[Sustained efficacy of alpha-interferon therapy combined with Yixuesheng Capsule in treatment of chronic hepatitis B].
OBJECTIVE
To observe the difference between the combination therapy of alpha-interferon (IFN-alpha) therapy Yixuesheng Capsule and the monotherapy of IFN-alpha in treatment of chronic hepatitis B.


METHODS
A total of 288 patients with HBeAg-positive chronic hepatitis B proven by liver biopsy were included in this study. During the individualized therapy, they received hypodermic injection of IFN-alpha 1b, with 5 MU x time(-1) and three times x w(-1). Of them, 125 patients received combination therapy with Yixuesheng Capsule for three months, with 1.0 g/time and three times/d; and 163 patients received only IFN-alpha 1b (the IFN-alpha monotherapy group). After the course of therapy, all patients were followed up for at least 24 months. The intention-to-treat analysis was adopted for statistic analysis.


RESULTS
The two groups showed no statistical significance by gender, age, liver necroinflammation grading, liver fibrosis staging, serum ALT levels, serum HBV DNA levels and IFN-alpha therapy course. The whole course and the 24-month follow-up visit cover all of 112 patients in the combination treatment group and 141 cases in the IFN-alpha monotherapy group. The response rates of the combination treatment group and the IFN-alpha monotherapy group were 48.0% (60/125) and 35.0% (57/163) (x = 4.980, P = 0.026) at the end of treatment, respectively, 45.6% (57/125) and 33.1% (54/163) (x2 = 4.645, P =0.031) at the end of 12-month-follow-up period, respectively, and 38.4% (48/125) and 32.5% (53/163) (x2 = 1.076, P = 0.300) at the end of 24-month follow-up period, respectively.


CONCLUSIONS
The combination treatment with IFN-alpha and Yixuesheng Capsule shows a slightly better sustained efficacy on HBeAg-positive chronic hepatitis B patients compared with IFN-alpha monotherapy.
Hepatology Center, Xiamen Hospital of Traditional Chinese Medicine, Xiamen 361009, China.
Qianguo
Q
Mao
Yayong
Y
Su
Chuncheng
C
Wu
Zhicheng
Z
Duan
Jinmo
J
Tang
Chongi
C
Gu
Huiqing
H
Liang
Jiaen
J
Yang
Lijian
L
Huang
Ying
Y
Zheng
Min
M
Wang
Xianqiong
X
Gong
D000328:Adult; D002214:Capsules; D003131:Combined Modality Therapy; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D016896:Treatment Outcome
D002214:Capsules; D004365:Drugs, Chinese Herbal; D016898:Interferon-alpha; C544739:yixuesheng