Viral Hepatitis
Copyright ©The Author(s) 2003. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Nov 15, 2003; 9(11): 2480-2483
Published online Nov 15, 2003. doi: 10.3748/wjg.v9.i11.2480
Oxymatrine therapy for chronic hepatitis B: A randomized double-blind and placebo-controlled multi-center trial
Lun-Gen Lu, Min-De Zeng, Yi-Min Mao, Ji-Qiang Li, Mo-Bin Wan, Cheng-Zhong Li, Cheng-Wei Chen, Qing-Chun 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
Lun-Gen Lu, Min-De Zeng, Yi-Min Mao, Ji-Qiang Li, 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-Chun Fu, Liver Disease Research Center, Nanjing Military Command, 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 200062, 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 the Key Project of Shanghai Medical Development Foundation (NO: 99ZDI001) and grants from 1999 Foundation of Chinese Liver Diseases Association for Yong Scholars
Correspondence to: Lun-Gen Lu, MD, Shanghai Institute of Digestive Disease, Renji Hospital, Shanghai Second Medical University, Shanghai 200001, China. lulungen@online.sh.cn
Telephone: +86-21-33070834 Fax: +86-21-63364118
Received: May 13, 2003
Revised: June 12, 2003
Accepted: June 19, 2003
Published online: November 15, 2003
Abstract

AIM: To evaluate the efficacy and safety of capsule oxymatrine in the treatment of chronic hepatitis B.

METHODS: A randomised double-blind and placebo-controlled multicenter trial was conducted. Injection of oxymatrine was used as positive-control drug. A total of 216 patients with chronic hepatitis B entered the study for 24 wk, of them 108 received capsule oxymatrine, 36 received injection of oxymatrine, and 72 received placebo. After and before the treatment, clinical symptoms, liver function, serum hepatitis B virus markers, and adverse drug reaction were observed.

RESULTS: Among the 216 patients, six were dropped off, and 11 inconsistent with the standard were excluded. Therefore, the efficacy and safety of oxymatrine in patients were analysed. In the capsule treated patients, 76.47% became normal in ALT level, 38.61% and 31.91% became negative both in HBV DNA and in HBeAg. In the injection treated patients, 83.33% became normal in ALT level, 43.33% and 39.29% became negative both in HBV DNA and in HBeAg. In the placebo treated patients, 40.00% became normal in ALT level, 7.46% and 6.45% became negative both in HBV DNA and in HBeAg. The rates of complete response and partial response were 24.51% and 57.84% in the capsule treated patients, and 33.33% and 50.00% in the injection treated patients, and 2.99% and 41.79% in the placebo treated patients, respectively. There was no significance between the two groups of patients, but both were significantly higher than the placebo. The adverse drug reaction rates of the capsule, injection and placebo were 7.77%, 6.67% and 8.82%, respectively. There was no statistically significant difference among them.

CONCLUSION: Oxymatrine is an effective and safe agent for the treatment of chronic hepatitis B.

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