Sorensen P S, Fazekas F, Lee M
MS Research Unit, Department of Neurology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Eur J Neurol. 2002 Nov;9(6):557-63. doi: 10.1046/j.1468-1331.2002.00501.x.
Intravenous immunoglobulin (IVIG) has several effects on the immune system that could have a beneficial influence on disease processes in multiple sclerosis (MS). Four double-blind trials in relapsing-remitting MS have demonstrated that IVIG may reduce the relapse rate, progression and the number of gadolinium-enhancing lesions. However, these trials were smaller than the pivotal trials of interferon-beta and glatiramer acetate, and therefore, we performed a meta-analysis of the four trials in order to provide an overall assessment of the benefits of IVIG in relapsing-remitting multiple sclerosis in comparison with other drugs currently available for treatment of disease activity in MS. The meta-analysis showed a significant beneficial effect on the annual relapse rate (effect size -0.5; P = 0.00003), on the proportion of relapse-free patients (0.29 difference; P = 2.1 x 10(-8)), change in Expanded Disability Status Scale (EDSS) score (effect size: 0.25; P = 0.04), and a trend towards a reduction in the proportion of patients who deteriorated (P = 0.03). Each single study in the meta-analysis had its weaknesses, but all studies were positive regarding their primary end-point, and the results yield concordant evidence for reduction of relapse rate and progression. The ideal dosage of IVIG for treating MS needs still to be determined. In conclusion, IVIG may be a valuable alternative for treatment of relapsing-remitting MS, but can presently not be considered as a first-line treatment. IVIG could be considered in patients who do not tolerate or are unwilling to take the approved injectable medications, but additional studies are needed to establish the role of IVIG in the management of multiple sclerosis.
静脉注射免疫球蛋白(IVIG)对免疫系统有多种作用,可能对多发性硬化症(MS)的疾病进程产生有益影响。四项针对复发缓解型MS的双盲试验表明,IVIG可能降低复发率、疾病进展以及钆增强病灶的数量。然而,这些试验规模小于干扰素-β和醋酸格拉替雷的关键试验,因此,我们对这四项试验进行了荟萃分析,以便与目前可用于治疗MS疾病活动的其他药物相比,全面评估IVIG在复发缓解型多发性硬化症中的益处。荟萃分析显示,IVIG对年复发率有显著有益影响(效应量-0.5;P = 0.00003),对无复发患者比例有影响(差异为0.29;P = 2.1×10⁻⁸),对扩展残疾状态量表(EDSS)评分有变化(效应量:0.25;P = 0.04),并且在病情恶化患者比例降低方面有趋势(P = 0.03)。荟萃分析中的每项单项研究都有其不足之处,但所有研究在其主要终点方面都是阳性的,并且结果为降低复发率和疾病进展提供了一致的证据。治疗MS的IVIG理想剂量仍有待确定。总之,IVIG可能是治疗复发缓解型MS的一种有价值的替代方法,但目前不能被视为一线治疗方法。对于不耐受或不愿意服用已批准注射药物的患者,可以考虑使用IVIG,但需要更多研究来确定IVIG在多发性硬化症管理中的作用。