PRELIMINARY CRITERIA FOR THE CLASSIFICATION OF SJOGRENS-SYNDROME - RESULTS OF A PROSPECTIVE CONCERTED ACTION SUPPORTED BY THE EUROPEAN COMMUNITY
PRELIMINARY CRITERIA FOR THE CLASSIFICATION OF SJOGRENS-SYNDROME - RESULTS OF A PROSPECTIVE CONCERTED ACTION SUPPORTED BY THE EUROPEAN COMMUNITY
复制标题
DOI：
10.1002/art.1780360309
复制
发表时间：
1993-03-01
影响因子：
--
通讯作者：
YOUINOU, P
中科院分区：
文献类型：
--
作者：
VITALI, C;BOMBARDIERI, S;YOUINOU, P
目标。对于干燥综合征(SS)，已经提出了不同的诊断标准，但没有一套标准在大量患者或多中心研究中得到验证。我们对来自12个国家(欧洲11个，加上以色列)的26个中心进行了本次研究，目的是就SS的诊断程序达成共识，并确定可用于流行病学调查和科学界采用的分类标准。研究方案分为两部分。对于第一部分，编制了关于眼部和口部受累的问卷，分别包括13个问题和7个问题。对于第二部分，选择了一组有限的诊断测试，并确定了执行这些测试时应遵循的确切程序。研究的第一部分包括240名原发SS患者和240名年龄和性别匹配的对照组。246例原发SS，201例继发性SS，113例结缔组织病但无SS相关。第二部分为对照研究，共133例。这项研究的结果是：(A)确认了一份简单的6项问卷，用于确定干眼症和口干症，该问卷在患者和对照组之间显示出良好的区分能力，用于干燥综合征的初步筛查；以及(B)定义了一套新的SS分类标准。此外，还确定了该标准在正确识别SS原发变异型或继发变异型患者方面的敏感性和特异性。利用这项前瞻性的多中心欧洲研究的结果，可以在SS患者的诊断程序上达成大致一致。SS初步分类标准的最终确认工作正在进行中。
Objective. Different sets of diagnostic criteria have been proposed for Sjogren's syndrome (SS), but none have been validated with a large series of patients or in a multicenter study. We conducted the present study involving 26 centers from 12 countries (11 in Europe, plus Israel), with the goals of reaching a consensus on the diagnostic procedures for SS and defining classification criteria to be used in epidemiologic surveys and adopted by the scientific community.Methods. The study protocol was subdivided into two parts. For part I, questionnaires regarding both ocular and oral involvement were developed; they included 13 questions and 7 questions, respectively. For part II a limited set of diagnostic tests was selected, and the exact procedure to be followed in performing these tests was defined. Part I of the study included 240 patients with primary SS and 240 age- and sex-matched controls. Two hundred forty-six patients with primary SS, 201 with secondary SS, 113 with connective tissue diseases but without associated SS. and 133 control patients were studied in part II Results. The study resulted in (a) the validation of a simple 6-item questionnaire for determination of dry eyes and dry mouth, which showed good discriminant power between patients and controls, to be used in the initial screening for sicca syndrome; and (b) the definition of a new set of criteria for the classification of SS. The sensitivity and specificity of the criteria in correctly identifying patients with either the primary or the secondary variant of SS were also determined.Conclusion. Using the findings of this prospective multicenter European study, general agreement can be reached on the diagnostic procedures to be used for patients with SS. Final validation of the preliminary classification criteria for SS is underway.