학술논문

Randomized Trial of Thymectomy in Myasthenia Gravis
Document Type
article
Source
New England Journal of Medicine. 375(6)
Subject
Biomedical and Clinical Sciences
Clinical Sciences
Myasthenia Gravis
Clinical Trials and Supportive Activities
Neurosciences
Autoimmune Disease
Clinical Research
Rare Diseases
Evaluation of treatments and therapeutic interventions
6.1 Pharmaceuticals
Adolescent
Adult
Aged
Combined Modality Therapy
Female
Glucocorticoids
Hospitalization
Humans
Male
Middle Aged
Prednisone
Severity of Illness Index
Single-Blind Method
Thymectomy
Treatment Outcome
Young Adult
MGTX Study Group
Medical and Health Sciences
General & Internal Medicine
Biomedical and clinical sciences
Health sciences
Language
Abstract
BackgroundThymectomy has been a mainstay in the treatment of myasthenia gravis, but there is no conclusive evidence of its benefit. We conducted a multicenter, randomized trial comparing thymectomy plus prednisone with prednisone alone.MethodsWe compared extended transsternal thymectomy plus alternate-day prednisone with alternate-day prednisone alone. Patients 18 to 65 years of age who had generalized nonthymomatous myasthenia gravis with a disease duration of less than 5 years were included if they had Myasthenia Gravis Foundation of America clinical class II to IV disease (on a scale from I to V, with higher classes indicating more severe disease) and elevated circulating concentrations of acetylcholine-receptor antibody. The primary outcomes were the time-weighted average Quantitative Myasthenia Gravis score (on a scale from 0 to 39, with higher scores indicating more severe disease) over a 3-year period, as assessed by means of blinded rating, and the time-weighted average required dose of prednisone over a 3-year period.ResultsA total of 126 patients underwent randomization between 2006 and 2012 at 36 sites. Patients who underwent thymectomy had a lower time-weighted average Quantitative Myasthenia Gravis score over a 3-year period than those who received prednisone alone (6.15 vs. 8.99, P