Efficacy of granulocyte and monocyte apheresis for antibiotic-refractory pouchitis after proctocolectomy for ulcerative colitis: an open-label, prospective, multicentre study.
Efficacy of granulocyte and monocyte apheresis for antibiotic-refractory pouchitis after proctocolectomy for ulcerative colitis: an open-label, prospective, multicentre study.
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DOI：
10.1177/1756283x16679348
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发表时间：
2017-02
影响因子：
4.2
通讯作者：
Watanabe T
中科院分区：
文献类型：
--
作者：
Yamamoto T;Tanaka T;Yokoyama T;Shimoyama T;Ikeuchi H;Uchino M;Watanabe T
粒细胞和单核细胞单采术（GMA）已显示出对活动性溃疡性结肠炎（UC）的治疗效果。我们认为，对于UC患者行直肠结肠切除术后发生的结肠袋炎，GMA可能会对肠粘膜产生免疫作用，从而改善临床症状。本前瞻性研究旨在评价GMA治疗UC患者行直肠结肠切除术后难治性结肠袋炎的疗效。共纳入13例结肠袋炎疾病活动指数（PDAI）> 7对2周抗生素治疗无反应的患者。所有患者在连续5周内接受10次GMA治疗，每周2次。主要终点是反应（PDAI降低0.03分）和缓解（PDAI < 4）。次要终点包括白色血细胞（WBC）、C反应蛋白（CRP）、粪便标志物（钙卫蛋白和乳铁蛋白）的减少、PDAI内镜分项评分的减少和GMA安全性。中位PDAI评分从入组时的11（范围，9-15）显著降低至GMA治疗后的9（范围，6-13）（p = 0.02）。共有6名患者（46%）对治疗有反应，但没有一名患者获得缓解。入组时的中位内镜分项评分（最大值：6）为5（范围：4-6），治疗后为5（范围：1-6）（p = 0.10）。治疗期间，实验室标志物（WBC、CRP、粪便钙卫蛋白和乳铁蛋白）均无显著变化。在2例患者（15%）中观察到一过性不良事件（AE），1例呼吸困难，1例头痛。AE均不严重，所有患者均完成了10次GMA治疗。GMA具有良好的安全性，但其疗效似乎是有限的慢性难治性结肠袋炎的管理。然而，应该进行一项大型对照研究，以评估GMA治疗在早期临床阶段的结肠袋炎患者中的疗效，在疾病变得难以接受常规药物治疗之前。
Granulocyte and monocyte apheresis (GMA) has shown therapeutic efficacy in active ulcerative colitis (UC). We thought that in patients with pouchitis after proctocolectomy for UC, GMA might produce immunological effects in the intestinal mucosa, and improve clinical symptoms. This prospective study was to evaluate the efficacy of GMA for antibiotic-refractory pouchitis after proctocolectomy for UC. A total of 13 patients with pouchitis disease activity index (PDAI) > 7 unresponsive to 2 weeks of antibiotic therapy were included. All patients received 10 GMA sessions at 2 sessions/week over 5 consecutive weeks. The primary endpoints were response (a decrease of ⩾3 points in the PDAI) and remission (PDAI < 4). Secondary endpoints included reduction of white blood cells (WBCs), C-reactive protein (CRP), faecal markers (calprotectin and lactoferrin), reduction of the PDAI endoscopic subscore, and GMA safety. The median PDAI score was significantly decreased from 11 (range, 9–15) at entry to 9 (range, 6–13) after the GMA therapy (p = 0.02). A total of six patients (46%) responded to the treatment, but none achieved remission. The median endoscopic subscore (maximum: 6) was 5 (range, 4–6) at entry and 5 (range, 1–6) after the treatment (p = 0.10). None of the laboratory markers (WBCs, CRP, faecal calprotectin and lactoferrin) significantly changed during the treatment. Transient adverse events (AEs) were observed in two patients (15%), dyspnoea in one and headache in one. The AEs were not serious, and all patients completed the 10 GMA sessions. GMA has a good safety profile, but its efficacy appears to be limited in the management of chronic refractory pouchitis. However, a large controlled study should be conducted to evaluate the efficacy of GMA therapy in patients with pouchitis at an earlier clinical stage, before the disease has become refractory to conventional medical therapy.