Second intravenous immunoglobulin dose in patients with Guillain-Barré syndrome with poor prognosis (SID-GBS): a double-blind, randomised, placebo-controlled trial

نویسندگان

چکیده

Background Treatment with one standard dose (2 g/kg) of intravenous immunoglobulin is insufficient in a proportion patients severe Guillain-Barré syndrome. Worldwide, around 25% severely affected the syndrome are given second (SID), although it has not been proven effective. We aimed to investigate whether SID effective predicted poor outcome. Methods In this randomised, double-blind, placebo-controlled trial (SID-GBS), we included (?12 years) admitted 59 participating hospitals Netherlands. Patients were on first day treatment g/kg over 5 days). Only prognosis (score ?6) according modified Erasmus Outcome Score randomly assigned, via block randomisation stratified by centre, days) or placebo, 7–9 days after inclusion. Patients, outcome adjudicators, monitors, and steering committee masked allocation. The primary measure was disability score 4 weeks All whom allocated medication started intention-to-treat analysis. This study registered Netherlands Trial Register, NTR 2224/NL2107. Findings Between Feb 16, 2010, June 5, 2018, 327 339 assessed for eligibility included. 112 had prognosis. Of those, 93 analysis: 49 (53%) received 44 (47%) placebo. adjusted common odds ratio improvement at 1·4 (95% CI 0·6–3·3; p=0·45). more serious adverse events (35% vs 16% 30 days), including thromboembolic events, than those placebo group. Four died intervention group (13–24 randomisation). Interpretation Our does provide evidence that benefit from course; moreover, entails risk events. Therefore, course should be considered Guillain-Barre because results indicate need trials other immune modulators Funding Prinses Beatrix Spierfonds Sanquin Plasma Products.

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ژورنال

عنوان ژورنال: Lancet Neurology

سال: 2021

ISSN: ['1474-4422', '1474-4465']

DOI: https://doi.org/10.1016/s1474-4422(20)30494-4