再生柱免疫吸附治疗多发性硬化症和视神经炎的类固醇难治性复发

D. Johannes, K. Martin, Olga, S. Makbule, R. Daniela, F. Panteha, H. Anna, E. Sonja, F. Tanja, T. Daniela, G. Regina, J. Sarah, S. Joachim, Albert Cl, T. Hayrettin
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引用次数: 4

摘要

目的:免疫吸附(IA)越来越被认为是一种有前途的低风险治疗选择,用于治疗各种自身免疫性神经系统疾病。与血浆置换(PE)一起,它被认为是多发性硬化症(MS)和视神经炎(ON)的二线治疗,在大多数指南中,它通常被视为类固醇难治性复发的治疗选择。然而,系统的前瞻性数据是缺失的,特别是关于现代高效的吸附系统与再生柱。本研究的目的是为类固醇难治性多发性硬化症和视神经炎患者提供疗效和耐受性数据。方法:对25例类固醇难治性多发性硬化症或ON复发患者采用再生蛋白A柱进行IA治疗的临床过程进行前瞻性研究。连续5天进行IA,每天处理2 ~ 2.5倍血浆体积。作为客观结果参数,在IA治疗前、第5天和治疗后14天分别进行扩展残疾状态量表(EDSS)和视力测量。此外,还收集了不良事件和实验室数据。结果:术后14 d,平均EDSS由3.4±2.0改善至2.3±2.0 (p=0.001),视力由0.39±0.33改善至0.66±0.36 (p=0.01)。应答率为64%。未观察到相关不良事件。即使对于复发后潜伏期较长的患者(定义为首次症状和治疗之间的时间>6周),IA也有效。解释:我们的数据提供了初步证据,表明再生柱免疫吸附是治疗类固醇难治性MS和ON的有效且耐受性良好的治疗选择,甚至可以考虑用于复发后潜伏期较长的患者。然而,我们的研究结果需要通过更多受试者的随机对照试验来证实,并且需要更多的研究来比较IA和PE的疗效。
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Immunoadsorption with Regenerating Columns in Treatment of Steroid-Refractory Relapse in Multiple Sclerosis and Optic Neuritis
Abstract Objective: Immunoadsorption (IA) is increasingly recognized as a promising and low-risk therapy option in a variety of autoimmune neurologic disorders. Along with plasma exchange (PE) it is considered as a second line therapy in multiple sclerosis (MS) and optic neuritis (ON) and usually regarded as a therapy option in case of steroid-refractory relapse in most guidelines. However, systematic prospective data is missing, especially regarding modern efficient adsorber systems with regenerating columns. The aim of this study was to provide efficacy and tolerability data in patients with steroid-refractory multiple sclerosis and optic neuritis. Methods: We prospectively investigated the clinical course of 25 patients with steroid-refractory relapse of MS or ON who were treated with IA using regenerating protein A columns. IA was performed on 5 consecutive days, and 2- to 2.5-fold plasma volumes were processed each day. As objective outcome parameters, Expanded Disability Status Scale (EDSS) and visual acuity measurement were conducted before as well as on day 5 of IA and 14 days after treatment. Additionally, adverse events and laboratory data were collected. Results: After 14 days, mean EDSS improved from 3.4 ± 2.0 to 2.3 ± 2.0 (p=0.001), and visual acuity improved from 0.39 ± 0.33 to 0.66 ± 0.36 (p=0.01). Response rate was 64%. No relevant adverse events were observed. IA was effective even in patients with long latency since relapse, defined as a time of >6 weeks between first symptoms and treatment. Interpretation: Our data provide preliminary evidence that immunoadsorption with regenerating columns is an effective and well-tolerated treatment option for steroid-refractory MS and ON and might even be considered for patients with long latency since relapse. However, our results have to be confirmed by a randomized controlled trial with a higher number of subjects, and additional studies are needed to compare efficacy of IA and PE.
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