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法莫替丁治疗慢性有症状胃炎的疗效:来自 FUTURE 研究的亚组分析。

Therapeutic effects of famotidine on chronic symptomatic gastritis: subgroup analysis from FUTURE study.

机构信息

Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan.

出版信息

J Gastroenterol. 2012 Apr;47(4):377-86. doi: 10.1007/s00535-011-0503-x. Epub 2011 Dec 21.

Abstract

BACKGROUND

A therapeutic strategy for symptomatic patients with chronic gastritis has not been established. Gastric acid has been reported to induce a variety of unpleasant abdominal symptoms. We investigated whether the histamine H2 receptor antagonist famotidine attenuated upper abdominal symptoms in patients with chronic gastritis.

METHODS

In this multicenter prospective single-arm open-label study, 10,311 patients with a clinical diagnosis of chronic symptomatic gastritis were enrolled and each patient was administered famotidine at 20 mg/day for 4 weeks. The intensity levels of upper abdominal symptoms, epigastralgia, epigastric fullness, and heartburn were evaluated using a face scale (grade 0-4). Abdominal symptom-related quality of life (QOL) impairment was also evaluated, using an Izumo scale before and after famotidine administration. In a subgroup analysis, symptomatic responses in patients diagnosed with functional dyspepsia (FD) according to the Rome III criteria were analyzed.

RESULTS

In 8,460 patients who completed the protocol, famotidine administration significantly attenuated epigastralgia, epigastric fullness, and heartburn, and famotidine also attenuated abdominal symptom-related QOL impairment in all patients with chronic symptomatic gastritis, in those with FD-like symptoms without organic disease, and in those with FD as defined by the Rome III criteria.

CONCLUSION

Famotidine is effective to relieve abdominal symptoms and improve QOL, not only in patients with Rome III-defined FD, but also in those with chronic symptomatic gastritis.

摘要

背景

目前尚未确立针对慢性胃炎症状患者的治疗策略。据报道,胃酸会引起各种不适的腹部症状。我们研究了组胺 H2 受体拮抗剂法莫替丁是否可以减轻慢性胃炎患者的上腹部症状。

方法

在这项多中心前瞻性单臂开放标签研究中,纳入了 10311 例临床诊断为慢性有症状胃炎的患者,每位患者接受法莫替丁 20mg/天治疗 4 周。使用脸谱量表(0-4 级)评估上腹部症状、上腹痛、上腹饱胀和烧心的严重程度。使用 Izumo 量表评估治疗前后与腹部症状相关的生活质量(QOL)受损情况。在亚组分析中,分析了根据 Rome III 标准诊断为功能性消化不良(FD)的患者的症状反应。

结果

在完成方案的 8460 例患者中,法莫替丁治疗可显著减轻上腹痛、上腹饱胀和烧心,并且可减轻所有慢性有症状胃炎患者、无器质性疾病的 FD 样症状患者以及 Rome III 标准定义的 FD 患者的与腹部症状相关的 QOL 受损。

结论

法莫替丁不仅可有效缓解 FD 患者的腹部症状,还可改善 QOL,而且对 Rome III 标准定义的 FD 患者和慢性有症状胃炎患者均有效。

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