Cohen S B, Rubbert A
St Paul University Medical Center, Dallas, Texas, USA.
Rheumatology (Oxford). 2003 May;42 Suppl 2:ii36-40. doi: 10.1093/rheumatology/keg331.
The recombinant interleukin-1 receptor antagonist, anakinra (Kineret; Amgen Inc., Thousand Oaks, CA), has been approved by the US Food and Drug Administration and the European Commission for the treatment of patients with active rheumatoid arthritis (RA). Approval was granted following the extensive evaluation of anakinra in five pivotal clinical trials that assessed its efficacy and safety in RA patients. These studies have indicated that anakinra has a favourable risk-benefit profile, producing rapid and sustained reductions in the signs and symptoms of RA, as measured by improvements in the American College of Rheumatology response criteria, particularly in patient-reported indicators of function and disability. The data from these trials suggest that anakinra is likely to provide a useful therapeutic option to clinicians and also meet the treatment expectations of patients with RA; however, further studies are underway to investigate additional benefits that anakinra may offer, particularly in patients with existing co-morbidities.
重组白细胞介素-1受体拮抗剂阿那白滞素（Kineret；安进公司，加利福尼亚州千橡市）已获美国食品药品监督管理局和欧盟委员会批准，用于治疗活动性类风湿关节炎（RA）患者。在五项关键临床试验中对阿那白滞素进行了广泛评估，评估其在类风湿关节炎患者中的疗效和安全性后，该药获得批准。这些研究表明，阿那白滞素具有良好的风险效益比，按照美国风湿病学会反应标准衡量，能使类风湿关节炎的体征和症状迅速且持续减轻，尤其是在患者报告的功能和残疾指标方面。这些试验的数据表明，阿那白滞素可能为临床医生提供一种有用的治疗选择，也能满足类风湿关节炎患者的治疗期望；然而，正在进行进一步研究以调查阿那白滞素可能带来的其他益处，特别是在已有合并症的患者中。
