[Preliminary diagnostic criteria for primary Sjogren's syndrome in China]

Primary Sjogren's syndrome (pSS) is a common autoimmune connective tissue disease in China yet without a universally accepted diagnostic criteria. In this study a new criteria was proposed and compared with other six sets of criteria. Fifty-five items in 112 pSS and 185 controls were evaluated. Results show the criteria we proposed contained one major and nine minor items. For the purpose of identifying patients in clinical studies, a major with at least three of the nine minor items or at least five of the minor items should be presented. The major item is anti-SSA/SSB(+) and the minors are, (1) dry eyes or dry mouth (> 3 months, persistently), (2) swollen salivary glands (recurrently or persistently), (3) rampant dental caries, (4) Schirmer test (< 5 mm in 5 min.) or corneal staining(+), (5) unstimulated salivary flow (< 0.03 ml/min) or abornal parotid sialography, (6) minor salivary gland biopsy (> or = 1 focus), (7) renal tubular acidosis, (8) hypergammaglobuminemia (gamma globulin > or = 30%) or hypergammaglobuminemic purpura, (9) RF > 1 : 20 or ANA > 1 : 20. Other connective tissure diseases, pre-existing lymphoma, AIDS, sarcoidosis, graft vs host disease must be excluded. The criteria we proposed had a high specificity of 98.2% and sensitivity of 94.1%.