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系统性硬化症分类标准

发布者:鑫达医学翻译 发布时间:2012-09-13阅读:

题目:Validation of potential classification criteria for systemic sclerosis.
摘要
背景:
近期,美国风湿病学会(ACR)与欧洲抗风湿病联盟硬皮病试验研究组(EULAR)对系统性硬化症的分类标准进行了更新。该组织采用德尔菲法与名义群体技术将系统性硬化症分类的相关因子降至23项。本文对这些因子的表面效度、区别效度与构想效度予以评价。
方法:
患者样本获自加拿大硬皮病研究组、LUPUS数据库、以及匹兹堡、多伦多、马德里及柏林当地的结缔组织病数据库,并对因子的出现频率进行表面效度评估。将783名硬皮病患者与1071名疑似硬皮病患者进行比较。其中,系统性红斑狼疮患者499人,肌炎患者171人,干燥综合征患者95人,伴有雷诺现象患者228人,混合型结缔组织病患者29人,特发性肺动脉高压患者49人。利用比值比(OR)进行区别效度评估。采用经验评分与专家评分实施构想效度评估。
结果:
与疑似似患者相比,系统性硬皮病患者更易产生皮肤肥厚(OR=427)、毛细管扩张(OR=91)、抗核糖核酸聚合酶III抗体(OR=75)、手指浮肿(OR=35)、手指屈曲挛缩(OR=29)、腱/囊摩擦感(OR=27)、抗拓扑异构酶I抗体(OR=25)、雷诺现象(OR=24)、指尖溃疡/凹陷性疤痕(OR=19)、抗着丝点抗体(OR=14)、甲襞毛细血管异常(OR=10)、胃食管反流病(OR=8)、抗核抗体-钙质沉着-吞咽困难-食道扩张(OR=6)、间质性肺病/肺部纤维化(OR=5)、抗多发性肌炎/硬皮病抗体(OR=2)。肺一氧化碳弥散量降低、肺动脉高压降低、用力肺活量(FVC)降低比值比均低于2。疑似患者内未发现肾危象、指腹缺损/肢端骨质溶解,因此,未测定比值比。经验评分与专家评分相关(Spearman rho 0.53, p=0.01)。
结论:
候选因子的表面效度、区别效度与构想效度良好。后续研究仍需对进行性系统性硬皮病及疑似患者相关因子实施进一步筛选、排除。

OBJECTIVE: Classification criteria for systemic sclerosis (SSc; scleroderma) are being updated jointly by the American College of Rheumatology and European League Against Rheumatism. Potential items for classification were reduced to 23 using Delphi and nominal group techniques. We evaluated the face, discriminant, and construct validity of the items to be further studied as potential criteria.

METHODS: Face validity was evaluated using the frequency of items in patients sampled from the Canadian Scleroderma Research Group, 1000 Faces of Lupus, and the Pittsburgh, Toronto, Madrid, and Berlin connective tissue disease (CTD) databases. Patients with SSc (n = 783) were compared to 1,071 patients with diseases similar to SSc (mimickers): systemic lupus erythematosus (n = 499), myositis (n = 171), Sjögren's syndrome (n = 95), Raynaud's phenomenon (RP; n = 228), mixed CTD (n = 29), and idiopathic pulmonary arterial hypertension (PAH; n = 49). Discriminant validity was evaluated using odds ratios (ORs). For construct validity, empirical ranking was compared to expert ranking.

RESULTS: Compared to mimickers, patients with SSc were more likely to have skin thickening (OR 427); telangiectasias (OR 91); anti-RNA polymerase III antibody (OR 75); puffy fingers (OR 35); finger flexion contractures (OR 29); tendon/bursal friction rubs (OR 27); anti-topoisomerase I antibody (OR 25); RP (OR 24); fingertip ulcers/pitting scars (OR 19); anticentromere antibody (OR 14); abnormal nailfold capillaries (OR 10); gastroesophageal reflux disease symptoms (OR 8); antinuclear antibody, calcinosis, dysphagia, and esophageal dilation (all OR 6); interstitial lung disease/pulmonary fibrosis (OR 5); and anti-PM-Scl antibody (OR 2). Reduced carbon monoxide diffusing capacity, PAH, and reduced forced vital capacity had ORs of <2. Renal crisis and digital pulp loss/acroosteolysis did not occur in SSc mimickers (OR not estimated). Empirical and expert ranking were correlated (Spearman's ρ = 0.53, P = 0.01).

CONCLUSION: The candidate items have good face, discriminant, and construct validity. Further item reduction will be evaluated in prospective SSc and mimicker cases.
 


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