Table 1.
Demographic and SS-related phenotypic characteristics among 1208 participants enrolled in the SICCA Registry as of September 15, 2008.
| Characteristics | |||||
|---|---|---|---|---|---|
| Sources of complete baseline enrollments: | N | (%)1 | |||
| Argentina | 221 | (18) | |||
| China | 236 | (20) | |||
| Denmark | 231 | (19) | |||
| Japan | 184 | (15) | |||
| United Kingdom (since May 2007) | 55 | (5) | |||
| United States | 281 | (23) | |||
| Gender: | |||||
| Women | 1116 | (93) | |||
| SS-related characteristics: | |||||
| Symptoms of: | dry mouth | 1093 | (91) | ||
| dry eyes | 1025 | (85) | |||
| both dry mouth and eyes | 960 | (80) | |||
| Positive serum: | anti-SS-A (Ro) | 456 | (39) | ||
| anti-SS-B (La) | 289 | (25) | |||
| anti-SS-A and –B | 285 | (26) | |||
| rheumatoid factor | 468 | (40) | |||
| ANA ≥ 1:40 | 787 | (67) | |||
| Anti-Hepatitis C (repeatedly +) | 15 | (1) | |||
| Hypergammaglobulinema (IgG > 1445 mg/dL) | 484 | (41) | |||
| Unanesthetized Schirmer test ≤ 5 mm/5 min | 388 | (33) | |||
| Tear break-up time < 10 sec | 991 | (83) | |||
| Ocular staining score ≥ 3 (max of left and right2) | 869 | (72) | |||
| Unstimulated whole salivary flow < 0.5 ml/5 min | 666 | (55) | |||
| Labial salivary gland biopsy diagnosis results:3 | |||||
| Non-specific/sclerosing chronic sialadenitis | 409 | (34) | |||
| Granulomatous inflammation / within normal limits | 11 | (1) | |||
| Inadequate specimen | 26 | (2) | |||
| Focal lymphocytic sialadenitis4 (focus scores on N=740): | 762 | (63) | |||
| focus score > 1 | 500 | (68) | |||
| focus score = 1 | 27 | (4) | |||
| focus score < 1 | 213 | (29) | |||
| Continuous variables: | |||||
| Age, years (median and range) | 54 (21–90) | ||||
| Unstimulated whole salivary flow rate (UWS): (ml/5 min) (median and 25th – 75th percentile) |
0.42 (0.13 – 0.93) | ||||
| Stimulated parotid flow (PFR): (ml/min) (median and 25th – 75th percentile) |
0.12 (0.03 – 0.26) | ||||
1
Denominators may vary due to missing observations (< 3%) for some variables
2
Ocular surface staining is assessed by fluorescein staining of the cornea and lissamine green staining of the interpalpebral conjunctivae and scored by a system in which ≥3 represents the presence of keratoconjunctivitis sicca. Details and results of these examinations will be published elsewhere.
3
Details of the histopathological examination and further analyses of the labial salivary gland biopsy specimens will be published elsewhere.
4
Reference #12