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国际脊柱关节炎协会轴性脊柱关节炎分类标准的制定(第二部分):验证与最终选定

The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection.

作者信息

Rudwaleit M, van der Heijde D, Landewé R, Listing J, Akkoc N, Brandt J, Braun J, Chou C T, Collantes-Estevez E, Dougados M, Huang F, Gu J, Khan M A, Kirazli Y, Maksymowych W P, Mielants H, Sørensen I J, Ozgocmen S, Roussou E, Valle-Oñate R, Weber U, Wei J, Sieper J

机构信息

Med Klinik I, Charité, Campus Benjamin Franklin, Berlin, Germany.

出版信息

Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17.

DOI:10.1136/ard.2009.108233
PMID:19297344
Abstract

OBJECTIVE

To validate and refine two sets of candidate criteria for the classification/diagnosis of axial spondyloarthritis (SpA).

METHODS

All Assessment of SpondyloArthritis international Society (ASAS) members were invited to include consecutively new patients with chronic (> or =3 months) back pain of unknown origin that began before 45 years of age. The candidate criteria were first tested in the entire cohort of 649 patients from 25 centres, and then refined in a random selection of 40% of cases and thereafter validated in the remaining 60%.

RESULTS

Upon diagnostic work-up, axial SpA was diagnosed in 60.2% of the cohort. Of these, 70% did not fulfil modified New York criteria and, therefore, were classified as having "non-radiographic" axial SpA. Refinement of the candidate criteria resulted in new ASAS classification criteria that are defined as: the presence of sacroiliitis by radiography or by magnetic resonance imaging (MRI) plus at least one SpA feature ("imaging arm") or the presence of HLA-B27 plus at least two SpA features ("clinical arm"). The sensitivity and specificity of the entire set of the new criteria were 82.9% and 84.4%, and for the imaging arm alone 66.2% and 97.3%, respectively. The specificity of the new criteria was much better than that of the European Spondylarthropathy Study Group criteria modified for MRI (sensitivity 85.1%, specificity 65.1%) and slightly better than that of the modified Amor criteria (sensitivity 82.9, specificity 77.5%).

CONCLUSION

The new ASAS classification criteria for axial SpA can reliably classify patients for clinical studies and may help rheumatologists in clinical practice in diagnosing axial SpA in those with chronic back pain.

TRIAL REGISTRATION NUMBER

NCT00328068.

摘要

目的

验证并完善两组用于轴向型脊柱关节炎(SpA)分类/诊断的候选标准。

方法

邀请所有国际脊柱关节炎评估协会(ASAS)成员纳入年龄在45岁之前起病、持续时间超过或等于3个月的不明原因慢性背痛新患者。候选标准首先在来自25个中心的649例患者的整个队列中进行测试,然后在随机选取的40%的病例中进行完善,之后在其余60%的病例中进行验证。

结果

经诊断性检查,该队列中60.2%的患者被诊断为轴向型SpA。其中,70%的患者不符合改良纽约标准,因此被归类为“非放射学”轴向型SpA。候选标准的完善产生了新的ASAS分类标准,定义为:通过X线摄影或磁共振成像(MRI)显示骶髂关节炎,加上至少一项SpA特征(“影像学标准”),或者存在HLA-B27加上至少两项SpA特征(“临床标准”)。整套新标准的敏感性和特异性分别为82.9%和84.4%,仅影像学标准的敏感性和特异性分别为66.2%和97.3%。新标准的特异性远优于针对MRI修改后的欧洲脊柱关节病研究组标准(敏感性85.1%,特异性65.1%),略优于改良的Amor标准(敏感性82.9%,特异性77.5%)。

结论

新的ASAS轴向型SpA分类标准可在临床研究中可靠地对患者进行分类,并可能有助于风湿病学家在临床实践中诊断慢性背痛患者的轴向型SpA。

试验注册号

NCT00328068。

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