共 50 条
Efficacy of apheresis as maintenance therapy for patients with ulcerative colitis in an open-label prospective multicenter randomised controlled trial
被引:20
作者:
Naganuma, Makoto
[1
]
Yokoyama, Yoko
[2
]
Motoya, Satoshi
[3
]
Watanabe, Kenji
[2
]
Sawada, Koji
[4
]
Hirai, Fumito
[5
]
Yamamoto, Takayuki
[6
]
Hanai, Hiroyuki
[7
]
Omori, Teppei
[8
]
Kanai, Takanori
[1
]
Hibi, Toshifumi
[9
]
机构:
[1] Keio Univ, Sch Med, Dept Internal Med, Div Gastroenterol & Hepatol,Shinjuku Ku, 35 Shinanomachi, Tokyo 1608582, Japan
[2] Hyogo Coll Med, Dept Intestinal Inflammat Res, Nishinomiya, Hyogo, Japan
[3] Sapporo Kosei Gen Hosp, Inflammatory Bowel Dis Ctr, Sapporo, Hokkaido, Japan
[4] Dojima Gen & Gastroenterol Clin, Osaka, Japan
[5] Fukuoka Univ, Chikushi Hosp, Inflammatory Bowel Dis Ctr, Chikushino, Japan
[6] Yokkaichi Hazu Med Ctr, IBD Ctr, Yokaichi, Japan
[7] Hamamatsu South Hosp, IBD Ctr, Hamamatsu, Shizuoka, Japan
[8] Tokyo Womens Med Univ, Inst Gastroenterol & Hepatol, Tokyo, Japan
[9] Kitasato Univ, Kitasato Inst Hosp, Ctr Adv IBD Res & Treatment, Tokyo, Japan
关键词:
Granulocyte and monocyte adsorption apheresis;
Leukocytapheresis ulcerative colitis;
Maintenance therapy;
Endoscopic remission;
DOUBLE-BLIND;
GRANULOCYTE/MONOCYTE APHERESIS;
ADSORPTIVE APHERESIS;
MONOCYTE APHERESIS;
CLINICAL-RESPONSE;
LEUKOCYTAPHERESIS;
REMISSION;
INDUCTION;
OUTCOMES;
INFLIXIMAB;
D O I:
10.1007/s00535-019-01651-0
中图分类号:
R57 [消化系及腹部疾病];
学科分类号:
摘要:
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.
引用
收藏
页码:390 / 400
页数:11
相关论文
共 50 条