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| I.
Ocular symptoms: 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 3 times a day? |
| II.
Oral symptoms: a positive response to at least one of
the following questions: |
| | 1. |
Have you had a daily feeling of dry mouth for more than
3 months? |
| | 2. | Have
you had recurrently or persistently swollen salivary glands
as an adult? |
| | 3. | Do
you frequently drink liquids to aid in swallowing dry
food? |
| III.
Ocular signs - that is, objective evidence of ocular involvement
defined as a positive result for at least one of the following
two tests: |
| | 1. | Shirmer's
test, performed without anaesthesia ( <= 5 mm in 5
minutes ) |
| | 2. | Rose
bengal score or other ocular dye score ( >= 4 according
to van Bijsterveld's scoring system ) |
| IV.
Histopathology: In minor salivary glands (obtained through
normal-appearing mucosa ) focal lymphocytic sialoadenitis,
evaluated by an expert histopathologist, with a focus
score >= 1, defined as a number of lymphocytic foci
(which are adjacent to normal-appearing mucous acini and
contain more than 50 lymphocytes) per 4 mm2
of glandular tissue .
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| V.
Salivary gland involvement: objective evidence of salivary
gland involvement defined by a positive result for at
least one of the following diagnostic tests: |
| | 1. | Unstimulated
whole salivary flow ( <= 1.5 ml in 15 minutes ) |
| | 2. | Parotid
sailography showing the presence of diffuse sialectasias
(punctate, cavitary,or destructive pattern ), without
evidence of obstruction in the major ducts. |
| | 3. | Salivary
scintigraphy showing delayed uptake, reduced concentration
and/or delayed excretion of tracer |
| VI.
Autoantibodies: presence in the serum of the following
autoantibodies: |
| | 1. | antibodies
to Ro(SSA) or La(SSB) antigens, or both |
| For
primary SS |
| | In
patients without any potentially associated disease, primary
SS may be defined as follows: |
| | a. | The
presence of any 4 of the 6 items is indicative of primary
SS, as long as either item ?(Histopathology) or ? (Serology)
is positive. |
| | b. | The
presence of any 3 of the 4 objective criteria items (that
is, items III, IV, V, VI) |
| For
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 may be considered as indicative of secondary
SS |
| Exclusion
criteria: |
| | Past
head and neck radiation treatment |
| | Hepatitis
C infection |
| | Acquired
immunodeficiency disease (AIDS) |
| | Pre-existing
lymphoma |
| | Sarccoidosis |
| | Graft
versus host disease |
| | Use
of anticholinergic drugs (since a time shorter than 4-fold
life of the drug) |
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