Linked Life Data

9493517

Source:http://linkedlifedata.com/resource/pubmed/id/9493517

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1
pubmed:dateCreated
1998-4-13
pubmed:abstractText
The efficacy of a high-dose de-escalating treatment regimen versus the standard, fixed-treatment regimen of interferon-alpha2a (IFN; Roferon-A) in chronic hepatitis C was evaluated in 291 patients who had elevated alanine aminotransferase (ALT) levels, for at least 6 months prior to the study, and histologically proven chronic hepatitis. Patients were randomized into two groups: 142 patients received IFN at a fixed dose (3 million international units (MIU) three times a week for 6 months) and 149 patients received 6 MIU three times a week for 3 months followed by 3 MIU three times a week for the next 3 months. The groups did not differ significantly with respect to age, gender or percentage of patients with cirrhosis. Response was evaluated by monitoring ALT levels monthly during treatment and during the 6 months post-treatment follow-up. Sixty-one per cent and 66% of the patients in the fixed and de-escalating treatment groups had a primary response (serum ALT normalization) during the treatment period; sustained-response rates at the end of follow-up were 20% and 29%, respectively (not significant). In non-cirrhotic patients, a primary response was recorded in 65% and 70% of the patients in the fixed and de-escalating groups; sustained-response rates were 22% and 33%, respectively. Overall, 62% of patients with a sustained response showed histological improvement. In univariate analysis, patients with sustained response tended to be non-cirrhotic and had lower initial serum gamma-glutamyl transpeptidase and ferritin levels. Multivariate analysis indicated that only ALT activity assessed at month 1 (P < 0.01) was a significant predictor of sustained response. These findings suggest that although the difference in the response rates between the de-escalating (6 MIU three times a week for 3 months; 3 MIU three times a week for 3 months) and fixed (3 MIU three times a week for 6 months) treatment regimens did not reach statistical significance, there was a clear trend towards higher response with the 6 MIU induction dose in patients without cirrhosis.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jan
pubmed:issn
1352-0504
pubmed:author
pubmed:issnType
Print
pubmed:volume
5
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
53-9
pubmed:dateRevised
2011-11-17
pubmed:meshHeading
pubmed-meshheading:9493517-Adolescent, pubmed-meshheading:9493517-Adult, pubmed-meshheading:9493517-Aged, pubmed-meshheading:9493517-Alanine Transaminase, pubmed-meshheading:9493517-Antiviral Agents, pubmed-meshheading:9493517-Biopsy, pubmed-meshheading:9493517-Female, pubmed-meshheading:9493517-Ferritins, pubmed-meshheading:9493517-Hepatitis C, Chronic, pubmed-meshheading:9493517-Humans, pubmed-meshheading:9493517-Interferon-alpha, pubmed-meshheading:9493517-Liver, pubmed-meshheading:9493517-Liver Cirrhosis, pubmed-meshheading:9493517-Male, pubmed-meshheading:9493517-Middle Aged, pubmed-meshheading:9493517-Multivariate Analysis, pubmed-meshheading:9493517-Predictive Value of Tests, pubmed-meshheading:9493517-Prospective Studies, pubmed-meshheading:9493517-Recombinant Proteins, pubmed-meshheading:9493517-gamma-Glutamyltransferase
pubmed:year
1998
pubmed:articleTitle
Comparison of high initial and fixed-dose regimens of interferon-alpha2a in chronic hepatitis C: a randomized controlled trial. French Multicenter Interferon Study Group.
pubmed:affiliation
Institut Arnault-Tzanck, Saint-Laurent-du-Var, France.
pubmed:publicationType
Journal Article, Clinical Trial, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Multicenter Study