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探讨类风湿关节炎患者使用阿那白滞素的安全性。

Addressing the safety of anakinra in patients with rheumatoid arthritis.

作者信息

Fleischmann R M

机构信息

St Paul University Hospital, Department of Rheumatology, Dallas, TX 75235, USA.

出版信息

Rheumatology (Oxford). 2003 May;42 Suppl 2:ii29-35. doi: 10.1093/rheumatology/keg330.

DOI:10.1093/rheumatology/keg330
PMID:12817093
Abstract

Anakinra (Kineret; Amgen Inc., Thousand Oaks, CA) is the first and only recombinant human interleukin-1 receptor antagonist available for therapeutic use. It has been approved by the US Food and Drug Administration and the European Commission for the treatment of patients with rheumatoid arthritis (RA). Anakinra, as an anti-rheumatic therapy, has been assessed in five placebo-controlled clinical trials, either alone or in combination with methotrexate. These trials have shown anakinra to be efficacious and well tolerated by most patients, with the most frequently reported adverse events being mild-to-moderate injection-site reactions that generally resolved rapidly. One of these trials was a large, prospective safety study, which included typical RA patients with a wide variety of co-morbid conditions and receiving concomitant medications. This confirmed that anakinra is a well-tolerated treatment in an RA population representative of that seen by the practising rheumatologist.

摘要

阿那白滞素(凯那立;安进公司,加利福尼亚州千橡市)是首个也是唯一可用于治疗的重组人白细胞介素-1受体拮抗剂。它已获得美国食品药品监督管理局和欧盟委员会批准,用于治疗类风湿关节炎(RA)患者。阿那白滞素作为一种抗风湿疗法,已在五项安慰剂对照临床试验中进行了评估,试验中它单独使用或与甲氨蝶呤联合使用。这些试验表明,阿那白滞素对大多数患者有效且耐受性良好,最常报告的不良事件是轻度至中度注射部位反应,这些反应通常会迅速消退。其中一项试验是一项大型前瞻性安全性研究,纳入了患有多种合并症并正在接受其他药物治疗的典型RA患者。这证实了阿那白滞素在执业风湿病学家所见到的具有代表性的RA患者群体中是一种耐受性良好的治疗方法。

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