Background
Methods
Study population
Clinical and laboratory assessment
Histological assessment
The therapeutic schedule
Statistical analysis
Results
Base-line characteristics of patients
Variables | All patients (n = 123) | Normal ALT (n = 38) | Elevated ALT (n = 85) |
---|---|---|---|
Demographic characteristics | |||
Median age, years (range) | 35 (18–65) | 39 (23–61) | 33 (18–65) |
Males, n (%) | 85 (69.1) | 25 (65.8) | 60 (70.6) |
Laboratory data | |||
Median ALT, U/L (range) | 68.0 (5–483) | 24.5 (5–50) | 98 (51–483) |
Median AST, U/L (range) | 44.0 (15–323) | 23.0 (15–40) | 56 (27–323) |
HBeAg (+), n (%) | 66 (53.7) | 9 (23.7) | 57 (67.1) |
HBV DNA (mean ± SD), log10IU/ml | 5.99 ± 1.76 | 4.43 ± 1.79 | 6.67 ± 1.24 |
Liver histology | |||
Inflammation activity, n (%) | |||
G2, n (%) | 61 (87.1) | 20 (80.0) | 41 (91.1) |
G3, n (%) | 9 (12.9) | 5 (20.0) | 4 (8.9) |
Fibrosis (%) | |||
S1, n (%) | 22 (31.4) | 7 (28.0) | 15 (33.3) |
S2, n (%) | 37 (52.8) | 11 (44.0) | 26 (57.8) |
S3, n (%) | 11 (15.8) | 7 (28.0) | 4 (8.9) |
Biochemical improvement and virological and serological responses in patients after bicyclol treatment
variable | All patients (n = 123) | Normal ALT (n = 38) | Elevated ALT (n = 85) |
---|---|---|---|
ALT≤1 × upper limit of normal, n(%) | 107 (87.0) | 37 (97.4) | 70 (82.4) |
HBeAg loss, n(%) | 11 (16.7) | 2 (22.2) | 9 (15.8) |
HBV DNA (mean ± SD), log10IU/ml | |||
Pre-treatment | 5.99 ± 1.76 | 4.43 ± 1.79 | 6.67 ± 1.24 |
Post-treatment | 5.20 ± 1.77* | 4.23 ± 1.66 | 5.76 ± 1.59* |
Histological improvement
variables | Bicyclol group (n = 30) | ETV group (n = 30) |
---|---|---|
Inflammation activity, n (%) | ||
Inflammation improvement | 16 (53.3) | 19 (63.3) |
No change | 12 (40.0) | 10 (33.4) |
Inflammation progression | 2 (6.7) | 1 (3.3) |
Liver Fibrosis, n (%) | ||
Fibrosis improvement | 11 (36.7) | 13 (43.4) |
No change | 16 (53.3) | 16 (53.3) |
Fibrosis progression | 3 (10.0) | 1 (3.3) |
Related factors of improvement in liver inflammation after bicyclol treatment
Factor | I Improved n (%) | Not improved n (%) |
P
| Unadjusted OR (95%CI) |
---|---|---|---|---|
Treatment course of bicyclol (weeks) | 0.001 | 6.750 (2.300, 19.811) | ||
≥ 48 | 21 (70.00) | 9 (30.00) | ||
< 48 | 10 (25.00) | 30 (75.00) | ||
Age (years) | 0.211 | 2.639 (0.577, 12.064) | ||
≥ 50 | 5 (62.50) | 3 (37.50) | ||
< 50 | 24 (38.71) | 38 (61.29) | ||
Sex | 0.176 | 2.816 (0.705, 6.777) | ||
Female | 9 (56.25) | 7 (43.75) | ||
Male | 20 (37.04) | 34 (62.96) | ||
ALT (U/L) | 0.024 | 0.301 (0.107, 0.851) | ||
≥ 40 | 15 (31.91) | 32 (68.09) | ||
< 40 | 14 (60.87) | 9 (39.13) | ||
HBeAg | 0.184 | 1.923 (0.733, 5.043) | ||
Negative | 16 (50.00) | 16 (50.00) | ||
Positive | 13 (34.21) | 25 (65.79) | ||
HBV-DNA | 0.341 | 0.532 (0.146, 1.948) | ||
≥ 105 IU/mL | 23 (38.98) | 36 (61.02) | ||
< 105 IU/mL | 6 (54.55) | 5 (45.45) |
Factor | Wald Chi-square | P | Adjusted OR (95% CI) |
---|---|---|---|
Treatment course of bicyclol (≥48 weeks or < 48 weeks) | 9.517 | 0.002 | 5.756 (1.893,17.500) |
ALT (≥40 U/L or < 40 U/L) | 1.779 | 0.182 | 0.395 (0.101,1.546) |
HBeAg (negative or positive) | 0.480 | 0.489 | 1.519 (0.465,4.957) |
HBV-DNA (≥105 IU/mL or < 105 IU/mL) | 0.311 | 0.577 | 1.652 (0.283,9.648) |