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オオモリ テツペイ
Oomori Tetsupei
大森 鉄平 所属 医学部 医学科（東京女子医科大学病院） 職種 非常勤講師 |
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| 論文種別 | 原著 |
| 言語種別 | 英語 |
| 査読の有無 | 査読なし |
| 表題 | Efficacy of apheresis as maintenance therapy for patients with ulcerative colitis in an open-label prospective multicenter randomised controlled trial. |
| 掲載誌名 | 正式名：Journal of gastroenterology 略 称：J Gastroenterol ISSNコード：14355922/09441174 |
| 掲載区分 | 国内 |
| 巻・号・頁 | 55(4),pp.390-400 |
| 著者・共著者 | Naganuma Makoto, Yokoyama Yoko, Motoya Satoshi, Watanabe Kenji, Sawada Koji, Hirai Fumito, Yamamoto Takayuki, Hanai Hiroyuki, OMORI Teppei, Kanai Takanori, Hibi Toshifumi, |
| 発行年月 | 2020/04 |
| 概要 | BACKGROUND:Apheresis therapy involves the selective removal of leukocytes and is used to induce remission in ulcerative colitis (UC) patients. The aim of this study was to demonstrate the efficacy and safety of apheresis therapy for maintaining UC remission.METHODS:We conducted a multicenter, prospective, randomised-control trial of patients with remitting UC induced by granulocyte and monocyte adsorption apheresis or leukocytapheresis. Patients were randomly assigned to the apheresis group (twice per month for 12 months) or the control group (no apheresis treatment) using a 1:1 allocation ratio. The primary endpoint was the rate of cumulative clinical remission (Mayo score ≤ 2) at 12 months. The secondary endpoints were the rates of clinical remission, endoscopic remission, and complete endoscopic remission at 12 months.RESULTS:Between March 2013 and March 2017, 164 patients were enrolled. The cumulative remission rate at 12 months was 46.6% in the apheresis group and 36.4% in the control group (p = 0.1621). The rate of endoscopic remission at 12 months was significantly higher in the apheresis group than in the control group (42.5% vs. 25.9%) p = 0.0480). The rate of clinical remission (47.5% vs.32.1%, p = 0.0540) and complete endoscopic remission (33.8% vs.19.8%, p = 0.0513) tended to be higher in the apheresis than in the control group; however, the difference was not significant. No severe adverse events were observed in either group.CONCLUSIONS:Apheresis was well tolerated as maintenance therapy for UC although the cumulative clinical remission rate at 12 months was comparable between the apheresis and control groups. |
| DOI | 10.1007/s00535-019-01651-0 |
| PMID | 31811562 |