Objective : This study will examine the validity, sensitivity and specificity of Chinese diagnostic criteria for Sjogren's syndrome (SS) in comparison with Daniels-Talal's criteria (D-T cri-teria), European criteria, and Japanese criteria proposed by the Ministry of Health and Welfare of Japan.
Materials and Methods : Ninety-six cases fulfilling at least two of the above cited criteria comprised the SS patients' group. Nineteen cases that met at most one criterion were used as the controls' group. The validity of Chinese criteria was also examined in relation to findings of anti-SS-A/ B antibodies, in addition to comparative studies of sensitivity and specificity among the above four criteria.
Results : From sixty cases of primary SS, we found that the order of sensitivity was 100 % for Japanese criteria, 98.3 % for Chinese criteria, 98.3 % for European criteria, and 78.9 % for D-T criteria, which showed significantly lower sensitivity than the first three. In contrast, the specificity was 100% for Japanese criteria, 100 % for D-T criteria, 94.7 % for Chinese criteria, and 89.5 % for European criteria in the controls' group. When the primary SS patients fulfilled Chinese criteria were compared with controls, we found the former was significantly associated with Schirmer test, rose bengal staining, fluorescein staining, lower lip biopsy, gum test, rheumatoid factor (RF) positivity, hyperglobulinemia, renal failure, leukopenia and anemia. By investigating whether any clinical features of primary SS might correlate with presence of anti-SS-A or SS-B antibodies, we found the patients with anti-SS-A or SS-B antibodies showed significantly increased RF positivity and hyperglobulinemia, significantly decreased urinary abnormalities and renal failure compared with those in the seronegative group. A revision of the Chinese criteria to include the items of anti-SS-A or SS-B antibodies and tests of the lacrymal and salivary glands was proposed, and its sensitivity and specificity were 100 % in our cases.
Conclusion : Chinese criteria showed high sensitivity and specificity compared to the Japanese criteria. By studying of the combination of highly specific items, criteria that have not only fewer items but also higher sensitivity and specificity could be developed.
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