臨床神経学

第48回日本神経学会総会

<シンポジウム5-4>免疫性神経疾患治療のControversy: 1. MG, 2. MS
国際プロジェクトについて―MGTX Study―

吉川 弘明

金沢大学保健管理センター〔〒920-1192 石川県金沢市角間町〕

MGTX Study is a multi-center, international, single-blinded, randomized trial to determine whether extended transsternal thymectomy (ETTX) for patients with myasthenia gravis receiving the prednisone protocol confers added benefits to the prednisone protocol alone. The aims of the study are answering following three questions. 1) Does ETTX combined with prednisone result in a greater improvement in myasthenic weakness, compared to prednisone alone? 2) Does ETTX combined with prednisone result in a lower total dose of prednisone, thus decreasing the likelihood of concurrent and long-term toxic effects, compared to prednisone alone? 3) Does ETTX combined with prednisone enhance quality of life by reducing adverse events and symptoms associated with the therapies, compared to prednisone alone? Primary outcome measure is consists with 1) Comparison of the prednisone protocol alone to prednisone protocol plus ETTX, based on the clinical response to therapy measured over the 3 year trial period by the Area Under the Quantitative Myasthenia Gravis (QMG) Weakness Score (AUQMG), and 2) Testing the difference in the total prednisone used over the 3 year trial period measured by pill count from blister packs (Area Under the Prednisone Dose Time Curve, AUDTC), conditional on the results of comparing AUQMG.

(臨床神経, 47:880−882, 2007)
key words:重症筋無力症, 胸腺摘除術, ステロイド療法, 臨床試験, 国際プロジェクト

(受付日:2007年5月16日)