A randomized controlled trial of kurorinone versus interferon‐α2a treatment in patients with chronic hepatitis B

Abstract

It has recently been shown that a Chinese traditional medicine, kurorinone, extracted from Sophora Flavescens Ait, possesses antiviral properties. We evaluated the efficacy and safety of kurorinone treatment in patients with chronic hepatitis B. Ninety-four patients with abnormal alanine transaminase (ALT) levels and hepatitis B e antigen (HBeAg) and/or hepatitis B virus (HBV) DNA-positivity were randomly assigned to receive either kurorinone 400 mg daily (45 patients) or 3 million units (MU) of interferon-alpha (IFN-alpha) (49 patients, daily for 1 month, every other day for 2 months) for 3 months. Patients were followed-up for 12 months. At baseline, both groups were comparable regarding age, gender and serological parameters. At the end of treatment, complete response (defined as ALT normalization and HBeAg and/or HBV DNA loss) occurred in 50% of the kurorinone group and in 61.3% of the IFN-alpha-treated group (P > NS). At the end of the 12-month follow-up period, a complete response (sustained response) occurred in 26.7-36.7% of kurorinone-treated patients with moderate or mild liver damage and in 44.4-46.7% of IFN-alpha-treated patients with similar liver injury. In kurorinone- as well as in IFN-alpha-treated patients, there was no statistical significant difference with respect to complete response rates between HBeAg-positive and hepatitis B e antibody-positive subgroups. Kurorinone had no untoward side-effects except for local pain at injection sites. The results of this trial suggest that kurorinone is able to inhibit HBV replication and improve disease remission in patients with chronic hepatitis B.

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

“…The results in The comparison of ALT normalization rate was performed with chi-square test, statistic was χ 2 . present study were similar to the therapeutic effect of interferon in the treatment of chronic hepatitis B at home and abroad [9,11,17,43] , indicating that capsule oxymatrine is an effective and safe agent for treatment of chronic hepatitis B.…”

“…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.…”

Dimeric Matrine-Type Alkaloids from the Roots of Sophora flavescens and Their Anti-Hepatitis B Virus Activities

“…1,2 The modern pharmacological studies showed that the extracts of S. flavescens displayed the anti-virus, anti-fungi, anti-inflammation, and anti-tumor effects. [3][4][5][6] Phytochemical investigations suggested that matrine-type alkaloids and flavonoids were the main components of this plant. [7][8][9][10][11][12][13][14][15] More than forty matrine-type alkaloids had been isolated from Sophora plants since 1895.…”

Quantitative Analysis of Matrine and Oxymatrine in Sophora flavescens Extract and Its Biopesticides by UPLC

“…Sophora flavescens is a traditional Chinese medicinal herb and has been used for anti-tumor, viral hepatitis and anti-arthritis [7]- [9]. Also, various bioactive compounds such as quinolizidine alkaloid, flavonoids, and saponin have been reported in S. flavescens [10]- [15].…”