TY - T1的随机试验的疫苗接种fingolimod-treated多发性硬化症患者JF -神经学乔-神经病学SP - 872 LP - 879 - 10.1212 / WNL。首页0000000000001302六世- 84 - 9 AU -路德维希卡波斯盟马提亚梅林AU -拉斐尔•阿罗约盟Guillermo Izquierdo盟Krzysztof Selmaj AU -瓦伦提娜Curovic-Perisic AU -阿斯特丽德凯尔盟Mahendra Bijarnia AU -阿伦辛格盟菲利普·冯·罗森斯蒂尔Y1 - 2015/03/03 UR - //www.ez-admanager.com/content/84/9/872.abstract N2 -目的:评价免疫反应在fingolimod-treated多发性硬化(MS)患者对流感疫首页苗(测试响应与预期小说抗原血清反应阴性的患者)和回忆(破伤风类毒素(TT)升压剂)抗原。方法:这是一个盲、随机、多中心、安慰剂对照研究。患者年龄在18岁到55年复发女士被随机分配(2:1)为12周fingolimod 0.5毫克或安慰剂。在第6周,患者接受季节性流感疫苗(包含加州抗原、珀斯和布里斯班病毒株)和TT助推剂。抗流感的抗体滴度和TT估计基线(prevaccination)和3和6周postvaccination。主要疗效变量是应答率(比例的患者显示血清转化或显著增加(≥4倍)抗体滴度与至少一个流感病毒株)在3周postvaccination vs安慰剂。结果:138名随机患者(fingolimod 95,安慰剂43),136年完成了研究(2停止fingolimod组)。应答率(优势比;95%置信区间)流感疫苗(fingolimod vs安慰剂)分别为54%和85% (0.21;3周0.08 - -0.54)和43% vs 75% (0.25;在6周postvaccination 0.11 - -0.57)。 For TT, responder rates were 40% vs 61% (0.43; 0.20–0.92) at 3 weeks and 38% vs 49% (0.62; 0.29–1.33) at 6 weeks postvaccination. Adverse events were reported in 86.3% and 79.1% of patients receiving fingolimod and placebo, respectively.Conclusion: Most fingolimod-treated patients with MS were able to mount immune responses against novel and recall antigens and the majority met regulatory criteria indicating seroprotection. However, response rates were reduced compared with placebo-treated patients. This should be kept in mind when vaccinating patients on fingolimod.Classification of evidence: This study provides Class I evidence that in some patients with MS receiving immunizations, concurrent fingolimod treatment in comparison to placebo decreases vaccination-induced immune responses.CCR7=C-C chemokine receptor 7; CI=confidence interval; HAI=hemagglutination inhibition; Ig=immunoglobulin; KLH=keyhole limpet hemocyanin; MS=multiple sclerosis; OR=odds ratio; PPV-23=23-valent pneumococcal polysaccharides vaccine; S1P=sphingosine 1-phosphate; TT=tetanus toxoid ER -