Abstract:
:We conducted an analytical review of 194 full papers on interferon (IFN) therapy for chronic hepatitis C to evaluate current methodology (i.e. study design, criteria for evaluating the efficacy of therapy and predictors of response). Of the papers evaluated, 64 were randomized controlled trials (RCT), 40 were non-randomized controlled trials (NRCT) and 90 were observational studies (OS). The methodological analysis was focused mainly on clinical trials. The number of patients enrolled in RCT was higher compared with the number enrolled in NRCT. Uniform enrolment criteria were used in less than 50% of the trials. Only 20% of RCT and 2.5% of NRCT used criteria for defining sample size. The response rate was calculated on an intention-to-treat basis in 36 of the RCT and in 14 of the NRCT. The outcome of treatment and the criteria employed to define the response to treatment were found to be far from standardized. In 51.5% of the RCT and 42.5% of the NRCT, normalization of alanine aminotransferase (ALT) level at the end of follow-up was the only marker of response studied. Only 57.6% of the trials considered histological evidence as an important outcome. Among the clinical trials, 71.1% evaluated predictors of good response to IFN therapy. In 51% of the OS, ALT normalization by the end of follow-up was the only criterion for defining response. In conclusion, to ensure a high level of reliability in comparing or combining the results of different studies, some basic general requirements must be followed when planning trials on antiviral therapy.
journal_name
J Viral Hepatjournal_title
Journal of viral hepatitisauthors
Kondili LA,Taliani G,Tosti ME,De Bac C,Pasquazzi C,Mele Adoi
10.1046/j.1365-2893.2000.00214.xsubject
Has Abstractpub_date
2000-05-01 00:00:00pages
184-95issue
3eissn
1352-0504issn
1365-2893pii
jvh214journal_volume
7pub_type
杂志文章,评审abstract::Advanced age and high hepatitis B virus (HBV) DNA level are risk factors associated with the development of HBV-related hepatocellular carcinoma (HCC). However, little is known about the role of viral load in the carcinogenesis of HCC in young people. A total of 183 HBV-related HCC patients and 202 HBV carriers were t...
journal_title:Journal of viral hepatitis
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journal_title:Journal of viral hepatitis
pub_type: 杂志文章
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journal_title:Journal of viral hepatitis
pub_type: 杂志文章
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更新日期:2008-10-01 00:00:00
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journal_title:Journal of viral hepatitis
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journal_title:Journal of viral hepatitis
pub_type: 杂志文章,评审
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更新日期:1999-09-01 00:00:00
abstract::Sequence motifs within the non-structural protein NS5 or NS5B of the members of the family Flaviviridae suggest that this protein is the RNA-dependent RNA polymerase. This protein has now been expressed in various in vitro systems and used in polymerase assays. To understand the role of the RNA polymerase in RNA repli...
journal_title:Journal of viral hepatitis
pub_type: 杂志文章,评审
doi:10.1046/j.1365-2893.1999.00173.x
更新日期:1999-07-01 00:00:00
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journal_title:Journal of viral hepatitis
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:2004-09-01 00:00:00
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journal_title:Journal of viral hepatitis
pub_type: 杂志文章
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更新日期:2016-03-01 00:00:00
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journal_title:Journal of viral hepatitis
pub_type: 杂志文章
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journal_title:Journal of viral hepatitis
pub_type: 杂志文章
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journal_title:Journal of viral hepatitis
pub_type: 杂志文章
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journal_title:Journal of viral hepatitis
pub_type: 杂志文章
doi:10.1046/j.1365-2893.1999.00171.x
更新日期:1999-11-01 00:00:00
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pub_type: 杂志文章
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更新日期:2003-07-01 00:00:00
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journal_title:Journal of viral hepatitis
pub_type: 杂志文章
doi:10.1111/jvh.12491
更新日期:2016-04-01 00:00:00
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journal_title:Journal of viral hepatitis
pub_type: 临床试验,杂志文章
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更新日期:2005-07-01 00:00:00
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journal_title:Journal of viral hepatitis
pub_type: 杂志文章
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pub_type: 杂志文章
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journal_title:Journal of viral hepatitis
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pub_type: 杂志文章,多中心研究
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journal_title:Journal of viral hepatitis
pub_type: 杂志文章
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pub_type: 杂志文章,多中心研究,随机对照试验
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更新日期:2006-12-01 00:00:00
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journal_title:Journal of viral hepatitis
pub_type: 临床试验,杂志文章
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journal_title:Journal of viral hepatitis
pub_type: 杂志文章
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pub_type: 杂志文章
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journal_title:Journal of viral hepatitis
pub_type: 杂志文章
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更新日期:1996-11-01 00:00:00
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journal_title:Journal of viral hepatitis
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:2000-11-01 00:00:00
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journal_title:Journal of viral hepatitis
pub_type: 杂志文章
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更新日期:2014-01-01 00:00:00