Effect of methylprednisolone when added to standard treatment with intravenous immunoglobulin for Guillain-Barré syndrome: randomised trial.
Background: 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.Methods: We...
| Publicado en: | Lancet Vol. 363; no. 9404; pp. 192 - 197 |
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| Autores principales: | , , , , , , , , , , , |
| Formato: | clinical trial research tables/charts Journal Article |
| Publicado: |
Lancet
1/17/2004
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=106592875&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 106592875 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 01406736 LAN jtl: Lancet issn: 01406736 maglogo: N pubinfo: dt: 1/17/2004 vid: 363 iid: 9404 pid: 1297 pub: Lancet place: Philadelphia, Pennsylvania artinfo: ui: 106592875 106592875 NLM14738791 2005049320 10.1016/s0140-6736(03)15324-x NLM14738791 106592875 ppf: 192 ppct: 5 formats: fmt: @attributes: type: P tig: atl: Effect of methylprednisolone when added to standard treatment with intravenous immunoglobulin for Guillain-Barré syndrome: randomised trial. aug: au: van Koningsveld R Schmitz PIM van der Meché FGA Visser LH Meulstee J van Doorn PA van Koningsveld, R Schmitz, P I M Meché, F G Avander Visser, L H Meulstee, J van Doorn, P A affil: Department of Neurology, Erasmus MC, Rotterdam, Netherlands sug: subj: Immunoglobulins, Intravenous Therapeutic Use Methylprednisolone Administration and Dosage Polyradiculoneuritis Drug Therapy Adolescence Adult Aged Aged, 80 and Over Chi Square Test Child Clinical Trials Confidence Intervals Data Analysis Software Double-Blind Studies Drug Therapy, Combination Female Kaplan-Meier Estimator Log-Rank Test Male Methylprednisolone Adverse Effects Middle Age Multivariate Analysis Netherlands Odds Ratio Random Assignment Research Instruments Treatment Outcomes Univariate Statistics Human Adolescent: 13-18 years Adult: 19-44 years Aged: 65+ years Aged, 80 & over Child: 6-12 years Middle Aged: 45-64 years Female Male ab: Background: 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.Methods: 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.Findings: 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.Interpretation: 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. pubtype: Academic Journal doctype: clinical trial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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