Rheumatology Clinic, Department of Medical and Biological Sciences, Azienda Ospedaliero-Universitaria S Maria della Misericordia, Udine, Italy.
Ann Rheum Dis. 2011 Jul;70(7):1183-90. doi: 10.1136/ard.2011.150755. Epub 2011 May 13.
To develop preliminary classification criteria for the cryoglobulinaemic syndrome or cryoglobulinaemic vasculitis (CV).
Study part I developed a questionnaire for CV to be included in the formal, second part (study part II). Positivity of serum cryoglobulins was defined by experts as an essential condition for CV classification. In study part II, a core set of classification items (questionnaire, clinical and laboratory items, as agreed) was tested in three groups of patients and controls-that is, group A (new patients with the CV), group B (controls with serum cryoglobulins but lacking CV) and group C (controls without serum cryoglobulins but with features which can be observed in CV).
In study part I (188 cases, 284 controls), a positive response to at least two of three selected questions showed a sensitivity of 81.9% and a specificity of 83.5% for CV. This questionnaire was employed and validated in study part II, which included 272 patients in group A and 228 controls in group B. The final classification criteria for CV, by pooling data from group A and group B, required the positivity of questionnaire plus clinical, questionnaire plus laboratory, or clinical plus laboratory items, or all the three, providing a sensitivity of 88.5% and a specificity of 93.6% for CV. By comparing data in group A versus group C (425 controls), the same classification criteria showed a sensitivity 88.5% and a specificity 97.0% for CV.
Classification criteria for CV were developed, and now need validation.
为了制定冷球蛋白血症综合征或冷球蛋白血症血管炎（CV）的初步分类标准。
研究 I 部分制定了一个 CV 问卷，将包含在正式的第二部分（研究 II 部分）中。血清冷球蛋白阳性由专家定义为 CV 分类的必要条件。在研究 II 部分中，一组核心分类项目（问卷、临床和实验室项目，如同意）在三组患者和对照组中进行了测试，即 A 组（新的 CV 患者）、B 组（血清冷球蛋白阳性但缺乏 CV 的对照组）和 C 组（无血清冷球蛋白但具有 CV 可观察到的特征的对照组）。
在研究 I 部分（188 例，284 例对照）中，对三个选定问题中的至少两个问题的阳性反应对 CV 的敏感性为 81.9%，特异性为 83.5%。该问卷在研究 II 部分中进行了测试和验证，该部分包括 A 组 272 例患者和 B 组 228 例对照。通过汇集 A 组和 B 组的数据，最终的 CV 分类标准需要问卷阳性加上临床、问卷阳性加上实验室，或临床加上实验室项目，或所有三个项目，对 CV 的敏感性为 88.5%，特异性为 93.6%。通过比较 A 组与 C 组（425 例对照）的数据，相同的分类标准对 CV 的敏感性为 88.5%，特异性为 97.0%。
制定了 CV 的分类标准，现在需要验证。
