Capsule oxymatrine in treatment of hepatic fibrosis due to chronic viral hepatitis: a randomized, double blind, placebo-controlled, multicenter clinical study.
OBJECTIVE
To evaluate the efficacy and safety of oxymatrine capsule in treatment of hepatic fibrosis in patients with chronic viral hepatitis.


METHODS
It was a randomized, double blind, placebo-controlled, multicenter clinical study. One hundred and forty-four patients were divided into oxymatrine capsule group(group A) and placebo group (group B). The course was 52 wk. Patients were visited once every 12 wk and the last visit was at 12 wk after cessation of the treatment. All patients had liver biopsy before treatment. part of them had a second biopsy at the end of therapy. Clinical symptoms, liver function test, serum markers of hepatic fibrosis were tested. Ultrasound evaluation was performed before, during and at the end of therapy.


RESULTS
One hundred and forty-four patients enrolled in the study. Of them 132 patients completed the study according to the protocol,49 patients had liver biopsy twice (25 patients in group A and 24 in group B). At the end of therapy, significant improvements in hepatic fibrosis and inflammatory activity based on Semi-quantitative scoring system (SSS) were achieved in group A. The total effective rate of the treatment was 48.00%, much higher than that of 4.17% in group B (P<0.05). Significant improvement in serum markers of hepatic fibrosis such as hyaluronic acid (HA) and type III procollagenic peptide (P III P) in group A was seen (P<0.05). The total effective rate of serum markers at the end of therapy in group A was 68.19%, much higher than that of 34.85% in group B (P<0.05). The total effective rate of noninvasive markers at the end of therapy in group A was 66.67%, much higher than that of 30.30% in group B (P<0.05). The rate of adverse events was similar in two groups.


CONCLUSIONS
Oxymatrine capsule is effective and safe in treatment of hepatic fibrosis due to chronic viral hepatitis.
Mao
Yi-Min
YM
Shanghai Institute of Digestive Disease, Renji Hospital, Shanghai Second Medical University, Shanghai 200001, China. maoyimin1@sina.com
Zeng
Min-De
MD
Lu
Lun-Gen
LG
Wan
Mo-Bin
MB
Li
Cheng-Zhong
CZ
Chen
Cheng-Wei
CW
Fu
Qing-Chuen
QC
Wang
Ji-Yao
JY
She
Wei-Min
WM
Cai
Xiong
X
Ye
Jun
J
Zhou
Xia-Qiu
XQ
Wang
Hui
H
Wu
Shan-Ming
SM
Tang
Mei-Fang
MF
Zhu
Jin-Shui
JS
Chen
Wei-Xiong
WX
Zhang
Hui-Quan
HQ
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000470:Alkaloids / Q000008:administration & dosage* / Q000009:adverse effects; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015415:Biomarkers; D002214:Capsules; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D006525:Hepatitis, Viral, Human / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008099:Liver / Q000473:pathology / Q000502:physiology; D008103:Liver Cirrhosis / Q000188:drug therapy / Q000473:pathology / Q000821:virology; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011807:Quinolizines; D016896:Treatment Outcome; D000093842:Matrines
D000470:Alkaloids; D000998:Antiviral Agents; D015415:Biomarkers; D002214:Capsules; D010919:Placebos; D011807:Quinolizines; C037573:oxymatrine; D000093842:Matrines