I – Ocular symptoms (at least one of the following symptoms) Daily, persistent troublesome dry eyes for more than 3 months Recurrent sensation of sand or gravel in the eyes Use of tear substitutes more than 3 times per day |
II – Oral symptoms (at least one of the following symptoms) Daily feeling of dry mouth for more than 3 months Recurrent or persistent swollen salivary glands, as an adult Need to drink liquids to aid swallowing dry food |
III – Ocular signs (positive result from at least one of the
following tests) Schrimer's I test, performed without anesthesia (< 5 mm in 5 minutes) Rose Bengal score or other ocular dye score (> 4, according to van Bijstervald's scoring system) |
IV – Histopathology
In minor salivary glands – biopsied from normal-appearing mucosa – focal lymphocytic sialoadenitis, evaluated by an expert histopathologist, with a focus score > 1 (defined as the number of lymphocytic foci containing more than 50 lymphocytes, adjacent to normal-appearing mucous acini, per 4 mm2 of glandular tissue |
V – Salivary gland involvement (positive result from at least one
of the following tests) Unstimulated whole salivary flow (< 1.5 ml in 15 minutes) Parotid sialography showing the presence of diffuse sialectasias Salivary scintigraphy showing delayed uptake, reduced concentration, and/or delayed excretion of tracer |
VI – Autoantibodies (serum presence of the following
autoantibodies) Antibodies to Ro (SSA) or La (SSB), or both, in the serum |
Exclusion criteria Past head and neck radiation treatment; Hepatitis C infection; Acquired immunodeficiency syndrome; Pre-existing lymphoma or sarcoidosis; Graft versus host disease; Use of anticholinergic drugs |