van Koningsveld R, Schmitz P I M, Meché F G Avander, Visser L H, Meulstee J, van Doorn P A
Department of Neurology, Erasmus MC, Rotterdam, Netherlands.
Lancet. 2004 Jan 17;363(9404):192-6. doi: 10.1016/s0140-6736(03)15324-x.
Despite available treatment with intravenous immunoglobulin (IVIg), morbidity and mortality are considerable in patients with Guillain-Barré syndrome (GBS). Our aim was to assess whether methylprednisolone, when taken with IVIg, improves outcome when compared with IVIg alone.
We did a double-blind, placebo-controlled, multicentre, randomised study, to which we enrolled patients who were unable to walk independently and who had been treated within 14 days after onset of weakness with IVIg (0.4 g/kg bodyweight per day) for 5 days. We assigned 233 individuals to receive either intravenous methylprednisolone (500 mg per day; n=116) or placebo (n=117) for 5 days within 48 h of administration of first dose of IVIg. Because age is an important prognostic factor, we split treatment groups into two age-groups-ie, younger than age 50 years, or 50 years and older. Our primary outcome was an improvement from baseline in GBS disability score of one or more grades 4 weeks after randomisation. Analysis was by intention to treat.
We analysed 225 patients. GBS disability scores increased by one grade or more in 68% (76 of 112) of patients in the methylprednisolone group and in 56% (63 of 113) of controls (odds ratio [OR] 1.68, 95% CI 0.97-2.88; p=0.06). After adjustment for age and degree of disability at entry, treatment OR was 1.89 (95% CI 1.07-3.35; p=0.03). Side-effects did not differ greatly between groups.
We noted no significant difference between treatment with methylprednisolone and IVIg and IVIg alone. Because of the relevance of prognostic factors and the limited side-effects of methylprednisolone, the potential importance of combination treatment with the drug and IVIg, however, warrants further investigation.
尽管有静脉注射免疫球蛋白（IVIg）这种可用的治疗方法，但吉兰-巴雷综合征（GBS）患者的发病率和死亡率仍然很高。我们的目的是评估甲基强的松龙与IVIg联合使用时，与单独使用IVIg相比是否能改善治疗效果。
我们进行了一项双盲、安慰剂对照、多中心随机研究，纳入了无法独立行走且在肌无力发作后14天内接受IVIg（每天0.4 g/kg体重）治疗5天的患者。我们将233名个体随机分为两组，在首剂IVIg给药后48小时内，一组接受静脉注射甲基强的松龙（每天500 mg；n = 116），另一组接受安慰剂（n = 117），疗程均为5天。由于年龄是一个重要的预后因素，我们将治疗组分为两个年龄组，即年龄小于50岁或50岁及以上。我们的主要结局是随机分组4周后GBS残疾评分较基线改善一个或更多等级。分析采用意向性分析。
我们分析了225例患者。甲基强的松龙组68%（112例中的76例）的患者GBS残疾评分提高了一个或更多等级，对照组为56%（113例中的63例）（优势比[OR] 1.68，95%置信区间0.97 - 2.88；p = 0.06）。在对年龄和入组时的残疾程度进行校正后，治疗的OR为1.89（95%置信区间1.07 - 3.35；p = 0.03）。两组间副作用差异不大。
我们发现甲基强的松龙与IVIg联合治疗和单独使用IVIg之间没有显著差异。然而，鉴于预后因素的相关性以及甲基强的松龙的副作用有限，该药物与IVIg联合治疗的潜在重要性值得进一步研究。
