【单克隆抗体在高活度多发性硬化症患者治疗中的实际临床应用】。

Q3 Medicine
S V Kotov, T I Yakushina, E S Novikova, V Yu Lizhdvoy, Yu A Belova
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引用次数: 0

摘要

目的:在实际临床实践中,利用活动性和进展指标研究ocrelizumab (OCR)和natalizumab (NAT)在高活性多发性硬化症(HAMS)患者治疗第一年的疗效。材料和方法:研究纳入110例HAMS患者和13例快速进展性MS (RPMS)患者,年龄19 ~ 60岁,接受单克隆抗体(MAT)治疗12个月。组1采用NAT治疗77例,组2采用OCR治疗46例。为了评估治疗效果,我们使用了每年平均恶化频率、EDSS估计值和MRI数据等指标。结果:MAT治疗开始时,组1的EDSS评分为2.4±1.0,组2的EDSS评分为2.8±1.2 (p=0.047);MAT治疗开始12个月后,1组患者EDSS评分略有下降(p=0.001), 2组患者EDSS评分无变化。MAT治疗开始后每年加重次数1组为0.04±0.2次,2组为0.07±0.2次(组间pp=0.629)。在OCR治疗开始前接受1线DMT (n=22)或NAT (n=21)的患者亚组被单独考虑。在两个亚组中,EDSS的稳定评估被注意到,平均年加重次数没有差异(p=0.117)。经MAT治疗一年后,RPMS患者的EDSS评分稳定,年均加重频率为0.08±0.3次/年。结论:在第一年的随访中,MAT治疗导致神经功能障碍恶化次数的显著减少和稳定。经过12个月的治疗,两组患者的年平均病情加重次数均显著减少,残疾没有增加,MRI结果显示为积极动态。在从DMT 1线治疗和NAT转换的患者中发现了相似水平的OCR疗效。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[The use of monoclonal antibodies in the treatment of patients with high-active multiple sclerosis in real clinical practice].

Objective: To study the efficacy of ocrelizumab (OCR) and natalizumab (NAT) using indicators of activity and progression in patients with highly active multiple sclerosis (HAMS) during the first year of therapy in real clinical practice.

Material and methods: The study included 110 patients with HAMS and 13 patients with rapidly progressive MS (RPMS), aged 19 to 60 years, who received monoclonal antibody (MAT) therapy for 12 months. Group 1 consisted of 77 patients receiving NAT therapy, group 2 of 46 patients receiving OCR therapy. To assess the efficacy of therapy, we used indicators of the average frequency of exacerbations per year, EDSS estimates, and MRI data.

Results: EDSS score at the time of initiation of MAT therapy was 2.4±1.0 in group 1 and 2.8±1.2 in group 2 (p=0.047); 12 months after the start of MAT therapy, EDSS score in group 1 decreased slightly (p=0.001), in group 2 it has not changed. The frequency of exacerbations per year after the start of MAT therapy was 0.04±0.2 in group 1 and 0.07±0.2 in group 2 (p<0.0001 in both groups). The number of foci accumulating gadolinium detected during the year was 3 in group 1, one in group 2 (p=0.629 between groups). Subgroups of patients who received line 1 DMT (n=22) or NAT (n=21) before the start of OCR therapy were considered separately. In both subgroups, a stable assessment of EDSS was noted, the average annual number of exacerbations did not differ (p=0.117). In patients with RPMS after a year of MAT therapy, EDSS scores were stable, the average annual frequency of exacerbations was 0.08±0.3 per year.

Conclusion: The administration of MAT therapy led to a statistically significant decrease in the number of exacerbations and stabilization of neurological deficits during the first year of follow-up. After 12 months of therapy, both groups experienced a dramatic decrease in the average annual number of exacerbations, no increase in disability, and positive dynamics according to MRI results. A similar level of OCR efficacy was found in patients who switched from DMT 1 line therapy and NAT.

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来源期刊
Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova
Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova Medicine-Psychiatry and Mental Health
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