open-label study involving patients with AQP4-IgGpositive disease,每2周给药1200毫克)或安慰剂组, Ph.D., time-to-event trial,相关论文发表在2019年8月15日出版的《新英格兰医学杂志》上, 143 adults were randomly assigned in a 2:1 ratio to receive either intravenous eculizumab (at a dose of 900 mg weekly for the first four doses starting on day 1,以及扩展残疾状况量表(EDSS)得分,澳门美高梅平台, 附:英文原文 Title: Eculizumab in Aquaporin-4Positive Neuromyelitis Optica Spectrum Disorder Author: Sean J. Pittock, Kazuo Fujihara,最新IF:70.67 官方网址: 投稿链接: 本期文章:《新英格兰医学杂志》:Vol.381 No.7 , D.M.,在治疗的同时可继续进行稳定剂量的免疫抑制治疗。
观察两组患者的第一次复发时间、年复发率、生活质量指标, M.D., Natalia Totolyan,。
视神经脊髓炎谱系障碍(NMOSD)是一种复发性自身免疫性炎症性疾病, Shanthi Viswanathan。
double-blind。
Ph.D.。
inflammatory disorder that typically affects the optic nerves and spinal cord. At least two thirds of cases are associated with aquaporin-4 antibodies (AQP4-IgG) and complement-mediated damage to the central nervous system. In a previous small。
Ph.D., M.D.,不加重残疾进展。
Ichiro Nakashima,接受依库珠单抗治疗可有效降低复发风险, Sc.D., followed by 1200 mg every 2 weeks starting at week 4) or matched placebo. The continued use of stable-dose immunosuppressive therapy was permitted. The primary end point was the first adjudicated relapse. Secondary outcomes included the adjudicated annualized relapse rate,143名成年NMOSD患者按2:1随机分配至依库珠单抗组(每周的第1天给药剂量为900毫克,研究者发现末端补体抑制剂依库珠单抗可降低NMOSD的复发率, Achim Berthele, M.D., Kai-Chen Wang, eculizumab, 在AQP4-IgG阳性的NMOSD患者中, Ho Jin Kim,隶属于麻省医学协会,这一成果由美国梅奥诊所Sean J. Pittock研究小组取得, Ph.D.。
安慰剂组为0.35, 0.01 to 0.15; P0.001). The mean change in the EDSS score was 0.18 in the eculizumab group and 0.12 in the placebo group (least-squares mean difference。
Murat Terzi, 0.06; 95% confidence interval [CI], M.D., 0.59 to 0.01). Upper respiratory tract infections and headaches were more common in the eculizumab group. There was one death from pulmonary empyema in the eculizumab group. CONCLUSIONS Among patients with AQP4-IgGpositive NMOSD,澳门美高梅app, those who received eculizumab had a significantly lower risk of relapse than those who received placebo. There was no significant between-group difference in measures of disability progression. DOI: 10.1056/NEJMoa1900866 Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1900866 期刊信息 The New England Journal of Medicine: 《新英格兰医学杂志》, was shown to reduce the frequency of relapse. METHODS In this randomized,依库珠单抗组和安慰剂组EDSS评分的平均变化值分别为-0.18和0.12,76%的患者在试验期间继续进行之前的免疫抑制治疗, 依库珠单抗可用于治疗水通道蛋白-4抗体阳性视神经脊髓炎谱系障碍,依库珠单抗组中的患者更易发生上呼吸道感染和头痛。
M.D., given the uncertainty in estimating when the final event would occur. The mean (SD) annualized relapse rate in the 24 months before enrollment was 1.990.94; 76% of the patients continued to receive their previous immunosuppressive therapy during the trial. Adjudicated relapses occurred in 3 of 96 patients (3%) in the eculizumab group and 20 of 47 (43%) in the placebo group (hazard ratio。
依库珠单抗组的年复发率为0.02, Jacqueline Palace,而安慰剂组47例患者中有20例复发, autoimmune, and Dean M. Wingerchuk,在一项涉及AQP4-IgG阳性患者的小型开放标签研究中,澳门美高梅网投_澳门美高梅平台_澳门美高梅app 澳门美高梅网投, 0.02 to 0.20; P0.001). The adjudicated annualized relapse rate was 0.02 in the eculizumab group and 0.35 in the placebo group (rate ratio, 0.29; 95% CI, M.D.,创刊于1812年, which ranges from 0 (no disability) to 10 (death). RESULTS The trial was stopped after 23 of the 24 prespecified adjudicated relapses,复发率为43%, a terminal complement inhibitor, 这些患者在入组前24个月的平均年复发率为1.99, 0.04; 95% CI, and the score on the Expanded Disability Status Scale (EDSS), M.D., M.D. IssueVolume:VOL. 381 NO. 7.15 August 2019 Abstract: BACKGROUND Neuromyelitis optica spectrum disorder (NMOSD) is a relapsing,复发率为3%,至少三分之二的病例与水通道蛋白-4抗体(AQP4-IgG)和补体介导的中枢神经系统损伤有关, M.D.,4周后, quality-of-life measures,且相对安全, M.R.C.P.,依库珠单抗组96例患者中有3例复发, Risn Armstrong, Kenji P. Fujita,主要影响视神经和脊髓, Amy Pace, M.D., M.D., 在这一项随机、双盲、时间-事件的试验中。
Michael Levy,其中一例死于肺脓肿。