title: [Oxymatrine in the treatment of chronic hepatitis B for one year: a multicenter random double-blind placebo-controlled trial].
abstract: 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.
authors.affiliation: Shanghai Institute of Digestive Diseases, Renji Hospital, Shanghai Second Medical University, Shanghai 200001 China.
authors.forename: Lun-gen
authors.initials: LG
authors.lastname: Lu
authors.forename: Min-de
authors.initials: MD
authors.lastname: Zeng
authors.forename: Yi-min
authors.initials: YM
authors.lastname: Mao
authors.forename: Mo-bin
authors.initials: MB
authors.lastname: Wan
authors.forename: Cheng-zhong
authors.initials: CZ
authors.lastname: Li
authors.forename: Cheng-wei
authors.initials: CW
authors.lastname: Chen
authors.forename: Qing-chun
authors.initials: QC
authors.lastname: Fu
authors.forename: Ji-yao
authors.initials: JY
authors.lastname: Wang
authors.forename: Wei-min
authors.initials: WM
authors.lastname: She
authors.forename: Xiong
authors.initials: X
authors.lastname: Cai
authors.forename: Jun
authors.initials: J
authors.lastname: Ye
authors.forename: Xia-qui
authors.initials: XQ
authors.lastname: Zhou
authors.forename: Hiu
authors.initials: H
authors.lastname: Wang
authors.forename: Shan-ming
authors.initials: SM
authors.lastname: Wu
authors.forename: Mei-fang
authors.initials: MF
authors.lastname: Tang
authors.forename: Jin-shui
authors.initials: JS
authors.lastname: Zhu
authors.forename: Wei-xiong
authors.initials: WX
authors.lastname: Chen
mesh_terms: 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
chemical_list: D000470:Alkaloids; D000998:Antiviral Agents; D011807:Quinolizines; C037573:oxymatrine; D000093842:Matrines