用Infliximab治疗活跃的结性脊柱炎:一个随机对照的多中心试验
1Department of Rheumatology, Benjamin Franklin Hospital, Free University of Berlin, Berlin, Germany. J.Braun@rheumazentrum-ruhrgebeit.de
Lancet (London, England)
|April 17, 2002
概括
恩弗利西马布有效治疗活跃结脊髓炎,改善疾病活性和生活质量. 这种瘤亡因子 (TNF) -α抑制剂显示出显著的益处,但由于潜在的严重不良影响,需要仔细监测.
科学领域:
- 类风湿病学 类风湿病学
- 免疫学 免疫学 免疫学
- 临床药理学 临床药理学
背景情况:
- 结性脊柱炎的治疗选择有限.
- 瘤亡因子 (TNF) -α在炎症性疾病中起作用.
- 因弗利西马布是一种针对TNF-alpha的生物药物.
研究的目的:
- 为了评估Infliximab在患有活跃结性脊柱炎的患者中的疗效.
- 评估Infliximab对疾病活动,功能和生活质量的影响.
主要方法:
- 一个为期12周的,安慰剂控制的多中心研究.
- 随机分配70名患者接受静脉注射因弗利西马布或安慰剂.
- 主要结局:使用经过验证的标准,至少50%的疾病活动回归.
主要成果:
- 53%的INFLIXIMAB患者实现了≥50%的疾病活动减少,而安慰剂患者的比例为9% (p<0.0001).
- 在使用infliximab时观察到功能和生活质量的显著改善.
- 不良事件包括结核病,肺部颗粒病和白血病.
结论:
- 恩弗利西马布在活跃的结性脊柱炎中表现出显著的有效性.
- 潜在的严重不良影响需要关节炎中心的监督.
- 在这种情况下,Infliximab提供了一种有价值的治疗选择.
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