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

被引:513
作者
Hughes, R [1 ]
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
[1] Guys Kings & St Thomas Sch Med, Dept Neuroimmunol, Guys Hosp, London SE1 9RT, England
[2] Univ Glasgow, So Gen Hosp, Dept Neurol, Glasgow, Lanark, Scotland
[3] Univ Catholique Louvain, Clin Univ St Luc, Neurol Serv, B-1200 Brussels, Belgium
[4] Osped San Raffaele, Dipartimento Sci & Technol, Biomed Clin Neurol 4, Milan, Italy
[5] Hosp Univ Sta Creu & St Pau, Serv Neurol, Barcelona, Spain
[6] Univ Milan, Osped Maggiore Policlin, Inst Clin Neurol, Milan, Italy
[7] Erasmus Med Ctr Rotterdam, Dept Neurol, Rotterdam, Netherlands
[8] Univ Athens, Sch Med, Eginit Univ Hosp, Athens, Greece
[9] NIH, Neuromusc Dis Sect, Bethesda, MD 20892 USA
[10] Charles Univ Hosp, Sch Med 2, Prague, Czech Republic
[11] PHLS, Stat Unit, London, England
关键词
D O I
10.1002/ana.1088
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
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 Mg 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 Mg 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 Mg 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 Mg.
引用
收藏
页码:195 / 201
页数:7
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