Division of Gastroenterology, Department of Internal Medicine, University of Michigan Health System, Ann Arbor, MI 48109, USA.
J Viral Hepat. 2010 Oct;17(10):675-84. doi: 10.1111/j.1365-2893.2010.01369.x.
The goal of hepatitis B treatment is to prevent the development of cirrhosis, liver failure, and hepatocellular carcinoma. Ideally, clinical studies should demonstrate that hepatitis B therapies can prevent liver-related complications; however, these clinical endpoints evolve over years or decades. Therefore, clinical trials have relied on intermediate endpoints to evaluate the efficacy of treatment and to determine when treatment can be stopped. Intermediate endpoints that have been used include biochemical, histological, virological, and serological endpoints. This review will discuss the validity of these intermediate endpoints as surrogates of clinical endpoints, and the rates at which these intermediate endpoints can be achieved with currently available therapies.
乙肝治疗的目标是预防肝硬化、肝功能衰竭和肝细胞癌的发生。理想情况下，临床研究应表明乙肝治疗可以预防肝脏相关并发症；然而，这些临床终点需要经过数年或数十年的时间才能显现。因此，临床试验依赖于中间终点来评估治疗的疗效，并确定何时可以停止治疗。已使用的中间终点包括生化、组织学、病毒学和血清学终点。这篇综述将讨论这些中间终点作为临床终点替代指标的有效性，以及目前可用治疗方法可以达到这些中间终点的速度。
