Assessment of the European classification criteria for Sjogren's syndrome in a series of clinically defined cases: Results of a prospective multicentre study
Assessment of the European classification criteria for Sjogren's syndrome in a series of clinically defined cases: Results of a prospective multicentre study
复制标题
DOI：
10.1136/ard.55.2.116
复制
发表时间：
1996-02-01
影响因子：
27.4
通讯作者：
Nelson, M
中科院分区：
文献类型：
--
作者：
Vitali, C;Bombardieri, S;Nelson, M
目的：评价最近提出的干燥综合征（SS）的初步分类标准，该标准包括6个项目：I =眼部症状; II =口腔症状; III =干燥性角结膜炎的证据; IV =小涎腺活检的局灶性涎腺炎; V =唾液腺受累的仪器证据; VI =存在自身抗体。每个中心被要求提供5例原发性SS患者，5例继发性SS患者，5例结缔组织病（CTD）但无SS患者，以及5例对照（眼部或口腔特征可能模拟SS的患者）。初步的6个项目的分类标准集被应用到SS患者和非SS对照，和性能的标准的敏感性和特异性进行了test.Results-The标准集进行了测试，共278例（157 SS患者和121非SS对照）收集从16个中心在10个国家。在81名最初被归类为原发性SS的患者中，有79名患者至少存在标准集中的6个项目中的4个（将项目VI限制为Ro（SS-A）或La（SS-B）抗体的存在）（敏感性97.5%），但在121名非SS对照中仅7名（特异性94.2%）。当存在第I项或第II项加上标准集第III-V项中的任何两项被认为是继发性SS的指示时，百分之九十七点三（71/73）最初定义为患有这种疾病的患者和91.8% 49例无SS的CTD对照患者中有45例被正确分类。这项前瞻性研究证实了欧洲共同体研究小组最近提出的SS分类标准的高度有效性和可靠性。
Objective-To assess the recently proposed preliminary criteria for the classification of Sjogren's syndrome (SS) in a multicentre European study of a new series of clinically defined cases.Methods-The criteria included six items: I = ocular symptoms; II = oral symptoms; III = evidence of keratoconjunctivitis sicca; IV = focal sialoadenitis by minor salivary gland biopsy; V = instrumental evidence of salivary gland involvement; VI = presence of autoantibodies. Each centre was asked to provide five patients with primary SS, dive with secondary SS, five with connective tissue diseases (CTD) but without SS, and five controls (patients with ocular or oral features that may simulate SS). The preliminary six item classification criteria set was applied to both the SS patients and the non-SS controls, and the performance of the criteria in terms of sensitivity and specificity was tested.Results-The criteria set was tested on a total of 278 cases (157 SS patients and 121 non-SS controls) collected from 16 centres in 10 countries. At least four of the six items in the criteria set (Limiting item VI to the presence of Ro(SS-A) or La(SS-B) antibodies) were present in 79 of 81 patients initially classified as having primary SS (sensitivity 97.5%), but in only seven of 121 non-SS controls (specificity 94.2%). When the presence of item I or II plus any two of items III-V of the criteria set was considered as indicative of secondary SS, 97.3% (71 of 73) of the patients initially defined as having this disorder and 91.8% (45 of 49) of the control patients with CTD without SS were correctly classified.Conclusion-This prospective study confirmed the high validity and reliability of the classification criteria for SS recently proposed by the European Community Study Group.