Walker Chris, Essex Margaret N, Li Chunming, Park Peter W
Pfizer Ltd, Walton-on-the-Hill, UK
Pfizer Inc., New York, NY, USA.
J Int Med Res. 2016 Jun;44(3):483-95. doi: 10.1177/0300060516628704. Epub 2016 Mar 15.
To compare the efficacy and safety of two different doses of celecoxib and diclofenac in the treatment of Norwegian patients with ankylosing spondylitis.
In this 12-week, double-blind, non-inferiority trial patients were randomized to 200 mg once daily (qd) celecoxib, 400 mg qd celecoxib, or 50 mg three times daily (tid) diclofenac. The primary objective compared patients' assessments of Global Pain Intensity, measured on a visual analogue scale.
A total of 330 patients were randomized (200 mg celecoxib, n = 107; 400 mg celecoxib, n = 108; diclofenac, n = 115). Least squares mean changes in Global Pain Intensity at 12 weeks were -25.8 mm, -30.6 mm and -28.2 mm, respectively. Both celecoxib treatment groups were non-inferior to diclofenac. More patients in the 400 mg celecoxib group met the Assessments in Ankylosing Spondylitis 20 responder criteria at Week 12 (60.2%) than in the celecoxib 200 mg (51.4%) and the diclofenac 50 mg (57.4%) groups. Adverse events were mild-to-moderate in severity, with dyspepsia and diarrhoea the most commonly reported.
Celecoxib and diclofenac both provided pain reduction, in addition to improvements in disease activity and functional capacity, in patients with ankylosing spondylitis.
比较两种不同剂量的塞来昔布和双氯芬酸治疗挪威强直性脊柱炎患者的疗效和安全性。
在这项为期12周的双盲、非劣效性试验中，患者被随机分为每日一次200毫克（qd）塞来昔布组、每日一次400毫克塞来昔布组或每日三次50毫克（tid）双氯芬酸组。主要目的是比较患者通过视觉模拟量表对总体疼痛强度的评估。
共有330例患者被随机分组（200毫克塞来昔布组，n = 107；400毫克塞来昔布组，n = 108；双氯芬酸组，n = 115）。12周时总体疼痛强度的最小二乘均值变化分别为-25.8毫米、-30.6毫米和-28.2毫米。两个塞来昔布治疗组均不劣于双氯芬酸组。在第12周时，400毫克塞来昔布组达到强直性脊柱炎评估20反应标准的患者（60.2%）比200毫克塞来昔布组（51.4%）和50毫克双氯芬酸组（57.4%）更多。不良事件严重程度为轻至中度，最常报告的是消化不良和腹泻。
对于强直性脊柱炎患者，塞来昔布和双氯芬酸除了能改善疾病活动度和功能能力外，还能减轻疼痛。
