An Open-Label Prospective Randomized Multicenter Study Shows Very Rapid Remission of Ulcerative Colitis by Intensive Granulocyte and Monocyte Adsorptive Apheresis as Compared With Routine Weekly Treatment
An Open-Label Prospective Randomized Multicenter Study Shows Very Rapid Remission of Ulcerative Colitis by Intensive Granulocyte and Monocyte Adsorptive Apheresis as Compared With Routine Weekly Treatment
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DOI：
10.1038/ajg.2009.453
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发表时间：
2009-12-01
影响因子：
9.8
通讯作者：
Hibi, Toshifumi
中科院分区：
文献类型：
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作者：
Sakuraba, Atsushi;Motoya, Satoshi;Hibi, Toshifumi
目的：粒细胞和单核细胞吸附分离术（GMA）已在活动性溃疡性结肠炎（UC）患者中显示出疗效。然而，如果每周进行常规治疗，可能需要几周的时间才能达到缓解，并且迄今为止，更频繁的治疗方案的疗效仍然未知。本研究的目的是评估强化 GMA 治疗对活动性 UC 患者的临床疗效和安全性。 方法：这是一项开放标签、前瞻性、随机多中心研究，旨在比较每周两次 GMA 强化治疗与每周一次 GMA 常规治疗。共有 163 名轻至中度活动性 UC 患者被随机分配接受每周常规治疗或强化治疗。允许的 GMA 最大次数为 10 次。然而，当患者获得缓解时，GMA 就会停止。研究结束时对两组的缓解率、缓解时间和不良事件进行评估。结果：在 163 名患者中，149 名患者可按照方案进行疗效分析，76 名患者接受每周 GMA，73 名患者接受强化 GMA。研究结束时，每周 GMA 治疗的 76 名患者中有 41 名 (54.0%) 获得临床缓解，强化 GMA 治疗的 73 名患者中有 52 名 (71.2%) 获得临床缓解 (P=0.029)。每周 GMA 治疗组的平均缓解时间为 28.1 +/- 16.9 天，强化 GMA 组的平均缓解时间为 14.9 +/- 9.5 天（P
OBJECTIVES: Granulocyte and monocyte adsorptive apheresis (GMA) has shown efficacy in patients with active ulcerative colitis (UC). However, with routine weekly treatment, it may take several weeks to achieve remission, and to date, the efficacy of a more frequent treatment schedule remains unknown. The aim of this study was to assess the clinical efficacy and safety of intensive GMA treatment in patients with active UC.METHODS: This was an open-label, prospective, randomized multicenter study to compare an intensive, two GMA sessions per week, with the routine, one GMA session per week. A total of 163 patients with mild-to-moderately active UC were randomly assigned to routine weekly treatment or intensive treatment. The maximum number of sessions of GMA permitted was 10. However, when patients achieved remission, GMA was discontinued. Remission rate at the end of the study, time to remission, and adverse events were assessed in both groups.RESULTS: Of the 163 patients, 149 were available for efficacy analysis as per protocol, 76 were in weekly GMA, and 73 were in intensive GMA. At the end of the study period, clinical remission was achieved in 41 of 76 patients (54.0%) in weekly GMA and in 52 of 73 patients (71.2%) in intensive GMA (P=0.029). The mean time to remission was 28.1 +/- 16.9 days in the weekly GMA treatment group and 14.9 +/- 9.5 days in the intensive GMA group (P