循证医学推动药品新适应证的发展

• 作 者: 詹思延
• 机 构: 北京大学循证医学中心,
• 出 处: 中华高血压杂志
• 发表日期: 2009年04期
• 关键词: 适应证 临床试验 阿司匹林 临床医师 勃起功能障碍 西地那非 抗高血压药 心血管事件 说明书 药品说明书

根据上市前临床试验的设计,任何新药在批准上市时都有特定的适应证,但由于观察结果的指标相对单一,上市前临床试验结果通常只能确定药物一种或几种疗效。随着医药研究的进展,许多药物新的药理作用逐渐被发现并应用于临床,如阿司匹林作为解热镇痛的百年老药被用于预防血栓形成;?

According to the pre-market clinical trial design, any new drug has specific indications when it is approved for marketing. However, as the indicators of the observation result are relatively simple, pre-market clinical trial results usually only determine one or several effects of the drug. With the progress of medical research, many new pharmacological effects of drugs gradually discovered and applied to clinical, such as aspirin as a century-old antipyretic and analgesic drugs used to prevent thrombosis;