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免疫吸附治疗多发性硬化症患者:一项开放标签的试点研究。

Immunoadsorption patients with multiple sclerosis: an open-label pilot study.

作者信息

Moldenhauer A, Haas J, Wäscher C, Derfuss T, Hoffmann K-T, Kiesewetter H, Salama A

机构信息

Charité--Universitätsmedizin Berlin, Germany.

出版信息

Eur J Clin Invest. 2005 Aug;35(8):523-30. doi: 10.1111/j.1365-2362.2005.01518.x.

Abstract

BACKGROUND

Immunoadsorption (IA) is occasionally applied in patients with acute relapses of multiple sclerosis (MS). This pilot study was undertaken to determine whether IA might help in secondary progressive and relapsing-remitting multiple sclerosis.

DESIGN

IA was performed at 1-week intervals in 12 patients with secondary progressive or relapsing-remitting MS. These patients had an extended disability status scale (EDSS) score of 4.5-7 and an EDSS increase of 0.5 within 6 months before inclusion in the study despite conventional drug therapy. The change in the EDSS and that in the MS functional composite (MSFC) score, which consisted of quantitative tests of arm function, ambulation, visual acuity and cognition, served as the primary outcome variables, which were measured at baseline and at 3, 6 and 12 months. Changes in quality of life and cerebral lesions by magnetic resonance imaging (MRI) were also assessed at baseline and after the last immunoadsorption (month 3).

RESULTS

A significant reduction of the median EDSS change was observed after the treatment period, which reversed 3 months after the immunoadsorptions had been stopped. Ten of 12 patients remained stable during the first year of follow-up with no significant changes of the MSFC scores. No significant changes in magnetic resonance imaging T2-hyperintense brain lesions or in the number of gadolinium-positive lesions and in the patients' quality of life were observed. Western blot analyses demonstrated a reduction of serum myelin-specific antibodies, which were collected in the adsorber eluates.

CONCLUSIONS

Removal of immunoglobulins, including myelin-specific antibodies by immunoadsorption, seems to delay disease progression as defined by EDSS, MSFC and MRI, while the patients' quality of life did not deteriorate.

摘要

背景

免疫吸附(IA)偶尔应用于多发性硬化症(MS)急性复发的患者。本前瞻性研究旨在确定IA是否有助于继发进展型和复发缓解型多发性硬化症。

设计

对12例继发进展型或复发缓解型MS患者每隔1周进行一次IA治疗。这些患者的扩展残疾状态量表(EDSS)评分为4.5 - 7分,且在纳入本研究前6个月内尽管接受了传统药物治疗,EDSS仍增加了0.5分。EDSS的变化以及MS功能综合评分(MSFC)的变化作为主要结局变量,MSFC评分由手臂功能、步行、视力和认知的定量测试组成,在基线以及3、6和12个月时进行测量。还在基线和最后一次免疫吸附后(第3个月)评估了生活质量的变化以及磁共振成像(MRI)显示的脑损伤情况。

结果

治疗期后观察到EDSS变化中位数显著降低,在免疫吸附停止3个月后这种变化逆转。12例患者中有10例在随访的第一年保持稳定,MSFC评分无显著变化。未观察到磁共振成像T2高信号脑损伤、钆增强阳性损伤数量以及患者生活质量有显著变化。蛋白质印迹分析表明吸附剂洗脱液中收集的血清髓鞘特异性抗体减少。

结论

通过免疫吸附去除包括髓鞘特异性抗体在内的免疫球蛋白,似乎可以延缓由EDSS、MSFC和MRI定义的疾病进展,而患者的生活质量并未恶化。

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