[Oxymatrine in the treatment of chronic hepatitis B for one year: a multicenter random double-blind placebo-controlled trial].
OBJECTIVE
To evaluate the efficacy and safety of oxymatrine in the treatment of chronic hepatitis B.


METHODS
A multicenter randomized double-blind placebo-controlled trial was conducted. A total of 144 patients with chronic hepatitis B entered the study for 52 weeks; of them 72 received oxymatrine, and 72 received a placebo. Before and after the treatment, clinical symptoms, liver function, serum hepatitis B virus markers, and adverse drug reactions were observed.


RESULTS
In 144 patients, 14 were dropped and excluded due to inconsistencies in the included standard. Therefore, the efficacy and safety of 130 patients were analyzed. After being treated for 52 weeks, 70.77% of the patients in the study group had a normal ALT level, and in 43.08% and 33.33% their HBV DNA and HBeAg became negative. In the placebo group, 39.68% had normal ALT level, and 12.31% and 3.33% had their HBV DNA and HBeAg become negative. The rates of complete response and partial response in the oxymatrine group were 23.08% and 58.46%, and in the placebo group they were 3.08% and 44.62%. They were significantly higher in the oxymatrine group than in the placebo group. In the oxymatrine treated patients, 12 weeks after its withdrawal, 60.00% had a normal ALT level, 41.54% and 23.33% had both HBV DNA and HBeAg negative. In the placebo group, 31.75% had a normal ALT level, 3.08% and 1.67% had both HBV DNA and HBeAg negative. The rates of complete response and partial response in the oxymatrine group were 21.54% and 47.69%, and in the placebo group they were 0 and 41.54%. They were significantly higher in the study group than in the placebo group. The adverse reaction rates of oxymatrine in the study and the placebo group were 7.69% and 6.15%, respectively, but there was no statistical significant difference between them.


CONCLUSIONS
Oxymatrine is an effective and safe agent for the treatment of chronic hepatitis B.
Lu
Lun-gen
LG
Shanghai Institute of Digestive Diseases, Renji Hospital, Shanghai Second Medical University, Shanghai 200001 China.
Zeng
Min-de
MD
Mao
Yi-min
YM
Wan
Mo-bin
MB
Li
Cheng-zhong
CZ
Chen
Cheng-wei
CW
Fu
Qing-chun
QC
Wang
Ji-yao
JY
She
Wei-min
WM
Cai
Xiong
X
Ye
Jun
J
Zhou
Xia-qui
XQ
Wang
Hiu
H
Wu
Shan-ming
SM
Tang
Mei-fang
MF
Zhu
Jin-shui
JS
Chen
Wei-xiong
WX
D000293:Adolescent; D000328:Adult; D000368:Aged; D000470:Alkaloids / Q000009:adverse effects / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011807:Quinolizines; D000093842:Matrines
D000470:Alkaloids; D000998:Antiviral Agents; D011807:Quinolizines; C037573:oxymatrine; D000093842:Matrines