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タイトル: | An open-label prospective randomized multicenter study of intensive versus weekly granulocyte and monocyte apheresis in active crohn's disease |
著者: | Yoshimura, Naoki Yokoyama, Yoko Matsuoka, Katsuyoshi Takahashi, Hiroki Iwakiri, Ryuichi Yamamoto, Takayuki Nakagawa, Tomoo Fukuchi, Takumi Motoya, Satoshi Kunisaki, Reiko Kato, Shingo Hirai, Fumihito Ishiguro, Yoh Tanida, Satoshi Hiraoka, Sakiko Mitsuyama, Keiichi Ishihara, Shunji Tanaka, Shinji Otaka, Michiro Osada, Taro Kagaya, Takashi Suzuki, Yasuo Nakase, Hiroshi Hanai, Hiroyuki Watanabe, Kenji Kashiwagi, Nobuhito Hibi, Toshifumi |
著者名の別形: | 仲瀬, 裕志 |
キーワード: | Crohn’s disease Prospective study Granulocyte and monocyte adsorptive apheresis Intensive therapy Leucocyte count Erythrocyte sedimentation rate C-reactive protein |
発行日: | 19-Nov-2015 |
出版者: | BioMed Central Ltd. |
誌名: | BMC Gastroenterology |
巻: | 15 |
論文番号: | 163 |
抄録: | Background: Granulocyte and monocyte adsorptive apheresis (GMA) has shown efficacy in patients with active Crohn's disease (CD). However, with routine weekly therapy, it may take several weeks to achieve remission. This study was performed to assess clinical efficacy and safety of intensive GMA in patients with active CD. Methods: In an open-label, prospective, randomized multicentre setting, 104 patients with CD activity index (CDAI) of 200 to 450 received intensive GMA, at two sessions per week (n = 55) or one session per week (n = 49). Clinical remission was defined as a CDAI score <150. Patients in each arm could receive up to 10 GMA sessions. However, GMA treatment could be discontinued when CDAI decreased to <150 (clinical remission level). Results: Of the 104 patients, 99 were available for efficacy evaluation as per protocol, 45 in the weekly GMA group, and 54 in the intensive GMA group. Remission was achieved in 16 of 45 patients (35.6 %) in the weekly GMA and in 19 of 54 (35.2 %) in the intensive GMA (NS). Further, the mean time to remission was 35.4 ± 5.3 days in the weekly GMA and 21.7 ± 2.7 days in the intensive GMA (P = 0.0373). Elevated leucocytes and erythrocyte sedimentation rate were significantly improved by intensive GMA, from 8005/μL to 6950/μL (P = 0.0461) and from 54.5 mm/hr to 30.0 mm/hr (P = 0.0059), respectively. In both arms, GMA was well tolerated and was without safety concern. Conclusions: In this study, with respect to remission rate, intensive GMA was not superior to weekly GMA, but the time to remission was significantly shorter in the former without increasing the incidence of side effects. UMIN registration 000003666. |
著作権等: | © 2015 Yoshimura et al. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
URI: | http://hdl.handle.net/2433/212476 |
DOI(出版社版): | 10.1186/s12876-015-0390-3 |
PubMed ID: | 26585569 |
出現コレクション: | 学術雑誌掲載論文等 |
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