神戸大学附属図書館デジタルアーカイブ
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https://hdl.handle.net/20.500.14094/90005721
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2024-06-03
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90005721 (fulltext)
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メタデータID
90005721
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open access
出版タイプ
Version of Record
タイトル
Intravenous immunoglobulin for maintenance treatment of chronic inflammatory demyelinating polyneuropathy: a multicentre, open-label, 52-week phase III trial
著者
Kuwabara, Satoshi ; Mori, Masahiro ; Misawa, Sonoko ; Suzuki, Miki ; Nishiyama, Kazutoshi ; Mutoh, Tatsuro ; Doi, Shizuki ; Kokubun, Norito ; Kamijo, Mikiko ; Yoshikawa, Hiroo ; Abe, Koji ; Nishida, Yoshihiko ; Okada, Kazumasa ; Sekiguchi, Kenji ; Sakamoto, Ko ; Kusunoki, Susumu ; Sobue, Gen ; Kaji, Ryuji
著者名
Kuwabara, Satoshi
著者名
Mori, Masahiro
著者名
Misawa, Sonoko
著者名
Suzuki, Miki
著者名
Nishiyama, Kazutoshi
著者名
Mutoh, Tatsuro
著者名
Doi, Shizuki
著者名
Kokubun, Norito
著者名
Kamijo, Mikiko
著者名
Yoshikawa, Hiroo
著者名
Abe, Koji
著者名
Nishida, Yoshihiko
著者名
Okada, Kazumasa
著者ID
A1416
研究者ID
1000070533793
KUID
https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail?systemId=0e1f5850c91c57cf520e17560c007669
著者名
Sekiguchi, Kenji
関口, 兼司
セキグチ, ケンジ
所属機関名
医学研究科
著者名
Sakamoto, Ko
著者名
Kusunoki, Susumu
著者名
Sobue, Gen
著者名
Kaji, Ryuji
収録物名
Journal of Neurology Neurosurgery and Psychiatry
巻(号)
88(10)
ページ
832-838
出版者
BMJ Publishing Group
刊行日
2017-10
公開日
2019-03-22
抄録
Objective Short-term efficacy of induction therapy with intravenous immunoglobulin (Ig) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) is well established. However, data of previous studies on maintenance therapy were limited up to 24-week treatment period. We aimed to investigate the efficacy and safety of longer-term intravenous Ig therapy for 52 weeks. Methods This study was an open-label phase 3 clinical trial conducted in 49 Japanese tertiary centres. 49 patients with CIDP who fulfilled diagnostic criteria were included. After an induction intravenous Ig therapy (0.4 g/kg/day for five consecutive days), maintenance dose intravenous Ig (1.0g/kg) was given every 3 weeks for up to 52 weeks. The primary outcome measures were the responder rate at week 28 and relapse rate at week 52. The response and relapse were defined with the adjusted Inflammatory Neuropathy Cause and Treatment scale. Results At week 28, the responder rate was 77.6% (38/49 patients; 95% CI 63% to 88%), and the 38 responders continued the maintenance therapy. At week 52, 4 of the 38 (10.5%) had a relapse (95% CI 3% to 25%). During 52 weeks, 34 (69.4%) of the 49 enrolled patients had a maintained improvement. Adverse events were reported in 94% of the patients; two patients (66-year-old and 76-year-old men with hypertension or diabetes) developed cerebral infarction (lacunar infarct with good recovery), and the other adverse effects were mild and resolved by the end of the study period. Conclusions Maintenance treatment with 1.0 g/kg intravenous Ig every 3 weeks is an efficacious therapy for patients with CIDP, and approximately 70% of them had a sustained remission for 52 weeks. Thrombotic complications should be carefully monitored, particularly in elderly patients with vascular risk factors.
カテゴリ
医学研究科
学術雑誌論文
権利
© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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資源タイプ
journal article
言語
English (英語)
ISSN
0022-3050
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eISSN
1468-330X
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関連情報
DOI
https://doi.org/10.1136/jnnp-2017-316427
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