University of Zaragoza Medical School, Aragn Health Research Institute (IIS Aragn), CIBERehd, Zaragoza, Spain.
Drugs R D. 2011 Sep 1;11(3):277-88. doi: 10.2165/11593880-000000000-00000.
Acetylsalicylic acid (ASA [aspirin]) is a commonly used over-the-counter drug for the treatment of pain, fever, or colds, but data on the safety of this use are very limited. The aim of this study was to provide data on the safety of this treatment pattern, which is of interest to clinicians, regulators, and the public.
A meta-analysis of individual patient data from 67 studies sponsored by Bayer HealthCare was completed. The primary endpoints were patient-reported gastrointestinal (GI) adverse events (AEs); the secondary endpoints were the incidence of patient-reported non-GI AEs. Event incidence and odds ratios (ORs) based on Cochran-Mantel-Haenszel estimates are reported. In total, 6181 patients were treated with ASA, 3515 with placebo, 1145 with acetaminophen (paracetamol), and 754 with ibuprofen. Exposure to ASA was short term (82.5% of patients had a single dose).
GI AEs were more frequent with ASA (9.9%) than with placebo (9.0%).[OR 1.3; 95% CI 1.1, 1.5]. Dyspeptic symptoms were infrequent (4.6% in placebo subjects). The ORs for ASA were 1.3 (95% CI 1.1, 1.6) versus placebo; 1.55 (95% CI 0.7, 3.3) versus ibuprofen; and 1.04 (95% CI 0.8, 1.4) versus acetaminophen. There were very few serious GI AEs (one ASA case; three placebo cases). No differences were found for non-GI AEs and no cases of cerebral hemorrhage were reported.
Short-term, mostly single-dose exposure to ASA for the treatment of pain, fever, or colds was associated with a small but significant increase in the risk of dyspepsia relative to placebo. No serious GI complications were reported.
乙酰水杨酸（ASA[阿司匹林]）是一种常用的非处方药物，用于治疗疼痛、发热或感冒，但关于这种用途的安全性数据非常有限。本研究的目的是提供有关这种治疗模式安全性的数据，这是临床医生、监管机构和公众感兴趣的问题。
对拜耳医疗保健公司赞助的 67 项研究的个体患者数据进行了荟萃分析。主要终点是患者报告的胃肠道（GI）不良事件（AE）；次要终点是患者报告的非 GI AE 的发生率。报告了基于 Cochran-Mantel-Haenszel 估计的事件发生率和比值比（OR）。共有 6181 名患者接受 ASA 治疗，3515 名患者接受安慰剂治疗，1145 名患者接受对乙酰氨基酚（扑热息痛）治疗，754 名患者接受布洛芬治疗。ASA 的暴露时间较短（82.5%的患者单次剂量）。
ASA 组的 GI AE 发生率（9.9%）高于安慰剂组（9.0%）。[OR 1.3；95% CI 1.1, 1.5]。消化不良症状不常见（安慰剂组 4.6%）。ASA 的 OR 为 1.3（95% CI 1.1, 1.6）与安慰剂相比；1.55（95% CI 0.7, 3.3）与布洛芬相比；1.04（95% CI 0.8, 1.4）与对乙酰氨基酚相比。仅有极少数严重的 GI AE（ASA 一例；安慰剂三例）。未发现非 GI AE 差异，也未报告脑出血病例。
短期、主要为单次剂量的 ASA 治疗疼痛、发热或感冒与安慰剂相比，消化不良风险略有增加，但具有统计学意义。未报告严重的 GI 并发症。
