Fukushima Kouhei, Sugita Akira, Futami Kitaro, Takahashi Ken-Ichi, Motoya Satoshi, Kimura Hideaki, Yoshikawa Shusaku, Kinouchi Yoshitaka, Iijima Hideki, Endo Katsuya, Hibi Toshihumi, Watanabe Mamoru, Sasaki Iwao, Suzuki Yasuo
Surgical Research Group, the Research Comittee of Inflammatory Bowel Disease, the Ministry of Health, Welfare and Labor of Japan, Tokyo, Japan.
Surg Today. 2018 Jun;48(6):584-590. doi: 10.1007/s00595-018-1627-x. Epub 2018 Jan 30.
The prevention of postoperative recurrence is a critical issue in surgery for Crohn's disease. Prospective randomized trials in Western countries have shown that the postoperative use of anti-tumor necrosis factor α-antibodies was effective in reducing the recurrence rate. We investigated the efficacy of infliximab (IFX) for the prevention of postoperative Crohn's disease recurrence.
We performed a prospective randomized multicenter study. Patients who underwent intestinal resection were assigned to groups treated with or without IFX. Immediately after surgery, patients in the IFX group received IFX at 5 mg/kg at 0, 2, and 6 weeks, followed by every 8 weeks for 2 years. The primary study outcome was the proportion of patients with endoscopic and/or clinical recurrence at 2 years after surgery.
Thirty-eight eligible patients participated in this study: 19 in the IFX group and 19 in the non-IFX group. The disease recurrence rate in the IFX group was 52.6% (10/19), which was significantly lower than that in the non-IFX group (94.7% [18/19]).
The postoperative use of IFX is effective in preventing Crohn's disease recurrence for 2 years.
预防术后复发是克罗恩病手术中的关键问题。西方国家的前瞻性随机试验表明，术后使用抗肿瘤坏死因子α抗体可有效降低复发率。我们研究了英夫利昔单抗（IFX）预防克罗恩病术后复发的疗效。
我们进行了一项前瞻性随机多中心研究。接受肠道切除术的患者被分为接受或不接受IFX治疗的组。术后立即，IFX组患者在第0、2和6周接受5mg/kg的IFX治疗，随后每8周一次，持续2年。主要研究结果是术后2年出现内镜和/或临床复发的患者比例。
38名符合条件的患者参与了本研究：IFX组19名，非IFX组19名。IFX组的疾病复发率为52.6%（10/19），显著低于非IFX组（94.7%[18/19]）。
术后使用IFX可有效预防克罗恩病复发2年。
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