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静脉注射免疫球蛋白与口服泼尼松龙治疗慢性炎症性脱髓鞘性多发性神经根神经病的随机对照试验

Randomized controlled trial of intravenous immunoglobulin versus oral prednisolone in chronic inflammatory demyelinating polyradiculoneuropathy.

作者信息

Hughes R, Bensa S, Willison H, Van den Bergh P, Comi G, Illa I, Nobile-Orazio E, van Doorn P, Dalakas M, Bojar M, Swan A

机构信息

Department of Neuroimmunology, Guy's, King's, and St. Thomas' School of Medicine, Guy's Hospital, London, United Kingdom.

出版信息

Ann Neurol. 2001 Aug;50(2):195-201. doi: 10.1002/ana.1088.

Abstract

This multicenter, randomized, double-blind, crossover trial compared a six week course of oral prednisolone tapering from 60 mg to 10 mg daily with intravenous immunoglobulin (IVIg) 2.0 g/kg given over one to two days for treating chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Twenty-four of the thirty-two randomized patients completed both treatment periods. Both treatments produced significant improvements in the primary outcome measure, change in an 11-point disability scale two weeks after randomization. There was slightly, but not significantly, more improvement after IVIg than with prednisolone, the mean difference between the groups in change in disability grade being 0.16 (95% CI = -0.35 to 0.66). There were also slightly, but not significantly, greater improvements favoring IVIg in the secondary outcome measures: time to walk 10 meters after two weeks and improvement in disability grade after six weeks. Results may have been biased against IVIg by the eight patients who did not complete the second arm of the trial. A serious adverse event (psychosis) attributable to treatment occurred in one patient while on prednisolone and in none with IVIg.

摘要

这项多中心、随机、双盲、交叉试验比较了为期六周的口服泼尼松龙疗程(剂量从每日60毫克逐渐减至10毫克)与静脉注射免疫球蛋白(IVIg)2.0克/千克(在一至两天内给予)用于治疗慢性炎症性脱髓鞘性多发性神经根神经病(CIDP)的效果。32名随机分组的患者中有24名完成了两个治疗阶段。两种治疗方法在主要结局指标(随机分组后两周时11分残疾量表的变化)上均产生了显著改善。IVIg治疗后的改善略多于泼尼松龙,但差异无统计学意义,两组残疾等级变化的平均差异为0.16(95%CI = -0.35至0.66)。在次要结局指标方面,IVIg也有略大但无显著差异的改善:两周后行走10米的时间以及六周后残疾等级的改善。未完成试验第二阶段的8名患者可能使结果对IVIg不利。一名患者在服用泼尼松龙期间出现了与治疗相关的严重不良事件(精神病),而接受IVIg治疗的患者中未出现此类情况。

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