作者: Stefan Beissert , Thomas Werfel , Uta Frieling , Markus Böhm , Michael Sticherling
DOI: 10.1001/ARCHDERM.143.12.1536
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摘要: Objective To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine sodium or mycophenolate mofetil for treatment bullous pemphigoid. Design A prospective, multicenter, randomized, nonblinded clinical trial to compare 2 parallel groups patients pemphigoid undergoing different treatments. Setting Thirteen departments dermatology in Germany. Patients (n = 73) as evidenced by lesions suggestive pemphigoid, signs subepidermal blistering on histologic analysis skin biopsy specimens, linear deposition IgG C3 along dermoepidermal junction, autoantibodies at blister roof split-skin analysis. Interventions Treatment plus (azathioprine group) (mycophenolate group). Main Outcome Measures The cumulative total doses rates remission. Secondary outcome measures were profiles duration Results In 38 group (100%), complete remission was achieved after a mean ± SD 23.8 ± 18.9 days vs 42.0 ± 55.3 35 (100%). group, median ± SD dose used 4967.0 ± 12 190.7 mg 5754.0 ± 9692.8 group. Nine (24%) experienced grade 3 4 adverse effects 6 (17%). Azathioprine therapy induced significantly elevated liver function test results compared ( P = .03), alanine aminotransferase γ-glutamyltransferase = .01) than did those Conclusions Mycophenolate demonstrate similar during corticosteroid given both arms control disease. However, showed lower toxicity profile therapy. Trial Registration clinicaltrials.gov Identifier:NCT00431119