Table 1.
Summary of demographics and characteristics at baseline of pSS patients.
| JieDuTongLuoShengJin granules + HCQ | Placebo + HCQ | p value | |
|---|---|---|---|
| Patients randomized, n | 20 | 20 | |
| Age (years) | 0.857 | ||
| Mean ± SD | 51.6 ± 11.28 | 52.3 ± 12.40 | |
| Median | 52 | 53 | |
| Range | (27, 69) | (24, 68) | |
| Gender, n (%) | 1.000 | ||
| Male | 0 (0.00) | 1 (5.00) | |
| Female | 20 (100.00) | 19 (95.00) | |
| Disease duration (years) | 0.989 | ||
| Mean ± SD | 5.6 ± 5.12 | 5.6 ± 3.65 | |
| Median (IQR) | 4.5 (2, 8.25) | 5 (3, 7.25) | |
| Range | (0.2, 20) | (0.5, 15) | |
| Dryness (0–10) | 0.907 | ||
| Mean ± SD | 5.7 ± 2.81 | 5.8 ± 2.55 | |
| Median (IQR) | 5.5 (3, 7.25) | 5.5 (4.75, 8) | |
| Fatigue (0–10) | 0.957 | ||
| Mean ± SD | 5.6 ± 3.22 | 5.7 ± 2.64 | |
| Median (IQR) | 5 (3.75, 8.25) | 5 (4, 7.25) | |
| Pain (0–10) | 0.678 | ||
| Mean ± SD | 2.7 ± 2.25 | 2.4 ± 2.50 | |
| Median (IQR) | 3 (0, 4) | 2 (0, 4) | |
| ESSPRI (0–10) | 0.939 | ||
| Mean ± SD | 4.7 ± 2.09 | 4.6 ± 1.99 | |
| Median (IQR) | 5 (2.7, 6.4) | 4.3 (3.8, 5.9) | |
| PASS, n (%) | 9 (45.00) | 11 (55.00) | 0.752 |
| PGA (0–10) | 0.624 | ||
| Mean ± SD | 5.4 ± 2.19 | 5.8 ± 2.29 | |
| Median (IQR) | 6 (3, 7) | 6 (4, 7) | |
| ESSDAI (0–124) | 0.655 | ||
| Mean ± SD | 2.6 ± 1.31 | 2.4 ± 1.31 | |
| Median (IQR) | 3 (1, 4) | 2 (1, 4) | |
| Salivary flow rate (ml/15 min) | 0.989 | ||
| Mean ± SD | 0.8 ± 0.70 | 0.7 ± 0.62 | |
| Median (IQR) | 0.8 (0.1, 1.0) | 0.7 (0.2, 1.0) | |
| Schirmer's test (left) (mm/5 min) | 0.224 | ||
| Mean ± SD | 4.5 ± 3.82 | 4.0 ± 4.66 | |
| Median (IQR) | 3.8 (2.0, 5.3) | 2.0 (1.0, 4.5) | |
| Schirmer's test (right) (mm/5 min) | 0.126 | ||
| Mean ± SD | 4.3 ± 3.01 | 3.2 ± 3.31 | |
| Median (IQR) | 4.0 (2.0, 6.3) | 2.0 (1.0, 4.0) | |
| BUT (Left) (second) | 0.140 | ||
| Mean ± SD | 3.6 ± 1.54 | 3.0 ± 1.69 | |
| Median (IQR) | 3.0 (3.0, 4.0) | 2.5 (2.0, 4.0) | |
| BUT (Right) (second) | 0.633 | ||
| Mean ± SD | 3.4 ± 1.57 | 3.2 ± 1.39 | |
| Median (IQR) | 3.0 (2.8, 3.3) | 3.0 (2.0, 4.0) | |
| van Bijsterveld score (Left) | 0.622 | ||
| Mean ± SD | 3.5 ± 1.88 | 3.2 ± 1.94 | |
| Median (IQR) | 4.0 (2.0, 5.0) | 3.0 (2.0, 4.0) | |
| van Bijsterveld score (Right) | 0.695 | ||
| Mean ± SD | 3.0 ± 1.69 | 3.2 ± 1.51 | |
| Median (IQR) | 3.0 (2.0, 4.0) | 3.0 (2.8, 4.0) | |
| IgG (g/L) | 0.596 | ||
| Mean ± SD | 18.3 ± 3.07 | 19.2 ± 6.91 | |
| Median (IQR) | 17.8 (16.4, 20.8) | 17.3 (14.3, 20.5) | |
| C3 (g/L) | 0.204 | ||
| Mean ± SD | 0.9 ± 0.20 | 0.8 ± 0.20 | |
| Median (IQR) | 0.9 (0.8, 1.0) | 0.9 (0.8, 1.0) | |
| C4 (g/L) | 0.071 | ||
| Mean ± SD | 0.2 ± 0.05 | 0.2 ± 0.05 | |
| Median (IQR) | 0.2 (0.2, 0.2) | 0.2 (0.1, 0.2) | |
| ESR (mm/h) | 0.871 | ||
| Mean ± SD | 35.9 ± 25.74 | 34.4 ± 31.83 | |
| Median (IQR) | 36.5 (14.3, 46.3) | 23.5 (18.0, 40.3) | |
| CRP (mg/L) | 0.756 | ||
| Mean ± SD | 3.4 ± 2.69 | 3.4 ± 2.81 | |
| Median (IQR) | 2.4 (2.1, 3.2) | 2.6 (1.7, 4.2) | |
| RF positive, n (%) | 9 (45.0) | 7 (35.0) | 0.748 |
| Autoantibodies | |||
| Anti-SSA | 14 (70.0) | 16 (80.0) | 0.716 |
| Anti-SSB | 4 (20.0) | 3 (15.0) | 1.000 |