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多化合物营养配方对有症状非复杂憩室病患者的疗效。

Performance of a multicompounds nutraceutical formulation in patients with symptomatic uncomplicated diverticular disease.

机构信息

Division of Internal Medicine and Gastroenterology, Cristo Re Hospital, Rome, Italy.

Section of Human Health, Department of Human Health and Exercise Sciences, Foro Italico University, Rome, Italy.

出版信息

Minerva Gastroenterol (Torino). 2022 Jun;68(2):216-222. doi: 10.23736/S2724-5985.22.03132-1. Epub 2022 Mar 8.

Abstract

BACKGROUND

Symptomatic uncomplicated diverticular disease (SUDD) is a recognized clinical condition characterized by abdominal pain and changes in bowel habits, attributed to diverticula but without macroscopic signs of diverticulitis. There is no consensus about the management of these patients. Enteroflegin, an association of natural active ingredients, could be effective in the treatment of those patients.

METHODS

We conducted a retrospective observational study to evaluate the performances of Enteroflegin in patients with SUDD. Patients were treated with Enteroflegin 2 cp/day for 10 days per month for 6 months. Primary endpoint was the clinical remission rate, defined as the absence of any symptoms; secondary endpoints were the impact of the treatment on reduction of symptoms, on fecal calprotectin (FC) expression, and the prevention of acute diverticulitis.

RESULTS

Three hundred and fifty patients were retrospectively enrolled (183 males, median age 64 years, IQR 54-70). Enteroflegin was effective in inducing remission in 9.34% and 17.64% of patients at 3 and 6 months respectively (P<0.001). Reduction of symptoms occurred in 92.3% and in 85.3% of patients at 3 and 6 months respectively (P<0.001), and symptoms' recurrence or worsening was recorded in only 1.71% of patients during the follow-up. FC expression dropped from 181.3 μg/g at baseline to 100.2 μg/g (P<0.001) and to 67.9 μg/g (P<0.001) at 3 and 6 months of follow-up respectively. No adverse event was recorded during the follow-up. Finally, acute diverticulitis occurred in just 2% of patients during the follow-up.

CONCLUSIONS

Enteroflegin seems to be an effective nutraceutical compound in obtaining remission and symptom relief in SUDD patients. Further randomized, placebo-controlled clinical trials are needed to confirm these preliminary data.

摘要

背景

有症状但不复杂的憩室疾病(SUDD)是一种公认的临床病症,其特征为腹痛和排便习惯改变,归因于憩室,但无憩室炎的宏观征象。目前,对于这些患者的治疗尚无共识。Enteroflegin 是一种天然活性成分的混合物,可能对这些患者的治疗有效。

方法

我们进行了一项回顾性观察性研究,以评估 Enteroflegin 在 SUDD 患者中的疗效。患者每月用 Enteroflegin 治疗 10 天,每天 2 次,持续 6 个月。主要终点为临床缓解率,定义为无任何症状;次要终点为治疗对减轻症状、粪便钙卫蛋白(FC)表达的影响,以及预防急性憩室炎的影响。

结果

共回顾性纳入 350 例患者(183 例男性,中位年龄 64 岁,IQR 54-70)。Enteroflegin 在 3 个月和 6 个月时分别使 9.34%和 17.64%的患者获得缓解(P<0.001)。症状缓解分别发生在 92.3%和 85.3%的患者中(P<0.001),在随访期间仅有 1.71%的患者出现症状复发或加重。FC 表达从基线时的 181.3μg/g 降至 3 个月时的 100.2μg/g(P<0.001)和 6 个月时的 67.9μg/g(P<0.001)。在随访期间未记录到任何不良事件。最后,在随访期间仅有 2%的患者发生急性憩室炎。

结论

Enteroflegin 似乎是一种有效的营养保健品,可使 SUDD 患者获得缓解并减轻症状。需要进一步进行随机、安慰剂对照的临床试验来证实这些初步数据。

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