Patient selection: overt dry symptoms
Definite Sjogren's Syndrome - 2 or more of the following:
(1) keratoconjunctivitis sicca of unknown etiology
(2) Histology of lacrimal or salivary glands shows 2 or more lesions with >= 50 mononuclear cells around an intralobular duct (focus score > 1).
(3) The sialogram shows diffuse nodular or globular shadows with a diameter more than 1 mm diffusely in lobules.
Possible Sjogren's Syndrome - 2 or more of the following:
(1) keratoconjunctivitis sicca of unknown etiology
(2) decreased salivary gland secretion
(3) recurrent or chronic salivary gland swelling of unknown etiology
Criteria for definite keratoconjunctivitis sicca - 1 or both of the following:
(1) positive Rose-Bengal test (2+ or more) and positive Schirmer's test (less than 10 mm in 5 minutes)
(2) positive Rose-Bengal test (2+ or more) and positive fluorescent dye test
Criteria for suspected keratoconjunctivitis sicca - 1 or both of the following:
(1) positive Rose-Bengal test (1+) and positive Schirmer's test (less than 10 mm in 5 minutes)
(2) positive Rose-Bengal test (1+) and positive fluorescent dye test
where:
• "Unknown etiology" implies that the patient does not have another autoimmune disease.
• While there is some overlap in the first criterion, the second and third in each group do not overlap. Situations could arise where only #2 or #3 of the definite group and one of the items of the possible group would be present. It would seem that these also should be included in the possible group.
• The criteria do not include serologic test results.
