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血浆置换与静脉注射免疫球蛋白治疗吉兰-巴雷综合征的长期疗效:一项双盲随机临床试验

Long-term outcomes of plasma exchange versus intravenous immunoglobulin for the treatment of Guillain-Barré Syndrome: A double-blind, randomized clinical trial.

作者信息

Haridy Nourelhoda A, Shehab Mohamed M, Khedr Eman M

机构信息

Department of Neurology and Psychiatry, Faculty of Medicine, Assiut University, Assiut, Egypt.

出版信息

Restor Neurol Neurosci. 2023;41(5-6):203-217. doi: 10.3233/RNN-231369.

Abstract

BACKGROUND

Most previous studies comparing the effectiveness of Plasma Exchange (PE) or intravenous immunoglobulin (IVIG) in treating Guillain-Barre syndrome (GBS) have focused on the short-term outcome at around 1 month.

OBJECTIVE

To compare the long-term efficacy of PE and IVIG at one year in adult patients with GBS.

METHODS

Eighty-one adult patients with acute GBS were randomized into two groups with a ratio of 2 : 1: PE (N = 54) and IVIG (N = 27). Patients were assessed with the Medical Research Council sum score (MRC sum score), GBS Disability Scale (GDS), and Functional assessment of acute inflammatory neuropathy (FAAIN) at baseline, ten days, one month, three months, and one year. Neurophysiological examinations were performed at baseline and three months following treatment.

RESULTS

There were no significant differences between groups in demographic, clinical, and laboratory data. Both treatments produced a significant improvement in all clinical rating scales in both groups that continued up to one year. There were significant differences in the time course of recovery in the MRC and FAAIN scales, with significantly more improvement in the IVIG group at 1 and 3 months, although there was no significant difference in outcome at one year. However the effect size showed measurable differences between the PE and IVIG groups across the different measures at one-year. Electrophysiological studies showed equal improvement in most measures in both groups at three months, with a slightly greater effect in the IVIG group.

CONCLUSION

long term outcomes of IVIG and PE were equivalent. However the effect size showed measurable differences between the PE and IVIG groups across the different measures at one-year follow-up that indicate the superiorty of IVIG. There was also a tendency for improvement to be slightly faster in the IVIG group.

摘要

背景

以往大多数比较血浆置换(PE)或静脉注射免疫球蛋白(IVIG)治疗吉兰-巴雷综合征(GBS)有效性的研究都集中在约1个月时的短期结果。

目的

比较PE和IVIG对成年GBS患者1年时的长期疗效。

方法

81例成年急性GBS患者按2∶1的比例随机分为两组:PE组(N = 54)和IVIG组(N = 27)。在基线、10天、1个月、3个月和1年时,采用医学研究委员会总分(MRC总分)、GBS残疾量表(GDS)和急性炎症性神经病功能评估(FAAIN)对患者进行评估。在基线和治疗后3个月进行神经生理学检查。

结果

两组在人口统计学、临床和实验室数据方面无显著差异。两种治疗方法均使两组所有临床评分量表有显著改善,且持续至1年。MRC和FAAIN量表在恢复时间过程上存在显著差异,IVIG组在1个月和3个月时改善更显著,尽管1年时结局无显著差异。然而,效应量显示在1年时PE组和IVIG组在不同测量指标上存在可测量的差异。电生理学研究表明,两组在3个月时大多数测量指标改善程度相同,IVIG组的效果稍大。

结论

IVIG和PE的长期结局相当。然而,效应量显示在1年随访时PE组和IVIG组在不同测量指标上存在可测量的差异,表明IVIG更具优势。IVIG组改善也有稍快的趋势。

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