阿狄科®英夫利昔单抗药物浓度检测试剂盒（酶联免疫法）

【产品名称】
通用名称：阿狄科®英夫利昔单抗药物浓度检测试剂盒（酶联免疫法）
英文名称：IDKmonitor® Infliximab drug level

【包装规格】
规格：96人份（复孔检测样本：40个）/盒
测试次数：96（40份样本一式两份）

【预期用途】
适用于从 EDTA 血浆和血清中测定游离嵌合 TNFα 治疗古董体英夫利昔单抗（例如 REMICADE“Remsima”“Inflectra”）。仅供科研使用。

【背景知识】
肿瘤坏死因子α (TNFa) 是促进和维持炎症反应的促炎细胞因子之一。巨噬细胞和 T 细胞产生的细胞因子在急性和慢性炎症中都发挥着核心作用。因此，越来越多的慢性炎症性疾病，如克罗恩病、溃疡性结肠炎、风湿病或银屑病，都使用抗 TNFα 的抗体来治疗，直接干扰潜在的炎症。反应[5]。
抗 TNFa 治疗的有效性通常与下一次服药前不久可在患者血清中检测到的治疗抗体量相关，即所谓的谷水平。各种因素影响谷水平的水平。这些因素包括抗 TNFa 治疗的剂量和频率、疾病活动性、药代动力学的个体差异以及抗药物抗体 (ADA) 的出现 [1,13]。
IDKmonitor“英夫利昔单抗药物水平 ELISA”用于确定英夫利昔单抗中活性成分的浓度，定量测量 EDTA 血浆和血清中的游离英夫利昔单抗。连同针对英夫利昔单抗的 ADA 检测，IDKmonitor“英夫利昔单抗药物水平 ELISA”为主治医师提供机会监控治疗并在早期阶段对其进行优化。

参考文献：
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2. Beglinger C, Binek J, Braegger C, Michetti P, Rogler G, Sauter B, et al. lnfliximab-Monotherapie versus Kombinationstherapie mit Immunmodulatoren.The medi-cal journal. 2008;1:32-4.
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rheumatoid arthritis: results from ATTRACT, a multicenter, randomized, double-blind, placebo-controlled trial.Arthritis and rheumatism. 2002 Jun;46(6):1451-9.
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8. Colombel J-F, Loftus EV,Tremaine WJ,Egan LJ,Harmsen Ws, Schleck CD,et al.The safety profile of infliximab in patients with Crohn's disease: the Mayo clinic expe-rience in 500 patients.Gastroenterology. 2004 Jan;126(1):19-31.
9. Cominelli F. Cytokine-based therapies for Crohn's disease--new paradigms. The New England journal of medicine.2004 Nov 11;351(20):2045-8.
10.Cornillie F, Shealy D, D'Haens G, Geboes K, Van Assche G, Ceuppens J, et al. Infli-ximab induces potent anti-inflammatory and local immunomodulatory activitybut no systemic immune suppression in patients with Crohn's disease.Alimentarypharmacology & therapeutics. 2001 Apr;15(4):463-73.
11.Maser E a, Villela R, Silverberg MS,Greenberg GR.Association of trough serum infliximab to clinical outcome after scheduled maintenance treatment for Crohn'sdisease.Clinical gastroenterology and hepatology : the official clinical practice jour-nal of the American Gastroenterological Association. 2006 Oct;4(10):1248-54.
12.Rutgeerts P, Van Assche G, Vermeire S. Optimizing anti-TNF treatment in inflamm-atory bowel disease.Gastroenterology. 2004 May;126(6):1593-610.
13.Vande Casteele N, Gils A. Pharmacokinetics of anti-TNF monoclonal antibodies in inflammatory bowel disease: Adding value to current practice.Journal of clinicalpharmacology. 2015 Mar;55 Suppl 3(May 2014):S39-50.
14.Perry M, Bewshea C, Brown R, So K,Ahmad T, McDonald T. Infliximab and adali-mumab are stable in whole blood clotted samples for seven days at room tempe-rature.Annals of clinical biochemistry. 2015 Nov;52(Pt 6):672-4.