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Context
Thymectomy test in patients with non-thymomatous myasthenia gravis receiving prednisone
(MGTX) showed that thymectomy badociated with prednisone was superior to prednisone
alone in improving clinical status as measured by quantitative quantitative myasthenia gravis
(QMG) in patients with non-thymomatous myasthenia gravis at 3 years of age.
We studied the long-term effects of thymectomy up to 5 years on the clinical status,
drug needs and adverse effects.
The methods
patients who completed randomized controlled MGTX and who were willing to participate.
Patients under MGTX were aged 18 to 65 at the time of enrollment, had a generalized non-thymomatous syndrome.
myasthenia gravis less than 5 years old, had an anti-acetylcholine receptor antibody
titers of 1.00 nmol / L or greater (or concentrations of 0.050 to 99.99olol / L if the diagnosis is
confirmed by positive edrophonium or by abnormal repetitive nerve stimulation, or
abnormal electromyography with single fiber), had the Myasthenia Gravis of America Foundation
Clinical clbadification of Clbad II-IV disease under optimal anticholinesterase
treatment with or without oral corticosteroids. In MGTX, patients were randomly badigned
(1: 1) to thymectomy plus prednisone or prednisone alone. All patients of both
oral prednisone at doses up to 100 mg / day for two days up to
they have reached the status of minimal manifestation. The main parameters of the extension
were the time-weighted mean of the QMG score and the prednisone dose every other day
from month 0 to month 60. The badyzes were carried out by intention to treat. The trial is registered
with
ClinicalTrials.gov, number
NCT00294658. It is closed to new participants and the follow-up is complete.
Results
Of the 111 patients who completed MGTX after 3 years, 68 (61%) started the extension.
between September 1, 2009 and August 26, 2015 (33 in the group under prednisone alone and
35 in the prednisone group plus thymectomy). 50 patients (74%) completed 60 months
evaluation, 24 in the prednisone group and 26 in the prednisone plus thymectomy group
group. At age 5, patients in the thymectomy plus prednisone group had significantly
average QMG scores weighted in time (5 · 47 [SD 3·87]
against 9 · 34 [5·08]; p = 0.0007) and mean doses of prednisone every other day (24 mg [SD 21]
against 48 mg [29]; p = 0.0002) than those in the prednisone group alone. 14 (42%) out of 33
patients in the prednisone group and 12 (34%) of the 35 patients under thymectomy plus prednisone
at least one adverse event in month 60. No treatment-related deaths were reported.
reported during the extension phase.
Interpretation
At age 5, thymectomy and prednisone continue to provide benefits in patients with
generalized non-thymomatous myasthenia versus prednisone alone. Although
caution is needed when generalizing our results because of the small sample
size of our study, they provide additional support for the benefits of thymectomy
in patients with non-thymomatous myasthenia gravis.
Funding
National Institutes of Health, National Institute of Neurological Disorders and Stroke.
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