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评估慢性丙型肝炎临床试验的证据。

Assessing evidence from clinical trials in chronic hepatitis C.

作者信息

Bacon B R

机构信息

Division of Gastroenterology and Hepatology, Saint Louis University Liver Center, Saint Louis University School of Medicine, St Louis, MO 63110, USA.

出版信息

J Viral Hepat. 2006 May;13 Suppl 1:1-5. doi: 10.1111/j.1365-2893.2006.00755.x.

Abstract

Hepatitis C is a global problem with significantly associated morbidity and mortality. Although some recent therapeutic advances have shown rates of sustained virologic remission of 50% or higher, combination therapy with interferon and ribavirin is often not well tolerated and is giving rise to a growing number of nonresponders. As a result, a large number of experimental drugs for the treatment of chronic hepatitis C are in development. As the clinical trial reports are made available, physicians need to become familiar with issues related to the design of these studies and to develop strategies to interpret the evidence they yield. The articles in this supplement describe the issues in clinical trial design and the evaluation of evidence from clinical trials in patients with chronic hepatitis C.

摘要

丙型肝炎是一个全球性问题,其发病率和死亡率显著相关。尽管最近的一些治疗进展显示持续病毒学缓解率达到50%或更高,但干扰素和利巴韦林的联合治疗往往耐受性不佳,并且导致无反应者的数量不断增加。因此,大量用于治疗慢性丙型肝炎的实验性药物正在研发中。随着临床试验报告的公布,医生需要熟悉与这些研究设计相关的问题,并制定策略来解读它们所产生的证据。本增刊中的文章描述了慢性丙型肝炎患者临床试验设计中的问题以及对临床试验证据的评估。

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