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短期使用阿司匹林的胃肠道不良反应:已发表的随机对照试验的荟萃分析。

Gastrointestinal adverse effects of short-term aspirin use: a meta-analysis of published randomized controlled trials.

机构信息

University of North Carolina School of Medicine, Chapel Hill, NC, USA.

出版信息

Drugs R D. 2013 Mar;13(1):9-16. doi: 10.1007/s40268-013-0011-y.

DOI:10.1007/s40268-013-0011-y
PMID:23532576
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3627011/
Abstract

BACKGROUND AND OBJECTIVES

Aspirin is widely used for short-term treatment of pain, fever or colds, but there are only limited data regarding the safety of this use. To summarize the available data on this topic, we conducted a meta-analysis of the published clinical trial literature regarding the gastrointestinal adverse effects of short-term use of aspirin in comparison with placebo and other medications commonly used for the same purpose.

DATA SOURCES AND METHODS

An extensive literature search identified 119,310 articles regarding possible adverse effects of aspirin, among which 23,131 appeared to possibly include relevant data. An automated text-mining procedure was used to score the references for potential relevance for the meta-analysis. The 3,983 highest-scoring articles were reviewed individually to identify those with data that could be included in this analysis. Ultimately, 78 relevant articles were identified that contained gastrointestinal adverse event data from clinical trials of aspirin versus placebo or an active comparator. Odds ratios (ORs) computed using a Mantel-Haenszel estimator were used to summarize the comparative effects on dyspepsia, nausea/vomiting, and abdominal pain, considered separately and also aggregated as 'minor gastrointestinal events'. Gastrointestinal bleeds, ulcers, and perforations were also investigated.

RESULTS

Data were obtained regarding 19,829 subjects (34 % treated with aspirin, 17 % placebo, and 49 % an active comparator). About half of the aspirin subjects took a single dose. Aspirin was associated with a higher risk of minor gastrointestinal events than placebo or active comparators: the summary ORs were 1.46 (95 % confidence interval [CI] 1.15-1.86) and 1.81 (95 % CI 1.61-2.04), respectively. Ulcers, perforation, and serious bleeding were not seen after use of aspirin or any of the other interventions.

CONCLUSIONS

During short-term use, aspirin is associated with a higher frequency of gastrointestinal complaints than other medications commonly used for treatment of pain, colds, and fever. Serious adverse events were not observed with aspirin or any of the comparators.

摘要

背景与目的

阿司匹林被广泛用于短期治疗疼痛、发热或感冒,但关于其短期使用安全性的数据有限。为了汇总这一主题的现有数据,我们对已发表的临床试验文献进行了荟萃分析,比较了短期使用阿司匹林与安慰剂和其他常用于相同目的的药物的胃肠道不良反应。

数据来源与方法

广泛的文献检索确定了 119310 篇关于阿司匹林可能的不良反应的文章,其中 23131 篇似乎包含了相关数据。使用自动文本挖掘程序对参考文献进行评分,以确定是否可能与荟萃分析相关。对得分最高的 3983 篇文章进行了单独审查,以确定那些有可纳入本分析的数据的文章。最终,确定了 78 篇相关文章,这些文章包含了阿司匹林与安慰剂或阳性对照药物的临床试验中胃肠道不良事件的数据。使用 Mantel-Haenszel 估计器计算的比值比(OR)用于分别汇总消化不良、恶心/呕吐和腹痛的比较效果,并将其汇总为“轻微胃肠道事件”。还研究了胃肠道出血、溃疡和穿孔。

结果

共获得了 19829 名受试者的数据(34%接受阿司匹林治疗,17%接受安慰剂治疗,49%接受阳性对照药物治疗)。大约一半的阿司匹林受试者单次给药。与安慰剂或阳性对照药物相比,阿司匹林发生轻微胃肠道事件的风险更高:汇总 OR 分别为 1.46(95%置信区间 [CI] 1.15-1.86)和 1.81(95% CI 1.61-2.04)。使用阿司匹林或任何其他干预措施后未出现溃疡、穿孔和严重出血。

结论

在短期使用期间,与其他常用于治疗疼痛、感冒和发热的药物相比,阿司匹林与胃肠道不适的发生频率更高。阿司匹林或任何对照药物均未观察到严重不良反应。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bd5b/4238116/3b02bd628549/40268_2013_11_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bd5b/4238116/3b02bd628549/40268_2013_11_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bd5b/4238116/3b02bd628549/40268_2013_11_Fig1_HTML.jpg

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