艾瑞昔布和塞来昔布对中轴脊柱关节炎疗效和安全性的随机双盲试验

A randomly double-bland study of efficacy and safety of imrecoxib and celecoxib in axial spondyloarthritis

目的观察艾瑞昔布和塞来昔布对中轴脊柱关节炎(ax-SpA)患者的疗效和安全性。方法本院风湿免疫科就诊的ax-SpA患者60例,诊断符合2009年ASAS推荐的ax-SpA分类标准。随机给予艾瑞昔布或塞来昔布200 mg,每日2次服用,分别于基线和12周记录患者巴氏强直性脊柱炎疾病活动指数(BASDAI)、巴氏强直性脊柱炎功能指数(BASFI)、患者总体评估、耳壁距、腰椎活动度、Schober试验、踝间距、前指地距、红细胞沉降率(ESR)、C反应蛋白(CRP)的变化和不良反应。加拿大脊柱关节炎研究协会评分系统(SPARCC)法对基线期、12周骶髂关节核磁共振进行评分。结果最终51例患者完成12周随访,其中艾瑞昔布组25例,塞来昔布组26例。12周时艾瑞昔布组与塞来昔布组患者在BASDAI、患者总体评估、腰椎活动度、Schober试验、踝间距、ESR和CRP方面均有改善(P<0.05)。艾瑞昔布组前指地距前后比较无显著差异(P>0.05),塞来昔布组前指地距有显著差异(P<0.05)。BASFI、耳壁距前后比较无显著差异(P>0.05)。两组间的不良反应发生率无显著差异(P>0.05)。随访12周两组患者SPARCC评分无显著差异(P>0.05)。结论选择性COX-2抑制剂治疗12周可改善ax-SpA患者疼痛、疾病活动、功能指标和炎症指标,艾瑞昔布与塞来昔布疗效相当。

AIM To observe the efficacy and safety of imrecoxib and celecoxib on patients with axial spondyloarthritis （ax-SpA）. METHODS A total of 60 cases of ax-SpA patients in our hospital were included in the study, who fufilled the ASAS recommendation of ax-SpA classification criteria and the following exclusion criteria. The patients were randomly assigned to receive imrecoxib 200 mg or celecoxib 200 mg twice daily. At baseline and week 12, BASDAI, BASFI, patients＇ global assessment, tragus-to-wall distance, lumbar side flexion, Schober test, finger to floor distance, inter-malleoar istance, ESR, CRP and adverse reactions were recorded. Radiographic scores were calculated by sacroiliac joint SPARCC score method at baseline and week 12. RESULTS Fifty-one patients completed 12 weeks of follow-up. There were 25 cases in the imrecoxib group and 26 cases in the celecoxib group. The patients of the imrecoxib group and celecoxib group were improved in the following aspects at week 12： BASDAI, patients＇ global assessment, lumbar spine mobility, the Schober test, ankle spacing, ESR and CRP （P 〈 0.05）. Tragus-to-wall in imrecoxib group had no statistical significance comparison with baseline （P 〉 0.05）, but tragus-to-wall in celecoxib group had significant difference （P 〈 0.05）. BASFI, ear wall spacing had no significant difference （P 〉 0.05）. Adverse drug reactions of two groups had no significant difference （P 〉 0.05）. Radiographic score （SPARCC score） in patients of the two groups wasn＇ t significant difference （P 〉 0.05）. CONCLUSION The patients with ax-SpA can expect to significant improvement in disease activity, functional paramaters and inflammatory markers when treated with selective COX-2 inhibitors for 12 week, and the efficacy of imrecoxib is not inferior to celecoxib.