Interleukin 10 (Tenovil) in the prevention of postoperative recurrence of Crohn's disease
Interleukin 10 (Tenovil) in the prevention of postoperative recurrence of Crohn's disease
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DOI：
10.1136/gut.49.1.42
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发表时间：
2001-07-01
期刊：
影响因子：
24.5
通讯作者：
Cohard, M
中科院分区：
文献类型：
--
作者：
Colombel, JF;Rutgeerts, P;Cohard, M
背景和目的：克罗恩病的新病变发生在回肠或回结肠切除和回结肠吻合术后的早期。我们进行了一项双盲对照试验，以评估重组人白细胞介素10的安全性和耐受性（IL-10; Tenovil）在克罗恩病手术的受试者中，我们还评估了Tenovil在预防术后12周内镜下复发方面的作用。接受根治性回肠或回结肠切除和一期吻合术的克罗恩病患者在术后2周内随机分配至接受皮下Tenovil 4 μ g/kg每日一次（QD）（n = 22）或8 μ g/kg每周两次（TIW）（n = 21），或安慰剂（QD或TIW）（n = 22）。治疗12周后进行回结肠镜检查。结果-依从性非常好。最常观察到的不良事件的严重程度为轻度和中度，并且在治疗组间均匀分布。合并Tenovil组中的37名患者和合并安慰剂组中的21名患者可通过内窥镜进行评估。在12周时，安慰剂组21例患者中有11例（52%）复发，而Tenovil组37例患者中有17例（46%）复发。严重的内镜下复发的发生率是相似的，在两组（9%）。结论Tenovil治疗连续12周的克罗恩病患者肠切除术后是安全的，耐受性良好。未观察到Tenovil预防克罗恩病内镜复发的证据。
Background and aims-New lesions of Crohn's disease occur early after ileal or ileocolonic resection and ileocolonic anastomosis. We performed a double blind controlled trial to evaluate the safety and tolerance of recombinant human interleukin 10 (IL-10; Tenovil) in subjects operated on for Crohn's disease, We also assessed the effect of Tenovil in preventing endoscopic recurrence 12 weeks after surgery.Methods-Patients with Crohn's disease who underwent curative ileal or ileocolonic resection and primary anastomosis were randomised within two weeks after surgery to receive subcutaneous Tenovil 4 mug/kg once daily (QD) (n=22) or 8 mug/kg twice weekly (TIW) (n=21), or placebo (QD or TIW) (n=22). An ileocolonoscopy was performed after 12 weeks of treatment.Results-Compliance was excellent. The most frequently observed adverse events were mild and moderate in severity and equally distributed across treatment groups. Thirty seven patients in the pooled Tenovil group and 21 patients in the pooled placebo group were evaluable by endoscopy. At 12 weeks, 11 of 21 patients (52%) in the placebo group had recurrent lesions compared with 17 of 37 patients (46%) in the Tenovil group (ns). The incidence of severe endoscopic recurrence was similar in both groups (9%).Conclusion-Tenovil treatment for 12 consecutive weeks in patients with Crohn's disease after intestinal resection was safe and well tolerated. No evidence of prevention of endoscopic recurrence of Crohn's disease by Tenovil was observed.