摘要
肿瘤坏死因子(tumor necrosis factor-alpha,TNF-α)介导的免疫反应在众多自身免疫性疾病的发病中均具有重要的作用。通过PubMed及中国知网(CNKI,2001-2009年)检索并综合统计,发现除了FDA批准的适应证外,TNF-α抑制剂在多种自身免疫性疾病中都有指征外应用,国外文献中有9个随机对照试验,国内文献只有依那西普治疗贝赫切特病(白塞病)的两篇病例报告。综合文献结果,提示英夫利昔单抗对贝赫切特病、系统性红斑狼疮、结节病治疗有效,不推荐应用于干燥综合征、新发巨细胞动脉炎和风湿性多肌痛;依那西普对贝赫切特病有效,不推荐应用于干燥综合征、韦格纳肉芽肿和结节病。目前临床证据主要基于无对照的临床研究及个案报道,以上结论有待大规模随机对照试验进一步证实。
TNF-α is a crucial cytokine in the establishment and maintenance of inflammation in many autoim- mune diseases, and TNF-α inhibitors are being used for a growing number of autoimmune diseases even though they are not yet licensed for this use by the FDA. A Pubmed and CNKI search (2001-2009) was conducted to identify published reports of off-label uses of TNF-α inhibitors. Anti-TNF-α therapies have been reported in the following autoimmune diseases: systemic lupus erythematosus, Sjogren’s syndrome, systemic sclerosis, inflammatory myopathies, systemic vasculitis, adult-onset Still’s disease, relapsing polychondritis and sarcoidosis. The vast majority of these reports are in the form of uncontrolled trails and individual case reports. There are nine published randomized controlled trials generally and only two case reports about the use of etanercept for Behcet’s disease domestically. Currently the best results have been observed in the use of infliximab for Behcet’s disease, systemic lupus erythematosus, and sarcoidosis; etan- ercept for Behcet’s disease. Lack of efficacy was demonstrated for infliximab in Sjogren’s syndrome, newly diagnosed giant cell arteritis, and polymyalgia rheumatica; for etanercept in Sjogren’s syndrome, Wegener granulomatosis and sarcoidosis. Future controlled trials are needed to confirm the potential use of TNF-α inhibitors in patients with systemic autoimmune disease.
出处
《中华临床免疫和变态反应杂志》
2010年第1期36-49,共14页
Chinese Journal of Allergy & Clinical Immunology
关键词
肿瘤坏死因子抑制剂
自身免疫性疾病
指征外
tumor necrosis factor-α inhibitors
systemic autoimmune disease
off-label