两种剂量艾瑞昔布和塞来昔布对中轴脊柱关节炎疗效的随机对照研究

目的：观察两种选择性环氧化酶（Cyclooxygenase，COX）-2抑制剂艾瑞昔布和塞来昔布对中轴型脊柱关节炎（Axial Spondyloarthritis，ax-SpA）患者的疗效和不良反应。方法：某院风湿免疫科就诊的ax-SpA患者180例，诊断符合2009年ASAS推荐的ax-SpA分类标准；分别随机给予艾瑞昔布0.1，0.2 g或塞来昔布0.2 g，每天2次，主要疗效指标为12周末患者背痛视觉模拟评分（Visual Analogue Scale，VAS）总体评分，次要疗效指标包括Schober试验、Bath强直性脊柱炎病情活动指数（Bath Ankylosing Spondylitis Disease Activity Index，BASDAI）、Bath强直性脊柱炎功能指数（Bath Ankylosing Spondylitis Functional Index，BASFI）、ESR、CRP的变化和不良反应。结果：最终完成12周随访者168例，其中艾瑞昔布0.2 g·d^-1组55例，艾瑞昔布0.4 g·d^-1组57例，塞来昔布组56例。12周时与基线期相比，艾瑞昔布组与塞来昔布组患者背痛VAS总体评分、Schober试验、BASDAI评分、ESR、CRP均较基线期改善有统计学意义（P<0.05），艾瑞昔布0.4 g·d^-1和塞来昔布0.4 g·d^-1之间差异无统计学意义（P>0.05），患者背痛VAS总体评分、Schober试验、BASDAI评分优于艾瑞昔布0.2 g·d^-1组。随访12周3组患者不良反应发生均轻微可控。结论：艾瑞昔布0.4 g·d^-1和塞来昔布0.4 g·d^-1在ax-SpA治疗中具有相似的疗效和不良反应，在症状控制和功能改善方面均优于艾瑞昔布0.2 g·d^-1。

Comparison of two different dosages of imrecoxib combined with celecoxib against ax-SpA

OBJECTIVE To demonstrate the clinical efficacy and safety of the selective cyclooxygenase (COX)-2 inhibitor imrecoxib compared with celecoxib in subjects with axial spondyloarthritis (ax-SpA). METHODS A total of 180 patients with ax-SpA in a hospital, diagnosed as per 2009 ASAS recommended ax-SpA classification standard, were randomly given imrecoxib 0.1, 0.2 g or celecoxib 0.2 g, twice daily for 12 week. The primary efficacy endpoint was the change from baseline in global pain intensity on a visual analogue scale (VAS) at week 12. Secondary endpoints covered the Schober test, bath ankylosing spondylitis disease activity index (BASDAI), bath ankylosing spondylitis functional index (BASFI), ESR, CRP changes and adverse events. RESULTS A total of 168 patients finished the 12-week trial:imrecoxib 100 mg twice a day (n=55), imrecoxib 200 mg twice a day (n=57) and celecoxib 200 mg twice a day (n=56). The back pain VAS total score, Schober test, BASDAI score, BASFI score, ESR, CRP were improved significantly compared with baseline data in all imrecoxib groups and celecoxib groups (P<0.05). There was no difference between imrecoxib 0.4 g·d^-1 and celecoxib 0.4 g·d^-1 (P>0.05). Imrecoxib 0.2 g·d^-1 group was all inferior in back pain VAS total score, Schober test, BASDAI score and BASFI score (P<0.05).The side effects were mild and controllable. CONCLUSION Celecoxib and imrecoxib 200 mg twice a day has similar efficacy and side effects against ax-SpA, and the combination is more effectively than imrecoxib 0.2 g·d^-1 in symptom control and function improvement. Imrecoxib (either dose) and celecoxib are well tolerable.