled clinical trial of lymphoblastoid interferon-alpha for chronic hepatitis C
Autore:
Arase, Y; Chayama, K; Ikeda, K; Tsubota, A; Suzuki, Y; Saitoh, S; Kobayashi, M; Suzuki, F; Akuta, N; Someya, T; Kobayashi, M; Kumada, H;
Indirizzi:
Toranomon Gen Hosp, Dept Gastroenterol, Minato Ku, Tokyo, Japan Toranomon Gen Hosp Tokyo Japan t Gastroenterol, Minato Ku, Tokyo, Japan Hiroshima Univ Med, Dept Internal Med 1, Minami Ku, Hiroshima, Japan Hiroshima Univ Med Hiroshima Japan l Med 1, Minami Ku, Hiroshima, Japan Toranomon Gen Hosp, Hepat Res Unit, Minato Ku, Tokyo, Japan Toranomon Gen Hosp Tokyo Japan Hepat Res Unit, Minato Ku, Tokyo, Japan
Titolo Testata:
HEPATOLOGY RESEARCH
fascicolo: 1, volume: 21, anno: 2001,
pagine: 55 - 66
SICI:
1386-6346(200109)21:1<55:RCCTOL>2.0.ZU;2-U
Fonte:
ISI
Lingua:
ENG
Soggetto:
POLYMERASE CHAIN-REACTION; LONG-TERM RESPONSE; VIRUS GENOTYPES; THERAPY; DISEASE; COMBINATION; RIBAVIRIN; EFFICACY; RELAPSE; SERUM;
Keywords:
chronic hepatitis C; interferon therapy; randomized controlled trial;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
22
Recensione:
Indirizzi per estratti:
Indirizzo: Arase, Y Toranomon Gen Hosp, Dept Gastroenterol, Minato Ku, 2-2-2 Toranomon, Tokyo,Japan Toranomon Gen Hosp 2-2-2 Toranomon Tokyo Japan mon, Tokyo,Japan
Citazione:
Y. Arase et al., "Randomized controlled clinical trial of lymphoblastoid interferon-alpha for chronic hepatitis C", HEPATOL RES, 21(1), 2001, pp. 55-66

Abstract

Objective: Most of chronic hepatitis C patients with HCV-genotype 1 and a high virus load fail to eradicate the HCV-RNA by the interferon (IFN) or IFN/ribavirin therapy. But in these patients, IFN is often effective with regard to normalization of alanine aminotransferase (ALT). We had therefore the following two randomized controlled clinical trials to evaluate the effect of IFN which reduce ALT and maintain normalization of ALT. One approach (study 1) was to compare the efficacy of a 6 month course of three differentdosages of recombinant IFN-alpha -2a in patients with chronic hepatitis C associated with HCV-genotype lb and a high serum HCV-RNA level of more than1 Meq/ml. Another approach (study 2) was to make clear the significance ofan additional 6 month course of IFN in patients who had biochemical response during the first 6 month course of IFN (study 1). Methods: (1) Study 1; 45 patients with HCV-genotype lb and a high serum HCV-RNA level of more than 1 Meq/ml were randomly assigned into three equal groups: group 1 was treated with 3 million units (MU), group 2 with 6 MU and group 3 with 9 MU. They were treated with IFN 3 times weekly for 6 months. Biochemical response was defined as normalization of ALT at the 6 month after initiation of IFN, (2) Study 2: Subsequently, of 23 patients with biochemical response by the first study, 22 were randomly assigned to two groups; patients in group A were continued to receive 3 MU of IFN-alpha -2a three times a week for an additional 6 months and patients in group B were discontinued IFN therapy. Results: (1) Study 1; One patient in group 1, three in group 2 and five in group 3 withdrew from IFN therapy because of IFN-related side-effects. Biochemical response was 10 (66.7%) patients of group 1. 8 (53.3%) of group 2 and5 (33%) of group 3 by the intention-to-treat (ITT) analysis. The biochemical response rate in group 1 was slightly higher than that in other two groups by the Cochran Armitage two-tailed test (P = 0.066). With respect to serum HCV-RNA level, one patient in group 1, six patients in group 2 and four patients in group 3 became negative for HCV-RNA by reversed transcription nested-polymerase chain reaction (RT nested-PCR) at the end point of first 6month course of IFN, (2) Study 2; The maintenance rate of ALT normalization was 88.9% (9/11) in group A and 11.1% (2/11) in group B. The maintenance rate of ALT normalization in group A was significantly higher than that in group B by the Fisher exact's test (P=0.0089). With respect to serum HCV-RNA level by RT nested-PCR, four patients in group A had negative HCV-RNA at the end of an additional IFN therapy. On the other hand, all the patients in group B had positive HCV-RNA at the same time. Conclusion: Our data suggested that a prolonged IFN therapy using a dose of 3 MU of IFN-alpha -2a is safe strategy to reduce ALT and to maintain ALT normalization in patients with HCV-genotype lb and a high serum HCV-RNA level of more than 1 Meq/ml. (C) 2001 Elsevier Science B.V. All rights reserved.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 28/01/20 alle ore 14:49:59