Profermin is Efficacious in Patients with Active Ulcerative Colitis-A Randomized Controlled Trial
Profermin is Efficacious in Patients with Active Ulcerative Colitis-A Randomized Controlled Trial
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DOI：
10.1097/01.mib.0000437046.26036.db
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发表时间：
2013-11-01
影响因子：
4.9
通讯作者：
Bendtsen, Flemming
中科院分区：
文献类型：
--
作者：
Krag, Aleksander;Munkholm, Pia;Bendtsen, Flemming
背景：Profermin被开发用于溃疡性结肠炎（UC）的饮食管理。它由水、发酵燕麦、大麦芽、卵磷脂和植物乳杆菌299 v组成。本研究的目的是评估Profermin.Methods的临床疗效：74例轻度至中度UC（定义为简单临床结肠炎活动指数[SCCAI]评分5和11）的患者被随机分配到Profermin（n = 32）或Fresubin（n = 41）。主要终点是评估是否除了Profermin在UC可以显着降低SCCAI相比Fresubin.Results：在运行期间，平均SCCAI为7.2 - 1.50在Profermin组和7.6 +/- 1.47在Fresubin组（不显着）。治疗8周后，在意向性治疗分析中，Profermin组SCCAI评分的平均降低更高（平均差异：-1.77 SCCAI，95%置信区间-2.97至-0.55; P < 0.005）。Profermin组32例患者中有10例（31%）和Fresubin组41例患者中有6例（15%）达到缓解（定义为SCCAI 2.5）（P = 0.048）。Profermin组SCCAI评分下降50%的比例较高，32例患者中有17例（53%），而41例患者中有11例（27%）（P = 0.04）。Fresubin组因治疗失败/缺乏效果而退出的风险更高（42%比13%，P = 0.02）。结论：补充Profermin安全、耐受性良好、可口，并且能够降低SCCAI评分在统计学上和临床上显着降低轻至中度UC患者的评分。
Background:Profermin is developed for the dietary management of ulcerative colitis (UC). It consists of water, fermented oats, barley malt, lecithin, and Lactobacillus plantarum 299v. The aim of this study was to assess the clinical efficacy of Profermin.Methods:Seventy-four patients with a mild-to-moderate flare-up of UC (defined as Simple Clinical Colitis Activity Index [SCCAI] score 5 and 11) were randomly assigned to Profermin (n = 32) or Fresubin (n = 41). The primary endpoint was to assess whether addition of Profermin in UC could significantly reduce SCCAI in comparison with Fresubin.Results:In the run-in period, the mean SCCAI was 7.2 1.50 in the Profermin group and 7.6 +/- 1.47 in the Fresubin group (not significant). After 8 weeks of treatment, the mean reduction of SCCAI score was higher in the Profermin group (mean difference: -1.77 SCCAI, 95% confidence interval -2.97 to -0.55; P < 0.005), in intention-to-treat analyses. Remission defined as SCCAI 2.5 was achieved in 10 of 32 (31%) in the Profermin group and in 6 of 41 (15%) in the Fresubin group (P = 0.048). The decrease in SCCAI scores of 50% was higher in the Profermin group 17 of 32 (53%) versus 11 of 41 (27%) (P = 0.04). The risk of dropping out due to treatment failure/lack of effect was higher in the Fresubin group (42% versus 13%, P = 0.02).Conclusions:Supplementation with Profermin is safe, well tolerated, palatable, and able to reduce SCCAI scores at a statistically and clinically significant level in patients with mild-to-moderate UC with a flare-up.