阿狄科®依那西普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®依那西普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】
用于从 EDTA 血浆和血清中测定游离嵌合 TNFα 治疗抗体依那西普（例如 ENBREL R）。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 的抗体进行治疗，这些抗体直接干预潜在的炎症。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]。
用于确定依那西普 (zBENBREL_) 活性物质浓度的 IDKmonitorREtanercept 药物水平 ELISA 定量测量 EDTA 血浆和血清中的游离依那西普。与检测依那西普的 ADA 一起，IDKmonitor@etanercept药物水平 ELISA 为主治医师提供了监测的机会治疗并在早期对其进行优化。

参考文献：
1. Afif W, LoftusEJ, Faubion w, et al. Clinical utility of measuring Etanercept and human anti-chimeric antibody concentrations in patients with inflammatory boweldisease.American Journal of Gastroenterology. 2010;105(5):1133-9.
2. Beglinger C, Binek J, Braegger C, Michetti P, Rogler G, Sauter B, Seibold F, Straumann A(2008) Monotherapie versus Kombinationstherapie mit lmmunmodula-toren.TMl 1:32-34
3. Bender NK,Heilig CE, Droll B,Wohlgemuth J, Armbruster FP,Heilig B(2007)Immunogenicity, efficacy and adverse events of adalimumab in RA patients.Rheumatollnt.Jan;27(3):269-74
4. Bendtzen K,Geborek P, Svenson M, Larsson L, Kapetanovic MC， Saxne T (2006)Individualized monitoring of drug bioavailability and immunogenicity in rheu-matoid arthritis patients treated with the tumor necrosis factor alpha inhibitorEtanercept.Arthritis Rheum. Dec;54(12):3782-9
5. Bradley JR.(2008)TNF-mediated inflammatory disease. Journal of Pathology.214:149-160.
6. St Clair EW, Wagner CL, Fasanmade AA,Wang B, Schaible T, Kavanaugh A, Keystone EC (2002) The relationship of serum Etanercept concentrations to clinical improvement in rheumatoid arthritis: results from ATTRACT, a multicenter, rando-mized, double-blind, placebo-controlled trial.Arthritis Rheum.Jun;46(6):1451-9
7. Chang JT, Lichtenstein GR (2006)Drug insight: antagonists of tumor-necrosis factor-alpha in the treatment of inflammatory bowel disease.Nat Clin Pract Gas-troenterol Hepatol.Apr;3(4):220-8.Review
8. Colombel JF, Loftus EV Jr, Tremaine WJ, Egan LJ, Harmsen WS, Schleck CD, Zinsmeister AR, Sandborn WJ(2004) The safety profile of Etanercept in patients withCrohn's disease: the Mayo clinic experience in 500 patients. Gastroenterology.Jan;126(1):19-31
9. CominelliF(2004)Cytokine-based therapies for Crohn's disease--new paradigms.N Engl J Med.Nov 11;351(20):2045-8
10.Cornillie F, Shealy D, D'Haens G, Geboes K, Van Assche G, Ceuppens J, Wagner C,Schaible T,Plevy SE,Targan SR,Rutgeerts P(2001)Etanercept induces po-tent anti-inflammatory and local immunomodulatory activity but no systemicimmune suppression in patients with Crohn's disease.Aliment Pharmacol Ther.Apr;15(4):463-73
11.Maser EA, Villela R, Silverberg MS, Greenberg GR (2006)Association of trough serum Etanercept to clinical outcome after scheduled maintenance treatment forCrohn's disease.Clin Gastroenterol Hepatol.Oct;4(10):1248-54
12.Rutgeerts P; Van Assche G, Vermeire s(2004)Optimizing anti-TNF treatment in inflammatory bowel disease.Gastroenterology. May;126(6):1593-610.Review13.Vande Casteele N, Gils A. Pharmacokinetics of anti-TNF monoclonal antibodies in inflammatory bowel disease: Adding value to current practice.Journal of clinicalpharmacology. 2015;55 Suppl 3:s39-50.doi:10.1002/jcph.374.
14.Perry, M.,Bewshea,C.,Brown, R., So, K., Ahmad, T.,& McDonald,T. (2015).Etanercept and adalimumab are stable in whole blood clotted samples for seven days atroom temperature.Annals of Clinical Biochemistry. Epub ahead of print.