Viscido A, Habib F I, Kohn A, Papi C, Marcheggiano A, Pimpo M T, Vernia P, Cadau G, Caprilli R
GI Unit, Department of Clinical Sciences, University of Rome La Sapienza, Rome, Italy.
Aliment Pharmacol Ther. 2003 May 15;17(10):1263-71. doi: 10.1046/j.1365-2036.2003.01535.x.
To determine the efficacy of infliximab in the treatment of chronic refractory pouchitis complicated by fistulae following ileal pouch-anal anastomosis for ulcerative colitis.
This open study included seven patients (four females, three males) with chronic refractory pouchitis complicated by fistulae. Pouchitis was diagnosed by clinical, endoscopic and histological criteria. The sites of the fistulae were as follows: pouch-bladder in one, vaginal in three, perianal in two, and both vaginal and perianal in one. Extra-intestinal manifestations (erythema nodosum, arthralgia) were present in four patients. Crohn's disease was carefully excluded in all patients after re-evaluation of the history, re-examination of the original proctocolectomy specimen and examination of the proximal small bowel. All patients had been treated with antibiotics and three with steroids. Patients received infliximab, 5 mg/kg, at 0, 2 and 6 weeks. Azathioprine (2.5 mg/kg) was also started for all patients as bridge therapy. Clinical response was classified as complete, partial or no response. Fistulae closure was classified as complete (cessation of fistulae drainage and total closure of all fistulae), partial (a reduction in the number, size, drainage or discomfort associated with fistulae) or no closure. The pouchitis disease activity index and quality of life were also used as outcome measures.
Clinically, all patients improved. At the 10-week follow-up, six of the seven patients had a complete clinical response, and five had complete fistulae closure. At the 10-week follow-up, the median pouchitis disease activity index decreased from 12 (baseline) (range, 10-15) to 5 (range, 3-8); the median quality of life decreased from 37 points (range, 33-40) to 14 (range, 9-18). Erythema nodosum and arthralgia showed complete remission soon after the first infusion of infliximab.
These preliminary results indicate that infliximab may be recommended for the treatment of refractory pouchitis complicated by fistulae following ileal pouch-anal anastomosis for ulcerative colitis.
确定英夫利昔单抗治疗溃疡性结肠炎回肠储袋肛管吻合术后并发瘘管的慢性难治性储袋炎的疗效。
这项开放性研究纳入了7例（4例女性，3例男性）并发瘘管的慢性难治性储袋炎患者。储袋炎根据临床、内镜及组织学标准诊断。瘘管部位如下：1例为储袋-膀胱瘘，3例为阴道瘘，2例为肛周瘘，1例为阴道及肛周瘘。4例患者有肠外表现（结节性红斑、关节痛）。在重新评估病史、重新检查原直肠结肠切除标本及检查近端小肠后，仔细排除了所有患者的克罗恩病。所有患者均接受过抗生素治疗，3例接受过类固醇治疗。患者在第0、2和6周接受5mg/kg英夫利昔单抗治疗。所有患者还开始使用硫唑嘌呤（2.5mg/kg）作为桥接治疗。临床反应分为完全缓解、部分缓解或无反应。瘘管闭合分为完全闭合（瘘管停止引流且所有瘘管完全闭合）、部分闭合（瘘管数量、大小、引流量或相关不适减轻）或未闭合。储袋炎疾病活动指数和生活质量也用作疗效指标。
临床上，所有患者均有改善。在10周随访时，7例患者中有6例获得完全临床缓解，5例瘘管完全闭合。在10周随访时，储袋炎疾病活动指数中位数从12（基线）（范围10 - 15）降至5（范围3 - 8）；生活质量中位数从37分（范围33 - 40）降至14分（范围9 - 18）。结节性红斑和关节痛在首次输注英夫利昔单抗后很快完全缓解。
这些初步结果表明，英夫利昔单抗可推荐用于治疗溃疡性结肠炎回肠储袋肛管吻合术后并发瘘管的难治性储袋炎。
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