摘要
目的观察选择性COX-2抑制剂艾瑞昔布和塞来昔布对中轴脊柱关节炎(ax—SpA)患者的疗效和不良反应,及其和骶髂关节影像学评分、血清DickoDff相关蛋白1(DKK1)水平之间的相关性。方法收集郑州大学第一附属医院风湿免疫科就诊的ax—SpA患者60例,采用单纯随机、双盲分组,给予艾瑞昔布或塞来昔布200mg,每天2次治疗,分别于基线、治疗4周、12周记录患者BASDAI评分、BASFI评分、患者总体评估、耳壁距、腰椎活动度、Schober试验、踝间距、前指地距、ESR、CRP的变化和不良反应;采用SPARCC评分系统对治疗前、治疗12周ax—SpA骶髂关节MRI进行评分;ELISA法检测治疗前、治疗12周血清DKK.1表达水平。正态分布的计量资料两者比较采用独立样本t检验。计量资料之间的相关性分析采用Pearson相关分析方法。结果最终完成12周随访者51例,其中艾瑞昔布组25例,塞来昔布组26例。4周和12周与治疗前相比,2组分别在BASDAI评分(F=1.69)、BASFI评分(F=0.43)、患者总体评估(F=12.51)、耳壁距(F=0.10)、腰椎活动度(F=0.23)、Schober试验(F=0.54)、踝间距(F=2.58)、前指地距(F=0.25)和ESR(F=0.65)均较治疗前改善(P〈0.05),但2组之间差异无统计学意义(P〉0.05);4周和12周时CRP在塞来昔布组较基线下降,艾瑞昔布组较治疗前升高(P〉0.05),2组之间差异无统计学意义(P>0.05)。随访12周2组患者不良反应发生率差异无统计学意义(P〉0.05)。艾瑞昔布组与塞来昔布组12周SPARCC评分较治疗前下降,但差异无统计学意义(P>0.05);2组患者血清中DKK-1水平呈下降趋势,差异无统计学意义(t=1.967,P=-0.064)。治疗前患者血清DKK-1水平与临床指标(BASDAI、BASFI、患者总体评估、耳壁距、腰椎活动度、Schober试验、前指地距、踝间距)、炎症指标(ESR、CRP)、SPARCC评分均相关不显著(t=1.815,P=0.085);治疗后塞来昔布组DKK-1水平与BASF1呈负相关(r=-0.048,P=0.027)、与Schober呈正相关(r=0.437,P=-0.048)。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;随访12周艾瑞昔布和塞来昔布对血清DKK-1水平无明显影响。
Objective To observe the therapeutic and side effects of the selective COX-2 inhibitor imrecoxib and celecoxib in patients with axial spondyloarthritis (ax-SpA), and explore the correlation with sacroiliac joint score and serum DKK1. Methods A total of 60 cases of axial spondyloarthritis (SPA) patients in the Rheumatism Immunity Branch of the First Affiliated Hospital of Zhengzhou University were included in the study. Patients were randomly assigned to receive 200 mg imrecoxib or 200 mg celecoxib twice daily. At the baseline, week 4 and week 12, the clinical parameters [Bath AS diseaseactivity index (BASDAD and Bath AS functional index (BASFI), patients global assessment, tragus-to-wall distance, lumbar side flexion, Schober test, finger to floor distance, inter-malleoar distance], inflammatory markers erythrocyte sedimentation rate (ESR), C reactive protein (CRP) and adverse reactions were recorded. Serum levels of DKK-1 and SPARCC scores of sacroiliac joint were investigated at baseline and week 12. Results Fifty-one patients were included in the analysis of clinical efficacy and safety at last. Patients of the imrecoxib group and the celecoxib group were improved in the following aspects at week 4: BASDAI (F=1.69), BASFI (F=0.43), patient global assessment (F=12.51), tragus-to-wall (F=0.10), lumbar side flexion (F=0.23), Schober test (F=0.54), front distance (F=2.58), inter-malleoar distance (F=0.25) and ESR (F=0.65) (P〈0.05), and the difference was not statistically significant corn-pared with baseline between the two groups (P〉0.05). At week 12, all clinical parameters and inflammatory markers were improved in the two group (P〈0.05) and the difference was not significant between the 2 groups (P〉0.05). The difference of adverse drug reactions in the two groups was not statistically significant (P〉0.05). The difference of radiographic score (SPARCC score) in patients of imrecoxib and celecoxib group from baseline to 12 weeks was not significant (t=1.967, P=0.064). The serum levels of DKK-1 was decreased and the difference was not statistically significant (t=1.815, P=0.085). Serum levels of DKK-1 in patients of the imrecoxib group at baseline was negatively correlated with all aspects. Serum levels of DKK-1 in the celecoxib group at baseline were correlated with BASFI (r=-0.048, P=0.027) and Schober test (r=0.437, P=- 0.048), but not correlated with other clinical parameters or inflammatory markers. Conclusion Patients with ax-SpA can have significant improvement in disease activity, functional parameters and inflammatory markers when treated with selective COX-2 inhibitors for 12 weeks, and the efficacy of imrecoxib is not inferior to celecoxib. Imrecoxib and celecoxib has no obvious effect on the serum level of DKK-1.
出处
《中华风湿病学杂志》
CAS
CSCD
北大核心
2016年第12期836-840,共5页
Chinese Journal of Rheumatology
基金
河南省高等学校重点科研项目(16A320011)
关键词
椎关节炎
环氧化酶-2
药理作用分子作用机制
Axial spondyloarthritis
Cyclooxygenase-2
Molecular mechanisms of pharmaclogical action