HUSCAP logo Hokkaido Univ. logo

Hokkaido University Collection of Scholarly and Academic Papers >
医学研究院・医学院  >
雑誌発表論文等  >

Effects of intravenous immunoglobulin therapy in Japanese patients with polymyositis and dermatomyositis resistant to corticosteroids : a randomized double-blind placebo-controlled trial

この資料はクリエイティブ・コモンズ・ライセンスの下で公開されています。

フルテキスト
82_ModRheumatol22_382.pdf415.09 kBPDF見る/開く
この文献へのリンクには次のURLを使用してください:http://hdl.handle.net/2115/62837

タイトル: Effects of intravenous immunoglobulin therapy in Japanese patients with polymyositis and dermatomyositis resistant to corticosteroids : a randomized double-blind placebo-controlled trial
著者: Miyasaka, Nobuyuki 著作を一覧する
Hara, Masako 著作を一覧する
Koike, Takao 著作を一覧する
Saito, Eizo 著作を一覧する
Yamada, Masahito 著作を一覧する
Tanaka, Yoshiya 著作を一覧する
Additional Members of the GB-0998 Study Group 著作を一覧する
キーワード: Intravenous immunoglobulin (IVIG)
Manual muscle test (MMT)
Polymyositis (PM)
Dermatomyositis (DM)
Randomized, double-blind, placebo-controlled study
発行日: 2012年
出版者: Springer
誌名: Modern Rheumatology
巻: 22
号: 3
開始ページ: 382
終了ページ: 393
出版社 DOI: 10.1007/s10165-011-0534-4
抄録: High-dose intravenous immunoglobulin (IVIG) therapy has been effective in treating various autoimmune and systemic inflammatory diseases. Here, we assessed the efficacy and safety of IVIG therapy with polyethylene glycol-treated human IgG (drug code GB-0998) for patients with corticosteroid-refractory polymyositis (PM) and dermatomyositis (DM) by means of a randomized, double-blind, placebo-controlled study. We randomly assigned 26 subjects (16 PM and 10 DM) to receive either GB-0998 or placebo. Intragroup comparison in the GB-0998 group showed statistically significant improvements due to GB-0998 administration in the primary endpoint (manual muscle test score) and secondary endpoints (serum creatine kinase level and activities of daily living score). However, significant improvements were also found in the placebo group, and comparison of the GB-0998 group with the placebo group did not show any significant difference between the groups. We discuss possible reasons for the absence of a clear intergroup difference in efficacy. Nineteen adverse drug reactions were observed in 11 of 26 subjects (42.3%), of which 2 events (decreased muscle strength and increased serum creatine kinase) were assessed as serious; however, they are previously known events. These results indicate that GB-0998 can be safely used with the same precautions as other current IVIG therapy.
資料タイプ: article
URI: http://hdl.handle.net/2115/62837
出現コレクション:雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

提供者: 小池 隆夫

 

本サイトに関するご意見・お問い合わせは repo at lib.hokudai.ac.jp へお願いします。 - 北海道大学