INSERM, U871, 69003 Lyon, France.
Expert Rev Gastroenterol Hepatol. 2010 Feb;4(1):37-49. doi: 10.1586/egh.09.65.
This review assesses the relevance of the clinical, histological, biochemical and virological end points in the course and outcome of chronic hepatitis B. The pathway and the impact of the variation in these end points are presented, as well as their definitions. The treatment goals are discussed in terms of quality of life and survival. Prevention of the progression of the disease to cirrhosis, decompensated cirrhosis, end-stage liver disease and hepatocellular carcinoma seems to be the best approach to improve survival. As these criteria are long-term end points, easier to use end points assessed in clinical trials as efficacy objectives were also analyzed to determine whether they can be used as accurate surrogate criteria. Results of therapy were then analyzed according to the approved end points and in terms of management of chronic hepatitis B. Finally, an attempt to define new clinical end points is discussed in view of the development of more potent antiviral strategies.
本综述评估了慢性乙型肝炎病程和结局的临床、组织学、生化学和病毒学终点的相关性。本文呈现了这些终点的变化途径及其影响，以及它们的定义。根据生活质量和生存率来讨论治疗目标。预防疾病进展为肝硬化、失代偿性肝硬化、终末期肝病和肝细胞癌似乎是改善生存率的最佳方法。由于这些标准是长期终点，因此还分析了临床试验中更易于使用的评估疗效的终点，以确定它们是否可以用作准确的替代标准。然后根据批准的终点和慢性乙型肝炎的管理分析治疗结果。最后，鉴于更有效的抗病毒策略的发展，尝试讨论定义新的临床终点。
