Lingmao Formula Combined with Entecavir for HBeAg-Positive Chronic Hepatitis B Patients with Mildly Elevated Alanine Aminotransferase: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Table 2
Histological, virologic, serologic, and biochemical response at week 52.
End points
Treatment group ()
Control group ()
value
Necroinflammatory improvement*
22 (53.7)
13 (33.3)
0.076
Fibrosis improvement*
17 (41.5)
14 (35.9)
0.652
HBV DNA <1000 copies/mL by PCR assay
93 (68.4)
91 (67.4)
0.897
≥2 lg copies/mL reduction in HBV DNA compared to baseline
134 (98.5)
125 (92.6)
0.019
Mean change in HBV DNA from baseline by PCR assay (lg copies/mL)†
0.010
HBeAg loss
31 (22.8)
17 (12.6)
0.038
Undetectable HBV DNA and HBeAg loss
29 (21.3)
12 (8.9)
0.006
HBeAg seroconversion
19 (14.0)
15 (11.1)
0.583
Undetectable HBV DNA and HBeAg seroconversion
19 (14.0)
11 (8.1)
0.175
HBsAg loss
2 (1.5)
1 (0.7)
1.000
ALT normalization
106 (77.9)
106 (78.5)
1.000
A total of 80 patients had adequate baseline and liver-biopsy specimens at week 52 (41 patients in treatment group and 39 in control group). Values in parentheses are percentages unless indicated otherwise; †value was presented as mean ± standard deviation.
