Brown R S
Center for Liver Disease & Transplantation, Columbia University College of Physicians & Surgeons, New York, NY 10032, USA.
J Viral Hepat. 2006 May;13 Suppl 1:15-25. doi: 10.1111/j.1365-2893.2006.00756.x.
A number of studies are being published on investigational agents for the treatment of patients with chronic hepatitis C. Before incorporating new medications into therapy or electing to postpone therapy until an investigational agent receives regulatory approval, it is important to evaluate the following specific features of the published evidence: quality of the evidence, precision of the treatment effect, magnitude of the treatment effect, magnitude of the hazards, and other factors such as risk-benefit analysis and cost, including cost-effectiveness. Previous studies of treatment of patients with the disease allow us to establish some benchmarks and provide structure to evaluate the evidence of the efficacy and safety of these newer drugs.
目前有多项关于治疗慢性丙型肝炎患者的研究药物的研究正在发表。在将新药物纳入治疗方案或选择推迟治疗直至研究药物获得监管批准之前,评估已发表证据的以下具体特征非常重要:证据质量、治疗效果的精确性、治疗效果的大小、风险程度以及其他因素,如风险效益分析和成本,包括成本效益。以往对该疾病患者的治疗研究使我们能够建立一些基准,并为评估这些新药的疗效和安全性证据提供框架。