Florent C, Cortot A, Quandale P, Sahmound T, Modigliani R, Sarfaty E, Valleur P, Dupas J L, Daurat M, Faucheron J L, Lerebours E, Michot F, Belaiche J, Jacquet N, Soulé J C, Rothman N, Gendre J P, Malafosse M
Division of Gastroenterology and Surgery, University of Paris, Saint-Antoine Hospital, France.
Eur J Gastroenterol Hepatol. 1996 Mar;8(3):229-33. doi: 10.1097/00042737-199603000-00008.
Endoscopic postoperative recurrences occur early after 'curative' surgery for Crohn's disease. Pentasa has been shown to be effective in the maintenance treatment of quiescent Crohn's disease. The aim of this study was to test the efficacy of a 12-week oral intake of Claversal in the prevention of endoscopic recurrences after 'curative' resection for ileal, colonic or ileocolonic Crohn's disease. We conducted a multicentre double-blind controlled trial comparing Claversal (1g tid) with placebo, starting within 15 days after surgery. The macroscopic normality of the two anastomotic segments was assessed at surgery. Patients were clinically and biologically evaluated twice (6-week interval), and colonoscopy was performed at 12 weeks. Endoscopic relapse was defined by any anastomotic ulcerations or stenosis and staged according to a four-grade score.
Between May 1989 and May 1991 12 centres included 126 patients, 70 women and 56 men, aged 33 +/- 12 years (range 16-70) in the study. Disease locations were ileal, colonic and ileocolonic in 45, 6 and 49%, respectively. Claversal and placebo groups were similar at inclusion, except for ESR (37 +/- 26 vs. 27 +/- 23 mm/h in the Claversal and placebo groups, respectively; P < 0.05). Nine patients were withdrawn from the study. Adverse reactions occurred only in six patients. Five patients were excluded for protocol violation. Finally, 106 patients could be evaluated at 12 weeks (55 Claversal and 51 placebo). An endoscopic relapse was observed in 50% and 63% of the Claversal and placebo groups, respectively (P = 0.16), with a similar grade distribution. Claversal was well tolerated.
Our study confirms that a large proportion of endoscopic recurrences occur within 3 months of resection in Crohn's disease. There was a slight trend towards greater efficacy of Claversal; it could be worthwhile trying higher dosages and/or 5-ASA compounds with different intestinal release profiles.
克罗恩病“根治性”手术后内镜下复发出现较早。已证明颇得斯安在静止期克罗恩病的维持治疗中有效。本研究的目的是测试口服克拉维酸12周预防回肠、结肠或回结肠克罗恩病“根治性”切除术后内镜复发的疗效。我们进行了一项多中心双盲对照试验，比较克拉维酸（1克，每日三次）与安慰剂，于术后15天内开始。手术时评估两个吻合段的宏观正常情况。对患者进行两次临床和生物学评估（间隔6周），并在12周时进行结肠镜检查。内镜复发定义为任何吻合口溃疡或狭窄，并根据四级评分进行分期。
1989年5月至1991年5月，12个中心纳入了126例患者，其中70例女性和56例男性，年龄33±12岁（范围16 - 70岁）参与本研究。疾病部位分别为回肠、结肠和回结肠的占45%、6%和49%。克拉维酸组和安慰剂组在纳入时相似，除了血沉（克拉维酸组和安慰剂组分别为37±26与27±23毫米/小时；P < 0.05）。9例患者退出研究。仅6例患者出现不良反应。5例患者因违反方案被排除。最后，106例患者在12周时可进行评估（55例克拉维酸组和51例安慰剂组）。克拉维酸组和安慰剂组分别有50%和63%观察到内镜复发（P = 0.16），分级分布相似。克拉维酸耐受性良好。
我们的研究证实，克罗恩病切除术后很大一部分内镜复发发生在3个月内。克拉维酸有稍大疗效的轻微趋势；尝试更高剂量和/或具有不同肠道释放特性的5 - 氨基水杨酸化合物可能是值得的。
