Viral Hepatitis
Copyright ©The Author(s) 2004. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Nov 15, 2004; 10(22): 3269-3273
Published online Nov 15, 2004. doi: 10.3748/wjg.v10.i22.3269
Capsule oxymatrine in treatment of hepatic fibrosis due to chronic viral hepatitis: A randomized, double blind, placebo-controlled, multicenter clinical study
Yi-Min Mao, Min-De Zeng, Lun-Gen Lu, Mo-Bin Wan, Cheng-Zhong Li, Cheng-Wei Chen, Qing-Chuen Fu, Ji-Yao Wang, Wei-Min She, Xiong Cai, Jun Ye, Xia-Qiu Zhou, Hui Wang, Shan-Ming Wu, Mei-Fang Tang, Jin-Shui Zhu, Wei-Xiong Chen, Hui-Quan Zhang
Yi-Min Mao, Min-De Zeng, Lun-Gen Lu, Shanghai Institute of Digestive Disease, Renji Hospital, Shanghai Second Medical University, Shanghai 200001, China
Mo-Bin Wan, Cheng-Zhong Li, Changhai Hospital, Second Military Medical University, Shanghai 200433, China
Cheng-Wei Chen, Qing-Chuen Fu, Nanjing Military Command Liver Disease Research Center, Shanghai 200233, China
Ji-Yao Wang, Wei-Min She, Zhongshan Hospital, Fudan University, Shanghai 200032, China
Xiong Cai, Changzheng Hospital, Second Military Medical University, Shanghai 200003, China
Jun Ye, Shanghai Putuo District Central Hospital, Shanghai 200333, China
Xia-Qiu Zhou, Hui Wang, Ruijin Hospital, Shanghai Second Medical University, Shanghai 200025, China
Shan-Ming Wu, Mei-Fang Tang, Shanghai General Hospital of Infectious Diseases, Shanghai 200083, China
Jin-Shui Zhu, Wei-Xiong Chen, Shanghai No.6 People's Hospital, Shanghai 200230, China
Hui-Quan Zhang, Shanghai Shibei Hospital, Shanghai 200073, China
Author contributions: All authors contributed equally to the work.
Supported by Grants From the Key Project of Shanghai Medical Development Foundation, NO:99ZDI001 and Grants From 1999 Youth Liver Diseases Foundation of Chinese Liver Diseases Association
Correspondence to: Yi-Min Mao, M.D., Shanghai Institute of Digestive Disease, Renji Hospital, Shanghai Second Medical University, Shanghai 200001, China. maoyimin1@sina.com
Telephone: +86-21-33070834 Fax:+86-21-63364118
Received: December 17, 2003
Revised: February 4, 2004
Accepted: February 24, 2004
Published online: November 15, 2004
Abstract

AIM: 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.

CONCLUSION: Oxymatrine capsule is effective and safe in treatment of hepatic fibrosis due to chronic viral hepatitis.

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