| AECG Criteria | NIS Criteria | Weight/Score |
|---|---|---|
| Item | Item | – |
| I. Ocular symptoms | I. Ocular symptoms | 1 |
| II. Oral symptoms | II. Oral symptoms | 1 |
| III. Ocular signs: a. Schirmer’s I test b. Fluorescein vital staining |
III. Ocular signs: a. Schirmer’s I test b. Fluorescein vital staining |
1 2 (only count the higher score) |
| IV. Histopathology: LSGB | ||
| V. Oral sign: UWSF | IV. Oral sign: UWSF | 1 |
| VI. Autoantibodies: presence in the serum of the following autoantibodies: a. Positive anti-SSA or anti-SSB antibodies |
V. Autoantibodies a. Positive anti-SSA or anti-SSB or anti-RO52 antibodies b. ANA titre ≥1:160 (Speckeld pattern) or positive anti-centromere B antibodies and negative anti-dsDNA and anti-Sm antibodies |
2 1 (only count the higher score) |
| VI Addition item: existence of autoimmune thyroid disease | 2 | |
| Classification rules | Classification rules | |
| For PSS: Presence of any four of the six items with at least item IV or VI, or presence of any three of the four objective items (items III, IV, V and VI) | The total score is determined by adding the maximum weight (score) in each category. A. Patients with a score ≥5 are classified as having definite SS B. Patients with a score <4 were supposed to be excluded from SS C. Patients with a score of 4, LSGB was suggested. a. LSGB positive: definite SS b. LSGB negative: non-SS |
|
| For Secondary SS: In patients with a potentially associated disease, the presence of item I or item II plus any 2 from among items III, IV and V. | Eliminated the distinction between PSS and SSS | |
| Exclusion criteria | Exclusion criteria | |
| 1. Past head and neck radiation treatment 2. Hepatitis C infection 3. AIDS 4. Pre-existing lymphoma 5. Sarcoidosis 6. Graft versus host disease 7. Use of anticholinergic drugs (since a time shorter than 4-fold the half-life of the drug) |
Prior diagnosis of any of the following conditions would exclude 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. Hepatitis C infection 3. AIDS 4. Sarcoidosis 5. Amyloidosis 6. Graft versus host disease 7. IgG4-related disease |
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