Fifty-six subjects (46 females and 10 males) with signs of Sjögren's Syndrome (SS) have been evaluated for clinical and serological parameters. In 12 subjects such clinical signs were associated with a definite connective tissue disease (secondary SS): Rheumatoid Arthritis (2 cases), Systemic Lupus Erythematosus (4 cases), Progressive Systemic Sclerosis (4 cases), Essential Mixed Cryoglobulinemia (2 cases). All patients underwent a lip biopsy which was evaluated according to the Chisholm-Mason scale. Six out of 56 subjects (10.7%) had a normal salivary gland with few lymphocytes (class I); 5 (10%) had a scattered lymphoid infiltrate containing less than 1 focus/4 mm2 (class II); 36 (64.3%) had one focus/4 mm2 (class III) and, finally, 9 (16%) had more than 1 focus/4 mm2 (class IV). The great majority (91%) of the patients had some abnormalities at the ophthalmological examination (Schirmer test, Break up times, van Bijsterveld score): even those with a class I lip biopsy. Xerostomia was present in 69% of the patients, xerophthalmia in 78%, arthralgias in 78%, parotid swelling in 19%, Raynaud's phenomenon in 16%, recurrent abortion in 9 patients. The prevalence of autoantibodies in the group of primary SS was high: ANA 43.2%, anti-Ha 40%, anti-Ro 12%, anti-phospholipids 52.2%, rheumatoid factor (RF) 45.7%. A decrease of lysozyme concentration in tears and saliva has been demonstrated and a correlation between level of lysozyme and lip-biopsy has been observed.(ABSTRACT TRUNCATED AT 250 WORDS)