『徳島大学 教育・研究者情報データベース (EDB)』---[学外] /
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種別 (必須): 学術論文 (審査論文) [継承]
言語 (必須): 英語 [継承]
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カテゴリ (推奨):
共著種別 (推奨): 国内共著 (徳島大学内研究者と国内(学外)研究者との共同研究 (国外研究者を含まない)) [継承]
学究種別 (推奨):
組織 (推奨):
著者 (必須): 1. (英) Sonoko Misawa (日) (読)
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[継承]
2. (英) Satoshi Kuwabara (日) (読)
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[継承]
3. (英) Yasunori Sato (日) (読)
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[継承]
4. (英) Nobuko Yamaguchi (日) (読)
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[継承]
5. (英) Kengo Nagashima (日) (読)
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[継承]
6. (英) Kanako Katayama (日) (読)
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[継承]
7. (英) Yukari Sekiguchi (日) (読)
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[継承]
8. (英) Yuta Iwai (日) (読)
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[継承]
9. (英) Hiroshi Amino (日) (読)
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[継承]
10. (英) Tomoki Suichi (日) (読)
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11. (英) Takanori Yokota (日) (読)
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12. (英) Yoichiro Nishida (日) (読)
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13. (英) Tadashi Kanouchi (日) (読)
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14. (英) Nobuo Kohara (日) (読)
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15. (英) Michi Kawamoto (日) (読)
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16. (英) Junko Ishii (日) (読)
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17. (英) Motoi Kuwabara (日) (読)
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18. (英) Hidekazu Suzuki (日) (読)
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19. (英) Koichi Hirata (日) (読)
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20. (英) Norito Kokubun (日) (読)
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21. (英) Ray Masuda (日) (読)
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22. (英) Juntaro Kaneko (日) (読)
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23. (英) Ichiro Yabe (日) (読)
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24. (英) Hidenao Sasaki (日) (読)
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25. (英) Ken-ichi Kaida (日) (読)
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26. (英) Hiroshi Takazaki (日) (読)
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27. (英) Norihiro Suzuki (日) (読)
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28. (英) Shigeaki Suzuki (日) (読)
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29.野寺 裕之
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30.松井 尚子 ([徳島大学.大学院医歯薬学研究部.医学域.医科学部門.社会医学系.医療教育学])
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31. (英) Shoji Tsuji (日) (読)
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32. (英) Haruki Koike (日) (読)
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33. (英) Ryo Yamasaki (日) (読)
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34. (英) Susumu Kusunki (日) (読)
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[継承]
題名 (必須): (英) Safety and efficacy of eculizumab in Guillain-Barré syndrome: a multicentre, double-blind, randomised phase 2 trial.  (日)    [継承]
副題 (任意):
要約 (任意): (英) Despite the introduction of plasmapheresis and immunoglobulin therapy, many patients with Guillain-Barré syndrome still have an incomplete recovery. Evidence from pathogenesis studies suggests the involvement of complement-mediated peripheral nerve damage. We aimed to investigate the safety and efficacy of eculizumab, a humanised monoclonal antibody against the complement protein C5, in patients with severe Guillain-Barré syndrome. This study was a 24 week, multicentre, double-blind, placebo-controlled, randomised phase 2 trial done at 13 hospitals in Japan. Eligible patients with Guillain-Barré syndrome were aged 18 years or older and could not walk independently (Guillain-Barré syndrome functional grade 3-5). Patients were randomly assigned (2:1) to receive 4 weeks of intravenous immunoglobulin plus either eculizumab (900 mg) or placebo; randomisation was done via a computer-generated process and web response system with minimisation for functional grade and age. The study had a parallel non-comparative single-arm outcome measure. The primary outcomes were efficacy (the proportion of patients with restored ability to walk independently [functional grade 2] at week 4) in the eculizumab group and safety in the full analysis set. For the efficacy endpoint, we predefined a response rate threshold of the lower 90% CI boundary exceeding 50%. This trial is registered with ClinicalTrials.gov, number, NCT02493725. Between Aug 10, 2015, and April 21, 2016, 34 patients were assigned to receive either eculizumab (n=23) or placebo (n=11). At week 4, the proportion of the patients able to walk independently (functional grade 2) was 61% (90% CI 42-78; n=14) in the eculizumab group, and 45% (20-73; n=5) in the placebo group. Adverse events occurred in all 34 patients. Three patients had serious adverse events: two in the eculizumab group (anaphylaxis in one patient and intracranial haemorrhage and abscess in another patient) and one in the placebo group (depression). The possibility that anaphylaxis and intracranial abscess were related to eculizumab could not be excluded. No deaths or meningococcal infections occurred. The primary outcome measure did not reach the predefined response rate. However, because this is a small study without statistical comparison with the placebo group, the efficacy and safety of eculizumab could be investigated in larger, randomised controlled trials. The Japan Agency for Medical Research and Development, Ministry of Health, Labor and Welfare, and Alexion Pharmaceuticals.  (日)    [継承]
キーワード (推奨):
発行所 (推奨):
誌名 (必須): The Lancet Neurology ([Elsevier])
(pISSN: 1474-4422, eISSN: 1474-4465)

