The objective was to compare the incidence of adverse reactions reported with three nonsteroidal anti-inflammatory drugs with different cyclo-oxygenase (COX)-2 selectivity. All spontaneous adverse reaction notifications in the pharmacovigilance database of the World Health Organisation Collaborating Centre for International Drug Monitoring with aceclofenac, meloxicam, and rofecoxib that were recorded during the first year of marketing were included. The incidence rate (adverse reactions/10(6) defined daily dose) and 95% confidence interval for total adverse reactions was 8.7 (6.1-12.0) for aceclofenac, 24.8 (23.1-26.6) for meloxicam, and 52.6 (49.9-55.4) for rofecoxib. Aceclofenac had a lower incidence of gastrointestinal bleeding, abdominal pain, and arterial hypertension than meloxicam and a lower incidence of gastrointestinal bleeding, abdominal pain, liver toxicity, thromboembolic cardiovascular events, arterial hypertension, and edema than rofecoxib. The incidence of total and gastrointestinal adverse reactions was significantly lower with aceclofenac than with meloxicam or rofecoxib, thus raising doubts about the hypothetical advantage of COX-2 selective inhibitors.

译文

目的是比较三种具有不同环加氧酶 (COX)-2选择性的非甾体抗炎药报告的不良反应发生率。世界卫生组织国际药物监测合作中心药物警戒数据库中的所有自发性不良反应通知均包括在上市第一年记录的醋氯芬酸,美洛昔康和罗非昔布。对于醋氯芬酸,总不良反应的发病率 (不良反应/10(6) 定义的每日剂量) 和95% 置信区间为8.7 (6.1-12.0),美洛昔康为24.8 (23.1-26.6),罗非昔布为52.6 (49.9-55.4)。与美洛昔康相比,醋氯芬酸的胃肠道出血,腹痛和动脉高血压的发生率较低,而胃肠道出血,腹痛,肝毒性,血栓栓塞心血管事件,动脉高血压和水肿的发生率低于罗非昔布。与美洛昔康或罗非昔布相比,醋氯芬酸的总和胃肠道不良反应发生率显着降低,因此对COX-2选择性抑制剂的假设优势产生了怀疑。

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