艾瑞昔布和塞来昔布治疗中轴型脊柱关节炎的随机平行对照研究

Imrecoxib and Celecoxib for the Treatment of Axial Spondyloarthritis:A Randomized Double-blind Parallel Control Study

目的评价选择性环氧化酶2(cyclooxygenase-2,COX-2)抑制剂对中轴脊柱关节炎(axial spondyloarthritis,ax-Sp A)的疼痛、功能和骶髂关节磁共振影像学的影响。方法选取2014年10月至2015年9月本院就诊的ax-Sp A患者120例,采用单纯随机分组,分别服用塞来昔布或者艾瑞昔布0.2 g,每日2次,记录治疗前、治疗12周后的红细胞沉降率(erythrocyte sedimentation rate,ESR)、C反应蛋白(C-reaction protein,CRP)、Bath强直性脊柱炎疾病活动指数(Bath ankylosing spondylitis disease activity index,BASDAI)、Bath强直性脊柱炎功能指数(Bath ankylosing spondylitis functional index,BASFI)、加拿大脊柱关节炎研究协会评分系统(Spondyloarthritis Research Consortium of Canada,SPARCC)评分的变化。结果治疗12周后,完成随访的患者共116例,其中艾瑞昔布组57例,塞来昔布组59例,艾瑞昔布组与塞来昔布组治疗后ESR[(14.85±14.67)mmol/1 h vs.(20.58±18.90))mmol/1 h,P=0.027;(9.5±8.44))mmol/1h vs.(16.81±15.04))mmol/1 h,P=0.000]、BASDAI(3.22±1.80 vs.4.01±1.77,P=0.006;2.98±1.49 vs.4.19±1.66,P=0.000)和患者总体评估(3.67±2.07 vs.5.28±2.30,P=0.000;3.76±2.08 vs.5.55±2.00,P=0.000)均较治疗前降低,治疗前后比较差异具有统计学意义;Schober试验较治疗前升高,差异具有统计学意义(4.11±2.26 vs.3.75±2.05,P=0.034;4.59±2.78 vs.3.90±2.08,P=0.016);两组BASFI、耳壁距和腰椎侧弯度治疗前后的变化均无统计学意义(P>0.05),两组间相比各项指标治疗前后的变化差异均无统计学意义(P>0.05)。治疗前骶髂关节SPARCC评分11.40±12.85,治疗后SPARCC评分6.60±9.01,两者比较差异具有统计学意义(P<0.05),两组间SPARCC评分变化比较差异无统计学意义(P>0.05)。骶髂关节影像学的改变与ESR、BASFI和腰椎侧弯度的变化情况具有相关性,差异具有统计学意义(P<0.05)。结论艾瑞昔布和塞来昔布可以改善ax-Sp A的症状和功能、减轻骶髂关节炎症,两种药物疗效和不良反应相当。影像学改变和ESR的高低具有相关性。

Objective To study the effect of selective COX-2 inhibitor on the pain, function and sacroiliac joint magnetic resonance imaging evaluation of axial spondyloarthritis. Methods 120 patients with ax-spondyoarthritis from October 2014 to October 2015 in our hospital were randomly treated with celecoxib or Imrecoxib 0. 2 g, two times daily. The changes of ESR, CRP, BASDAI, BASFI, SPARCC score before and after 12 weeks of treatment were recorded. Results After 12 weeks of treatment, a total of 116 patients completed the follow-up , including 57 cases of Imrecoxib group and 59 cases of the celecoxib group. BASDAI （3.22 ± 1.80 vs. 4. 01 ± 1.77, P = 0. 006 ; 2.98 ± 1.49 vs. 4. 19 ± 1.66, P=0.000） andESR [ （14.85±14.67） mmol/1 h vs. （20.58±18.90） mmol/1 h, P=0.027; （9.5±8.44） mmol/1 h vs. （16.81±15.04） mmol/1 h, P=0. O00] and overall evaluation [ （3.67± 2.07） vs. （5.28±2.30）, P=0. 000; （3.76±2.08） vs. （5.55±2.00）, P=0. 000] were statistically significant lower after treatment, Schober test were statistically significantly increased compared to whose after treatment （4. 11±2.26 vs. 3.75±2.05, P=0.034; 4.59±2.78 vs. 3.90±2.08, P= 0. 016） , BASFI, wall to the ear and lumbar lateral curvature changes were not statistically significant （P〉0. 05）. The changes of indicators before and after treatment showed no significant difference between the two groups （P〉0.05）. Before the treatment the sacroiliac joint SPARCC score was 11.40 ± 12. 85, SPARCC score was 6.60 ± 9.01 after treatment, and the difference was statistically significant （P〈0.05）. There was no statistically significant differences between the two groups of the changes of SPARCC score （P〉0.05）. There was statistically significant correlation between the change of ESR, BASFI, lumbar lateral curvature of sacroiliac and joint inflammation （ P〈0.05 ）. Conclusions Imrecoxib and celecoxib can improve the symptoms and functions of ax-SpA, reduce the sacroiliac joint inflammation. There are no significant difference between the two drugs. Image changes and the level of ESR are correlated.