Abstract:
BACKGROUND:Myasthenia gravis (MG) is an autoimmune disorder affecting neuromuscular transmission. Exacerbations may involve increasing bulbar weakness and/or sudden respiratory failure, both of which can be critically disabling. Management of MG exacerbations includes plasma exchange and intravenous immunoglobulin (IVIG); they are equally effective, but patients experience fewer side effects with IVIG. The objective of this study was to assess the efficacy and safety of immune globulin caprylate/chromatography purified (IGIV-C) in subjects with MG exacerbations. METHODS:This prospective, open-label, non-controlled 28-day clinical trial was conducted in adults with MG Foundation of America class IVb or V status. Subjects received IGIV-C 2 g/kg over 2 consecutive days (1 g/kg/day) and were assessed for efficacy/safety on Days 7, 14, 21, and 28. The primary efficacy endpoint was the change from Baseline in quantitative MG (QMG) score to Day 14. Secondary endpoints of clinical response, Baseline to Day 14, included at least a 3-point decrease in QMG and MG Composite and a 2-point decrease in MG-activities of daily living (MG-ADL). RESULTS:Forty-nine subjects enrolled. The change in QMG score at Day 14 was significant (p < 0.001) in the Evaluable (-6.4, n = 43) and Safety (-6.7, n = 49) populations. Among evaluable subjects, Day 14 response rates were 77, 86, and 88% for QMG, MG Composite, and MG-ADL, respectively. IGIV-C showed good tolerability with no serious adverse events. CONCLUSIONS:The results of this study show that IGIV-C was effective, safe, and well tolerated in the treatment of MG exacerbations.
journal_name
Eur Neuroljournal_title
European neurologyauthors
Karelis G,Balasa R,De Bleecker JL,Stuchevskaya T,Villa A,Van Damme P,Lagrange E,Heckmann JM,Nicolle M,Vilciu C,Bril V,Mondou E,Griffin R,Chen J,Henriquez W,Garcia B,Camprubi S,Ayguasanosa Jdoi
10.1159/000502818subject
Has Abstractpub_date
2019-01-01 00:00:00pages
223-230issue
5-6eissn
0014-3022issn
1421-9913pii
000502818journal_volume
81pub_type
杂志文章,多中心研究abstract:BACKGROUND:Half of Parkinson's disease (PD) patients with mild cognitive impairment (MCI) develop dementia. We studied topographic distribution of cerebral hypometabolism in PD with different types of MCI. METHODS:This study included 61 nondemented PD patients and 14 age-matched controls. PD patients were grouped into...
journal_title:European neurology
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pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:2008-01-01 00:00:00
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