Polymeric diet alone versus corticosteroids in the treatment of active pediatric Crohn's disease: A randomized controlled open-label trial
Polymeric diet alone versus corticosteroids in the treatment of active pediatric Crohn's disease: A randomized controlled open-label trial
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DOI：
10.1016/j.cgh.2006.03.010
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发表时间：
2006-06-01
影响因子：
12.6
通讯作者：
Cucchiara, Salvatore
中科院分区：
文献类型：
--
作者：
Borrelli, Osvaldo;Cordischi, Letizia;Cucchiara, Salvatore
背景和目标：据报道，营养治疗在实现活动性克罗恩病（CD）临床缓解方面与皮质类固醇几乎具有等同的疗效。然而，这两种治疗对肠粘膜炎症的影响很少报道。在一项针对活动性CD儿童的随机对照试验中，我们比较了单独营养治疗或皮质类固醇对临床变量和肠粘膜愈合的疗效。研究方法：在一项为期10周的前瞻性开放标签试验中，患有活动性初治CD的儿童随机接受单独口服聚合物配方或口服皮质类固醇。在第0周评价临床活动指数和营养及活动血清变量，然后每2周评价一次;在第0周和第10周通过内镜检查和组织学评估肠粘膜炎症。主要疗效结局为临床缓解和粘膜愈合。结果：在37名随机化的儿童中，1.9名接受聚合物配方奶粉，18名接受皮质类固醇。在第10周，基于意向治疗，两组之间达到临床缓解的患者比例相当（聚合公式：15/19 [79%; 95%置信区间（CI），56%-92%];皮质类固醇组：12/18 [67%; 95% CI，44%-84%]; P = 0.4;不显著）。相反，聚合物组显示粘膜愈合的儿童比例（14/19; 74%; 95%CI，51%-89%）显著高于皮质类固醇组（6/18 [33%; 95%CI，16%-57%]; P <0.05）。在第10周，内镜和组织学评分仅在聚合物组中显著降低（P <0.001）。结论：在活动期和近期诊断的CD患儿中，短期聚合物饮食在诱导肠道炎性病变愈合方面比皮质类固醇更有效。
Background & Aims: Nutritional therapy has been reported to have an almost equivalent efficacy of corticosteroids in achieving clinical remission in active Crohn's disease (CD). However, the effects of both treatments on intestinal mucosal inflammation rarely are reported. In a randomized controlled trial in children with active CD we compared the efficacy of nutritional therapy alone or corticosteroids on clinical variables and intestinal mucosal healing. Methods: In a prospective, 10-week open-label trial, children with active, naive CD were randomized to orally polymeric formula alone or oral corticosteroids. The clinical activity index and nutritional and activity serum variables were evaluated at week 0 and then every 2 weeks; intestinal mucosal inflammation was assessed through endoscopy and histology at weeks 0 and 10. Primary efficacy outcomes were clinical remission and mucosal healing. Results: Of the 37 children randomized, 1.9 received polymeric formula and 18 received corticosteroids. At week 10, on an intention-to-treat basis, the proportion of patients achieving clinical remission was comparable between the 2 groups (polymeric formula: 15/19 [79%; 95% confidence interval (CI), 56%-92%]; corticosteroid group: 12/18 [67%; 95% CI, 44%-84%]; P = .4; not significant). On the contrary, the proportion of children showing mucosa healing was significantly higher in the polymeric (14/19; 74%; 95% CI, 51%-89%) than the corticosteroid group (6/18 [33%; 95% CI, 16%-57%]; P < .05). At week 10 both endoscopic and histologic scores significantly decreased only in the polymeric group (P < .001). Conclusions: In children with active and recently diagnosed CD, a short course of polymeric diet is more effective than corticosteroids in inducing healing of gut inflammatory lesions.