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首页> 外文期刊>Journal of International Medical Research >Efficacy and Safety of Celecoxib in the Treatment of Acute Pain due to Ankle Sprain in a Latin American and Middle Eastern Population
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Efficacy and Safety of Celecoxib in the Treatment of Acute Pain due to Ankle Sprain in a Latin American and Middle Eastern Population

机译:塞来昔布治疗拉丁美洲和中东人群脚踝扭伤引起的急性疼痛的疗效和安全性

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Ankle sprains are common acute soft-tissue injuries. This 7-day open-label, multicentre, randomized study compared the efficacy and safety of celecoxib with non-selective non-steroidal antiinflammatory drugs (NSAIDs) in treating acute ankle sprain with moderate-to-severe ankle pain in 278 patients. Patients received either celecoxib (400 mg loading dose followed by 200 mg twice daily) or standard doses of non-selective NSAIDs. The primary endpoint was a change in the patient's assessment of ankle pain on a 0 mm (no pain) ?100 mm (worst possible pain) visual analogue scale (VAS) at day 3 compared with baseline. From a baseline of 73 mm, mean VAS pain scores decreased to 29 and 32 mm in the celecoxib and non-selective NSAID groups, respectively. The lower limit of the 95% confidence interval for the treatment difference with regard to change from baseline was greater than the pre-established non-inferiority margin of ?10 mm. Using an initial loading dose, celecoxib was at least as efficacious as non-selective NSAIDs in treating acute pain due to ankle sprain.
机译:踝关节扭伤是常见的急性软组织损伤。这项为期7天的开放标签,多中心,随机研究比较了塞来昔布与非选择性非甾体抗炎药(NSAIDs)在治疗278例中度至重度踝关节疼痛的急性踝关节扭伤中的有效性和安全性。患者接受塞来昔布(400 mg负荷剂量,然后每天200 mg两次,两次)或标准剂量的非选择性NSAID。主要终点是与基线相比,患者在第3天的0毫米(无疼痛)≤100毫米(最可能的疼痛)视觉模拟量表(VAS)评估踝关节疼痛的变化。塞来昔布和非选择性NSAID组的平均VAS疼痛评分从73 mm的基线分别降至29 mm和32 mm。与基线相比的变化,治疗差异的95%置信区间的下限大于预先确定的非劣效性余差10 mm。使用初始负荷剂量,塞来昔布在治疗由于踝关节扭伤引起的急性疼痛方面至少与非选择性NSAID一样有效。

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