Maksymowych W P, Mallon C, Morrow S, Shojania K, Olszynski W P, Wong R L, Sampalis J, Conner-Spady B
Department of Medicine, University of Alberta, Canada.
Ann Rheum Dis. 2009 Jun;68(6):948-53. doi: 10.1136/ard.2007.084244. Epub 2008 Jun 4.
Enthesitis is a recommended core domain for assessment of ankylosing spondylitis (AS), but no measurement has yet been validated according to Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) criteria.
The purpose of this study was to seek to validate an enthesitis index for patients with AS according to OMERACT criteria.
An enthesitis index was validated in two AS patient cohorts: (1) a longitudinal cohort (n = 223) and (2) 22 patients from three Canadian sites participating in a 24-week randomised placebo-controlled trial of adalimumab in AS. Construct validity was evaluated by correlation analysis with the Bath AS Disease Activity Index (BASDAI), the Bath AS Functional Index (BASFI) and quality of life instruments. Reproducibility was assessed by intraclass correlation coefficient (ICC), and responsiveness was assessed by Guyatt's effect size and standardised response mean.
The most frequently affected sites were the greater trochanter and supraspinatus insertion ( approximately 20%). Patients with enthesitis had significantly greater scores for the BASDAI, BASFI, patient global, AS-specific quality of life index (ASQOL) and the Short Form 36 (SF-36) General Health Survey (p<0.001). The enthesitis score contributed significantly to variance in the BASDAI and BASFI. Interobserver ICCs were 0.96 in the longitudinal cohort and 0.89 and 0.77 in the adalimumab clinical trial cohort (for status and change score, respectively). Significant differences in change scores were evident for all patients after 24 weeks of adalimumab treatment, (p = 0.04), this being more significant when a subset of the most commonly affected entheses were analysed (p = 0.01).
AS patients with enthesitis constitute a more severe subset of disease, and the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index is feasible and reliable for measurement of this condition. Discrimination requires further study in larger trials.
附着点炎是强直性脊柱炎（AS）评估推荐的核心领域，但尚无测量方法依据类风湿关节炎临床试验疗效指标（OMERACT）标准得到验证。
本研究旨在依据OMERACT标准验证一种AS患者的附着点炎指数。
在两个AS患者队列中验证附着点炎指数：（1）一个纵向队列（n = 223）和（2）来自加拿大三个地点参与AS患者阿达木单抗24周随机安慰剂对照试验的22例患者。通过与巴斯强直性脊柱炎疾病活动指数（BASDAI）、巴斯强直性脊柱炎功能指数（BASFI）及生活质量工具进行相关分析来评估结构效度。通过组内相关系数（ICC）评估可重复性，通过盖亚特效应量和标准化反应均值评估反应性。
最常受累的部位是大转子和冈上肌附着点（约20%）。有附着点炎的患者在BASDAI、BASFI、患者整体评估、AS特异性生活质量指数（ASQOL）和简明健康调查问卷36项（SF - 36）的总体健康测评中得分显著更高（p<0.001）。附着点炎评分对BASDAI和BASFI的变异有显著贡献。纵向队列中观察者间ICC为0.96，阿达木单抗临床试验队列中分别为0.89和0.77（分别针对状态和变化评分）。阿达木单抗治疗24周后，所有患者的变化评分有显著差异（p = 0.04），分析最常受累附着点的亚组时差异更显著（p = 0.01）。
有附着点炎的AS患者构成病情更严重的亚组人群，加拿大脊柱关节炎研究联盟（SPARCC）附着点炎指数用于测量该病情可行且可靠。鉴别能力需在更大规模试验中进一步研究。
