Indications | FAS | PPS | ||||||
---|---|---|---|---|---|---|---|---|
TLHS 4.8 g | TLHS 3.6 g | TLHS 2.4 g | Placebo | TLHS 4.8 g | TLHS 3.6 g | TLHS 2.4 g | Placebo | |
Pain (VAS), cm, mean ± SD | 2.62 ± 1.37** | 3.31 ± 1.30** | 3.64 ± 1.29 | 3.99 ± 1.42 | 2.48 ± 1.30** | 3.24 ± 1.32* | 3.62 ± 1.30 | 3.89 ± 1.45 |
Pain changes, cm, mean ± SD | −3.06 ± 1.95** | −2.37 ± 1.31** | −1.85 ± 1.51 | −1.53 ± 1.70 | −3.31 ± 1.87** | −2.44 ± 1.25* | −1.88 ± 1.51 | −1.63 ± 1.74 |
Tender joint counts, n, mean ± SD | 3.88 ± 3.73** | 4.80 ± 3.24 | 4.24 ± 2.54* | 5.63 ± 4.10 | 3.96 ± 3.89 | 4.80 ± 3.38 | 4.19 ± 2.53 | 5.67 ± 4.32 |
Tender joint changes, n, mean ± SD | −5.24 ± 3.54** | −3.68 ± 3.19 | −3.12 ± 2.88 | −3.61 ± 3.51 | −5.66 ± 3.46 | −3.81 ± 3.24 | −3.21 ± 2.88 | −3.96 ± 3.54 |
Swollen joint counts, n, mean ± SD | 2.24 ± 2.09** | 2.68 ± 1.82 | 3.03 ± 1.88 | 3.41 ± 2.49 | 2.30 ± 2.13 | 2.56 ± 1.77 | 3.02 ± 1.90 | 3.31 ± 2.47 |
Swollen joint changes, n, mean ± SD | −4.03 ± 3.58* | −3.15 ± 2.48 | −2.17 ± 2.43 | −2.78 ± 2.96 | −4.38 ± 3.61* | −3.31 ± 2.43 | −2.30 ± 2.37 | −3.04 ± 3.01 |
Morning stiffness, min, mean ± SD | 36.53 ± 24.69** | 46.10 ± 26.57 | 50.14 ± 36.08 | 54.93 ± 41.78 | 35.00 ± 23.27** | 45.56 ± 27.29 | 50.14 ± 36.67 | 55.21 ± 44.38 |
Morning stiffness changes, min, mean ± SD | −45.51 ± 34.71 | −35.25 ± 21.40 | −33.17 ± 28.42 | −35.32 ± 42.23 | −50.09 ± 33.56 | −38.15 ± 19.96 | −33.81 ± 28.70 | −39.12 ± 43.33 |
Grip strength, mmHg, mean ± SD | 47.68 ± 28.59 | 38.80 ± 24.49 | 40.58 ± 26.27 | 38.84 ± 25.12 | 47.14 ± 29.13 | 36.00 ± 23.63 | 39.63 ± 26.22 | 36.99 ± 25.07 |
Grip strength changes, mmHg, mean ± SD | 11.57 ± 21.19** | 6.27 ± 7.07 | 5.51 ± 10.01 | 3.97 ± 8.53 | 12.32 ± 22.21** | 6.76 ± 6.98 | 5.70 ± 10.13 | 3.93 ± 8.75 |
Physician’s assessments, score, mean ± SD | 2.65 ± 1.40** | 3.32 ± 1.37 | 3.62 ± 1.34 | 3.79 ± 1.42 | 2.52 ± 1.34** | 3.24 ± 1.37 | 3.62 ± 1.36 | 3.68 ± 1.45 |
Physician’s assessments changes, score, mean ± SD | −2.67 ± 1.91** | −2.02 ± 1.36 | −1.45 ± 1.48 | −1.51 ± 1.65 | −2.92 ± 1.84** | −2.07 ± 1.30 | −1.46 ± 1.49 | −1.60 ± 1.71 |
HAQ, score, mean ± SD | 10.31 ± 9.91 | 12.69 ± 11.05 | 11.36 ± 9.64 | 12.92 ± 11.35 | 11.19 ± 10.06 | 12.89 ± 11.25 | 11.65 ± 9.67 | 13.60 ± 11.64 |
HAQ changes, score, mean ± SD | −6.37 ± 8.60 | −5.41 ± 6.98 | −4.03 ± 5.60 | −4.15 ± 7.90 | −6.89 ± 8.89 | −5.83 ± 7.13 | −4.18 ± 5.64 | −4.31 ± 8.13 |
RF, U/ml, mean ± SD | 122.61 ± 194.75 | 60.55 ± 99.04 | 90.35 ± 160.68 | 64.88 ± 102.79 | 129.88 ± 203.21 | 63.42 ± 104.21 | 93.28 ± 165.28 | 67.93 ± 109.24 |
CRP, mg/dl, median ± IQR | 12.63 ± 44.50 | 5.68 ± 10.62 | 5.48 ± 8.48 | 6.81 ± 15.15 | 14.05 ± 47.27 | 5.75 ± 11.03 | 5.78 ± 8.70 | 7.25 ± 16.20 |
ESR, mm/h, mean ± SD | 21.24 ± 21.91 | 21.32 ± 24.15 | 22.95 ± 20.24 | 23.25 ± 19.66 | 20.69 ± 21.89 | 21.39 ± 25.25 | 23.75 ± 20.42 | 24.26 ± 20.56 |
Joint functional stage, I : II : III | 22:37:0 | 14:44:1 | 16:40:3 | 20:37:2 | 21:32:0 | 14:39:1 | 16:38:3 | 19:32:1 |
Voltaren use : no use | 3:56** | 10:47** | 20:38** | 23:33 | 3:50** | 9:45** | 20:37 | 21:31 |
Frequency of Voltaren use, mean ± SD | 7.40 ± 8.08** | 17.80 ± 13.02** | 22.03 ± 17.11** | 39.32 ± 20.13 | 7.40 ± 8.08** | 17.63 ± 13.35** | 22.03 ± 17.11** | 39.29 ± 20.34 |
Leflunomide use : no use | 14:45 | 22:35 | 22:36 | 24:32 | 41:39 | 20:34 | 22:35 | 22:30 |