Oxymatrine therapy for chronic hepatitis B: A randomized double-blind and placebo-controlled multi-center trial

Abstract

AIM:To evaluate the efficacy and safety of capsule oxymatrine in the treatment of chronic hepatitis B. METHODS:A randomised double-blind and placebocontrolled 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 weeks, 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.

Heat Stress Cognate 70 Host Protein as a Potential Drug Target against Drug Resistance in Hepatitis B Virus

“…Antiviral agents working through this mechanism inhibit the replication of not only wild-type HBV, but also drugresistant mutants. Clinical studies have shown that injection of OMTR (0.4 g/day for 6 months) in CHB patients caused over 40% of the patients to become negative for HBV DNA (12), and viral-load measurement showed that OMTR injection (0.4 g/day for 3 months) decreased the HBV viral load by about 2 log units on average (4). The anti-HBV effect of OMTR in patients basically agrees with that described here in HepG2.2.15 cells, but with higher efficacy, because the HBV viral-load test in the clinical setting measures the de novo synthesized viruses in blood.…”

“…2b). The results were of great interest to us, because the compound has been used to treat viral hepatitis in China since the 1990s (3,4,12,24). However, its anti-HBV mechanism remains unclear.…”

Oxymatrine Ameliorates l-Arginine-Induced Acute Pancreatitis in Rats

“…It has been used to treat chronic hepatitis B patients in China for decades with confirmed safety [14]. Recent evidence has shown that oxymatrine possesses a wide variety of pharmacological effects, including anti-inflammatory, anti-apoptosis, anti-tumor, anti-hepatic fibrosis, and anti-arrhythmic functions [15][16][17][18][19].…”

A Review of Novel Non-Nucleoside Anti-HBV Agents and Their Mechanism of Action

“…Oxymatrine (Figure 6), an alkaloid from the herb Sophora alopecuraides L., was reported to exhibit anti-HBV effect in HBV transgenic mice [25,26] and patients with chronic HBV infection [27]. The antiviral mechanisms may be interfering with the reverse transcription process from pgRNA to DNA by destabilizing Hsc70 mRNA, and then inhibiting the replication of HBV [28].…”