Forder Samantha, Voelker Michael, Lanas Angel
Bayer, Whippany, NJ, USA.
Bayer, Leverkusen, Germany.
Drugs R D. 2016 Sep;16(3):263-269. doi: 10.1007/s40268-016-0138-8.
Aspirin is a commonly used over-the-counter (OTC) agent for the symptomatic treatment of acute pain, fever, or the common cold, but data regarding safety in this context are limited. In order to characterize the safety of aspirin beyond single-dose or long-term use data, we conducted a meta-analysis of multiple-dose, multiple-day studies of OTC aspirin at a label-approved dosage.
We conducted a meta-analysis of individual patient data from three Bayer-sponsored studies. The meta-analysis was performed in 2015; the individual studies were conducted between 2008 and 2012 and were of a randomized, parallel-group, placebo-controlled design. Patients received a minimum dosage of aspirin of 2000 mg/day over at least 3 days. The endpoints were patient-reported adverse events (AEs) with an emphasis on the system organ class gastrointestinal system. Event incidences were estimated and an analysis of the odds ratios (ORs) and risk differences (RDs) of aspirin versus placebo were performed.
Of the 819 patients included, 433 were treated with aspirin and 386 were treated with placebo. The majority of patients (85.7 %) received a median dose of aspirin of 3000 mg/day for 3 days. The incidence of the overall AEs was low and rates were comparable between the aspirin (10.9 %) and placebo (12.4 %) groups [OR: 0.86 (95 % confidence interval [CI] 0.56, 1.34); RD: -1.49 (95 % CI -6.01, 3.03)]. Gastrointestinal AEs were more common in subjects treated with aspirin (7.4 %) than with placebo (5.4 %), and although this difference did not reach statistical significance, a trend towards increased risk was observed with aspirin use [OR: 1.41 (95 % CI 0.78, 2.54); RD: 2.00 (95 % CI -1.35, 5.35)]. Nausea, upper abdominal pain, dyspepsia, and diarrhea were the most frequently reported gastrointestinal AEs. There were no reports of serious gastrointestinal complications such as bleeding, perforation, or ulceration.
The multiple-dose regimen of aspirin used for several days according to the OTC label is well-tolerated by otherwise healthy non-elderly subjects for short-term and symptomatic treatment of pain, fever, and the common cold. There were no reports of serious gastrointestinal complications in either of the groups.
阿司匹林是一种常用的非处方药（OTC），用于急性疼痛、发热或普通感冒的症状治疗，但这方面的安全性数据有限。为了描述超出单剂量或长期使用数据的阿司匹林安全性，我们对按照标签批准剂量进行的多剂量、多日OTC阿司匹林研究进行了荟萃分析。
我们对三项由拜耳公司赞助的研究中的个体患者数据进行了荟萃分析。荟萃分析于2015年进行；个体研究在2008年至2012年之间开展，采用随机、平行组、安慰剂对照设计。患者至少3天内接受最低剂量为2000毫克/天的阿司匹林治疗。终点为患者报告的不良事件（AE），重点是系统器官分类中的胃肠道系统。估计事件发生率，并对阿司匹林与安慰剂的比值比（OR）和风险差异（RD）进行分析。
纳入的819名患者中，433名接受阿司匹林治疗，386名接受安慰剂治疗。大多数患者（85.7%）接受的阿司匹林中位剂量为3000毫克/天，持续3天。总体不良事件发生率较低，阿司匹林组（10.9%）和安慰剂组（12.4%）的发生率相当[OR：0.86（95%置信区间[CI]0.56，1.34）；RD：-1.49（95%CI -6.01，3.03）]。胃肠道不良事件在接受阿司匹林治疗的受试者中（7.4%）比接受安慰剂治疗的受试者中（5.4%）更常见，尽管这种差异未达到统计学显著性，但观察到使用阿司匹林有风险增加的趋势[OR：1.41（95%CI 0.78，2.54）；RD：2.00（95%CI -1.35，5.35）]。恶心、上腹部疼痛、消化不良和腹泻是最常报告的胃肠道不良事件。没有关于严重胃肠道并发症如出血、穿孔或溃疡的报告。
按照OTC标签使用数天的阿司匹林多剂量方案，对于健康的非老年受试者用于疼痛、发热和普通感冒的短期症状治疗耐受性良好。两组均未报告严重胃肠道并发症。
