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

发布时间：2018-08-07 15:49

【摘要】：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(P0.05),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(P0.05),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)。
[Abstract]:Aim: to observe the efficacy and side effects of two selective cyclooxygenase Cox-2 inhibitors, irixib and celecoxib, in the treatment of Axial Spondyloarthritis ax-spa. Methods: one hundred and eighty patients with ax-SpA from rheumatic immunology department in a hospital were diagnosed according to the ax-SpA classification standard recommended by ASAS in 2009, and were randomly given alexib 0.1g or celecoxib 0.2g, twice a day, respectively. The main outcome measures were visual analogue score of back pain (Visual Analogue scale) and total score of visual analogue score (VAS) in patients with back pain at the end of 12 weeks. The secondary curative effect indexes included the changes and adverse reactions of Schober test, (Bath Ankylosing Spondylitis Disease Activity index (Bath Ankylosing Spondylitis Disease Activity index), Bath ankylosing spondylitis function index (Bath Ankylosing Spondylitis Functional index, basic index) and adverse reactions (ADR) in patients with ankylosing spondylitis (ankylosing spondylitis), including Bath ankylosing spondylitis disease activity index (Bath Ankylosing Spondylitis Disease Activity index) and Bath ankylosing spondylitis (Bath Ankylosing Spondylitis Functional index). Results: a total of 168 cases were followed up for 12 weeks, including 55 cases in the Erexib 0.2 g d-1 group, 57 cases in the Erexib 0.4 g d-1 group and 56 cases in the celecoxib group at week 12 compared with the baseline period. The total score of VAS in patients with back pain and celecoxib group were significantly improved compared with baseline period (P0.05), but there was no significant difference between the two groups (P0.05). The VAS of patients with backache was not different from that of celecoxib 0.4 g d-1 (P0.05). The total score of Schober test was better than that of Erexib 0.2 g d-1 group. The adverse reactions in all the 3 groups were controlled at 12 weeks follow-up. Conclusion: the effects and side effects of erexib 0.4 g d-1 and celecoxib 0.4 g d-1 are similar in the treatment of ax-SpA, and are better than that of ERB 0.2 g d-1 in symptom control and functional improvement.
【作者单位】：郑州大学第一附属医院风湿免疫科河南省高等学校临床医学重点学科开放实验室;中国人民解放军304医院风湿免疫科;郑州大学第一附属医院药学部;
【基金】：河南省高等学校重点科研项目计划(编号:16A320011)
【分类号】：R593.2

【相似文献】