Nadarajah A, Abrahan L, Lau F L, Hwang L J, Fakir-Bolte C
Armed Forces Hospital, Kem Terendak, Malacca 76200, Malaysia.
Singapore Med J. 2006 Jun;47(6):534-42.
Cyclooxygenase (COX)-2 selective inhibitors are attractive candidates for treatment of ankle sprain because of their efficacy as anti-inflammatory and analgesic agents and their overall safety, including lack of effect on platelet aggregation. The objective of this study was to assess the efficacy and tolerability of celecoxib compared with diclofenac slow release (SR) in the treatment of acute ankle sprain in an Asian population.
In this seven-day, multicentre, double-blind, randomised, parallel-group trial, 370 patients with first- or second-degree ankle sprain occurring at or less than 48 hours prior to the first dose of study medication were randomised to receive celecoxib 200 mg bid (189 patients) after a 400 mg loading dose or diclofenac SR 75 mg bid (181 patients). Patients were required to demonstrate moderate to severe ankle pain on weight bearing (45 mm or greater on a 100 mm visual analogue scale [VAS]) at baseline. The primary efficacy end point was the patient's assessment of ankle pain (VAS on full weight bearing) on day 4.
Celecoxib was as effective as diclofenac SR in improving the signs and symptoms of ankle sprain. At day 4, mean VAS scores for celecoxib and diclofenac SR had decreased to 28 mm and 30 mm, respectively. Treatment differences were not statistically significant. Incidence of upper gastrointestinal adverse events was low in both treatment groups (0.5 percent versus 2.2 percent for celecoxib and diclofenac SR, respectively).
Celecoxib, a COX-2 selective inhibitor, is as effective as diclofenac SR in treating ankle sprains. With its platelet-sparing properties, celecoxib may offer an advantage over diclofenac SR in managing musculoskeletal injuries.
环氧化酶(COX)-2选择性抑制剂因其具有抗炎和止痛作用以及总体安全性(包括对血小板聚集无影响),成为治疗踝关节扭伤的有吸引力的候选药物。本研究的目的是评估在亚洲人群中,塞来昔布与双氯芬酸缓释剂(SR)相比治疗急性踝关节扭伤的疗效和耐受性。
在这项为期7天的多中心、双盲、随机、平行组试验中,370例在首次服用研究药物前48小时内发生一度或二度踝关节扭伤的患者被随机分组,189例患者在给予400mg负荷剂量后接受塞来昔布200mg每日两次治疗,181例患者接受双氯芬酸SR 75mg每日两次治疗。患者在基线时需表现出负重时中度至重度踝关节疼痛(在100mm视觉模拟量表[VAS]上为45mm或更高)。主要疗效终点是患者在第4天对踝关节疼痛(完全负重时的VAS)的评估。
塞来昔布在改善踝关节扭伤的体征和症状方面与双氯芬酸SR效果相当。在第4天,塞来昔布和双氯芬酸SR的平均VAS评分分别降至28mm和30mm。治疗差异无统计学意义。两个治疗组的上消化道不良事件发生率均较低(塞来昔布和双氯芬酸SR分别为0.5%和2.2%)。
COX-2选择性抑制剂塞来昔布在治疗踝关节扭伤方面与双氯芬酸SR效果相当。由于其对血小板的保护特性,塞来昔布在处理肌肉骨骼损伤方面可能比双氯芬酸SR具有优势。