Korean J Med > Volume 92(6); 2017 > Article |
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Exclusion criteria: past head and neck radiation treatment, hepatitis C infection, acquired immunodeficiency disease, preexisting lymphoma, sarcoidosis, graft versus host disease, and use of anticholinergic drugs (since a time shorter than 4-fold the half life of the drug); definition of primary Sjögren’s syndrome (SS): the presence of any 4 of the 6 items is indicative of primary SS, as long as either item IV (histopathology) or VI (serology) is positive, the presence of any 3 of the 4 objective criteria items (that is, items III, IV, V, VI); definition of secondary SS: in patients with a potentially associated disease (for instance, another well-defined connective tissue disease), the presence of item I or item II plus any 2 from among items III, IV, and V.
Item | Weight/score |
---|---|
Labial salivary gland with focal lymphocytic sialadenitis and focus score of ≥ 1 foci/4 mm2c | 3 |
Anti-SSA/Ro-positive | 3 |
Ocular Staining Score ≥ 5 (or van Bijsterveld score ≥ 4) in at least one eyed,e | 1 |
Schirmer’s test ≤ 5 mm/5 min in at least one eyed | 1 |
Unstimulated whole saliva flow rate ≤ 0.1 mL/mind,f | 1 |
a These inclusion criteria are applicable to any patient with at least one symptom of ocular or oral dryness, defined as a positive response to at least one of the following questions: (1) have you had daily, persistent, troublesome dry eyes for more than 3 months? (2) do you have a recurrent sensation of sand or gravel in the eyes? (3) do you use tear substitutes more than three times a day? (4) have you had a daily feeling of dry mouth for more than 3 months? (5) do you frequently drink liquids to aid in swallowing dry food? or in whom there is suspicion of SS from the European League Against Rheumatism SS Disease Activity Index questionnaire (at least one domain with a positive item).
b Exclusion criteria include prior diagnosis of any of the following conditions, which would exclude diagnosis of SS and participation in SS studies or therapeutic trials because of overlapping clinical features or interference with criteria tests: (1) history of head and neck radiation treatment, (2) active hepatitis C infection (with confirmation by polymerase chain reaction), (3) acquired immunodeficiency disease, (4) sarcoidosis, (5) amyloidosis, (6) graft-versus-host disease, (7) IgG4-related disease.
c The histopathologic examination should be performed by a pathologist with expertise in the diagnosis of focal lymphocytic sialadenitis and focus score count, using the protocol described by Daniels et al. [19].
d Patients who are normally taking anticholinergic drugs should be evaluated for objective signs of salivary hypofunction and ocular dryness after a sufficient interval without these medications in order for these components to be a valid measure of oral and ocular dryness.
e Ocular Staining Score described by Whitcher et al. [20]; van Bijsterveld score described by van Bijsterveld [21].
f Unstimulated whole saliva flow rate measurement described by Navazesh and Kumar [22].