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随机临床试验:质子泵抑制剂治疗具有糜烂性胃食管反流病重叠症状的功能性消化不良和肠易激综合征患者的症状持续缓解。

Randomised clinical trial: sustained response to PPI treatment of symptoms resembling functional dyspepsia and irritable bowel syndrome in patients suffering from an overlap with erosive gastro-oesophageal reflux disease.

机构信息

Department of Medicine, Martin-Luther-Hospital, Academic Teaching Hospital of Charité Universitätsmedizin, Berlin, Germany.

出版信息

Aliment Pharmacol Ther. 2012 Jun;35(11):1279-89. doi: 10.1111/j.1365-2036.2012.05085.x. Epub 2012 Apr 8.

DOI:10.1111/j.1365-2036.2012.05085.x
PMID:22486552
Abstract

BACKGROUND

Gastro-oesophageal reflux disease (GERD), functional dyspepsia (FD) and irritable bowel syndrome (IBS) are highly prevalent gastrointestinal conditions with accumulating evidence of overlap in patients. Despite availability of a vast body of research related to individual disorders, major pharmacological breakthrough in treatment of the overlap condition is still lacking.

AIM

To assess sustainability of GERD healing and whether known beneficial effects of proton pump inhibitor treatment on GERD also extend to symptoms suggestive of FD and IBS.

METHODS

A total of 626 patients with reflux oesophagitis were treated with pantoprazole for up to 16 weeks depending on healing of GERD, followed by an observational phase of up to 6 months without treatment. Rates of patients suffering from GERD, FD or IBS were assessed at baseline, and at last visits of treatment and observational phase.

RESULTS

Rates of patients with reflux oesophagitis and concomitantly with reflux symptoms, FD or IBS were each significantly lower after pantoprazole treatment (P < 0.0001). While rates of patients with reflux signs or symptoms increased again during observational phase, rates of FD and IBS were maintained at the low level after cessation of medication (P < 0.0001).

CONCLUSIONS

Pantoprazole is efficacious in the treatment of patients suffering from signs and symptoms suggesting an overlap of GERD, FD and/or IBS, providing a sustained response post-treatment in FD and IBS symptom categories. Mechanisms underlying the beneficial effects of improvement in reflux oesophagitis on symptoms suggestive of FD or IBS still need to be determined.

摘要

背景

胃食管反流病(GERD)、功能性消化不良(FD)和肠易激综合征(IBS)是高发的胃肠道疾病,患者中存在重叠的证据不断增加。尽管有大量与单一疾病相关的研究,但治疗重叠疾病的重大药物突破仍未出现。

目的

评估 GERD 愈合的可持续性,以及质子泵抑制剂(PPI)治疗 GERD 的已知有益效果是否也延伸到提示 FD 和 IBS 的症状。

方法

共有 626 例反流性食管炎患者根据 GERD 的愈合情况接受泮托拉唑治疗,最长可达 16 周,然后进行长达 6 个月的无治疗观察期。在基线、治疗结束和观察期最后一次就诊时评估 GERD、FD 或 IBS 患者的发生率。

结果

在泮托拉唑治疗后,患有反流性食管炎且同时伴有反流症状、FD 或 IBS 的患者比例均显著降低(P < 0.0001)。虽然在观察期内,有反流迹象或症状的患者比例再次增加,但在停止用药后,FD 和 IBS 的比例仍保持在较低水平(P < 0.0001)。

结论

泮托拉唑在治疗有 GERD、FD 和/或 IBS 重叠症状的患者中有效,在 FD 和 IBS 症状类别中提供了治疗后的持续反应。改善反流性食管炎对 FD 或 IBS 提示症状的有益效果的机制仍需确定。

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