Bushen Jianpi Formula Combined with Entecavir for the Treatment of HBeAg-Negative Chronic Hepatitis B: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Table 1
Demographics and baseline characteristics of the patients.
Characteristic
Treatment group (n = 271)
Control group (n = 272)
Age (years)†
42.36 ± 11.23
39.61 ± 12.40
0.631
Male, n (%)
188 (69.89)
162 (62.79)
0.31
Duration of illness (years)†
11.17 ± 6.22
10.7 ± 6.28
0.43
MTCT, n (%)
63 (23.42)
49 (18.99)
0.52
Family history, n (%)
99 (36.8)
82 (31.78)
0.29
Smoking, n (%)
25 (9.29)
26 (10.08)
0.78
Alcohol consumption, n (%)
38 (14.13)
28 (10.85)
0.534
BMI†
24.08 ± 14.98
24.06 ± 13.04
0.99
ALT (U/L)†
73.31 ± 15.42
72.65 ± 16.29
0.68
AST (U/L)†
49.51 ± 19.21
51.93 ± 20.08
0.31
HBsAg (lg IU/mL)†
3.15 ± 0.59
3.12 ± 0.67
0.87
HBV DNA (lg IU/mL)†
6.90 ± 1.31
6.84 ± 1.45
0.82
cccDNA (lg IU/mL)†
8.89 ± 3.22
9.10 ± 3.35
0.77
HBV genotypes
0.312
B
113 (42.8)
139 (48.4)
C
152 (56.5)
144 (50.2)
D
0 (0)
1 (0.3)
G
2 (0.7)
3 (1.0)
kPa score†
9.99 ± 6.97
10.16 ± 8.16
0.719
Grade of necroinflammation
0.733
G1
5 (5.7)
7 (7.7)
G1–2
0 (0)
1 (1.1)
G2
71 (80.7)
72 (79.1)
G2–3
2 (2.3)
1 (1.1)
G3
10 (11.4)
10 (11.0)
Stage of fibrosis
0.183
S0
1 (1.1)
0 (0.0)
S1
16 (18.2)
21 (23.3)
S1–2
1 (1.1)
2 (2.2)
S2
49 (55.7)
54 (60.0)
S2–3
1 (1.1)
1 (1.1)
S3
20 (22.7)
9 (10.0)
S4
0 (0.0)
3 (3.3)
Values in parentheses are percentages; †value is the mean ± standard deviation. ALT, alanine aminotransferase; AST, aspartate aminotransferase; BMI, body mass index; MTCT, mother-to-child transfection.
