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随机双盲安慰剂对照研究评价长程美沙拉嗪对感染后腹泻型肠易激综合征的疗效。

Randomized double-blind placebo-controlled study to evaluate the effect of long-acting mesalamine on postinfectious irritable bowel syndrome with diarrhea.

机构信息

George E. Whalen Veterans Affairs Medical Center, Salt Lake City, Utah, USA.

Divisions of Gastroenterology, University of Utah, Salt Lake City, Utah, USA.

出版信息

Neurogastroenterol Motil. 2024 Oct;36(10):e14889. doi: 10.1111/nmo.14889. Epub 2024 Aug 5.

DOI:10.1111/nmo.14889
PMID:39104061
Abstract

BACKGROUND

A subset of patients with irritable bowel syndrome (IBS) develop their symptoms after gastroenteritis, referred to as postinfectious IBS (PI-IBS). PI-IBS is associated with low-grade intestinal inflammation. Previous studies have evaluated mesalamine, an anti-inflammatory drug, in patients with IBS. We evaluated the efficacy of long-acting mesalamine in patients with PI-IBS.

METHODS

Sixty-one patients who developed diarrhea-predominant IBS (IBS-D) after gastroenteritis were randomized to receive either 2.4 g of long-acting mesalamine or placebo daily for 8-weeks. The symptoms assessed were abdominal pain, bloating, stool frequency, stool consistency, severity of diarrhea and constipation, satisfaction with bowel habits, and IBS affecting or interfering with life. Quality-of-life (QOL) was assessed using the IBS-QOL questionnaire. The prespecified primary outcome variable was the overall bowel symptom score (BSS) after 8-weeks of treatment. Effect sizes were expressed as standardized mean differences (Cohen's d).

RESULTS

Fifty-four patients completed the 8-week treatment (n = 28 mesalamine, n = 26 placebo), 49 (91%) were male, and age range 23-71 years (mean ± SD 43 ± 13). Mesalamine demonstrated superior efficacy compared to placebo on the primary outcome variable, overall BSS (Cohen's d = 0.57, p = 0.042). Mesalamine was also superior for the secondary outcome of how much IBS affects your life in general (d = 0.72, p = 0.01). For the secondary outcomes of IBS symptoms, 7 of the 7 symptoms had trends of mesalamine superiority. For the secondary outcomes of IBS-QOL subscales, 8 of 9 had trends of mesalamine superiority.

CONCLUSION

In patients with PI-IBS, long-acting mesalamine demonstrated to be effective in reducing IBS symptoms and improving QOL.

摘要

背景

一部分肠易激综合征(IBS)患者在肠胃炎后出现症状,称为感染后肠易激综合征(PI-IBS)。PI-IBS 与低度肠道炎症有关。先前的研究评估了用于 IBS 患者的抗炎药美沙拉嗪。我们评估了长效美沙拉嗪在 PI-IBS 患者中的疗效。

方法

61 名在肠胃炎后出现腹泻型 IBS(IBS-D)的患者被随机分配每日接受 2.4g 长效美沙拉嗪或安慰剂治疗 8 周。评估的症状包括腹痛、腹胀、排便频率、粪便稠度、腹泻和便秘严重程度、对排便习惯的满意度以及 IBS 对生活的影响或干扰。使用 IBS-QOL 问卷评估生活质量(QOL)。主要预设结局变量是治疗 8 周后的整体肠症状评分(BSS)。效应大小用标准化均数差(Cohen's d)表示。

结果

54 名患者完成了 8 周的治疗(n=28 名美沙拉嗪,n=26 名安慰剂),49 名(91%)为男性,年龄 23-71 岁(平均±SD 43±13)。与安慰剂相比,美沙拉嗪在主要结局变量,即整体 BSS(Cohen's d=0.57,p=0.042)上显示出更好的疗效。美沙拉嗪在一般而言 IBS 对生活的影响(d=0.72,p=0.01)这一次要结局上也更优。在次要结局 IBS 症状方面,7 种症状有美沙拉嗪优势的趋势。在次要结局 IBS-QOL 亚量表方面,8 种中有美沙拉嗪优势的趋势。

结论

在 PI-IBS 患者中,长效美沙拉嗪在减轻 IBS 症状和改善 QOL 方面表现出疗效。

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