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撤回:非溃疡性消化不良的药物干预措施。

WITHDRAWN: Pharmacological interventions for non-ulcer dyspepsia.

作者信息

Moayyedi Paul, Shelly Soo, Deeks Jonathan J, Delaney Brendan, Innes Michael, Forman David

机构信息

Department of Medicine, Division of Gastroenterology, McMaster University, 1200 Main Street West, Room 4W8E, Hamilton, Ontario, Canada, L8N 3Z5.

出版信息

Cochrane Database Syst Rev. 2011 Feb 16;2011(2):CD001960. doi: 10.1002/14651858.CD001960.pub4.

DOI:10.1002/14651858.CD001960.pub4
PMID:21328253
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10734254/
Abstract

BACKGROUND

The commonest cause of upper gastrointestinal symptoms is non-ulcer dyspepsia (NUD) and yet the pathophysiology of this condition has been poorly characterised and the optimum treatment is uncertain. It is estimated that £450 million is spent on dyspepsia drugs in the UK each year.

OBJECTIVES

This review aims to determine the effectiveness of six classes of drugs (antacids, histamine H2 antagonists, proton pump inhibitors, prokinetics, mucosal protecting agents and antimuscarinics) in the improvement of either the individual or global dyspepsia symptom scores and also quality of life scores patients with non-ulcer dyspepsia.

SEARCH STRATEGY

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2005), MEDLINE (1966 to January 2006), EMBASE (1988 to January 2006), CINAHL (1982 to January 2006), SIGLE, and reference lists of articles. We also contacted experts in the field and pharmaceutical companies. Trials were located through electronic searches of the Cochrane Controlled Trials Register (CCTR), MEDLINE, EMBASE, CINAHL and SIGLE, using appropriate subject headings and text words, searching bibliographies of retrieved articles, and through contacts with experts in the fields of dyspepsia and pharmaceutical companies.

SELECTION CRITERIA

All randomised controlled trials (RCTs) comparing drugs of any of the six groups with each other or with placebo for non-ulcer dyspepsia (NUD).

DATA COLLECTION AND ANALYSIS

Two review authors independently assessed eligibility, trial quality and extracted data.

MAIN RESULTS

We included 73 trials: prokinetics (19 trials with dichotomous outcomes evaluating 3178 participants; relative risk reduction (RRR) 33%; 95% confidence intervals (CI) 18% to 45%), H(2)RAs (12 trials evaluating 2,183 participants; RRR 23%; 95% CI 8% to 35%) and PPIs (10 trials evaluating 3,347 participants; RRR 13%; 95% CI 4% to 20%) were significantly more effective than placebo. Bismuth salts (six trials evaluating 311 participants; RRR 40%; 95% CI -3 to 65%) were superior to placebo but this was of marginal statistical significance. Antacids (one trial evaluating 109 participants; RRR -2%; 95% CI -36% to 24%) and sucralfate (two trials evaluating 246 participants; RRR 29%; 95% CI -40% to 64%) were not statistically significantly superior to placebo. A funnel plot suggested that the prokinetic results could be due to publication bias or other small study effects.

AUTHORS' CONCLUSIONS: There is evidence that anti-secretory therapy may be effective in NUD. The trials evaluating prokinetic therapy are difficult to interpret as the meta-analysis result could have been due to publication bias. The effect of these drugs is likely to be small and many patients will need to take them on a long-term basis so economic analyses would be helpful and ideally the therapies assessed need to be inexpensive and well tolerated.

摘要

背景

上消化道症状最常见的病因是非溃疡性消化不良(NUD),然而这种病症的病理生理学特征尚不明确,最佳治疗方法也不确定。据估计,英国每年在消化不良药物上的花费为4.5亿英镑。

目的

本综述旨在确定六类药物(抗酸剂、组胺H2拮抗剂、质子泵抑制剂、促动力药、黏膜保护剂和抗胆碱能药)在改善非溃疡性消化不良患者的个体或整体消化不良症状评分以及生活质量评分方面的有效性。

检索策略

我们检索了Cochrane对照试验中心注册库(CENTRAL)(《Cochrane图书馆》2005年第4期)、MEDLINE(1966年至2006年1月)、EMBASE(1988年至2006年1月)、CINAHL(1982年至2006年1月)、SIGLE以及文章的参考文献列表。我们还联系了该领域的专家和制药公司。通过使用适当的主题词和文本词对Cochrane对照试验注册库(CCTR)、MEDLINE、EMBASE、CINAHL和SIGLE进行电子检索、检索所获文章的参考文献以及与消化不良领域的专家和制药公司联系来查找试验。

入选标准

所有比较六组中任何一组药物与其他药物或安慰剂治疗非溃疡性消化不良(NUD)的随机对照试验(RCT)。

数据收集与分析

两位综述作者独立评估入选资格、试验质量并提取数据。

主要结果

我们纳入了73项试验:促动力药(19项试验,二分法结局,评估3178名参与者;相对危险度降低(RRR)为33%;95%置信区间(CI)为18%至45%)、H2受体拮抗剂(12项试验,评估2183名参与者;RRR为23%;95%CI为8%至35%)和质子泵抑制剂(10项试验,评估3347名参与者;RRR为13%;95%CI为4%至20%)比安慰剂显著更有效。铋盐(6项试验,评估311名参与者;RRR为40%;95%CI为 -3%至65%)优于安慰剂,但这仅具有边际统计学意义。抗酸剂(1项试验,评估109名参与者;RRR为 -2%;95%CI为 -36%至24%)和硫糖铝(2项试验,评估246名参与者;RRR为29%;95%CI为 -40%至64%)在统计学上并不显著优于安慰剂。漏斗图表明促动力药的结果可能是由于发表偏倚或其他小研究效应。

作者结论

有证据表明抗分泌治疗可能对非溃疡性消化不良有效。评估促动力治疗的试验难以解读,因为荟萃分析结果可能是由于发表偏倚。这些药物的效果可能较小,许多患者需要长期服用,因此经济分析将有所帮助,理想情况下所评估的治疗方法应价格低廉且耐受性良好。

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