ISSN (任意): 1474-4465
ISSN: 1474-4422 (pISSN: 1474-4422, eISSN: 1474-4465)
Title: The Lancet. Neurology
Title(ISO): Lancet Neurol
Publisher: The Lancet Publishing Group
 (NLM Catalog  (Scopus  (CrossRef (Scopus information is found. [need login])
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(必須): 17 [継承]
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(必須): 519 529 [継承]
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年月日 (必須): 西暦 2018年 4月 21日 (平成 30年 4月 21日) [継承]
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DOI (任意): 10.1016/S1474-4422(18)30114-5    (→Scopusで検索) [継承]
PMID (任意): 29685815    (→Scopusで検索) [継承]
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Scopus (任意): 2-s2.0-85045902073 [継承]
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備考 (任意): 1.(英) Article.ELocationID: S1474-4422(18)30114-5  (日)    [継承]
2.(英) Article.ELocationID: 10.1016/S1474-4422(18)30114-5  (日)    [継承]
3.(英) Article.DataBankList.DataBank.DataBankName: ClinicalTrials.gov  (日)    [継承]
4.(英) Article.DataBankList.DataBank.AccessionNumberList.AccessionNumber: NCT02493725  (日)    [継承]
5.(英) Article.PublicationTypeList.PublicationType: Journal Article  (日)    [継承]

標準的な表示

和文冊子 ● Misawa Sonoko, Kuwabara Satoshi, Sato Yasunori, Yamaguchi Nobuko, Nagashima Kengo, Katayama Kanako, Sekiguchi Yukari, Iwai Yuta, Amino Hiroshi, Suichi Tomoki, Yokota Takanori, Nishida Yoichiro, Kanouchi Tadashi, Kohara Nobuo, Kawamoto Michi, Ishii Junko, Kuwabara Motoi, Suzuki Hidekazu, Hirata Koichi, Kokubun Norito, Masuda Ray, Kaneko Juntaro, Yabe Ichiro, Sasaki Hidenao, Kaida Ken-ichi, Takazaki Hiroshi, Suzuki Norihiro, Suzuki Shigeaki, Hiroyuki Nodera, Naoko Matsui, Tsuji Shoji, Koike Haruki, Yamasaki Ryo and Kusunki Susumu : Safety and efficacy of eculizumab in Guillain-Barré syndrome: a multicentre, double-blind, randomised phase 2 trial., The Lancet Neurology, Vol.17, No.6, 519-529, 2018.
欧文冊子 ● Misawa Sonoko, Kuwabara Satoshi, Sato Yasunori, Yamaguchi Nobuko, Nagashima Kengo, Katayama Kanako, Sekiguchi Yukari, Iwai Yuta, Amino Hiroshi, Suichi Tomoki, Yokota Takanori, Nishida Yoichiro, Kanouchi Tadashi, Kohara Nobuo, Kawamoto Michi, Ishii Junko, Kuwabara Motoi, Suzuki Hidekazu, Hirata Koichi, Kokubun Norito, Masuda Ray, Kaneko Juntaro, Yabe Ichiro, Sasaki Hidenao, Kaida Ken-ichi, Takazaki Hiroshi, Suzuki Norihiro, Suzuki Shigeaki, Hiroyuki Nodera, Naoko Matsui, Tsuji Shoji, Koike Haruki, Yamasaki Ryo and Kusunki Susumu : Safety and efficacy of eculizumab in Guillain-Barré syndrome: a multicentre, double-blind, randomised phase 2 trial., The Lancet Neurology, Vol.17, No.6, 519-529, 2018.

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