| |
|
I. OCULAR
SYMPTOMS |
| |
|
A positive
response to at least one of the three selected 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?
|
|
| |
|
II. ORAL
SYMPTOMS |
| |
|
A positive
response to at least one of the three selected questions:
| |
1. |
Have you had a
daily feeling of dry mouth for more than 3 months? |
| |
2. |
Have you had
recurrent or persistently swollen salivary glands as an adult? |
| |
3. |
Do you
frequently drink liquids to aid in swallowing dry food?
|
|
| |
|
III. OCULAR
SIGNS |
| |
|
Objective
evidence of ocular involvement defined as a positive result in at least one of
the following two tests:
| |
1. |
Schirmer's
test (≤5 mm in 5 minutes) |
| |
2. |
Rose bengal
score (≥4 according to van Bijsterveld scoring system)
|
|
| |
|
IV.
HISTOPATHOLOGY |
| |
|
A focus score
≥1 in a minor salivary gland biopsy specimen. (A focus is defined as an
agglomerate of at least 50 mononuclear cells; the |
| |
|
focus score is
defined by the number of foci in 4 mm2 of glandular tissue.)
|
| |
|
V. SALIVARY
GLAND INVOLVEMENT |
| |
|
Objective
evidence of salivary gland involvement defined by a positive result in at least
one of the following three diagnostic tests:
| |
1. |
Salivary
scintigraphy |
| |
2. |
Parotid
sialography |
| |
3. |
Unstimulated
salivary flow (≤1.5 mL in 15 minutes)
|
|
| |
|
VI.
AUTOANTIBODIES |
| |
|
Presence in
the serum of the following autoantibodies:
| |
1. |
Antibodies to
Ro (SSA) or La (SSB) antigens, or both
|
|
| |
|
RULES FOR
CLASSIFICATION |
| |
|
In patients
without any potentially associated disease, primary SS is diagnosed if
| |
1. |
4 of 6
criteria are met but including IV or VI |
| |
2. |
3 of 4 of
criteria III, IV, V, VI |
|
| |
|
For secondary
SS criteria, I or II plus any 2 of criteria III, IV, V should be met.
|
| |
|
EXCLUSION
CRITERIA |
| |
|
- Preexisting
lymphoma,
- acquired immunodeficiency syndrome,
- sarcoidosis,
- graft-versus-host
disease,
- past head and neck radiation treatment,
- use of anticholinergic drugs,
and
- hepatitis C
|
Referensi:
Cecil Medicine 23rd Edition (Saunders) 2008